VOLUME 34 · ISSUE 3 · MARCH 2021
Visit AAN.com/Covid19 for the latest pandemic information and resources to support you and your crucial work.
PROPOSED SLATE OF AAN BOARD OF DIRECTORS NOMINEES ANNOUNCED Vote During Business Meeting on April 17 The AAN Nominations Committee, chaired by former President Terrence L. Cascino, MD, FAAN, has announced the slate of nominees for AAN officer and director positions for the 2021–2023 term. The slate of nominees will be presented to the voting membership for approval during the AAN’s 2021 Business Meeting on Saturday, April 17, from 4:00 p.m. to 5:00 p.m. ET during the virtual Annual Meeting. Members are encouraged to attend the Business Meeting and participate in this election and other matters, including reports from officers on the accomplishments of the AAN during 2020 and a review of the organizations’ fiscal health.
Jackson
Miyasaki
Benish
Flippen
For more information, contact Karen Kasmirski, Executive Assistant, at kkasmirski@aan.com. Continued on page 12
›
AAN Position Statement on COVID-19 Vaccinations Published
Early Annual Meeting Registration Savings End March 25
The AAN has published Position Statement: Covid-19 Vaccination to address questions and concerns around the COVID-19 vaccine.
March 25 is the last chance to save on registration for the virtual 2021 AAN Annual Meeting—coming straight to you no matter where you are in the world and without the worry of travel. Even though we can’t be together in April 17– April 22 person, the flexible, virtual format will make it easier than ever for us to come together in a new way to experience the excellent education, science, and community of the world’s top neurology meeting. Access sessions when it works for you—with on-demand content available for 30 days after the live event—and fulfill all the CME requirements you'll need for the year. Visit AAN.com/21AM today to secure the best rates.
The AAN has confidence in the clinical trials of two COVID-19 vaccines (Pfizer/BioNTech and Moderna) for vaccination from the SARS-CoV-2 virus and the Food and Drug Administration (FDA) data evaluation processes, which have been evidence-based, rigorous, and transparent, using well-established methods and principles to systematically review and rate evidence. The AAN supports the vaccination recommendations by the Centers for Disease Control Continued on page 39
25 2020 Annual Report Captures
Successes of Challenging Year
›
28 Experiential Learning Areas Offer Fun, Unconventional Learning Opportunities
Continued on page 24
35 Enhanced 2021 Neurology
Compensation and Productivity Survey Launches
›
Discover an oral therapy for your patients with relapsing forms of multiple sclerosis (MS)1…
ZEPOSIA—FOCUSED ON WHAT COUNTS ZEPOSIA was studied in the largest number of patients with RMS in 2 pivotal head-to-head trials against an active comparator (N=2659)2,3a:
POWERFUL Efficacy1a
Proven superior in reducing relapses vs Avonexc Proven superior in reducing GdE and T2 lesions vs Avonex
COMPARABLE
Safety Profile vs Avonex in Overall Incidence of Adverse Reactions1-3b Consistently low discontinuation rates vs Avonex Comparable rates of serious infections and malignancies vs Avonex
Study designs: SUNBEAM (1 year; N=1346) and RADIANCE (2 years; N=1313) were multicenter, randomized, double-blind, double-dummy, active treatment-controlled studies of daily oral ozanimod 0.46 mg (not approved for maintenance dose) or 0.92 mg vs weekly Avonex (interferon beta-1a), 30-μg intramuscular injection. Primary endpoint: ZEPOSIA reduced ARR vs Avonex by 48% at 1 year (0.18 vs 0.35, respectively) and by 38% at 2 years (0.17 vs 0.28, respectively). Secondary endpoints: ZEPOSIA reduced the number of new or enlarging T2 lesions by 48% at 1 year and by 42% at 2 years and reduced the number of GdE lesions vs Avonex by 63% at 1 year and 53% at 2 years. 9 of 10 patients showed no confirmed 3-month disability progression. There was no significant difference in 3-month confirmed disability between ZEPOSIA and Avonex.1-3 b Adverse reactions: Overall incidence of adverse reactions for ZEPOSIA vs Avonex at 1 year was 59.8% and 75.5%, respectively, and at 2 years was 74.7% and 83.0%, respectively. Across 2 head-to-head trials, the most common adverse reactions with an incidence of at least 2% in patients treated with ZEPOSIA and at least 1% greater than Avonex, respectively, were as follows: upper respiratory infection, 26% (vs 23%); hepatic transaminase elevation, 10% (vs 5%); orthostatic hypotension, 4% (vs 3%); urinary tract infection, 4% (vs 3%); back pain, 4%
a
The FIRST AND ONLY S1P With No First-Dose Observation Required1,4,5d
Full Prescribing Information for ZEPOSIA has NO FIRST-DOSE OBSERVATION required NO genetic testing required NO ophthalmic testing required for most patients6e
(vs 3%); hypertension, 4% (vs 2%); and abdominal pain upper, 2% (vs 1%). Data are not an adequate basis for comparison of rates between ZEPOSIA and the active control. Upper respiratory infection includes nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis. Hepatic transaminase elevation includes alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminase increased. Hypertension includes hypertension, essential hypertension, and orthostatic hypertension. Overall discontinuation rates for ZEPOSIA vs Avonex at 1 year were 6% and 8%, respectively, and at 2 years were 10% and 15%, respectively. Discontinuation rates due to adverse reactions for ZEPOSIA vs Avonex at 1 year were 2.9% and 3.6%, respectively, and at 2 years were 3.0% and 4.1%, respectively. Serious infections: The rate of serious infections at 1 year for ZEPOSIA was 1.1% vs 0.7% for Avonex and the rate at 2 years for ZEPOSIA was 0.9% vs 0.9% for Avonex. Malignancy rates: The rate of malignancies at 1 year for ZEPOSIA was 0.2% vs 0% for Avonex and the rate at 2 years for ZEPOSIA was 0.9% vs 0.5% for Avonex.1-3
Indication ZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
Contraindications: • Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization,
or Class III/IV heart failure or have a presence of Mobitz type II second or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial, unless the patient has a functioning pacemaker • Patients with severe untreated sleep apnea • Patients taking a monoamine oxidase (MAO) inhibitor
Please see Important Safety Information throughout and Brief Summary of full Prescribing Information.
A relapse was defined as the occurrence of new or worsening neurological symptoms persisting for more than 24 hours attributable to MS and immediately preceded by a relatively stable or improving neurological state of at least 30 days.2,3
c
Start at ZEPOSIAhcp.com
Before initiating treatment with ZEPOSIA, all patients require a recent CBC including lymphocyte count (within 6 months or after discontinuation of prior MS therapy), an ECG to check for preexisting conduction abnormalities, a recent liver function test (within 6 months), and consideration of current and prior medications, including vaccinations.1 Patients without a confirmed history of varicella (chickenpox) or without documented VZV vaccination should be tested for antibodies. If VZV or other live attenuated immunizations are required, administer at least 1 month prior to initiation.1 For patients with a history of uveitis or macular edema, an ophthalmic assessment is required.1 An up-titration scheme should be used to reach the maintenance dosage of ZEPOSIA, as a transient decrease in heart rate and atrioventricular conduction delays may occur.1
d
Diabetes mellitus and uveitis increase the risk of macular edema; patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation. A prompt ophthalmic evaluation is recommended if there is any change in vision while taking ZEPOSIA.1
e
ARR=annualized relapse rate; CBC=complete blood count; ECG=electrocardiogram; GdE=gadolinium enhancing; RMS=relapsing multiple sclerosis; S1P=sphingosine-1-phosphate; VZV=varicella-zoster virus.
IMPORTANT SAFETY INFORMATION (CONTINUED) Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA • Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA • Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
• Progressive Multifocal Leukoencephalopathy (PML) is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. No cases of PML were identified in active-controlled MS clinical trials with ZEPOSIA. PML has been reported in patients treated with S1P receptor modulators and other MS therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued • In clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immunemodulating therapies used for treatment of MS. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects • Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA
Discover an oral therapy for your patients with relapsing forms of multiple sclerosis (MS)1…
ZEPOSIA—FOCUSED ON WHAT COUNTS IMPORTANT SAFETY INFORMATION (CONTINUED)
Start at ZEPOSIAhcp.com
Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: • with significant QT prolongation • with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs • with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension • with a history of Mobitz type II second-degree or higher AV block, sick-sinus syndrome, or sinoatrial heart block Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIA in patients with history of significant liver disease Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated Macular edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended Severe Increase in Disability After Stopping ZEPOSIA: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA Most common Adverse Reactions (≥ 4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.
Please see Important Safety Information throughout and Brief Summary of full Prescribing Information. References: 1. ZEPOSIA. Prescribing information. Bristol Myers Squibb; 2020. 2. Comi G, Kappos L, Selmaj KW, et al; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11):1009-1020 and Suppl 1-26. doi:10.1016/S1474-4422(19)30239-X 3. Cohen JA, Comi G, Selmaj KW, et al; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021-1033 and Suppl 1-31. doi:10.1016/S1474-4422(19)30238-8 4. Gilenya. Prescribing information. Novartis Pharmaceuticals Corporation; 2019. 5. Mayzent. Prescribing information. Novartis Pharmaceuticals Corporation; 2019. 6. Marrie RA. Comorbidity in multiple sclerosis: implications for patient care. Nat Rev Neurol. 2017;13(6):375-382. doi:10.1038/ nrneurol.2017.33
ZEPOSIA® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company. All other trademarks are the property of their respective owners. © 2020 Bristol-Myers Squibb Company. All rights reserved. Printed in the USA. 08/20 US-ZEP-19-0074
ZEPOSIA® (ozanimod) capsules, for oral use The following is a Brief Summary; refer to full Prescribing Information for complete product information. 1
• Have the presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker [see Warnings and Precautions (5.2)]
INDICATIONS AND USAGE
ZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 2
DOSAGE AND ADMINISTRATION
2.1 Assessments Prior to First Dose of ZEPOSIA Before initiation of treatment with ZEPOSIA, assess the following: Complete Blood Count Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1)]. Cardiac Evaluation Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought [see Warnings and Precautions (5.2)]. Liver Function Tests Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.3)]. Ophthalmic Assessment In patients with a history of uveitis or macular edema, obtain an evaluation of the fundus, including the macula [see Warnings and Precautions (5.7)]. Current or Prior Medications • If patients are taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with ZEPOSIA [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. • Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction [see Warnings and Precautions (5.2) and Drug Interactions (7.2)]. Vaccinations Test patients for antibodies to varicella zoster virus (VZV) before initiating ZEPOSIA; VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with ZEPOSIA [see Warnings and Precautions (5.1) and Drug Interactions (7.3)]. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. 2.2 Dosing Information Maintenance Dosage After initial titration (see Treatment Initiation), the recommended maintenance dosage of ZEPOSIA is 0.92 mg taken orally once daily starting on Day 8. ZEPOSIA capsules should be swallowed whole and can be administered with or without food. Treatment Initiation Initiate ZEPOSIA with a 7-day titration, as shown in Table 1 [see Warnings and Precautions (5.2)]. Table 1: Dose Titration Regimen Days 1-4
0.23 mg once daily
Days 5-7
0.46 mg once daily
Day 8 and thereafter
0.92 mg once daily
2.3 Reinitiation of ZEPOSIA After Treatment Interruption If a dose of ZEPOSIA is missed during the first 2 weeks of treatment, reinitiate treatment using the titration regimen [see Dosage and Administration (2.2)]. If a dose of ZEPOSIA is missed after the first 2 weeks of treatment, continue with the treatment as planned. 4
CONTRAINDICATIONS
ZEPOSIA is contraindicated in patients who: • In the last 6 months, have experienced a myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure [see Warnings and Precautions (5.2)]
• Have severe untreated sleep apnea [see Warnings and Precautions (5.2)] • Are taking a monoamine oxidase (MAO) Inhibitor [see Drug Interactions (7.7)] 5
WARNINGS AND PRECAUTIONS
5.1 Infections Risk of Infections ZEPOSIA causes a mean reduction in peripheral blood lymphocyte count to 45% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues [see Clinical Pharmacology (12.2)]. ZEPOSIA may therefore increase the susceptibility to infections, some serious in nature. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. In Study 1 and Study 2, the overall rate of infections and rate of serious infections in patients treated with ZEPOSIA was similar to that in patients who received interferon (IFN) beta-1a (35% vs 34% and 1% vs 0.8%, respectively). ZEPOSIA increased the risk of viral upper respiratory tract infections, urinary tract infections, and herpes zoster [see Adverse Reactions (6.1)]. The proportion of patients who experienced lymphocyte counts less than 0.2 x 109/L was 3.3%. These values generally returned to greater than 0.2 x 109/L while patients remained on treatment with ZEPOSIA. After discontinuing ZEPOSIA 0.92 mg, the median time for peripheral blood lymphocytes to return to the normal range was 30 days, with approximately 90% of patients in the normal range within 3 months [see Clinical Pharmacology (12.2)]. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Because the elimination of ZEPOSIA after discontinuation may take up to 3 months, continue monitoring for infections throughout this period.
Herpes Viral Infection In Study 1 and Study 2, herpes zoster was reported as an adverse reaction in 0.6% of patients treated with ZEPOSIA 0.92 mg and in 0.2% of patients who received IFN beta-1a. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA (see Vaccinations below). Cryptococcal Infection Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with S1P receptor modulators. Physicians should be vigilant for clinical symptoms or signs of CM. Patients with symptoms or signs consistent with a cryptococcal infection should undergo prompt diagnostic evaluation and treatment. ZEPOSIA treatment should be suspended until a cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated. Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. PML has been reported in patients treated with S1P receptor modulators and other multiple sclerosis (MS) therapies and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants). Physicians should be vigilant for clinical symptoms or MRI findings that may be suggestive of PML. MRI findings may be apparent before clinical signs or symptoms. If PML is suspected, treatment with ZEPOSIA should be suspended until PML has been excluded by an appropriate diagnostic evaluation. If PML is confirmed, treatment with ZEPOSIA should be discontinued.
ZEPOSIA® (ozanimod) capsules, for oral use Prior and Concomitant Treatment with Anti-neoplastic, Immunosuppressive, or Immune-modulating Therapies In clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with anti-neoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for the treatment of MS. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. Antineoplastic, immune-modulating, or immunosuppressive therapies (including corticosteroids) should be co-administered with caution because of the risk of additive immune system effects during such therapy. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects. Vaccinations Patients without a healthcare professional-confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA, following which initiation of treatment with ZEPOSIA should be postponed for 4 weeks to allow the full effect of vaccination to occur. No clinical data are available on the efficacy and safety of vaccinations in patients taking ZEPOSIA. Vaccinations may be less effective if administered during ZEPOSIA treatment. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. Avoid the use of live attenuated vaccines during and for 3 months after treatment with ZEPOSIA. 5.2 Bradyarrhythmia and Atrioventricular Conduction Delays Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, an up-titration scheme should be used to reach the maintenance dosage of ZEPOSIA [see Dosage and Administration (2.2) and Clinical Pharmacology (12.2)]. ZEPOSIA was not studied in patients who had: • A myocardial infarction, unstable angina, stroke, TIA, or decompensated heart failure requiring hospitalization within the last 6 months • New York Heart Association Class III / IV heart failure • Cardiac conduction or rhythm disorders, including sick sinus syndrome, significant QT prolongation (QTcF > 450 msec in males, > 470 msec in females), risk factors for QT prolongation, or other conduction abnormalities or cardiac condition that in the opinion of the treating investigator could jeopardize the patient’s health • Other pre-existing stable cardiac conditions without clearance from a cardiologist • Severe untreated sleep apnea • A resting heart rate less than 55 beats per minute (bpm) at baseline Reduction in Heart Rate Initiation of ZEPOSIA may result in a transient decrease in heart rate. In Study 1 and Study 2, after the initial dose of ZEPOSIA 0.23 mg, the greatest mean decrease from baseline in heart rate of 1.2 bpm occurred at Hour 5 on Day 1, returning to near baseline at Hour 6. With continued up-titration, the maximal heart rate effect of ozanimod occurred on Day 8. The utility of performing first-dose cardiac monitoring when initiating ZEPOSIA in patients with characteristics similar to those studied in the clinical trials of ZEPOSIA is unclear. Heart rates below 40 bpm were not observed. Initiation of ZEPOSIA without titration may result in greater decreases in heart rate [see Dosage and Administration (2.2)]. In Study 1 and Study 2, bradycardia was reported on the day of treatment initiation in 0.6% of patients treated with ZEPOSIA compared to no patients who received IFN beta-1a. After Day 1, the incidence of bradycardia was 0.8% in patients treated with ZEPOSIA compared to 0.7% of patients who received IFN beta-1a. Atrioventricular Conduction Delays Initiation of ZEPOSIA may result in transient atrioventricular conduction delays. At ZEPOSIA exposures higher than the recommended dosage without dose titration, first- and second-degree type 1 atrioventricular blocks were observed in healthy volunteers; however, in Study 1 and Study 2 with dose titration, second- or third-degree atrioventricular blocks were not reported in patients treated with ZEPOSIA. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals: • With significant QT prolongation (QTcF > 450 msec in males, > 470 msec in females) • With arrhythmias requiring treatment with Class 1a or Class III anti-arrhythmic drugs
• With ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension • With a history of with second-degree Mobitz type II or higher AV block, sick-sinus syndrome, or sinoatrial heart block [see Contraindications (4)] 5.3 Liver Injury Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain transaminase and bilirubin levels, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. In Study 1 and Study 2, elevations of ALT to 5-fold the upper limit of normal (ULN) or greater occurred in 1.6% of patients treated with ZEPOSIA 0.92 mg and 1.3% of patients who received IFN beta-1a. Elevations of 3-fold the ULN or greater occurred in 5.5% of patients treated with ZEPOSIA and 3.1% of patients who received IFN beta-1a. The median time to an elevation of 3-fold the ULN was 6 months. The majority (79%) of patients continued treatment with ZEPOSIA with values returning to less than 3 times the ULN within approximately 2-4 weeks. In clinical trials, ZEPOSIA was discontinued for a confirmed elevation greater than 5-fold the ULN. Overall, the discontinuation rate because of elevations in hepatic enzymes was 1.1% of patients treated with ZEPOSIA 0.92 mg and 0.8% of patients who received IFN beta-1a. Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine, should have hepatic enzymes checked, and ZEPOSIA should be discontinued if significant liver injury is confirmed. Individuals with an AST or ALT greater than 1.5 times ULN were excluded from Study 1 and Study 2. Although there are no data to establish that patients with preexisting liver disease are at increased risk to develop elevated liver function test values when taking ZEPOSIA, caution should be exercised when using ZEPOSIA in patients with a history of significant liver disease. 5.4 Fetal Risk There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm [see Use in Specific Populations (8.1)]. Because it takes approximately 3 months to eliminate ZEPOSIA from the body, women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA [see Use in Specific Populations (8.1)]. 5.5 Increased Blood Pressure In Study 1 and Study 2, patients treated with ZEPOSIA had an average increase of approximately 1 to 2 mm Hg in systolic pressure over patients who received IFN beta-1a, and no effect on diastolic pressure. The increase in systolic pressure was first detected after approximately 3 months of treatment and persisted throughout treatment. Hypertension was reported as an adverse reaction in 3.9% of patients treated with ZEPOSIA 0.92 mg and in 2.1% of patients who received IFN beta-1a. Two patients treated with ZEPOSIA in Study 1 and one patient treated with interferon (IFN) beta-1a in Study 2 experienced a hypertensive crisis that was not clearly influenced by a concomitant medication. Blood pressure should be monitored during treatment with ZEPOSIA and managed appropriately. Certain foods that may contain very high amounts (i.e., more than 150 mg) of tyramine could cause severe hypertension because of potential tyramine interaction in patients taking ZEPOSIA, even at the recommended doses. Because of an increased sensitivity to tyramine, patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA. 5.6 Respiratory Effects Dose-dependent reductions in absolute forced expiratory volume over 1 second (FEV1) were observed in patients treated with ZEPOSIA as early as 3 months after treatment initiation. In pooled analyses of Study 1 and Study 2, the decline in absolute FEV1 from baseline in patients treated with ZEPOSIA compared to patients who received IFN beta-1a was 60 mL (95% CI: -100, -20) at 12 months. The mean difference in percent predicted FEV1 at 12 months between patients treated with ZEPOSIA and patients who received IFN beta-1a was 1.9% (95% CI: -2.9, -0.8). Dose-dependent reductions in forced vital capacity (FVC) (absolute value and %-predicted) were also seen at Month 3 in pooled analyses comparing patients treated with ZEPOSIA to patients who received IFN beta-1a (60 mL, 95% CI (-110, -10); 1.4%, 95% CI: (-2.6, -0.2)), though significant reductions were not seen at other timepoints. There is insufficient information to determine the reversibility of the decrease in FEV1 or FVC after drug discontinuation. One patient discontinued ZEPOSIA because of dyspnea. Spirometric evaluation of respiratory function should be performed during therapy with ZEPOSIA, if clinically indicated.
ZEPOSIA® (ozanimod) capsules, for oral use 5.7 Macular Edema S1P modulators, including ZEPOSIA, have been associated with an increased risk of macular edema. In Study 1 and Study 2, macular edema was observed in 0.3% of patients treated with ZEPOSIA and in 0.3% of patients who received IFN beta-1a. An ophthalmic evaluation of the fundus, including the macula, is recommended in all patients at any time if there is any change in vision while taking ZEPOSIA. Continuation of ZEPOSIA therapy in patients with macular edema has not been evaluated. A decision on whether or not ZEPOSIA should be discontinued needs to take into account the potential benefits and risks for the individual patient.
B:11.125" T:10.875" S:9.875"
Macular Edema in Patients with a History of Uveitis or Diabetes Mellitus Patients with a history of uveitis and patients with a history of diabetes mellitus are at increased risk of macular edema during ZEPOSIA therapy. The incidence of macular edema is also increased in MS patients with a history of uveitis. In addition to the examination of the fundus, including the macula, prior to treatment, MS patients with diabetes mellitus or a history of uveitis should have regular follow-up examinations. 5.8 Posterior Reversible Encephalopathy Syndrome Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving a S1P receptor modulator. In controlled clinical trials with ZEPOSIA, one case of PRES was reported. Should a ZEPOSIA-treated patient develop any unexpected neurological or psychiatric symptoms/signs (e.g., cognitive deficits, behavioral changes, cortical visual disturbances, or any other neurological cortical symptoms/signs), any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration, the physician should promptly schedule a complete physical and neurological examination and should consider an MRI. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued. 5.9 Unintended Additive Immunosuppressive Effects From Prior Treatment with Immunosuppressive or Immune-Modulating Drugs When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation, when initiating ZEPOSIA. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended [see Drug Interactions (7.1)]. 5.10 Severe Increase in Disability After Stopping ZEPOSIA Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment. Patients should be observed for a severe increase in disability upon ZEPOSIA discontinuation and appropriate treatment should be instituted, as required. 5.11 Immune System Effects After Stopping ZEPOSIA After discontinuing ZEPOSIA, the median time for peripheral blood lymphocytes to return to the normal range was 30 days, with approximately 90% of patients in the normal range within 3 months [see Clinical Pharmacology (12.2)]. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA [see Drug Interactions (7.1)]. 6
ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling: • Infections [see Warnings and Precautions (5.1)] • Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2)] • Liver Injury [see Warnings and Precautions (5.3)] • Fetal Risk [see Warnings and Precautions (5.4)] • Increased Blood Pressure [see Warnings and Precautions (5.5)] • Respiratory Effects [see Warnings and Precautions (5.6)] • Macular Edema [see Warnings and Precautions (5.7)] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.8)] • Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Drugs [see Warnings and Precautions (5.9)] • Severe Increase in Disability After Stopping ZEPOSIA [see Warnings and Precautions (5.10)] • Immune System Effects After Stopping ZEPOSIA [see Warnings and Precautions (5.11)]
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ZEPOSIA was evaluated in two randomized, double-blind, active comparator-controlled clinical studies in which 882 patients received ZEPOSIA 0.92 mg [see Clinical Studies (14)]. Table 2 lists adverse reactions that occurred in at least 2% of ZEPOSIA-treated patients and greater than comparator. The most common adverse reactions that occurred in at least 4% of ZEPOSIA-treated patients and greater than in patients who received IFN beta-1a were upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension. Table 2: Adverse Reactions with an Incidence of at Least 2% in ZEPOSIA-Treated Patients and at Least 1% Greater than IFN beta-1aa (Pooled Study 1 and Study 2)
Adverse Reactions
Studies 1 and 2 ZEPOSIA IFN beta-1a 0.92 mg 30 mcg (n=882) Intramuscularly % Once Weekly (n=885) %
Upper respiratory infectionb
26
23
Hepatic transaminase elevationc
10
5
Orthostatic hypotension
4
3
Urinary tract infection
4
3
Back pain
4
3
Hypertensiond
4
2
Abdominal pain upper
2
1
a
Data are not an adequate basis for comparison of rates between ZEPOSIA and the active control. b Includes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, and laryngitis. c Includes the following terms: alanine aminotransferase increased, gammaglutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, and transaminases increased. d Includes hypertension, essential hypertension, and orthostatic hypertension. Reduction in Heart Rate Initiation of ZEPOSIA may result in transient decrease in heart rate [see Warnings and Precautions (5.2)]. Respiratory Effects Dose-dependent reductions in absolute FEV1 and FVC were observed in patients treated with ZEPOSIA [see Warnings and Precautions (5.6)]. Malignancies Malignancies, such as melanoma, basal cell carcinoma, breast cancer, and seminoma, were reported with ZEPOSIA in the active-controlled trials for ZEPOSIA. An increased risk of cutaneous malignancies has been reported with another S1P receptor modulator. Hypersensitivity Hypersensitivity, including rash and urticaria, has been reported with ZEPOSIA in active-controlled MS clinical trials. 7
DRUG INTERACTIONS
7.1 Anti-Neoplastic, Immune-Modulating, or Immunosuppressive Therapies ZEPOSIA has not been studied in combination with anti-neoplastic, immunemodulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during such therapy and in the weeks following administration [see Warnings and Precautions (5.1)]. When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive immunosuppressive effects [see Warnings and Precautions (5.9)].
ZEPOSIA® (ozanimod) capsules, for oral use Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with ZEPOSIA after alemtuzumab is not recommended. ZEPOSIA can generally be started immediately after discontinuation of beta interferon or glatiramer acetate. 7.2 Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs That may Decrease Heart Rate ZEPOSIA has not been studied in patients taking QT prolonging drugs. Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought. Because of the potential additive effects on heart rate, treatment with ZEPOSIA should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties [see Warnings and Precautions (5.2)]. If treatment initiation with ZEPOSIA is considered in patients on QT prolonging drugs, advice from a cardiologist should be sought. 7.3 Vaccination During, and for up to three months after, discontinuation of treatment with ZEPOSIA, vaccinations may be less effective. The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during ZEPOSIA treatment and for up to 3 months after discontinuation of treatment with ZEPOSIA [see Warnings and Precautions (5.1)]. 7.4 Strong CYP2C8 Inhibitors Co-administration of ZEPOSIA with strong CYP2C8 inhibitors increases the exposure of the active metabolites of ozanimod [see Clinical Pharmacology (12.3)], which may increase the risk of ZEPOSIA adverse reactions. Therefore, co-administration of ZEPOSIA with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. 7.5 Breast Cancer Resistance Protein (BCRP) Inhibitors Co-administration of ZEPOSIA with BCRP inhibitors increases the exposure of the active metabolites of ozanimod [see Clinical Pharmacology (12.3)], which may increase the risk of ZEPOSIA adverse reactions. Therefore, co-administration of ZEPOSIA with inhibitors of BCRP (e.g., cyclosporine, eltrombopag) is not recommended. 7.6 Strong CYP2C8 Inducers Co-administration of ZEPOSIA with strong CYP2C8 inducers (e.g., rifampin) reduces the exposure of the major active metabolites of ozanimod [see Clinical Pharmacology (12.3)], which may decrease the efficacy of ZEPOSIA. Therefore, co-administration of ZEPOSIA with strong CYP2C8 inducers should be avoided. 7.7 Monoamine Oxidase (MAO) Inhibitors Co-administration of ZEPOSIA with MAO-B inhibitors may decrease exposure of the active metabolites of ozanimod. In addition, metabolites of ozanimod may inhibit MAO [see Clinical Pharmacology (12.3)]. The potential for a clinical interaction with MAO inhibitors has not been studied; however, the increased risk of nonselective MAO inhibition may lead to a hypertensive crisis. Therefore, co-administration of ZEPOSIA with MAO inhibitors (e.g., selegiline, phenelzine, linezolid) is contraindicated. At least 14 days should elapse between discontinuation of ZEPOSIA and initiation of treatment with MAO inhibitors. 7.8 Adrenergic and Serotonergic Drugs Because an active metabolite of ozanimod inhibits MAO-B in vitro, there is a potential for serious adverse reactions, including hypertensive crisis. Therefore, co-administration of ZEPOSIA with drugs or over-the-counter medications that can increase norepinephrine or serotonin [e.g., opioid drugs, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), tricyclics, tyramine] is not recommended. Monitor patients for hypertension with concomitant use. Opioid Drugs Serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, or tramadol) and MAOIs, including selective MAO-B inhibitors. Although a small number of patients treated with ZEPOSIA were concomitantly exposed to opioids, this exposure was not adequate to rule out the possibility of an adverse reaction from co-administration. Serotonergic Drugs Although a small number of patients treated with ZEPOSIA were concomitantly exposed to serotonergic medications, this exposure was not adequate to rule out the possibility of an adverse reaction from co-administration.
Sympathomimetic Medications Concomitant use of ZEPOSIA with pseudoephedrine did not potentiate the effects on blood pressure [see Clinical Pharmacology (12.3)]. However, hypertensive crisis has occurred with administration of ZEPOSIA alone [see Warnings and Precautions (5.5)] and hypertensive crisis has been reported with co-administration of other selective and nonselective MAO inhibitors (e.g., rasagiline) with sympathomimetic medications. 7.9 Tyramine MAO in the gastrointestinal tract and liver (primarily type A) provides protection from exogenous amines (e.g., tyramine). If tyramine were absorbed intact, it could lead to severe hypertension, including hypertensive crisis. Aged, fermented, cured, smoked, and pickled foods containing large amounts of exogenous amines (e.g., aged cheese, pickled herring) may cause release of norepinephrine resulting in a rise in blood pressure (tyramine reaction). Patients should be advised to avoid foods containing a large amount of tyramine while taking recommended doses of ZEPOSIA [see Warnings and Precautions (5.5)]. 8
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ZEPOSIA in pregnant women. In animal studies, administration of ozanimod during pregnancy produced adverse effects on development, including embryolethality, an increase in fetal malformations, and neurobehavioral changes, in the absence of maternal toxicity. In rabbits, fetal blood vessel malformations occurred at clinically relevant maternal ozanimod and metabolite exposures (see Data). The receptor affected by ozanimod (sphingosine-1-phosphate) has been demonstrated to have an important role in embryogenesis, including vascular and neural development. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of ozanimod (0, 0.2, 1, or 5 mg/kg/day) to female rats during organogenesis resulted in a marked increase in embryofetal mortality, increased fetal malformations and skeletal variations (abnormal/delayed ossification), and reduced fetal body weight at the highest dose tested. No maternal toxicity was observed. At the no-effect dose (1 mg/kg/day) for adverse effects on embryofetal development, plasma ozanimod exposure (AUC) for ozanimod was approximately 60 times that in humans at the maximum recommended human dose (MRHD) of 0.92 mg/day. Plasma AUCs for major human metabolites, CC112273 and CC1084037, were similar to and less than, respectively, those in humans at the MRHD. Oral administration of ozanimod (0, 0.2, 0.6, or 2.0 mg/kg/day) to female rabbits during organogenesis resulted in a marked increase in embryofetal mortality at the highest dose tested and increased fetal malformations (malformed blood vessels) and skeletal variations at the mid and high doses. Maternal toxicity was not observed. At the no-effect dose (0.2 mg/kg/day) for adverse effects on embryofetal development in rabbit, plasma ozanimod exposure (AUC) was approximately 2 times that in humans at the MRHD; plasma AUCs for major human metabolites, CC112273 and CC1084037, were less than those in humans at the MRHD. Oral administration of ozanimod (0, 0.2, 0.7, or 2 mg/kg/day) to female rats throughout gestation and lactation resulted in persistent body weight reductions and long-term effects on reproductive (prolonged estrus cycle) and neurobehavioral (increased motor activity) function in offspring at the highest dose tested, which was not associated with maternal toxicity. At the no-effect dose (0.7 mg/kg/day) for adverse effects on pre- and postnatal development, plasma ozanimod exposure (AUC) was 30 times that in humans at the MRHD; plasma AUCs for major human metabolites, CC112273 and CC1084037, were less than those in humans at the MRHD. 8.2 Lactation Risk Summary There are no data on the presence of ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Following oral administration of ozanimod, ozanimod and/or metabolites were detected in the milk of lactating rat at levels higher than those in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZEPOSIA and any potential adverse effects on the breastfed infant from ZEPOSIA or from the underlying maternal condition.
ZEPOSIA® (ozanimod) capsules, for oral use 8.3 Females and Males of Reproductive Potential Contraception Before initiation of ZEPOSIA treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for contraception during treatment with ZEPOSIA [see Use in Specific Populations (8.1)]. Because of the time it takes to eliminate the drug from the body after stopping treatment, the potential risk to the fetus may persist and women of childbearing age should also use effective contraception for 3 months after stopping ZEPOSIA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of ZEPOSIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of the ozanimod major active metabolites is unknown [see Clinical Pharmacology (12.3)]. Use of ZEPOSIA in patients with hepatic impairment is not recommended. 13
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Oral administration of ozanimod (0, 8, 25, or 80 mg/kg/day) to Tg.rasH2 mice for 26-weeks resulted in an increase in hemangioma and hemangiosarcoma (combined) in males and females at the mid and high doses tested. Oral administration of ozanimod (0, 0.2, 0.7, or 2 mg/kg/day) to rats for 2 years resulted in no increase in tumors. At the highest dose tested (2 mg/kg/day), plasma exposure (AUC) for ozanimod was approximately 100 times that in humans at the maximum recommended human dose (MRHD) of 0.92 mg/day. Plasma AUCs for major human metabolites, CC112273 and CC1084037, were similar to and less than, respectively, those in humans at the MRHD. Mutagenesis Ozanimod was negative in a battery of in vitro (Ames, mouse lymphoma tk) and in vivo (rat micronucleus) assays. Metabolite CC1122273 was negative in in vitro (Ames, chromosomal aberration in mammalian cell) assays. Metabolite CC1084037 was negative in an Ames assay, and positive in an in vitro chromosomal aberration assay in human (TK6) cells but negative in an in vivo rat micronucleus/comet assay. Impairment of Fertility Oral administration of ozanimod (0, 0.2, 2, or 30 mg/kg/day) to male and female rats prior to and during mating and continuing through gestation day 7 resulted in no adverse effects on fertility. At the highest dose tested (30 mg/kg/day), plasma ozanimod exposure (AUC) was approximately 1600 times that in humans at the maximum recommended human dose (MRHD) (0.92 mg/day); plasma AUCs for metabolites, CC112273 and CC1084037, at 30 mg/kg/day were 13 and 3 times, respectively, those in humans at the MRHD. 17
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Infections Inform patients that they may be more likely to get infections, some of which could be life-threatening, when taking ZEPOSIA and for 3 months after stopping it, and that they should contact their healthcare provider if they develop symptoms of infection [see Warnings and Precautions (5.1)].
Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection. Advise patients that some vaccines containing live virus (live attenuated vaccines) should be avoided during treatment with ZEPOSIA. If immunizations are planned, administer at least 1 month prior to initiation of ZEPOSIA. Avoid the use of live attenuated vaccines during and for 3 months after treatment with ZEPOSIA. Patients without a healthcare professional-confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating ZEPOSIA. Cardiac Effects Advise patients that initiation of ZEPOSIA treatment may result in a transient decrease in heart rate. Inform patients that to reduce this effect, dose titration is required. Advise patients that the dose titration is also required if a dose is missed for 1 day or more during the first 14 days of treatment [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.2)]. Liver Injury Inform patients that ZEPOSIA may increase liver enzymes. Advise patients that they should contact their healthcare provider if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see Warnings and Precautions (5.3)]. Pregnancy and Fetal Risk Inform patients that, based on animal studies, ZEPOSIA may cause fetal harm. Discuss with women of childbearing age whether they are pregnant, might be pregnant, or are trying to become pregnant. Advise women of childbearing potential of the need for effective contraception during treatment with ZEPOSIA and for 3 months after stopping ZEPOSIA. Advise a female patient to immediately inform her healthcare provider if she is pregnant or planning to become pregnant [see Warnings and Precautions (5.4)]. Respiratory Effects Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea [see Warnings and Precautions (5.6)]. Macular Edema Advise patients that ZEPOSIA may cause macular edema, and that they should contact their healthcare provider if they experience any changes in their vision. Inform patient with diabetes mellitus or a history of uveitis that their risk of macular edema maybe increased [see Warnings and Precautions (5.7)]. Posterior Reversible Encephalopathy Syndrome Advise patients to immediately report to their healthcare provide any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological consequences [see Warnings and Precautions (5.8)]. Severe Increase in Disability After Stopping ZEPOSIA Inform patients that severe increase in disability has been reported after discontinuation of a S1P receptor modulator like ZEPOSIA. Advise patients to contact their physician if they develop worsening symptoms of MS following discontinuation of ZEPOSIA [see Warnings and Precautions (5.10)]. Immune System Effects After Stopping ZEPOSIA Advise patients that ZEPOSIA continues to have effects, such as lowering effects on peripheral lymphocyte count, for up to 3 months after the last dose [see Warnings and Precautions (5.11)]. Manufactured for: Celgene Corporation Summit, NJ 07901 Patent: www.celgene.com/therapies ZEPOSIA® is a trademark of Celgene, a Bristol-Myers Squibb Company. © 2020 Bristol-Myers Squibb Company. All rights reserved. ZEP_HCP_BSv.001.05 03/2020
AANnews · March 2021
March Highlights The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. The Vision of the AAN is to be indispensable to our members. Contact Information American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415 Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:
memberservices@aan.com
Website: AAN.com For advertising rates, contact: Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com
26
Assessment of Leadership Program Graduates Shows Positive Impact
To better understand the progress of graduates, the Leadership Development Committee embarked on a long-term follow-up assessment that would survey all leadership program graduates every two years.
28
Experience the Annual Meeting Your Way with Curated Career-focused Program Tracks
29
Membership Provides Essential Tools for Your Essential Care Team Members
Don’t miss these specially curated course lineups, designed to help you experience the meeting your way and maximize your time with consecutive programming intended to meet your individual career stage, path, and needs.
Why not give your advanced practice providers and business administrators an edge with access to the world’s best tools and resources to help strengthen their knowledge and skills, your practice, and patient care?
AAN Chief Executive Officer: Mary E. Post, MBA, CAE
Editor-in-Chief: Melissa W. Ko, MD, FAAN, CPE Managing Editor: Angela M. Babb, MS, CAE, APR Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com AANnews® is published monthly by the American Academy of Neurology for its 36,000 members worldwide. Access this magazine and other AAN publications online at AAN.com. The American Academy of Neurology ’ s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States. The inclusion of advertisements and/or promotions of Sponsors and other Internet sites or resources that offer content, goods, or services on the Website does not imply endorsement of the advertised/promoted products or services by AAN.
News Briefs Diversity Officer Article Published, Webinar Scheduled The AAN published the article " “Developing the Neurology Diversity Officer—A Roadmap for Academic Neurology Departments” (https://bit. ly/2Nm0DX0) in the January 5, 2021, issue of Neurology ®. The article was developed by the AAN’s Diversity Officer Work Group, which is part of the AAN’s academic initiative to bring together the resources that help support everyone involved in academic neurology as well as build new programs to meet their needs. Join us for a webinar to learn about the importance of having diversity officers in academic constitutions on March 18. Learn more at https://bit.ly/2NdM2gh.
AAN Research Program The AAN has selected 16 recipients chosen from 140 applicants for the 2021 Research Program awards funded by the AAN, American Brain Foundation, and funding partners.
Industry Roundtable Grows A record number of companies have joined the Industry Roundtable for 2021—40 companies, nine of which are new. More than 80 percent of 2020 companies have renewed their membership so far.
President’s Column
Virtual Annual Meeting Designed to Deliver Value Since the AAN began battling the effects of the COVID-19 pandemic more than a year ago, our foremost thoughts have been about the health and well-being of our members and staff and working hard to ensure that the value you enjoy from your AAN membership is not diminished. This year, as in 2020, public safety concerns in the city where we had intended to hold our Annual Meeting do not allow us to go ahead with our plans. Unlike last year, however, we are not canceling the Annual Meeting but offering you instead a virtual experience from April 17 to 22 that will deliver the unparalleled science and education that have made this meeting the best in the world. And believe me, this is not going to be just another Zoom conference! You will have access to the latest cutting-edge science you won’t find anywhere else, with more than 2,000 eye-opening abstracts being presented from across the world. You can choose from more than 20 education topics and more than 90 courses to explore in the carefully planned education program. Over the course of the meeting, you can receive all the CME credits needed for the entire year! That’s what I call value. We have selected a virtual platform provider that excels at creating an immersive environment to promote engagement and interaction with peers. You will see and hear from some of the leading innovators who have changed the face of neurology. As always, we have an exciting line-up of speakers for plenary sessions and exceptional presentations by the brightest minds in neurology. You’ll enjoy the return of our popular Experiential Learning Areas, which will feature HeadTalks, Academic Neurology, Live Well, Advancing Leadership in Neurology, Careers in Neurology, and Pioneering Policy, Practice, and Performance: Staying Ahead of Change. There will be numerous ways for you to connect and network with colleagues from around the globe and enjoy some downtime with virtual group lounges, an interactive experience night, and a night of fun and games. Convenience is another significant value of this year’s virtual gathering. The meeting has a strong schedule of both live and pre-recorded events carefully set for the Eastern Time zone to allow for the most widespread global participation. But the great thing about this virtual meeting is that you can participate in sessions when you are able, as programs will be available online to you for 30 days after the meeting—or for nearly a full year if you opt for the 2021 Annual Meeting On Demand access by upgrading to Virtual Gold.
Stevens
your patients, no suitcases to pack, no airfare, and no expense receipts to tally. If the combined costs of hotel and airfare along with registration have prevented you from attending past meetings, this virtual meeting enjoyed in your clinic or home will be much more economical. We know this will be appreciated by members who have been hurt financially by the pandemic or who live in distant parts of the world. Register by March 25 to secure the best rates. We have been determined to turn this crisis into new opportunities to continue delivering value to you. Reimagining the Annual Meeting and creating the same excellence in content programming you expect from your AAN has been challenging and I want to thank the hundreds of volunteer members involved in making it happen. I especially want to cite the Meeting Management Committee, Science Committee, Education Committee, and our staff for their imagination, perseverance, and dedication to our membership and their patients. Please join us April 17 to 22 when the AAN makes history with our virtual 73rd AAN Annual Meeting, created with you in mind. Sincerely
James C. Stevens, MD, FAAN President, AAN jstevens@aan.com @JimStevensMD on Twitter
Although I look forward to eventually returning to a traditional in-person meeting, consider the benefits of this unconventional meeting: less time away from
April 17– April 22
Conferences & Community
Proposed Slate of AAN Board of Directors Nominees Announced continued from cover Officers
President Elect—Carlayne E. Jackson, MD, FAAN Vice President—Janis M. Miyasaki, MD, MEd, FRCPC, FAAN Secretary—Sarah M. Benish, MD, FAAN Treasurer—Charles C. Flippen II, MD, FAAN
Directors
Wayne E. Anderson, DO, FAHS, FAAN Brenda Banwell, MD, FAAN Charlene Gamaldo, MD, FAAN, FAASM James N. Goldenberg, MD, FAAN Larry B. Goldstein, MD, FAHA, FAAN Lily Jung Henson, MD, MMM, FAAN Shannon M. Kilgore, MD, FAAN Brett M. Kissela, MD, MS, FAHA, FAAN Bruce I. Ovbiagele, MD, MSc, MAS, MBA, FAAN
The current President Elect, Orly Avitzur, MD, MBA, FAAN, will begin her term as President on April 23, 2021. The current President, James C. Stevens, MD, FAAN, will then serve on the Board of Directors as Immediate Past President. The following additional directors will serve as ex officio directors beginning on April 23: Bruce H. Cohen, MD, FAAN, Chair, Advocacy Committee (ex officio) Brad C. Klein, MD, MBA, FAAN, Chair, Medical Economics and Practice Committee (ex officio) José G. Merino, MD, MPhil, FAHA, FAAN, Editor-in-Chief of Neurology ® (ex officio) Maisha T. Robinson, MD, MSHPM, FAAN, Chair, Member Engagement Committee (ex officio) Mary E. Post, MBA, CAE, Chief Executive Officer (ex officio, non-voting)
The Academy is comprised of two legal entities, the AAN and the AAN Institute. Most of the elected members of the AAN Board of Directors also serve ex officio on the Board of Directors of the AAN Institute, which includes an independent secretary-treasurer and additional members who serve in ex officio capacities. The AAN Institute Board of Directors will include the following additional members: Jonathan P. Hosey, MD, FAAN, AAN Institute Secretary-Treasurer Lyell K. Jones, Jr., MD, FAAN, Chair, Quality Committee (ex officio) Natalia S. Rost, MD, MPH, FAHA, FAAN, Chair, Science Committee (ex officio) Joseph I. Sirven, MD, FAAN, Chair, Education Committee (ex officio) There also will be consideration of amendments to Article VI, Section 2B of the AAN Bylaws relating to the term for the Editor-in-Chief of Neurology ® as follows: B. The Board of Directors shall appoint the Editor-in-Chief, who shall have responsibility for all the contents of the journal NEUROLOGY and oversee the activities of the Editorial Board. The Editor-in-Chief will serve one five– six-year term, which is renewable for another five- four-year term, unless otherwise approved by the Board of Directors. The proposed amendment would follow the industry standard for academic medical journals, which is a term increment of five years, renewable for another five years. The proposed amendment would also allow the Board of Directors to make an exception to the term length and increments, if necessary, in order to align the end of the term with the academic year. The AAN Bylaws may be amended at the Business Meeting by the vote of at least two-thirds of the voting members present and voting.
Meet the AAN and AAN Institute Boards of Directors Nominees Officers President—Orly Avitzur, MD, MBA, FAAN Orly Avitzur, MD, MBA, FAAN, is president of the American Academy of Neurology. She is a former chair of the AAN Medical Avitzur Economics and Management Committee, the Practice Management and Technology Subcommittee, and the
12
AANnews • March 2021
Audit Committee. She is a medical writer and the editor-in-chief of Brain & Life®, the AAN's patient and caregiver magazine and website. She has been writing for Neurology Today®, reporting on trends and innovations in the practice of neurology since 2001. Her stories have included broad coverage of technology in clinical care; the evolution of the health care regulatory environment; the neurology pipeline; equity, diversity, and inclusion; and most recently, neurologists on the front line during the COVID-19 pandemic. For 10 years, she served as a health editor
for Consumer Reports, and as its medical director from 2015–2018. She is the recipient of several APEX writing awards and the 2009 AAN Journalism Fellowship award. A graduate of Pennsylvania State University School of Medicine, she is a clinical instructor at Yale University School of Medicine in New Haven, CT, where she completed her neurology residency, and a clinical assistant professor at New York Medical College in Valhalla, NY. She is a practicing neurologist in Tarrytown, NY, and a medical consultant to the New York Rangers.
Immediate Past President— James C. Stevens, MD, FAAN James C. Stevens, MD, FAAN, has been a private practicing neurologist and specialist in sleep disorders medicine at the Fort Wayne Stevens Neurological Center for the past 32 years. He received his medical degree from the Indiana University School of Medicine (IUSM), where he graduated at the top of his class, receiving AOA honors his junior year. He completed his neurology resident training at Indiana University, where he was a multi-year recipient of the Alexander Ross Award for outstanding neurologic research. He currently serves as a professor of neurology for the IUSM. Stevens has been a participant, coauthor, and/or principal investigator in over 90 clinical trials dealing with a wide variety of neurologic diseases. He has also been involved with the development, authorship and/or reviewer for over 100 clinical practice guidelines submitted by the AAN. He has held many leadership positions within the Academy, serving as the chair of the Practice Committee, chair of the AAN Board Planning Committee, member of the Quality Standards Subcommittee and the Therapeutics and Technology Subcommittee, as well as serving on numerous work groups and task forces, including the Health Reform Task Force, the Solo and Small Group Task Force, and is currently serving as president of the AAN. Stevens is a graduate of the Palatucci Advocacy Leadership Forum, has been a special advisor to the NINDS clinical research consortium, and is a past-president of the Indiana Neurological Society. He also served on the executive committee for the Lutheran Hospital of Indiana and serves as chair of the board of directors for Physicians Health Plan of Indiana. He has been recognized annually as one the “Best Doctors in America,” and has been a recipient of the “Patients
Choice Award” since 2008 as one of the outstanding physicians in the United States, and has received multi-year recognition as the “Top Doc” in neurology by the Fort Wayne Journal Gazette.
previously served the AAN as a member of the Science Committee, Meeting Management Committee, Leadership Development Committee, and the Board of Directors. She was a member of the Continuum® editorial board from 2007–2017. She co-chaired the ALS Measurement Development Panel and co-authored the ALS Practice Parameters. She has actively participated on the Education Subcommittee and the Neuromuscular Topic Work Group. Jackson participated in the Palatucci Advocacy Leadership Forum in 2013 and has been a delegate to Neurology on the Hill. She has served as a mentor in the Emerging Leaders Program, the Diversity Leaders Program, Women Leading in Neurology and the Transforming Leaders Program and received the AAN Leading in Excellence Mentorship Award in 2017.
President Elect— Carlayne E. Jackson, MD, FAAN Carlayne E. Jackson, MD, FAAN, is currently professor of neurology and otolaryngology at the University of Texas Health Science Jackson Center San Antonio (UTHSCSA). She also serves as vice chair for Faculty Development and Wellness and is Chief of the Neuromuscular Section. Jackson is a graduate of Texas A&M University, where she received a Bachelor of Science degree in chemical engineering. She obtained her medical degree at UTHSCSA, where she subsequently completed her neurology residency training and clinical neurophysiology fellowship. She has obtained board subspecialty certification in both clinical neurophysiology and neuromuscular medicine. She is a graduate of the Executive Leadership in Academic Medicine (ELAM) program sponsored by Drexel University College of Medicine.
Vice President— Janis M. Miyasaki, MD, MEd, FRCPC, FAAN Janis M. Miyasaki, MD, MEd, FRCPC, FAAN, is a graduate of the University of Toronto medical school, neurology residency program, Miyasaki and a movement disorders fellowship under Anthony Lang, MD, FAAN. From 1994 to 1998, she was a community neurologist. In 1999, she became full-time faculty at the University of Toronto assuming the roles as director of education for neurology for four hospitals, ward chief, member of the Board of Trustees for the University Health Network, president of the Medical Staff Association, president of the Canadian Movement Disorders Group, deputy physician-in-chief at Toronto Western Hospital, and associate clinical director of the Movement Disorders Centre at Toronto Western Hospital from 2001 to 2013. In 2007, Miyasaki initiated the first neurologist-led palliative Care for movement disorders in the world.
Jackson serves as medical director for the South Texas ALSA Center of Excellence and the South Texas MDA Clinic. She is a member of the Western ALS Study Group, Northeast ALS Research Group, and the Muscle Study Group. She has participated in over 60 multi-center clinical trials in the areas of ALS, muscular dystrophy, and myasthenia gravis and has published over 230 abstracts, journal articles, and book chapters. Jackson currently serves as the chair of the AAN Meeting Management Committee and Board Planning Committee in addition to her role as secretary on the Executive Committee of the Board of Directors. She has
Continued on page 14
›
AANnews • March 2021 13
Conferences & Community
Meet the AAN and AAN Institute Boards of Directors Nominees continued from page 13
Since 2014, Miyasaki joined the University of Alberta and is currently the director of Parkinson and Movement Disorders and co-director of the Complex Neurologic Symptoms Clinic, Neuropalliative care. In 2019, she received the Parkinson Alberta Association award for outstanding contribution to patient care, education, and research (Louise Plewse Award). She is an active clinical researcher, holding grants, mentoring young researchers in several spheres of movement disorders, physician wellness, and equity (h-index 43). Her AAN activities began in 2000 through writing a guideline on Parkinson's disease. Since that time, she has worked on many AAN committees (Practice Committee, Technology and Therapeutics Subcommittee, Practice Improvement Subcommittee, Patient Safety Subcommittee, and co-chaired the Technology and Therapeutics Subcommittee—now the Guideline Development Subcommittee—and Education Committee, Business Innovation), numerous task forces, and a member of the Board of Directors from 2011–2017. Since 2017, she has been treasurer of the AAN serving as chair of the Compensation Committee and serves on all committees related to finances for the AAN. Secretary— Sarah M. Benish, MD, FAAN
Benish
14
Sarah M. Benish, MD, FAAN, is currently the physician co-chief for M Health/Fairview Neuroscience service line. She works for University
AANnews • March 2021
of Minnesota physicians and is also section head for general neurology at the University of Minnesota. She enjoys her clinic time as a general neurologist. Over her career, she has developed an interest in treating headache patients but continues to enjoy caring for all neurologic diseases. Prior to joining the University of Minnesota, she was a physician owner/ partner at Minneapolis Clinic of Neurology (MCN), one of the largest physician-owned, single-specialty neurology clinics in the country. She spent seven years on their Board of Directors and was treasurer for one year. During her decade with this clinic, she learned a lot about the business of medicine and what it takes to survive in the days of modern medicine and payment reform. Benish began her involvement with the American Academy of Neurology as a member of the inaugural class of the Emerging Leaders Forum. At the end of ELF, she joined the Practice Committee where she led a work group investigating whether the AAN should invest in a registry. When the Axon Registry was started, she joined the Registry Committee and chaired the Registry Analytics Subcommittee. In 2019, she started her third term on the Board of Directors for the AAN and being the chair of the Registry Subcommittee, as well as a member of the newly formed Quality Committee. She has found her involvement in the AAN to be the antidote to burnout. She views herself as a clinician first and tries hard to represent the views of all neurologists in her roles at the AAN.
Treasurer— Charles C. Flippen II, MD, FAAN Charles C. Flippen II, MD, FAAN, is the Richard D. and Ruth P. Walter Professor of Neurology faculty member of the Headache Research Flippen and Treatment Program at the Ronald Reagan UCLA Medical Center, attending neurologist at the Olive View-UCLA Medical Center, and vice chair for education and director of the residency program in adult neurology at the David Geffen School of Medicine at UCLA. Flippen is a diplomate of adult neurology of the American Board of Psychiatry Neurology (ABPN) and of headache medicine of the United Council of Neurologic Subspecialties. He is a member of the American Headache Society, International Headache Society, Fellow of the American Neurological Association, and Fellow of the American Academy of Neurology, where he serves as secretary-treasurer of the American Academy of Neurology Institute. In addition to his AAN activities, Flippen represents the ABPN on the Neurology Residency Review Committee of the Accreditation Council of Graduate Medical Education and serves on several intramural committees in the DGSOM. Flippen is also active within the general Los Angeles community through his service as a former trustee of the Carlthorp School, a development team captain for the Harvard-Westlake School, board member of 100 Black Men of Los Angeles, member of Sigma Pi Phi Fraternity, Delta Xi Boulé, and member of Alpha Phi Alpha Fraternity, Inc.
2021–2023 AAN Board of Directors Wayne E. Anderson, DO, FAHS, FAAN Wayne E. Anderson, DO, FAHS, FAAN, is a neurologist subspecialty certified in headache and in pain medicine. Since Anderson childhood he knew he wanted to be a physician and work with the brain but did not know which path to take: psychiatry, neurology, or something related such as neuroradiology. However, after a few medical school rotations, it became clear: neurology. After residency at University of California, Davis, he worked in both solo and group practice models, including a hybrid private practice within a hospital-based neurology center. The different practice models have offered a unique understanding of the benefits and challenges of both employed and private practices. He has been actively engaged in Academy projects, participating on the Practice Committee, eLearning Subcommittee, Advocacy Engagement Subcommittee, and in several work groups. He has represented the American Academy of Neurology in joint work groups in other specialties, including the American Board of Anesthesiology exam writing committee and the American Academy of Ophthalmology workforce on vision and concussion. A graduate of both the Palatucci Advocacy Leadership Program and the Transforming Leaders Program, he is dedicated to the field of neurology and is passionate about ensuring the future of the profession. In addition to advocacy programs such as Neurology on the Hill, current projects include promoting awareness of the importance of neurology through public education. Brenda Banwell, MD, FAAN
Banwell
Brenda Banwell, MD, FAAN, currently serves as the chief of child neurology and professor of neurology and pediatrics at The
Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania. Banwell's clinical and research focus is in the area of pediatric multiple sclerosis, and she leads a multisite North American prospective study of clinical outcomes, genetics, immunology, and neuroimaging features of MS in children. Banwell also serves as the chair of the International Pediatric Multiple Sclerosis Study Group.
psychiatry, nursing, anesthesiology, and schools of public health. She is currently the medical director of the Johns Hopkins Center for Sleep and the vice chair for faculty development for the Neurology department. Gamaldo's research interest is studying the impact of sleep on manifestation and progression of neurologic diseases. Her research activities have relied heavily on the interdisciplinary and interprofessional collaborative model for conducting sleep research using the efforts of a diverse group of collaborators and, as a result, have led to ongoing and evolving research projects that now include a growing list of collaborators at Johns Hopkins in neurology, psychiatry, urology, biomedical engineering, Schools of Nursing and Public Health, along with the National Institute on Aging. In addition, upon considering the projected shortage of sleep practitioners and the neurology pipeline as a whole, she has developed programs to involve and expose undergraduates (sleep learning module), medical students (sleep learning module), graduate students, post-docs, and residents to attract the best and the brightest early on in their career. Gamaldo has served on the AAN's Sleep Section Leadership Committee, Medical Student Pipeline Committee, Undergraduate Education Subcommittee, and the Minority Scholars Subcommittee. Gamaldo is the vice chair of the Joint Coordinating Council on Equity, Diversity, Inclusion and Disparities for the AAN and member of the Leadership Development Committee. She serves on the Advisory Panel for the AASM, Obstructive Sleep Apnea Outcomes Monitoring Tool committee.
Banwell studied medicine at the University of Western Ontario, followed by residencies in pediatrics at the University of Western Ontario and Child Neurology at the University of Toronto. She then pursued a Neuromuscular Fellowship at the Mayo Clinic, Rochester, MN. Banwell was appointed as an assistant professor of pediatrics and neurology at The Hospital for Sick Children, University of Toronto in 1999, and rose to the rank of full professor at the University of Toronto prior to relocating to The Children's Hospital of Philadelphia in 2012. Banwell remains as adjunct senior scientist in the Research Institute at The Hospital for Sick Children. Banwell has been a member of the AAN since 1996 and has attended every Annual Meeting since joining the Academy. She served on the Science Committee from 2005 to 2012, was a member of the AAN Meeting Management Committee from 2012 to 2017, and was elected to the Board of Directors in 2017. Banwell was a selected attendee at the Leadership Development Program in 2007 and 2008 and has more recently served as a mentor in the Emerging Leaders Program of the AAN. She serves on the Brain Health Fair Committee and has been an active participant in Brain Health Fair activities annually.
James N. Goldenberg, MD, FAAN
Charlene Gamaldo, MD, FAAN, FAASM Charlene Gamaldo, MD, FAAN, FAASM, has been a faculty member of the Johns Hopkins School of Medicine neurology department since Gamaldo 2004, with joint appointments in the department of
Goldenberg
James N. Goldenberg, MD, FAAN, is a boardcertified neurologist who practiced in Palm Beach County, Florida for 25 years. Continued on page 16
›
AANnews • March 2021 15
Conferences & Community
Meet the AAN and AAN Institute Boards of Directors Nominees continued from page 15
He currently serves as senior vice president and associate medical director of JEM Research Institute. Goldenberg cofounded the JEM Research Institute, a clinical research site that performs phase I–IV clinical trials to help develop new treatments in the area of neurology. He previously served as medical director for Atlantic Coast Health Network, a regional super clinically integrated network (CIN), representing over 1,900 physicians and 200,000 lives in South Florida. In that role, he is responsible for strategy, value-based care initiatives, population health, and patient safety. His undergraduate training is in psychology from the University of Florida. He received his Medical Degree from the University of South Florida. His neurology training and fellowship in neuromuscular disease were completed at the University of Miami. Goldenberg has served JFK Hospital in Atlantis Florida in multiple leadership roles including chair of the Board of Trustees, chair of the Credentials Committee, chair of the Bylaws Committee, and chief of the Department of Psychiatry and Neurology. He was the founding medical director of JFK Hospital’s stroke program and has helped develop their Comprehensive Stroke Center. Goldenberg has also served The Joint Commission as a disease-specific surveyor in stroke, the first physician to hold that position nationally. Goldenberg is an affiliated assistant professor of neurology at the Leonard M. Miller School of Medicine at the University of Miami. He has coordinated the neurology rotation for second-year residents at JFK Hospital’s University of Miami sponsored Internal Medicine Residency program. He has also coordinated the neurology medical student rotation for fourth-year medical students at the University of Miami’s Palm Beach Regional Campus.
16
AANnews • March 2021
Goldenberg is an advocate for patients and physicians at the local, regional, and national levels. He is a past president of the Palm Beach County Medical Society and currently serves on the Board of Directors. He is responsible for the development of the Physician Leadership Academy of South Florida. He has served the Florida Medical Association on the Board of Governors and the Council on Medical Economics and Practice Innovation. He is serving the American Academy of Neurology on the Board of Directors, Advocacy Committee, and chairs the Business Innovation Subcommittee. Through advocacy, education, and the promotion of physician leadership training, he would like to help physicians prepare for the changing health care landscape. Larry B. Goldstein, MD, FAHA, FAAN Larry B. Goldstein, MD, FAHA, FAAN, is the Ruth L. Works Professor and Chair, department of neurology, codirector of the Goldstein Kentucky Neuroscience Institute, co-director of the UK Neuroscience Research Priority Area, and Interim Director of the UK-Norton Healthcare Stroke Care Network at the University of Kentucky. Goldstein received his BA degree in 1977 from Brandeis University and MD from Mount Sinai School of Medicine in 1981. His subsequent professional training included internship and neurology residency at Mount Sinai Medical Center, New York (1981–1985) and a research fellowship in cerebrovascular disease at Duke University (1985–1987). Goldstein advanced at Duke University to the rank of professor of neurology and director of the Duke Stroke Center until moving to the University of Kentucky in 2015. Goldstein focuses his clinical, research, educational and service activities
on stroke and related disorders. He has published over 780 peer review journal articles, reviews, editorials, book chapters, abstracts, and other professional papers. His research spans stroke-related laboratory-based studies, clinical trials, quality of care and care delivery studies, as well as clinical effectiveness and epidemiological investigations. He serves as a reviewer for numerous professional journals as well as national and international granting agencies. He is a member of the editorial boards of Stroke, Neurology®, Cerebrovascular Diseases, the Journal of Stroke and Cerebrovascular Diseases, and Cardiology Today, and has been an editor for Circulation: Cardiovascular Quality and Outcomes, Emergency Medicine, and Continuum® in addition to several other medical journals. He has chaired or has been a member of national guideline writing committees, including the AHA Guidelines for the Primary Prevention of Stroke, Guidelines for the Prevention of Stroke in Patients with Ischemic Stroke or TIA, Guidelines for Early Management of Ischemic Stroke, and Guidelines for the Primary Prevention of Cardiovascular Disease. He has been a member of the AAN Quality Standards Subcommittee (2005–2007), the Practice Committee (2007–2015) the Stroke Systems Work Group (2007–2017), the Education Committee (2017–), the Joint Audit Committee (2017–2012; vice chair 2019–2021), Neurology Chair’s Workgroup (2018–), Health Policy Subcommittee (2019–), and is an AAN Media Expert (2019–) He also served on the first examination writing committee for certification in vascular neurology for the American Board of Psychiatry and Neurology (2003–2010). He has been a member of the Board of Directors of the American Heart Association (2002–2004, 2008–2011), as well as numerous leadership roles within the organization. He was a member of the Operations Committee for the VA Stroke Quality Improvement program, was appointed
to the FDA Peripheral and Central Nervous System Advisory Committee (2005–2009; 2014–2019) and served as advisor or panel member for several other FDA committees in addition to the CMS Medicare Evidence Development & Coverage Advisory Committee (MEDCAC, 2013–2015), and as a member of the National Committee for Quality Assurance (NCQA) Advisory Committee. Goldstein received the G. Milton Shy Award from the American Academy of Neurology (1979) and numerous national and state awards. He was awarded the Order of the Long Leaf Pine, North Carolina’s highest civilian honor, by the governor in 2015 for his service to the state related to improving stroke care. Lily Jung Henson, MD, MMM, FAAN Lily Jung Henson, MD, MMM, FAAN, is the chief executive officer of Piedmont Henry Hospital in Stockbridge, GA. She formerly served Henson as the chief medical officer at Piedmont Henry as well as the former chief of neurology of the Piedmont Healthcare System in Atlanta, GA. Prior to her move to Atlanta in 2015, Henson served as the vice president of medical affairs of Swedish Ballard Hospital in Seattle, WA, after her tenure as the inaugural chief of staff of Swedish Issaquah Hospital. Henson has been a neurologist with 30 years of practice with a focus on multiple sclerosis and a principal investigator in many clinical trials involving MS diseasemodifying therapies. She was an associate professor of neurology at the University of Washington Medical School. Henson attended the honors program in medical education at Northwestern University in Chicago, where she obtained her BS and MD degrees. She completed her neurology training at the University of Washington in Seattle. She went on to get a Certificate of Medical Management and a Master of Medical Management through Tulane University’s School of Public Health and Tropical Medicine.
taught medical students, neurology residents, and geriatrics fellows in both outpatient and inpatient settings, as a clinical associate professor, affiliated of Stanford’s department of neurology. At Stanford, she serves as the site director for the neurology residency program and as a member of the Clinical Competency Committee.
She is a 2016 ACHE Thomas Dolan Executive Diversity Scholar. She is a Fellow of the American College of Healthcare Executives and a past Regentat-Large of District 2. Henson is the former chair of the Board of Directors of the Hands of Hope Clinic in Stockbridge, GA. She had served on the National Board of Directors of the National Multiple Sclerosis Society, the Board of Managers of Fast Forward and was a board trustee of the Georgia Chapter and of the Greater Northwest Chapter of the NMSS. She also served as the chair of the BrainPAC of the American Academy of Neurology, the advocacy editor of the AAN’s website and as vice chair of the AAN Government Relations Committee.
Kilgore has maintained a long-held interest in combining both education and advocacy. She joined the Neurology Review Committee for the Accreditation Council for Graduate Medical Education (ACGME) twice, first as a resident/ fellow, serving on the ACGME/ABMS Competencies Project. This sparked her interest in education policy, leading to her return to the Neurology Review Committee as a regular member, ultimately serving as chair, before rotating off in 2017. She has continued work within the ACGME on the initial Neurology Milestones, as well as on Milestones 2.0, and chaired the original Vascular Milestones committee. Having represented the AAN at the American Medical Association (AMA) since 2004, she was elected to the AMA’s Council on Medical Education in 2019, allowing her to advocate for medical students, residents, international medical graduates, and practicing physicians to the various accreditation/certification/ licensure and oversight bodes within medicine. She has also sought to broaden the influence of neurology within the greater medical community, while balancing the perspectives and needs of other specialists.
Shannon M. Kilgore, MD, FAAN Shannon M. Kilgore, MD, FAAN, practices neurology within the Veterans Affairs Health Care System in Palo Alto, CA. She works as both the Kilgore director of stroke services and the Palo Alto representative of the National VA Parkinson’s Disease Consortium. Additionally, Kilgore focuses on pharmaceutical pricing and medication safety, representing neurology on the Medical Advisory Panel to Pharmacy Benefits Management, which determines the formulary for the entire Department of Veterans Affairs. She also serves as the physician lead for the regional VA Integrated Service Network (VISN) Pharmacy Benefits Committee and on Palo Alto’s Medication Management Committee.
Kilgore also serves the Academy on the Editorial Board of Continuum: Lifelong Learning in Neurology® and the Education Committee, overseeing the Program Accreditation work group. She has also been a member of the Government Relations Committee, contributed to the Drug Pricing Task Force, and attended multiple Neurology on the Hill events. A member of the 2014–2015 Emerging Leaders Forum class, she now enjoys giving back as a mentor within the various AAN Leadership Programs.
A native Texan, Kilgore obtained her Bachelor of Arts in psychology from the University of Texas at Austin, and her Doctor of Medicine from the University of Texas Health Science Center at Houston. She then completed her neurology residency and fellowships in both cerebrovascular disease and movement disorders at Stanford. In 2003, she brought this unique combination of experience to the VA, where she has
Continued on page 20
›
AANnews • March 2021 17
COGNITIVE ASSESSMENT: Elevated subjective memory complaints; MMSE=28/30; re-evaluation after continued complaints, MoCA=25/30 STAGES OF AD PROGRESSION: BIOMARKER CONFIRMATION: Amyloid-positive
Preclinical DIAGNOSIS:
MCI due to AD Mild AD Dementia
Moderate AD Dementia
Severe AD Dementia
HOW DO YOU KNOW IF MCI IS LIKELY TO PROGRESS TO AD DEMENTIA?
TESTING FOR AMYLOID BETA CAN HELP CONFIRM A CLINICAL DIAGNOSIS.
U
ntil recently, the diagnosis of Alzheimer’s disease (AD) was almost solely based on clinical evaluation. And the average time to diagnosis has been 2 to 3 years after symptom onset.1 But diagnosis of AD may be ready to evolve.
Recently, the large-scale IDEAS Study (N=11,409) showed the utility of Aβ confirmation to inform appropriate care, which led to changes in the management of over 60% of MCI patients and ~64% of patients with dementia.9
AD is thought to be caused by a cascade of neurological damage triggered by the accumulation of amyloid beta (Aβ).2 These Aβ aggregates can serve as a biological marker of AD pathology, and may help inform the diagnosis and management of the first symptomatic stage of AD: mild cognitive impairment (MCI) due to AD.3,4
With the potential for Aβ testing to impact the management of AD, and other biomarker tests on the horizon, advances in AD diagnostics offer hope that diagnosing AD at the MCI stage may become the standard of care and improve the management of Alzheimer’s disease.10
Currently used in cutting-edge investigational research, biomarker confirmation of Aβ via positron emission tomography (PET) scan or cerebrospinal fluid (CSF) test is beginning to move into clinical practice.3,5-8 The diagnostic value of ascertaining AD as the cause of MCI is that the clinician can intervene before greater neuronal damage occurs and more cognition and function are lost.4
Aβ testing can help support a diagnosis of Alzheimer’s disease7,8,11
COGNITIVELY NORMAL
ALZHEIMER’S DISEASE
Images from Huang CC, et al, used under CC BY 4.0, https://creativecommons.org/licenses/by/4.0/.
See how Aβ testing can help confirm AD pathology at identifyalz.com. MMSE=Mini-Mental State Examination; MoCA=Montreal Cognitive Assessment; IDEAS=Imaging Dementia—Evidence for Amyloid Scanning. References: 1. Sabbagh MN, Lue L-F, Fayard D, Shi J. Increasing precision of clinical diagnosis of Alzheimer’s disease using a combined algorithm incorporating clinical and novel biomarker data. Neurol Ther. 2017;6(suppl 1):S83-S95. 2. Hardy J, Selkoe DJ. The amyloid hypothesis of Alzheimer’s disease: progress and problems on the road to therapeutics. Science. 2002;297(5580):353-356. 3. Oboudiyat C, Glazer H, Seifan A, Greer C, Isaacson RS. Alzheimer’s disease. Semin Neurol. 2013;33(4):313-329. 4. Jack CR Jr, Knopman DS, Jagust WJ, et al. Hypothetical model of dynamic biomarkers of the Alzheimer’s pathological cascade. Lancet Neurol. 2010;9(1):119-128. 5. Cummings J, Lee G, Ritter A, Sabbagh M, Zhong K. Alzheimer’s disease drug development pipeline: 2019. Alzheimers Dement. 2019;5:272-293. 6. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer’s disease: recommendations from the National Institute on Aging–Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):263-269. 7. Shaw LM, Arias J, Blennow K, et al. Appropriate use criteria for lumbar puncture and cerebrospinal fluid testing in the diagnosis of Alzheimer’s disease. Alzheimers Dement. 2018;14(11):1505-1521. 8. Johnson KA, Minoshima S, Bohnen NI, et al. Appropriate use criteria for amyloid PET: a report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer’s Association. Alzheimers Dement. 2013;9(1):e1-e16. 9. Rabinovici GD, Gatsonis C, Apgar C, et al. Association of amyloid positron emission tomography with subsequent change in clinical management among Medicare beneficiaries with mild cognitive impairment or dementia. JAMA. 2019;321(13):1286-1294. 10. Jack CR Jr, Bennett DA, Blennow K, et al. NIA-AA research framework: toward a biological definition of Alzheimer’s disease. Alzheimers Dement. 2018;14(4):535-562. 11. Huang CC, Hsiao IT, Huang CY, et al. Tau PET with 18F-THK-5351 Taiwan patients with familial Alzheimer’s disease with the APP p.D678H mutation. Front Neurol. 2019;10:503. doi:10.3389/fneur.2019.00503.
©2021 Biogen. All rights reserved. 03/21 ALZ-US-1224
Conferences & Community
Meet the AAN and AAN Institute Boards of Directors Nominees continued from page 17
Brett M. Kissela, MD, MS, FAHA, FAAN Brett M. Kissela, MD, MS, FAAN, is professor and chair of the department of neurology and rehabilitation medicine and senior Kissela associate dean for Clinical Research at the University of Cincinnati College of Medicine and Chief of Research Services for UC Health. Since 2008, he has been co-director of the Stroke Recovery Center at Drake and a member of the University of Cincinnati Stroke team since 2000. He is fellowshiptrained in vascular neurology and has extensive clinical trial experience in acute stroke treatment, prevention, and recovery trials. He is an internationally recognized expert on causes, outcomes, and recovery of stroke, with a special interest in the impact of diabetes on stroke and factors that influence stroke outcomes. He also participates in a variety of stroke recovery projects which look to improve recovery with the use of innovative techniques and devices. Honors and awards include the Cincinnati Business Courier's Forty Under 40 Award, Michael S. Pessin Stroke Leadership Prize from the American Academy of Neurology, Alpha Omega Alpha membership, National Medical Honor Society, Phi Beta Kappa, UC Faculty Senate Award, American Heart Association 2018–2019 Gold Standard Board Award (highest since the program’s inception), and has continuously been named as one of the Best Doctors in America (national surveys from Woodward-White and Best Doctors, Inc.). Bruce Ovbiagele, MD, MSc, MAS, MBA, FAAN
Ovbiagele
20
Bruce Ovbiagele, MD, MSc, MAS, MBA, FAAN, is professor of neurology and associate dean at the University of California, San
AANnews • March 2021
Francisco as well as chief of staff at the San Francisco Veterans Affairs Health Care System. Prior to these roles he served for six years as professor of neurology and chair of the department of neurology at the Medical University of South Carolina. His primary research involves the translation of evidence-based interventions into clinical practice and community settings, to improve stroke outcomes for underserved and vulnerable populations in the United States and around the world. He currently leads several NIH-funded studies of stroke in the US and sub-Saharan Africa. Ovbiagele has published over 500 peer-reviewed articles (h-index 75) in the areas of stroke prevention, epidemiology, risk factors, and outcomes; and edited five textbooks. He served as a member of the NIH-NINDS Advisory Council (2015–2019), chair of the International Stroke Conference (2016–2018), officer of the World Federation of Neurology (2015–2019), and been a member of the FDA Peripheral and Central Nervous System Drugs Advisory Committee since 2014. He is chair of the annual “Health Equity and Actionable Disparities in Stroke: Understanding and ProblemSolving (HEADS-UP) symposium” and an associate editor of the journal Stroke. Ovbiagele has been a member of the AAN since 1998. He has been privileged to serve on several committees and subcommittees including the Clinical Research Training Fellowship Award Committee, Clinical Research Subcommittee, Minority Scholars Subcommittee, and Education Committee. Ovbiagele received the Michael Pessin Stroke Leadership Award in 2008. He was a Neurology on the Hill participant in 2008, Palatucci Advocacy Leadership Fellow in 2009, and minority scholars visiting professor to Morehouse School of Medicine in 2011. He has served as director of stroke courses at both the Annual Meeting and Fall Conference, faculty chair/guest editor for a Continuum®
issue, and abstracts reviewer for the Annual Meeting. Ovbiagele is a member of the Media Expert Panel. Since 2016, Ovbiagele has been the principal investigator on an NIHfunded R25 educational program, implemented in partnership with the AAN, entitled “Training in Research for Academic Neurologists to Sustain Careers and Enhance the Numbers of Diverse Scholars (TRANSCENDS).” The goal of TRANSCENDS is to train, mentor, and inspire a national cohort of underrepresented in medicine (UIM) individuals who are post-residency fellows and junior faculty to conduct high-quality neurological research and develop successful academic careers.
Ex Officio (voting) Bruce H. Cohen, MD, FAAN Bruce H. Cohen, MD, FAAN, is the director of the NeuroDevelopmental Science Center, interim vicepresident and Cohen medical director of the Rebecca D. Considine Research Institute at The Children’s Hospital Medical Center of Akron, and professor of pediatrics as well as professor of integrative medical sciences at Northeast Ohio Medical University. He holds the Rebecca D. and William Considine Chair in Research at Akron Children's Hospital. Cohen attended Washington University, graduating summa cum laude with a BA in chemistry. He attended the Albert Einstein College of Medicine of Yeshiva University and received his MD degree in 1982. Following pediatric training at The Children’s Hospital of Philadelphia, he did his neurology training at the Neurological Institute of New York, before returning to Children’s Hospital of Philadelphia for a fellowship in pediatric neuro-oncology. He spent the next two decades at The Cleveland Clinic, serving
as a pediatric neurologist, neurooncologist and practicing neuro-genetics before moving to Akron Children’s Hospital in 2011 where he first assumed the role as director of neurology before his promotion to his current title(s). His clinical practice is centered on caring for children and adults with mitochondrial disorders, neurogenetic illness, and brain tumors, and he has a busy clinical research practice. His administrative responsibilities dovetail into his academic and practical interests in health care economics and health care delivery models. Cohen’s academic career initially involved clinical trials for treatment of brain tumors in infants and children, and then transitioned in the emerging field of mitochondrial medicine. He also developed an interest in health care economics and practice management in the early 1990s. Cohen has served as chair of the Child Neurology Section of the American Academy of Neurology, chair of the Practice Committee of the CNS, and chair of the Coding Subcommittee of the Medical Economics and Management Committee of the AAN. He is just completing a five-year term as secretary-treasurer of The Child Neurology Society and is now presidentelect for the society, which is the largest society in the world representing child neurology. In 2010, he joined the AAN’s CPT team and became the lead advisor to the CPT Panel in 2016. In 2021, he will begin two new additional roles within the AAN: chair of the Advocacy Committee (which includes all the subcommittees covering the legislative and regulatory work) and have a seat on the Board of Directors. Cohen has participated in the education of dozens of neurology residents and fellows, lead over a dozen international symposia, organized, and conducted investigatorinitiated clinical trials in brain tumors, neurofibromatosis, and mitochondrial disorders and has authored over 120 peer-reviewed manuscripts and delivered over 650 invited lectures.
Brad C. Klein, MD, MBA, FAAN
He has been the recipient of numerous local, regional, and national awards, including “Patient’s Choice Award,” and Castle Connelly’s “Top Doctor.”
Brad C. Klein, MD, MBA, FAAN, is a full-time practicing neurologist with additional certifications in Klein headache medicine and electromyography in his private practice at Abington Neurological Associates, Ltd., in Abington, PA. He has been a participant and/or principal investigator in more than 20 clinical trials and further serves as the practice’s chief operating officer. He is also the director of the Abington Headache Center, AbingtonJefferson Health and a clinical associate professor of neurology at Thomas Jefferson University (TJU).
Maisha T. Robinson, MD, MSHPM, FAAN Maisha T. Robinson, MD, MSHPM, FAAN, is an assistant professor in the department of neurology at Mayo Clinic in Florida, with Robinson a joint appointment in the department of family medicine. Upon joining the staff of Mayo Clinic, she established the clinic’s first neuropalliative care program and she currently serves as the medical director of palliative medicine and as the program director for the Palliative Medicine Fellowship.
He received his medical degree from Sidney Kimmel Medical College, previously known as Jefferson Medical College, at TJU in Philadelphia, concurrently with his Master of Business Administration degree at Widener University. He completed his neurology residency and headache fellowship at Thomas Jefferson University Hospital.
Robinson earned her undergraduate degree from Princeton University and her medical degree from Tufts University School of Medicine, subsequently completing a residency in neurology at Mayo Clinic in Minnesota, where she served as chief resident. She pursued a fellowship in hospice and palliative medicine at Memorial Sloan Kettering Cancer Center and returned to Mayo Clinic in Florida for a neurohospitalist fellowship. She was awarded a postdoctoral fellowship in health services and health policy research through the Robert Wood Johnson Foundation Clinical Scholars Program at UCLA, during which she earned a Master of Science degree in health policy and management and engaged in research focused on the intersection of neurology and palliative medicine. Robinson has spoken nationally and internationally on neuropalliative care, she edited a book titled Case Studies in Neuropalliative Care, and she is a member of the American Board of Internal Medicine Test Writing Committee on Hospice and Palliative Medicine.
During Klein’s residency, he graduated from the Palatucci Advocacy Leadership Forum and founded the Pennsylvania Neurological Society, serving as its first president. Through his tenure, he provided multiple testimonies to the state legislature and was an advisor on many legislative bills. Thereafter, he served in a number of other state and national leadership roles, including treasurer of the Alliance for Headache Disorders Advocacy, chair of the Practice Committee of the American Headache Society, and as a member of the Pennsylvania Health Care Cost Containment Council. Within the AAN, Klein has served as a member of the Practice Management and Technology Subcommittee, Health Services Research Subcommittee, Benchmark Survey Work Group, Solo and Small Practice Work Group, Meeting Management Committee, multiple education topic work groups, and vice chair of the Medical Economics and Management Committee.
Within the AAN, Robinson was selected for the inaugural cohort of the Emerging Leaders Forum and she has participated in the Palatucci Advocacy Leadership Continued on page 22
›
AANnews • March 2021 21
Conferences & Community
Meet the AAN and AAN Institute Boards of Directors Nominees continued from page 21 Forum. She has served as vice chair of the Meeting Management Committee, chair of the Medical Student Diversity Subcommittee, vice chair of the Pain and Palliative Care Section, and a member of the Leadership Development Committee, Diversity Leadership Subcommittee, Nominating Committee, and Medical Advisory Board of Brain and Life® magazine. She has also served as a mentor in the Emerging Leaders Program and in the Women Leading Neurology Program. She currently serves as chair of the Member Engagement Committee. José G. Merino, MD, MPhil, FAHA, FAAN José G. Merino, MD, MPhil, FAHA, FAAN, is a professor in the department of neurology at Georgetown University Hospital, Merino where he is also co-vice chair for education. Merino studied medicine at the Universidad Anáhuac in Mexico City and obtained a Master of Philosophy degree on the history of medicine from the University of Cambridge in England. He trained in neurology and psychiatry at the Albert Einstein College of Medicine and in stroke at the University of Western Ontario. He has worked as faculty and clinical staff of the Section of Stroke Diagnosis and Therapeutics of NINDS, the University of Florida, Johns Hopkins Medicine, and the University of Maryland. His clinical and research interests focus on the management of patients with acute stroke. Merino has been engaged in editorial pursuits throughout his career. He has been a member of the editorial board of Stroke, the Revista Mexicana de Neurociencia, and science editor of AAN.com. Most recently, he was the US research editor of The BMJ from 2012 until 2019. He has served the AAN as a member of the Science Committee, Nominations
22
AANnews • March 2021
Committee, Meeting Management Committee, Leadership Development Committee, and immediate past chair of the Diversity Leadership Subcommittee. Currently, he is editor-in-chief of Neurology® journals and is a member of the editorial board of the AAN’s Brain & Life en Español.
Ex Officio (non-voting) Mary E. Post, MBA, CAE Mary E. Post, MBA, CAE, is the chief executive officer of the American Academy of Neurology, the world’s largest Post association of neurologists with more than 36,000 members. Leading a team of more than 200 staff with locations in Minneapolis, MN, and Washington, DC, Post is responsible for the AAN achieving its mission of promoting the highest quality patient-centered care and enhancing member career satisfaction, as well as the AAN’s vision of being indispensable to its membership. Post began her position as CEO of the AAN in April 2020. She is the fourth CEO since the AAN was established in 1948. Post was selected for the role based on her extensive experience leading a major nonprofit medical specialty organization as well as her broad prior experience at the AAN, where she served for 16 years in many leadership roles, including as deputy executive director. Post is a Certified Association Executive (CAE), the highest credential in the association management industry. She also holds a Post-Master’s Certificate in organizational leadership, a Master of Business Administration Degree in human resources, and a Bachelor of Science Degree in business administration. She has over 25 years of experience in the
nonprofit medical specialty industry. Post has led meaningful, sustainable, programmatic, operational, and financial growth within organizations while increasing value for stakeholders and creating an award-winning, resilient culture. In Post’s most recent position as the executive director for the American Board of Anesthesiology (ABA), she established a strong and collaborative partnership with its board of directors and 700 volunteer physicians to innovate and transform the organization’s programs. Under Post’s leadership, the ABA became the first US medical specialty certifying board to successfully implement an Objective Structured Clinical Examination (OSCE) into the ABA’s initial certification program. In 2014, the ABA also reimagined its Maintenance of Certification in Anesthesiology Program (MOCA) and incorporated learning and assessment of knowledge into its physicians’ daily practice through MOCA Minute®. Post also led collaboration with the Accreditation Council for Continuing Medical Education (ACCME) and the CME community to link the ABA’s assessment with relevant CME programs. This collaboration positioned the ABA as a nationally recognized leader and demonstrated the benefits of partnering with other organizations to provide value to physicians. The National Association for Business Resources named the ABA one of the Best and Brightest Companies to Work For® in 2019. This was the third consecutive year the ABA was honored with this prestigious award. It recognized the ABA, under Post’s leadership, as an effective workplace, along with its strategies and employee enrichment programs that increased staff satisfaction and organizational success.
2021–2023 AAN Institute Board of Directors The AAN Institute Board of Directors will include the following additional members.
Officer
Ex Officio (voting)
Treasurer— Jonathan P. Hosey, MD, FAAN
Lyell K. Jones, Jr., MD, FAAN
Jonathan P. Hosey, MD, FAAN, is currently the chair of neuroscience for the St. Luke's University Health Network in Bethlehem, PA, Hosey which is composed of seven hospitals in two states. He has been involved with the development of neurology residency programs at the Madigan Army Medical Center in Tacoma in 1990, and as the founding director of the Geisinger Health System program in 2010. He is a professor of neurology at the Lewis Katz School of Medicine at Temple University, and has served on numerous American Academy of Neurology subcommittees and committees. He is most proud of being in the inaugural class of the Palatucci Advocacy Leadership Forum. Hosey is active in his community, having served as a past president of the American Heart Association/American Stroke Association (AHA/ASA) of Pennsylvania/Delaware chapter. He has served on many boards, including the Three Rivers Affiliate of the AHA/ASA, Geisinger Health Plan, Pennsylvania Rural Stroke Institute, and was a longserving trustee of Wyoming Seminary Preparatory School of Pennsylvania, where he was awarded the Joseph Donchess Lifetime Achievement Award for his service. He currently serves on the Board of King's College in WilkesBarre, PA, of which he is an alumnus. He is married to Linda M. Famiglio, MD, FAAP, a pediatric neurologist, and has two children.
at Wilford Hall Medical Center in San Antonio, TX. Jones serves as the program director of the Mayo Clinic–Rochester Adult Neurology Residency Program, and has developed with his colleagues a competency-based neurology assessment system, neurology wellness program, and health care disparities initiative. He has been recognized with the AAN Program Director Award, the ACGME Parker J. Palmer Courage to Teach Award, and has been inducted into the Mayo Clinic Teacher of the Year Hall of Fame.
Lyell K. Jones, Jr., MD, FAAN, is a consultant and professor of neurology at the Mayo Clinic in Rochester, MN. Jones Jones received his undergraduate and medical degrees from Wake Forest University before completing his neurology residency and neurophysiology fellowship at the Mayo Clinic, where he has been a member of the consulting staff since 2009.
Natalia S. Rost, MD, MPH, FAHA, FAAN Natalia S. Rost, MD, MPH, FAHA, FAAN, is chief of Stroke Division at Massachusetts General Hospital Department of Rost Neurology and professor of neurology at Harvard Medical School. A cum laude graduate of Boston University School of Medicine, she also holds a master's degree from Harvard School of Public Health. Rost trained in neurology and vascular neurology at Partners (Massachusetts General Hospital/Brigham and Women's Hospital) residency and fellowship programs.
Jones’s clinical and research focus is in neuromuscular medicine, particularly neurodegenerative, infectious, and autoimmune neuromuscular disorders. Jones has additional interests in health care policy and economics, specifically value-based care systems. In his role as chair of Government Program Strategy at Mayo Clinic, he has led system-wide implementation of novel care models such as bundled payment programs and the Mayo Clinic Accountable Care Organization (ACO). He is a former medical director for the Mayo Clinic Office of Patient Experience and Chair of Payment Model Operations. Jones has served on several national society committees, and as the chair of the American Academy of Neurology Quality Committee he oversees development of AAN practice guidelines, quality measures, and implementation of the Axon Registry. His intramural and extramural efforts are collectively devoted to improving quality of care for patients and delivering the tools physicians need to thrive in an era of evolving value-based care models. He currently serves on the Boards of Directors of the AANI (ex officio) and the Mayo Clinic ACO.
Rost is a clinician-scientist and international expert on neuroimaging markers of cerebrovascular disease, stroke genetics, and big data science for outcome prediction in patients with acute stroke. Her line of research on the role of white matter disease burden and mechanisms of brain resilience in stroke has been continuously funded since 2007, and Rost is currently principal investigator of two NIH R01 awards and is the Samana Cay MGH Research Scholar. As of September 2019, Rost leads DISCOVERY (Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY), a new collaborative
Prior to joining the staff at the Mayo Clinic, Jones served on active duty in the USAF
Continued on page 24
›
AANnews • March 2021 23
Conferences & Community
Meet the AAN and AAN Institute Boards of Directors Nominees continued from page 23
national network supported jointly by the National Institute of Neurological Disorders and Stroke/National Institute of Aging (U19NS115388), which consists of four cores and 30 premier academic clinical sites with access to acute stroke populations and the expertise and capacity for systematic assessment of post-stroke cognitive impairment and dementia. DISCOVERY will become a landmark study to unravel the mechanisms of post-stroke cognitive disability, early stroke recovery, and potential targets for personalized stroke prevention, intervention, and rehabilitation. Rost is an author of numerous peer-reviewed publications, book chapters, a co-author of the MGH Handbook of Neurology, and medical editor of the Harvard Medical School Special Health Report on stroke. She is an accomplished mentor, clinical educator, and recipient of the 2017 MGH Neurology Department’s Ray Adams Clinical Mentor Award and of the 2012 Michael S. Pessin Stroke Leadership Award from the American Academy of Neurology. She serves as assistant editor of the journal Stroke and is past president of the Boston Board of the American Heart Association. Among her professional accomplishments, Rost is particularly proud of her career-long involvement with the American Academy of Neurology, where she currently serves as chair of the Science Committee.
Joseph (Joe) I. Sirven, MD, FAAN Joseph (Joe) I. Sirven, MD, FAAN, is professor of neurology and chair emeritus of the department of neurology at the Sirven Mayo Clinic in Arizona and currently practicing at Mayo Clinic in Florida. He is editor-in-chief of Brain & Life en Español and on the editorial board of the English language Brain & Life. He is currently chair of the AAN Education Committee and previously served as chair of the AAN Education Conference Subcommittee and served on the Board of Directors for the American Brain Foundation. He was the previous vice chair of the Epilepsy Section of the American Academy of Neurology, chair of the Communication Council for the American Epilepsy Society, and former chair of the Professional Advisory Board for the Epilepsy Foundation. Previously, he served as director of education for Mayo Clinic Arizona with oversight over all educational activities at the Mayo Clinic Arizona campus including, medical student rotations, residencies, fellowships, PhD candidates, nursing, allied health, and continuing medical education programs. Sirven is Cuban American and served as chief medical contributor for NBC Latino, the English language website for Latinos by NBC News. He is currently the medical commentator for KJZZ radio in Phoenix, the NPR affiliate for Phoenix and Tucson, Arizona, in addition
to KTBS TV 3. He also is creator and a comoderator for the podcast “We Need to Talk—Tough Conversations in Healthcare” produced by Arizona State University. In addition to being a neurologist, Sirven is a certified aviation medical examiner and a consultant to the Federal Aviation Authority on pilot and passenger health. Sirven is a professor of practice in the College of Health Solutions at Arizona State University, where he teaches science of health care delivery. Sirven has published extensively on epilepsy and its treatment. His interests in epilepsy include status epilepticus, surgical therapy for epilepsy, epilepsy in older adults, and psychosocial issues particularly those involving Hispanic populations and transportation. His articles have appeared in Neurology®, Epilepsia, Lancet, Archives of Neurology, Annals of Neurology, Epilepsy & Behavior, and Mayo Clinic Proceedings. He is editor of seven textbooks: Clinical Neurology of the Older Adult, the American Epilepsy Society’s Introduction to Epilepsy; Clinical Epilepsy, and An Atlas of Video EEG Monitoring. He is currently a neurology core clerkship director for Mayo Clinic College of Medicine and Dartmouth Medical School. Sirven received his undergraduate degree, a BS in biology, from Georgetown University in Washington, DC. He received his MD degree from Louisiana State University in New Orleans. He completed a residency in neurology from the University of Minnesota. His clinical neurophysiology and epilepsy fellowship was completed at the University of Pennsylvania.
Early Annual Meeting Registration Savings End March 25 Continued from cover Upgrade to Gold!
While registering, consider upgrading your 2021 Annual Meeting registration to the Virtual Gold Registration for the best value. Virtual Gold Registration offers extended and exclusive access to additional courses through March 31, 2022, with Annual Meeting On Demand. In addition to all of the benefits of regular registration, you’ll retain access to all meeting syllabi and virtual session recordings, CME, and receive more than 25 exclusive bonus sessions and presentations to round out this comprehensive digital reference library that’s accessible anytime, anywhere.
24
AANnews • March 2021
2020 Annual Report Captures Successes of Challenging Year It’s a year we may wish to put behind us, but to not read the 2020 Annual Report would be to miss out on how the Academy overcame extraordinary obstacles to end the year stronger and with more members than ever before. “2020 was a year like no other in the AAN’s history,” said President James C. Stevens, MD, FAAN. “Against a turbulent pandemic that endangered the health and welfare of our members and their patients, the Academy did everything it could to support your delivery of high-quality health care and increase the value of your membership. Virtual conferencing and added online education resources helped you continue to stay current with
your skills. Our advocacy successes improved reimbursements, strengthened telehealth, increased research support, and helped ensure neurologists had the tools needed to confront the COVID-19 epidemic. The Academy publicly declared itself an antiracist organization and recommitted to a proven track record of promoting inclusion, diversity, equality, and social justice. All of this and more is captured in this report to members.” Visit AAN.com/AnnualReort to read how the AAN’s actions had a positive impact for neurologists, resulting in record membership numbers by the end of the year.
I'm #NeurologyProud and proud to call the AAN my home!
Conferences & Community
Assessment of Leadership Program Graduates Shows Positive Impact The AAN provides opportunities for all members to engage with its events, programs, and services at every point in their career. The Academy’s Leadership Program is one such offering. These graduates are prepared to assume leadership roles in their places of work, their communities, and within the AAN.
Hope O’Brien, MD, MBA, FAAN, and Beau Nakamoto, MD, PhD, MBA, FAAN, chair and vice chair respectively of the Leadership Engagement Subcommittee, were charged with gathering and evaluating these responses. O'Brien
To better understand the progress of graduates in that regard, the Leadership Development Committee embarked on a long-term follow-up assessment that would survey all leadership program graduates every two years. Results of the first long-term follow-up assessment include responses from 143 of 148 graduates from the 2013 to 2018 programs for Diversity Leadership, Emerging Leaders, Practice Leadership, Transforming Leaders, and Women Leading in Neurology. Individuals who participate in these programs are asked to complete a pre-assessment prior to the start of their multi-month program, a post-assessment immediately following the completion of their program, and a one-year follow-up assessment as alumni of the program.
“Based on the results of this assessment,” said O’Brien, “I am pleased to see such a positive response to the leadership programs. However, there is still a need to support opportunities for leadership within and outside of the organization. As we continue to build on what we’ve learned, we will work to expand our definition of leadership and strive to meet the needs of all our members.” Nakamoto
“I am impressed by the overwhelming desire to engage with the AAN,” said Nakamoto. “I think the 97 percent participation with the long-term follow-up assessment is a reflection of the level of engagement from our leadership program graduates.” Below are some of the results of the assessment.
AAN Mission and Vision Respondents rated their agreement or disagreement with understanding AAN mission and vision, understanding AAN committee structure and function, feeling that their contributions to AAN are meaningful, and that they have a strong network of colleagues on a 5-point Likert scale from as strongly agree (2) to strongly disagree (-2). Overall, 98 percent of leadership program graduates clearly understand the AAN’s mission and vision, 91 percent felt they had a strong network of AAN colleagues, 90 percent had a deep understanding of AAN’s committee structure and function, and 88 percent felt their contributions to the AAN were personally meaningful.
Leadership Potential Respondents rated their agreement or disagreement to statements about achieving their leadership potential inside and outside of the AAN on a 5-point Likert scale from as strongly agree (2) to strongly disagree (-2). Overall, 80 percent of leadership program graduates felt that they were achieving their leadership potential outside the AAN while 56 percent thought they were doing so inside the AAN.
26
AANnews • March 2021
Current and Desired Level of Engagement with the AAN Respondents rated their current and desired level of engagement with the AAN on a 5-point Likert scale from as very engaged (4) to not at all engaged (0). Overall, 92 percent of leadership program graduates desire to remain engaged with the AAN, and 72 percent stated that they currently are engaged.
Well-being and Resilience Respondents rated their quality of life and average level of fatigue on an 11-point Likert scale from as bad as it can get (0) to as good as it can get (10) with 5 being the neutral point in the middle. Charts below show the percent of graduates who rated each question as good, with scores between 6 and 10. Overall, 87 percent of leadership program graduates rated their overall quality of life as good while 68 percent rated their average level of fatigue as good. Nakamoto said, “I am excited to work with the AAN on the possibility of creating new ways for our members to engage with the AAN. It is also noteworthy to see the AAN’s commitment to diversity and equity in our organization. Training leaders
who are representative of the AAN membership and our profession will improve the care we deliver to the patient communities we serve.
who feel a strong connection to one another,” he continued. “I am excited about working with the AAN to help us develop deeper connections with other members within our organization.”
“It makes me happy to be part of an organization of health care professionals
Member Featured in Spotlight Video for International Accomplishments A new entry in the series of inspirational Member Spotlight videos is available for viewing. AAN President James C. Stevens, MD, FAAN, has interviewed members living the values of the AAN in inspiring ways, and in this episode he chats with Jerome Chin, MD, MPH, PhD, FAAN, an adjunct professor in the department of neurology at New York University School of Medicine, the chair of the Academy’s International Subcommittee, and the founding chair of our Global Health Section.
screening and counseling for high blood pressure diabetes in Uganda, Tanzania, India, and Nepal. This exchange and previous videos that show how members are demonstrating AAN values can be seen in a playlist on the AAN YouTube channel at YouTube.com/AANchannel.
Chin shared with Stevens some of his experiences and motivations in carrying out international work and his proudest accomplishments. He is a visiting faculty member at Mulago National Referral Hospital in Kampala, Uganda, and Muhumbili University of Health and Allied Sciences in Dar es Salaam, Tanzania, where he teaches neurology for two months every year. Chin founded the Alliance for Stroke Awareness and Prevention Project, a student-led, volunteer initiative providing free, community-based
AANnews • March 2021 27
Conferences & Community
Experiential Learning Areas Offer Fun, Unconventional Learning Opportunities Don’t miss this year’s Experiential Learning Areas for unconventional learning opportunities at the 2021 AAN Annual Meeting. Look for fun and innovative presentations that will employ various teaching and presentation styles and compelling visuals to push the boundaries of storytelling, learning, reflection, and engagement even further. For a full Experiential Learning Area schedule, visit AAN.com/21AM.
Advancing Leadership in Neurology
HeadTalks
Look for unique opportunities to learn about core leadership competencies, including how to lead in the virtual world, and topics around equity, diversity, and inclusion. The area is designed to enhance attendees’ leadership potential and help train, support, and prepare them for desired leadership roles. Highlights include:
Look for presentations designed to engage audiences through unconventional platforms that offer a truly transformational exploration of non-traditional neurology topics, including: Neuro-Jeopardy: Telencephalon Twisters Saturday, April 17, 1:00 p.m.–2:00 p.m. ET Looking to take a break from the scientific programs? Want to show what you know? Test your neurologic fortitude against top neurologists or simply sit back and watch the action from the comfort of your virtual space with Neuro-Jeopardy: Telencephalon Twisters.
Blind Spots: The Impact of Conscious and Unconscious Biases Saturday, April 17, 6:00 p.m.–6:45 p.m. ET This panel discussion will feature experts discussing the impact that bias can have while treating patients. COVID and Leadership: Case Studies Sunday, April 18, 6:00 p.m.–6:30 p.m. ET Hear intriguing examples of innovative approaches to leadership during the COVID-19 pandemic. Health Care Disparities in Populations Tuesday, April 20, 6:00 p.m.–6:30 p.m. ET This talk will highlight issues concerning health care disparities related to neurology. Learn constructive ways to promote awareness regarding disparities.
Pioneering Policy, Practice, and Performance: Staying Ahead of Change Look for an exciting variety of talks designed to empower attendees to improve their practice and increase revenue through innovation and advocacy: Meet Your Practice Support Network: Ask Us Anything About Managing Your Practice Sunday, April 18, 6:00 p.m.–7:00 p.m. ET Ask questions of neurologists on how they manage their practices, especially during these unprecedented times. Neurology Networking and Advocacy Through Social Media Monday, April 19, 2:00 p.m.–3:00 p.m. ET Learn from social media experts on how to foster community and increase visibility for neurology-centered topics. The Midas Touchscreen: Turn Your App Idea into Gold Monday, April 19, 6:00 p.m.–6:20 p.m. ET If you’ve ever been curious about how to launch an app to help your patients and other health care professionals, then this is the session for you.
April 17– April 22
28
AANnews • March 2021
Getting to Know Neurologists: Outside the Office Saturday, April 17, 5:00 p.m.–5:35 p.m. ET Have you ever wanted to learn more about the lifestyles of neurology leaders? This new session will feature homes, hobbies, and interesting talents of a variety of your fellow neurologists. The Salem Witch Trials: How Could that Have Happened? Sunday, April 18, 3:00 p.m.–3:35 p.m. ET When one hears tales of the Salem witch trials, it conjures up thoughts of possible demonic possession. Or was it instead even something more menacing? Was it an unexpected neurotoxin? Was it a Puritanical political ploy or perhaps what we still see in contagious hysteria? In the end, you will need to consider the theories and decide what truly happened. But one undeniable fact is that it was a regrettable historical moment that took the lives of innocent people. Neuro HeadTalk: Story Slams Sunday, April 18, 5:00 p.m.–5:35 p.m. ET Storytelling is the foundation for human communication and society. Neurologists are blessed with countless stories to share that range from the profane to the profound. This session highlights true tales told by neurologists about lessons learned from their various patients, families, and other individuals they have encountered throughout their careers in neurology. Is There a Neurologist on the Flight During a COVID Pandemic? Tuesday, April 20, 3:00 p.m.–3:35 p.m. ET For those of us who must fly not knowing other passengers' COVID status, a sudden medical emergency may leave you concerned about your medical role. Through a highly interactive format, this session will address the various medical emergencies one might encounter during a flight and outline a neurologist's role during the pandemic. The Neurology of Wine Tasting Tuesday, April 20, 5:00 p.m.–5:35 p.m. ET This talk is designed to engage you intellectually, emotionally, and socially. Grab a glass of wine and learn about the science behind what you are tasting.
Membership Provides Essential Tools for Your Essential Care Team Members Each member of the neurology practice is essential to high-quality patient care. Why not give your advanced practice providers and business administrators an edge with access to the world’s best tools and resources to help strengthen their knowledge and skills, your practice, and patient care? Visit AAN.com/CareTeam to learn more and encourage your care team members to join today.
Advance Practice Provider Membership Options
Business Administrator Membership
With the $275 PLUS membership, your care team members can:
The new, affordable $120 single-tier membership provides:
Complete online education courses through the AAN including the new NeuroReady: Advanced Practice Provider Edition at a discounted member-only rate
Member-only resources including quality improvement resources, payment and reform tools, clinical practice guidelines, and online education programs
Access Neurology ® journal, Neurology ® Clinical Practice, and Neurology Today ®
Opportunities to connect with a network of administrators, neurologists, and neuroscience professionals worldwide through Synapse Online Communities
Connect with a network of advanced practice providers, neurologists, and neuroscience professionals worldwide through SynapseSM Online Communities Save big on AAN conference registration, including the 2021 virtual AAN Annual Meeting
Free online education courses designed specifically to help with questions that may arise in the business of running a neurology practice or department
$120 membership offers many of the same membership benefits, excluding online education courses, Neurology journal (print and online), and Neurology Today (print).
Thank You Neurology COVID-19 Relief Fund Supporters The AAN thanks the 11 contributing organizations for their support of the Neurology COVID-19 Relief Fund, which was created to assist neurology professionals or practices experiencing acute hardship to continue providing needed health care services in communities that have also become distressed as a result of the pandemic. The Academy seeded the fund with $100,000 and matched additional donations from industry partners. A total of 15 grants totaling $259,580 were awarded. “We read many heartbreaking stories about clinics facing staff layoffs, reduced hours, patients postponing appointments, unpaid bills piling up, and lack of personal protective equipment,” said AAN President James C. Stevens, MD, FAAN. “Even though our hearts ached at not being able to completely satisfy each request, we are pleased that with the generosity of our contributing sponsors we were able to help many stay afloat through these difficult days so they could continue to be a beacon of care and comfort to their patients and their communities. I would like to recognize and thank the following for their invaluable contribution to this important initiative.”
Recipient Alison Allen, MD, of Roaring Fork Neurology PC in Basalt, CO, used the funds she received to improve patient online access to care and services throughout Colorado’s Roaring Fork Valley region. “[I used the funds to] pay for telemedicine costs through enrollment in a HIPAA compliant service; to pay for PPE that we need to offer services in the clinic, including PPE for our MS patients who are there receiving infusions; to continue to pay my staff to keep the practice open and running efficiently; and to offer online access to balance and Tai Chi classes, breathwork and counseling, biofeedback, yoga for MS, and other alternative neurological services for those with chronic headache, MS, and concussion.”
Thank You
Boston Scientific Wolters Kluwer Lundbeck, LLC. Teva Amneal Pharmaceuticals, Inc. Merz Amylyx Pharmaceuticals Ovid Therapeutics McKesson Verana Health BrainStorm Cell Therapeutics
AANnews • March 2021 29
FOR PATIENTS WITH RELAPSING FORMS OF MS
PLAYING WITH FEWER RELAPSES • The efficacy of VUMERITY® (diroximel fumarate) is based upon bioavailability studies in patients with relapsing forms of multiple sclerosis and healthy subjects comparing dimethyl fumarate to VUMERITY1 • In Study 1 and Study 2 pivotal trials, dimethyl fumarate demonstrated a 53% and 44% relative reduction in annualized relapse rate (ARR) vs placebo, respectively (0.172 vs 0.364; P<0.0001), (0.224 vs 0.401; P<0.0001)1
Indication
• Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present
Important Safety Information
Herpes Zoster and Other Serious Opportunistic Infections • Serious cases of herpes zoster have occurred in patients treated with dimethyl fumarate (which has the same active metabolite as VUMERITY), including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on VUMERITY for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered • Other serious opportunistic infections have occurred with dimethyl fumarate, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment • Consider withholding VUMERITY treatment in patients with herpes zoster or other serious infections until the infection has resolved
VUMERITY® (diroximel fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
CONTRAINDICATIONS VUMERITY is contraindicated in patients • With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema • Taking dimethyl fumarate
WARNINGS AND PRECAUTIONS Anaphylaxis and Angioedema • VUMERITY can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (which has the same active metabolite as VUMERITY) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue VUMERITY and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema Progressive Multifocal Leukoencephalopathy • Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (which has the same active metabolite as VUMERITY). PML is an opportunistic viral infection of the brain caused by the JC virus ( JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial • PML has occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9 × 10 9/L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8×10 9/L persisting for more than 6 months • At the first sign or symptom suggestive of PML, withhold VUMERITY and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes
© 2020 Biogen. All rights reserved. 09/20 VUM-US-0458 v2
Lymphopenia • VUMERITY may decrease lymphocyte counts. In the MS placebo-controlled trials with dimethyl fumarate (which has the same active metabolite as VUMERITY), mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable. Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased but did not return to baseline. The incidence of infections and serious infections was similar in patients treated with dimethyl fumarate or placebo. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8 x 109/L or ≤0.5 x 10 9/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5 x 109/L for 3.5 years) • In controlled and uncontrolled clinical trials with dimethyl fumarate, 2% of patients experienced lymphocyte counts <0.5 x 10 9/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy. Neither VUMERITY nor dimethyl fumarate have been studied in patients with preexisting low lymphocyte counts
Full access to Biogen Support Services • Helping patients start treatment, manage common side effects, and navigate financial assistance
Learn more about additional studies on VUMERITY in RRMS patients2,3
Visit www.vumerityhcp.com
RRMS=relapsing-remitting multiple sclerosis.
• Obtain a complete blood count (CBC), including lymphocyte count, before initiating treatment with VUMERITY, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of VUMERITY in patients with lymphocyte counts less than 0.5 x 10 9/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if VUMERITY is discontinued or interrupted because of lymphopenia. Consider withholding treatment from patients with serious infections until resolution Liver Injury
• Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate (which has the same active metabolite as VUMERITY) in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients • Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials with dimethyl fumarate • Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with VUMERITY and during treatment as clinically indicated. Discontinue VUMERITY if clinically significant liver injury induced by VUMERITY is suspected Flushing
• VUMERITY may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials of dimethyl fumarate (which has the same active metabolite as VUMERITY), 40% of dimethyl fumarate-treated patients experienced flushing. Flushing symptoms generally began soon after initiating dimethyl fumarate and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued dimethyl fumarate for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization
ADVERSE REACTIONS • The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate (which has the same active metabolite as VUMERITY) were flushing, abdominal pain, diarrhea, and nausea • Gastrointestinal adverse reactions: Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with dimethyl fumarate • Hepatic transaminases: An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate was seen primarily during the first six months of treatment and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with dimethyl fumarate or placebo • Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy
USE IN SPECIFIC POPULATIONS Renal Impairment • No dosage adjustment is necessary in patients with mild renal impairment. Because of an increase in the exposure of a major metabolite, use of VUMERITY is not recommended in patients with moderate or severe renal impairment Please see following pages for Brief Summary of full Prescribing Information. Study Designs • Study 1: A 2-year, randomized, double-blind, placebo-controlled study in 1234 patients with RRMS. Secondary endpoint: ARR. • Study 2: A 2-year, multicenter, randomized, double-blind, placebo-controlled study in 1417 patients with RRMS. Primary endpoint: ARR. References: 1. VUMERITY Prescribing Information, Biogen, Cambridge, MA. 2. Naismith RT, et al. CNS Drugs. 2020;34(2):185-196. doi:10.1007/ s40263-020-00700-0 3. Naismith RT, et al. Mult Scler. Published online November 4, 2019. doi:10.1177/1352458519881761
VUMERITY® (diroximel fumarate) delayed-release capsules, for oral use of the brain caused by the JC virus (JCV) that typically only occurs Brief Summary of full Prescribing Information in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who 1. INDICATIONS AND USAGE received dimethyl fumarate for 4 years while enrolled in a clinical trial. VUMERITY is indicated for the treatment of relapsing forms of multiple During the clinical trial, the patient experienced prolonged lymphopenia sclerosis (MS), to include clinically isolated syndrome, relapsing- (lymphocyte counts predominantly <0.5 × 109/L for 3.5 years) while remitting disease, and active secondary progressive disease, in adults. taking dimethyl fumarate [see Warnings and Precautions (5.4)]. The patient had no other identified systemic medical conditions resulting 2. DOSAGE AND ADMINISTRATION in compromised immune system function and had not previously 2.1 Blood Tests Prior to Initiation of VUMERITY been treated with natalizumab, which has a known association with Obtain the following prior to treatment with VUMERITY: PML. The patient was also not taking any immunosuppressive or • A complete blood cell count (CBC), including lymphocyte count immunomodulatory medications concomitantly. [see Warnings and Precautions (5.4)] PML has also occurred in patients taking dimethyl fumarate in the • Serum aminotransferase, alkaline phosphatase, and total bilirubin postmarketing setting in the presence of lymphopenia (<0.9 × 109/L). levels [see Warnings and Precautions (5.5)] While the role of lymphopenia in these cases is uncertain, the PML 2.2 Dosing Information cases have occurred predominantly in patients with lymphocyte counts The starting dosage for VUMERITY is 231 mg twice a day orally. After <0.8×109/L persisting for more than 6 months. 7 days, the dosage should be increased to the maintenance dosage At the first sign or symptom suggestive of PML, withhold VUMERITY of 462 mg (administered as two 231 mg capsules) twice a day orally. and perform an appropriate diagnostic evaluation. Typical symptoms Temporary dosage reductions to 231 mg twice a day may be considered associated with PML are diverse, progress over days to weeks, and for individuals who do not tolerate the maintenance dosage. Within include progressive weakness on one side of the body or clumsiness 4 weeks, the recommended dosage of 462 mg twice a day should of limbs, disturbance of vision, and changes in thinking, memory, and be resumed. Discontinuation of VUMERITY should be considered orientation leading to confusion and personality changes. for patients unable to tolerate return to the maintenance dosage. Magnetic resonance imaging (MRI) findings may be apparent before Administration of non-enteric coated aspirin (up to a dose of 325 mg) clinical signs or symptoms. Cases of PML diagnosed based on MRI 30 minutes prior to VUMERITY dosing may reduce the incidence or findings and the detection of JCV DNA in the cerebrospinal fluid in severity of flushing [see Clinical Pharmacology (12.3)]. the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with other MS medications associated with 2.3 Administration Instructions Swallow VUMERITY capsules whole and intact. Do not crush or chew, PML. Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent or sprinkle the capsule contents on food. If taken with food, avoid a high-fat, high-calorie meal/snack; the with PML may be useful, and any suspicious findings should lead to meal/snack should contain no more than 700 calories and no more than further investigation to allow for an early diagnosis of PML, if present. 30 g fat [see Warnings and Precautions (5.6) and Clinical Pharmacology Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with (12.3)]. PML in patients with PML who were initially asymptomatic compared to Avoid co-administration of VUMERITY with alcohol [see Clinical patients with PML who had characteristic clinical signs and symptoms Pharmacology (12.3)]. at diagnosis. It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in 2.4 Blood Tests to Assess Safety After Initiation of VUMERITY Obtain a complete blood cell count (CBC), including lymphocyte count, disease in these patients. 6 months after initiation of VUMERITY and then every 6 to 12 months 5.3 Herpes Zoster and Other Serious Opportunistic Infections thereafter, as clinically indicated [see Warnings and Precautions (5.4)]. Serious cases of herpes zoster have occurred in patients treated Obtain serum aminotransferase, alkaline phosphatase, and total with dimethyl fumarate (which has the same active metabolite as bilirubin levels during treatment with VUMERITY, as clinically indicated VUMERITY) including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster [see Warnings and Precautions (5.5)]. meningomyelitis. These events may occur at any time during treatment. 2.5 Patients With Renal Impairment Monitor patients on VUMERITY for signs and symptoms of herpes No dosing adjustment is recommended in patients with mild renal zoster. If herpes zoster occurs, appropriate treatment for herpes zoster impairment. should be administered. VUMERITY is not recommended in patients with moderate or severe Other serious opportunistic infections have occurred with dimethyl renal impairment [see Use in Specific Populations (8.6) and Clinical fumarate, including cases of serious viral (herpes simplex virus, Pharmacology (12.3)]. West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium 3. DOSAGE FORMS AND STRENGTHS VUMERITY is available as hard, delayed-release capsules containing tuberculosis) infections. These infections have been reported in 231 mg of diroximel fumarate. The capsules have a white cap and a patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, white body, printed with “DRF 231 mg” in black ink on the body. meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and 4. CONTRAINDICATIONS ear. Patients with symptoms and signs consistent with any of these VUMERITY is contraindicated in patients infections should undergo prompt diagnostic evaluation and receive • With known hypersensitivity to diroximel fumarate, dimethyl appropriate treatment. fumarate, or to any of the excipients of VUMERITY. Reactions Consider withholding VUMERITY treatment in patients with herpes may include anaphylaxis and angioedema [see Warnings and zoster or other serious infections until the infection has resolved [see Precautions (5.1)]. Adverse Reactions (6.2)]. • Taking dimethyl fumarate [see Drug Interactions (7.1)]. 5.4 Lymphopenia 5. WARNINGS AND PRECAUTIONS VUMERITY may decrease lymphocyte counts. In the MS placebo5.1 Anaphylaxis and Angioedema controlled trials with dimethyl fumarate (which has the same active VUMERITY can cause anaphylaxis and angioedema after the first metabolite as VUMERITY), mean lymphocyte counts decreased by dose or at any time during treatment. Signs and symptoms in patients approximately 30% during the first year of treatment with dimethyl taking dimethyl fumarate (which has the same active metabolite as fumarate and then remained stable. Four weeks after stopping dimethyl VUMERITY) have included difficulty breathing, urticaria, and swelling fumarate, mean lymphocyte counts increased but did not return to of the throat and tongue. Patients should be instructed to discontinue baseline. Six percent (6%) of dimethyl fumarate patients and <1% of VUMERITY and seek immediate medical care should they experience placebo patients experienced lymphocyte counts <0.5 × 109/L (lower signs and symptoms of anaphylaxis or angioedema. limit of normal 0.91 × 109/L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with 5.2 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in dimethyl fumarate or placebo, respectively. There was no increased infections observed in patients with lymphocyte patients with MS treated with dimethyl fumarate (which has the same incidence of serious 9 9 active metabolite as VUMERITY). PML is an opportunistic viral infection counts <0.8 × 10 /L or ≤0.5 × 10 /L in controlled trials, although one
patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5 × 109/L for 3.5 years) [see Warnings and Precautions (5.2)]. In controlled and uncontrolled clinical trials with dimethyl fumarate, 2% of patients experienced lymphocyte counts <0.5 × 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 × 109/L with continued therapy. Neither VUMERITY® (diroximel fumarate) nor dimethyl fumarate have been studied in patients with preexisting low lymphocyte counts. Obtain a complete blood count (CBC), including lymphocyte count, before initiating treatment with VUMERITY, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of VUMERITY in patients with lymphocyte counts less than 0.5 × 109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if VUMERITY is discontinued or interrupted because of lymphopenia. Consider withholding treatment from patients with serious infections until resolution. Decisions about whether or not to restart VUMERITY should be individualized based on clinical circumstances.
The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules, which has the same active metabolite as VUMERITY. Adverse Reactions in Placebo-Controlled Trials with Dimethyl Fumarate In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [see Clinical Studies (14)]. The adverse reactions presented in Table 1 below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea. Table 1: Adverse Reactions in Study 1 and 2 Reported for Dimethyl Fumarate at ≥2% Higher Incidence than Placebo
Adverse Reactions
Dimethyl Fumarate 240 mg Twice Daily (N=769) %
Placebo (N=771)%
5.5 Liver Injury Clinically significant cases of liver injury have been reported in patients 40 6 treated with dimethyl fumarate (which has the same active metabolite Flushing as VUMERITY) in the postmarketing setting. The onset has ranged Abdominal pain 18 10 from a few days to several months after initiation of treatment with Diarrhea 14 11 dimethyl fumarate. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper Nausea 12 9 limit of normal and elevation of total bilirubin to greater than 2-fold 9 5 the upper limit of normal have been observed. These abnormalities Vomiting resolved upon treatment discontinuation. Some cases required Pruritus 8 4 hospitalization. None of the reported cases resulted in liver failure, Rash 8 3 liver transplant, or death. However, the combination of new serum 6 4 aminotransferase elevations with increased levels of bilirubin caused Albumin urine present by drug-induced hepatocellular injury is an important predictor of Erythema 5 1 serious liver injury that may lead to acute liver failure, liver transplant, Dyspepsia 5 3 or death in some patients. Elevations of hepatic transaminases (most no greater than 3 times Aspartate aminotransferase 4 2 the upper limit of normal) were observed during controlled trials with increased dimethyl fumarate [see Adverse Reactions (6.1)]. Lymphopenia 2 <1 Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with VUMERITY and during Gastrointestinal treatment, as clinically indicated. Discontinue VUMERITY if clinically Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, significant liver injury induced by VUMERITY is suspected. abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and 5.6 Flushing VUMERITY may cause flushing (e.g., warmth, redness, itching, and/ usually decreased over time in patients treated with dimethyl fumarate or burning sensation). In clinical trials of dimethyl fumarate (which has compared with placebo. Four percent (4%) of patients treated with the same active metabolite as VUMERITY), 40% of dimethyl fumarate- dimethyl fumarate and less than 1% of placebo patients discontinued treated patients experienced flushing. Flushing symptoms generally due to gastrointestinal events. The incidence of serious GI events was began soon after initiating dimethyl fumarate and usually improved 1% in patients treated with dimethyl fumarate. or resolved over time. In the majority of patients who experienced Hepatic Transaminases flushing, it was mild or moderate in severity. Three percent (3%) of An increased incidence of elevations of hepatic transaminases in patients discontinued dimethyl fumarate for flushing and <1% had patients treated with dimethyl fumarate was seen primarily during serious flushing symptoms that were not life-threatening but led the first six months of treatment, and most patients with elevations to hospitalization. had levels <3 times the upper limit of normal (ULN) during controlled Administration of VUMERITY with food may reduce the incidence of trials. Elevations of alanine aminotransferase and aspartate flushing [see Dosage and Administration (2.3)]. Studies with dimethyl aminotransferase to ≥3 times the ULN occurred in a small number of fumarate show that administration of non-enteric coated aspirin (up to patients treated with both dimethyl fumarate and placebo and were a dose of 325 mg) 30 minutes prior to dosing may reduce the incidence balanced between groups. There were no elevations in transaminases or severity of flushing [see Clinical Pharmacology (12.3)]. ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases 6. ADVERSE REACTIONS The following important adverse reactions are described elsewhere were <1% and were similar in patients treated with dimethyl fumarate or placebo. in labeling: • Anaphylaxis and Angioedema [see Warnings and Precautions (5.1)] Eosinophilia • Progressive Multifocal Leukoencephalopathy [see Warnings and A transient increase in mean eosinophil counts was seen during the Precautions Section (5.2)] first 2 months of therapy. • Herpes Zoster and Other Serious Opportunistic Infections [see Adverse Reactions in Clinical Studies with VUMERITY Warnings and Precautions (5.3)] In clinical studies assessing safety in patients with RRMS, approximately • Lymphopenia [see Warnings and Precautions (5.4)] 700 patients were treated with VUMERITY and approximately • Liver Injury [see Warnings and Precautions (5.5)] 490 patients received more than 1 year of treatment with VUMERITY. • Flushing [see Warnings and Precautions (5.6)] The adverse reaction profile of VUMERITY was consistent 6.1 Clinical Trials Experience with the experience in the placebo-controlled clinical trials with Because clinical trials are conducted under widely varying conditions, dimethyl fumarate. adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may 6.2 Postmarketing Experience The following adverse reaction has been identified during post approval not reflect the rates observed in clinical practice.
use of dimethyl fumarate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Liver function abnormalities (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN) have been reported following dimethyl fumarate administration in post marketing experience [see Warnings and Precautions (5.5)]. Herpes zoster infection and other serious opportunistic infections have been reported with dimethyl fumarate administration in postmarketing experience [See Warnings and Precautions (5.3)]. 8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of VUMERITY® (diroximel fumarate) or dimethyl fumarate (which has the same active metabolite as VUMERITY) in pregnant women. In animal studies, administration of diroximel fumarate during pregnancy or throughout pregnancy and lactation resulted in adverse effects on embryofetal and offspring development (increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment) at clinically relevant drug exposures [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosage and Administration Inform patients that they will be provided a starter dose bottle: one capsule twice a day for the first 7 days and then two capsules twice a day thereafter. Advise patients to take VUMERITY as instructed. Inform patients to swallow VUMERITY capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that they should avoid a high-fat, high-calorie meal/snack at the time they take VUMERITY. If taken with food, the meal/snack should contain no more than 700 calories and no more than 30 g fat. Advise patients to avoid co-administration of VUMERITY with alcohol [see Dosage and Administration (2.2)]. Anaphylaxis and Angioedema Advise patients to discontinue VUMERITY and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.1)].
Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occured in patients who received dimethyl fumarate, and therefore may occur with VUMERITY. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Inform the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms Data associated with PML are diverse, progress over days to weeks, and Animal Data include progressive weakness on one side of the body or clumsiness Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/ of limbs, disturbance of vision, and changes in thinking, memory, day) to pregnant rats throughout organogenesis resulted in a decrease and orientation leading to confusion and personality changes [see in fetal body weight and an increase in fetal skeletal variations at the Warnings and Precautions (5.2)]. highest dose tested, which was associated with maternal toxicity. Plasma exposures (AUC) for MMF and HES (the major circulating drug- Herpes Zoster and Other Serious Opportunistic Infections related compound in humans) at the no-effect dose (100 mg/kg/day) Inform patients that herpes zoster and other serious opportunistic for adverse effects on embryofetal development were approximately infections have occurred in patients who received dimethyl fumarate 2 times those in humans at the recommended human dose (RHD) of and therefore may occur with VUMERITY. Instruct the patient of the importance of contacting their doctor if they develop any signs or 924 mg/day. Oral administration of diroximel fumarate (0, 50, 150, or 350 mg/kg/ symptoms associated with herpes zoster or other serious opportunistic day) to pregnant rabbits throughout organogenesis resulted in an infections [see Warnings and Precautions (5.3)]. increase in fetal skeletal malformations at the mid and high doses and Lymphocyte Counts reduced fetal body weight and increases in embryofetal death and Inform patients that VUMERITY may decrease lymphocyte counts. A fetal skeletal variations at the highest dose tested. The high dose was blood test should be obtained before they start therapy. Blood tests are associated with maternal toxicity. Plasma exposures (AUC) for MMF also recommended after 6 months of treatment, every 6 to 12 months and HES at the no-effect dose (50 mg/kg/day) for adverse effects on thereafter, and as clinically indicated [see Warnings and Precautions embryofetal development were similar to (MMF) or less than (HES) (5.4) and Adverse Reactions (6.1)]. those in humans at the RHD. Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/day) Liver Injury to rats throughout gestation and lactation resulted in reduced weight, Inform patients that VUMERITY may cause liver injury. Instruct which persisted into adulthood, and adverse effects on neurobehavioral patients treated with VUMERITY to report promptly to their healthcare function in offspring at the highest dose tested. Plasma exposures provider any symptoms that may indicate liver injury, including fatigue, (AUC) for MMF and HES at the no-effect dose for adverse effects on anorexia, right upper abdominal discomfort, dark urine, or jaundice. A postnatal development (100 mg/kg/day) were approximately 3 times blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions (5.5)]. (MMF) or similar to (HES) those in humans at the RHD. Flushing and Gastrointestinal (GI) Reactions 8.2 Lactation Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are Risk Summary There are no data on the presence of diroximel fumarate or metabolites the most common reactions, especially at the initiation of therapy, and (MMF, HES) in human milk. The effects on the breastfed infant and on may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI milk production are unknown. The developmental and health benefits of breastfeeding should be reactions. Advise patients experiencing flushing that taking VUMERITY considered along with the mother’s clinical need for VUMERITY and with food (avoid high-fat, high-calorie meal or snack) or taking a nonany potential adverse effects on the breastfed infant from the drug or enteric coated aspirin prior to taking VUMERITY may help [see Dosage and Administration (2.2) and Adverse Reactions (6.1)]. from the underlying maternal condition. Pregnancy 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been Instruct patients that if they are pregnant or plan to become pregnant while taking VUMERITY they should inform their healthcare provider established. [see Use in Specific Populations (8.1)]. 8.5 Geriatric Use Clinical studies of dimethyl fumarate and VUMERITY did not include 54499-02 sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Manufactured for: Biogen Inc. 8.6 Renal Impairment No dosage adjustment is necessary in patients with mild renal Cambridge, MA 02142 impairment. Because of an increase in the exposure of a major metabolite [2-hydroxyethyl succinimide (HES)], use of VUMERITY is VUMERITY is a registered trademark of Biogen. not recommended in patients with moderate or severe renal impairment © Biogen 2019 - 2020 [see Clinical Pharmacology (12.3)].
Tools & Resources
Enhanced Neurology Compensation and Productivity Survey Launches The AAN’s Neurology Compensation and Productivity Survey is available to US members on March 8. It is the largest and only survey and report dedicated solely to the field of neurology and neurologic subspecialties.
continues to provide meaningful data for neurologists and advanced practice providers, representing up to 18 subspecialties and various practice settings including solo and private, government-based, and academic.
The enhanced survey will capture data on how the COVID-19 pandemic disrupted practices in 2020, including effects on telehealth use, salaries, hours worked, visit volume, and more. It is easy to take the survey as it lets you skip question that aren’t relevant, and you can save your work and come back to it later. Business administrators can participate on behalf of their practice or department via an easy to fill out spreadsheet.
Visit AAN.com/benchmark to learn more.
Complete the survey by May 14 to equip yourself with powerful benchmarking data to help improve your practice and evaluate factors that affect neurologist and APP compensation. Participants will receive complimentary access to the customizable dashboard for free―a $500 value. The dashboard will be available by July 2021. The 2019 survey had more than 3,000 responses, and this year the AAN seeks greater participation to ensure this survey
Free Dashboard Access for Participants Complete the Neurology Compensation and Productivity Survey so you can: Filter by subspecialty, gender, practice setting, region, and more Benchmark compensation for neurologists and APPs Identify wRVU and other productivity benchmarks Assess the COVID-19 pandemic impact View on-call rates and duties
Change in Use of New G2211 Code An article in the January issue of AANnews reported that the Centers for Medicare & Medicaid Services planned to implement a new add-on code (G2211) to account for the additional complexity
associated with certain E/M services.
2021 was signed into law. One of the provisions delays the implementation of G2211 for three years, meaning this code will not be effective for use in 2021.
However, in late December after the AANnews issue went to print, the Consolidated Appropriations Act,
Education & Research
UCNS Certifies New Diplomates in Headache Medicine The United Council for Neurologic Subspecialties (UCNS) recently certified 117 physicians after they passed the 2020 UCNS Headache Medicine Certification Examination. Demonstrating their expert knowledge in Headache Medicine, these physicians now hold the distinction of being UCNS diplomates. There are currently 707 physician diplomates certified in Headache Medicine.
For a complete list of all new Headache Medicine Diplomates, visit UCNS.org/News.
Physicians in the United States and Canada who meet the eligibility requirements may apply for certification in Headache Medicine. The next Headache Medicine certification examination will take place in 2022.
AANnews • March 2021 35
Tools & Resources
Understand the Impact of Benchmarking on MIPS The requirements for Quality Payment Program (QPP) Merit-based Incentive Payment System (MIPS) administered by the Centers for Medicare & Medicaid Services (CMS) are complex. AAN members may not be aware of how CMS has benchmarked quality measure performance and the impact on MIPS reporting score. What is benchmarking? Benchmarking is a method of evaluating performance of group practices and individual providers. For MIPS, CMS sets the benchmark annually for every quality measure that has sufficient historical data to determine a benchmark. Each submission method will have specific benchmarks to meet the requirements. Providers that are reporting on the same measure may have different benchmarks depending on if they are reporting via claims, electronic health record (EHR) vendor, or Qualified Clinical Data Registry (QCDR) like the Axon Registry ®. How many measures do I need to submit to be eligible for MIPS? For the MIPS quality category, providers should be reporting six measures and at least one of these measures should be an outcome measure. If an outcome measure is not available, eligible providers must report one high priority measure.
What is the total score I can earn for a benchmarked Axon Registry measure? The points available will vary for each measure. CMS will award between zero and 10 points for each of the six quality measures reported. If there is no benchmark for the measure, up to three points will be awarded. Currently, there are multiple Axon Registry QCDR measures with benchmark data. Examples of measures only available via Axon Registry and their potential points to be awarded are listed below. The decile corresponds with the points awarded for a measure assuming data completeness thresholds are met. AAN members can enroll in the Axon Registry and report for 2021 MIPS if they meet the following deadlines: complete enrollment by June 30 and complete onboarding with measure refinement completed by December 1. Request more information at registry@aan.com. If you have additional QPP or MIPS questions, the AAN has resources to help you at AAN.com/qpp. You also can send your questions to practice @aan.com.
Decile 3
Decile 4
Decile 5
Decile 6
Decile 7
Decile 8
Decile 9
Decile 10
MIPS Average Rate
16.67 – 49.62
49.63 – 54.48
54.49 – 57.87
57.88 – 62.6
62.61 – 67.04
67.05 – 73.17
73.18 – 79.66
>= 79.67
62.39
Exercise and Appropriate Physical Activity Counseling for Patients with MS
2.65 – 58.32
58.33 – 69.99
70.0 – 73.99
74.0 – 80.44
80.45 – 88.88
88.89 – 92.49
92.5 – 96.14
Querying About Symptoms of Autonomic Dysfunction for Patients with Parkinson’s Disease
6.25 – 53.69
53.7 – 64.72
64.73 – 81.21
81.22 – 86.79
86.8 – 90.19
90.2– – 92.66
92.67 – 96.29
Measure Title Medication Prescribed for Acute Migraine Attack
PODCAST
>= 96.15
>= 96.3
73.53
72.91
Neurology ® Podcast:
20 Minutes Pack a Punch!
Subscribe and download the latest podcast at Neurology.org/podcast 36
AANnews • March 2021
Advice on Collecting Patient Reported Outcome Data Allen L. Gee, MD, PhD, FAAN, has more than 20 years’ experience in private practice. He is the founder of Frontier NeuroHealth, providing in-person care in Cody and Gillette, WY, as well as virtual neurology care throughout the state. Gee answers some common questions on Patient Reported Outcome (PRO) that can help members successfully integrate Patient Reported Outcome Measures (PROM) data in their practice. Patient-Reported Outcomes are defined by the National Quality Forum as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”
Gee
What Patient Reported Outcome (PRO) scales or tools are you currently collecting in practice?
communicating and tracking appropriate follow-up evaluation and treatment.
Historically, we have been using Epworth Sleep Scale, STOPBANG, PHQ-9, and embedded anxiety and depression assessments as part of a computerized cognitive testing. More recently, we have digitized a series of Quality of Life (QoL) PROs.
What do you do with this data once you have it? Does it impact treatment planning or payment?
Why do you collect PRO data? What value does this data add for you, your patients, and practice? The patient's perception of their health, function, and needs are elements of insight contributing to the success of treating their conditions. They are privy, 24/7, to their functionality and their status, and their subjective observations can provide valuable information. I am part of a team that has developed machine learning algorithms combining the digitized PROs with digital gate, cognitive function, and brain volumetrics to give us a more extensive understanding of overall real and perceived functionality and responsiveness to treatments. I believe quality sleep is critical for the successful treatment of neurologic conditions including, and not limited, to headaches and cognitive complaints. Sleep-related PROs help us to identify those patients in need of further evaluation including diagnostic sleep studies. How do you collect this data? Do you fill out these surveys with your patients during the office exam, use a portal to get info in advance of the visit, or use other staff to ask questions? Data can be collected in many ways. We have the digital devices which can capture digital PROs directly from the patient. We have not yet successfully, at scale, implemented patient portal access to PROs. We also utilize medical assistants to collect information from the patients. Assuming, at some point, you have had a patient whose depression or anxiety scores were worrying, how does your practice address these concerns? There are expectations, and there is reality. Reality is that when we surface concerning information it typically falls upon the clinical staff to address and follow up on the abnormal PROs that are worrisome. We address the concerns with the patient and refer for appropriate care. This does not always happen. In a perfect world, technology will assist us in that process of
Physicians in general are suffering from information overload. This has been severely exacerbated not only by electronic health records but also the development of more discrete data elements such as genomics and wearable devices. The amount of information is well beyond what a physician can assimilate and appropriately act upon. In the Wyoming Health Innovation Living Laboratory, we are exploring technologies to organize and contextualize the data into relevant knowledge. Do you have any tips to share with neurologists or neurology practices who are thinking about collecting this data? PROs are valuable and staying in practice is also valuable. PROs need to be integrated into the workflow. When possible, collecting that information from the patients either prior to the visit or in the waiting room would be a more efficient use of time. Some of the PROs can be revenue generating and this must be evaluated in the context of the cost of the personnel necessary to capture the PROs. PROs will be an integral part of value-based medicine in the future and so solutions that are revenue positive and efficient will need to be integrated into the clinical practice. Solutions do exist to capture information and surface relevant knowledge for us to use as clinicians. Where do you see PRO data heading in the future? PROs will be an invaluable data source to help facilitate the appropriate evaluation and treatment of patients based on their experiences and their perceptions of their health needs. PROs are challenging to collect and assimilate into the patient assessment. Integrating PRO data with digital assessments will create information and allow contextualization of that information into usable operational knowledge delivered to the provider in the continuum of care enhancing the quality and efficiency of health care. Any other thoughts or input on PROs? Be aware of which PROs are proprietary and the costs associated with using them.
For more information, or to browse common PRO scales and tools used in neurology, visit AAN.com/PRO.
AANnews • March 2021 37
Policy & Guidelines
Capitol Hill Report Capitol Hill Report presents regular updates on legislative and regulatory actions and how the Academy ensures that the voice of neurology is heard on Capitol Hill. It is emailed to US members twice monthly and is posted at AAN.com/view/HillReport. Below are some recent highlights.
Building New Relationships Key to Future Advocacy Success: Member Perspective by Amy Guzik, MD Connecting neurologists with members of Congress is a key part of AAN advocacy efforts to promote awareness of issues affecting our patients and our profession as it continues via remote visits during the pandemic. Spearheaded by Neurology on the Hill in the spring, Neurology off the Hill in the summer, and the Legislative Summit in the Fall, the AAN continues to work year-round to advocate for our patients and members. With the start of the 117th Congress this month, virtual visits are being used to educate freshman lawmakers about the AAN and our top issues. AAN advocacy staff arranged for a Zoom meeting with my newly sworn-in North Carolina district Rep. Kathy Manning and a member of her staff. This Zoom visit was a great opportunity to introduce the AAN and discuss priorities such as reducing the burden of prior authorization and step therapy, the importance of addressing drug pricing, and support of telehealth. I was able to relay the importance of telemedicine to my patients during the pandemic and maintaining access to this technology beyond the public health emergency. As a new member of Congress, Rep. Manning was incredibly receptive to hearing how these issues are affecting constituents in her district and Derek Brandt, the AAN’s director of congressional affairs, was able to support my patient stories with details of relevant legislation. The virtual visit provided a relaxed and comfortable atmosphere and meeting my local representative allowed us to connect on issues important to our community. With this connection, I was able to offer to be a resource as future bills are introduced, particularly important with the changing landscape of telehealth reimbursement and health care legislation. With nearly a year of Zoom experience under our belt, the virtual visit felt as impactful as an in-person visit. I would encourage anyone with new representation to reach out to the AAN and consider a visit. Local advocacy will continue virtually during Neurology on the Hill in May.
38
AANnews • March 2021
AAN Priorities Reintroduced for 117th Congress A bill that is not enacted in a two-year Congress perishes when that Congress adjourns. It must be reintroduced in the next Congress to be considered further. Several pieces of legislation that are supported by the AAN were reintroduced over the last few weeks, including: R. 315: Medicare Sequester COVID Moratorium Act Introduced by Reps. Brad Schneider (D-IL) and David McKinley, PE (R-WV) Extends the Medicare sequester moratorium through the end of the public health emergency (PHE) Contact your representatives in support of this legislation
R. 366: Protecting Access to Post-COVID-19 Telehealth Act Introduced by Reps. Mike Thompson (D-CA), David Schweikert (R-AZ), Bill Johnson (R-OH), Peter Welch (D-VT), and Doris Matsui (D-CA) Expands access to telehealth services for patients during and following the current PHE and ensures flexibility for future PHEs
New Health Care Executive Orders Signed On January 28, President Biden signed executive orders aimed at promoting access to care and reversing key policies from the previous administration. Specifically, the executive orders reopened access to the Health Insurance Exchange marketplace through a special enrollment period and directed federal agencies to reconsider rules and other policies that limit Americans’ access to health care. The executive orders also rescinded the global gag rule, which bars international nonprofit organizations that provide abortion counseling from using American tax dollars and directed the Department of Health and Human Services to consider immediate action to protect access to reproductive health care. The AAN continues to closely monitor as the new administration works to implement its health care agenda.
AAN Position Statement on COVID-19 Vaccinations Published continued from cover and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). Furthermore, the AAN strongly encourages that all eligible neurology health care providers become vaccinated against COVID-19 and support vaccination for all patients who qualify. In addition, the AAN strongly supports efforts to ensure all patients have equitable access to COVID-19 vaccination. Health care professionals must model and promote evidence-based public health education and practices including vaccinations, mask wearing, social distancing, and hand washing.
April 17– April 22
Read the complete position statement at AAN.com/policy-andguidelines/policy/position-statements/aan-position-statementon-covid-19-vaccination. Pictured clockwise from upper right: AAN President James C. Stevens, MD, FAAN; Paul G. Mathew, MD, DNBPAS, FAAN, FAHS; Aileen A. Antonio, MD; Sarah Song, MD, MPH, FAAN.
AAN Excellence— Delivered Unconventionally Register by March 25 for the best rates
AAN.com/21AM
American Brain Foundation
Virtual Commitment to Cures Gala to Feature Dr. Sanjay Gupta, Cindy McCain, Khloé Kardashian, Jim Cramer An impressive lineup of honorees will be on hand during the American Brain Foundation’s inspiring 2021 Commitment to Cures gala, set to take place virtually on Wednesday, April 21, during the week of the AAN Annual Meeting. Jim Cramer, host of NBC’s Mad Money, will serve as master of ceremonies; CNN Chief Medical Correspondent and neurosurgeon Sanjay Gupta, MD, will be honored with the Public Leadership in Neurology Award; Cindy McCain will receive the Commitment to Cures Award; and Khloé Kardashian will receive the Ambassador Award. The Foundation’s Scientific Breakthrough Award will be presented to Peter Goadsby, MD, PhD, for his seminal research that led to the development of biologics and drugs that block the CGRP pathway and has changed the lives of so many people with migraine. In addition, attendees will enjoy a live musical performance, craft cocktail
Gupta
Sanjay Gupta, MD Public Leadership in Neurology Award Gupta will be honored for his role in raising public awareness of brain health. As a neurosurgeon and neuroscientist who has become America’s doctor, and through his new book, Keep Sharp, he has made a massive contribution to the public’s awareness of brain health for overall health.
40
AANnews • March 2021
Goadsby
McCain
demonstration, moving patient stories, a live fundraising opportunity, and more. The popular annual Commitment to Cures event has a long tradition of supporting the Foundation by offering an opportunity for attendees to come together to celebrate how far we have come in the fight against brain disease and honor both public leaders and scientists for their contributions to finding cures for brain diseases. Funds raised from the event will support the Foundation’s research mission, which includes providing funds for crucial medical research across the whole spectrum of brain diseases and disorders. Visit AmericanBrainFoundation.org/C2C2021 to learn more and to secure your ticket or contact events@americanbrainfoundation. org or (866) 770-7570 for more information.
Kardashian
Cramer
Cindy McCain Commitment to Cures Award
Khloé Kardashian, Ambassador Award
Jim Cramer Master of Ceremonies
McCain will be honored for the awareness-building and philanthropic work she has initiated for glioblastoma after her late husband, US Senator John McCain, lost his life to the disease. She joined the American Brain Foundation board of directors in January 2020 to help raise disease awareness in the public conscience. Her fundraising work has helped advance neuroscience research and patient care.
Kardashian will be honored for courageously sharing her personal struggle with migraine and her work to destigmatize migraine. For more than 20 years, she has lived with migraine and knows first-hand that it is so much more than just a headache.
“As one of an estimated 39 million Americans and 1 billion people worldwide who live with migraine, I understand its debilitating effects, despair, stigma, and utter disruption of every aspect of life… By sharing my story, I hope to connect those living with migraine to quicker diagnosis and treatment, and to help migraine be recognized and treated like the public health crisis it is.”
WEDNESDAY, APRIL 21, 2021
Jim Cramer
Cindy McCain
Master of Ceremonies
Commitment to Cures Award
Sanjay Gupta, MD
Khloé Kardashian
Public Leadership in Neurology Award
Ambassador Award
ARE YOU FREE APRIL 21ST? We invite you to join us virtually at our Commitment to Cures gala to recognize the outstanding work being done in the pursuit of life without brain disease. Join us to learn about groundbreaking research, be inspired by patient advocates and hear from celebrity guests. This is a night you don’t want to miss.
Register today at americanbrainfoundation.org/C2C2021
Dates & Deadlines MARCH 2021 TUE
WED
THU
APRIL 2021
SUN
MON
FRI
SAT
1
2
3
4
5
6
7
8
9
10
11
12
13
SUN
MON
TUE
WED
4
5
6
7
THU
MAY 2021 FRI
SAT
1
2
3
8
9
10
SUN
MON
TUE
WED
THU
FRI
2
3
4
5
6
7
SAT
1 8
14
15
16
17
18
19
20
11
12
13
14
15
16
17
9
10
11
12
13
14
15
21
22
23
24
25
26
27
18
19
20
21
22
23
24
16
17
18
19
20
21
22
28
29
30
31
25
26
27
28
29
30
25
26
27
28
29
MARCH 1
Applications Open: UCNS Autonomic Disorders Certification UCNS.org/ADcertification
MARCH 18
Diversity Officer Webinar https://bit.ly/2NdM2gh
MARCH 25
Early Registration Deadline: 2021 AAN Annual Meeting AAN.com/21AM
APRIL 1
Applications Deadline: UCNS Clinical Neuromuscular Pathology Certification UCNS.org/CNMPcertification
APRIL 17–22
24 23 30 31
MAY 13
Applications Open: UCNS Neurocritical Care Certification UCNS.org/NCCcertification
MAY 19
2021 AAN Annual Meeting AAN.com/21AM
Neurology on the Hill Virtual Event AAN.com/NOH
APRIL 17
2021 AAN Business Meeting AAN.com/21AM
APRIL 19
Virtual Career Fair Careers.aan.com
Careers.aan.com
Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added. Neurologist/Epileptologist - Minneapolis VA Healthcare System - Minneapolis, MN The Minneapolis VA Healthcare System is actively seeking a full-time, board-certified Academic Neurologist with added expertise in epilepsy management. The Minneapolis VA Epilepsy Center of Excellence (ECOE) is a national leader in evaluation, cutting-edge treatment and clinical research involving Veterans with epilepsy, and enjoys rich collaboration with other regional ECOEs at the Madison, Portland and Seattle VA facilities. The successful candidate is fellowship trained in EEG with experience in epilepsy monitoring and management of epilepsy in the outpatient and inpatient settings and must hold added subspecialty certification in Epilepsy and/or Clinical Neurophysiology. The preferred candidate also holds Certification in Epilepsy Monitoring through the American Board of Clinical Neurophysiology. A track record of peer-reviewed publication and postfellowship clinical experience in epilepsy monitoring is also desired. The individual will be expected to engage in program development within the Minneapolis VA ECOE including; 1) evaluation and management of epilepsy patients in inpatient and outpatient settings, 2) interpret diagnostic standard, ambulatory, ICU and continuous video-EEG monitoring, 3) perform epilepsy pre-surgical evaluations, 4) precept medical students and neurology residents in outpatient general neurology clinics and on the neurology inpatient-consultation service, 5) educate clinical neurophysiology and epilepsy fellows, and 6) actively participate in research activities. The physician will participate in the Neurology on-call rotation on a regular basis and expected to work off-hour shifts, weekends, and holidays per the on-call schedule. The position offers academic
20 Career Center Ad—Full Page> AANnews, NJ, NCP appointment with the University ofNCC: Minnesota School of Placed in AANnews, Neurology Journal, or Neurology Clinical Practice +0.125 bleed, 4C Medicine – Department of Neurology8.25atx 10.875 an academic rank AANnews® Classified Advertising commensurate with level of experience. Education Debt The AAN offers a complete package of print, online, Reduction Program is Authorized. Recruitment/Relocation and in-person recruitment advertising opportunities. Incentive Authorized. Basic Requirements: United States Visit careers.AAN.com for all AAN options, rates, and Citizenship: Non-citizens may only be appointed when it is deadlines. not possible to recruit qualified citizens in accordance with Ad copy for the April 2021 print edition of AANnews VA Policy. Degree of doctor of medicine or an equivalent must be submitted by March 1, 2021. The same degree resulting from a course of education in medicine or deadline applies to changes/cancellations. osteopathic medicine. The degree must have been obtained
The American Academy of Neurology is proud to offer
THE #1 CAREER CENTER FOR NEUROLOGISTS
The American Academy of Neurology reserves the from one of the schools approved by the Department of right to decline, withdraw, or edit advertisements at its Veterans Affairs for the year in which the course of study discretion. Every care is taken to avoid mistakes, but was completed. Current, full and unrestricted license the responsibility for clerical or printer errors does to practice medicine or surgery in a State, Territory, or not exceed the cost of the ad. Commonwealth of the United States, or in the District of Columbia. Completion of residency training, or its JOB AffairsTOP TALENT equivalent, approved by the Secretary ofA Veterans in an accredited core specialty training program leading to eligibility for board certification. Proficiency in spoken Learn more! and written English. Physical requirements outlined below.Careers.AAN.com Preferred Experience: Board Certification or Board Eligibility in Neurology, Subspecialty certification in Epilepsy and/or Clinical Neurophysiology, Fellowship trained in EEG with experience in epilepsy. For additional information please contact Dr. Kevin Brown at 763.232.2942.
FIND
Apply online: USAJobs: https://www.usajobs.gov/GetJob/ViewDetails/590524000 VA Benefits information: https://www.vacareers.va.gov/why-choose-va/benefits/ index.asp
RECRUIT