VOLUME 31 · ISSUE 12 · DECEMBER 2017
Y O U R M O N T H LY A A N M E M B E R S H I P M A G A Z I N E
2018 Annual Meeting Preview Features New Innovations Look for the 2018 Annual Meeting publication, featuring meeting preview and registration information, to arrive in your mailbox this month. The publication will showcase new program innovations and highlight more than 300 top-quality programs covering the spectrum of neurology; exciting networking opportunities; and expanded experiential learning areas that allow you to interact, explore, and learn outside of the classroom. Whether you’re a clinician, researcher, resident, student, or other neurology professional—and no matter what your subspecialty area of interest—the totally flexible and dynamic 2018 Annual Meeting has what you need to succeed with new and innovative ways to nourish your mind, body, and spirit so that you can focus on doing what you do best: providing the best possible care, research, and support for patients with neurologic disease. With programming innovations inside and out of the classroom, the meeting continues to evolve to meet the diverse needs of all attendees. Continued on page 14
APRIL 21–April 27, 2018 Los Angeles •
THIS ISSUE 17
27
Be Aware of Changes in the 2018 Quality Payment Program Final Rule Free Webinar Preps You for 2018 Changes to Rules, Codes
30 Advocate Takes DIY
Approach to Creating Neurological Society
34
Don’t Forget to Renew Your Membership for 2018
Abstracts Sought for 2018 Annual Meeting Emerging Science Program Have you conducted major research since the October 23, 2017, AAN Annual Meeting abstract deadline? If so, we encourage you to submit your abstracts for the 2018 AAN Emerging Science program by February 8, 2018. Abstracts may be submitted online at AAN.com/view/18Abstracts. Work should be of major scientific importance, with key aspects of the research having been conducted after the October 23 deadline, warranting expedited presentation and publication. Case studies are not eligible for submission. The fee for abstract submission is $100 for AAN member first authors and $200 for nonmember first authors. Junior and Student members may submit abstracts at no charge. For more information, contact science@aan.com or (612) 928-6088. •
Launch Your Career at AAN’s New Career Essentials Conference The new AAN Career Essentials Conference provides a wealth of education for early career neurologists and anyone looking to brush up on key skills for success. This not-to-be-missed offering will provide a unique opportunity to learn the Continued on page 16
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1. Statistics on Parkinson’s. Parkinson's Disease Foundation. http://www.pdf.org/en/parkinson_ statistics. Accessed July 2017. 2. Ahlskog JE et al. Mov Disord. 2001;16(3):448-458. 3. Decision Resources. Parkinson’s Disease (Report: January 2015). 4. Hechtner MC et al. Parkinsonism Relat Disord. 2014;20:969-974. 5. The Michael J. Fox Foundation Survey of Parkinson’s Patients’ Off Time Experience, July 2014. ACORDA THERAPEUTICS® and the stylized ACORDA THERAPEUTICS® logo are registered trademarks of Acorda Therapeutics, Inc. ©2017 Acorda Therapeutics, Inc. All rights reserved.
Official Publication of the American Academy of Neurology
PUBLICATION The Vision of the AAN is to be indispensable to our members. The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. 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
Eileen.Henry@wolterskluwer.com
Table of Contents
COVER 2018 Annual Meeting Preview Features New Innovations Abstracts Sought for 2018 Annual Meeting Emerging Science Program Launch Your Career at AAN’s New Career Essentials Conference
PRESIDENT’S COLUMN
4 AAN Task Force Tackles Disparities in Health Care for Neurology
GUIDELINES
5 AAN Publishes Guideline on Testing of Vestibular Evoked Myogenic Potentials
MEET YOUR LEADER
12 Natalia S. Rost, MD, MPH, FAAN, FAHA
CONFERENCE
13 AAN Gives Back to Las Vegas Shooting Victims
AAN Executive Director Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela Babb, CAE Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designers: Siu Lee and Jim Hopwood Email: aannews@AAN.com AANnews is published monthly by the American Academy of Neurology for its 32,000 members worldwide. Access this magazine and other AAN publications online at AAN.com/go/elibrary. 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.
15 Entertaining, Provocative
Presentations to Headline HeadTalks Experiential Learning Area
PRACTICE
17 Be Aware of Changes in the 2018 Quality Payment Program Final Rule
18 Empower Your Practice with the
2017 Neurology Compensation and Productivity Report
18 Axon Registry Makes Great Strides in 2017
26 2017 Quality Measures Help Improve Patient Care
27 Free Webinar Preps You for
2018 Changes to Rules, Codes
28 New Interactive Electronic Exam Room Posters Help Improve Patient Experience
28 Here’s What’s New in
Neurology Now and Neurology: Clinical Practice
POLICY
29 Capitol Hill Report 30 Advocate Takes DIY Approach to Creating Neurological Society
EDUCATION
32 Review Neuro-oncology
Treatment, Complications, and More with Continuum
MEMBERSHIP
34 Don’t Forget to Renew Your Membership for 2018
34 Neuroscience Is… Rewarding Day Reflex Hammer Giveaway Is Huge Success
35 AAN Aids Neurologists in Devastated Puerto Rico
36 Apply Now for FAAN Designation
AMERICAN BRAIN FOUNDATION 37 Alzheimer’s Advocate Calls Caregivers “Unrecognized Victims”
CAREERS | 38 DATES AND DEADLINES | 39
NEWS BRIEFS The new and improved Emerging Leaders Program launched in October. The participants will be working on two AAN projects determined by the chairs of the Practice, Education, Government Relations, Member Engagement, and Science Committees: 1) How can the AAN generate innovative and meaningful volunteer opportunities for its members? and 2) How can the AAN better communicate amongst committees and integrate its many ongoing activities? The two groups will present their findings at AAN 101 at the Annual Meeting. •
AANnews • December 2017
3
President’s Column
AAN Task Force Tackles Disparities in Health Care for Neurology As neurologists, we strive to provide the highest quality patient-centered care for all of our patients. We believe and take an oath that basically pledges that we can provide this care to all patients regardless of their backgrounds. Despite our best intentions, disparities in outcomes and health care exist across sex, race, ethnicity, culture, religion, region, gender identity, and other communities for many medical conditions—including neurologic disorders.
Addressing these disparities is critical as we seek to promote high-quality patient-centered neurologic care for an increasingly diverse and aging population. We need to develop programs and resources to help our membership better handle the specific needs of our diverse patient populations. To begin to better understand and address the issue of disparities in patient outcomes in neurologic care, I have created a presidential task force. The first meeting of our new Neurology Health Care Disparities In my own professional career, I have focused Ralph L. Sacco, MD, MS, Task Force kicked off in October. AAN Board much of my research on addressing health care FAHA, FAAN members Brett M. Kissela, MD, FAAN, and disparities for stroke and helping to identify Charlene Gamaldo, MD, FAAN, are committee differences across race, ethnicity, sex, and region. chair and vice chair, respectively. The goals of Stroke disparity is just one example, and there are numerous this Health Care Disparities Task Force are to: others in our neurological profession. Identifying the difference 1. Develop strategic approach to further our understanding is often the initial step, but explanations for these inequities of the current state of health care disparities among are complex. Disparities in the incidence and outcomes for individuals suffering with neurological conditions neurologic conditions are likely driven by socioeconomic and 2. Identify an approach for the AAN to develop interventions educational differences, geographic access to care, implicit to reduce these health care disparities and explicit biases, and other factors. Regardless of cause, much more difficult work is needed to develop interventions 3. Develop methods to improve our awareness of the and correct these disparities. impact of implicit bias in the health outcomes of the neurological patient We hold dear the physician-patient relationship. It is among the most intimate and trusting relationships one can have. In our busy work day, we may lose sight of this crucial dynamic. And we may forget that, along with the burden of illness, our patients may also carry into the exam room social issues that impact their ability to engage in their care. An inability to comprehend a diagnosis and course of treatment may lead a patient to neglect a doctor’s recommendation; having inadequate access or no insurance may delay necessary care or put prescribed curative, preventative, or disease-modifying drugs out of reach; cultural fears and mistrusts, worries over financial hardships, or barriers of language and understanding can impact our ability to produce positive health outcomes. Added to that, our personal social biases—real or perceived, explicit or implicit—can further alter this relationship. These issues can have a direct bearing on whether the patient has a successful outcome and lead to disparities.
The AAN recognizes the importance of having leaders that reflect the demographics of its members and the patients they serve. We have already invested in enriching our talent pool and training our members of diverse backgrounds through our Diversity Leadership Program. I am happy to report that the third graduating class this October has already helped kick-start this task force by presenting their collective thoughts and recommendations on ways that the AAN can help address neurological disparities. With this excellent foundation, we are confident that our task force will provide some important recommendations and strategies to help move the AAN forward and be a leader in this area. We anticipate that the creation and implementation of these strategies will require input and involvement across the AAN, from science, education, and practice, to member engagement, government relations, and even our Axon Registry ®. The Neurology Health Care Disparities Task Force will present its final report to the board in June 2018. We look forward to helping our members and our patients tackle this critical issue with a goal of achieving equity for all with neurological conditions. •
Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN rsacco@aan.com @DrSaccoNeuro on Twitter
4
AANnews • December 2017
Guidelines
AAN Publishes Guideline on Testing of Vestibular Evoked Myogenic Potentials The AAN published a new practice guideline “Cervical and Ocular Vestibular Evoked Myogenic Potential Testing,” in Neurology ® online on November 1, 2017, and in the November 28 print issue. The guideline says there is weak evidence that VEMP testing may help diagnose superior canal dehiscence syndrome, or SCDS. The evidence comes from Terry Fife, MD, FAAN studies that indicated that, with VEMP testing, SCDS is possibly distinguishable from controls. While cVEMP may be used as an ancillary test in Ménière’s disease for vestibular dysfunction, it should not be used to make a diagnosis of benign paroxysmal positional vertigo. Although an absent VEMP response in one or both ears appears to occur more often in patients with vestibular migraine (VM) than in normal controls, VEMP may not be used to assist in VM diagnosis or management. “VEMP testing is a relatively new vestibular testing technique,” said Terry Fife, MD, FAAN, guideline lead author.
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“Neurologists, neurotologists, and other health care providers who diagnose and treat individuals with a variety of vestibular disorders need more evidence from better-designed studies to clarify the role of VEMP testing in diagnosing vestibular and related neurologic disorders.” Read the guideline and access PDF summaries for clinicians and patients at AAN.com. For more information, contact Julie Cox at jcox@aan.com or (612) 928-6069. • Summar y of Practice
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AAN.com
When in Doubt Check it Out AAN.com/Concussion
The World’s Largest Association of Neurologists
For the treatment of partial-onset seizures as monotherapy or adjunctive therapy
ANTISEIZURE THERAPY FINE-TUNED FOR YOUR PATIENTS
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APTIOM® (eslicarbazepine acetate) IS A ONCE-DAILY ANTIEPILEPTIC DRUG (AED) IN THE DIBENZAZEPINE CARBOXAMIDE CLASS1 APTIOM is indicated for the treatment of partial-onset seizures as monotherapy or adjunctive therapy • Proven seizure reduction as adjunctive therapy in 3 double-blind, placebo-controlled studies1 • Proven effective as monotherapy in 2 dose-blinded, historical-control studies1 • The most frequently reported adverse reactions in patients receiving APTIOM as adjunctive therapy at doses of 800 mg or 1200 mg (≥4% and ≥2% greater than placebo) were dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor1 • In adjunctive clinical studies, incidence of most common adverse reactions was generally lower when initiating APTIOM at 400 mg without concomitant carbamazepine2 • Once-daily immediate-release AED therapy—can be taken either whole or crushed, with or without food1
Important Safety Information for APTIOM Contraindications: APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including APTIOM, increase the risk of suicidal thoughts or behavior. Anyone considering prescribing APTIOM or any other AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients and caregivers should also be advised to be alert to these behavioral changes and to immediately report them to the health care provider. Serious Dermatologic Reactions, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with APTIOM use. Serious and sometimes fatal dermatologic reactions, including TEN and SJS, have also been reported in patients using oxcarbazepine or carbamazepine, which are chemically related to APTIOM. Should a patient develop a dermatologic reaction while using APTIOM, discontinue APTIOM use unless it is clearly not drug related.
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Please see additional Important Safety Information and Brief Summary of Full Prescribing Information on adjacent pages.
Dosing Considerations Some adverse reactions occur more frequently when patients take APTIOM adjunctively with carbamazepine. When APTIOM and carbamazepine are taken concomitantly, the dose of APTIOM or carbamazepine may need to be adjusted based on efficacy and tolerability. APTIOM should not be taken as an adjunctive therapy with oxcarbazepine. For patients taking other enzyme-inducing AEDs (i.e., phenobarbital, phenytoin, and primidone), higher doses of APTIOM may be needed. A dose reduction is recommended in patients with moderate and severe renal impairment (i.e., creatinine clearance <50 mL/min). Dose adjustments are not required in patients with mild to moderate hepatic impairment. Use of APTIOM in patients with severe hepatic impairment has not been studied, and use in these patients is not recommended. Concomitant use of APTIOM and oral contraceptives containing ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones. Patients should use additional or alternative non-hormonal birth control during APTIOM treatment and after discontinuation of APTIOM for one menstrual cycle, or until otherwise instructed.
For more information, visit www.AptiomHCP.com.
Important Safety Information
these adverse reactions in patients 60 years of age and older compared to younger adults. The incidences of dizziness and Indications and Usage diplopia were greater with concomitant use of APTIOM and Aptiom® (eslicarbazepine acetate) is indicated for the treatment carbamazepine compared to the use of APTIOM without of partial-onset seizures as monotherapy or adjunctive therapy. carbamazepine. Prescribers should advise patients against engaging in hazardous activities requiring mental alertness, such Important Safety Information for APTIOM as operating motor vehicles or dangerous machinery, until the Contraindications: APTIOM is contraindicated in patients with effect of APTIOM is known. Dizziness, disturbance in gait and a hypersensitivity to eslicarbazepine acetate or oxcarbazepine. coordination, somnolence, fatigue, cognitive dysfunction, and Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), visual changes were also observed in monotherapy trials. including APTIOM, increase the risk of suicidal thoughts or Withdrawal of AEDs: As with all AEDs, APTIOM should be behavior. Anyone considering prescribing APTIOM or any other withdrawn gradually because of the risk of increased seizure AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed frequency and status epilepticus. Drug Induced Liver Injury: Hepatic effects, ranging from mild to are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients treated moderate elevations in transaminases (>3 times the upper limit of normal) to rare cases with concomitant elevations of total with any AED for any indication should be monitored for the bilirubin (>2 times the upper limit of normal) have been reported emergence or worsening of depression, suicidal thoughts or with APTIOM use. Baseline evaluations of liver laboratory tests behavior, and/or any unusual changes in mood or behavior. are recommended. APTIOM should be discontinued in patients Patients and caregivers should also be advised to be alert to with jaundice or other evidence of significant liver injury. these behavioral changes and to immediately report them to the health care provider. Abnormal Thyroid Function Tests: Dose-dependent decreases in serum T3 and T4 (free and total) values have been observed Serious Dermatologic Reactions, including Stevens-Johnson in patients taking APTIOM. These changes were not associated Syndrome (SJS) and toxic epidermal necrolysis (TEN), have with other abnormal thyroid function tests suggesting been reported in association with APTIOM use. Serious and sometimes fatal dermatologic reactions, including TEN and SJS, hypothyroidism. Abnormal thyroid function tests should be clinically evaluated. have also been reported in patients using oxcarbazepine or carbamazepine, which are chemically related to APTIOM. Should Adverse Reactions: The most frequently reported adverse a patient develop a dermatologic reaction while using APTIOM, reactions in patients receiving APTIOM as adjunctive therapy discontinue APTIOM use unless it is clearly not drug related. at doses of 800 mg or 1200 mg (≥4% and ≥2% greater than placebo) were dizziness, somnolence, nausea, headache, Drug Reaction with Eosinophilia and Systemic Symptoms diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and (DRESS), also known as Multiorgan Hypersensitivity, has been tremor. Adverse reactions in monotherapy studies were reported in patients taking APTIOM. DRESS typically, although generally similar to those observed and attributed to APTIOM not exclusively, presents with fever, rash, and/or in adjunctive therapy studies. lymphadenopathy, in association with other organ system involvement. If this reaction is suspected, treatment with Safety and Efficacy in Patients <18 Years of Age: Safety and APTIOM should be discontinued. effectiveness in patients below 18 years of age have not been established. Anaphylactic Reactions and Angioedema: Rare cases of anaphylaxis and angioedema have been reported in patients Dosing Considerations taking APTIOM. Anaphylaxis and angioedema associated with Some adverse reactions occur more frequently when patients laryngeal edema can be fatal. If a patient develops any of these take APTIOM adjunctively with carbamazepine. When APTIOM reactions, the drug should be discontinued. Patients with a prior and carbamazepine are taken concomitantly, the dose of anaphylactic-type reaction after treatment with either APTIOM or carbamazepine may need to be adjusted based on oxcarbazepine or APTIOM should not be treated with APTIOM. efficacy and tolerability. APTIOM should not be taken as an Hyponatremia: Clinically significant hyponatremia (sodium adjunctive therapy with oxcarbazepine. For patients taking other <125 mEq/L) can develop in patients taking APTIOM. In the enzyme-inducing AEDs (i.e., phenobarbital, phenytoin, and controlled adjunctive epilepsy trials, 1.0% (800 mg) and 1.5% primidone), higher doses of APTIOM may be needed. (1200 mg) of patients treated with APTIOM had at least one A dose reduction is recommended in patients with moderate serum sodium level value less than 125 mEq/L, compared to and severe renal impairment (i.e., creatinine clearance none on placebo. These effects were dose related and generally <50 mL/min). Dose adjustments are not required in patients appeared within the first 8 weeks of treatment (as early as after with mild to moderate hepatic impairment. Use of APTIOM in 3 days). Measurement of serum sodium and chloride levels patients with severe hepatic impairment has not been studied, should be considered during maintenance treatment with and use in these patients is not recommended. APTIOM, particularly if the patient is receiving other medications Concomitant use of APTIOM and oral contraceptives containing known to decrease serum sodium levels. Hyponatremia was ethinylestradiol and levonorgestrel is associated with lower also observed in monotherapy trials. plasma levels of these hormones. Patients should use additional Neurological Adverse Reactions: APTIOM causes doseor alternative non-hormonal birth control during APTIOM dependent increases in the following reactions (dizziness, treatment and after discontinuation of APTIOM for one disturbance in gait and coordination, somnolence, fatigue, menstrual cycle, or until otherwise instructed. cognitive dysfunction, and visual changes) compared to Please see Brief Summary of Full Prescribing Information placebo. These events were more often serious in APTIOMon adjacent pages. treated patients than placebo. There was an increased risk of dizziness, disturbance in gait and coordination, and visual References: 1. APTIOM [prescribing information]. Sunovion changes during the titration period (compared to the Pharmaceuticals Inc., Marlborough, MA, September 2016. 2. Data maintenance period), and there may be an increased risk of on file, Sunovion Pharmaceuticals Inc.
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Under license from SUNOVION and are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. ©2016 Sunovion Pharmaceuticals Inc. All rights reserved. 10/16 APT638-16
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE
Partial-Onset Seizures APTIOM (eslicarbazepine acetate) is indicated for the treatment of partial-onset seizures as monotherapy or adjunctive therapy.
CONTRAINDICATIONS
APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine.
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including APTIOM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% confidence interval [CI]: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebotreated patients, but the number of events is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs. Table 2: Risk of Suicidal Thoughts or Behaviors by Indication for Antiepileptic Drugs in the Pooled Analysis
Indication
Drug Relative Risk: Placebo Incidence of Patients Patients with Events in with Events Events Drug Patients/ Per 1000 Per 1000 Incidence in Patients Patients Placebo Patients
Risk Differences: Additional Drug Patients with Events Per 1000 Patients
Epilepsy
1.0
3.4
3.5
2.4
Psychiatric
5.7
8.5
1.5
2.9
Other
1.0
1.8
1.9
0.9
Total
2.4
4.3
1.8
1.9
The relative risk for suicidal thoughts or behavior was higher in clinical trials in patients with epilepsy than in clinical trials in patients with psychiatric or other conditions, but the absolute risk differences were similar for epilepsy and psychiatric indications. Anyone considering prescribing APTIOM or any other AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and
mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression; any unusual changes in mood or behavior; or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Serious Dermatologic Reactions Serious dermatologic reactions including StevensJohnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with APTIOM use. Serious and sometimes fatal dermatologic reactions, including TEN and SJS, have also been reported in patients using oxcarbazepine or carbamazepine which are chemically related to APTIOM. The reporting rate of these reactions associated with oxcarbazepine use exceeds the background incidence rate estimates by a factor of 3- to 10-fold. The reporting rates for APTIOM have not been determined. Risk factors for the development of serious and potentially fatal dermatologic reactions with APTIOM use have not been identified. If a patient develops a dermatologic reaction while taking APTIOM, discontinue APTIOM use, unless the reaction is clearly not drug-related. Patients with a prior dermatologic reaction with oxcarbazepine, carbamazepine, or APTIOM should ordinarily not be treated with APTIOM. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan Hypersensitivity, has been reported in patients taking APTIOM. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. APTIOM should be discontinued and not be resumed if an alternative etiology for the signs or symptoms cannot be established. Patients with a prior DRESS reaction with either oxcarbazepine or APTIOM should not be treated with APTIOM. Anaphylactic Reactions and Angioedema Rare cases of anaphylaxis and angioedema have been reported in patients taking APTIOM. Anaphylaxis and angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with APTIOM, the drug should be discontinued. Patients with a prior anaphylactic-type reaction with either oxcarbazepine or APTIOM should not be treated with APTIOM. Hyponatremia Clinically significant hyponatremia (sodium <125 mEq/L) can develop in patients taking APTIOM. In the controlled adjunctive epilepsy trials, 4/415 patients (1.0%) treated with 800 mg and 6/410 (1.5%) patients treated with 1200 mg of APTIOM had at least one serum sodium value less than 125 mEq/L, compared to none of the patients assigned to placebo. A higher percentage of APTIOM-treated patients (5.1%) than placebo-treated patients (0.7%) experienced decreases in sodium values of more than 10 mEq/L. These effects were dose-related and generally appeared within the first 8 weeks of treatment (as early as after 3 days). Serious, lifethreatening complications were reported with APTIOMassociated hyponatremia (as low as 112 mEq/L) including seizures, severe nausea/vomiting leading to dehydration, severe gait instability, and injury. Some
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patients required hospitalization and discontinuation of APTIOM. Concurrent hypochloremia was also present in patients with hyponatremia. Depending on the severity of hyponatremia, the dose of APTIOM may need to be reduced or discontinued. Hyponatremia was also observed in monotherapy trials. Measurement of serum sodium and chloride levels should be considered during maintenance treatment with APTIOM, particularly if the patient is receiving other medications known to decrease serum sodium levels and should be performed if symptoms of hyponatremia develop (e.g., nausea/vomiting, malaise, headache, lethargy, confusion, irritability, muscle weakness/spasms, obtundation, or increase in seizure frequency or severity). Neurological Adverse Reactions Dizziness and Disturbance in Gait and Coordination APTIOM causes dose-related increases in adverse reactions related to dizziness and disturbance in gait and coordination (dizziness, ataxia, vertigo, balance disorder, gait disturbance, nystagmus, and abnormal coordination). In controlled adjunctive epilepsy trials, these events were reported in 26% and 38% of patients randomized to receive APTIOM at doses of 800 mg and 1200 mg/day, respectively, compared to 12% of placebo-treated patients. Events related to dizziness and disturbance in gait and coordination were more often serious in APTIOM-treated patients than in placebo-treated patients (2% vs. 0%), and more often led to study withdrawal in APTIOM-treated patients than in placebo-treated patients (9% vs. 0.7%). There was an increased risk of these adverse reactions during the titration period (compared to the maintenance period) and there also may be an increased risk of these adverse reactions in patients 60 years of age and older compared to younger adults. Nausea and vomiting also occurred with these events. Dizziness and disturbance in gait and coordination were also observed in monotherapy trials. The incidence of dizziness was greater with the concomitant use of APTIOM and carbamazepine compared to the use of APTIOM without carbamazepine (up to 37% vs. 19%, respectively). Therefore, consider dosage modifications of both APTIOM and carbamazepine if these drugs are used concomitantly. Somnolence and Fatigue APTIOM causes dose-dependent increases in somnolence and fatigue-related adverse reactions (fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy). In the controlled adjunctive epilepsy trials, these events were reported in 13% of placebo patients, 16% of patients randomized to receive 800 mg/day APTIOM, and 28% of patients randomized to receive 1200 mg/day APTIOM. Somnolence and fatigue-related events were serious in 0.3% of APTIOM-treated patients (and 0 placebo patients) and led to discontinuation in 3% of APTIOM-treated patients (and 0.7% of placebo-treated patients). Somnolence and fatigue were also observed in monotherapy trials. Cognitive Dysfunction APTIOM causes dose-dependent increases in cognitive dysfunction-related events (memory impairment, disturbance in attention, amnesia, confusional state, aphasia, speech disorder, slowness of thought, disorientation, and psychomotor retardation). In the controlled adjunctive epilepsy trials, these events were reported in 1% of placebo patients, 4% of patients randomized to receive 800 mg/day APTIOM, and 7% of patients randomized to receive 1200 mg/day APTIOM. Cognitive dysfunction-related events were serious in 0.2% of APTIOM-treated patients (and 0.2% of placebo patients) and led to discontinuation in 1% of APTIOM-treated patients (and 0.5% of placebo-treated patients). Cognitive dysfunction events were also observed in monotherapy trials. Visual Changes APTIOM causes dose-dependent increases in events related to visual changes including diplopia, blurred vision, and impaired vision. In the controlled adjunctive epilepsy trials, these events were reported in 16% of patients randomized to receive APTIOM compared to 6% of placebo patients. Eye events were serious in 0.7% of APTIOMtreated patients (and 0 placebo patients) and led to discontinuation in 4% of APTIOM-treated patients (and
0.2% of placebo-treated patients). There was an increased risk of these adverse reactions during the titration period (compared to the maintenance period) and also in patients 60 years of age and older (compared to younger adults). The incidence of diplopia was greater with the concomitant use of APTIOM and carbamezepine compared to the use of APTIOM without carbamazepine (up to 16% vs. 6%, respectively). Events related to visual changes were also observed in monotherapy trials. Hazardous Activities Prescribers should advise patients against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of APTIOM is known. Withdrawal of AEDs As with all antiepileptic drugs, APTIOM should be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. Drug Induced Liver Injury Hepatic effects, ranging from mild to moderate elevations in transaminases (>3 times the upper limit of normal) to rare cases with concomitant elevations of total bilirubin (>2 times the upper limit of normal) have been reported with APTIOM use. Baseline evaluations of liver laboratory tests are recommended. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury. APTIOM should be discontinued in patients with jaundice or other evidence of significant liver injury (e.g., laboratory evidence). Abnormal Thyroid Function Tests Dose-dependent decreases in serum T3 and T4 (free and total) values have been observed in patients taking APTIOM. These changes were not associated with other abnormal thyroid function tests suggesting hypothyroidism. Abnormal thyroid function tests should be clinically evaluated.
ADVERSE REACTIONS
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 practice. In monotherapy trials in patients with partial-onset seizures [Study 1 and Study 2], 365 patients received APTIOM, of whom 225 were treated for longer than 12 months and 134 for longer than 24 months. Of the patients in those trials, 95% were between 18 and 65 years old; 48% were male, and 84% were Caucasian. Across controlled and uncontrolled trials in patients receiving adjunctive therapy for partial-onset seizures, 1195 patients received APTIOM, of whom 586 were treated for longer than 6 months and 462 for longer than 12 months. In the placebo controlled adjunctive therapy trials in patients with partial-onset seizures (Study 3, Study 4 and Study 5), 1021 patients received APTIOM. Of the patients in those trials, approximately 95% were between 18 and 60 years old, approximately 50% were male, and approximately 80% were Caucasian. Monotherapy Historical Control Trials In the monotherapy epilepsy trials (Study 1 and Study 2), 13% of patients randomized to receive APTIOM at the recommended doses of 1200 mg and 1600 mg once daily discontinued from the trials as a result of an adverse event. The adverse reaction most commonly (≥1% on APTIOM) leading to discontinuation was hyponatremia. Adverse reactions observed in these studies were generally similar to those observed and attributed to drug in adjunctive placebo-controlled studies. Because these studies did not include a placebo control group, causality could not be established. Dizziness, nausea, somnolence, and fatigue were all reported at lower incidences during the AED Withdrawal Phase and Monotherapy Phase compared with the Titration Phase. Adjunctive Therapy Controlled Trials In the controlled adjunctive therapy epilepsy trials (Study 3,
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AANnews • September 2017
Study 4, and Study 5), the rate of discontinuation as a result of any adverse reaction was 14% for the 800 mg dose, 25% for the 1200 mg dose, and 7% in subjects randomized to placebo. The adverse reactions most commonly (≥1% in any APTIOM treatment group, and greater than placebo) leading to discontinuation, in descending order of frequency, were dizziness, nausea, vomiting, ataxia, diplopia, somnolence, headache, blurred vision, vertigo, asthenia, fatigue, rash, dysarthria, and tremor. The most frequently reported adverse reactions in patients receiving APTIOM at doses of 800 mg or 1200 mg (≥4% and ≥2% greater than placebo) were dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Table 3 gives the incidence of adverse reactions that occurred in ≥2% of subjects with partial-onset seizures in any APTIOM treatment group and for which the incidence was greater than placebo during the controlled clinical trials. Adverse reactions during titration were less frequent for patients who began therapy at an initial dose of 400 mg for 1 week and then increased to 800 mg compared to patients who initiated therapy at 800 mg. Table 3: Adverse Reactions Incidence in Pooled Controlled Clinical Trials of Adjunctive Therapy in Adults (Events ≥2% of Patients in the APTIOM 800 mg or 1200 mg Dose Group and More Frequent Than in the Placebo Group) APTIOM
Placebo
800 mg 1200 mg (N=426) (N=415) (N=410) % % % Ear and labyrinth disorders Vertigo Eye disorders Diplopia Blurred vision Visual impairment Gastrointestinal disorders Nausea Vomiting Diarrhea Constipation Abdominal pain Gastritis General disorders and administration site conditions Fatigue Asthenia Gait disturbance Peripheral edema Infections and Infestations Urinary tract infections Injury, poisoning and procedural complications Fall Metabolism and nutrition disorders Hyponatremia Nervous system disorders Dizziness Somnolence Headache Ataxia Balance disorder Tremor Dysarthria Memory impairment Nystagmus Psychiatric disorders Depression Insomnia Respiratory, thoracic and mediastinal disorders Cough Skin and subcutaneous tissue disorders Rash Vascular disorders Hypertension
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2
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Other Adverse Reactions with APTIOM Use Compared to placebo, APTIOM use was associated with slightly higher frequencies of decreases in hemoglobin and hematocrit, increases in total cholesterol, triglycerides, and LDL, and increases in creatine phosphokinase. Adverse Reactions Based on Gender and Race No significant gender differences were noted in the incidence of adverse reactions. Although there were few non-Caucasian patients, no differences in the incidences of adverse reactions compared to Caucasian patients were observed.
DRUG INTERACTIONS
General Information Several AEDs (e.g., carbamazepine, phenobarbital, phenytoin, and primidone) can induce enzymes that metabolize APTIOM and can cause decreased plasma concentrations of eslicarbazepine (see Figure 1). APTIOM can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and omeprazole). In vivo studies suggest that APTIOM can induce CYP3A4, decreasing plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., simvastatin) (see Figure 2). Potential for Other AEDs to Affect Eslicarbazepine The potential impact of other AEDs on the systemic exposure (area under the curve, AUC) of eslicarbazepine, the active metabolite of APTIOM, is shown in Figure 1: Figure 1: Potential Impact of Other AEDs on AUC of Eslicarbazepine Change due to Fold Change and 90% CI Recommendation
6
Carbamazepine
May need dose adjustment
Gabapentin Lamotrigine Levetiracetam Phenobarbital*
None None None
2 1 1
9 6 2
11 5 1
5 3 3 1 1 <1
10 6 4 2 2 2
16 10 2 2 2 <1
4 2 <1 1
4 2 2 2
7 3 2 1
1
2
2
1
3
1
<1
2
2
9 8 9 2 <1 1 0 <1 <1
20 11 13 4 3 2 1 1 1
28 18 15 6 3 4 2 2 2
2 1
1 2
3 2
1
2
1
1
1
3
1
1
2
May need higher dose of APTIOM
Phenytoin
May need higher dose of APTIOM None None
Topiramate Valproate
0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 Change of eslicarbazepine relative to reference *Phenobarbital and/or phenobarbital-like AEDs (e.g., primidone)
Potential for APTIOM to Affect Other Drugs The potential impact of APTIOM on the systemic exposure (AUC) of other drugs (including AEDs) is shown in Figures 2a and 2b: Figure 2a: Potential Impact of APTIOM on the AUC of AEDs Change in Fold Change and 90% CI Recommendation AEDs: Carbamazepine Gabapentin Lamotrigine Levetiracetam Phenobarbital Phenytoin
Topiramate Valproate
*May need dose adjustment None None None None Monitor plasma phenytoin concentration; in epilepsy, dose adjustment may be needed based on clinical response and serum levels of phenytoin None None
0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 Change of other drugs relative to reference *Potential pharmacodynamic interaction
Figure 2b: Potential Impact of APTIOM on the AUC of Non-AEDs Change in
Fold Change and 90% CI Recommendation
Non-AEDs Digoxin
None
Metformin Statins: Simvastatin
Rosuvastatin
Oral Contraceptives: Ethinylestradiol Levonorgestrel Warfarin: S-Warfarin R-Warfarin
None Adjust dose of simvastatin if a clinically significant change in lipids is noted Adjust dose of rosuvastatin if a clinically significant change in lipids is noted Additional or alternative non-hormonal birth control should be used Patients should be monitored to maintain INR
0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 Change of other drugs relative to reference Oral Contraceptives Because concomitant use of APTIOM and ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones, females of reproductive potential should use additional or alternative nonhormonal birth control.
USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including teratogenicity (mice), embryolethality (rats), and fetal growth retardation, at clinically relevant doses. APTIOM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When eslicarbazepine acetate was orally administered (150, 350, 650 mg/kg/day) to pregnant mice throughout organogenesis, increased incidences of fetal malformations was observed at all doses and fetal growth retardation was observed at the mid and high doses. A no-effect dose for adverse developmental effects was not identified. At the lowest dose tested, plasma eslicarbazepine exposure (Cmax, AUC) is less than that in humans at the maximum recommended human dose (MRHD, 1600 mg/day). Oral administration of eslicarbazepine acetate (40, 160, 320 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in fetal growth retardation and increased incidences of skeletal variations at the mid and high doses. The no-effect dose (40 mg/kg/day) is less than the MRHD on a mg/m2 basis. Oral administration to pregnant rats (65, 125, 250 mg/kg/day) throughout organogenesis resulted in embryolethality at all doses, increased incidences of skeletal variations at the mid and high doses, and fetal growth retardation at the high dose. The lowest dose tested (65 mg/kg/day) is less than the MRHD on a mg/m2 basis. When eslicarbazepine acetate was orally administered to female mice during pregnancy and lactation (150, 350, 650 mg/kg/day), the gestation period was prolonged at the highest dose tested. In offspring, a persistent reduction in offspring body weight and delayed physical development and sexual maturation were observed and the mid and high doses. The lowest dose tested (150 mg/kg/day) is less than the MRHD on a mg/m2 basis.
When eslicarbazepine acetate was orally administered (65, 125, 250 mg/kg/day) to rats during pregnancy and lactation, reduced offspring body weight was seen at the mid and high doses. Delayed sexual maturation and a neurological deficit (decreased motor coordination) were observed at the highest dose tested. The no-effect dose for adverse developmental effects (65 mg/kg/day) is less than the MRHD on a mg/m2 basis. The rat data are of uncertain relevance to humans because of differences in metabolic profile between species. Pregnancy Registry Physicians are advised to recommend that pregnant patients taking APTIOM enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling 1-888-233-2334 (toll-free), and must be done by patients themselves. Information on the registry can also be found at the website http://www. aedpregnancyregistry.org/. Nursing Mothers Eslicarbazepine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from APTIOM, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in patients below 18 years of age have not been established. In a juvenile animal study in which eslicarbazepine acetate (40, 60, 160 mg/kg/day) was orally administered to young dogs for 10 months starting on postnatal day 21, mortality and evidence of immunotoxicity (bone marrow hypocellularity and lymphoid tissue depletion) were observed at all doses. Convulsions were seen at the highest dose tested. Adverse effects on bone growth (decreased bone mineral content and density) were seen in females at all doses at the end of the dosing period, but not at the end of a 2-month recovery period. None of these findings were reported in adult dogs dosed with eslicarbazepine acetate for up to 12 months in duration. A no-effect dose for adverse effects on juvenile dogs was not identified.
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Geriatric Use There were insufficient numbers of patients ≥65 years old enrolled in the controlled adjunctive epilepsy trials (N=15) to determine the efficacy of APTIOM in this patient population. The pharmacokinetics of APTIOM were evaluated in elderly healthy subjects (N=12). Although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions and drug therapies in the elderly patient. Dose adjustment is necessary if CrCl is <50 mL/min. Patients with Renal Impairment Clearance of eslicarbazepine is decreased in patients with impaired renal function and is correlated with creatinine clearance. Dosage adjustment is necessary in patients with CrCl<50 mL/min. Patients with Hepatic Impairment Dose adjustments are not required in patients with mild to moderate hepatic impairment. Use of APTIOM in patients with severe hepatic impairment has not been evaluated, and use in these patients is not recommended.
DRUG ABUSE AND DEPENDENCE Controlled Substance APTIOM is not a controlled substance. Abuse Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority
to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence). In a human abuse study in recreational sedative abusers APTIOM showed no evidence of abuse. In Phase 1, 1.5% of the healthy volunteers taking APTIOM reported euphoria compared to 0.4% taking placebo. Dependence Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. The potential for APTIOM to produce withdrawal symptoms has not been adequately evaluated. In general, antiepileptic drugs should not be abruptly discontinued in patients with epilepsy because of the risk of increased seizure frequency and status epilepticus.
OVERDOSAGE Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans Symptoms of overdose are consistent with the known adverse reactions of APTIOM and include hyponatremia (sometimes severe), dizziness, nausea, vomiting, somnolence, euphoria, oral paraesthesia, ataxia, walking difficulties, and diplopia. The maximum dosage studied in open-label monotherapy treatment following withdrawal of concomitant AEDs was 2400 mg once daily. Treatment or Management of Overdose There is no specific antidote for overdose with APTIOM. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered. Standard hemodialysis procedures result in partial clearance of APTIOM. Hemodialysis may be considered based on the patient’s clinical state or in patients with significant renal impairment.
PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide and Patient Counseling Information section in the Full Prescribing Information.
Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA Under license from SUNOVION and are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. © 2016 Sunovion Pharmaceuticals Inc. All rights reserved. September 2016 9/16 APT550-16
Meet Your Leader
Natalia S. Rost, MD, MPH, FAAN, FAHA Natalia S. Rost, MD, MPH, FAAN, FAHA, is director of the Acute Stroke Services at Massachusetts General Hospital and associate 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. As clinician-scientist, Rost dedicated her career to the care of patients with stroke and reducing the burden of post-stroke disability through excellence and innovation in care and neurological science. Her research has been continuously supported by the National Institutes of Health and foundations including National Stroke Association, Bugher Foundation of the American Heart/Stroke Association, and the NIH Career Development Award (K23). Rost is an author of numerous peerreviewed publications, book chapters, and co-author of the MGH Handbook of Neurology. She serves as assistant editor of the journal STROKE, and she recently completed her tenure as president of the Boston Board of the American Heart/Stroke Association. How did you first get involved as a volunteer on committees/ subcommittees and what moved you to participate? I am proud to say that I have been involved with the Academy since 1999, when I joined as a first-year medical student member, and I became the founding president of the Student Interest Group in Neurology (SIGN) chapter at Boston University School of Medicine. I was looking for a community of individuals who were as enthusiastic and passionate about neurology as I was, and I was fortunate to find support and mentorship at the AAN at that critical point in my professional career. I was asked to serve as a medical student liaison on the Undergraduate Education Subcommittee led by Dr. Ralph Józefowicz. He was such an inspiration to so many neurology trainees and was instrumental in giving me an opportunity to develop my leadership skills and to spearhead the nationwide expansion of the SIGN program in the years to follow. Ever since, the Academy provided an outstanding platform for my career development, including an opportunity to build professional networks, to develop programs that have made and continue to make a terrific impact on our field, and, not in the least, to collaborate with the most outstanding professional staff one can imagine working with. Throughout the years, I have volunteered at the Academy in many ways, including my
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AANnews • December 2017
service on the Graduate Education Subcommittee and a number of working groups (e.g., Academic Career, Brain Health, Women in Leadership) and task forces (e.g., Industry Guidelines, Award Guidelines). However, as a clinician-scientist myself, I found my best fit as a member, past vice chair, and now chair of the AAN Science Committee. I enjoy tremendously the opportunity to work with a brilliant and dedicated AAN science group, staying at the leading edge of discovery while shaping the Scientific Program at the Annual Meeting and beyond. The transformation of science at the AAN has been impressive over the past decade, and I cannot wait to see it evolve and expand even further, in an innovative and comprehensive way, as we continue to integrate the cuttingedge of science into the everyday practice of neurology. Why did you wish to be on the Board of Directors? The chairs of the major AAN committees serve ex officio on the Board of the AAN Institute. The charge of the Science Committee and its subcommittees is to develop and maintain a robust and effective scientific agenda for the Academy, including the Annual Meeting program and beyond. As chair of Science, I represent my committee on the Board by keeping my focus on “all things science” at the Academy, including a number of the priority objectives associated with the science activities in the current Board’s
strategic and operational plans. This is an important opportunity to impact the future directions our organization and the field in general are headed, as science plays a major role in that. What experiences and viewpoints do you bring to this role? I bring to this role my experience as an academic neurologist and clinician-scientist, which provide the foundation for my collaborative and innovative leadership style. I see the AAN as the home for academic neurologists and practitioners alike, and I fully subscribe to the core values of integrity, leadership, professionalism, commitment, respect, diversity and equality, and compassion championed by the Academy. It is important to me that we nurture our neurology trainees in the culture of integrity and enthusiasm for our profession, and that scientific underpinnings of neurological practice remain front and center at the AAN. The future cures for neurological disorders depend on close collaboration between the dedicated scientists and clinicians, and I am committed to supporting this mission in every capacity as a new Board member and the AAN Science Committee chair. From your experiences as an AAN leader, what is one of the more common misperceptions members may have about the Academy? I am always surprised to know how many AAN initiatives that are instrumental to the well-being of our
profession may not be fully recognized by the membership. The Academy has been the first to acknowledge the importance of “the pipeline” by opening doors to medical students and even pre-med (both college and high school!) involvement decades ago, by developing career opportunities for the growing number of neurologists in the US, and importantly, by funding research training. With regard to funding, the AAN recognized the importance of funding aspiring academic neurologists and neuroscientists nearly three decades ago. Today, the AAN is the only professional neurological organization that provides dedicated research funding through its ambitious Research Program portfolio, which includes 19 different awards ranging from $130,000 to $450,000 and designed for all types of research across all career levels, discovery stages, and disease states. I am very proud of the AAN’s vision and leadership in this matter!
member should take a moment to assess how has the AAN supported and continues to support their careers. Was it through the RITE exam during your residency or Continuum publications after you started your practice? Was it through the opportunities to apply for your first clinical research training fellowship award, through providing basic training on MACRA, or through giving you an opportunity to engage with patient advocacy at the Neurology on the Hill? Perhaps, you have met your mentor at one of the AAN Annual Meetings, or your residents—just like mine—presented their first poster there. Each one of us has arrived to the AAN with different goals and aspirations for our careers in neurology, and the AAN is doing its best to help us succeed. Importantly, though, the AAN is also a learning organization; it’s always listening to its members, dynamically transforming in response, and always looking for opportunities to find more ways of being truly indispensable. Any feedback is always welcome! •
In your view, how does the AAN benefit the field of neurology most? By bringing everyone together! The AAN provides a cohesive matrix, which allows all members to benefit from the expertise and experience of their colleagues coming from various career paths and stages of their careers. The AAN provides the vision for the field of neurology to move forward, and it engages the membership in developing the strategy on getting there. The AAN membership is robust in its sheer size and diversity, and it feels like a true community of neurologists and for neurologists. There is really nothing like that for neurologists out there. This is what “being indispensable” is all about. How should members evaluate the success of the AAN and the Board of Directors in supporting their careers and in neurology in general? The AAN’s success can be measured in many ways, and is probably quite personal to every member. Each
Conference
AAN Gives Back to Las Vegas Shooting Victims For the past five years, the AAN has held its Fall Conference in Las Vegas. “The Academy and many of our members have greatly enjoyed this wonderful venue. So, we wanted to honor this community after the horrific shooting in October,” said AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN. Consequently, the AAN has donated $5,000 to the Las Vegas Victims Fund. “We hope this donation can be used to help promote healing and recovery for some of these tragic victims,” said Sacco. At October’s Fall Conference, directors of the first programs read a statement and asked for a moment of silence. Also, leadership held a breakfast with the Nevada region neurology team members to express the Academy’s concern and thanks. In this small breakfast setting, leaders and guests shared thoughts and profound experiences. AAN member Gabriela Gregory, MD, chief of staff at a hospital that admitted nearly 200 victims, was grateful for the time together. “Thank you so much to the Academy for hosting this get-together and supporting us as neurologists and residents of this town. It was emotional to hear the story of our colleague who was present at the concert and reinforced the notion that while we think of ourselves as caregivers, we are a heartbeat away from being on the other side of the gurney, reaching out for the same help we so often give. We are part of the human family and events such as this reminds us to be grateful for each other.” • Gabriela Gregory, MD
AANnews • December 2017
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Conferences
2018 Annual Meeting Preview Features New Innovations Look for these new opportunities in 2018:
nn Continuing the Conversation
At the conclusion of select courses, director and faculty will relocate to engage in small group conversations with interested audience members.
Career-focused Tracks Our new audience-based programming tracks will make navigating the meeting easier than ever, with focused programming geared specifically toward a variety of neurology professionals.
nn New E-poster Setup
Twelve semi-private viewing areas will allow for a more intimate poster viewing experience, and more interactive and dynamic engagement and discussion with presenters. Look for 12 different E-posters each day! Topics and abstracts coming in February 2018.
nn Neurohospitalist Track
For neurohospitalists, those whose primary focus is inpatient care, or for anyone who would like to learn more about the care of hospitalized patients.
nn Business of Neurology Track
For those starting a new practice, as well as anyone who wants to learn the fundamentals of neurology business.
nn Foundations of Clinical Neurology Track
For advanced practice providers who are new to neurology, this track will help lay the foundation for success as a new care team member.
Specialty Tracks If your schedule won’t allow you to stay for the whole meeting, this new pilot program will maximize your time in Los Angeles with six tracks that will take place on consecutive days and help you get the most out of a shorter trip. nn nn nn nn nn nn
Pain and Palliative Care / Sunday to Tuesday Child Neurology / Sunday to Tuesday Neuro-rehabilitation / Wednesday to Friday Infectious Disease / Wednesday to Friday Neuro-oncology / Tuesday to Thursday Sleep / Sunday to Tuesday
Education Program Enhancements If you’re looking to be further challenged and engaged, then these program innovations will provide even more opportunity for participation: nn “What Do I Do Now?”
Faculty will share a challenging real-life case before asking “What do I do now?” Audience members will be given the opportunity to weigh in on what they would do in a similar scenario before the panel explains how they actually handled the situation.
Continued from cover
Expanded Spanish-language Curriculum We’re offering programming on a variety of topics in variety of formats, including education courses and experiential learning areas—taught entirely in Spanish. nn nn nn nn nn nn nn
MS Therapy CNS Infection and Tropical Medicine Epilepsy Stroke Annual Meeting Science Updates Neuroexam More
70th Anniversary Celebration Join us on Sunday, April 22, from 7:00 p.m. to 11:00 p.m. at Universal Studios to celebrate the start of the meeting… and 70 years of the AAN! A limited quantity of free tickets is available to the first 4,000 registered Annual Meeting attendees who sign up, and will include transportation to/from the event, delicious food and beverages, and access to Universal Studios, including rides. Additional guest tickets may be purchased through the registration process.
Controversies in Neurology Plenary Session— Based on Member Suggestions! For the first time, AAN members will have a chance to weigh in on what they would like to see presented at this year’s Controversies in Neurology Plenary Session. You won’t want to miss the opportunity to hear what’s on your peers’ minds.•
Register Early to Save Big! Deep early-bird discounts end March 29, and the deadline to reserve your hotel room is March 2. Visit AAN.com/view/AM18 today!
14
AANnews • December 2017
Entertaining, Provocative Presentations to Headline HeadTalks Experiential Learning Area The HeadTalks Experiential Learning Area at the 2018 Annual Meeting is poised to offer up some of the week’s most entertaining, provocative, and educational presentations to expand the meeting’s rich tradition of learning in a casual outside-of-the-classroom format. From talks about dealing with unintentional bias in the work place to the demand for neurologists on planes—and even a zombie apocalypse!—presentations at this year’s HeadTalks stage are sure to generate dynamic and thought-provoking dialogue. The area will be open Saturday through Friday of the meeting and feature 30 distinct presentations. Highlights include: nn Successful Women in Neurology Panel
Saturday, April 21, 3:15 p.m.–4:15 p.m. Speakers: Cynthia L. Comella, MD, FAAN; Mona Bahouth, MD; Allison Brashear, MD, MBA, FAAN; Helena C. Chui, MD; and Merit E. Cudkowicz, MD, MSC Panel members will share their personal journeys to success, the challenges they have faced, and some of their most important life lessons.
nn Hall of Presidents: Neurology Through the Years—
back by popular demand! Sunday, April 22, 1:30 p.m.–2:30 p.m. Speakers: Francis I. Kittredge Jr., MD, FAAN; Roger N. Rosenberg, MD, FAAN; Stanley Fahn, MD, FAAN; Stephen M. Sergay, MB BCh, FAAN; Terrence L. Cascino, MD, FAAN; Thomas R. Swift, MD, FAAN
A panel of past AAN presidents will discuss how the field of neurology has evolved through the years. They will share how they led through challenges and successes. nn How Bias Impacts Judgment and Decision-making
Sunday, April 22, 3:00 p.m.–4:00 p.m. Speakers: Charles C. Flippen II, MD, FAAN; Jeffrey McClean II, MD, FAAN; and Laraine Kaminsky
Research shows that our brains automatically sort information and reach conclusions without our awareness or input. The science of unconscious bias applies to how we perceive and categorize other people. We are hard-wired to prefer people who are like us and who share our interests, resulting in perceptions of those different from us that are illogical, illegal, and out-of-line with modern values. Research indicates that unconscious bias plays a role in decision-making among medical professionals, too, and results in a disparity of outcomes. A panel of AAN expert members will provide a professional perspective on the impact of unconscious bias on judgements and decision-making in the medical field.
encounter on a flight, the frequently asked question is “How does a neurologist address such a situation?” Incorporating a mock airplane set into the presentation, this HeadTalk will explore various potential scenarios and onboard resources. nn Zombie Apocalypse! The Neuroscience of the Undead
Tuesday, April 24, 4:30 p.m.–5:30 p.m. Speakers: Joseph I. Sirven MD, FAAN; Bert B. Vargas, MD, FAAN; Constantine Moschonas, MD; and Jennifer Bickel MD, FAAN “Zombies” will be used to illustrate clinical neuroanatomy and how symptoms and signs are used to localize health problems in the nervous system. Moreover, the scenario will be used to demonstrate and explore how society deals with health care in pandemics and disaster situations.
In addition, look for lunch-hour “game shows” in the spirit of Pictionary, Jeopardy, and Who Wants to Be a Millionaire, with a neurology focus. The last HeadTalks presentation of each day will conclude with a special wine and cheese social. Visit AAN.com/view/headtalks for more information and a full HeadTalks Experiential Learning Area lineup. •
nn Is There a Neurologist on This Flight?
Monday, April 23, 12:00 p.m.–1:00 p.m. Speaker: Joseph I. Sirven, MD, FAAN
With the ever-increasing number of packed planes loaded with passengers of various ages and with various conditions, neurologists are often called to serve when a passenger has a medical condition on a flight. Given that neurological issues are one of the most common conditions that a physician will
AANnews • December 2017
15
Conferences
Launch Your Career at AAN’s New Career Essentials Conference Continued from cover
things you weren’t taught in residency that can help set the stage for a successful career. The conference’s all-inclusive registration allows you to attend all sessions to maximize your learning.
Top Reasons to Attend
requirements. Get an overview of MACRA/MIPs requirements and find out what you need to know about the growing and in-demand field of teleneurology as a costeffective alternative to traditional clinical visits.
1. Improve Your Communications Skills to Lower Your Risk
Many malpractice claims stem from communication oversights and misunderstanding. Effective communication with patients is a key skill; however, it is one that is not often formally taught during postgraduate medical education. Lower your liability exposure and improve communications by attending a series of courses intended help you hone your skills with patients as well as everyone else.
2. Increase Your Net Worth: Both Personally and Professionally
There is often a lack of education and training in basic business principles critical for financial success. Get the foundation you need to succeed, from effective negotiation tactics to application of sound business strategies, tools to maintain and grow income in current and future models, and student loan repayment strategies and longterm personal financial planning.
3. Stay Up-to-date
It can be a challenge to keep up-todate on new care delivery models, reimbursement, and reporting
4. Promote Wellness
Experience 30-minute activities to reinforce the importance of maintaining health, self-care, and stress management—for you and your patients.
5. Earn CME and Bring the Whole Family
In addition to offering 8.5 CME and the opportunity to network with other neurologists facing similar challenges, the conference will create fun opportunities for families to spend quality time together. Programs run half-days with free afternoons to allow for ample time to enjoy Orlando area attractions. •
Deadlines Approaching for Breakthroughs in Neurology and Career Essentials Conference Save $200+ by Booking Your Hotel and Registering Early December 8 is your last chance to receive early-bird rates on accommodations at the Caribe Royale. This beautiful getaway offers spacious suite-style accommodations with separate living room with a full-size sofa bed, in-suite refrigerator, and microwave; complimentary Wi-Fi; shuttle service to the four Walt Disney World™ Theme Parks, Disney Springs, and Orlando Vineland Premium Outlets (reservations required); and much more. Visit AAN.com/conferences to learn more, book your room, and register early to save. •
January 12–15, 2018 • Orlando, FL
January 14–15, 2018 • Orlando, FL
Practice
Be Aware of Changes in the 2018 Quality Payment Program Final Rule The Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) led to the creation of the Quality Payment Program (QPP) that is transforming how providers are paid. The QPP has two pathways: Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (A-APMs). In November, the Centers for Medicare & Medicaid Services (CMS) published its final rule for 2018. AAN members should be aware of these changes.
MIPS Key changes
nn Starting in 2018, CMS will measure clinicians’
performance in all four MIPS categories, each comprising a different percentage of an overall performance score, which determines how the provider is paid in 2020
More help for treating complex patients
nn Clinicians who treat complex patients could earn up
to five bonus points based on Hierarchical Condition Categories (HCC) scores
A-APMS
nn Quality will comprise 50 percent of the final MIPS
nn CMS relaxed standards for qualifying as an Advanced
nn Cost will comprise 10 percent of final score. Clinicians will
nn CMS did not make major changes to the definition of
score (down from 60 percent in 2017). Starting in 2018, clinicians must report one year of data (January 1, 2018, to December 31, 2018) be measured using two measures previously used in the Value-based Modifier Program: Medicare Spending Per Beneficiary and Total Per Capita Costs. Starting in 2018, clinicians must report one year of data (January 1, 2018, to December 31, 2018)
nn No changes to the weights of the Advancing Care
Information (25 percent) or Improvement Activities (15 percent) categories. For both categories, clinicians must report at least 90 days of data
Alternative Payment Model (A-APMs) and included a new All-Payer Option for those participating in APMs outside of Medicare
physician-focused payment models (PFPMs) or the Physician-Focused Payment Model Technical Advisory Committee (PTAC)
Remember, these changes do not impact 2017 reporting. Read the AAN’s detailed summary of the changes to expect at http://bit.ly/2iAzPiF, and email macra@aan.com with your QPP questions. Don’t forget to visit AAN.com for the latest updates and tools to help you succeed and avoid penalties. •
nn Clinicians must achieve an overall MIPS score of 15
points in 2018 to avoid a penalty in 2020 (up from 3 points in 2017)
nn Quality measures will now be worth 1−10 points (up
from a 3-point floor in 2017); clinicians who do not meet a 60-percent data completeness threshold will earn just one point for QMs
More help for small or solo practices
nn Low-volume threshold more than doubles
to $90,000 or less in Medicare Part B charges, or 200 or fewer Medicare patients annually (from $30k or 100 patients)
APMs
MIPS
nn Some practitioners that were eligible
in year one will NOT be in year two
nn Small practices (those with 15 or
fewer clinicians) can submit data on just one performance category to automatically earn five bonus points to their final score
nn Implementation of virtual groups nn Hardship exemptions, including a
new significant hardship exception for the Advancing Care Information (ACI) category and those impacted by recent natural disasters
AANnews • December 2017
17
Practice
Empower Your Practice with the 2017 Neurology Compensation and Productivity Report Don’t let the year end without accessing the online 2017 Neurology Compensation and Productivity Report. What you learn could make a great deal of difference to your practice in 2018!
nn Apply dashboard filters to make the data more applicable
AAN members who completed the Neurology Compensation and Productivity Survey receive free access to this valuable data. Visit reporting.qualtrics.com/AAN and just log in with your AAN ID and password.
nn Download the full pdf report with national statistics and
Members who did not complete the survey should visit The AAN Store® at AAN.com/AANStore where access to the report and dashboard is available for only $600 for AAN members—just half the $1,200 cost for nonmembers.
Dashboard Helps You Maximize Your Data Want to learn how to get the best out of the customizable dashboard? View the online video demonstration at bit.ly/2z0WLPI and use these helpful tips:
to you and your practice
nn Create custom charts and graphs and download them to
your desktop
save it to your computer for quick access when offline
The 2017 Neurology Compensation and Productivity Report is the only such report specific to neurology. Use the local and national data to adjust how you practice and how you are compensated for your work, and help ensure that 2018 is a stellar year for you and your practice. •
nn Check out the My Data tab to see how you compare to
your peers
Axon Registry Makes Great Strides in 2017 The Axon Registry ® was created in 2014 as way for neurologists to implement quality improvement projects while also meet government reporting requirements. In 2016, the registry completed pilot phases and 2017 was the first year the registry opened for more members to join. There have been many successes over the course of 2017 as the registry has grown. To make the registry relevant for many subspecialties within neurology, the number of measures in the registry grew by 50 percent in 2017. There are now 12 domains covered by the registry including: epilepsy, Parkinson’s disease, dementia, distal symmetric polyneuropathy, headaches, multiple sclerosis, sleep, child neurology, ALS, essential tremor, ophthalmology, and cross-cutting. There are multiple process measures, outcome measures, highpriority measures, and newly integrated Patient Reported Outcomes (PROs). With the registry maturing and amassing nearly 3 million patent visits and over 900,000 unique patients, the Registry Committee is preparing to use the
18
AANnews • December 2017
data to identify gaps in care and research how to assist in improving the quality of care in neurology. A large data validation plan was executed in 2017 to ensure that the data in the registry is valid for use before the research projects begin. The data covers a wide breadth of neurology practice, from solo practitioners to large academic centers and more than 33 electronic medical record systems.
The American Board of Psychiatry and Neurology has approved the Axon Registry as an MOC Part IV PIP clinical module activity, and, as of September 2017, it can be used to waive up to eight credits of Part II selfassessment. Providers that have fully integrated with Joseph V. Fritz, PhD the registry can reap the benefits of participation for the certification purposes.
Registry Now Helps Alleviate MOC Burden The Axon Registry has applied to The Centers for Medicare & Medicaid Services (CMS) to be a Qualified Clinical Data Registry for the third year in a row. Once approved, it can be used by participants to meet up to three reporting requirements for the MIPS track of the Quality Payment Program. Once providers receive a dashboard and map their performance rates, they can submit Quality, Advancing Care Information, and Improvement Activity data to CMS.
Joseph V. Fritz, PhD, vice chair of the Registry Committee, said, “As we are now a part of a quality-centric health care system, registries such as the Axon Registry are more important than ever to illustrate the quality of work done by neurologists. The registry successes in 2017 show how hard we have worked to make this a valuable product for our members and the specialty of neurology.” To submit your name for participation, visit AAN.com/view/Axon. •
IN THE MANAGEMENT OF RMS
THINK
BEYOND Ad Page
RELAPSES RMS=relapsing forms of multiple sclerosis.
FOR PATIENTS WITH RELAPSING MS
IMPACT
DISABILITY
PROGRESSION NOW DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; MS=multiple sclerosis.
INDICATION AUBAGIO® (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Ad Page
IMPORTANT SAFETY INFORMATION WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY • Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. • Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for 6 months after starting AUBAGIO. If drug-induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or activated charcoal. AUBAGIO is contraindicated in patients with severe hepatic impairment. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. • AUBAGIO is contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposure lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant. CONTRAINDICATIONS • Patients with severe hepatic impairment. • Pregnant women and females of reproductive potential not using effective contraception. • Patients with a history of hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. • Co-administration with leflunomide.
QUIETING MS Quietly for your patients with relapsing MS
‡
Start or switch to AUBAGIO (teriflunomide) 14 mg—the only oral DMT with a proven impact on disability progression in 2 Phase III trials ®
1-3
The majority of patients remained free from disability progression* with AUBAGIO 14 mg1
80 84 AN ESTIMATED
AN ESTIMATED
%
%
IN TEMSO
IN TOWER
OVER 108 WEEKS (P =0.03)1†
OVER 108 WEEKS (P <0.05)1†
*Disability progression was a secondary endpoint in TEMSO and TOWER.4,5 † Based on Kaplan-Meier estimates.1 TEMSO: A double-blind, placebo-controlled trial in patients with relapsing forms of MS (N=1088). Patients were randomized to receive AUBAGIO 14 mg (n=359), AUBAGIO 7 mg (n=366), or placebo (n=363) once daily for 108 weeks.4 TOWER: A double-blind, placebo-controlled trial in patients with relapsing forms of MS (N=1169). Patients were randomized to receive AUBAGIO 14 mg (n=372), AUBAGIO 7 mg (n=408), or placebo (n=389) once daily with results for up to 40 months of treatment.5
• The estimated proportion of patients with sustained disability progression: —TEMSO: 20.2%, 21.7%, and 27.3% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively1 —TOWER: 15.8%, 21.1%, and 19.7% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively1 • AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression versus placebo in either trial1 • Sustained disability progression was defined as at least a 1-point increase from baseline EDSS score ≤5.5 (or at least a 0.5-point increase for those with a baseline EDSS score >5.5) sustained for at least 12 weeks1 • AUBAGIO 14 mg and 7 mg achieved a significant relative reduction in risk of relapse in TEMSO (31% for both doses; P<0.05) and TOWER (36% and 22%, respectively; P<0.05)1
WARNINGS AND PRECAUTIONS • Hepatotoxicity: Patients with pre-existing acute or chronic liver disease, or those with serum ALT >2 times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. In clinical trials, if ALT elevation was >3 times the ULN on 2 consecutive tests, patients discontinued AUBAGIO and underwent accelerated elimination. Consider additional monitoring if co-administering AUBAGIO with other potentially hepatotoxic drugs; monitor patients who develop symptoms suggestive of hepatic dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine). • Teratogenicity: AUBAGIO may cause fetal harm when administered in pregnant women. Teratogenicity and embryo-fetal lethality occurred in animal reproduction studies in multiple animal species at plasma teriflunomide exposures similar to or lower than that in humans at the maximum human recommended dose of 14 mg/day. AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception. Women who become pregnant while taking AUBAGIO may enroll in the AUBAGIO pregnancy registry by calling 1-800-745-4447, option 2. • Procedure for Accelerated Elimination of Teriflunomide: Teriflunomide is eliminated slowly from the plasma—it takes an average of 8 months, or up to 2 years, to reach plasma concentrations <0.02 mcg/mL. Elimination may be accelerated by administration of cholestyramine or activated charcoal, but this may cause disease activity to return in patients who were responding to AUBAGIO. • Bone Marrow Effects/Immunosuppression Potential/Infections: Decreases in white blood cell counts, mainly of neutrophils and lymphocytes, and platelets have been reported with AUBAGIO. Thrombocytopenia, including rare cases with platelet counts less than 50,000/mm3, has been reported in the postmarketing setting. Obtain a complete blood cell count within 6 months before starting treatment, with further monitoring based on signs and symptoms of bone marrow suppression. AUBAGIO is not recommended for patients with severe immunodeficiency, bone marrow disease, or severe uncontrolled infections. Tuberculosis (TB) has been observed in clinical studies of AUBAGIO. Before starting treatment, screen patients for latent TB infection with a tuberculin test. Treatment in patients with acute or chronic infections should not be started until the infection(s) is resolved. Administration of live vaccines is not recommended. The risk of malignancy, particularly lymphoproliferative disorders, or infection may be increased with the use of some medications with immunosuppressive potential, including teriflunomide.
Ad Page
(continued on back)
Please see additional Important Safety Information and Brief Summary of Full Prescribing Information, including boxed WARNING, on the following pages. ‡
AUBAGIO is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and treatment discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.1,6
Proven impact in newly diagnosed RMS patients1 In patients who had a first clinical event characteristic of RMS, AUBAGIO® (teriflunomide) provided freedom from relapses1
72
% REMAINED
IN TOPIC
RELAPSE FREE
VS 62% WITH PLACEBO (P <0.05)1
• 71% of patients remained relapse free with AUBAGIO 7 mg in the TOPIC trial1 • TOPIC is the only trial of an oral RMS therapy that studied patients who had a first clinical event consistent with acute demyelination occurring within 90 days of randomization1-3 TOPIC: A double-blind, placebo-controlled trial in patients with relapsing forms of MS (N=618). Patients were randomized to receive AUBAGIO 14 mg (n=216), AUBAGIO 7 mg (n=205), or placebo (n=197) once daily for 108 weeks. Patients had a first clinical event consistent with acute demyelination occurring within 90 days of randomization with 2 or more T2 lesions at least 3 mm in diameter characteristic of RMS.7
MAKE AUBAGIO YOUR FIRST CHOICE FOR NEWLY DIAGNOSED RMS PATIENTS IMPORTANT SAFETY INFORMATION (continued) • Hypersensitivity and Serious Skin Reactions: AUBAGIO can cause anaphylaxis and severe allergic reactions. Signs and symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Cases of serious skin reactions, including Stevens-Johnson syndrome and a fatal case of toxic epidermal necrolysis, have been reported with AUBAGIO. Very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms have also been reported with leflunomide. If a severe skin reaction develops with AUBAGIO, stop treatment and begin accelerated elimination. In such cases, patients should not be re-exposed to teriflunomide. • Peripheral Neuropathy: Peripheral neuropathy, including polyneuropathy and mononeuropathy, has been reported with AUBAGIO. Age >60 years, concomitant neurotoxic medications, and diabetes may increase the risk. If peripheral neuropathy is suspected, consider discontinuing treatment and performing accelerated elimination. • Increased Blood Pressure: Blood pressure increases and hypertension have occurred with AUBAGIO. Measure blood pressure at treatment initiation and manage any elevations during treatment. • Respiratory Effects: Interstitial lung disease (ILD), including acute interstitial pneumonitis, has been reported with AUBAGIO. ILD may be fatal and may occur acutely at any time during therapy with a variable clinical presentation. If discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure. Adverse Reactions: The most frequent adverse reactions (≥10% and ≥2% greater than placebo) with AUBAGIO 7 mg and 14 mg and placebo, respectively, were headache (18% and 16% vs 15%), ALT increased (13% and 15% vs 9%), diarrhea (13% and 14% vs 8%), alopecia (10% and 13% vs 5%), and nausea (8% and 11% vs 7%). Drug Interactions: Monitor patients when teriflunomide is coadministered with warfarin, or with drugs metabolized by CYP1A2, CYP2C8, substrates of OAT3 transporters, substrates of BCRP, or OATP1B1/1B3 transporters. Use in Specific Populations: Women who wish to become pregnant should discontinue AUBAGIO and undergo an accelerated elimination procedure. Use of effective contraception should be continued until plasma concentrations of teriflunomide are <0.02 mcg/mL. Nursing mothers should not use AUBAGIO. AUBAGIO is detected in human semen. To minimize any possible fetal risk, men not wishing to father a child and their female partners should use effective contraception. Men wishing to father a child should discontinue therapy and either undergo accelerated elimination or verify plasma teriflunomide concentration is <0.02 mcg/mL.
Ad Page
Please see additional Important Safety Information on the previous pages and Brief Summary of Full Prescribing Information, including boxed WARNING regarding hepatotoxicity and use in pregnancy, on the following pages. References: 1. AUBAGIO (teriflunomide) [package insert]. Cambridge, MA: Genzyme Corporation; November 2016. 2. Tecfidera (dimethyl fumarate) [package insert]. Cambridge, MA: Biogen Inc.; February 2016. 3. Gilenya (fingolimod) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2016. 4. O’Connor P, Wolinsky JS, Confavreux C, et al; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293-1303. 5. Confavreux C, O’Connor P, Comi G, et al; for the TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(3):247-256. 6. Data on file, Sanofi/Genzyme. Summary of safety HMR1726-teriflunomide. December 5, 2013. 7. Miller AE, Wolinsky JS, Kappos L, et al; for the TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(10):977-986.
©2016 Genzyme Corporation. All rights reserved. AUBAGIO, Sanofi, and Genzyme registered in U.S. Patent and Trademark Office. GZUS.AUBA.15.01.0245(3) December 2016
AUBAGIO® (teriflunomide) tablets, for oral use
Rx Only
Brief Summary of Prescribing Information WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY • Hepatotoxicity Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1)]. If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3)]. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. • Risk of Teratogenicity AUBAGIO is contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.1), and Clinical Pharmacology (12.3) in the full prescribing information].
1 INDICATIONS AND USAGE AUBAGIO® is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 2 DOSAGE AND ADMINISTRATION The recommended dose of AUBAGIO is 7 mg or 14 mg orally once daily. AUBAGIO can be taken with or without food. Monitoring to assess safety • Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1)]. • Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms of infection [see Warnings and Precautions (5.4)]. • Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions (5.4)]. • Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential [see Warnings and Precautions (5.2)]. • Check blood pressure before start of AUBAGIO treatment and periodically thereafter [see Warnings and Precautions (5.7)]. 4 CONTRAINDICATIONS AUBAGIO is contraindicated in/with: • Patients with severe hepatic impairment [see Warnings and Precautions (5.1)]. • Pregnant women and females of reproductive potential not using effective contraception. AUBAGIO may cause fetal harm [see Warnings and Precautions (5.2 and 5.3) and Use in Specific Populations (8.1)]. • Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5)]. • Coadministration with leflunomide [see Clinical Pharmacology (12.3) in the full prescribing information]. 5 WARNINGS AND PRECAUTIONS 5.1 Hepatotoxicity Severe liver injury including fatal liver failure and dysfunction has been reported in some patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. In placebo-controlled trials, ALT greater than three times the ULN occurred in 61/1045 (5.8%) and 62/1002 (6.2%) of patients receiving AUBAGIO 7 mg and 14 mg, respectively, and 38/997 (3.8%) of patients receiving placebo, during the treatment period. These elevations occurred mostly within the first year of treatment. Half of the cases returned to normal without drug discontinuation. In clinical trials, if ALT elevation was greater than three times the ULN on two consecutive tests, AUBAGIO was discontinued and patients underwent an accelerated elimi-
nation procedure [see Warnings and Precautions (5.3)]. Of the patients who underwent discontinuation and accelerated elimination in controlled trials, half returned to normal or near normal values within 2 months. One patient in the controlled trials developed ALT 32 times the ULN and jaundice 5 months after initiation of AUBAGIO 14 mg treatment. The patient was hospitalized for 5 weeks and recovered after plasmapheresis and cholestyramine accelerated elimination procedure. AUBAGIO-induced liver injury in this patient could not be ruled out. Obtain serum transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO. Consider additional monitoring when AUBAGIO is given with other potentially hepatotoxic drugs. Consider discontinuing AUBAGIO if serum transaminase increase (greater than three times the ULN) is confirmed. Monitor serum transaminase and bilirubin on AUBAGIO therapy, particularly in patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. If liver injury is suspected to be AUBAGIO-induced, discontinue AUBAGIO and start an accelerated elimination procedure [see Warnings and Precautions (5.3)] and monitor liver tests weekly until normalized. If AUBAGIO-induced liver injury is unlikely because some other probable cause has been found, resumption of AUBAGIO therapy may be considered. 5.2 Teratogenicity AUBAGIO may cause fetal harm when administered to a pregnant woman. Teratogenicity and embryo-fetal lethality occurred in animal reproduction studies in multiple animal species at plasma teriflunomide exposures similar to or lower than that in humans at the maximum human recommended dose (MHRD) of 14 mg/day [see Use in Specific Populations (8.1)]. AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception [see Contraindications (4) and Warnings and Precautions (5.3)]. 5.3 Procedure for Accelerated Elimination of Teriflunomide Teriflunomide is eliminated slowly from the plasma [see Clinical Pharmacology (12.3) in the full prescribing information]. Without an accelerated elimination procedure, it takes on average 8 months to reach plasma concentrations less than 0.02 mg/L, although because of individual variations in drug clearance it may take as long as 2 years. An accelerated elimination procedure could be used at any time after discontinuation of AUBAGIO. Elimination can be accelerated by either of the following procedures: • Administration of cholestyramine 8 g every 8 hours for 11 days. If cholestyramine 8 g three times a day is not well tolerated, cholestyramine 4 g three times a day can be used. • Administration of 50 g oral activated charcoal powder every 12 hours for 11 days. If either elimination procedure is poorly tolerated, treatment days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly. At the end of 11 days, both regimens successfully accelerated teriflunomide elimination, leading to more than 98% decrease in teriflunomide plasma concentrations. Use of the accelerated elimination procedure may potentially result in return of disease activity if the patient had been responding to AUBAGIO treatment. 5.4 Bone Marrow Effects/Immunosuppression Potential/Infections Bone Marrow Effects A mean decrease compared to baseline in white blood cell (WBC) count of approximately 15% (mainly neutrophils and lymphocytes) and in platelet count of approximately 10% was observed in placebo-controlled trials with 7 mg and 14 mg of AUBAGIO. The decrease in mean WBC count occurred during the first 6 weeks and WBC count remained low during treatment. In placebo-controlled studies, neutrophil count <1.5×109/L was observed in 12% and 16% of patients receiving AUBAGIO 7 mg and 14 mg, respectively, compared with 7% of patients receiving placebo; lymphocyte count <0.8× 109/L was observed in 10% and 12% of patients receiving AUBAGIO 7 mg and 14 mg, respectively, compared with 6% of patients receiving placebo. No cases of serious pancytopenia were reported in premarketing clinical trials of AUBAGIO but rare cases of pancytopenia and agranulocytosis have been reported in the postmarketing setting with leflunomide. A similar risk would be expected for AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. Cases of thrombocytopenia with AUBAGIO, including rare cases with platelet counts less than 50,000/mm3, have been reported in the postmarketing setting. Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms suggestive of bone marrow suppression. Risk of Infection / Tuberculosis Screening Patients with active acute or chronic infections should not start treatment until the infection(s) is resolved. If a patient develops a serious infection consider suspending treatment with AUBAGIO and using an accelerated elimination procedure. Reassess the benefits and risks prior to resumption of therapy. Instruct patients receiving AUBAGIO to report symptoms of infections to a physician. AUBAGIO is not recommended for patients with severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections. Medications like AUBAGIO that have immunosuppression potential may cause patients to be more susceptible to infections, including opportunistic infections. In placebo-controlled studies of AUBAGIO, no overall increase in the risk of serious infections was observed with AUBAGIO 7 mg (2.2%) or 14 mg (2.7%) compared to placebo (2.2%). However, one fatal case of klebsiella pneumonia sepsis occurred in a patient taking AUBAGIO 14 mg for 1.7 years. Fatal infections have been reported in the postmarketing setting in patients receiving leflunomide, especially Pneumocystis jiroveci pneumonia and aspergillosis. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness which, in addition to rheumatoid disease, may predispose patients to infection. In clinical studies with AUBAGIO, cytomegalovirus hepatitis reactivation has been observed. In clinical studies with AUBAGIO, cases of tuberculosis have been observed. Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or with a blood test for mycobacterium tuberculosis infection. AUBAGIO has not been studied in patients with a positive tuberculosis screen, and the safety of AUBAGIO in individuals with latent tuberculosis infection is unknown. For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with AUBAGIO.
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Vaccination No clinical data are available on the efficacy and safety of live vaccinations in patients taking AUBAGIO. Vaccination with live vaccines is not recommended. The long half-life of AUBAGIO should be considered when contemplating administration of a live vaccine after stopping AUBAGIO. Malignancy The risk of malignancy, particularly lymphoproliferative disorders, is increased with the use of some immunosuppressive medications. There is a potential for immunosuppression with AUBAGIO. No apparent increase in the incidence of malignancies and lymphoproliferative disorders was reported in the AUBAGIO clinical trials, but larger and longer-term studies would be needed to determine whether there is an increased risk of malignancy or lymphoproliferative disorders with AUBAGIO. 5.5 Hypersensitivity and Serious Skin Reactions AUBAGIO can cause anaphylaxis and severe allergic reactions [see Contraindications (4)]. Signs and symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Cases of serious skin reactions, including cases of Stevens-Johnson syndrome (SJS) and a fatal case of toxic epidermal necrolysis (TEN), have been reported with AUBAGIO. In patients treated with leflunomide, the parent compound, very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Inform patients of the signs and symptoms of anaphylaxis and angioedema and signs and symptoms that may signal a serious skin reaction. Inform patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, or hepatic dysfunction) may be drug-related. Instruct patients to discontinue AUBAGIO and seek immediate medical care should these signs and symptoms occur. Discontinue AUBAGIO, unless the reactions are clearly not drug-related, and begin an accelerated elimination procedure immediately [see Warnings and Precautions (5.3)]. In such cases, patients should not be re-exposed to teriflunomide [see Contraindications (4)]. 5.6 Peripheral Neuropathy In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), occurred more frequently in patients taking AUBAGIO than in patients taking placebo. The incidence of peripheral neuropathy confirmed by nerve conduction studies was 1.4% (13 patients) and 1.9% (17 patients) of patients receiving 7 mg and 14 mg of AUBAGIO, respectively, compared with 0.4% receiving placebo (4 patients). Treatment was discontinued in 0.7% (8 patients) with confirmed peripheral neuropathy (3 patients receiving AUBAGIO 7 mg and 5 patients receiving AUBAGIO 14 mg). Five of them recovered following treatment discontinuation. Not all cases of peripheral neuropathy resolved with continued treatment. Peripheral neuropathy also occurred in patients receiving leflunomide. Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy. If a patient taking AUBAGIO develops symptoms consistent with peripheral neuropathy, such as bilateral numbness or tingling of hands or feet, consider discontinuing AUBAGIO therapy and performing an accelerated elimination procedure [see Warnings and Precautions (5.3)]. 5.7 Increased Blood Pressure In placebo-controlled studies, the mean change from baseline to the end of study in systolic blood pressure was +2.3 mmHg and +2.7 mmHg for AUBAGIO 7 mg and 14 mg, respectively, and -0.6 mmHg for placebo. The change from baseline in diastolic blood pressure was +1.4 mmHg and +1.9 mmHg for AUBAGIO 7 mg and 14 mg, respectively, and -0.3 mmHg for placebo. Hypertension was an adverse reaction in 3.1% and 4.3% of patients treated with 7 mg or 14 mg of AUBAGIO compared with 1.8% for placebo. Check blood pressure before start of AUBAGIO treatment and periodically thereafter. Elevated blood pressure should be appropriately managed during treatment with AUBAGIO. 5.8 Respiratory Effects Interstitial lung disease, including acute interstitial pneumonitis, has been reported with AUBAGIO in the postmarketing setting. Interstitial lung disease and worsening of pre-existing interstitial lung disease have been reported during treatment with leflunomide. Interstitial lung disease may be fatal and may occur acutely at any time during therapy with a variable clinical presentation. New onset or worsening pulmonary symptoms, such as cough and dyspnea, with or without associated fever, may be a reason for discontinuation of therapy and for further investigation as appropriate. If discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure [see Warnings and Precautions (5.3)]. 5.9 Concomitant Use with Immunosuppressive or Immunomodulating Therapies Coadministration with antineoplastic, or immunosuppressive therapies used for treatment of multiple sclerosis has not been evaluated. Safety studies in which AUBAGIO was concomitantly administered with other immune modulating therapies for up to one year (interferon beta, glatiramer acetate) did not reveal any specific safety concerns. The long term safety of these combinations in the treatment of multiple sclerosis has not been established. In any situation in which the decision is made to switch from AUBAGIO to another agent with a known potential for hematologic suppression, it would be prudent to monitor for hematologic toxicity, because there will be overlap of systemic exposure to both compounds. Use of an accelerated elimination procedure may decrease this risk, but may also potentially result in return of disease activity if the patient had been responding to AUBAGIO treatment [see Warnings and Precautions (5.3)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: • Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1)] • Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4)] • Hypersensitivity and Serious Skin Reactions [see Contraindications (4) and Warnings and Precautions (5.5)] • Peripheral Neuropathy [see Warnings and Precautions (5.6)] • Increased Blood Pressure [see Warnings and Precautions (5.7)]
AUBAGIO® (teriflunomide) tablets, for oral use • Respiratory Effects [see Warnings and Precautions (5.8)] 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. A total of 2047 patients receiving AUBAGIO (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female. The average age was 37 years. Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for AUBAGIO patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea. The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo treatment arms, respectively). Table 1. Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis AUBAGIO AUBAGIO 7 mg 14 mg Placebo Adverse Reaction (N=1045) (N=1002) (N=997) Headache 18% 16% 15% Increase in Alanine aminotransferase 13% 15% 9% Diarrhea 13% 14% 8% Alopecia 10% 13% 5% Nausea 8% 11% 7% Paresthesia 8% 9% 7% Arthralgia 8% 6% 5% Neutropenia 4% 6% 2% Hypertension 3% 4% 2% Cardiovascular Deaths Four cardiovascular deaths, including three sudden deaths, and one myocardial infarction in a patient with a history of hyperlipidemia and hypertension were reported among approximately 2600 patients exposed to AUBAGIO in the premarketing database. These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between AUBAGIO and cardiovascular death has not been established. Acute Renal Failure In placebo-controlled studies, creatinine values increased more than 100% over baseline in 8/1045 (0.8%) patients in the 7 mg AUBAGIO group and 6/1002 (0.6%) patients in the 14 mg AUBAGIO group versus 4/997 (0.4%) patients in the placebo group. These elevations were transient. Some elevations were accompanied by hyperkalemia. AUBAGIO may cause acute uric acid nephropathy with transient acute renal failure because AUBAGIO increases renal uric acid clearance. Hypophosphatemia In clinical trials, 18% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels of at least 0.6 mmol/L, compared to 7% of placebo-treated patients; 4% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels at least 0.3 mmol/L but less than 0.6 mmol/L, compared to 0.8% of placebo-treated patients. No patient in any treatment group had a serum phosphorus below 0.3 mmol/L. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of AUBAGIO. 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. • Hypersensitivity reactions, some of which were severe, such as anaphylaxis and angioedema [see Warnings and Precautions (5.5)] • Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome [see Warnings and Precautions (5.5)] • Thrombocytopenia [see Warnings and Precautions (5.4)] • Interstitial lung disease [see Warnings and Precautions (5.8)] • Pancreatitis 7 DRUG INTERACTIONS Effect of AUBAGIO on CYP2C8 substrates Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on warfarin Coadministration of AUBAGIO with warfarin requires close monitoring of the international normalized ratio (INR) because AUBAGIO may decrease peak INR by approximately 25%. Effect of AUBAGIO on oral contraceptives AUBAGIO may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on CYP1A2 substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo. In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required [see Clinical Pharmacology (12.3) in the full prescribing information].
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Effect of AUBAGIO on organic anion transporter 3 (OAT3) substrates Teriflunomide inhibits the activity of OAT3 in vivo. In patients taking AUBAGIO, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on BCRP and organic anion transporting polypeptide B1 and B3 (OATP1B1/ 1B3) substrates Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo. For a patient taking AUBAGIO, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AUBAGIO during pregnancy. Healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2 Risk Summary AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data. Human data are not available at this time to inform the presence or absence of drug-associated risk with the use of AUBAGIO during pregnancy. In animal reproduction studies in rat and rabbits, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum human recommended dose (MHRD) of 14 mg/day [see Data]. In the US 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 in the indicated population is unknown. Clinical Considerations Women who wish to become pregnant should discontinue use of AUBAGIO and undergo an accelerated elimination procedure to decrease the plasma concentration of teriflunomide to less than 0.02 mg/L (0.02 mcg/mL). Effective contraception should be used until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Human plasma concentrations of teriflunomide less than 0.02 mg/L (0.02 mcg/mL) are expected to have minimal embryofetal risk [see Contraindications (4) and Warnings and Precautions (5.3)]. If the patient becomes pregnant while taking this drug, stop treatment with AUBAGIO, inform the patient of the potential risk to the fetus, and perform the accelerated drug elimination procedure to achieve plasma concentrations of less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) in the full prescribing information]. Refer the patient to an obstetrician/gynecologist, preferably experienced in reproductive toxicity, for further evaluation and counseling [see Warnings and Precautions (5.2, 5.3)]. Data Animal Data When teriflunomide (oral doses of 1, 3, or 10 mg/kg/day) was administered to pregnant rats throughout the period of organogenesis, high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death were observed at doses not associated with maternal toxicity. Adverse effects on embryofetal development were observed following dosing at various stages throughout organogenesis. Maternal plasma exposure at the no-effect level (1.0 mg/kg/day) for embryofetal developmental toxicity in rats was less than that in humans at the maximum recommended human dose (MRHD, 14 mg /day). Administration of teriflunomide (oral doses of 1, 3.5, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death at doses associated with minimal maternal toxicity. Maternal plasma exposure at the no-effect dose (1.0 mg/kg/day) for embryofetal developmental toxicity in rabbits was less than that in humans at the MRHD. In studies in which teriflunomide (oral doses of 0.05, 0.1, 0.3, 0.6, or 1.0 mg/kg/day) was administered to rats during gestation and lactation, decreased growth, eye and skin abnormalities, and high incidences of malformation (limb defects) and postnatal death were observed in the offspring at doses not associated with maternal toxicity. Maternal plasma exposure at the no-effect dose for pre- and postnatal developmental toxicity in rats (0.10 mg/kg/day) was less than that in humans at the MRHD. In animal reproduction studies of leflunomide, embryolethality and teratogenic effects were observed in pregnant rat and rabbit at or below clinically relevant plasma teriflunomide exposures (AUC). In published reproduction studies in pregnant mice, leflunomide was embryolethal and increased the incidence of malformations (craniofacial, axial skeletal, heart and great vessel). Supplementation with exogenous uridine reduced the teratogenic effects in pregnant mice, suggesting that the mode of action (inhibition of mitochondrial enzyme dihydroorotate dehydrogenase) is the same for therapeutic efficacy and developmental toxicity. At recommended doses in humans, teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. 8.2 Lactation Risk Summary It is not known whether this drug is excreted in human milk. Teriflunomide was detected in rat milk following a single oral dose. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AUBAGIO and any potential adverse effects on the breastfed infant from AUBAGIO or from the underlying maternal condition.
AUBAGIO® (teriflunomide) tablets, for oral use 8.3 Females and Males of Reproductive Potential Pregnancy Testing Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential. Advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.1)]. Contraception Females Females of reproductive potential should use effective contraception while taking AUBAGIO. If AUBAGIO is discontinued, use of contraception should be continued until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL). Females of reproductive potential who wish to become pregnant should undergo an accelerated elimination procedure. Effective contraception should be used until it is verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Males AUBAGIO is detected in human semen. Animal studies to specifically evaluate the risk of male-mediated fetal toxicity have not been conducted. To minimize any possible risk, men not wishing to father a child and their female partners should use effective contraception. Men wishing to father a child should discontinue use of AUBAGIO and either undergo an accelerated elimination procedure or wait until verification that the plasma teriflunomide concentration is less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Infertility Administration of teriflunomide to male rats resulted in no adverse effects on fertility. However, reduced epididymal sperm count was observed [see Nonclinical Toxicology (13.1) in the full prescribing information]. Effects of AUBAGIO on fertility in humans have not been evaluated. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of AUBAGIO did not include patients over 65 years old. 8.6 Hepatic Impairment No dosage adjustment is necessary for patients with mild and moderate hepatic impairment. The pharmacokinetics of teriflunomide in severe hepatic impairment have not been evaluated. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3) in the full prescribing information]. 8.7 Renal Impairment No dosage adjustment is necessary for patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3) in the full prescribing information]. 10 OVERDOSAGE There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects. In the event of clinically significant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination [see Warnings and Precautions (5.3)].
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2017 Quality Measures Help Improve Patient Care Quality measures have become an essential part of practicing medicine, demonstrating medical professionalism, and a commitment to quality care. Now, quality measures are used to determine reimbursement, as well. In 2017, the AAN released two new quality measurement sets to improve the care of patients with essential tremor, and those receiving Anup Patel, MD, FAAN care in the inpatient and emergency settings. Measurement sets for children with neurologic disease and for neuro-oncologists are pending publication in early 2018. The AAN also updated its measurement sets for dementia management and stroke and stroke rehabilitation, and reaffirmed the multiple sclerosis and muscular dystrophy measurement sets. “The AAN is committed to developing reliable and valid measures to help neurologists drive quality improvement in practice,” noted Anup Patel, MD, FAAN, vice chair of the AAN’s Quality and Safety Subcommittee (QSS). In today’s health care environment, neurologists must demonstrate a commitment to continuous improvement in the quality of health care. This includes working collaboratively with other professionals to reduce medical error, increase patient safety, minimize overuse of health care resources, and optimize the outcomes of care. “There is a common misperception that quality measures are new guideline statements, and measures are created
to penalize, or ‘ding,’ neurologists. This is not true,” Patel said. Existing clinical practice guidelines, systematic reviews, and metaanalyses statements serve as the foundation for creating measures from established research. These measures help neurologists identify how closely they are adhering to guideline recommended care. Some neurologists mistakenly believe they need to do all the measures. “We encourage individuals to start small, identifying one or two measures that could drive improvement in their practice,” said QSS Chair Amy Sanders, MD, MS, FAAN. Amy Sanders, MD, MS, FAAN
In 2018, QSS will release updates to the epilepsy and headache measurement sets and will release new measurement sets for neurotology, concussion, and mild cognitive impairment. The AAN also intends to release a cross-cutting measurement set that will apply to patients with multiple neurologic conditions, and prove meaningful for general neurologists. Additional measure testing is planned to meet requirements of the Centers for Medicare & Medicaid Services for measures to be considered in the Quality Payment Program (QPP) and specifically Merit-based Incentive Payment System (MIPS). The AAN is also planning additional quality improvement resources to help neurologists implement the measures. For more information and measure specifications, visit AAN.com/practice/quality-measures or contact quality@aan.com. •
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15 mi lli Ov an on d er d g ow row nlo ing ads ... !
Neurology ® Podcasts Visit Neurology.org to listen to Neurology podcasts and earn 0.5 AMA PRA Category 1 CME Credits™ by answering the multiple-choice questions in the online podcast quiz. Interviews based on articles from Neurology ® Clinical Practice, Neurology ® Genetics, and Neurology ® Neuroimmunology & Neuroinflammation are excluded from the CME program.
Available by December 1 nn Neurology: Long-term Benefit of Enzyme-replacement Therapy in Pompe Disease: A 5-year Prospective Study
Kelly Graham Gwathmey, MD, and Nadine A.M.E. van der Beek, MD, PhD
nn Neurology: Neuroimmunology & Neuroinflammation: Cryptogenic NORSE: Its Distinctive Clinical Features and Response
to Immunotherapy Stacey Lynn Clardy, MD, PhD, and Takahiro Iizuka, MD
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AANnews • December 2017
Free Webinar Preps You for 2018 Changes to Rules, Codes
AAN ANNUAL MEETING:
SHINING THE SPOTLIGHT ON YOUR CAREER REGISTER NOW Lyell K. Jones, MD, FAAN
William S. Henderson, FACMPE
The AAN wants you to get off on the right foot for 2018, so it is offering a FREE webinar on changes you can expect to see to Medicare fees, MACRA reporting, and other aspects of care management.
Free: New Year, New Rules: Preparing for 2018 December 5, 2017 12:00 p.m.–1:00 p.m. ET Deadline to Register: December 4 Directors: Lyell K. Jones, MD, FAAN, and William S. Henderson, FACMPE Upon completion of this free webinar, you should be able to: nn Understand payment changes in the Medicare Physician
Fee Schedule effective January 1, 2018
nn Review final MACRA reporting requirements for 2017 nn Learn how to implement new procedure codes (CPT)
effective January 1, 2018
nn Identify opportunities and challenges for neurology
This [meeting] provided so many fundamentals that I need in everyday practice. —Advanced Practice Provider Member
I especially liked the experiential learning areas. They really captured the kinetic energy of the meeting. —Neurologist Member
I’m going to tell my fellowresidents to go to the Annual Meeting. It’s a fantastic networking and educational opportunity. I plan to go for years to come. —Junior Member
practices based on final regulations
Even though 2017 is coming to an end, you can access recordings of all this year’s AAN practice management webinars to gain the valuable insights and tools you need to navigate through the ever-changing health care landscape— and receive year-end CME credits! Single webinars are $99 but AAN members get the greatest value with the $189 subscription to all 10 live one-hour webinars (not including the New Year, New Rules webinar that is free to all AAN members). All webinars include access to presentation slides and recordings. Physicians receive 1 AMA PRA Category 1 Credit™ per webinar; non-physicians receive a certificate of completion. Visit AAN.com/view/pmw17 to learn more and register, or contact Jessica Nickrand at jnickrand@aan.com. •
Register now: AAN.com/view/AM18 Hotel deadline: March 2, 2018 Early registration deadline: March 29, 2018
APRIL 21–April 27, 2018 ADVANCING NEUROLOGY. ADVANCING YOU.
Practice
New Interactive Electronic Exam Room Posters Help Improve Patient Experience Using the new interactive electronic exam room posters has helped in explaining neurologic conditions to patients, says Mill Etienne, MD, MPH, FAAN, of Bon Secours Neurology group, part of the Westchester Medical Center Health Network in New York. “Often, I come into the exam room and see patients clicking and learning more about their medical Mill Etienne, MD, MPH, FAAN condition, and what they have learned from reviewing the poster board often leads to questions that could be addressed during the visit,” said Etienne. “It has definitely been worthwhile to have the electronic poster board in the office. Patients like it, and the waiting time flies by for the patient. This is great for a busy office.”
Each poster features educational charts, diagrams, and tips on managing neurologic conditions. The 21.5” screen silently rotates panels every 25 seconds, with no interaction needed from health care professionals, office staff, or patients. Clear, engaging videos play only when activated, with a suite of controls, including an easy-to-find pause button. Installation of the posters is free, and they do not require WiFi. They plug into the wall, and any maintenance is conducted by Health Monitor Network. The posters, which include advertising secured by Health Monitor Network, are available for all member practices in the US, excluding Alaska, Hawaii, and Puerto Rico. To learn more, visit http://bit.ly/HM_AAN. •
The AAN has partnered with Health Monitor Network, a patient education company, to offer the touchscreen posters for free to AAN US members’ exam rooms. The AAN is reviewing the medical content for accuracy, which is being expanded to cover a dozen common neurologic conditions and is updated quarterly.
Here’s What’s New in Neurology Now and Neurology: Clinical Practice TV host and actress Maria Menounos was diagnosed with a meningioma, a benign brain tumor, less than a year after her mother was diagnosed with stage 4 brain cancer. In the December 2017/January 2018 issue of Neurology Now ®, she discusses how she’s made her health a priority since her surgery. In another feature, Victoria Dillard, an actress who played Janelle Cooper in Spin City with Michael J. Fox, talks about her diagnosis of early-onset Parkinson’s disease and the additional challenges she faces as a young black woman with this disease. Readers also learn how to manage weight changes due to diseases and/or medications, and how self-management skills can improve their quality of life as they navigate chronic progressive conditions. AAN members may elect to receive multiple copies of Neurology Now to distribute to their patients, who also can subscribe for free. Visit
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AANnews • December 2017
NeurologyNow.com to learn more or email BeGreen@WasteFreeMail. com to adjust the number of magazine copies you receive for your patients or to update your clinic address. In Neurology® Clinical Practice, papers and accompanying editorials examine how incorporating students into clinic may both enhance student learning and improve preceptor productivity, and the future role of incorporating students to reduce physician burnout and mitigate shortages of neurologists. A commentary and an accompanying editorial discuss email strategies to target stress and increase productivity in clinical practice. Neurology: Clinical Practice, published six times a year, is available in print (for US members only), online, and for the iPad and Android. Visit Neurology.org/cp for more information. •
December 2017
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Policy
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.
AAN Members React to Opioid Emergency The opioid crisis has had a staggering impact on communities across the US, but few places have seen the challenges of this epidemic more than West Virginia. AAN Government Relations Committee members David Watson, MD, and Mitzi Payne, MD, practice in West Virginia and see their patients and community struggling. “This is a public health emergency in my state,” said Watson. President Trump on October 26 declared the opioid epidemic as a national public health emergency. This declaration allows federal agencies to make resources available to reduce deaths related to opioid abuse, which include telemedicine services for opioid treatment and assistance for people with opioid addictions seeking housing or employment. The Department of Health and Human Services can also allocate additional staff and increase flexibilities in programs to prevent addiction and support recovery. Neurologists like Drs. Watson and Payne have seen the devastating effects of opioid abuse in their practices and their communities. While most neurologists may not prescribe opioids, they treat many complications that result from opioid overuse and abuse. Babies diagnosed with neonatal abstinence syndrome (NAS) often visit pediatric neurologists to work through the symptoms of their condition and begin healing. Adults seeking help with addiction or working through recovery following an overdose may also see a neurologist as part of a care team. “The opioid crisis crosses all specialties,” said Watson, “but as protectors of the brain it is a problem that neurologists must address head on. This includes not only rehabilitation but also finding new and safe treatments for people with pain.” Policy makers recognize the critical role that physicians, including neurologists, play in combating this epidemic and routinely ask AAN members and our lobbyists in DC about the impact this crisis is having on patients. The AAN supported 21st Century Cures, which allocated funding for the opioid crisis, and partnered with other physician organizations on sign-on letters supportive of more money to combat the epidemic. The Academy is working on the state and federal level to support actions that promote access to care for people struggling with opioid use disorders.
Neurologic Patient Groups Meet with AAN in Washington, DC Representatives from nine neurology patient groups, including representatives from the Alzheimer’s, Parkinson’s, MS, and epilepsy communities, came together at our Washington office to discuss advocacy plans for 2018 and explore opportunities for collaboration. Each organization is preparing legislative priorities and getting ready for annual congressional fly-in days. In 2017, these nine groups brought nearly 2,500 advocates to Washington and are preparing for even larger events in 2018. Neurology patient groups, as well as the Academy, will continue to advocate for access to health care, affordable prescription medications, and telemedicine as some of their top issues. The AAN is excited to continue working together with neurology patient groups and ensuring the highest quality care is available to all patients living with neurologic disease. •
AANnews • December 2017
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Policy
Advocate Takes DIY Approach to Creating Neurological Society What do you do when your state does not have a neurological society? You start one yourself! That’s just what Sarah Song, MD, MPH, did, with the help of training through the AAN’s Palatucci Advocacy Leadership Forum. Song’s action plan for the forum was to establish the Illinois State Neurological Society. Not only did she accomplish that, she and her collaborators staged a successful first annual meeting and set the agenda for the year ahead. This is how she did it. Why did you wish to start a state neurosociety? I have been on the State Workgroup of the Government Relations Committee for several years, and the chair of the workgroup for the last year or two. I saw firsthand the benefit that state neurosocieties could provide to their neurologists. State neurosocieties can advocate on behalf of their neurologists on a very local level, on policies that affect everyday clinical practice, reimbursement, and scope of practice. Only neurologists can say what neurologists do on a daily basis; we are the authority on what services patients with neurological diseases will benefit from, and who should be providing these services. It is up to us to make sure that the practice of neurology is protected, so that our patients are protected. Given that state bills are being presented and passed at a much more rapid rate than federal legislation, we have a duty to our patients to advocate for the best and most evidence-based practices. And, given that many policies that affect the practical practicing of neurology are determined at the state level, having a state neurological society to quickly respond to issues could be very effective. State neurological societies can also provide convenient and locally obtainable CME. As there are so many advances in therapeutics for neurological conditions, it is vitally important for us to stay current on our knowledge, and the more we can learn from local experts, the fresher our knowledge base will be. Most importantly, it is important for neurologists to support each other. Burnout is at an all-time high, and regulatory burdens are making our jobs more difficult. In addition, many of us end up being the primary care providers for our patients, which takes time and effort. We’ve seen a decrease in numbers of students going into neurology. Given our aging population, this divide, between the number of providers and the number of patients who need us, will only grow. We need to support young doctors in training and encourage them to go into neurology. We also need to support neurologists at all stages from burning out and leaving the field. A state neurosociety can help to bring neurologists together.
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it really came down to action items, weekly phone meetings, and a constant stream of text messages and emails. What were some of your goals? Well, first of all, Austin and I wanted to make sure that we were structurally sound. That meant filing all of the non-profit paperwork correctly, and making sure that we had a lawyer and an accountant give input into what we were doing. We also worked on refining our bylaws and our mission statement, and had a couple of meetings with our other founding board member, Dr. Thomas Bleck, and other interested neurologists to get their input as well. We put up a website, opened a small business banking account, and put most of our efforts into getting our first face-to-face meeting off the ground. For the meeting, we recruited clinical experts—Dr. Shyam Prabhakaran from Northwestern, Dr. Adil Javed from the University of Chicago, and Dr. Rima Dafer from Rush University—to give our lectures. We also received support from the AAN to sponsor a speaker, AAN Board Member Dr. Jim Goldenberg, to discuss MACRA, and support from the ABPN to sponsor Dr. José Biller to talk about MOC. What were some of the obstacles you faced, and how did you move through/around them? The first obstacle was certainly financial! However, through a generous Palatucci Advocacy Leadership Forum grant, we could fund the non-profit paperwork and get the society up and running. The second obstacle was drumming up interest in the society, which was only an idea at that point. We were lucky enough to gather a small group of interested and engaged neurologists and neurologists-intraining who attended phone meetings and offered advice and help. The third obstacle was that we didn’t know what other obstacles we had ahead of us that we hadn’t yet considered! Luckily, with the help of the AAN and Grant Niver (the AAN Program Manager for State Affairs), we were able to crowdsource practical advice from other state neurological societies already in existence, who had experience in how to run a society, how to organize a meeting, and how to prepare for the unexpected.
When did you begin this action plan?
What was the most challenging aspect of setting up the first meeting?
I first started considering starting a state neurological society about three years ago. To be honest, I was rather hoping someone else would do it! Then, I figured that I would give it a go. I started gathering information and assessing interest in a society two years ago. The past year, and especially the last six months, my co-founder, Dr. Austin Hake, and I were working on the society several hours per week. Given that Austin is in Quincy and I am in Chicago,
Austin and I joked that we really didn’t know how many people would come to our first meeting, and that maybe it would just be us in a big empty room. I remember telling the event organizer that the room needed to hold anywhere from 10 to 100 people (and she laughed at me, thinking I was joking). It was intimidating, because we both put our own money down for things like the room deposit and the mailers, not knowing whether we would get paid back.
AANnews • December 2017
However, we both felt like it was worth it, and we were committed to getting as many people to the meeting as possible. We hoped that once we could show people the value of a state neurological society, more people would want to become active in the society, and to participate in future meetings, serve on committees, and help out with other endeavors. We also needed to convince exhibitors to come and support the meeting, which required us to make a lot of cold calls to justify our case. Also, neither of us had experience in the ins and outs of CME, which was logistically tricky. But, the Illinois State Medical Society (ISMS), which provided us with the CME for the meeting, was incredibly generous in their support and advice. What were some of the issues/action items that came out of the first meeting (where does the society go from here)? We were really surprised that we had such a great crowd at the meeting, and the feedback has been encouraging and overwhelmingly positive. We had around 110 people there, and they ranged from senior neurologists to medical students. At the meeting, we were happy to elect a group of engaged, hardworking neurologists and trainees to serve on the first Board of Directors. Our Board is responsible for putting together this year’s agenda. We also want to develop our website, work on outreach, and plan next year’s meeting. We have several medical students who are working with us on how to encourage trainees to get excited about neurology. In the future, we plan to set up an advocacy system to inform Illinois neurologists about upcoming legislation that could impact their practice, and hope to develop a state neurology advocacy day, where we meet up in Springfield to talk to our legislators in person. Personally, I’d like to get more patients with neurological conditions involved, perhaps on a subcommittee, and involve them in our advocacy efforts. We have a lot of big ideas and a lot of goals, and now it’s just the hard work of getting things done!
been a part of this process! Starting the state neurological society was a group effort, and everyone–from Austin and Tom, the other neurologists who offered their support, Grant Niver and the AAN, the ISMS, the ABPN, our gracious speakers who volunteered their time and hard work–has been part of it. I think that the tough part is just beginning, and for the Illinois State Neurological Society to be a success, the Board of Directors will need to keep the momentum going. For anyone who is thinking about starting a state neurological society, I would encourage you to do it! Not every state has one, but every state could benefit from one. If you need advice, encouragement, or don’t know where to start, I suggest participating in the Palatucci Advocacy Leadership Forum. PALF is a great program, one that teaches you media skills, trains you in advocacy, and puts you in touch with an amazing network of engaged neurologists doing incredible work, all across the globe. I credit PALF with so much of the society’s initial success, and not just the grant that helped us with the start-up costs. Being a PALF advocate and serving as a PALF advisor has been beneficial in a myriad of ways in this endeavor, and I encourage anyone interested in starting up a project, or anyone with a passion for positive change, to apply. •
What did you find most satisfying for you in the project, professionally and personally? This has been a lot of work, and very eye-opening. But, it has already been very rewarding and I’m glad to have
Sarah Song, MD, MPH, and AAN Board Member James N. Goldenberg, MD, FAAN.
AANnews • December 2017
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Education
Review Neuro-oncology Treatment, Complications, and More with Continuum Neuro-oncology topics ranging from neuroradiologic pearls to benign tumors to end-of-life care are covered in the current issue of Continuum: Lifelong Learning in Neurology ®. Guest edited by Amy A. Pruitt, MD, topics include: nn 2016 World Health Organization Classification of Central
Nervous System Tumors / Patrick Y. Wen, MD, FAAN; Jason T. Huse, MD, PhD
nn High-grade Gliomas / Lakshmi Nayak, MD;
David A. Reardon, MD
and Advance Care Planning in Neuro-oncology / Tobias Walbert, MD, PhD
nn Pediatric Brain Tumors /
nn Low-grade Gliomas / David Schiff, MD, FAAN nn Epidemiology, Treatment, and Complications of Central
Nervous System Metastases / Amy A. Pruitt, MD
nn Primary Central Nervous System Lymphoma / Catherine
H. Han, MD; Tracy T. Batchelor, MD, MPH
nn Neuroradiologic Pearls for Neuro-oncology /
Joshua P. Klein, MD, PhD, FANA, FASN, FAAN; Jorg Dietrich, MD, PhD
nn Medical Complications of Brain Tumors /
Nimish A. Mohile, MD
nn Paraneoplastic Disorders / Eric Lancaster, MD, PhD nn Common Histologically Benign Tumors of the Brain /
Roy E. Strowd III, MD; Jaishri O. Blakeley, MD
MarCom: 18 NFF Ad — Half Page Horizontal> AANnews, NJ, NCP Placed in AANnews, Neurology Journal, or Neurology Clinical Practice 8.25"x5.4375", +0.125", 4C
nn Palliative Care, End-of-Life Care,
Mai Dang, MD, PhD; Peter C. Phillips, MD
Amy A. Pruitt, MD Continuum® and Continuum® Audio are now offered in one subscription; the combined offering is currently available for new subscribers and will be phased in for current subscribers as they renew their subscriptions. Starting in February 2018, all current and new subscribers will have access to both Continuum and Continuum Audio.
Subscribe to Continuum and Continuum Audio by contacting Wolters Kluwer at (800) 361-0633, (301) 223-2300 (international), or Shop.LWW.com/continuum. Junior members who are transitioning to neurologist memberships can receive a 50-percent discount on the already low member rate for the Continuum and Continuum Audio subscription. •
What’s Your Story? Do you have a powerful story about the impacts of brain disease on yourself or a loved one? Are you studying neuroscience in school or considering neurology as a career? Do you want to help raise awareness of and funding for critical brain disease research? Or are you simply fascinated by the wonders of the brain?
We want to hear it: 4 categories…4 chances to win $1,000! 1. Why I think Neuroscience Is...™ Cool—Tell us why the brain is fascinating 2. Why I think Neuroscience Is...™ Rewarding—Tell us how discovery opens doors 3. Why I think Neuroscience Is...™ Essential—Tell us why research is important 4. Why I think Neuroscience Is...™ Critical—Tell us why advocacy makes an impact
SUBMISSION DEADLINE: March 2, 2018 Visit NeuroFilmFestival.com for complete contest rules, idea tips, and submission instructions.
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Presented by: AANnews • December 2017
Solve the case of his lifetime Identifying the link can lead to a crucial diagnosis1-5 Hereditary ATTR amyloidosis is an inherited, rapidly progressive disease that causes sensory-motor polyneuropathy that may be accompanied by autonomic or cardiac symptoms, eventually robbing patients of function—and even their lives. With increased research and development in hATTR amyloidosis, now it is more critical than ever to be aware of red-flag symptom clusters and investigate potential cases.
See the connections at: InvestigateRedFlagSymptoms.com
Not an actual patient.
References: 1. Conceição I, González-Duarte A, Obici L, et al. “Red-flag” symptom clusters in transthyretin familial amyloid polyneuropathy. J Peripher Nerv Syst. 2016;21(1):5-9. 2. Hanna M. Novel drugs targeting transthyretin amyloidosis. Curr Heart Fail Rep. 2014;11(1):50-57. 3. Adams D, Coelho T, Obici L, et al. Rapid progression of familial amyloidotic polyneuropathy: a multinational natural history study. Neurology. 2015;85(8):675-682. 4. Damy T, Judge DP, Kristen AV, et al. Cardiac findings and events observed in an open-label clinical trial of tafamidis in patients with non-Val30Met and non-Val122lle hereditary transthyretin amyloidosis. J Cardiovasc Transl Res. 2015;8(2):117-127. 5. Mohty D, Damy T, Cosnay P, et al. Cardiac amyloidosis: updates in diagnosis and management. Arch Cardiovasc Dis. 2013;106(10):528-540.
© 2017 Alnylam Pharmaceuticals, Inc. All rights reserved. 05.2017
AANnews • December 2017
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Membership
Don’t Forget to Renew Your Membership for 2018 The new year is just around the corner—and you don’t want to risk losing access to your valuable benefits. Only your AAN membership can provide a single source for all the essential education, science, and incomparable support you need to thrive throughout your professional lifetime. Remember: If you don’t renew before December 31, you will begin to lose access to your benefits beginning January 1, so make it your resolution to visit AAN.com/dues to renew today so you can continue to:
nn Access complimentary AAN online programs to earn
CME and help meet MOC requirements
nn Be the first to know about the latest scientific research
and news affecting the neuroscience community
nn Access member-only resources including clinical
practice guidelines and publications, including the Neurology ® journal
nn Connect with a network of more than 32,000
neurologists and neuroscience professionals worldwide
nn Save big on Annual Meeting registration, Continuum®,
and other AAN products and services
nn Contribute to public policy issues by representing your
issues at the federal, state, and local level
You can view a full listing of your exclusive AAN member benefits at AAN.com/benefits. While you are renewing your dues at AAN.com/dues, please be sure to update your member profile to receive information about AAN resources most relevant and interesting to you. For assistance, contact AAN Member Services at memberservices@aan.com or (800) 879-1960. •
Neuroscience Is… Rewarding Day Reflex Hammer Giveaway Is Huge Success The AAN designated November 30, 2017, as Neuroscience Is…™ Rewarding Day in honor of Wilhelm Henrich Erb, MD, who was born November 30, 1840, and is credited with popularizing the reflex hammer used in today’s neurologic exam. As part of the day’s celebration, and to encourage US medical students to learn more about the exciting, challenging, and rewarding field of neurology, the AAN hosted a campaign through which the first 100 medical students to respond could receive a free Troemner reflex hammer—a universal symbol of the field of neurology. The campaign proved a huge success, with all hammers claimed within 48 hours, and Twitter and Instagram lighting up with photos of the medical students posing with their new hammers and using the hashtags #NeuroscienceIs and #FutureNeurologist, and tagging @AANmember or @aanbrain.
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AANnews • December 2017
With the United States alone currently experiencing an 11 percent shortfall in the number of neurologists needed for patient care that will grow to 19 percent by 2025, the campaign was just one of many the AAN is currently
employing to engage medical students and encourage them to consider neurology to help fill this gap and ensure that future populations have access to high-quality, patientcentered neurologic care. •
AAN Aids Neurologists in Devastated Puerto Rico The destructive forces of Hurricane Maria crippled the medical facilities and services in Puerto Rico. When Carlos A. Luciano, MD, FAAN, professor and chair of neurology at the University of Puerto Rico School of Medicine, reached out to AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN, to see if the Academy could provide some form of assistance, the answer was, “Yes, we can.” “This may sound perhaps as a lot to ask from the AAN, but the situation is very critical,” said Luciano. “The system in which we work has been severely affected and we are looking for ways in which we can continue providing our services and keep the program working. I am foreseeing that the operational funds for the training program, which are generated from our faculty practice program, will be markedly reduced.” The AAN has agreed to: nn Waive 2018 membership dues for the University’s 12 adult neurology residents and four fellows nn Waive the 2018 RITE® fee for nine residents from PGY-2 to PGY-4 and the three pediatric neurology fellows nn Provide $2,500 travel grants to three senior residents and two fellows to attend the 2018 AAN Annual Meeting “We discussed this on our board officers call and I am happy to say that we unanimously approved this request,” said Sacco. “The AAN is trying to do everything we can to help our members in need including those in practice and on the academic side. I can really think of no better way than to help our young trainees complete their progress to becoming a neurologist.” This action is in addition to the AAN’s Hurricane Relief Fund for Affected Neurology Practices, established in September 2017 to help members affected by Hurricanes Harvey, Irma, and Maria. •
AAN Hurricane Relief Fund Helps Neurology Practices The AAN Hurricane Relief Fund for Affected Neurology Practices has provided grants to 17 AAN members whose practices were shattered by Hurricanes Harvey, Irma, and Maria. Below are some excerpts from their notes of gratitude to the Academy and its members. Thank you kindly. It’s just nice to know the AAN staff cares. This is a tough time right now for us down here. —Nancy J. Kaplitz, MD, Key West, FL I deeply appreciate the AAN providing this relief grant. Again, thank you for your kind support. — Orlando A. Torres, MD, Coto Laurel, PR On behalf of Dr. Weiss and myself, we would like to thank the AAN for their generous gift. We are extremely grateful and it is greatly appreciated in our time of need. Thank you again for your kind generosity. — Gary M. Weiss, MD (and office staff), Weiss and Newberry Medical Associates, Palm Bay, FL Wow. Thank you so much. This is happiness and tremendous relieve for me. Blessings. — Carlos A. Barreto, MD, Bayamón, PR
I want to convey my heartfelt appreciation to the Academy for the generous and timely disaster grant. These funds are definitely needed and will help my practice get back on its feet. I never expected to be in this situation. I’m grateful for the assistance. —Steven M. Croft, MD, Houston, TX Thanks to the AAN for establishing the hurricane aid fund. I understand that there are many neurologists, especially those at private practices like myself, at Houston, Florida, and Puerto Rico that are experiencing the same challenges. Please consider my application, I am in need for relief! — Briseida E. Feliciano-Astacio, MD, Caguas, PR On my name and my practice (Neurology and Pain Medicine) we want to thank the initiative of the AAN for the economic assistance in this difficult moment. I’m thrilled with such contribution. Thanks so very much. — Angel M. Carrasco, MD, Neurology and Pain Medicine, Homestead, FL •
AANnews • December 2017
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Membership
Apply Now for FAAN Designation Elevate your status and distinguish yourself from your peers by applying now to become an esteemed Fellow of the American Academy of Neurology (FAAN). Gain the recognition you deserve for your exemplary contributions to the field of neurology and become eligible to serve on the AAN Board of Directors. This offers a unique opportunity that could allow you to have a significant impact on the future direction of the AAN and the field of neurology. You also can nominate a deserving colleague to become an FAAN. View the qualification information and apply or nominate a colleague by visiting AAN.com/view/FAAN. If you have questions about the Fellow status, how to nominate a colleague, or the application process, contact FAAN@aan.com or (800) 879-1960.
Congratulate These New FAANs! The AAN congratulates the following members who were named Fellows between July and September 2017. Hasan A. Al-hamadani, MD, FAAN
Raghav Govindarajan, MD, FAAN
Laura Nist, MD, FAAN
C. Alan Anderson, MD, FAAN
Tomas H. Holmlund, MD, FAAN
Hope O’Brien, MD, FAAN
Antonio Bertolotto, MD, FAAN
Arshad Iqbal, MD, FAAN
Mayowa Owolabi, MD, FAAN
David Blady, MD, FAAN
Frances E. Jensen, MD, FAAN
Anup D. Patel, MD, FAAN
Christina M. Burch, MD, FAAN
Ryuji Kaji, MD, FAAN
Kiran A. Patil, MD, FAAN
Lawrence F. Buxton, MD, PhD, FAAN
Bernadette Kalman, MD, PhD, DSc, FAAN
James R. Perry, MD, FRCPC, FAAN
Ignacio M. Carrillo-Nunez, MD, FAAN Pablo R. Castillo, MD, FAAN
Ludwig Kappos, MD, FAAN
Michael D. Privitera, MD, FAAN
David E. Collins, MD, FAAN
Noriko Kawashima, MD, FAAN
John Pula, MD, FAAN
Steven C. Cramer, MD, FAAN
Brian K. Kelly, MD, FAAN
Aarti Sarwal, MD, FAAN
Said S. Dahbour, MD, FAAN
Christopher J. Klein, MD, FAAN
Nicholas Joseph Silvestri, MD, FAAN
Bryan X. DeSouza, MD, FAAN
Shaheen E. Lakhan, MD, PhD, MEd, MS, FAAN
Niranjan N. Singh, MD, FAAN
Shanker N. Dixit, MD, FAAN Richard L. Doty, PhD, FAAN Xiang Fang, MD, PhD, FAAN Samuel A. Frank, MD, FAAN Marshall C. Freeman, MD, FAAN Howard Parker Goodkin, MD, PhD, FAAN
Yuebing Li, MD, PhD, FAAN Maria V. Lopez-Bresnahan, MD, FAAN Margherita Milone, MD, FAAN Hans J. Moebius, MD, PhD, FAAN Constantine Moschonas, MD, FAAN Fatta Basil Nahab, MD, FAAN Pamela Z. New, MD, FAAN, FAAN
Are You Getting Your AANe-news? Don’t miss the latest news headlines from your Academy! As an exclusive member benefit, you should be receiving AANe-news ™ the second and fourth Wednesday of each month if your email address is on file. If not, be sure to set your email filter to accept mailer@aan.com as a friendly address. Or update your email address at AAN.com/MemberProfile.
It’s Not Spam... It’s AANe-news! 36
AANnews • December 2017
Tamara M. Pringsheim, MD, FAAN
Peter T. Skaff, MD, FAAN Agnieszka Slowik, MD, FAAN Marsha Smith, MD, FAAN Nilufer Taner, MD, PhD, FAAN Mona Chetan Thakre, MD, FAAN Zaki N. Al Uqla, MD, FAAN Michael Y. Xu, MD, FAAN •
AmericanBrainFoundation.org
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Alzheimer’s Advocate Calls Caregivers “Unrecognized Victims” Caregivers are unrecognized victims caught in the rising tide of Alzheimer’s disease, says advocate Dan Gasby in an editorial published in Neurology® online on October 6, 2017. Gasby has been caring for his wife, B. Smith, a nationally recognized celebrity chef, supermodel, and lifestyle maven, since she was diagnosed with Alzheimer’s disease in 2013. In the editorial, “Alzheimer Dementia’s Other Victim—The Spouse,” Gasby provides an unvarnished account of his marriage under the devastating influence of Alzheimer’s, where everything has changed—from the couple’s business partnership to their sexual relationship. “From my experience as a caregiver, I know that brain disease robs sufferers of their dreams and ambitions and of their hopes and even their homes,” said Gasby. “We must recognize that the devastation extends to the caregiver, the other victim in this epidemic.” Gasby chronicles the emotionally and physically draining life of the caregiver: “It’s a fact that when you see an iceberg, no matter how large, only one-fifth is seen above the surface. That which is unseen constitutes the bulk of its true mass. True also of what my fellow spousal caregivers and I reveal about the depth and breadth of what we confront and endure every minute of every day. Some days are worse than others. Hearing, ‘I hate your guts!’ from your spouse pierces your very being. Yes, I know it’s not her, it’s the disease, but I’m still human and still feel it. For the at-home caregiver, Alzheimer’s is nothing short of domestic torture.” An estimated 5.5 million people in the United States have Alzheimer’s disease. The cost of caring for an Alzheimer’s patient ranges from $20,000 to $90,000 annually according to estimates. Spouses and relatives often give
up their jobs to provide care for a family member with Alzheimer’s disease, yet another staggering cost that goes unrecognized. Gasby’s editorial points to research and advocacy for brain health as his sources of hope. He took his message to Capitol Hill on October 10, where he testified in a congressional briefing on “Healthy Aging: The Connection… Diabetes, Obesity, and Dementia.” Gasby and Smith were featured on the cover of the October and November issue of Neurology Now®. Gasby also has been an active advocate behind the new US postal stamp design drawing attention to Alzheimer’s disease that was announced in November. In January 2017, Gasby joined forces with the American Brain Foundation to serve as a director on the board that includes world-renowned neurologists, a former NFL Super Bowl champion, and Susan Schneider Williams, artist and widow of late actor and comedian Robin Williams. •
Join Gasby at Standing Strong and Support Research On December 12, Gasby will be part of the Foundation’s fourth Standing Strong event in the Twin Cities to raise money for research. The event will feature Gasby and the highly acclaimed New York play, Dot*, which adds an element of humor to the devastation of Alzheimer’s. For more information, contact Nicole Hecksel at nhecksel@AmericanBrainFoundation.org. •
AANnews • December 2017
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AAN.com/careers 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. Multiple Neurology Openings in Greater Cincinnati/Northern Kentucky Come join a growing, well-respected group with the full support of our award-winning hospital system, St. Elizabeth Healthcare. St. Elizabeth Physicians offers a competitive compensation and benefits package. Working at St. Elizabeth Physicians allows you to enjoy Kentucky’s natural charm while all that metropolitan greater Cincinnati has to offer is just minutes away. Northern Kentucky is on the banks of the Ohio River and boasts affordable costs of living, award-winning schools, colleges and professional sports, exceptional fine arts and the distinction of being sixth in the nation for its number of Fortune 500 Company headquarters. The Cincinnati area was also recently named one of the trendiest cities in the nation by Realtor.com Progressive 5-member physician/1 NP neurology division of St. Elizabeth Physicians is seeking to add two neurologists; one for neurohospitalist position and one for traditional in- and outpatient practice. St. Elizabeth Physicians is a financially successful, multi-specialty group consisting of 367 physicians, 116 advanced practitioners, and over 1,100 associates serving more than 340,000 patients in 116 conveniently located sites in Kentucky, Ohio and Indiana. In partnership with our five St. Elizabeth Hospitals, together we are transforming how healthcare is delivered in our region. Beginning in 2019, a partnership with the University of Kentucky will also result in a local medical school. St. Elizabeth is a proud member of the Mayo Clinic Care Network. This network provides access
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AANnews • December 2017
to proven protocols, eConsults and unparalleled experience. It supports our mission to ensure our patients receive comprehensive and compassionate care—anywhere. Join St. Elizabeth Physicians where our associates ranked us in the top 4% of the country for overall satisfaction. St. Elizabeth Physician is an Equal Opportunity Employer and values the diversity of our associates. If you are interested in joining this highly-talented group of physicians, please contact Dante Gapultos at dante.gapultos@ stelizabeth.com or (859) 344-5505. Fellowship in Neuroimaging Winchester Neurological Consultants, Inc., in conjunction with Virginia Commonwealth University and Winchester Medical Center, is offering a clinical Neuroimaging Fellowship for BC/BE neurology graduates that can be completed in one or two years. Located approximately an hour from Washington, DC, our United Council of Neurologic Subspecialties fully accredited fellowship offers extensive training in the performance and interpretation of diagnostic inpatient and outpatient MRI, CT, Doppler, TCD, and myelography— utilizing four state of the art MRI scanners and four multi-slice CT units. Responsibilities include supervision and interpretation of imaging, assisting with acute stroke protocols, and direct patient care. Availability: immediate. Research interests are encouraged. Salary is $60,000.00 per year plus benefits. CV’s should be emailed to gsteele@winchesterneurological.com
AANnews® Classified Advertising he AAN offers a complete package of print, online, T and in-person recruitment advertising opportunities. Visit AAN.com/careers for all AAN options, rates, and deadlines. d copy for the February 2018 print edition of A AANnews must be submitted by January 1, 2018. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the T right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.
Fill Your Open Job The hottest jobs meet the top candidates at the AAN Neurology Career Center.
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AANnews • December 2017
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