VOLUME 33 · ISSUE 4 · April 2020
Due to health concerns related to COVID-19 (Coronavirus), the 2020 AAN Annual Meeting has been cancelled. For more information see page 4 or visit AAN.com/view/20AM.
VISIT AAN.COM/COVID19 FOR LATEST INFORMATION AFFECTING NEUROLOGY The AAN has created a web page, COVID-19 Neurology Resource Center, to link the latest information and content related to neurology and COVID-19 (coronavirus) for you and your patients. Visit AAN.com/COVID19 for accurate, reliable information. The page provides current news on implications for practices, including telemedicine recommendations, a new CPT® code for COVID-19 for testing, and an AMA fact sheet on reporting COVID-19 testing. Articles include “The Spread of COVID-19: Questions Raised, Some Answered by Neuroinfectious Disease Experts” from Neurology Today®, and “Telemedicine in Neurology. Telemedicine Work Group of the American Academy of Neurology Update” from the journal Neurology®. Furthermore, a collection of articles and resources from Brain & Life®, the AAN’s public magazine and website, provides ongoing COVID-19 coverage for patients and caregivers from a neurologist perspective, addressing concerns specific to neurology patients. Additional resources include links to the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) for the most up-to-date information on COVID-19. Continue to visit this page often for continuous updates.
2019 Annual Report Recounts Amazing Year for AAN Members From a stellar advocacy win on E/M coding to the recordbreaking Annual Meeting in Philadelphia, the AAN had a successful 2019 that all members can be proud of. Review the many Academy accomplishments on your behalf in the 2019 AAN Annual Report, now online 2019 ANNUAL REPORT at AAN.com/AnnualReport.
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Emerging Leaders Program Graduate Emerges a Leader
To the Members of the AAN
I am saddened we will not be seeing each other at our Annual Meeting in Toronto which was cancelled due to the COVID-19 pandemic. With my retirement drawing near, I had so looked forward to reconnecting with you a final time in my role as the Academy’s CEO. I have many—well, hundreds, actually—colleagues and true friends among you that I wished to personally thank for all their time, skills, wisdom, and counsel over the past 21 years. You are the ones who deserve the kudos for our success. Rydell Continued on page 9
18 Capitol Hill Report:
Neurology on the Hill Recap
20 Cerebrovascular Disease
Is Focus of New Continuum
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COMING SOON
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AANnews · April 2020
April Highlights The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. The Vision of the AAN is to be indispensable to our members.
Falls: Querying About Falls for Patients Headache: Medication Prescribed for Acute Migraine Attack
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Parkinson's: Psychiatric Symptoms Assessment ALS: End of Life Planning Assistance
Contact Information American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415 Phone: (800) 879-1960 (toll free) (612) 928-6000 (international)
A P R I L/M AY 2 0 2 0
We hope that by showing up, Nanci knows we love her.” — R E N É E Z E L LW E G E R A N D C O U R T E N E Y C OX
Email:
memberservices@aan.com
Website: AAN.com
O N N A N C I RY D E R ’S B AT T L E W IT H A L S
Palliative Care When Is It Appropriate? Music Therapy A Choir for All Voices
For advertising rates, contact: Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins
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Use Measures in Axon Registry for Geriatrics Population
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ALS, ADHD, and Caregiving Among Timely Topic in Latest Brain & Life
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Capitol Hill Report: Neurology on the Hill Recap
Dementia: Caregiver Education and Support
The Axon Registry ® continues to evolve and incorporate additional measures to drive quality improvement for neurology practices caring for an aging population.
The April/May issue of Brain & Life® features Hollywood publicist Nanci Ryder, who was diagnosed with amyotrophic lateral sclerosis (ALS) in 2014. In the intervening years, a formidable team of advocates, including actresses Renee Zellweger and Courteney Cox, has assembled around her.
Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com
AAN Chief Executive Officer: Mary E. Post, MBA, CAE
Editor-in-Chief: Melissa Ko, MD
First-time Neurology on the Hill attendee Joohi Jimenez-Shahed, MD, shares her experiences advocating in the nation's capital.
News Briefs
Managing Editor: Angela M. Babb, MS, CAE, APR
AAN Reviewing Proposed Changes to Medicare
Editor: Tim Streeter
CMS proposed changes to Medicare Advantage plans and Medicare Part D plans in February. Relevant provisions to neurology include proposals related to real-time benefit tools, changes to network adequacy requirements related to telehealth providers, and modifications to formulary tiering requirements. The AAN is reviewing the proposed rule and plans to submit comments.
Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com AANnews® is published monthly by the American Academy of Neurology for its 36,000 members worldwide. Access this magazine and other AAN publications online at AAN.com. The American Academy of Neurology ’ s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
Academy Delivers Comments on Drug Importation The AAN submitted comments in response to a recent proposed rule from the FDA that would allow certain drugs to be imported from Canada. The comments focus on the need to provide patients with meaningful financial relief and set out the AAN’s concerns with the proposal’s limitations, highlight the unique implications of the high cost of drugs on neurology, and offer several recommendations on how to improve the proposal.
The inclusion of advertisements and/or promotions of Sponsors and other Internet sites or resources that offer content, goods, or services on the Website does not imply endorsement of the advertised/promoted products or services by AAN.
AANnews • April 2020 3
President’s Column
COVID-19, the AAN Annual Meeting, and Teleneurology As we communicated to members via email on March 13, due to the global COVID-19 (coronavirus) pandemic, the AAN announced that it had no choice but to make the necessary decision to cancel the AAN’s Annual Meeting originally scheduled for April 25–May 1, 2020, in Toronto. Protecting the health, safety, and well-being of our members, attendees, and ultimately our neurology patients is paramount, and serves as the reason for our decision to cancel the AAN Annual Meeting for the first time in our 72-year history. Put simply, canceling the AAN Annual Meeting was the right thing to do during this historic time. Our members have been affected by travel restrictions—which have only increased since the World Health Organization elevated the status of the novel coronavirus outbreak to a pandemic last month. These restrictions prevented many of our faculty and speakers from being able to attend the Annual Meeting and made us unable to provide the educational offerings you need and expect. The health concerns of members wishing to attend the meeting were also foremost in our mind. For their incredible work and leadership during this difficult time, I want to thank our Board of Directors and members of our committees who have worked tirelessly to organize the more than 3,000 scientific sessions, hundreds of education courses, and experiential learning areas for the 15,000 professionals we had originally expected to attend. I also thank the thousands of members who had registered and were patient as we navigated through these uncertain weeks and for whom we are processing full registration fee refunds. If you have further questions with regard to the Annual Meeting, please contact AAN Member Services at memberservices@aan.com. This pandemic has elevated the value and need for telehealth services to our communities as social distancing has been invoked to help prevent transmission of COVID-19. We recognize the important role you play every day in the welfare of your patients, and our advocacy efforts to promote telehealth have continued throughout this crisis. We have created two new web pages to provide you with the latest communications regarding the pandemic. The COVID-19 Neurology Resource Center, at AAN.com/COVID19, is your one stop for the latest resources and guidance from the AAN and other trusted organizations to help you care for neurologic patients during the COVID-19 pandemic. The second web page, AAN.com/telehealth, contains timely information on changes in regulations on national and state levels, as well as links to commercial payers for their policies. Also: The AAN has put together a panel of member and staff experts to stay on top of changing regulations. The AAN is seeking clarification from policy experts.
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AANnews • April 2020
The AAN will publish resources to clarify issues and assist members wanting to implement teleneurology services. In accordance with the AAN’s position on teleneurology, the AAN is advocating that its members be able to offer Stevens teleneurology services regardless of the patient’s location and receive fair reimbursement for the care they provide. We recognize these are very stressful and uncertain times for you, your patients, and your families. Please remember we have wellness resources available to you 24/7 at AAN.com/ LiveWell. You can also receive or share assistance through your colleagues in your SynapseSM community or AAN Section. We recognize canceling the world’s largest gathering of neurologists impacts many of you and your education needs. Look for more information on different AAN educational opportunities throughout the remainder of 2020. As I write this, we are assessing the impact of social distancing on our upcoming conferences, but we have a strong assortment of online learning resources, such as the practice management webinar “Practice Engagement Techniques to Improve Patient Care” offered beginning April 14 (see page 11 for more information). You also can take advantage of CME offered through Continuum®, Neurology ®, and a host of other programs at Learning.AAN.com. The days ahead may seem dark, but your Academy is here to help light your way, and we all shall get through this together. Our retiring CEO Cathy Rydell, her executive team, and staff are working tirelessly from the safety of their homes as we unwind the preparations for the Annual Meeting, confront the changes brought upon our profession by COVID-19, and continue to develop the tools and resources you need in your work. Our transition to our new CEO Mary Post is moving seamlessly, and the members of our Board and committees continue their efforts on your behalf. I thank them all for their remarkable ability to take these seismic changes in stride and their agility and creativity in turning crises into solutions. Please take care of yourselves! And thank you for your patience, understanding, and unwavering commitment to the field of neurology and the AAN.
James C. Stevens, MD, FAAN President, AAN jstevens@aan.com @JimStevensMD on Twitter
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Conferences & Community
Academy Welcomes 38 Companies to the Industry Roundtable in 2020 The AAN has long recognized the value of collaborating with industry. Since its founding in 1994 to identify mutual opportunities to improve the quality of care and life for people with neurologic disease, the Industry Roundtable (IRT) has offered member companies unique opportunities to deepen their engagement with the AAN to meet these shared objectives. Today, organizations continue to join the IRT to stay informed, engage in dialogue with AAN leaders, and gain recognition within the world’s largest professional association of neurologists. The Academy is pleased to have welcomed the following 38 partners in 2020*:
$50,000 Members: AbbVie, Inc. ACADIA Pharmaceuticals, inc. Acorda Therapeutics, Inc. Akcea Therapeutics Alexion Pharmaceuticals, Inc. Allergan, Inc. Amgen AveXis, Inc. Biogen Biohaven Pharmaceuticals Celgene Corporation Eisai Inc. Eli Lilly & Company EMD Serono, Inc. Genentech, a Member of the Roche Group
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AANnews • April 2020
Greenwich Biosciences, Inc. Lundbeck Neurocrine Biosciences Novartis Pharmaceuticals Corporation Sanofi Genzyme Sunovion Pharmaceuticals Inc. Supernus Pharmaceuticals, Inc. Teva CNS
$40,000 Members: Avanir Pharmaceuticals, Inc.
$25,000 Members: Adamas Pharmaceuticals, Inc. Amneal Specialty, a division of Amneal Pharmaceuticals LLC
Ipsen Biopharmaceuticals, Inc. Medtronic Mitsubishi Tanabe Pharma America, Inc. Neurelis, Inc. Ovid Therapeutics SK life science, a subsidiary of SK biopharmaceuticals UCB, Inc. Viela Bio
$10,000 Members: argenx Grifols Harmony Biosciences Sage Therapeutics As of March 16, 2020
Emerging Leaders Program Graduate Emerges as a Leader The AAN’s Emerging Leaders Program was created to identify, engage, and mentor talent among earlycareer members who are interested in future roles within the Academy and the field of neurology. And no one exemplifies the power of the program more than Justin T. Jordan, MD, MPH, a neurologist at Massachusetts General Hospital in Boston. In the few years since graduating from the program in 2016, Jordan has taken the AAN by storm, stepping up in numerous volunteer capacities as a member of the Education Committee, Health Policy Subcommittee, Medical Student Pipeline Work Group, Palatucci Advocacy Leadership Forum Graduates Community, AAN Leadership Program Alumni Community, Emerging Leaders Forum Alumni, Neuro-oncology Section, and as vice chair of the Pipeline Subcommittee. For the past two years, he also has served as co-chair of the Brain Health Fair work group and chaired the Consortium of Neurology Residents and Fellows. Jordan attributes much of this success to the invaluable skills he gained as a result of the Emerging Leaders Program. “The first skill I developed in the program was learning how to interact with and engage all personality types,” said Jordan, who finds this skill particularly useful in his role as vice chair of the Pipeline Subcommittee. There, he is challenged with uniting a variety of skill sets and personality types in the common goal of increasing the number of medical students going into neurology. “My learned ability to read team members' relative strengths and engage and empower in individualized ways has helped me lead a diverse team to produce incredible ideas and content for the future of the neurology workforce,” said Jordan, who also found this skill to be immeasurably helpful in group projects, research, meetings, patient care, and even in his non-professional life. “Understanding interactions and motivations serves to make the most out of relationships,” he explained. “The example where this plays out most is my role as clinical director for neuro-oncology, where our 11 physicians have different approaches to practice, and I do my best to help keep our personal and institutional goals aligned.” One of the most popular components of the Emerging Leaders Program is the personalized coaching and mentorship that all participants receive—an experience that Jordan cites as proving especially valuable in achieving his many successes since graduating from the program. “I learned how to give and receive coaching and mentorship to achieve career goals—all the while not exhausting their generosity or wasting their time. Making such relationships mutually beneficial—although they’re always imbalanced— serves to promote long-term connections,” he explained. “Simply put, without the generosity of my Emerging Leaders Program mentors and sponsors, I wouldn’t have the opportunity to work in health policy, guideline creation, education and pipeline work, and so much more.”
Jordan
relationships with trainees, but I also worked with faculty physician volunteers to optimize presentations and mentoring experiences for hundreds of student participants,” said Jordan, who also got to exercise his coaching chops as an advisor with the 2019 Palatucci Advocacy Leadership Forum. In this role, Jordan “got to play a small—but hopefully important—role in some amazing advocacy work improving brain tumor care, increasing the neurology workforce in rural Arkansas, and improving post-stroke care.” But of all the valuable skills the Emerging Leaders Program has taught him, Jordan credits the “unbelievably important skill of longitudinal and long-distance teamwork” as being the one that “in truth, I use the most in current days.” It’s also this skill upon which Jordan relies most heavily as co-chair of the Brain Health Fair, the AAN’s free public event that takes place each year in the Annual Meeting host city. “Along with some amazing AAN staff, my co-chair Dr. Rujuta Wilson, and our fellow volunteer physicians, we have been able to create an amazing experience for the public year after year to enhance awareness and education about brain health and neurology in general. I feel honored to work with this team and create the Brain Health Fair that is enjoyed by thousands of people every year.”
“I enjoyed the privilege of leading the first two—ever—medical student symposia at the 2018 AAN Annual Meeting, and applied my new mentorship skills not only to my one-on-one
2016 Emerging Leaders Program Graduates
AANnews • April 2020 7
Conferences & Community
To the Members of the AAN
continued from cover
“Volunteers do not necessarily have the time; they have the heart.” —Elizabeth Andrew While it is impossible in this message to recognize all who have impacted my life at the AAN, I would like to personally recognize a few. To the all those who served as members of the Boards of Directors I’ve collaborated with and have individually and collectively made the AAN exceptional, I sincerely thank you for… Giving freely of your time, your talent, and your treasures Respectfully asking the tough questions Putting the needs of the Academy before your own Building relationships with each other and with staff Believing and living the vision and mission Respecting your Executive Team as partners in AAN’s success Welcoming me into your office, your home, your community
(Front) Jason Kopinski, CAE, Deputy Executive Director; Rydell; Christine E. Phelps, Deputy Executive Director; Timothy Engel, CPA, Chief Financial Officer. (Rear) Angela Babb, MS, CAE, APR, Chief Communications and Membership Officer; Bruce Levi, JD, Chief Governance and Strategy Officer; John Hutchins, JD, General Counsel; Deanna Ekholm, SPHR, Chief Human Resources and Diversity Officer; Chris Becker, Chief Business Development Officer.
“Alone we can do so little; together we can do so much.” —Helen Keller I have been inspired by my executive team. There really are no words to fully express how they have made me a better leader, a better person, and a better friend. They, along with the entire AAN staff, are the ones who truly deserve the recognition for moving this organization forward with a level of expertise and skill that amaze me every day. They uniformly share attributes which have been critical in executing our strategic plans, leading our staff, and making our vision and mission a daily reality for each other as well as our members: Motivated and Dedicated Personal and Professional Integrity Consistent and Accountable Dependable and Committed Self-manageable and Creative Passionate and Loyal Mission-driven
“Find a group of people who challenge and inspire you, spend a lot of time with them, and it will change your life.” —Amy Poehler I especially will be forever grateful to Steve Ringel, who was AAN president and chair of the Search Committee when I was hired. He gave me an opportunity of a lifetime and I have been committed to this organization from the moment I said yes. Since 1999, I have worked with 12 AAN presidents who have been gracious and patient mentors. Even though I came to the Academy with experience in hospital administration and medical association management and served in a state legislature, I have been a sponge soaking up their knowledge, insights, and advice. They were my wise teachers, my trusted advisors, and my treasured friends. Steve Ringel taught me the patient comes first.
Tim Pedley taught me the wisdom of listening before speaking.
Fran Kittredge taught me the AAN is a business. Stan Fahn taught me the joy of research and teaching.
Terry Cascino taught me the positive impact of measuring what’s important.
Sandy Olson taught me to engage fully with the “house of medicine.”
Tom Swift taught me neurology can be fun. Ralph Sacco taught me to stay true to values and culture.
Steve Sergay taught me strategic planning is critical to growth and success.
Jim Stevens taught me tough decisions make us stronger.
Berch Griggs taught me to honor, encourage, and challenge the individual. Bruce Sigsbee taught me the power and importance of the private practice neurologist.
If past is prologue, as Shakespeare said, the accomplishments of these many wonderful people over the past two decades will serve as a strong foundation for the AAN’s future successes. I thank you for the honor of trusting me to play my part, and I exit this stage to cheer you on from the audience. With admiration and loyalty,
Catherine M. Rydell, CAE CEO, American Academy of Neurology
Conferences & Community
Go Inside the Makeup and Minds of AAN Membership What rouses your curiosity about your fellow AAN members? Their average age? How many are women, or are based internationally? Do you share similar views about AAN products and services? Are you an outlier?
2020 Insights Report Based on 2019 Data and Information
A Report from the Member Research Subcommittee of the American Academy of Neurology
This report is intended for AAN members and staff only, and any requests for dissemination outside of AAN membership should be requested through AAN Member Services (memberservices@aan.com).
The 2020 Insights Report is available, and not only does it provide demographic information about the AAN’s members, but it also contains summaries of member opinions derived from the 45 research projects undertaken by the Academy’s Member Research Subcommittee. While the primary audience of this report is AAN leadership as an aid to understanding the breadth, needs, and viewpoints of membership, some members may find the data useful for your own projects. You can access the 2020 Insights Report at AAN.com/InsightReports.
AAN.com/InsightReports
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NEUROLOGY COMPENSATION AND PRODUCTIVITY SURVEY DATA AVAILABLE! Compare. Act. Improve. AAN.com/view/NCPSurvey
Tools & Resources
New Webinar Helps You with Practice Engagement From patient management through your office or clinic to improvements in quality of care, proper patient engagement can increase your patients’ appreciation of their experience and your skills. This webinar will help you enhance that experience. Patient Engagement that Works for Your Practice Radhika Sampat, DO, and J. Todd Barnes, MBA, CMPE Available April 14 on Learning.AAN.com Chapter 1: Patient Engagement Techniques to Improve Patient Care Identify which patient engagement techniques you can incorporate into your practice, like efficient patient portal usage, and motivational interviewing. Chapter 2: Improvement Activities Identify which MIPS Improvement Activities to incorporate into your practice and how this can improve the quality of the care you offer your patients
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Chapter 3: Promoting Interoperability Identify how using patient portals by e-prescribing, exchanging health information, and tracking clinical data improves your patients’ experience and can help your practice make more money Chapter 4: How Patient Engagement Can Improve Your Practice Learn how proper patient engagement can improve patient satisfaction, increasing your census and improving your reputation Each full two-hour webinar is prerecorded and posted online in its entirety. After their premieres, webinars will remain accessible for a year. Attendees with follow-up questions to the webinars can submit them to practice@aan.com for a quick response. You can purchase a single webinar for $99 or purchase a 2020 Practice Management Webinar subscription for only $189—that’s less than $38 per webinar! Webinars are accessible through the AAN Online Learning Center and each one provides 2 AMA PRA Category 1 Credits™ per webinar for physicians or a certificate of completion for non-physicians. If you are a Business Administrator PLUS or Junior member, you receive free access to all AAN Practice Management Webinars. That saves you $99 on the purchase of a single webinar, or $189 for the full subscription! Visit AAN.com/pmw20 for more information and to register.
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FOR THE TREATMENT OF RELAPSING FORMS OF MS
START STRONG. STAY STRONG.
In the 2-year DEFINE and CONFIRM pivotal trials, TECFIDERA® (dimethyl fumarate) demonstrated a 53% and 44% relative reduction in annualized relapse rate (ARR) vs placebo, respectively (0.172 vs 0.364; P<0.0001), (0.224 vs 0.401; P<0.0001)1
INDICATION
TECFIDERA® (dimethyl fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS TECFIDERA® (dimethyl fumarate) is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema. WARNINGS AND PRECAUTIONS Anaphylaxis and Angioedema • TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue TECFIDERA and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema Progressive Multifocal Leukoencephalopathy (PML) • PML has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA for 4 years while enrolled in a clinical trial • PML has occurred in the postmarketing setting in the presence of lymphopenia (<0.9 x 109/L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8 x 109/L persisting for more than 6 months • At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes • Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present
©2020 Biogen. All rights reserved. 02/20 TEC-US-3189 v6
Herpes Zoster and Other Serious Opportunistic Infections • Serious cases of herpes zoster have occurred with TECFIDERA, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on TECFIDERA for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered • Other serious opportunistic infections have occurred with TECFIDERA, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment • Consider withholding TECFIDERA treatment in patients with herpes zoster or other serious infections until the infection has resolved Lymphopenia • TECFIDERA may decrease lymphocyte counts. In the MS placebo-controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. The incidence of infections and serious infections was similar in patients treated with TECFIDERA or placebo. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8 x 109/L or ≤0.5 x 109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5 x 109/L for 3.5 years) • In controlled and uncontrolled clinical trials with TECFIDERA, 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy. TECFIDERA has not been studied in patients with preexisting low lymphocyte counts
THE #1 PRESCRIBED oral RMS therapy in the US since September 2013 Based on number of prescriptions from IMS NPATM Weekly Data (September 27, 2013–August 9, 2019).
>425,000
people have been treated with TECFIDERA worldwide 2
This includes clinical trial use and patients prescribed TECFIDERA
>810,000
global patient-years of experience 2
This includes clinical trial use and patients prescribed TECFIDERA
>12 Years IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d) Lymphopenia (cont’d) • Obtain a CBC, including lymphocyte count, before initiating treatment with TECFIDERA, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of TECFIDERA in patients with lymphocyte counts less than 0.5 x 109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if TECFIDERA is discontinued or interrupted due to lymphopenia. Consider withholding treatment from patients with serious infections until resolution Liver Injury • Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients • Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials • Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected Flushing • TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). Forty percent of patients taking TECFIDERA reported flushing, which was mostly mild to moderate in severity. Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization. Taking TECFIDERA with food may reduce flushing. Alternatively, administration of non-enteric coated aspirin (up to 325mg) 30 minutes prior to dosing may reduce the incidence or severity of flushing
of combined clinical trial and real-world experience 1,2
ADVERSE REACTIONS
• The most common adverse reactions (incidence ≥10% and ≥2% more than
placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea
• Gastrointestinal adverse reactions: TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with TECFIDERA • Hepatic transaminases: An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. There were no elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with TECFIDERA or placebo • Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first two months PREGNANCY • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TECFIDERA during pregnancy. Encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com
Please see following pages for Brief Summary of full Prescribing Information. Study Designs1 DEFINE: A 2-year, randomized, double-blind, placebo-controlled study in 1234 patients with RRMS. Secondary endpoint: ARR. CONFIRM: A 2-year, multicenter, randomized, double-blind, placebo-controlled study in 1417 patients with RRMS. Primary endpoint: ARR. DEFINE=Determination of the Efficacy and Safety of Oral Fumarate in RelapsingRemitting MS 3; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis 4; RRMS=relapsing-remitting multiple sclerosis.
References: 1. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 2. Data on file, Biogen. 3. Gold R, et al. N Engl J Med. 2012;367(12):1098-1107. 4. Fox RJ, et al. N Engl J Med. 2012;367(12):1087-1097.
To get started, simply fill out a Start Form at www.tecfiderahcp.com
TECFIDERA® (dimethyl fumarate) delayed-release capsules, for oral use MRI findings may be apparent before clinical signs or symptoms. Brief Summary of full Prescribing Information Cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or 1 INDICATIONS AND USAGE symptoms specific to PML, have been reported in patients treated with TECFIDERA is indicated for the treatment of relapsing forms of other MS medications associated with PML. Many of these patients multiple sclerosis (MS), to include clinically isolated syndrome, subsequently became symptomatic with PML. Therefore, monitoring relapsing-remitting disease, and active secondary progressive with MRI for signs that may be consistent with PML may be useful, and disease, in adults. any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Lower PML-related mortality and 2 DOSAGE AND ADMINISTRATION morbidity have been reported following discontinuation of another MS 2.1 Dosing Information medication associated with PML in patients with PML who were initially The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 asymptomatic compared to patients with PML who had characteristic days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Temporary dose reductions to 120 mg twice a day clinical signs and symptoms at diagnosis. It is not known whether may be considered for individuals who do not tolerate the maintenance these differences are due to early detection and discontinuation of MS dose. Within 4 weeks, the recommended dose of 240 mg twice a treatment or due to differences in disease in these patients. day should be resumed. Discontinuation of TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of TECFIDERA with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3)]. TECFIDERA should be swallowed whole and intact. TECFIDERA should not be crushed or chewed and the capsule contents should not be sprinkled on food. TECFIDERA can be taken with or without food. 2.2 Blood Tests Prior to Initiation of Therapy Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy [see Warnings and Precautions (5.4)]. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with TECFIDERA [see Warnings and Precautions (5.5)].
5.3 Herpes Zoster and Other Serious Opportunistic Infections Serious cases of herpes zoster have occurred with TECFIDERA, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on TECFIDERA for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered. Other serious opportunistic infections have occurred with TECFIDERA, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment. Consider withholding TECFIDERA treatment in patients with herpes zoster or other serious infections until the infection has resolved [see Adverse Reactions (6.2)].
3 DOSAGE FORMS AND STRENGTHS TECFIDERA is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with “BG-12 120 mg” in black ink on the body. The 240 mg capsules have a green cap and a 5.4 Lymphopenia green body, printed with “BG-12 240 mg” in black ink on the body. TECFIDERA may decrease lymphocyte counts. In the MS placebo 4 CONTRAINDICATIONS controlled trials, mean lymphocyte counts decreased by approximately TECFIDERA is contraindicated in patients with known hypersensitivity 30% during the first year of treatment with TECFIDERA and then to dimethyl fumarate or to any of the excipients of TECFIDERA. remained stable. Four weeks after stopping TECFIDERA, mean Reactions have included anaphylaxis and angioedema [see Warnings lymphocyte counts increased but did not return to baseline. Six percent and Precautions (5.1)]. (6%) of TECFIDERA patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The 5 WARNINGS AND PRECAUTIONS incidence of infections (60% vs 58%) and serious infections (2% vs 2%) 5.1 Anaphylaxis and Angioedema was similar in patients treated with TECFIDERA or placebo, respectively. TECFIDERA can cause anaphylaxis and angioedema after the first There was no increased incidence of serious infections observed in dose or at any time during treatment. Signs and symptoms have patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled included difficulty breathing, urticaria, and swelling of the throat and trials, although one patient in an extension study developed PML in the tongue. Patients should be instructed to discontinue TECFIDERA setting of prolonged lymphopenia (lymphocyte counts predominantly and seek immediate medical care should they experience signs and <0.5x109/L for 3.5 years) [see Warnings and Precautions (5.2)]. symptoms of anaphylaxis or angioedema. In controlled and uncontrolled clinical trials, 2% of patients experienced 5.2 Progressive Multifocal Leukoencephalopathy lymphocyte counts <0.5 x 109/L for at least six months, and in this group Progressive multifocal leukoencephalopathy (PML) has occurred in the majority of lymphocyte counts remained <0.5x109/L with continued patients with MS treated with TECFIDERA. PML is an opportunistic viral therapy. TECFIDERA has not been studied in patients with pre-existing infection of the brain caused by the JC virus (JCV) that typically only low lymphocyte counts. occurs in patients who are immunocompromised, and that usually leads Obtain a CBC, including lymphocyte count, before initiating treatment to death or severe disability. A fatal case of PML occurred in a patient with TECFIDERA, 6 months after starting treatment, and then every 6 to who received TECFIDERA for 4 years while enrolled in a clinical trial. 12 months thereafter, and as clinically indicated. Consider interruption During the clinical trial, the patient experienced prolonged lymphopenia of TECFIDERA in patients with lymphocyte counts less than 0.5 x 109/L (lymphocyte counts predominantly <0.5x109/L for 3.5 years) while taking persisting for more than six months. Given the potential for delayed TECFIDERA [see Warnings and Precautions (5.4)]. The patient had no recovery of lymphocyte counts, continue to obtain lymphocyte counts other identified systemic medical conditions resulting in compromised until their recovery if TECFIDERA is discontinued or interrupted due to immune system function and had not previously been treated with lymphopenia. Consider withholding treatment from patients with serious natalizumab, which has a known association with PML. The patient infections until resolution. Decisions about whether or not to restart was also not taking any immunosuppressive or immunomodulatory TECFIDERA should be individualized based on clinical circumstances. medications concomitantly. 5.5 Liver Injury PML has also occurred in the postmarketing setting in the presence of Clinically significant cases of liver injury have been reported in patients 9 lymphopenia (<0.9x10 /L). While the role of lymphopenia in these cases treated with TECFIDERA in the postmarketing setting. The onset has is uncertain, the PML cases have occurred predominantly in patients ranged from a few days to several months after initiation of treatment with lymphocyte counts <0.8x109/L persisting for more than 6 months. with TECFIDERA. Signs and symptoms of liver injury, including elevation At the first sign or symptom suggestive of PML, withhold TECFIDERA of serum aminotransferases to greater than 5-fold the upper limit of and perform an appropriate diagnostic evaluation. Typical symptoms normal and elevation of total bilirubin to greater than 2-fold the upper associated with PML are diverse, progress over days to weeks, and limit of normal have been observed. These abnormalities resolved upon include progressive weakness on one side of the body or clumsiness treatment discontinuation. Some cases required hospitalization. None of limbs, disturbance of vision, and changes in thinking, memory, and of the reported cases resulted in liver failure, liver transplant, or death. orientation leading to confusion and personality changes. However, the combination of new serum aminotransferase elevations
with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients. Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials [see Adverse Reactions (6.1)]. Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected. 5.6 Flushing TECFIDERA may cause flushing (e.g., warmth, redness, itching, and/ or burning sensation). In clinical trials, 40% of TECFIDERA treated patients experienced flushing. Flushing symptoms generally began soon after initiating TECFIDERA and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued TECFIDERA for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization. Administration of TECFIDERA with food may reduce the incidence of flushing. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3)].
Gastrointestinal TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with TECFIDERA. Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both TECFIDERA and placebo and were balanced between groups. There were no elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with TECFIDERA or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy. Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received TECFIDERA and been followed for periods up to 4 years with an overall exposure of 4603 person-years. Approximately 1162 patients have received more than 2 years of treatment with TECFIDERA. The adverse reaction profile of TECFIDERA in the uncontrolled clinical studies was consistent with the experience in the placebo-controlled clinical trials.
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: • Anaphylaxis and Angioedema [see Warnings and Precautions (5.1)]. • Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.2)]. • Herpes Zoster and Other Serious Opportunistic Infections [see Warnings and Precautions (5.3)]. 8 USE IN SPECIFIC POPULATIONS • Lymphopenia [see Warnings and Precautions (5.4)]. 8.1 Pregnancy • Liver Injury [see Warnings and Precautions (5.5)]. Pregnancy Exposure Registry • Flushing [see Warnings and Precautions (5.6)]. There is a pregnancy exposure registry that monitors pregnancy 6.1 Clinical Trials Experience outcomes in women exposed to TECFIDERA during pregnancy. Because clinical trials are conducted under widely varying conditions, Encourage patients to enroll by calling 1-866-810-1462 or visiting adverse reaction rates observed in clinical trials of a drug cannot be www.tecfiderapregnancyregistry.com. directly compared to rates in the clinical trials of another drug and may Risk Summary not reflect the rates observed in clinical practice. The most common adverse reactions (incidence ≥10% and ≥2% more There are no adequate data on the developmental risk associated with than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, the use of TECFIDERA in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral and nausea. function were observed when dimethyl fumarate (DMF) was administered Adverse Reactions in Placebo-Controlled Trials during pregnancy and lactation at clinically relevant doses [see Data]. In the two well-controlled studies demonstrating effectiveness, 1529 In the U.S. general population, the estimated background risk of major patients received TECFIDERA with an overall exposure of 2244 person- birth defects and miscarriage in clinically recognized pregnancies is 2-4% years [see Clinical Studies (14)]. and 15-20%, respectively. The background risk of major birth defects and The adverse reactions presented in the table below are based on safety miscarriage for the indicated population is unknown. information from 769 patients treated with TECFIDERA 240 mg twice a 8.2 Lactation day and 771 placebo-treated patients. Risk Summary Table 1: Adverse Reactions in Study 1 and 2 reported for There are no data on the presence of DMF or MMF in human milk. The TECFIDERA 240 mg BID at ≥ 2% higher incidence than placebo effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be TECFIDERA Placebo considered along with the mother’s clinical need for TECFIDERA and any N=769 N=771 potential adverse effects on the breastfed infant from the drug or from the % % underlying maternal condition. Flushing 40 6 8.4 Pediatric Use Abdominal pain
18
10
Safety and effectiveness in pediatric patients have not been established.
Diarrhea
14
11
Nausea
12
9
8.5 Geriatric Use Clinical studies of TECFIDERA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Vomiting
9
5
Pruritus
8
4
Rash
8
3
Albumin urine present
6
4
Erythema
5
1
Dyspepsia
5
3
Aspartate aminotransferase increased
4
2
Lymphopenia
2
<1
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Inform patients that they will be provided two strengths of TECFIDERA when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow TECFIDERA capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration (2.1)].
Tools & Resources Anaphylaxis and Angioedema Advise patients to discontinue TECFIDERA and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.1)]. Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received TECFIDERA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.2)]. Herpes Zoster and Other Serious Opportunistic Infections Inform patients that herpes zoster and other serious opportunistic infections have occurred in patients who received TECFIDERA. Instruct the patient of the importance of contacting their doctor if they develop any signs or symptoms associated with herpes zoster or other serious opportunistic infections [see Warnings and Precautions (5.3)]. Lymphocyte Counts Inform patients that TECFIDERA may decrease lymphocyte counts. A blood test should be obtained before they start therapy. Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions (5.4), Adverse Reactions (6.1)]. Liver Injury Inform patients that TECFIDERA may cause liver injury. Instruct patients treated with TECFIDERA to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions (5.5)]. Flushing and Gastrointestinal (GI) Reactions Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI reactions. Advise patients experiencing flushing that taking TECFIDERA with food or taking a non-enteric coated aspirin prior to taking TECFIDERA may help [see Adverse Reactions (6.1)]. Pregnancy and Pregnancy Registry Instruct patients that if they are pregnant or plan to become pregnant while taking TECFIDERA they should inform their physician. Encourage patients to enroll in the TECFIDERA Pregnancy Registry if they become pregnant while taking TECFIDERA [see Use in Specific Populations (8.1)]. 41347-11 Manufactured for: Biogen Inc. Cambridge, MA 02142
Use Measures in Axon Registry for Geriatrics Population Currently, there are more than 46 million adults age 65 and older living in the US, and that number is expected to grow to almost 90 million by 2050. Every year, there are nearly 10 million new cases of dementia worldwide and it is estimated by the World Health Organization that by 2030 the number of people with dementia is projected to reach 82 million. The Axon Registry ® continues to evolve and incorporate additional measures to drive quality improvement for neurology practices caring for an aging population. In 2020, two new measures have been incorporated: Use of High-Risk Medications in the Elderly (QPP# 238) and Dementia: Cognitive Assessment (QPP# 281). In addition to these new measures, the Axon Registry already has several measures addressing the geriatrics population, which can be found on AAN.com: Dementia: Functional Status Assessment (Axon 09) Dementia: Associated Behavioral and Psychiatric Symptoms Screening and Management (Axon 10.1) Dementia: Caregiver Education and Support (Axon 30) Dementia: Counseling Regarding Safety Concerns (Axon 31) Falls Screening: Aggregation of AAN Disease Specific Falls Measure (Axon 07.1) Falls: Screening for Future Fall Risk (Axon 16A) Falls: Risk Assessment (Axon 16B) Falls: Plan of Care (Axon 16C) Falls Outcome (Axon 45) Falls Plan of Care (Axon 53) The AAN and American Psychiatric Association dementia management measures were updated in 2018 to remove patients with diagnoses of Parkinson’s disease and HIV from the denominator. Additionally, greater clarity was provided on how to meet numerator requirements. The Axon Registry has already incorporated these technical updates into specifications for 2020. For more information on how to join the Axon Registry, visit AAN.com/Axon or contact registry@aan.com.
TECFIDERA is a registered trademark of Biogen. © Biogen 2013 - 2019
Dementia: Caregiver Education and Support Falls: Querying About Falls for Patients Headache: Medication Prescribed for Acute Migraine Attack
Parkinson's: Psychiatric Symptoms Assessment ALS: End of Life Planning Assistance
Total
+
-
%
Q4
400
300
100
75%
Q3
400
250
150
62%
Q2
400
200
200
50%
Q1
400
100
300
25%
New AAN Study Reveals Effects of High Neurology Drug Costs The AAN published the study “Association of Out-of-pocket Costs on Adherence to Common Neurologic Medications” in the February 19, 2020, online issue of Neurology ®. The study’s objective was to determine the association between out-of-pocket costs and medication adherence in three common neurologic diseases: incident neuropathy, dementia, or Parkinson’s disease. Researchers examined privately insured health care database claims from 2001 to 2016, identifying 52,249 patients with neuropathy on gabapentinoids; 5,246 patients with neuropathy on SNRI; 19,820 patients with dementia on cholinesterase inhibitors; and 3,130 patients with Parkinson’s disease on dopamine agonists. The study concluded that: Higher out-of-pocket costs were associated with lower medication adherence in three common neurologic conditions
Physicians should consider these costs to increase adherence, especially as out-of-pocket costs continue to rise Minority populations should receive additional focus in future intervention efforts to improve adherence Since dementia and neuropathy are strongly associated with other conditions that require medication, the effect of out-of-pocket costs on drug adherence may be magnified and providers should consider comorbidities when evaluating the patient care plan “The fact that rising out-of-pocket drug costs reduce adherence has been talked about for years but we are still seeing no movement,” said Nicholas E. Johnson, MD, FAAN. “This has been a concern for the AAN and its members and a cap on out-of-pocket drug costs is one of the top three advocacy issues the Academy is pressing in 2020.”
ALS, ADHD, and Caregiving Among Timely Topics in Latest Brain & Life The April/May issue of Brain & Life® features Hollywood publicist Nanci Ryder, who was diagnosed with amyotrophic lateral sclerosis (ALS) in 2014. In the intervening years, a formidable team of advocates, including actresses Renee Zellweger and Courteney Cox, has assembled around her. Together, they have raised almost $1 million for research. Zellweger and Cox describe their friendship with Ryder and how they remain supportive. Another feature looks at the relationship between attention deficit hyperactivity disorder (ADHD) and neurologic conditions such as migraine, autism, and sleep apnea in adults. Experts explain why these conditions often occur together and if treating one improves the other. New Yorker cartoonist Roz Chast, author of the prize-winning graphic memoir Can’t We Talk About Something More Pleasant?, is featured in a story that offers expert tips for only-child caregivers on how to get the help they need and why avoiding burnout is especially important. Brain & Life magazine is free for AAN members in the United States to distribute to patients, who also can subscribe for free. If you would like to adjust the number of copies you receive for your patients or update your clinic address, email BeGreen@ WasteFreeMail.com. All members have online access to the magazine articles and additional resources at BrainandLife.org. Please share the website with your patients!
We hope that showing up, Nanciby knows we love her.”
A P R I L/M AY 2 0 20
— R E N É E Z E L LW EGER
A N D C O U R TE N E Y C OX O N N A N C I RY D E R ’S B AT TL E W ITH A LS
Palliative Care When Is It Appropriate? Music Therapy A Choir for All Voices
AANnews • April 2020 17
Policy & Guidelines
Capitol Hill Report: Neurology on the Hill Recap 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. Neurology on the Hill Recap, by Joohi Jimenez-Shahed, MD, first time NOH attendee and member of the Advocacy Engagement Committee Every year, I see the emails from the AAN about Neurology on the Hill (NOH) come and go, and have admired those individuals who have actually taken the time out of their busy schedules to advocate on behalf of our profession and our patients on Capitol Hill. But what are they doing over there? What is advocacy for neurology? This year, I got to participate in NOH for the first time―and saw neurology advocacy in action, firsthand―a great experience! The reality is that we all fight advocacy battles on our home turf. It is a day-to-day necessity in order ensure that our patients get the medicines, tests, ancillary services, or even assistance that they need to live their lives to the best of their ability and preserve their quality of life. The act of asking someone else’s permission to be able to treat our patients the way we have been trained to treat them is a necessary burden that neurologists bear—but do we really need to? Did you know that the average neurologist’s office spends at least two days per week dealing with things like prior authorizations, the vast majority of which (approximately 90 percent) are approved anyway? In the meantime, our patients are subject to unnecessary treatment delays (on average, two to 14 days
Joohi Jimenez-Shahed, MD, (second from left) and the New York delegation.
but sometimes more) and our office staff is bogged down in redundant phone calls, faxes, and paperwork. One of the AAN priorities at NOH was to ask House legislators to support or cosponsor the Improving Seniors' Timely Access to Care Act of 2019. This bill increases transparency and streamlines prior authorization (PA) in Medicare Advantage Plans by (amongst other things)
Sen. Chuck Grassley (R-IA), center, discussed health policy issues with David Moore, MD (left), and Stephen Rostad, MD (right).
(From left) Sen. Diane Feinstein (D-CA) posed with Nina Riggins, MD.
(From left) Sameh Mo Rep. Matt Cartwright Committee Chair Gle
requiring an electronic PA, minimizing the use of PA for routinely approved services, and ensuring PA requests are reviewed by qualified medical personnel. Over 130 representatives have already signed on and AAN delegates encouraged senators to support similar legislation that removes regulatory barriers when it is raised in that chamber. Another tremendous difficulty for many of our Medicare patients relates to the out-of-pocket cost threshold that they must meet before catastrophic coverage kicks back in―i.e., when the “donut hole” closes. This threshold has been slowly but steadily rising, held in check by the Affordable Care Act. Despite this, we have all had conversations with our patients regarding drug costs, which at times very prominently influences treatment decisions. Would you believe that in 2020, the threshold increased to a whopping $6350? These exorbitant costs lead to poor medication adherence, medication rationing, and poor treatment compliance―with potentially devastating consequences. Alongside this, patients’ share of these costs is rising, with some drug costs increasing annually despite no changes to the product or presence of actual market competition! The AAN therefore seeks to lower out-of-pocket medication costs by asking Congress to include a sweeping Part D program redesign in any final drug pricing package and to reduce the total out-of-pocket spending threshold to $3,100 or lower. Lastly, as in years past, the AAN asked Congressional members for continued support of research funding for neurologic diseases in four key areas: NIH funding, BRAIN Initiative funding,
orkous, MD, FAAN, with t (D-PA) and BrainPAC Executive en R. Finney, MD, FAAN.
and support for the Centers for Disease Control and Surveillance National Neurological Conditions Surveillance System and the Agency for Healthcare Research and Quality. I learned that the NIH supports nearly 476,000 jobs and more than $81 billion in economic activity across the US, and that each $1 the public spends on basic research (i.e., via the NIH) stimulates an $8.38 increase in industry R&D spending. Beyond this economic stimulus to our communities, maintaining the momentum of funding of these research initiatives is essential to promote neuroscience discoveries and cures for neurologic disease. After an extensive day of well-coordinated training and practicing our “pitches,” 211 NOH delegates from 48 states met congressional staffers (and sometimes the senators and representatives themselves!) on day two to describe these legislative priorities. Through pointed vignettes, we made the case for legislative action that directly impacts our patients and practices―and that is advocacy in action. So, the next time you think or read about AAN advocacy, NOH, or the Capitol Hill Report, think about what YOU can do to support these important activities and priorities: Email your representative asking them to support the AAN’s research funding priorities at AAN.quorum.us/campaign/24976/. Contact the AAN if interested in participating in Neurology off the Hill at advocacy@aan.com. Follow #AANadvocacy on social media.
Susan Anzalone, MD; Wesley Reynolds, MD, FAAN; and Jeanne Feuerstein, MD; met with a staff member for Colorado Sen. Michael Bennet (D).
(From left) Anthony Davis, MD, spoke with Sen. John Boozman (R-AR).
Rep. Doris Matsui (D-CA) shared time with constituents Jonathan Santoro, MD, (left) and AAN Board Member Charles C. Flippen II, MD, FAAN (right).
Education & Research
Cerebrovascular Disease Is Focus of New Continuum Readers of the Continuum: Lifelong Learning in Neurology ® issue on cerebrovascular disease will learn about an array of improvements in stroke care, according to Guest Editor Natalia S. Rost, MD, MPH, FAAN, FAHA. “Stroke is one of the most dynamic areas of neurology, and readers will be surprised at how far the field has come,” said Rost, who chairs the AAN’s Science Committee. “As a vascular neurologist, I learn every day about the new advances in diagnosis and management of stroke and other cerebrovascular disorders, and this issue reflects that learning and will serve as a great educational resource for readers.” Topics include: Epidemiology and Primary Prevention of Stroke Karen Furie, MD Update on Treatment of Acute Ischemic Stroke Alejandro A. Rabinstein, MD, FAAN Neuroimaging in Acute Stroke Bijoy K. Menon, MD, DM, MSc, FRCPC Endovascular Treatment of Acute Ischemic Stroke Gisele Silva MD, MPH, PhD; Raul Nogueira, MD Cerebral Small Vessel Disease Natalia S. Rost, MD, MPH, FAAN, FAHA; Mark Etherton, MD, PhD
Management of Unruptured Cerebral Aneurysms and Arteriovenous Malformations Ynte M. Ruigrok, MD, PhD Legal Liability Associated With rtPA Administration and Surrogate Decision Makers Joseph S. Kass, MD, JD, FAAN; Rachel V. Rose, JD, MBA Innovations in Prehospital Stroke Management Utilizing Mobile Stroke Units Anne W. Alexandrov, PhD, AGACNP-BC, ANVP-BC, FAAN; Andrei V. Alexandrov, MD
The Evolving Concept of Cryptogenic Stroke Hooman Kamel, MD
The issue also includes a postreading selfassessment and test with the opportunity to earn up to 20 AMA PRA Category 1 Credits™ toward SA-CME.
Stroke in Women Hanne Christensen, MD, PhD, DMSci; Cheryl Bushnell, MD, MHS Ischemic Stroke in Young Adults Jukka Putaala, MD, PhD, MSc Recovery After Stroke Steven C. Cramer, MD, MMSc, FAHA, FAAN Medical Management for Secondary Stroke Prevention Anthony S. Kim, MD, MAS Surgical Approaches to Stroke Risk Reduction Michael F. Waters, MD, PhD, FAAN, FAHA
Neurology Journal and Podcast CME Exams Now Available on Common Website A centralized location and CME platform redesign for Neurology ® Podcast and journal CME exams now make it easier to access all accredited interactive activities from Neurology.org in one place. The comprehensive Course Catalog located at cme.Neurology.org aggregates the newest available CME exams from both articles and podcasts. Updated features include the ability to rapidly find specific exams or search the course catalog with various filters, such as year or specialty. The newest exams are labeled “New” with a blue tab and exams “Expiring Soon” are marked red. Certificate printing is available immediately following successful exam completion.
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AANnews • April 2020
Rost
AAN members pay only $399 per year for a subscription to Continuum® and Continuum® Audio. Subscribe now by contacting Wolters Kluwer at (800) 361-0633 or (301) 223-2300 (international) or visit Shop.LWW.com/ continuum. AAN 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.
#NeurologyProud and proud to call the AAN my home. Share why you are #NeurologyProud on social media.
Christina Kelly Vest, NP
Education & Research
UCNS Certifies New Diplomates in Neurocritical Care The United Council for Neurologic Subspecialties (UCNS) has certified 136 physicians in Neurocritical Care. The physicians passed the 2019 Neurocritical Care certification examination, demonstrating their expert knowledge in the subspecialty. There are now 1,490 diplomates in Neurocritical Care. To see the list of diplomates, visit “News” at UCNS.org.
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AANnews • April 2020
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Webinar: Making Reimbursement Work in Your Practice AAN.com/pmw20
Webinar: Patient Engagement that Works for Your Practice AAN.com/pmw20
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