2019 November AANnews

VOLUME 33 · ISSUE 11 · November 2019

2020 ANNUAL MEETING HEADING TO VIBRANT TORONTO Registration Opens November 7 Registration opens November 7 for the 72nd Annual Meeting set to take place April 25 to May 1, 2020, in beautiful Toronto—known as one of the world’s April 25 – May 1 • Toronto, Canada most thriving multicultural cities. With its motto “Diversity Our Strength,” there’s no better city in which to experience the excitement and diversity of neurology’s preeminent, can’t-miss meeting. Whether you’re a clinician, researcher, resident, student, or other neurology professional—and no matter what your subspecialty area of interest—the meeting will offer a seemingly endless choice of top-tier education in nearly every topic and specialty imaginable; all the valuable CME you need for knowledge, growth, and maintenance; the most cutting-edge science covering every specialty; and the opportunity to connect with friends—both old and new—from more than 100 countries around the world.

Continued on page 17

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It’s Time to Renew Your Membership for 2020

Webinar Readies Your Practice for 2020

It’s time to renew your AAN membership for 2020. By visiting AAN.com/dues and renewing today, you’ll retain access to the world’s best neurology resources and education throughout the new year to help you grow and thrive professionally and personally.

Every year, CMS puts forth changes to the Medicare Fee Schedule that affect the way that neurologists can participate in the Benish Weathers Quality Payment Program (QPP), and how they can code for patient visits. This webinar series will provide an in-depth overview for all physicians, regardless of how they choose to participate in the QPP, and how to leverage the Axon Registry ® to assist in the participation of this program.

Your Academy is your single source for essential education, science, and support, including: Unique education opportunities to earn CME or continuous certification credits Up-to-date information on breakthrough scientific research Continued on page 21

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AAN Measures: Screen People 65+ Yearly for Memory Problems

9

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Prepare for 2019 and 2020 MIPS Reporting

Continued on page 9

15 New Advocacy Summit

Delivers Congressional Support on Drug Pricing

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In Multiple

Sclerosis —

GREY MATTERS, TOO

Learn more about Multiple Sclerosis at MSBrainPreservation.com/art © 2019 Celgene Corporation All rights reserved. 04/19 US-CLG-19-0570

AANnews · November 2019

CONTENTS

News Briefs

Cover 2020 Annual Meeting heading to vibrant Toronto

Conferences & Community Host In Conjunction With Events at the 2020 Annual Meeting · · · · · · · · · 19

It’s Time to Renew Your Membership for 2020

Earn Valuable End-of-year CME Credits with Annual Meeting On Demand · · · · · · 19

Webinar Readies Your Practice for 2020 President’s Column Voices of the Annual Meeting · · · · · · · · · 4 Tools & Resources AAN Education and Credit Opportunities Grow for Business Administrators · · · · 7 AAN Measures: Screen People 65+ Yearly for Memory Problems · · · · · · · · 8

Education & Research UCNS Launches New Website · · · · · · · · · · ·22 Rydell on Commission Honored for Work on Continuing Board Certification · · · · · · · · · · · 22 Careers · · · · · · · · · · · · · · 23 Dates & Deadlines · · · · · · · · 24

Prepare for 2019 and 2020 MIPS Reporting · · · · · · 9

Contact Information

For advertising rates, contact:

American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415

Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins

Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:

memberservices@aan.com

Website: AAN.com

Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com

New Mentorship Program A new pilot mentorship program to help newer Annual Meeting faculty succeed is being introduced for the 2020 Annual Meeting. The six participants, who applied to take part in the program, are paired with an experienced mentor to serve as a resource as newer faculty prepare their presentations.

Recently published AAN guidelines garnered strong media coverage.

Two AAN pediatric migraine guidelines were covered by NBC’s Today.com and MedPage Today. A guideline on vaccinations and multiple sclerosis was covered by U.S. News & World Report, Medscape, and several television stations across the country. The AAN also featured two AAN Sports Concussion Conference scientific abstracts in press releases, chosen by conference co-directors David W. Dodick, MD, FAAN, and Brian W. Hainline, MD, FAAN. Abstracts were covered by U.S. News & World Report, HealthDay, and Physician’s Briefing. 

Capitol Hill Report · · · · · · · 16

The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction.

The Industry Principles Task Force, chaired by James A. Russell, DO, FAAN, will review the AAN’s principles governing its relationships with industry, which was recommended by the Neurology Drug Pricing Task Force, and consider ways the AAN, through appropriate relationships with industry, can help hold companies accountable to ethical business conduct.

Guidelines in the Media

Policy & Guidelines New Advocacy Summit Delivers Congressional Support on Drug Pricing · · · · · · · · · 15

The Vision of the AAN is to be indispensable to our members.

New Presidential Task Force

AAN Chief Executive Officer: Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela M. Babb, MS, CAE, APR Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com

AANnews is published monthly by the American Academy of Neurology for its 36,000 members worldwide. Access this magazine and other AAN publications online at AAN.com.

The American Academy of Neurology ’ s registered trademarks and service marks are registered in the United States and various other countries around the world.

“American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.

President’s Column

Voices of the Annual Meeting

Stevens

It’s time to begin to make your plans to attend our upcoming 2020 Annual Meeting in Toronto. I can vividly recall my first Annual Meeting in New Orleans in 1986. I was excited to attend as a third-year resident (my first official neurology meeting outside my residency program). I was overwhelmed by the opportunity to choose courses that were taught by experts in their respective fields, names I had read in the green journal or in textbooks I had chosen to supplement my training. The initial feeling was that I was a guppy in a sea filled with more neurologists than I knew existed. I treasured the syllabi that were published in booklet form and my hand scribbled notes that I would carry home for further study. The meeting has certainly changed since my first trip to the “Big Easy” but remains my “go to event” for neurologic content and connecting with my colleagues.

Now, of course, the meeting is vastly different and better each year, with the registration fee covering nearly everything you’d want to take part in. Even as it has grown to more than 14,000 attendees over seven days, our volunteer members on the Meeting Management, Science, and Education Committees and Academy staff have found novel ways to make it more engaging, interactive, and intimate.

During most days of the meeting, we publish an on-site magazine, AANextra, that keeps attendees abreast of the highlights of the coming day and recaps some of the key moments of the day before. A popular feature is comments from attendees about what they Aashit K. Shah, MD, FAAN • Roanoke, VA Chair of neurology department, Virginia Tech Carilion School of Medicine “What brings you to the Annual Meeting?”

Two things: plenary sessions and meeting people. The plenary sessions cover diverse topics. They give you a chance to listen to experts outside of your subspecialty.

And I see friends and previous residents, networking.

And recruiting. It’s a great venue for residents and people who are recruiting because all of the residents come to this meeting.”

Lisa M. Ford, MD, FAAN • Morristown, NJ “What are the highlights of the meeting for you so far?”

“I’m a child neurologist. There are a lot of presentations on SMA and Batten disease, which is quite exciting. We’re really starting to see some progress in areas where there were no treatments. It’s a pleasure to be here.”

Abeera Ali, MD • Birmingham, AL • Resident “Why did you come to the Annual Meeting?”

“I’ve always been on patient rotation and couldn’t attend.

This year I was like, ‘No, I have to go this year.’ Next year I will be graduating and in a non-academic setting, so I need to get set with my continuing education. My main thing is CME and connecting with other people in private practice and hearing everyone else’s perspective.”

Angelique Manasseh • Garden City, MI Fourth-year medical student “What have you experienced so far?”

“I went to two sessions for medical students this morning about what to look for in a residency and what they are looking for. Those two alone were worth the trip! They really gave me the most valuable advice I’ve gotten to date on career issues in medical school! And then they were available to meet one-on-one with us at the end. Plus, I had a 30-minute mentorship meeting already this morning.”

4

AANnews • November 2019

Maria Gaughan, MBBCh • Dublin, Ireland “What brings you to the meeting this year?”

“Excellent teaching. And the opportunity to hear up-to-date research. But mainly the excellent teaching. Especially movement disorders where you can see the video analysis. And neuro-ophthalmology. It’s everyone’s opportunity to brush up on your skills, especially not in your own specialty.”

Heber Varela, MD • Miami, FL “Why did you come to the Annual Meeting this year?”

“It’s the biggest meeting, so I can get all of the updates.

It has everything I need in terms of clinical development. I moved into private practice. I’m more neuromuscular but also general neurology, so I need to know about everything.

The other reason I came was because the AAN website has been very useful to me, especially the recertification course, so I thought I would come to the meeting.”

Robert W. Baloh, MD, FAAN • Los Angeles, CA Faculty, Neuro-otology courses “How many Annual Meetings have you attended?”

“I don’t think I’ve missed one since 1971, when I was a third-year resident. I enjoy seeing friends and former trainees. Probably the social aspect is what I enjoy most. And I go to sessions.”

“How has the meeting changed over the years?”

“It’s gotten so big. There are so many things that it’s impossible to go to everything. Certainly, the plenary sessions are always very good and it’s still the best clinical neurology meeting there is.”

Claudia A. Chiriboga, MD, MPH • New York, NY “Why do you come to the Annual Meeting?”

“I come because it is the main general neurology meeting.

The main forum to disseminate information to neurologists.”

“What are you most interested in hearing about?”

“The SMA clinical trials and other cutting-edge research.

The Emerging Science clinical trials.”

have enjoyed or are looking forward to, and even tips for first-time participants. I’d like you to hear some of their observations about the many ways the event is valuable to them.

Note that Dr. Blackburn serves up a great reminder below for non-Canadian members planning to attend our Toronto meeting: Make sure you have your necessary documents in order to join us in this great city!

If you haven’t been to the meeting for a few years, I strongly encourage you to join us. Like the attendees say, you’ll find plenty to inform and energize you, and help strengthen your connection to our profession and how the AAN supports you in so many ways.

We’re planning the best Annual Meeting ever, April 25 to May 1, and we want to see you there! 

James C. Stevens, MD, FAAN President, AAN jstevens@aan.com @JimStevensMD on Twitter

Kasra John Sarhadi @kasrajohn First 12 hours of #AANAM and already figured out what I want to do for the rest of my life? I’d call that a successful day 1.

Wallace Brownlee @DrWBRO Fantastic week at #AANAM. Really great to see @AANMember making such a clear commitment to gender balance and diversity.

Kyle Blackburn @kyleblackburnmd At the airport: #AANAM never disappoints. Pro tip for next year: don’t forget a passport, and some of us will need visas! @husari_k.

Dr. Daniel Ackerman @DrDanAckerman What happens when you gather thousands of nerds and then expose them to wine, paint, and amazing education and collaboration opportunities? I guess we’re going to find out! #aanam #innovationhub #wineandpaint

Ilene Ruhoy, MD, PhD @MdRuhoy Discussing #physicianburnout, especially #neurologist burnout, all day at the #AANAM. Community is important. Don’t hesitate to just reach out. Take a chance on your colleague.

Chris Tarolli, MD @DrTarolliNeuro Always nervous that #AANAM won’t live up to how great it was year before but @AANMember never fails to deliver. Best part was seeing so many great friends and meeting so many new people.

And personal highlight was presenting for my #EmergingLeaders group. Best group of people!

DaraVFAlbert, DO @daravfalbert So long Philly, it’s been real. Time to go back to stomping out neurological disease armed with new knowledge learned at the #AANAM. Jerome P. Lisk, MD, FAAN @ParkinsonDoctor I wouldn’t see most of my Old Friends if it wasn’t for the AAN Annual Meeting. Time to catch up. #aanam #friends #neurology @davidevanstx @AANMember #neurologist #MBA #aan2019.

Registration opens November 7 at AAN.com/view/20AM

AANnews • November 2019 5

Patients with DRAVET SYNDROME deserve a giant leap forward.

Dravet syndrome is a rare, treatment-resistant developmental epileptic encephalopathy with onset in infancy, in which:1-4 • Most patients are not able to achieve freedom from their persistent seizures • Serious cognitive, developmental, motor, and behavioral impairments persist into adulthood • Substantial physical, emotional, and financial burdens reduce quality of life for patients and their families

There is an urgent need for more effective and better-tolerated treatment options that will

Deliver meaningful, consistent, and sustained seizure reduction

Reduce cognitive decline and long-term disability

Increase patient and caregiver freedom and quality of life

Please join us at AES 2019 at Booth #809 to review information that might change the way you think about Dravet syndrome.

References: 1. Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52(suppl 2):3-9. 2. Jensen MP, Brunklaus A, Dorris L, et al. The humanistic and economic burden of Dravet syndrome on caregivers and families: implications for future research. Epilepsy Behav. 2017;70(pt A):104-109.

3. Lagae L, Irwin J, Gibson E, Battersby A. Caregiver impact and health service use in high and low severity Dravet syndrome: a multinational cohort study.

Seizure. 2019;65:72-79. 4. Jensen MP, Liljenquist KS, Bocell F, et al. Life impact of caregiving for severe childhood epilepsy: results of expert panels and caregiver focus groups. Epilepsy Behav. 2017;74:135-143.

© 2019 Zogenix, Inc. All rights reserved. US-DS-1900028 October 2019

DravetUrgency.com

Tools & Resources

AAN Education and Credit Opportunities Grow for Business Administrators Business administrator (BA) members of the AAN who seek to improve their skills and earn continuing education credits have a greater array of opportunities than ever before.

An example is last month’s Fall Conference, which provided a special track of programs “for BAs, by BAs.” Dozens of business administrators learned about recent coding updates, improving patient access and engagement, managing the cost of care, moving practices to value-based and expanded services models, and running an efficient organization.

The AAN’s practice management webinars also provide a wealth of information that BAs can use in their daily operations throughout the year. In 2020, the webinar series will build off the same value as the Fall Conference programs—the faculty will be mostly business administrators, and the content will be directed at BAs and physician leaders. These webinars will emphasize practice management principles including financial management, organizational best practices, and leadership and human resources skills.

The AAN Is a Recognized Professional Organization for MGMA ACMPE CE CREDITS The AAN knows that BAs need continuing education credit opportunities. All AAN credit-granting courses are eligible for CMPE credits for people who are MGMA CMPEs. Getting the credits you’ve earned is easy: Simply log in to your MGMA account and navigate to the ACMPE Tracking Tool. Note the AAN as the sponsoring organization, the method of course (webinar, course, etc.), specify credit amounts, and any other necessary identifying information. The 2019 webinars are worth two CEUs each and Fall Conference courses are worth 1.5 CEUs. Check out the January 2020 AANnews to learn about the new lineup of webinars and CEU value. 

Neurologists: Business Administrator Memberships Bring Value to Your Practice To ensure your practice is positioned to thrive in this increasingly complex health care environment, encourage your business administrators to join the AAN. The small cost of membership may be the best ROI your practice sees this year!

Garms

Leeann Garms, CEO at Raleigh Neurology Associates in Raleigh, NC, can attest to the value. “As a practice administrator, I leverage the robust tools available through the AAN to stay informed on a wide range of topics that help me and my team understand, adapt, and effectively run a private neurology practice in an ever-changing health care environment.

“The AAN’s practice management webinars, targeted benchmarking data (Neurology Compensation and Productivity Survey), focused website tools and resources section (Practicing Neurologists & Administrators), and Synapse online peer community provide me with real world data that can be used on an almost daily basis.

Additionally, I benefit from the numerous opportunities to interact and collaborate with other administrators from across the country and the world, continuously learning through the sharing of our insights and experiences. I enjoyed the business administration program at the Fall Conference and left with new knowledge and ideas that can help my practice continue to thrive.”

From a wealth of online and on-site education programming to exclusive discounts on the AAN Annual Meeting and Fall Conference, networking and problem-solving on the Synapse online community, and eligibility for leadership training and advocacy programs, an AAN membership can be as vital to your business administrator’s career as it is to yours.

Visit AAN.com/view/careteam to learn more—and share with your staff! 

AANnews • November 2019 7

Tools & Resources

AAN Measures: Screen People 65+ Yearly for Memory Problems To help physicians provide the highest quality patientcentered neurologic care, the AAN recommends physicians measure how frequently they complete annual assessments of people age 65 and older for thinking and memory problems. This metric for yearly cognitive screenings with an objective measure is part of an AAN quality measurement set published in the September 18, 2019, online issue of Neurology ® journal.

People with mild cognitive impairment (MCI) have thinking and memory problems but usually do not know it because such problems are not severe enough to affect their daily activities. Yet MCI can be an early sign of Alzheimer’s disease or other forms of dementia. It can also be a symptom of sleep problems, medical illness, depression, or a side effect of medications.

“Since thinking skills are the most sensitive indicator of brain function and they can be tested cost-effectively, this creates an enormous opportunity to improve neurologic care,” said author Norman L. Foster, MD, FAAN, of the University of Utah in Salt Lake City. “The AAN is recommending the measurement of annual cognitive screenings for everyone age 65 and older because age itself is a significant risk factor for cognitive decline and mild cognitive impairment is increasingly prevalent with older age.” It joins the AAN recommendation for objective cognitive screening in patients with high risk neurologic disorders such as Parkinson’s disease, multiple sclerosis, and following stroke.

According to the 2018 AAN guideline on MCI, nearly seven percent of people in their early 60s worldwide have MCI, while 38 percent of people age 85 and older have it.

The new AAN quality measurement set recommends doctors measure how often they conduct annual screenings to improve the recognition of MCI and allow for earlier intervention.

“We cannot expect people to report their own memory and thinking problems because they may not recognize that they are having problems or Foster they may not share them with their doctors,” said Foster. “Annual objective assessments will not only help identify mild cognitive impairment early, it will also help physicians more closely monitor possible worsening of the condition.”

The new measurement set states that documenting MCI in a person’s medical record can be invaluable in alerting other physicians and medical staff so that the best care is provided to that patient. The measures are intended to drive quality improvement in practice. Physicians are encouraged to start small using one or two quality measures in practice that are meaningful for their patient population, and measure use is voluntary.

Early diagnosis can help identify forms of MCI that may be reversible, including those caused by sleep problems, depression, or medications, and lead to treatments that can improve a person’s quality of life such as correcting hearing loss and avoiding social isolation.

When MCI is not reversible and could develop into more severe forms of dementia like Alzheimer’s disease, the quality measurement set recommends measuring how frequently people are given information about their condition as early as possible, so they can take steps to avoid exploitation, plan for their care, and monitor their condition.

It is also important not to forget about family and caregivers. The measurement set also asks doctors to identify care partners to help describe symptoms. Doctors should quantify involvement with family and caregivers and provide them with information so that they too receive support and get access to services to help them cope as a person’s illness if it progresses and improve their well-being.

Read more at AAN.com/view/ MCImeasure. 

Tools & Resources

Prepare for 2019 and 2020 MIPS Reporting The time of year has arrived where clinicians participating in the Merit-based Incentive Payment System (MIPS) must prepare for the 2019 MIPS reporting as well as plan for the 2020 MIPS reporting year. The AAN offers tools and resources to help members manage the transition from one reporting year to the next and support the successful participation in reporting programs like MIPS, including the Axon Registry ®.

For 2019, clinicians required to or choosing to report MIPS are subject to payment adjustments up to +/- seven percent and must meet the 30-point performance threshold to receive a neutral payment adjustment. Performance in the Quality component accounts for 45 percent, Cost for 15 percent, Improvement Activities for 15 percent, and Promoting Interoperability for 25 percent of the total MIPS performance score and will affect 2021 Medicare Part B reimbursements. For members participating in the Axon Registry and choosing to perform MIPS reporting via the Axon Registry for 2019, keep in mind the following deadlines to ensure your data is submitted to the Centers for Medicare & Medicaid Services (CMS).

Axon Registry Deadlines for 2019 MIPS Soon: Inform client account manager of intent to submit MIPS 2019 via the Axon Registry December 1: Last day to request mapping refinements January 15, 2020: Sign the data release consent form (DRCF) February 15, 2020: Complete MIPS submission Final proposals related to the 2020 MIPS reporting year are expected to be announced in early November, and it is anticipated that clinicians who participate in MIPS next year can expect increases in the performance threshold required to meet a neutral payment adjustment and

December 1: Last day to request mapping refinements

slight changes to some of the component weights. MIPS eligible clinicians can also expect payment adjustments to range from -/+ nine percent for the 2020 performance year, which will apply to 2022 Medicare Part B reimbursements.

As practices look towards 2020 MIPS reporting, important enrollment dates for the Axon Registry include:

More information on the Axon Registry is available at AAN.com/view/Axon or email registry@aan.com with registry questions.

For updated MIPS resources and information for neurologists, visit AAN.com/view/QPP or email macra@aan.com. 

Axon Registry Deadlines for 2020 MIPS July 31: Complete Sign-up/ enrollment for new registry participant November 1: All providers submitting for the reporting year must be on the dashboard

Join us for this related upcoming online event!

November 19, Practice Management Webinar: Seeing the Future Clearly: How to Succeed in 2020 (see details below)

Webinar Readies Your Practice for 2020 continued from cover Webinar: Seeing the Future Clearly: How to Succeed in 2020 Faculty: Sarah M. Benish, MD, FAAN; Robert M. Kropp, MD, FAAN; Allison L. Weathers, MD, FAAN Begins November 19, 2019, 12:00 p.m. ET Register by November 18 • AAN.com/view/pmw19

Learning Objectives: 1. Understand payment changes in the Medicare Physician Fee Schedule effective January 1, 2020 2. Identify opportunities and challenges for neurology practices based on final regulations 3. Explore paths in the Quality Payment Program to develop the participation strategy that works best in your own practice 4. Identify how the Axon Registry can assist in the implementation of your participation strategy

The AAN’s practice management webinars have a new format but the same game-changing expert insights! A live, 30-minute webinar with expert faculty will be held on November 19, followed by several shorter recorded online lectures that go deeper into the topic posted the week of November 25, concluding with a 30-minute live webchat on December 17 for more Q&A. All course materials can be accessed on the new AAN online learning center at Learning.AAN.com.

Learn more and register at AAN.com/view/pmw19. 

Save December 12 for FREE Webinar: EEG and E/M Coding Updates With the numerous coding changes coming for 2020 and beyond, you will want to put this free webinar, “EEG and E/M Coding Updates,” on your calendar for December 12 at 12:00 p.m. ET. More details will be available on AAN.com/view/pmw19 and in the December AANnews.

AANnews • November 2019 9

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

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Patients experiencing signs and symptoms of anaphylaxis and angioedema (which have included difficulty breathing, urticaria, and swelling of the throat and tongue) should discontinue TECFIDERA and seek immediate medical care.

Progressive multifocal leukoencephalopathy (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 in a clinical trial. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. The 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

©2019 Biogen. All rights reserved. 09/19 TEC-US-3189 v4

confusion and personality changes. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms.

TECFIDERA may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had lymphocyte counts <0.5x109/L. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months.

In these patients, the majority of lymphocyte counts remained <0.5x109/L with continued therapy. A complete blood count including lymphocyte count should be obtained before initiating treatment, 6 months after starting, every 6 to 12 months thereafter and as clinically indicated. Consider treatment interruption if lymphocyte counts <0.5x109/L persist for more than six months and follow lymphocyte counts until lymphopenia is resolved.

Consider withholding treatment in patients with serious infections until resolved. Decisions about whether or not to restart TECFIDERA should be based on clinical circumstances.

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 - March 29, 2019).

>385,000

people have been treated with TECFIDERA worldwide2

This includes clinical trial use and patients prescribed TECFIDERA

>710,000

global patient-years of experience2

This includes clinical trial use and patients prescribed TECFIDERA

>11 Years

of combined clinical trial and real-world experience1,2

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.

TECFIDERA may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of TECFIDERA patients and <1% of placebo patients discontinued due to GI events. The incidence of serious GI events was 1%. The most common adverse reactions associated with TECFIDERA versus placebo are flushing (40% vs 6%) and GI events: abdominal pain (18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%).

Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials.

Please see following pages for Brief Summary of full Prescribing Information.

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.

TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% 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 prior to dosing may reduce the incidence or severity of flushing.

A transient increase in mean eosinophil counts was seen during the first two months.

TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant while taking TECFIDERA to enroll in the TECFIDERA pregnancy registry by calling 1-866-810-1462 or visiting www.TECFIDERApregnancyregistry.com.

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 Relapsing-Remitting MS3; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis4; 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(24):2362.

4. Fox RJ, et al. N Engl J Med. 2012;367(12):1087-1097.

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Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use Brief Summary of Full Prescribing Information Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use 1 INDICATIONS AND USAGE Brief Summary of Full Prescribing Information TECFIDERA is for treatment relapsing forms ® is indicated indicated forthe the treatmentof of patients with relapsing Tecfidera (dimethyl fumarate) delayed-release capsules, for of oral use 1 INDICATIONS multiple (MS),USAGE to include clinically isolated syndrome, forms of sclerosis multiple AND sclerosis.

Brief Summary of Full Prescribing Information relapsing-remitting disease, and active secondary progressive TECFIDERA is indicated for the treatment of patients with relapsing 2 DOSAGE AND ADMINISTRATION disease, in adults.

1forms INDICATIONS AND USAGE of multiple sclerosis.

2.1 Dosing Information TECFIDERA is indicated for the treatment of patients with relapsing 2 DOSAGE AND ADMINISTRATION The starting dosesclerosis. for TECFIDERA is 120 mg twice a day orally. After 7 forms of multiple 2.1 Dosing Information days, the dose should be increased to the maintenance dose of 240 mg 2The DOSAGE twice a dayAND orally.

Temporary doseisreductions to 120 mgorally. twiceAfter a day starting doseADMINISTRATION for TECFIDERA 120 mg twice a day 7 may be forbe individuals do maintenance not tolerate the maintenance 2.1 Dosing Information days, theconsidered dose should increasedwho to the dose of 240 mg dose.

4 weeks, the recommended dose of 120 240 twice aWithin day dose orally. dose to mgorally. twiceAfter a day The starting forTemporary TECFIDERA is reductions 120 mg twice a day 7 should be Discontinuation of should be may be forbe individuals domaintenance notTECFIDERA tolerate the maintenance days, theconsidered doseresumed. should increasedwho to the dose of 240 mg considered for patients unable to tolerate return to the maintenance dose.aWithin 4 weeks, the recommended dosetoof120 240mg mgtwice twice aa day day twice day orally.

Temporary dose reductions dose. flushing may reduced by the administration of should be incidence resumed.

Discontinuation TECFIDERA should be may beThe considered forofindividuals who be do of not tolerate maintenance TECFIDERA food.

Alternatively, administration ofmaintenance non-enteric considered patients to tolerate return to the dose.

Within for 4 with weeks, theunable recommended dose of 240 mg twice a day coatedThe aspirin (up to aofdose of 325may mg)be 30ofreduced minutes prior to TECFIDERA dose. flushing by administration of should be incidence resumed.

Discontinuation TECFIDERA should be dosing mayfor reduce the unable incidence or severity of flushing [see Clinical TECFIDERA with food.

Alternatively, administration non-enteric considered patients to tolerate return to theofmaintenance Pharmacology (12.3)]. coated aspirin (up to aofdose of 325 mg)be30reduced minutesby prior to TECFIDERA dose.

The incidence flushing may administration of dosing may reduce the or whole severity of flushing [see Clinical TECFIDERA should beincidence swallowed and intact.

TECFIDERA with food.

Alternatively, administration of TECFIDERA non-enteric Pharmacology (12.3)]. shouldaspirin not be (up crushed or chewed and 30 theminutes capsuleprior contents should not coated to a dose of 325 mg) to TECFIDERA be sprinkled onshould food.the TECFIDERA canseverity be taken or without food. dosing may reduce or of with flushing [see Clinical TECFIDERA beincidence swallowed whole and intact.

TECFIDERA Pharmacology (12.3)]. should not Tests be crushed or Initiation chewed and the capsule contents should not 2.2 Blood Prior to of Therapy be sprinkled on food. TECFIDERA canwhole be taken or without food.

TECFIDERA should be swallowed andwith intact.

TECFIDERA Obtain a complete blood cell count (CBC) including lymphocyte count should not be crushed or and capsule contents(5.3)]. should not 2.2 Blood Tests tochewed Initiation of the Therapy before initiation ofPrior therapy [see Warnings and Precautions be sprinkled on food. TECFIDERA can be taken with or without food.

Obtain complete blood cell count (CBC) lymphocyte Obtain aserum aminotransferase, alkalineincluding phosphatase, and count total 2.2 Blood Testsprior Prior Initiation of Therapy before initiation of therapy [see Warnings and Precautions (5.3)]. and bilirubin levels to to treatment with TECFIDERA [see Warnings Obtain a serum complete blood cell count (CBC) including lymphocyte Precautions (5.4)].

Obtain aminotransferase, alkaline phosphatase, andcount total before initiation of therapy [see Warnings and Precautions (5.3)]. and bilirubin levels prior to treatment with TECFIDERA [see Warnings 3 DOSAGE FORMS AND STRENGTHS Precautions (5.4)].

Obtain serum phosphatase, and total TECFIDERA is aminotransferase, available as hard alkaline gelatin delayed-release capsules bilirubin levels treatment with TECFIDERA [see Warnings and 3 DOSAGE FORMS AND STRENGTHS containing 120 prior mg orto240 mg of dimethyl fumarate. The 120 mg capsules Precautions (5.4)]. have a green cap and whiteas body, withdelayed-release “BG-12 120 mg”capsules in black TECFIDERA is available hardprinted gelatin ink on the 120 body.

240mg mgofcapsules a green andcapsules a green 3containing DOSAGE FORMS STRENGTHS mgThe orAND 240 dimethyl have fumarate.

The cap 120 mg body, aprinted “BG-12 240 mg” black with inkdelayed-release on the body. have greenwith capavailable and white printed “BG-12 120 mg”capsules in black TECFIDERA is asbody, hardin gelatin ink on the120 body.

240mg mgofcapsules have a green cap mg andcapsules a green containing mgThe or 240 dimethyl fumarate.

The 120 4 CONTRAINDICATIONS body,aprinted “BG-12 240 mg” printed in blackwith ink on the body. mg” in black have green with cap and white body, “BG-12 TECFIDERA is contraindicated in patients with known120 hypersensitivity ink on the body.

The 240 have a green cap and a green 4 CONTRAINDICATIONS to dimethyl fumarate or mg to capsules any of the excipients of TECFIDERA. body, printed with “BG-12 240 mg” in black ink on the body.

Reactions have included anaphylaxis and angioedema [see Warnings TECFIDERA is contraindicated in patients with known hypersensitivity and Precautions (5.1)]. or to any of the excipients of TECFIDERA. 4to CONTRAINDICATIONS dimethyl fumarate Reactions have included anaphylaxis and with angioedema [see Warnings TECFIDERA is AND contraindicated in patients known hypersensitivity 5 WARNINGS PRECAUTIONS and Precautions (5.1)].or to any of the excipients of TECFIDERA. to fumarate 5.1dimethyl Anaphylaxis and Angioedema Reactions haveAND included anaphylaxis and angioedema [see Warnings 5 WARNINGS PRECAUTIONS TECFIDERA can(5.1)]. cause anaphylaxis and angioedema after the first dose and Precautions 5.1 Anaphylaxis and Angioedema or at any time during treatment. Signs and symptoms have included 5TECFIDERA WARNINGS AND PRECAUTIONS difficulty breathing, urticaria, and swelling of the throat andfirst tongue. can cause anaphylaxis and angioedema after the dose Patients be instructed to Signs discontinue TECFIDERA seek 5.1 Anaphylaxis and Angioedema or at anyshould time during treatment. and symptoms haveand included immediatebreathing, medical care shouldand theyswelling experience signs and the symptoms of difficulty urticaria, of the throat andfirst tongue.

TECFIDERA can cause anaphylaxis and angioedema after dose anaphylaxis or angioedema.

Patients be instructed discontinue TECFIDERA seek or at any should time during treatment.toSigns and symptoms have and included immediate medical care should they experience signs and and symptoms of difficulty breathing, urticaria, and swelling of the throat tongue.

5.2 Progressive Multifocal Leukoencephalopathy anaphylaxis or angioedema.

Patients should be instructed to discontinue TECFIDERA and seek Progressive multifocal leukoencephalopathy (PML) has occurred in immediate medical care should they experiencePML signsisand of 5.2 Progressive Leukoencephalopathy patients with MSMultifocal treated with TECFIDERA. an symptoms opportunistic anaphylaxis or angioedema. viral infection of the brain caused by the JC virus (JCV) typically Progressive multifocal leukoencephalopathy (PML) has that occurred in onlyProgressive occurs patients whowith are immunocompromised, andopportunistic that usually 5.2 Multifocal Leukoencephalopathy patients within MS treated TECFIDERA. PML is an leadsinfection to death severe disability.

A the fatalJC case of (JCV) PML inina viral oforthe brain caused by virus that typically Progressive multifocal leukoencephalopathy (PML) hasoccurred occurred patient who received TECFIDERA for 4 years enrolled in a only occurs patients who areTECFIDERA. immunocompromised, and that usually patients withinMS treated with PML while is an opportunistic clinical During the clinical trial,byA the patient experienced prolonged leadsinfection totrial. death severe disability. fatal of(JCV) PML occurred in a viral ofor the brain caused the JCcase virus that typically 9 lymphopenia (lymphocyte counts predominantly <0.5x10 /L usually for in3.5 patient whoin received TECFIDERA for 4 years while a only occurs patients who are immunocompromised, andenrolled that years)towhile taking TECFIDERA [see Warnings and Precautions (5.3)]. clinical trial.

During the clinical trial, patient prolonged leads death or severe disability.

Athe fatal caseexperienced of PML occurred in a 9 The patient had no TECFIDERA othercounts identified medical conditions lymphopenia (lymphocyte predominantly <0.5x10 /L forin3.5 patient who received for systemic 4 years while enrolled a resulting inDuring compromised system function andprolonged had not years) while taking TECFIDERA [see and Precautions (5.3)]. clinical trial. the clinicalimmune trial, theWarnings patient experienced previously been treated with counts natalizumab, which has <0.5x10 a known9association The patient had no other identified systemic medical conditions lymphopenia (lymphocyte predominantly /L for 3.5 with PML. The patient was also not taking any and immunosuppressive or resulting in compromised immune system function and had not years) while taking TECFIDERA [see Warnings Precautions (5.3)]. immunomodulatory medications concomitantly. previously been treated with natalizumab, which hasmedical a known association The patient had no other identified systemic conditions with The patient was also not taking any immunosuppressive or resulting compromised immune system function and had not PMLPML. has in also occurred in the postmarketing setting in the presence of immunomodulatory medications concomitantly.

9with natalizumab, previously been treated whichthan has a6 known association lymphopenia (<0.8x10 /L) persisting for more months.

While the with The occurred patientinwas also not taking anysetting immunosuppressive or role ofhas lymphopenia these cases is uncertain, theinmajority of cases PMLPML. also in the postmarketing the presence of immunomodulatory medications concomitantly.

9 lymphocyte occurred in patients with counts /L. lymphopenia (<0.8x10 /L) persisting for more<0.5x10 than 6 9months.

While the role of lymphopenia in in these cases is uncertain, theinmajority of cases PML has also occurred thesuggestive postmarketing setting the TECFIDERA presence of At the first sign or symptom of PML, withhold 9 9 occurred in patients with counts <0.5x10 /L. lymphopenia (<0.8x10 /L)lymphocyte persisting for more than 6 months.

While the and perform an appropriate diagnostic evaluation.

Typical symptoms role of lymphopenia in are these cases progress is uncertain, majority of cases associated with or PML diverse, overthe days toTECFIDERA weeks, and At the first sign symptom suggestive of PML, withhold 9 occurred in patients with lymphocyte counts <0.5x10 /L. include progressive weakness on one side of the body or clumsiness of and perform an appropriate diagnostic evaluation.

Typical symptoms limbs, disturbance of are vision, and changes in thinking, associated withorPML diverse, progress over days tomemory, weeks, and At the first sign symptom suggestive of PML, withhold TECFIDERA orientation leading toweakness confusion and personality include progressive on one side of thechanges. body or clumsiness of and perform an appropriate diagnostic evaluation.

Typical symptoms limbs, disturbance vision, and changes in thinking, and associated with PML are diverse, progress days tomemory, weeks,Cases and MRI findings may beofapparent before clinical over signs or symptoms. orientation leading to confusion and personality include weakness onefindings side of the body or clumsiness of of PML,progressive diagnosed based onon MRI andchanges. the detection of JCV limbs, disturbance ofapparent vision,fluid and in thinking, memory, and DNAfindings in the may cerebrospinal inchanges the absence ofsymptoms. clinical signs or MRI be before clinical signs or Cases orientation leading confusion and personality changes. symptoms specifictotobased PML, on have been reported inthe patients treated with of PML, diagnosed MRI findings and detection of JCV DNAfindings in the may cerebrospinal in clinical the absence clinical signs or MRI be apparentfluid before signs orofsymptoms.

Cases symptoms specific to PML,on have been reported patients treated with of PML, diagnosed based MRI findings and inthe detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with

anddiverse, perform progress an appropriate diagnostic evaluation. sy ofTypical non-ent associated with PML are over days to weeks, and associated withside PML diverse, progress over to we to TECFID include progressive weakness on one of are the body or clumsiness of days progressive on one side ofand the body orDosin clum [see limbs, disturbance of include vision, and changesweakness in thinking, memory, limbs, disturbance of vision, and changes in thinking, mem orientation leading to confusion and personality changes.

6 ADVERS orientation leadingPML. to confusion and personality changes. otherfindings MS medications associated Many of these patients MRI may be apparent beforewith clinical signs or symptoms.

Cases The follow subsequently became symptomatic with monitoring MRI findings bePML. apparent clinical signs orinsymptom of PML, diagnosed based on MRI may findings and Therefore, the before detection of JCV labeling with MRI for signs thatofmay be consistent with PML befindings useful, PML, diagnosed based on MRI and detection other medications associated Many of these patients DNA inMSthe cerebrospinal fluid in with the PML. absence ofmay clinical signs or theleukoence any suspicious findings should lead to further investigation to allow for DNA in the cerebrospinal fluid in the absence of clinical(5 subsequently became symptomatic with PML. Therefore, monitoring symptoms specific to PML, have been reported in patients treated with Flushing an early of PML, ifbe present.

PML-related mortality andin patients trea symptoms specific to PML, have reported with MRI for signs that may consistent with PML may be useful, other MSdiagnosis medications associated withLower PML. Many of been these patients morbidity havebecame been reported discontinuation of another any suspicious findings shouldfollowing lead to further to allowMS for subsequently symptomatic with PML.investigation Therefore, monitoring medication with be in patients with PML who were initially an early of PML, ifPML present.

Lower PML-related and with MRI diagnosis for associated signs that may consistent with PML may bemortality useful, and asymptomatic to patients PML who hadofcharacteristic morbidity havecompared been reported following discontinuation another any suspicious findings should lead towith further investigation to allow MS for clinical and symptoms at diagnosis.

It is notPML known whether these medication associated withifPML in patients with who were initially an earlysigns diagnosis of PML, present.

Lower PML-related mortality and differences arecompared duereported to early detection and discontinuation of MS MS asymptomatic to patients with PML who hadofcharacteristic morbidity have been following discontinuation another treatment or due differences inindisease patients. clinical signs and to symptoms at diagnosis. isthese notPML known these medication associated with PML patientsItinwith whowhether were initially differences are due to to early detection and who discontinuation of MS asymptomatic compared patients with PML had characteristic 5.3 Lymphopenia treatment or and due symptoms to differences in diseaseItinisthese patients. clinical signs at diagnosis. not known whether these TECFIDERA may decrease lymphocyte counts. In the MS placebo differences are due early detection discontinuation of MS 5.3 Lymphopenia controlled trials, meantolymphocyte counts and decreased by approximately treatment or due to differences intreatment disease inwith these patients. and then 30% during the year oflymphocyte TECFIDERA TECFIDERA mayfirst decrease counts.

In the MS placebo remained stable.

Fourlymphocyte weeks after stopping TECFIDERA, mean 5.3 Lymphopenia controlled trials, mean counts decreased by approximately lymphocyte increased but did not return to baseline.

Six percent 30% duringcounts the first year oflymphocyte treatment with TECFIDERA and then TECFIDERA may decrease counts.

In the MS placebo (6%) of TECFIDERA patients and after <1% of placebo TECFIDERA, patients experienced remained stable.

Four weeks stopping mean controlled trials, mean lymphocyte counts decreased by approximately 9 9 lymphocyte counts <0.5x10 (lower limit of normal 0.91x10 /L).

The increased did not return to baseline.

Six percent 30% during counts the first year of/Lbut treatment with TECFIDERA and then incidence of infections (60% vsand 58%) and (2% vs 2%) (6%) of TECFIDERA patients <1% of serious placeboinfections patients experienced remained stable.

Four weeks after stopping TECFIDERA, mean 9 with TECFIDERA or placebo, respectively. was similar counts incounts patients treated lymphocyte <0.5x10 /L of normal 0.91x10 The lymphocyte increased but(lower did notlimit return to baseline.

Six9/L). percent Thereof was increased incidence observed in incidence of no infections (60% vs 58%) and seriousinfections infections (2% vs 2%) (6%) TECFIDERA patients and <1%of ofserious placebo patients experienced 9 9 9 with<0.8x10 9 patients within lymphocyte counts ≤0.5x10 /L in controlled was similar patients treated TECFIDERA or placebo, respectively. lymphocyte counts <0.5x10 /L (lower limit/Lofornormal 0.91x10 /L). The trials, patient invsan extension study infections developed(2% PML the There although was no one increased of serious observed in incidence of infections (60%incidence 58%) and serious infections vsin2%) 9 9 predominantly setting ofwith prolonged lymphopenia (lymphocyte counts patients lymphocyte counts <0.8x10 /L or or ≤0.5x10 /L respectively. in controlled was similar in patients treated with TECFIDERA placebo, 9 <0.5x10 /L no for increased 3.5 patient years)incidence [see Warnings and infections Precautions (5.2)].

In trials, although one in an extension study developedobserved PML in the There was of serious in 9 predominantly controlled and uncontrolled clinical trials,9/L2% of counts patients experienced setting of prolonged lymphopenia (lymphocyte patients with lymphocyte counts <0.8x10 or ≤0.5x10 /L in controlled 9 lymphocyte counts <0.5x10 /Lanforextension at least six months, and inPML this group <0.5x10 /L for 3.5 patient years) in9[see Warnings and Precautions (5.2)].

In trials, although one study developed in the 9 the majority of lymphocyte counts /L predominantly with continued controlled and uncontrolled clinicalremained trials, 2%<0.5x10 ofcounts patients experienced setting of prolonged lymphopenia (lymphocyte 9 9 TECFIDERA therapy. has not inmonths, patients withinpre-existing lymphocyte counts /L been forWarnings at studied least six and this group <0.5x10 /L for 3.5 <0.5x10 years) [see and Precautions (5.2)].

In 9 low counts. the lymphocyte majority of uncontrolled lymphocyte counts /L with continued controlled and clinical remained trials, 2%<0.5x10 of patients experienced 9 therapy. has not been studied inmonths, patients with Obtain a TECFIDERA CBC, including lymphocyte before initiating treatment with lymphocyte counts <0.5x10 /L for at count, least six and inpre-existing this group low lymphocyte counts.

TECFIDERA, months after starting treatment, and 9then every 6 to 12 the majority of 6lymphocyte counts remained <0.5x10 /L with continued monthsaTECFIDERA thereafter, and asnot clinically indicated.

Consider of therapy. has been studied in patients withinterruption pre-existing Obtain CBC, including lymphocyte count, before initiating treatment with 9 TECFIDERA patientsafter withstarting lymphocyte counts 0.5x10 /L low lymphocytein TECFIDERA, 6counts. months treatment, andless thenthan every 6 to 12 persisting for including moreand than months.

Given the potential for delayed months thereafter, assix clinically indicated.

Consider interruption of Obtain a CBC, lymphocyte count, before initiating treatment with 9 recovery of lymphocyte counts, continue to obtain lymphocyte counts TECFIDERA patients withstarting lymphocyte counts less 0.5x10 /L TECFIDERA, 6inmonths after treatment, and thenthan every 6 tountil 12 their recovery if TECFIDERA is discontinued orpotential interrupted due of to persisting for more than months.

Given the for delayed months thereafter, and as six clinically indicated.

Consider interruption 9 lymphopenia. withholding treatment from patients serious recovery of lymphocyte continue to obtain lymphocyte counts until TECFIDERA inConsider patientscounts, with lymphocyte counts less thanwith 0.5x10 /L infections untilmore about or not restart their recovery ifresolution.

TECFIDERA is discontinued interrupted due to persisting for than sixDecisions months.

Given whether the or potential for todelayed TECFIDERA should be individualized based on clinical circumstances. lymphopenia.

Considercounts, withholding treatment from patients with serious recovery of lymphocyte continue to obtain lymphocyte counts until infections until ifresolution.

Decisions about whether or not todue restart their recovery TECFIDERA is discontinued or interrupted to 5.4 Liver Injury TECFIDERA should be withholding individualized based on clinical circumstances. lymphopenia.

Consider treatment with serious Clinically significant cases of liver injury havefrom beenpatients reported in patients infections until resolution. in Decisions about whether or The not onset to restart 5.4 Liver Injury treated with TECFIDERA the postmarketing setting. has TECFIDERA should be individualized based on clinical circumstances. ranged from a few days to several months after initiation of Clinically significant cases of liver injury have been reported intreatment patients with TECFIDERA. Signs and of liver injury, including elevation 5.4 Liver Injury treated with TECFIDERA in symptoms the postmarketing setting.

The onset has of serum aminotransferases to greater thanafter 5-fold the upper limit of ranged from a few cases days toofseveral months initiation ofintreatment Clinically significant liver injury have been reported patients normal and TECFIDERA elevation of and total bilirubin to than 2-fold the upper with TECFIDERA. Signs symptoms of greater liver injury, including elevation treated with in the postmarketing setting.

The onset has limitserum of normal beentoobserved.

These abnormalities upon of aminotransferases to greater than 5-fold the resolved upper limit of ranged from a have few days several months after initiation of treatment treatment Some casesto hospitalization.

None normal anddiscontinuation. elevation total bilirubin greater than 2-fold the upper with TECFIDERA. Signsofand symptoms ofrequired liver injury, including elevation of serum the cases resulted liver failure, liver transplant, orlimit death. limit ofreported normal have been observed.

These abnormalities resolved upon of aminotransferases toingreater than 5-fold the upper of However, combination of bilirubin newcases serum aminotransferase elevations treatment discontinuation.

Some hospitalization.

None normal andthe elevation of total to required greater than 2-fold the upper with increased levels of bilirubin caused by drug-induced hepatocellular of the reportedhave cases resulted in liver failure, liver transplant, or death. limit of normal been observed.

These abnormalities resolved upon injury is an important predictor ofcases serious liver injury that may lead to However, the combination of new serum aminotransferase elevations treatment discontinuation.

Some required hospitalization.

None acute liver failure, liverof transplant, or death sometransplant, patients. with levels bilirubin by in drug-induced hepatocellular of theincreased reported cases resulted incaused liver failure, liver or death. injury is an important of serum serious livernoinjury thatthan may to However, theof combination of new aminotransferase elevations Elevations hepatic predictor transaminases (most greater 3lead times acute liver failure, orobserved death in some patients. with levels of transplant, bilirubin caused by drug-induced hepatocellular the increased upper limit ofliver normal) were during controlled trials injury is an important liverno injury that than may 3 lead to [see Adverse (6.1)].of serious Elevations of Reactions hepaticpredictor transaminases (most greater times acute liver failure, liver transplant, or observed death in some patients. the upper limit of normal) were during controlled trials Obtain serum aminotransferase, alkaline phosphatase (ALP), and total [see Adverse Reactions (6.1)]. with TECFIDERA Elevations of hepatic transaminases (most no greater thantreatment, 3 times bilirubin levels prior to treatment and during the upper limit of normal) werealkaline observed during controlled as clinically indicated.

Discontinue TECFIDERA if clinically Obtain serum aminotransferase, phosphatase (ALP),significant andtrials total [see Adverse Reactions (6.1)]. withisTECFIDERA liver injury induced TECFIDERA suspected. and during treatment, bilirubin levels prior by to treatment as Discontinue TECFIDERA if clinically Obtain serumindicated. aminotransferase, alkaline phosphatase (ALP),significant and total 5.5 clinically Flushing liver injury induced bytreatment TECFIDERA is suspected. and during treatment, bilirubin levels priorcause to with TECFIDERA TECFIDERA may flushing (e.g., warmth, redness, itching, and/or as clinically indicated.

Discontinue TECFIDERA if clinically significant 5.5 Flushing burning sensation).

In clinical trials, 40% of TECFIDERA treated patients liver injury induced

by TECFIDERA is suspected. experienced flushing.

Flushing symptoms generally began soonand/or after TECFIDERA may cause flushing (e.g., warmth, redness, itching, initiating TECFIDERA and usually or resolved over time.

In the 5.5 Flushing burning sensation).

In clinical trials,improved 40% of TECFIDERA treated patients majority of patients whoFlushing experienced it redness, was mild or moderate in experienced flushing. generally began soon after TECFIDERA may cause flushingsymptoms (e.g.,flushing, warmth, itching, and/or severity.sensation).

Three percent (3%) of patients for initiating TECFIDERA and usually improved or resolved TECFIDERA over time.

In the burning In clinical trials, 40% ofdiscontinued TECFIDERA treated patients flushing of and <1% had serious symptoms flushing symptoms that were notafter lifemajority patients who experienced flushing, it was mild or moderate in experienced flushing.

Flushing generally began soon threatening but led to hospitalization.

Administration of TECFIDERA severity.

Three percent of patients discontinued TECFIDERA for initiating TECFIDERA and(3%) usually improved or resolved over time. In with the food may reduce incidence flushing.

Alternatively, flushing <1%the had serious of flushing symptoms thatoradministration were not lifemajority ofand patients who experienced flushing, it was mild moderate in of non-enteric aspirin (uppatients to aAdministration dose of 325 mg) 30 minutes prior threatening butcoated led to hospitalization. of TECFIDERA with severity.

Three percent (3%) of discontinued TECFIDERA for to TECFIDERA dosing may reduce the incidence or severity of flushing food may reduce of flushing.

Alternatively, administration flushing and <1% the hadincidence serious flushing symptoms that were not life[see Dosingbut and Administration and Clinical (12.3)]. of non-enteric coated aspirin (up(2.1) to aAdministration dose of 325Pharmacology mg) 30 minutes prior threatening led to hospitalization. of TECFIDERA with to TECFIDERA dosing may reduce the incidence or severity of flushing food may reduce the incidence of flushing.

Alternatively, administration 6 ADVERSE REACTIONS [see Dosing and Administration Pharmacology (12.3)]. of non-enteric aspirin (up(2.1) to reactions a and doseClinical of 325 30 minutes prior The followingcoated important adverse are mg) described elsewhere to TECFIDERA dosing may the incidence or severity ofmultifocal flushing 6 ADVERSE REACTIONS in labeling: Anaphylaxis andreduce Angioedema (5.1), Progressive [see Dosing and AdministrationLymphopenia (2.1) and Clinical Pharmacology (12.3)]. leukoencephalopathy (5.3), Liver Injury (5.4), The following important(5.2), adverse reactions are described elsewhere Flushing (5.5) [see Warnings and Precautions].

6in ADVERSE REACTIONS labeling: Anaphylaxis and Angioedema (5.1), Progressive multifocal leukoencephalopathy Lymphopenia (5.3), Liver Injury (5.4), The following important(5.2), adverse reactions are described elsewhere Flushing (5.5) [see Warnings and Precautions]. in labeling: Anaphylaxis and Angioedema (5.1), Progressive multifocal leukoencephalopathy (5.2), Lymphopenia (5.3), Liver Injury (5.4), Flushing (5.5) [see Warnings and Precautions].

food may theofincidence administration ymptoms teric coated aspirin (up reduce to a dose 325 mg) of 30flushing. minutes Alternatively, prior non-enteric coated aspirin to a dose of 325 mg) 30 minutes prior eeks, and DERA dosing of may reduce the incidence or (up severity of flushing to TECFIDERA dosing may reduce the incidence msiness of ng and Administration (2.1) and Clinical Pharmacology (12.3)]. or severity of flushing [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3)]. mory, and SE REACTIONS 6 ADVERSE REACTIONS wing important adverse reactions are described elsewhere ms.

Cases The important reactions are described elsewhere g: Anaphylaxis andfollowing Angioedema (5.1), adverse Progressive multifocal n of JCV labeling: Anaphylaxis(5.3), and Angioedema ephalopathy in(5.2), Lymphopenia Liver Injury (5.1), (5.4), Progressive multifocal signs or leukoencephalopathy 5.5) [see Warnings and Precautions].(5.2), Lymphopenia (5.3), Liver Injury (5.4), ated with Flushing (5.5) [see Warnings and Precautions].

6.1 Clinical Trials Experience 6.1 Clinical Trialstrials Experience Because clinical are conducted under widely varying conditions, adverse ratesare observed in clinical a drug conditions, cannot be Because reaction clinical trials conducted under trials widelyofvarying directly to rates in the clinical trialstrials of another drugcannot and may adversecompared reaction rates observed in clinical of a drug be not reflect the ratestoobserved in clinical directly compared rates in the clinicalpractice. trials of another drug and may not reflect the rates adverse observedreactions in clinical(incidence practice. ≥10% and ≥2% more The most common than placebo) for TECFIDERA were flushing, abdominal pain,≥2% diarrhea, The most common adverse reactions (incidence ≥10% and more and thannausea. placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea.

Adverse Reactions in Placebo-Controlled Trials Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients TECFIDERA an overall effectiveness, exposure of 1529 2244 In the tworeceived well-controlled studieswith demonstrating person-years [see Clinical Studies (14)]. patients received TECFIDERA with an overall exposure of 2244 person-years [see Clinical Studies (14)].

The adverse reactions presented in the table below are based on safety information 769 patients treated 240 mg twice The adversefrom reactions presented in thewith tableTECFIDERA below are based on safety a day and 771 placebo-treated patients.with TECFIDERA 240 mg twice information from 769 patients treated a day and 771 placebo-treated Table 1: Adverse Reactions inpatients.

Study 1 and 2 reported for TECFIDERA 240 mg BID at ≥2% higher incidence thanfor placebo Table 1: Adverse Reactions in Study 1 and 2 reported TECFIDERA 240 mg BID at ≥2% higher incidence than placebo

Flushing Flushing pain Abdominal Abdominal pain Diarrhea Diarrhea Nausea Nausea Vomiting Vomiting Pruritus Pruritus Rash Rash Albumin urine present Albumin urine present Erythema Erythema Dyspepsia Dyspepsiaaminotransferase increased Aspartate Aspartate aminotransferase increased Lymphopenia Lymphopenia

TECFIDERA N=769 TECFIDERA % N=769 % 40 40 18 18 14 14 12 12 9 9 8 8 8 6 6 5 5 5 4 4 2 2

Placebo N=771 Placebo % N=771 % 6 6 10 10 11 11 9 9 5 5 4 4 3 3 4 4 1 1 3 3 2 2 <1 <1

Gastrointestinal Gastrointestinal TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). incidence of GIvomiting, events was higher TECFIDERA caused GI eventsThe (e.g., nausea, diarrhea, early in thepain, course of treatmentThe (primarily in ofmonth 1) and abdominal and dyspepsia). incidence GI events wasusually higher decreased timeofin treatment patients treated withinTECFIDERA compared early in theover course (primarily month 1) and usually with placebo.

Four percent (4%) of patients with TECFIDERA decreased over time in patients treated withtreated TECFIDERA compared and than 1% of placebo due with to gastrointestinal with less placebo.

Four percent patients (4%) of discontinued patients treated TECFIDERA events. of serious GI discontinued events was 1% treated and lessThe thanincidence 1% of placebo patients dueintopatients gastrointestinal with TECFIDERA. events.

The incidence of serious GI events was 1% in patients treated with TECFIDERA. Hepatic Transaminases Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA wasof seen primarily during the An increased incidence of elevations hepatic transaminases in first six months treatment, and most with elevations patients treated ofwith TECFIDERA waspatients seen primarily during had the levels times the limit of normal during first six<3months of upper treatment, and most (ULN) patients withcontrolled elevationstrials. had Elevations of alanine aminotransferase and aspartate levels <3 times the upper limit of normal (ULN) duringaminotransferase controlled trials. to ≥3 timesofthe ULNaminotransferase occurred in a small number ofaminotransferase patients treated Elevations alanine and aspartate with and placebo andnumber were balanced to ≥3both timesTECFIDERA the ULN occurred in a small of patientsbetween treated groups.

There were no elevations in transaminases ≥3 times between the ULN with both TECFIDERA and placebo and were balanced with concomitant in total bilirubin >2 ≥3 times groups.

There wereelevations no elevations in transaminases timesthe theULN. ULN Discontinuations to elevated transaminases werethe <1%ULN. and with concomitantdue elevations inhepatic total bilirubin >2 times were similar in patients treated with TECFIDERA or placebo.

Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with TECFIDERA or placebo.

Eosinophilia Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 therapy.in mean eosinophil counts was seen during the first A months transientofincrease 2 monthsReactions of therapy.in Placebo-Controlled and Uncontrolled Studies Adverse Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have receivedand TECFIDERA andclinical been followed up to In placebo-controlled uncontrolled studies,for a periods total of 2513 4 years with overallTECFIDERA exposure of and 4603been person-years. patients havean received followed forApproximately periods up to 1162 patients received more thanperson-years.

2 years of treatment with 4 years with anhave overall exposure of 4603 Approximately TECFIDERA. profile of TECFIDERA the 1162 patients The haveadverse receivedreaction more than 2 years of treatmentin with uncontrolled studies was consistent experience inin the TECFIDERA.clinical The adverse reaction profilewith of the TECFIDERA placebo-controlled trials. uncontrolled clinicalclinical studies was consistent with the experience in the placebo-controlled trials.

6.2 Post Marketingclinical Experience 6.2 Post Marketing Experience The following adverse reaction has been identified during post approval use TECFIDERA. these reactions areduring reported The of following adverseBecause reaction has been identified postvoluntarily approval from population of uncertain is not always possible voluntarily to reliably use ofa TECFIDERA. Because size, theseitreactions are reported estimate their frequency or establish causal relationship drug from a population of uncertain size, it is anot always possible to to reliably exposure. estimate their frequency or establish a causal relationship to drug exposure.

Liver function abnormalities (elevations in transaminases ≥3 times ULN concomitant elevations in total bilirubin >2 times ULN) have Liver with function abnormalities (elevations in transaminases ≥3 times been reported followingelevations TECFIDERA administration postULN) marketing ULN with concomitant in total bilirubin >2 in times have experience [See Warnings and Precautions (5.4)]. in post marketing been reported following TECFIDERA administration experience [See Warnings and Precautions (5.4)].

from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Liver function abnormalities (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN) have been reported following TECFIDERA administration in post marketing experience [See Warnings and Precautions (5.4)].

8 USE IN SPECIFIC POPULATIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.1 Pregnancy Pregnancy Exposure Registry There is a Exposure pregnancy exposure registry that monitors pregnancy Pregnancy Registry outcomes women exposed TECFIDERA during pregnancy.

There is ainpregnancy exposuretoregistry that monitors pregnancy Encourage enroll bytocalling 1-866-810-1462 or visiting outcomes inpatients womentoexposed TECFIDERA during pregnancy. www.tecfiderapregnancyregistry.com.

Encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com.

Risk Summary Risk Summary There are no adequate data on the developmental risk associated with the useare of TECFIDERA pregnant In animals, adverse effects There no adequate in data on the women. developmental risk associated with on survival, growth, sexual maturation, and neurobehavioral the offspring use of TECFIDERA in pregnant women.

In animals, adverse effects function were observed fumarate (DMF) was on offspring survival, growth,when sexualdimethyl maturation, and neurobehavioral administered during pregnancy and lactation function were observed when dimethylat clinically fumaraterelevant (DMF)doses. was [see data]. during pregnancy and lactation at clinically relevant doses. administered [see In thedata].

U.S. general population, the estimated background risk of major birth and miscarriage recognized pregnancies is In thedefects U.S. general population, in theclinically estimated background risk of major 2-4% and 15-20%, respectively. background risk pregnancies of major birth birth defects and miscarriage in The clinically recognized is defects and15-20%, miscarriage for the indicated population risk is unknown.

2-4% and respectively.

The background of major birth defects and miscarriage for the indicated population is unknown.

Data Data Data Animal In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout Animal Data organogenesis, embryofetal toxicity fetal body weight and In rats administered DMF orally (25, (reduced 100, 250 mg/kg/day) throughout delayed ossification) were observed at the highest organogenesis, embryofetal toxicity (reduced fetal dose body tested. weight This and dose also produced were evidence of maternal toxicitydose (reduced delayed ossification) observed at the highest tested. body This weight).

Plasma exposure (AUC) of for maternal monomethyl fumarate (MMF), the dose also produced evidence toxicity (reduced body major circulating metabolite, at the no-effect dose is approximately weight).

Plasma exposure (AUC) for monomethyl fumarate (MMF), the three that inmetabolite, humans at at thethe recommended human dose (RHD) major times circulating no-effect dose is approximately of 480times mg/day.

DMF orally (25, 75, and 150 three that In in rabbits humansadministered at the recommended human dose (RHD) mg/kg/day) organogenesis, embryolethality of 480 mg/day.throughout In rabbits administered DMF orally (25, 75, and and 150 decreased body weight were observed at the highest dose mg/kg/day)maternal throughout organogenesis, embryolethality and tested.

The plasmabody AUC for were MMFobserved at the at no-effect dose is decreased maternal weight the highest dose approximately 5 times that RHD.no-effect dose is tested. The plasma AUCin humans for MMFat the at the approximately 5 times in (25, humans the 250 RHD.mg/kg/day) to rats Oral administration of that DMF 100,atand throughout organogenesis lactation resulted in increased Oral administration of DMF and (25, 100, and 250 mg/kg/day) to rats lethality, reductions body weight, sexual throughoutpersistent organogenesis and inlactation resulteddelayed in increased maturation (male andreductions female pups), at lethality, persistent in and bodyreduced weight,testicular delayedweight sexual the highest (male dose tested.

Neurobehavioral impairment was observed maturation and female pups), and reduced testicular weight at at doses.

A no-effect dose for developmental toxicity was not theall highest dose tested. Neurobehavioral impairment was observed identified.

TheAlowest dosedose tested associated with plasma at all doses. no-effect forwas developmental toxicity wasAUC not for MMF lower than that in humans at the RHD. identified.

The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD. 8.2 Lactation

8.2 Lactation Risk Summary Risk Summary There are no data on the presence of DMF or MMF in human milk.

The theonbreastfed infant milk production are Thereeffects are noon data the presence of and DMFon or MMF in human milk. unknown.

The effects on the breastfed infant and on milk production are unknown.

The developmental and health benefits of breastfeeding should be considered along with thehealth mother’s clinical for TECFIDERA The developmental and benefits ofneed breastfeeding shouldand be any potential adverse on theclinical breastfed infant from the drug or considered along with effects the mother’s need for TECFIDERA and from the underlying maternal condition. any potential adverse effects on the breastfed infant from the drug or fromPediatric the underlying 8.4 Use maternal condition.

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use 8.5 Geriatric Use Clinical studies of TECFIDERA did not include sufficient numbers of patients aged 65 and over todid determine whether they respond Clinical studies of TECFIDERA not include sufficient numbers of differently from younger patients aged 65 and patients. over to determine whether they respond differently from younger patients.

10 OVERDOSE 10 OVERDOSE Cases of overdose with TECFIDERA have been reported. The symptoms these cases werehave consistent the known Cases of described overdose in with TECFIDERA been with reported.

The adverse event profile in of these TECFIDERA. symptoms described cases were consistent with the known adverse profiletherapeutic of TECFIDERA. There areevent no known interventions to enhance elimination of TECFIDERA northerapeutic is there ainterventions known antidote.

In theelimination event of There are no known to enhance overdose, initiatenor symptomatic treatment as event clinically of TECFIDERA is there a supportive known antidote.

In the of indicated. overdose, initiate symptomatic supportive treatment as clinically indicated.

17 PATIENT COUNSELING INFORMATION 17 PATIENT COUNSELING Advise the patient to read theINFORMATION FDA-approved patient labeling (Patient Information) Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Dosagepatients that they will be provided two strengths of TECFIDERA Inform when 120 capsules the 7 day starter dose Informstarting patientstreatment: that they will bemg provided twofor strengths of TECFIDERA and mg capsules for120 themg maintenance to be taken when240 starting treatment: capsules fordose, the 7both day starter dose twice daily. patients to swallow TECFIDERA capsules and 240 mgInform capsules for the maintenance dose, both to be whole taken and not crush, chew, or sprinkle twiceintact. daily. Inform patients to swallow TECFIDERA capsulescapsule whole contents on Inform food. Inform patients TECFIDERA be taken with and intact. patients to notthat crush, chew, or can sprinkle capsule or withouton food [see Dosage and Administration (2.1)]. contents food.

Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration (2.1)].

Inform pat when star and 240 m twice daily and intac contents o or without

eliably drug

times have keting

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)].

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)].

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 (5.3), 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 (5.4)].

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)].

10 41347-09

Manufactured by: Biogen Cambridge, MA 02142 TECFIDERA is a trademark of Biogen.

9 Biogen Š 2013-2017 7/19 2/18

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Policy & Guidelines

New Advocacy Summit Delivers Congressional Support on Drug Pricing Inaugural AAN Legislative Summit a Big Success On September 24, 33 AAN members visited Capitol Hill as part of the inaugural AAN Legislative Summit event. This new event is an additional opportunity for the AAN to influence members of Congress on current issues important to neurology, strengthening relationships that have been built at other AAN advocacy events throughout the year. AAN members discussed the We PAID (Protect American Investment in Drugs) Act of 2019, a bipartisan bill to prohibit pharmaceutical companies from charging unreasonable prices for drugs when companies develop prescription drugs using federally funded research, such as NIH or CDC grants. They also urged their representatives to sign a congressional letter led by Representatives Blumenauer (D-OR), McMorris Rodgers (R-WA), Sewell (D-AL), and Wenstrup (R-OH) expressing concerns over the proposal from the Centers for Medicare & Medicaid Services (CMS) on reduced values of the new long-term video EEG monitoring codes. The final letter was sent to CMS with 68 signatures—including 18 as a direct result of AAN member congressional visits.

2020 Physician Fee Schedule Proposed Rule CMS withdrew its plan to collapse the existing levels of E/M coding and instead proposed substantial reimbursement increases to outpatient E/M services beginning in 2021. The AAN received a national award in recognition of the highly coordinated advocacy efforts that resulted in this significant win to preserve access to neurologic care.

On September 16, the AAN submitted comments to CMS in response to the 2020 Physician Fee Schedule proposed rule.

The comments strongly opposed proposed payment cuts for long-term EEG monitoring services, supported substantial positive changes to evaluation and management (E/M) coding, and provided feedback on a number of proposals that would significantly impact the Merit-based Incentive Payment System (MIPS) program. The AAN’s 41-page comment letter is one of the longest letters that the AAN has ever submitted.

Members Engage Congress off the Hill Over the August congressional recess, nearly 40 AAN members met with their members of Congress and staff in their local communities as a part of Neurology off the Hill.

Advocates discussed drug pricing challenges in neurology, research funding including the NIH and BRAIN Initiative, Patient-Centered Outcomes Research Institute reauthorization, and the Safe Step Act, a bill to establish common-sense exceptions to step therapy in group health plans.

More than 1,800 AAN members have contacted their members of Congress this year through the AAN’s Advocacy Action Center regarding AAN priority issues. The Action Center also allows you to share your personal stories, such as the impact of high drug prices on patient care. Neurology-specific examples of broad health policy issues are essential in continuing our effective advocacy. Learn more at AAN.com/view/actnow. 

#AANadvocacy

AANnews • November 2019 15

Policy & Guidelines

Capitol Hill Report Capitol Hill Report presents regular updates on legislative and regulatory actions and how the Academy ensures that the voice of neurology is heard on Capitol Hill. It is emailed to US members twice monthly and is posted at AAN.com/view/HillReport.

Below are some recent highlights.

Legislative Summit—Member Perspective

by Alison E. Alford, MD 108.7 miles. About two hours of driving. Does not sound too bad, does it? It was a very daunting distance a few weeks ago.

I had decided to join my fellow Advocacy Committee members on Capitol Hill for the new AAN Legislative Summit. I had only been to Capitol Hill once before and was quite nervous at the prospect of doing it again. However, we were going to speak on drug pricing, and this has such a direct impact on our patients that how could I not go? I truly felt it was something we were direct experts on, and staffers, representatives, and senators need to hear our opinions.

As you stand on First Street in front of the Capitol building, it is quite the formidable structure. I could feel the butterflies churning, but like all strong-willed people, I pushed forward.

We started in the Senate, meeting staff from both Sen. Warner and Sen. Kaine’s office. Then we marched through Rep. McEachin’s office and finally landed at Rep. Spanberger’s office. We carried the same message all day. We told stories of how rapidly escalating drug prices are preventing our patients from getting the treatments they so desperately need. The We PAID Act will not solve the entire problem, but it is a start and we need them to help us. It was a busy day filled with meetings and just enough time for lunch, but we wanted to have the biggest impact we could and meet as many legislators as possible. And you know what? I am still nervous. I will always be intimated, but you learn that these staffers and legislators are people too. They have loved ones being failed by our health system. They, too, want change. So, there is no need to be nervous. There is no need to be intimidated. We need to be empowered. We need to be the voice for our patients. So, if you can’t make the 108.7-mile drive for any number of reasons, you can be the voice at home. You can speak with your legislators right in the home office. Be the voice our patients need. The Academy does a great job leading the charge all you have to do is get out there.

16

AANnews • November 2019

Alison E. Alford, MD, makes her case to a congressional staff member during the Legislative Summit.

AAN Neurology Patient Advocacy Roundtable Following the Legislative Summit last week in Washington, DC, the AAN held a Neurology Patient Advocacy Roundtable, bringing together the patient advocacy community to increase collaboration and engagement on state and federal issues.

There were eight patient advocacy groups present for the meeting: ALS Association, Alzheimer’s Association, Brain Injury Association of America, Epilepsy Foundation of America, Muscular Dystrophy Association, National MS Society, and the Tourette Association of America. The agenda focused on education of each group’s advocacy priorities and finding areas for collaboration including regulatory advocacy, research funding, telemedicine, and workforce shortage. The AAN hosts quarterly conference calls with patient advocacy groups to help guide and strategize our advocacy efforts, but this was the first time all the groups could meet in person. The AAN values the strong relationships that we have with patient advocacy groups; working together makes us stronger, and our voices louder. 

Conferences & Community

2020 Annual Meeting Heading to Vibrant Toronto continued from cover Top Reasons to Attend Science Be immersed in high-quality, innovative discoveries and science like no other, including: Seven cutting-edge Plenary sessions Scientific abstracts—both interactive electronic posters and presented orally by the author during platform sessions— featuring the latest research Invited Science

Education Whether you’re a clinician, researcher, resident, student, or other neurology professional, and no matter your subspecialty area of interest, the 2020 Annual Meeting is your go-to for the valuable CME and knowledge you need with sessions on every subspecialty topic imaginable, presented in a wide variety of formats. You’ll find fresh and creative education content all week long through more than 240 expert-led courses and experiential learning areas covering the full spectrum of neurology.

Innovative and Inspiration Talks—featuring a Saturday talk

by David Eagleman, PhD, followed by the opening reception Dedicated programming for academic business administrators, medical students and residents, and more Career-focused tracks in Academic Medicine, Business of Neurology, Career Essentials, Foundations of Clinical Neurology for APPs, Futures in Neurological Research, Neurohospitalist, Spanish-language Friday Grand Finale program with Science Innovation Lunch in the poster hall featuring some of the best scientific posters and presentations from the week focusing on neuroinflammation Closing Party featuring a performance by the hilarious improvisational comedy of Second City Learn more and secure the biggest savings on registration and the hotel room of your choice by visiting AAN.com/view/AM20 before the March 5, 2020, early registration deadline! 

Networking Unparalleled networking opportunities—from the Opening Party to the Closing Party, and everything in-between—within your community of neurology professionals from around the globe.

Other Don’t-miss Opportunities Opening party—Sunday Night at the ROM (Royal Ontario Museum) The poster hall is going electronic with all digital posters.

April 25 – May 1 • Toronto, Canada

C O N G R AT U L AT I O N S

Shafali Jeste, MD, FAAN 2008 Clinical Research Training Fellowship Recipient, American Brain Foundation Board Member RECIPIENT OF A

2019 Presidential Early Career Award for Scientists and Engineers

FUNDING WORLD-CLASS RESEARCH The American Brain Foundation continually invests in a broad range of innovative research projects and in new generations of investigative researchers. AAN members make this work possible.

When renewing your AAN membership this year, remember to include a gift to the American Brain Foundation and make a difference for millions impacted by brain disease.

AmericanBrainFoundation.org

Conferences & Community

Host In Conjunction With Events at the 2020 Annual Meeting Applications are now being accepted for In Conjunction With (ICW) meetings and events during the 2020 Annual Meeting in Toronto. Visit AAN.com/view/ICW before January 23, 2020, to take advantage of discounted pricing.

An ICW meeting is an AAN-affiliated organization’s event, meeting, or function available to Annual Meeting attendees that falls outside the official AAN Annual Meeting program but during inclusive dates of the Annual Meeting, whether held at AAN-contracted facilities or in the same metropolitan area as the Annual Meeting. 

April 25 – May 1 • Toronto, Canada

Earn Valuable End-of-year CME Credits with Annual Meeting On Demand Looking to earn valuable end-of-year CME? Missed the 2019 Annual Meeting in Philadelphia—or couldn’t get to all of your favorite sessions? With Annual Meeting On Demand you can still watch 500+ hours* of presentations like you’re there in person with slides and synchronized audio, access 200+ programs and syllabi**, and earn up to 242.75 AMA PRA Category 1 CreditsTM before year’s end. The convenient online format even allows you to learn at your desk or on the go.

Accessing Annual Meeting On Demand’s comprehensive collection of 2019 Annual Meeting education and science is quick and easy from the AAN’s Online Learning Center. Learn more or order today at AAN.com/view/19AMOD.  * With the move to an online offering, hard drives will not be provided. ** Specific presentations within a session may not be available or may be audio only if the presenter has confidential patient information or otherwise declines to be recorded.

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Conferences & Community

It’s Time to Renew Your Membership for 2020 continued from cover Valuable clinical practice guidelines The latest news relevant to the profession Representation of your interests at the federal/state levels Special pricing on AAN products, services, or meetings Exclusive access to AAN.com member-only resources Find the full list of exclusive member benefits at AAN.com/view/benefits. For more information, contact AAN Member Services at memberservices@aan.com, (800) 879-1960, or (612) 928-6000 (international). 

The AAN offers APPs the ability to come together from diverse settings with common needs and work with physician colleagues to shape practice.”

Members share why they renew: The AAN offers excellent programs, services, and benefits. In particular, excellence is guaranteed for up-to-date information on scientific research, networking with other neurology professionals, participation in very well-organized scientific international conferences, access to professional growth and career opportunities, prestige, and credibility.”

AAN membership offers an excellent opportunity for residents to get involved early and to learn more about their budding interests from the top neurologists in various subspecialty careers.”

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Education & Research

Rydell on Commission Honored for Work on Continuing Board Certification AAN CEO Catherine M. Rydell, CAE, and 24 other medical association leaders comprising the Continuing Board Certification: Vision for the Future Commission were honored recently with the 2019 Distinguished Service Award from the American Board of Medical Specialties (ABMS), which oversees physician board certification and continuing certification in the United States.

According to ABMS, “Created in 1986, this award recognizes individuals for their extraordinary contributions to the medical specialty certification process. The commission members were responsible for assessing the status of continuing board certification and making recommendations to transform Rydell the current process to a system that demonstrates the profession’s commitment to professional selfregulation; offers a consistent and clear understanding of continuing certification; and establishes a meaningful, relevant, and valuable program that meets the highest standard of quality patient care. Representing a diverse group of stakeholder communities, the independent commission released a final report in February 2019. The report supports and reinforces the important role that continuing certification plays in today’s health care system and offers recommendations to improve its value to all stakeholders.” 

UCNS Launches New Website The United Council for Neurologic Subspecialties (UCNS) has updated its website with a new look, easier navigation and search options, and increased functionality.

The site allows UCNS diplomates to log in to update their profile and licensure information and make payments. Diplomates can also attest to their CME for UCNS continuous certification through the site, which is now optimized for mobile use.

All diplomates were sent temporary log-in information to begin the process. If you did not receive your information via email, contact UCNS at ucns.org. 

ucns.org 22

AANnews • November 2019

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Neurohospitalist Opportunity in Northern Indiana. Immediate Need: Memorial Hospital in South Bend, Indiana and Elkhart General Hospital in Elkhart, Indiana are seeking Neurohospitalists to cover the medical neurology and stroke services for our 526 bed, level II Trauma Memorial Hospital of South Bend and our 365-bed Elkhart General Hospital.

Qualified candidates will be BC/BE in neurology with interest in providing inpatient neurology and stroke consultative services.

The Neuro-hospitalists will work with four neuro-Intensivist, neurosurgeons, interventional radiologists, emergency medicine physicians and hospitalists. Our goal aims to provide the highest standard of care including diagnosis, prevention and treatment for patients with stroke and other cerebrovascular diseases. We offer patients an extensive continuum of care beginning in the Emergency Department all the way to rehabilitative services after discharge, as both of these campuses are Certified Primary Stroke Centers by The Joint Commission. Beacon Medical Group, a division of Beacon Health System, is the largest, most integrated medical group in the region, employing more than 250 physicians and 125 advanced practice clinicians and representing over 35 different specialties throughout northern Indiana and southwestern Michigan. For more details on Beacon Health System, please visit: beaconhealthsystem.org. Beacon offers a market competitive salary and benefit package, including, but not limited to: Medical, Dental, and Vision Insurance. Life Insurance. Short/Long-term Disability. Relocation Allowance.

CME Allowance. 403(b) and 457(b) Retirement Savings Plans.

Paid Malpractice with Tail Coverage. Student Loan Repayment Assistance. Beacon Health System locations span across north central Indiana and into southwest Michigan. We are one of the top 2% of hospitals nationwide to achieve a 5 Star CMS Hospital Rating and a AA- bond rating, placing Beacon in the top 10th percentile of health systems across the country.

Our physicians and associates enjoy the vibrant surrounding communities which include Elkhart, Granger, LaPorte, Mishawaka and South Bend. Our area is home to several colleges, including the world-renowned University of Notre Dame, providing many options for athletic and cultural events.

Combined with the Morris Performing Arts Center in South Bend and the Lerner Theatre in Elkhart, live entertainment is easy to find. A “big little town,” South Bend is also home

to the South Bend Cubs, a Class-A minor league baseball team. Parks, Potawatomi Zoo and numerous festivals offer family-friendly fun. Nearby, the sandy shores of Lake Michigan beckon with opportunities for camping, hiking or just relaxing.

And, with Chicago just 90 minutes away by car or rail, options for weekend getaways are endless. To apply for this position, contact Caren Foster at cjfoster@beaconhealthsystem.org.

Phone: (574) 647-1647. Fax: (574) 647-1693.

available through the Norton Healthcare Research Office.

Neurological rehabilitation services. Because of an increasing elderly population in Greater Louisville, Parkinson’s disease is a significant health concern. As the region’s leader in providing care for neurological conditions, Norton Neuroscience Institute is dedicated to offering the most advanced treatments for people with Parkinson’s disease. Cressman Neurological Rehabilitation, a service of Norton Neuroscience Institute, provides rehabilitation for patients managing neurological conditions. Patients have access to some of the most advanced technology and specialized services in one location to help with gait, balance, strength, flexibility, speech, fine motor skills, swallowing, driving, cognition, vision and more. Specialized features include the ZeroG Gait and Balance System, the Biodex Gait Training System, deep brain stimulation, Parkinson Wellness Recovery-certified therapists, videostroboscopy, and one-on one personalized training and follow-up programs.

About Norton Neuroscience Institute. Established in early 2009, Norton Neuroscience Institute is the region’s leading provider of neurological care. The comprehensive program offers advanced treatment for complex neurological disorders, including ALS; aneurysms; brain tumors; epilepsy; headache and concussion; movement disorders, including Parkinson’s disease; multiple sclerosis; pediatric neurosurgery; spinal injuries and disorders; stroke; and more. In 2016, Norton Neuroscience Institute was the first in the region to use ROSA, a robotic surgical assistant, to provide advanced treatment for patients with epilepsy and brain tumors. Norton Neuroscience Institute also is one of the first in the region to use systems such as NeuroPace and NeuroBlate for performing minimally invasive surgical procedures. Patients and their families have access to patient navigators and support services through the Norton Neuroscience Institute Resource Center, the Center for Independent Living and rehabilitation services. The resource center offers health information and assistance with getting connected to clinical trials, educational programs, support services, community resources and more to help patients live better. More information is available at NortonNeuroscienceInstitute.com. Job Requirements. Medical degree/diploma. Residency/fellowship certification. Kentucky medical license or license eligible. To apply for this position, contact Amanda Bailey. Email address: amanda.bailey@ nortonhealthcare.org. Phone:(502) 439-5144. Apply URL: https://nortonhealthcare.com.

Neurologist Needed in Great Team Atmosphere. If you want to join a team focused on clinical quality and experience a great family lifestyle at the same time, this is without a doubt the unique place for you. Earn in excess of $500,000 (salary plus production and performance bonuses). Signon bonus/Relocation assistance. Student Loan Assistance.

Generous CME Allowance. Malpractice coverage, including tail coverage. Outstanding Medical, Dental, Vision, Disability, Life Insurance & Retirement Benefits. Paid Time Off up to 6 weeks (including CME). A team atmosphere where good clinicians and staff thrive. Board Certified or Board Eligible required. Job Requirements. Outpatient Neurologist with call. To apply for this position, contact Krisann Dikes. Email address: Krisann.Dikes@mysrhs.com. Phone: (228) 818-4024.

Fax: (228) 818-4014.

Epileptologist and Movement Disorders Neurologists for Norton Neuroscience Institute. Epileptologist. Louisville, Kentucky, United States. Norton Neurology Services, a part of Norton Neuroscience Institute, is seeking a fellowshiptrained physician to provide movement disorder services.

Norton Neuroscience Institute is composed of 65 neuroscience providers, including 19 neurologists, 14 neurosurgeons, two neuropsychologists and more than 30 advanced practice providers. The ideal candidate will join three fellowship-trained epileptologists and three advanced practice providers. Our program features a six-bed, state-of the-art Level IV Epilepsy Monitoring Unit located at Norton Brownsboro Hospital.

Opportunity to provide inpatient and outpatient epilepsy and general neurology services. Opportunity to participate in the annual Norton Neuroscience Institute Symposium, as well as other continuing medical education events. Weekly neuroscience clinical conference with neurosurgery and neurology providers. Research opportunities and support available through the Norton Healthcare Research Office.

Movement Disorders Neurologist. Louisville, Kentucky, United States. Norton Neurology Services, a part of Norton Neuroscience Institute, is seeking a fellowship-trained physician to provide movement disorder services. Norton Neuroscience Institute is composed of 65 neuroscience providers, including 19 neurologists, 14 neurosurgeons, two neuropsychologists and more than 30 advanced practice providers. The ideal candidate will join two fellowship-trained movement disorder neurologists. The practice enjoys referral patterns from other neurologists in the practice as well as other physicians and providers within Norton Medical Group.

Ability to practice majority movement disorder neurology. No mandatory system stroke call. Opportunity to provide general inpatient neurology services. Opportunity to participate in the annual Norton Neuroscience Institute Symposium, as well as other continuing medical education events. Weekly neuroscience clinical conference with neurosurgery and neurology providers. Research opportunities and support

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