2018 September AANnews

VOLUME 32 · ISSUE 9 · SEPTEMBER 2018

GET YOUR RESEARCH RECOGNIZED Submit Abstracts for 2019 Annual Meeting Your work could be seen by more than 14,000 neurologists, neuroscientists, and researchers from around the world if your abstract is selected for presentation at the 2019 AAN Annual Meeting, to be held in Philadelphia, PA, May 4 through 10.

Online abstract submission opens September 6 at AAN.com/view/19Abstracts and submissions are due no later than 11:59 p.m. CT on Monday, October 22.

Abstracts will be accepted in all facets of neurology and neuroscience and could be chosen for Neuroscience in the Clinic sessions, “Best Of” sessions, and scientific platform or poster sessions.

For more information, contact nkosher@aan.com or (612) 928-6088. 

2019 AAN Award Applications Deadline Approaching

Wednesday, October 24, is the last chance to apply or nominate a deserving colleague for a variety of prestigious AAN awards to be presented at the 2019 AAN Annual Meeting in Philadelphia. AAN awards honor the best research and achievements by neurologists and neuroscientists around the globe and at all career stages with prizes and other compensation, such as complimentary travel expenses and registration for the Annual Meeting. Learn more and apply or nominate at AAN.com/view/19Awards. 

AAN Strongly Opposes Proposed Changes to E/M Payments

CMS Announces Proposed Rule for MIPS and Advanced APMs

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule in July updating payment policies and rates for physicians paid under the Medicare Physician Fee Schedule (MPFS) in 2019.

CMS is inviting comments, due this month, on the proposal before it issues its final rule in November.

The Centers for Medicare & Medicaid Services (CMS) released in July the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) proposed rule for the 2019 performance period. The rule finalizes modifications to payment and policy to the Quality Payment Program (QPP) implemented in 2017 and 2018. The QPP is a Medicare quality payment incentive program for physicians and other eligible clinicians, which rewards value and outcomes in one of two ways: through the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (A-APMs).

Avitzur

While the AAN is appreciative that CMS is starting to recognize the increased complexity of the work neurologists do, and that administrative burden needs to be Continued on page 19

8

Webinar Helps You Master Guidelines and Measures

›

In the proposed rule, CMS continues the gradual ramp up of

20 AAN Publishes Updated

Disorders of Consciousness Guideline

Continued on page 10

23 Advance Registration and

Hotel Deadline Approaching for Expanded Fall Conference

›

In Multiple Sclerosis–

THE ART OF BRAIN PRESERVATION Adding Grey to the Palette Completes the Picture

GREY MATTERS, TOO

Learn more about Multiple Sclerosis at MSBrainPreservation.com/art © 2018 Celgene Corporation All rights reserved. 03/18 USII-CELG180067

AANnews · September 2018

CONTENTS

News Briefs

Cover Get Your Research Recognized AAN Strongly Opposes Proposed Changes to E/M Payments

Conferences & Community Participant Credits Diversity Leadership Program with Reducing Burnout, More · · · ·22 Synapse Continues Strong Growth, Engagement · · · · · ·23

CMS Announces Proposed Rule for MIPS and Advanced APMs President’s Column How Well Is the AAN Meeting Your Needs? · · · · · · · 4 Through Their Eyes Recollections of Past AAN Presidents · · · · · · · · · 6

B:11.125” T:10.875” S:10.375”

Tools & Resources Webinar Helps You Master Guidelines and Measures · · · 8 Join New EHR Synapse Online Community · · · · · · · · 9 State and Federal Legislative Update: Medical Marijuana and Cannabis · · · · · · · · · · · 12 Neurology: Clinical Practice Offers Wealth of Practical Insights · · · · · · · 13 Podcast Central · · · · · · · · · 13

The AAN requests public review and comments by September 27, 2018, on a draft guideline manuscript on prevention treatment for pediatric migraine. The guideline in development addresses: Efficacy and safety of pharmacological treatment for reducing headache frequency in children and adolescents

Advance Registration and Hotel Deadline Approaching for Expanded Fall Conference · 23

Efficacy of combining cognitive behavioral therapy with pharmacological treatment of migraine in reducing headache frequency in children and adolescents

Off to a Great Start · · · · · · · 25 APP Appointed to Neurology Today Editorial Board · · · · · ·25

Education & Research Apply for Education Research Opportunities

by October 1 · · · · · · · · · · · 26 October 1 Is Application Deadline for 2019 Research Program Opportunities · · · · ·26 Take Advantage of Continuum for Comprehensive Review of Headache Disorders · · · · · · 27 ABPN to Offer Certification in Neurocritical Care · · · · · · 27 Careers · · · · · · · · · · · · · · · 29 Dates & Deadlines · · · · · · · · 30

Policy & Guidelines AAN Publishes Updated Disorders of Consciousness Guideline · · · · · · · · · · · · · 20

Review and submit comments at AAN.com/practice-guidelines/home/ public-comments.

A record number of attendees participated in the AAN’s Sports Concussion Conference in Indianapolis. The conference also attracted significant media coverage. David W. Dodick, MD, FAAN, was interviewed by WXIN in Indianapolis, and AAN press releases on abstracts presented at the conference were covered by the Washington Post, US News & World Report, MedPage Today, and hundreds of other publications across the country. 

Capitol Hill Report · · · · · · · · 21

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

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

Contact Information

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

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

AANnews is published monthly by the American Academy of Neurology for its 34,000 members worldwide. Access this magazine and other AAN publications online at AAN.com/go/elibrary.

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

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

President’s Column

How Well Is the AAN Meeting Your Needs?

The AAN strives to provide innovative resources to help all of our members be successful across all career stages, focus areas, and professional settings. When asked in 1982 about the formation of the AAN and the needs it would fulfill for neurologists, Dr. Adolph L. Sahs, who helped Dr. A.B. Baker launch the Academy seventy years ago, replied, “[Our] organization took upon itself to include anyone who was really interested in the practice of neurology and in the academic field and in research and bring them into an organization in which they could have a forum and the chance to belong and to have an outlet.”

This broad and inclusive philosophy to engage practitioners and researchers in one organization continues today. Although that may have sounded fairly simple back then, over the years the AAN has expanded to include multiple constituents and the needs of our members have greatly grown in number and complexity since 1948.

Your AAN strives to not only meet your needs but anticipate them as well. We must provide value and be an indispensable part of your professional life. To make sure we’re on the right track, we often ask for your feedback and opinions that greatly matter to us.

The Academy recently completed the 2018 Needs Assessment Survey of US and international members from all dues-paying member types. We are pleased that more than 2,400 of you responded and I am proud to share these highlights with you: The top eight reasons why individuals choose to belong to the AAN are: 1. Access to education resources for professional knowledge and growth 2. Ability to earn continuing education credits for licensure or certification 3. Up-to-date information on scientific research 4. Access to clinical practice guidelines 5. Latest news relevant to the profession 6. Free or reduced rates for AAN products, services, or conferences 7. Representation of member interests at the US federal and state levels 8. Ability to network with other neurology professionals The survey analyzes membership loyalty, as determined by an individual’s responses to three survey questions: (1) likelihood to recommend an AAN membership to others, (2) likelihood to renew his/her AAN membership, and (3) perceived value of an AAN membership. The 2018 loyalty profile for AAN membership is 63 percent loyal, 29 percent neutral, and 8 percent vulnerable, which is a significant improvement from the 2015 profile of 58 percent loyal, 26 percent neutral, and 16 percent vulnerable.

These results are impressive for a membership of our size which includes 91.5 percent of all US neurologists as members.

When US respondents were asked about legislative/regulatory efforts overall, they had a significantly more favorable opinion in 2018 compared to 2015 (up 8 percentage points).

The excellent and very good ratings for quality improvement have increased significantly from 49 percent in 2015 to Sacco 56 percent in 2018.

All areas of the AAN Annual Meeting that were tested in both 2015 and 2018 saw a significant increase in performance ratings in the 2018 study.

Most respondents (79 percent) believe that they receive just the right amount of email communications from the AAN. These results inform us that we are on the right track and meeting your needs. But, your AAN is never complacent and always thinking of new ways to fulfill our mission. We constantly focus on quality improvement by getting feedback from our members, listening to our volunteers on committees, and implementing recommendations from workgroups, task forces and leadership groups. Our strategy is to always strive for being better, improve existing products, and build and create new ones to meet your needs. We are driven to identify ways we can continue to have a positive impact on your career.

One area where the Academy is ever vigilant is any attempt to reduce fair reimbursement to our members. Our lobbying voices are more active and stronger than they have ever been. If you have been following the news on AAN.com, Capitol Hill Report, and on the front page of this issue of AANnews, you are aware that CMS is proposing changes in the Medicare fee schedule. I want to assure you that we are working swiftly and tirelessly in Washington, DC, to prevent these suggested changes. We have been meeting with officials at CMS and key members of Congress to persuade them to properly value your time with your patients and let you do what you do best. We are submitting our formal comments to CMS this month. We will continue to work diligently, alone and with our partner organizations, to press CMS to make the right decision before their final rule in November.

This is just one of the many ways the AAN strives to make itself indispensable to your professional life. As we come up to our membership renewal season, I hope you will keep in mind these efforts and the multitude of tools and resources we make available to you on a daily basis. We greatly appreciate and value your input as we continually find ways to meet your needs in these challenging times. We are 34,000 members strong, something I’m sure Abe Baker and Ady Sahs never dreamed of 70 years ago when they formed the AAN. But they knew our members have needs only the AAN could answer. That’s what matters, and that’s why we are here. Yesterday, today, and tomorrow.

A significantly greater percentage of respondents rated the value of their AAN membership as excellent or very good in 2018 (68 percent) compared to 2011 (58 percent) and 2015 (62 percent).

Compared to those in a clinical practice, respondents in an academic practice place a higher priority on belonging to the AAN for the ability to network, while those in a clinical practice place a higher priority on ability to earn continuing education credits compared to academicians.

Performance ratings for NeuroSAE® and NeuroTracker™ have increased significantly since 2015.

4

AANnews • September 2018

Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN rsacco@aan.com @DrSaccoNeuro on Twitter

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Through Their Eyes

Recollections of Past AAN Presidents Thomas R. Swift, MD, FAAN AAN President 2005−2007 AANnews® celebrates the history of the Academy during its 70th anniversary with a series of interviews of past presidents. The following excerpt is from a 2017 interview with Thomas R. Swift, MD, FAAN (TRS), conducted by AANnews editor Tim Streeter (TS).

TS: You started Neurobowl®?

TRS: Yeah. I started Neurobowl…the reason I did it was, when I was an examiner for the boards, at that time, the candidate had to examine a live patient. I walked into the room, and the patient was sitting on the bed, and I walked in with a candidate, and I looked at this young girl, and I knew she had Huntington’s disease. She hadn’t moved, hadn’t talked, and I said to myself, “How did I know that?” And I realized I didn’t know how I knew that. She did have Huntington’s disease.

But then I began to realize that many of the diagnoses I was making, I had no idea how I was doing it.

So, I said, “Well, I’m kind of a quirky guy, so maybe other people do know how they’re doing it.” So, I started talking to people. They had no idea how they were doing it. But they were doing it. And sometimes doing it in a split second. So, I started Neurobowl to try to get people up on the stage to make diagnoses, and then ask them how they made the diagnosis.

Well, they invariably say they don’t know how they did it.

The first year, it was a course. The first year, 250 people showed up, and I learned something from that. Our meeting has a lot to do with genetic tests and neurology and various technologies and imaging. But what people are really hungry for that come to this meeting is clinical neurology. Because when they go to their offices, they’re faced with live patients.

They have to come up with the diagnosis and some kind of treatment options, and some kind of testing, and this kind of thing. So, we put on Neurobowl, and it just grew like Topsy.

It got bigger and bigger and bigger, and now it’s completely out of control. But it led to our publication of our book, Instant Neurological Diagnosis.

There’s a book for laypeople called Blink. Maybe you’re familiar with it, written by Malcolm Gladwell. But his book came out after Neurobowl started, about 10 years after Neurobowl started. I’ve tried to get him to come to this meeting, because what he’s talking about in that book is exactly what happens when a doctor’s making a diagnosis.

You don’t know where it comes from. It comes from something deep in your brain, but it’s also true in your everyday life.

When you see somebody, and you meet somebody, you have an affinity for them. You like them. You don’t know why you like them or you don’t like them. And you’re usually right.

Malcolm Gladwell uses the experience of the World Series of Poker. So, 10,000 people start playing. It’s in Las Vegas every year, and the winner wins $10 million or something.

You familiar with that?

6

AANnews • September 2018

TS: Yeah.

TRS: So, everyone’s getting the same cards, but every year it comes down to the final eight people, and they’re more or less the same people every year. He says the reason for that is that they make good decisions. So, what happens when you’re confronted with something, you have a feeling about it. This is good for me. This is not good for me. I like this. I don’t like this.

You don’t know where that comes from, but then your frontal lobes kick in and say, “Wait a second. Let’s analyze this.” And there may be some red flags or things like that. When those things come together, you make good decisions. And these people playing the World Series of Poker, if you see them, they’ve got hoods over their face. They’ve got dark glasses.

They have facial hair. Just the men.

And they don’t want—all this has to do with how you make

a decision, and the things that influence you are so subtle, you don’t know what they are. You never will know what they are, really. But this is what Neurobowl embodies, and that is, it really celebrates this very human function of our brains. That we’re able to do this. I put up a slide one time.

José Biller got it in a tenth of a second. A tenth of a second, he made the diagnosis.

That wasn’t unusual for him. To me, it’s a miracle of how the brain works, and how it’s so much better than any artificial intelligence you would ever have, because it takes so many things into account. Never so much as it does as when you’re making a diagnosis on a patient.

Visit AAN.com/view/AANhistory to read the complete transcript of Swift’s interview and learn about his experiences as one of the Academy’s leaders and his views on health care reform, prohibition of boxing, and more. 

AANnews • September 2018 7

Tools & Resources

Webinar Helps You Master Guidelines and Measures Quality measures and guidelines can be confusing and difficult, but their mastery can mean better patient care and higher value output. This webinar will reinforce best practices in quality improvement and coding to get the most for your work.

SEPT

Using Guidelines and Measures to Become a Better Neurologist September 25, 2018 12:00 p.m.–1:00 p.m. ET Deadline to Register: September 24 Faculty: Raissa Villanueva, MD, FAAN

25

Villanueva

You can purchase this single webinar for $99, or subscribe to the complete series of 2018 webinars for only $189—that’s less than $19 per webinar!

All webinars are now available in the new AAN Online Learning Center and feature: Convenient one-hour live webinar sessions from 12:00 p.m.–1:00 p.m. ET

Using Guidelines and Quality Measures to Become a Better Neurologist

On-demand access to webinar recording and presentation slides if you miss the live event 1 AMA PRA Category 1 Credit™ per webinar for physicians, or certificate of completion for non-physicians EdScience:Visit 18 Learning Mamagement System Pageand Horizontal> AAN.com/view/pmw18 to Ad—Half learn more register,ANor Placed in AANnews  contact Jessica Nickrand at jnickrand@aan.com.

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ONLINE LEARNING CENTER

NEW! Online Learning Cente Your hub for AAN continuing medical education AAN.com/view/LearningCenter

Join New EHR Synapse Online Community The AAN has created a new Synapse™ Online Community devoted to discussions and information sharing on electronic health records (EHR). Members can post questions and get advice from colleagues on all things EHR, whether it’s general information or related to a specific EHR software. Success stories can be shared for colleagues to implement in their own practices.

The community’s document library can be explored to discover additional helpful resources.

The EHR Synapse Online Community is a private community; join by emailing practice@aan.com. 

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IMPORTANT DATES AND DEADLINES Don’t miss these important dates for the 2019 AAN Annual Meeting, set for May 4-10, 2019 in Philadelphia.

Learn more at AAN.com/view/AM19 Abstract Submission Deadline: October 22, 2018 Awards Application Deadline: October 24, 2018

ADVANCING NEUROLOGY. ADVANCING YOU.

AANnews • September 2018 9

Tools & Resources

CMS Announces Proposed Rule for MIPS and Advanced APMs continued from cover

minimum participation in both MIPS and A-APMs and implemented a number of policies enabled by the Bipartisan Budget Act of 2018.

Along with this summary and other AAN resources at AAN.com/view/MACRA, members are encouraged to review CMS’ Quality Payment Program website at QPP.cms.gov, where CMS offers a fact sheet that provides details on this new program.

MIPS CMS will continue to measure performance for clinicians through MIPS in 2019, with payments based on those measures in 2021.

Eligible Clinicians For 2019, CMS proposed a new criterion for the low-volume threshold. To be excluded from MIPS, clinicians would need to have either $90,000 or fewer Part B allowed charges for covered professional services, provide care to 200 or fewer beneficiaries, or provide 200 or fewer covered professional services under the Physician Fee Schedule. Clinicians who meet one or two but not all of the criteria would be able to opt into MIPS. CMS also proposed new eligible clinician types including physical therapists, occupational therapists, clinical social workers, and clinical psychologists.

Performance Threshold Clinicians must achieve an overall MIPS score of 30 points to avoid a negative payment adjustment. This is up from 15 points in 2018. Those who achieve fewer than 30 points will face negative payment adjustments in 2021 of up to 7 percent; those who score above 30 points are eligible for a positive payment adjustment of up to 7 percent. CMS proposed to increase the threshold for “exceptional performance” from 70 to 80 points.

Performance Categories CMS will continue to measure clinicians’ performance in all four MIPS categories, each comprising a different percentage of an overall performance score which determines how the provider is paid.

Quality: 45 percent of the score (down from 50 percent in 2018). Starting in 2019, clinicians would be able to submit a single measure via multiple data submission mechanisms (e.g., Part B claims, QCDR, etc.) and be scored on the data submission with the greatest number of measure points.

CMS maintained policies around data completeness requirements (60 percent), the total quality measures required to achieve the maximum score, and definitions and lifecycles for topped out measures. Clinicians must report one year of data for this category.

10

AANnews • September 2018

Cost: 15 percent of the score (up from 10 percent in 2018).

CMS will continue to measure clinician performance on the Total Per Capita Cost and Medicare Spending Per Beneficiary measures. CMS also proposed to incorporate the eight episode-based cost measures developed by Acumen LLC and field tested in fall 2017.

Neurologists may be assessed on their performance on the Intracranial Hemorrhage or Cerebral Infarction measure. Clinicians do not need to submit any additional data for CMS to assess their Cost score and will be measured using one year of data.

Promoting Interoperability (formerly Advancing Care Information): 25 percent of score. CMS proposed a total overhaul of this category to emphasize the goal of supporting greater electronic health record (EHR) interoperability and patient access while aligning with the proposed new hospital requirements. CMS proposed to eliminate the base, performance, and bonus score requirements, which will be replaced by a new scoring methodology organized around four objectives: e-Prescribing, Health Information Exchange, Provider to Patient Exchange, and Public Health and Clinical Data Exchange. Starting in 2019, 2015-Certified EHR technology (CEHRT) is required. Clinicians must report data for 90 days for this category.

Improvement Activities: 15 percent of score. As in previous years, CMS requires most participants to attest to having completed four “medium-weighted” or two “high-weighted” activities for a minimum of 90 days to receive full credit. Small and rural practices do not need to report more than two activities to receive full credit.

In Year 3, CMS removed Improvement Activities that may be considered for a Promoting Interoperability bonus.

Clinicians must report data for 90 days for this category.

Note that if a clinician is scored on fewer than two performance categories, a final score equal to the performance threshold (30 points) will be assigned and the clinician will receive a payment adjustment of 0 percent.

Support for Small and Solo Practitioners CMS continued several flexibilities for small and solo practitioners (i.e., those with 15 or fewer clinicians) in Year 3 of the program.

CMS will continue to extend the option of virtual groups for those in practices with 10 or fewer clinicians. Established in 2018, eligible clinicians in these practices can come together to share the burden of reporting and pool performance to potentially compete for a higher overall performance score.

CMS will also continue to fund the QPP Small, Underserved, and Rural Support (QPP-SURS) program that provides free, regionally based technical assistance to those in practices with 15 or fewer clinicians. Learn more at QPP.cms.gov/about/small-underserved-rural-practices.

Finally, CMS will continue to offer 5 bonus points for those in practices with 15 or fewer clinicians. However, instead of applying to the overall MIPS score, CMS will apply the bonus to the Quality category.

Public Reporting MIPS performance will begin to be posted to Physician Compare. CMS proposed to not report Quality and Cost measures for the first two years of use in MIPS. CMS will include an indicator on Physician Compare for “successful” MIPS performance starting in Year 3.

Advanced Alternative Payment Models In 2019, CMS will continue to provide bonus payments to qualified participants in Advanced Alternative Payment Models (A-APM). A-APMs are models that require use of Certified EHR Technology, leverage quality metrics similar to those used in MIPS, and under which clinicians accept both risk and reward for providing coordinated, high-quality care.

Starting in Year 3, CMS would require that at least 75 percent of clinicians in each APM entity use CEHRT and amended the quality criteria to state that at least one measure upon which the A-APM bases payment must be on the MIPS final list, endorsed by a consensus-based entity, or otherwise determined to be evidence-based, reliable, and valid by CMS. CMS maintained the revenue-based nominal amount standard for risk in A-APMs at 8 percent through 2024.

CMS also streamlined definitions for A-APMs criteria and Other Payer Advanced APM criteria to reduce confusion and burden.

It also proposed flexibilities for the All-Payer Combination Option and Other Payer Advanced APMs, introduced in 2018, for non-Medicare payers to participate in the QPP. CMS did not address the Physician-focused Payment Model Technical Advisory Committee (PTAC) in the Year 3 proposed rule.

AAN Response The AAN is currently preparing a comment letter in reaction to changes to the QPP, which we will submit to CMS on September 10, 2018. In particular, the AAN is concerned to see that CMS is including the largely untested episode-based cost measures in the Cost Category of MIPS while increasing the weight of this category.

Additionally, the AAN notes that the NPRM included no mention of the PTAC, which was designed to be a key resource to allow physicians and stakeholders to develop and engage in APMs, including physician-focused payment models (PFPMs).

Specialty societies like the AAN have invested significant resources to developing these models, none of which have been implemented or otherwise pursued to date. CMS should provide additional guidance on PFPMs and PTAC to ensure societies are designing models that are consistent with CMS priorities.

Finally, the AAN would like to see positive payment adjustments in the MIPS reflect the amount of time and effort physicians are putting into program implementation. In the 2017 Performance Year final reports, AAN physicians who achieved very high MIPS scores discovered that they had received only modest positive payment adjustments. At current returns, the work involved only offsets the revenue, and, in fact, many practices will be accepting a loss after accounting for the resources required to implement quality improvement systems.

The AAN will continue to educate members about how to maximize their MIPS score in 2018 and in future programmatic years. Remember to visit AAN.com/view/MACRA, or email MACRA@aan.com with any questions. 

AAN.com/view/MACRA

AANnews • September 2018 11

Tools & Resources

State and Federal Legislative Update: Medical Marijuana and Cannabis Thirty-one states, the District of Columbia, Guam, and Puerto Rico allow for comprehensive public medical marijuana and cannabis programs, which protect users from criminal penalties, allow access to a variety of products and strains, and enable smoking or vaporizing of products. Separately, 15 states allow for the use of cannabidiol products for medical purposes.

While each of these states has enacted its own laws, marijuana remains a Schedule I drug at the federal level, which makes distribution of any form of the drug illegal.

Members of Congress have introduced more than 100 pieces of legislation on medical marijuana and are working on proposals that would make it easier for physicians to participate in medical marijuana research. Several bills focus on researching medical cannabis for veterans seeking care in US Department of Veterans Affairs facilities, while others promote availability for patients with conditions like post-traumatic stress disorder or non-cancer chronic pain to participate in clinical trials for medical marijuana therapies. The AAN closely monitors activity at the state and federal levels to keep members informed of changes to laws that impact prescribers and new medical marijuana research opportunities for physicians.

AAN Member Advocacy On May 21, 2018, AAN member Jack Tsao, MD, DPhil, FAAN, testified at a field hearing in support of the Medical Cannabis Research Act (H.R. 5634), a bill that aims to improve research on medical cannabis and allows health care providers of the Department of Veterans Affairs to provide recommendations to veterans regarding participation in federally approved cannabis clinical trials. Since Tsao is a US Navy neurologist, his remarks focused on whether VA doctors can refer patients to federal clinical trials and medical cannabis’s potential as a treatment for veterans’ health issues.

Recent Developments The Food and Drug Administration (FDA) recently approved its first medication derived from purified cannabidiol. Epidolex, an oral therapy, is approved to treat Lennox-Gastaut syndrome and Dravet syndrome. In his announcement of the approval, FDA Commissioner Scott Gottlieb, MD, noted, “because of the adequate and controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.”

The AAN updated its Position Statement on Medical Marijuana in 2018 to emphasize the importance of research to determine the safety and efficacy of medical marijuana. The approval process for Epidolex aligns with recommendations from the AAN position that each product and formulation of cannabis used in treating medical conditions follow scientific processes like those required by the FDA. The AAN position also supports the Drug Enforcement Agency (DEA) rescheduling marijuana from a Schedule I drug to a Schedule II in order to allow rigorous scientific research and determine the safety and potential benefits of other products like Epidolex.

Although Epidolex has been approved by the FDA, it is still considered a Schedule I drug. The FDA has recommended that the DEA reschedule Epidolex to a Schedule II drug so that it may be dispensed and prescribed for patients with Lennox-Gastaut syndrome and Dravet syndrome. The DEA has until September 23 to reschedule Epidolex to Schedule II or Schedule III. The agency could also decide to reschedule cannabidiol entirely as part of this process to promote further research and drug development.

Read the AAN’s position statement on Use of Medical Marijuana for Neurologic Disorders at AAN.com/ policy-and-guidelines/policy/positionstatements/medical-marijuana. 

Rep. Matt Gaetz (R-FL), the sponsor of the Medical Cannabis Research Act (H.R. 5634), left, and AAN member Jack Tsao, MD, DPhil, FAAN.

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AANnews • September 2018

Editorial: Waiting for Placement: Waiting for Solutions John Ney, MD, MPH The Burnout Patient Former AAN President Stephen M. Sergay, MB BCh, FAAN Editorial: Patients Are Harmed by Physician Burnout James L. Bernat, MD, FAAN Neurology: Clinical Practice, published six times a year, is available in print (for US members only), online, and for the iPad and Android. Visit Neurology.org/cp for more information. 

Volume 8,

Number 4,

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Post-Acute Care Discharge Delays for Neurology Inpatients: Opportunity to Improve Patient Flow Debra E. Roberts, MD, PhD

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The AAN’s Neurology® Clinical Practice delivers insightful articles on a range of practice-related topics, and the August/September issue is no exception. Readers will find much to inform and inspire them, including:

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Neurology: Clinical Practice Offers Wealth of Practical Insights

PODCAST CENTRAL Your Guide to New and Recent AAN Podcasts

Neurology Podcasts

Visit Neurology.org/podcast to listen to Neurology ® podcasts and earn 0.5 AMA PRA Category 1 CME Credits™ by answering the multiple-choice questions in the online podcast quiz.

Interviews based on articles from Neurology ® Clinical Practice, Neurology ® Genetics, and Neurology ® Neuroimmunology & Neuroinflammation are excluded from the CME program.

Available by September 1 ed clinical

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pediatric a exchange in cacy of plasm Safety and effi 327 tis eli my se transver behavior 331 REVIEW cide-related drugs and sui Antiepileptic iveness RESEARCH arative effect on and comp olimod 292 Discontinuati ng fi d an te fumara of dimethyl

RESEARCH

Neurology: Practice Guideline Recommendations Summary: Disorders of Consciousness Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living and Rehabilitation Research Jeffrey M. Burns, MD, MS, and Joseph T. Giacino, PhD Neurology: Dual Antiplatelet Therapy Pretreatment in Intravenous Thrombolysis for Acute Ischemic Stroke Andrew M. Southerland, MD, MSc, and Andrei V. Alexandrov, MD Neurology: Cerebello-spinal tDCS in Ataxia: A Randomized, Double-blind, Sham-controlled, Crossover Trial Jeffrey B. Ratliff, MD, and Barbara Borroni, MD Neurology: Antiepileptic Drug Clearances During Pregnancy and Clinical Implications for Women with Epilepsy Lara Vanessa Marcuse, MD, BA, and Page B. Pennell, MD Neurology: Clinical Practice: Persistent Focal Enhancement of the Cisternal Segment of Oculomotor Nerve in Ophthalmoplegic Migraine Heather D. Harle, MD, and Ihtesham A. Qureshi, MD 

AANnews • September 2018 13

BECAUSE RELAPSING MS AFFECTS MORE THAN HER. . .

NEWLY DIAGNOSED PATIENTS DESERVE THE #1 PRESCRIBED ORAL RMS THERAPY 1,2*†

Indication

Tecfidera® (dimethyl fumarate) is indicated for adults with relapsing forms of multiple sclerosis.

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 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.

Clinically significant cases of liver injury have been reported in

49

38

IN THE DEFINE‡ CLINICAL TRIAL, PATIENTS WERE:

%

LESS LIKELY TO EXPERIENCE

A RELAPSE3§ TECFIDERA: 27% (n=410) Placebo: 46% (n=408) [P<0.0001] Based on proportion of patients relapsed (PPR)||

%

LESS LIKELY TO EXPERIENCE

DISABILITY PROGRESSION3¶

TECFIDERA: 16% (n=410) Placebo: 27% (n=408) [P=0.0050]

84% OF PATIENTS IN THE DEFINE TRIAL WERE FREE OF DISABILITY PROGRESSION VS 73% OF PLACEBO PATIENTS3

IN A SEPARATE ANALYSIS, THE NEWLY DIAGNOSED PATIENTS FROM THE PIVOTAL TRIALS WERE:

71

%

LESS LIKELY TO EXPERIENCE

DISABILITY PROGRESSION1

TECFIDERA: 0.073 (n=221) Placebo: 0.233 (n=223) [P<0.0001]

STUDY DESIGN: This post hoc analysis of integrated data from DEFINE and CONFIRM# was conducted to examine the efficacy and safety of TECFIDERA in 678 newly diagnosed patients (59% of patients in DEFINE and 71% in CONFIRM were treatment-naive4,5). The newly diagnosed population included patients who had been diagnosed with RRMS within 1 year prior to study entry and were naive to MS disease-modifying therapy. The analysis included clinical and neuroradiological efficacy endpoints as well as basic safety data, or adverse events. This study was not designed in advance to analyze the endpoints presented in the subgroup of newly diagnosed patients.1 Most common adverse events reported in patients receiving TECFIDERA compared with placebo included flushing, nasopharyngitis, headache, diarrhea, nausea, upper abdominal pain, and abdominal pain.3

Important Safety Information (cont’d)

patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.

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

Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.

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.

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%).

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.

For additional Important Safety Information, please see adjacent Brief Summary of full Prescribing Information. *TECFIDERA is approved for adult patients only. † Based on prescriptions. ‡ Determination of Efficacy and Safety of Oral Fumarate in RelapsingRemitting MS.4 § Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted for at least 24 hours and were accompanied by new objective neurologic findings.4 || PPR is the percentage of patients who had one or more relapses over the course of the trial.4 ¶ Disability progression is defined as at least a 1-point increase from baseline EDSS of ≥1.0, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.3 # Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis.5 References: 1. Gold R, Giovannoni G, Phillips JT, et al. Mult Scler.

2015;21(1):57-66. 2. IMS data September 27, 2013-December 8, 2017.

3. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 4. Gold R, Kappos L, Arnold DL, et al. N Engl J Med. 2012;367:10981107. Erratum in: N Engl J Med. 2012;367:2362. 5. Fox RJ, Miller DH, Phillips JT, et al. N Engl J Med. 2012;367:1087-1097. Erratum in: N Engl J Med. 2012;367:1673. © 2018 Biogen. All rights reserved. 02/18 TEC-US-2505

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

2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Discontinuation of TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of TECFIDERA with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3)].

TECFIDERA should be swallowed whole and intact. TECFIDERA should not be crushed or chewed and the capsule contents should not be sprinkled on food. TECFIDERA can be taken with or without food.

2.2 Blood Tests Prior to Initiation of Therapy Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy [see Warnings and Precautions (5.3)].

Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with TECFIDERA [see Warnings and Precautions (5.4)].

3 DOSAGE FORMS AND STRENGTHS TECFIDERA is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with “BG-12 120 mg” in black ink on the body. The 240 mg capsules have a green cap and a green body, printed with “BG-12 240 mg” in black ink on the body.

4 CONTRAINDICATIONS TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS 5.1 Anaphylaxis and Angioedema TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue.

Patients should be instructed to discontinue TECFIDERA and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.

5.2 Progressive Multifocal Leukoencephalopathy 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 for 4 years while enrolled in a clinical trial. During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years) while taking TECFIDERA [see Warnings and Precautions (5.3)].

The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly.

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

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

other MS medications associated with PML. Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis. It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients.

5.3 Lymphopenia TECFIDERA may decrease lymphocyte counts. In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. Six percent (6%) of TECFIDERA patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with TECFIDERA or placebo, respectively.

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) [see Warnings and Precautions (5.2)]. In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5x109/L with continued therapy. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

Obtain a CBC, including lymphocyte count, before initiating treatment with TECFIDERA, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of TECFIDERA in patients with lymphocyte counts less than 0.5x109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if TECFIDERA is discontinued or interrupted due to lymphopenia. Consider withholding treatment from patients with serious infections until resolution. Decisions about whether or not to restart TECFIDERA should be individualized based on clinical circumstances.

5.4 Liver Injury Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death.

However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.

Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials [see Adverse Reactions (6.1)].

Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.

5.5 Flushing TECFIDERA may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials, 40% of TECFIDERA treated patients experienced flushing. Flushing symptoms generally began soon after initiating TECFIDERA and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued TECFIDERA for flushing and <1% had serious flushing symptoms that were not lifethreatening but led to hospitalization. Administration of TECFIDERA with food may reduce the incidence of flushing. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3)].

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere 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].

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea.

Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 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 from 769 patients treated with TECFIDERA 240 mg twice a day and 771 placebo-treated patients.

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

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

TECFIDERA N=769 %

Placebo N=771 %

40 18 14 12 9 8 8 6 5 5 4 2

6 10 11 9 5 4 3 4 1 3 2 <1

Gastrointestinal TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with TECFIDERA. Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials.

Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both TECFIDERA and placebo and were balanced between groups. There were no elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with TECFIDERA or placebo.

Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.

Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received TECFIDERA and been followed for periods up to 4 years with an overall exposure of 4603 person-years. Approximately 1162 patients have received more than 2 years of treatment with TECFIDERA. The adverse reaction profile of TECFIDERA in the uncontrolled clinical studies was consistent with the experience in the placebo-controlled clinical trials.

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

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

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

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

Risk Summary There are no adequate data on the developmental risk associated with the use of TECFIDERA in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. [see data].

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

Data Animal Data In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day. In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD. Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD. 8.2 Lactation Risk Summary There are no data on the presence of DMF or MMF in human milk.

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

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

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

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

10 OVERDOSE Cases of overdose with TECFIDERA have been reported. The symptoms described in these cases were consistent with the known adverse event profile of TECFIDERA. There are no known therapeutic interventions to enhance elimination of TECFIDERA nor is there a known antidote. In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Inform patients that they will be provided two strengths of TECFIDERA when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow TECFIDERA capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration (2.1)].

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)].

PHARMA AD

Pregnancy and Pregnancy Registry Instruct patients that if they are pregnant or plan to become pregnant while taking TECFIDERA they should inform their physician.

Encourage patients to enroll in the TECFIDERA Pregnancy Registry if they become pregnant while taking TECFIDERA. [see Use in Specific Populations (8.1)].

41347-09 Manufactured by: Biogen Cambridge, MA 02142 TECFIDERA is a trademark of Biogen. Š 2013-2017 Biogen 2/18

Tools & Resources

AAN Strongly Opposes Proposed Changes to E/M Payments continued from cover reduced, the AAN strongly opposes the proposed collapsed payments for evaluation and management (E/M) services.

“As chair of the Medical Economics and Management Committee, I oppose the reduced E/M payments and I want to assure AAN members that we are behind you,” said Orly Avitzur, MD, MBA, FAAN. “The AAN will work with our coalition partners and lead the way in advocacy with CMS. We will respond to the proposed regulation and keep members informed of our efforts in advance of a final rule being released around November 1. We will analyze how the change might impact our members, and most importantly, our patients. Devaluing the time that neurologists spend with patients is not an acceptable path forward.”

Below are highlights of changes within the proposed fee schedule that affect neurology.

E/M Updates In the proposed rule, CMS proposes a new payment structure for E/M services that collapses the level 2 through level 5 office codes into a single payment rate. This proposal represents a dramatic shift in practice, touting administrative relief for overburdened neurologists, however the financial impact likely is not justified for neurologists by the administrative relief CMS projects. Visit AAN.com/view/19EM for a more detailed table of these proposed changes.

For most neurologists, E/M represents the majority of service provided, and advocating for better cognitive reimbursement has been an Academy priority for many years. The proposal recognizes the additional complexity of patients seen by neurologists and the need to improve payment accuracy and creates an add-on code to reflect the additional visit complexity inherent to E/M associated with neurology. While the AAN views this recognition as a step in the right direction, it is undermined by the proposed single payment rate for level 2 through level 5 office codes.

CMS proposes compressing all level 2–5 office visits into one payment―not differentiating between the amount of work and time for a simple patient visit vs. the more complex, lengthy visits with patients with multiple chronic conditions. CMS proposes new add-on codes to supplement the low E/M payments, but overall reimbursement will still be lower than what it is today.

The AAN is doing several things to oppose the E/M payment change.

On the regulatory front, the AAN is writing a comment letter strongly opposing the E/M change. The AAN plans to meet with CMS and other leadership at Health and Human Services. We also are working with coalition partners to comment to CMS in opposition. Legislatively, the AAN is working with other specialty societies on the Hill. We are bringing the AAN’s position to Congress and getting members to join our cause, asking them to sign a letter that will be delivered to CMS opposing the E/M payment change. We also are reaching out to patient groups asking them to mobilize on behalf of their patients in opposition to this change.

Acute Stroke Telehealth Reimbursement Thanks to AAN advocacy efforts, Congress recently removed the restrictions on the geographic locations and the types of originating sites where acute stroke telehealth services can be furnished. CMS seeks to implement this law by proposing a new modifier that would be used to identify acute stroke telehealth services.

The practitioner and, as appropriate, the originating site, would add this modifier when clinically appropriate to the HCPCS code when billing for an acute stroke telehealth service or an originating site facility fee, respectively.

Practitioners would be responsible for assessing whether it would be clinically appropriate to use this modifier with codes from the Medicare telehealth list. By billing with this modifier, practitioners would be indicating that the codes billed were used to furnish telehealth services for diagnosis, evaluation, or treatment of symptoms of an acute stroke.

CMS believes that the adoption of a service level modifier is the least administratively burdensome means of implementing this provision for practitioners, while also allowing CMS to easily track and analyze utilization of these services.

Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging Changes to Be Implemented in 2020 CMS proposes a revision to the significant hardship criteria in the AUC program. The agency will include: 1) insufficient internet access; 2) electronic health record (EHR) or clinical decision support mechanism (CDSM) vendor issues; or 3) extreme and uncontrollable circumstances. CMS is additionally proposing to add independent diagnostic testing facilities to the definition of applicable setting under this program.

CMS also proposes to allow AUC consultations, when not personally performed by the ordering professional, to be performed by auxiliary personnel.

CMS is soliciting comments on the data elements and thresholds that CMS should consider when identifying outliers.

Part B Drugs Proposal According to the proposal, physician-administered drugs in Medicare Part B would be paid for at the wholesale acquisition cost plus 3 percent for 2019. Currently, new drugs are reimbursed at the wholesale acquisition cost plus 6 percent. The wholesale acquisition cost is an estimate of the manufacturer’s list price for a drug to wholesalers or direct purchasers but does not include discounts or rebates.

This change would only be for the first three months a drug is on the market. After that date, when there is average sales price data, Part B drugs would be paid for according to the average sales price plus 6 percent.

To learn more, visit AAN.com/view/MedicareNews. 

AANnews • September 2018 19

Policy & Guidelines

AAN Publishes Updated Disorders of Consciousness Guideline The AAN, together with the American Congress of Rehabilitation Medicine (ACRM) and the National Institute on Disability, Independent Living, and Rehabilitation Research, published Practice Guideline Update: Disorders of Consciousness on August 8, 2018, in Neurology ® and in Archives of Physical Medicine and Rehabilitation online ahead of print. The guideline appears in the September 4, 2018, print issue.

This guideline updates the 1995 AAN practice parameter regarding the persistent vegetative state and the 2002 case definition for the minimally conscious state. In this update, all but one of the 18 recommendations focus on people with a prolonged disorder of consciousness (DoC), defined as DoC lasting 28 days or longer.

Spanning diagnosis, natural history, prognosis, and care management of adults and children with a DoC, the guideline recommends that clinicians refer patients with DoC who have achieved medical stability to settings staffed by multidisciplinary

Summary of Evidence-based Guideline for Families and Caregivers

Disorders of Consciousness

Experts from the AAN, American Congress of Rehabilitation Medicine, or ACRM, and the National Institute on Disability, Independent Living, and Rehabilitation Research, or NIDILRR, carefully reviewed the available scientific studies on diagnosing and caring for people with disorders of consciousness, or DoC. This guideline looked at the evidence mainly for people with a DoC lasting 28 days or longer.

Overview Consciousness is a state of being awake and aware of one’s self and surroundings. A conscious person is aware of things through thoughts and the five senses: sight, hearing, smell, taste, and touch. A person with a DoC has trouble being awake, or being aware, or both.

Some people with a DoC might benefit from available tests and treatments. For them, an incorrect diagnosis can lead to inappropriate care decisions and poor health outcomes.

People who have had a DoC for 28 days or longer after a brain injury need ongoing specialized health care provided by experts. For these patients, health outcomes differ greatly. Some of these people may be permanently unconscious. Many will have severe disability and need help with daily functions.

Others will eventually be able to function on their own, and some will be able to go back to work.

Summary of Evidence-based Guideline for Clinicians

Practice Guideline Update: Disorders of Consciousness

A person can have a DoC because of a severe brain injury. This is an event that causes serious problems with the brain’s ability to sense, understand, and respond to the person’s internal feelings and surroundings.

There are two main types of severe brain injury: • Severe brain injury from trauma—This happens because of physical injury.

Examples are falls, car accidents, andThis head in sports. is ainjuries summary of the publication, “Practice guideline recommendations: Disorders of consciousness,” which was developed through a collaboration • Severe brain injury from disease or illness—This happens whenofaNeurology health problem of the American Academy (AAN), the American Congress of Rehabilitation Medicine (ACRM), and the National Institute on Disability, affects important systems in the body.

This sometimes or stops oxygen Independent Living,limits and Rehabilitation Research (NIDILRR). This article was published in Neurology ® and in Archives of Physical Medicine and Rehabilitation from reaching parts of the brain. Examples of these problems online on Augusthealth 8, 2018, and in are printdifficulty on September 4, 2018.1 breathing, heart attack, stroke, and brain bleed.

Please refer to the full guideline at AAN.com/guidelines for more information, including descriptions of the processes for classifying Diagnosing DoC in Adults evidence, deriving conclusions, and making recommendations, and for details concerning upgraded or downgraded recommendations.

Diagnosing a DoC accurately can be difficult. But an accurate diagnosis early after the brain injury is very important. It may help to understand better what care your loved one needs and what health outcomes to expect over time.

Disorders of Consciousness (DoC) Practice Recommendations

To get the correct diagnosis, the clinician should do a thorough evaluation. Then, the clinician should repeat the evaluation several times early in recovery— Unless otherwise noted, all recommendations specifically apply to the population addressed in this guideline (individuals with prolonged DoC, that is, especially during the first three months after brain injury.

DoC lasting 28 days or longer).

In fact, evaluations should be repeated until your loved one’s condition becomes stable. Then, your loved one’s condition should continue to be retested and watched over time.

Recommendations Concerning the Adult Population Predicting Health Outcomes for DoC in Adults

This guideline looked at the evidence mainly for people with Recommendation 1 a DoC lasting 28 days or longer after a brain injury. For these people, health outcomes differ greatly.

Rationale Some people with DoC will never recover or will recover only a basic level of conscious awareness. An example of basic awareness is when someone Our systematic review is only able to hold eye contact with other people in the room.has highlighted the complexities of caring for patients with a prolonged DoC (i.e., lasting 28 days or longer) Some of those who are severely disabled early stage, after injury and need some prognosis, help daily will some ability to function normally. This includes being able at every including diagnosis, andregain treatment. to communicate, do self-care activities,Such and patients interact with others. may be misdiagnosed due to confounding

neurologic deficits2 or inexperience in examining patients for subtle signs of consciousness.3 Accurate diagnosis is important to educate families about patients’ level of consciousness and function, to inform prognostic counseling, and to guide AAN.com treatment decisions. Knowledge gaps often lead to over- or under-estimation of prognosis by nonspecialists.4 In addition, patients with prolonged DoC frequently experience significant medical complications that can slow recovery and interfere 5 with treatment interventions. In view of this risk, patients are likely to have a better chance for recovery if care is provided in a specialized setting managed by clinicians who are knowledgeable about the risks associated with DoC and are capable of initiating timely treatment. This is supported by findings from a large retrospective trauma registry which found that cumulative mortality at three years post discharge is significantly lower for patients discharged to home or inpatient rehabilitation facilities than those discharged to skilled nursing facilities, even after adjusting for covariates.6 In the context of these diagnostic, prognostic, and treatment considerations, care for patients with prolonged DoC may benefit from a team of multidisciplinary rehabilitation specialists, which may include neurologists, psychologists, neuropsychologists, physiatrists, physical therapists, occupational therapists, speech pathologists, nurses, nutritionists, internists, and social workers.

Clinicians should refer patients with DoC who have achieved medical stability to settings staffed by multidisciplinary rehabilitation teams with specialized training to optimize diagnostic evaluation, prognostication, and subsequent management, including effective medical monitoring and rehabilitative care.

AAN.com

20

AANnews • September 2018

“The guideline panel was pleased to find evidence indicating greater frequency of recovery of consciousness than previously thought, with individuals in nontraumatic VS/UWS recovering consciousness after three months and individuals in traumatic VS/UWS after 12 months,” said guideline author Doug Katz, MD, FAAN, president of the ACRM. “These findings led the panel to recommend that the term ‘permanent vegetative state’ be replaced with ‘chronic vegetative state,’ which is in keeping with other disease states that have chronic phases.”

Clinicians must identify patient and family preferences early to help guide the decision-making process for prolonged DoC cases.

The following information is a summary of the evidence from those studies and other key information.

Level B

Furthermore, new guidance is provided on treatment approaches, recommending that amantadine 100 to 200 mg twice daily, if not contraindicated, be prescribed for traumatic vegetative state/unresponsive wakefulness syndrome (VS/ UWS) or minimally conscious state between four and 16 weeks postinjury to hasten functional recovery and reduce disability degree early in the recovery phase.

Of note, the guideline makes the following strong recommendations:

The American Academy of Neurology, or AAN, is the world’s largest association of neurologists and neuroscience professionals and is dedicated to promoting the highest quality patient-centered neurologic care. Neurologists are doctors who identify and treat diseases of the brain and nervous system.

Causes of DoC

teams with specialized training in diagnosis and management of DoC, makes recommendations for diagnostic testing to help reduce the occurrence of incorrect diagnosis (currently estimated at up to 40 percent), and clarifies prognosis and longterm outcome.

Clinicians must counsel family members to seek help in establishing care goals and completing forms regarding medical decision-making; applying for disability benefits; and starting estate, caregiver, and long-term care planning.

Clinicians must avoid statements that suggest a universally poor prognosis for patients with a DoC in the first 28 days after injury, as long-term outcomes are more positive than previously thought.

Read the guideline and access PDF summaries for clinicians and patients and a presentation slide set at AAN.com.

For more information, contact guidelines@aan.com or (612) 928-6069. 

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

Below are some recent highlights.

AAN Achieves Commercial Payer Advocacy Success

AAN Submits Comments on Stark Law

The Payment Policy Subcommittee met with Cigna to express concern over the intraoperative neurophysiological monitoring (IONM) reimbursement policy that went into effect in early 2018. Cigna’s policy bundled IONM reimbursement so that professional services were included as part of the facility fee.

The AAN submitted comments in response to a recent request for information from CMS aimed at reducing Stark Law-related regulatory burden on alternative payment models and other novel financial arrangements.

Cigna appreciated the opportunity to speak with our member experts about their policies. As a result of conversations with the AAN and other parties, Cigna removed the new IONM policy and reinstated its previous IONM policy.

This is part of ongoing efforts by the Payment Policy Subcommittee to advocate for our members with commercial payers.

In the comment letter, the AAN asked CMS to examine its current regulatory authority under which it could craft an alternative payment model-specific exception to the Stark Law. If CMS determines that it does not have the regulatory authority needed to craft such an alternative, the AAN asked that key terms in existing exceptions be defined to accommodate the development of new alternative payment models.

These comments are part of the AAN’s continued effort to advocate for decreased regulatory burden on physicians during the transition to value-based care. 

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AANnews • September 2018 21

Conferences & Community

Participant Credits Diversity Leadership Program with Reducing Burnout, More Burnout. It’s a word—a feeling—that is increasingly prevalent in the medical field, with neurologists experiencing among the highest rates. While many factors contribute to it, one AAN Leadership Program participant specifically credits the critical thinking, skills, and knowledge he gained from the Diversity Leadership Program with helping him combat this serious issue.

“I feel participation in the Diversity Leadership Program and my subsequent involvement in the Academy have helped decrease my burnout,” said 2015 graduate Roderick C. Spears, MD, FAAN, “which is ironic, I think, because it has actually required more energy and time.”

But the added time has come with great payoff, according to Spears, who is a neurologist at the University of Pennsylvania specializing in headache medicine. “It has been encouraging to participate in the process of changes occurring in the field and practice of neurology. I have been more proactive in my practice dealing with change and growth, such as recently adding an advanced practice provider. And I was selected to be on the Clinical and Professional Services Committee, which meets quarterly with the executive director and medical directors to discuss important matters affecting our division here at Penn.”

Discovering his own strengths—and weaknesses—and learning how to assess others through the program’s Insight Training was one of the highlights for Spears, and it provided important principles that he applies on a daily basis. “My single greatest accomplishment has been being selected to act as a liaison between the two departments I am a part of and report to the executive director and chair of my department on overlapping concerns.”

Spears also feels his Diversity Leadership Program experience primed him for his role on the AAN Practice Committee. “[I got an] excellent education about the AAN and the different opportunities available to serve the Academy and contribute to neurology as a field. It was also great to meet new people in the Academy motivated to contribute to the well-being of members,

patients, and others involved in neurology.

This has flowed well with my position on the AAN Practice Committee where similar issues are discussed and action plans are developed.”

Added Spears, “I would recommend the program to anyone interested in learning more about the Academy, being a leader, and getting more involved with the AAN and in their local practice.” 

Spears

Apply by October 15 for the 2019 Diversity Leadership Class The Diversity Leadership Program is a prestigious and interactive program designed to develop and engage a more diverse membership and demonstrate to participants the long-term benefits of AAN involvement.

The program is designed for talented and highly motivated individuals at any stage in their post-residency career who are committed to the profession of neurology and to providing high-quality patient-centered care, and are US AAN members from one of the following underrepresented minority groups: African American/ Black, Hispanic/Latino, American Indian, Native Hawaiian, or Alaska Native ethnicity. Applications for the 2019 program will be accepted through October 15. Visit AAN.com/view/DiversityLeadership to learn more and to apply. 

Synapse Continues Strong Growth, Engagement SynapseSM Online Communities, the official communication platform for AAN Sections, continues to experience substantial growth and engagement. Since its debut in 2016, it has expanded to include 37 sections, 16 private communities, and two open communities.

It now serves more than 18,000 member neurologists and neuroscience professionals, residents and fellows, researchers, advanced practice providers, and businesses administrators from around the world.

As the global conversation for all things neurology, Synapse offers a unique opportunity for members within similar areas of interest to: Exchange insights on professional-related topics and issues Share expertise, find answers to tough questions, and strengthen the care they provide Discuss timely news and science affecting the field of neurology Offer real-world solutions to practice, patient care, academia, and other areas of the neurology profession— across all career levels Quickly and easily provide feedback on section-relevant AAN programs and services Download and share documents and images through the Synapse digital library Because Synapse is an exclusive benefit of AAN membership, only AAN members can view conversations. To post or

comment on a conversation, participants must be a member of that particular AAN Section or open community. AAN members may easily join various AAN sections directly on the AAN webpage at AAN.com/view/sections, or on the Synapse site, where they may also update their profile preferences to change the frequency of online community notifications. 

Advance Registration and Hotel Deadline Approaching for Expanded Fall Conference September 20 is the last opportunity to take advantage of discounts and secure your accommodations to attend the Fall Conference, set for October 26 through 28 in Las Vegas. This popular year-end opportunity is your destination for the latest neurology and practice management updates and valuable CME credits. You won’t want to miss the new programmatic updates, including the addition of popular education courses and breakthrough scientific research from the Annual Meeting—carefully selected based on their innovative formats and complementary curriculum.

View the full schedule, book your room, and save on registration by visiting AAN.com/view/Fall today—then get ready to experience the next generation of Fall Conference programming. 

OCTOBER 26–28

The Cosmopolitan of Las Vegas

AANnews • September 2018 23

Jesse Li, MD Neurologist

Hendricks Regional Health is a nationally recognized, nonprofit, healthcare system with a deeply rooted legacy of community service. Hendricks thrives in a closeknit, growing community just west of Indianapolis. Close to all that Indianapolis has to offer, Hendricks County has wonderful schools, parks, arts and entertainment.

Our neurology candidates can expect: • Custom, innovative practice design • Optimal work/life balance • Personalized onboarding • Strong marketing support to grow your practice • Support from an award-winning clinical team • Comprehensive health and wellness package • Generous benefits program outpacing industry Interested? Take the next step at CHOOSEHENDRICKS.ORG or contact our provider liaison, Kirsten Tracy, at (317) 519-9396 or Kirsten.Tracy@Hendricks.org.

Conferences & Community

Off to a Great Start Gregory D. Cascino, MD, FAAN, chair of the AAN Member Engagement Committee, along with the rest of the committee, met with residents from the University of Minnesota recently at the AAN headquarters in Minneapolis. Cascino and the committee members shared information on AAN programs and services available to residents and how the AAN can support them throughout their careers. 

APP Appointed to Neurology Today Editorial Board Neurology Today ® Editor-in-Chief Joseph E. Safdieh, MD, FAAN, and his Editorial Board have selected Julie Gurwell, PhD, PA-C, as the first advanced practice provider (APP) member to join the Editorial Board. Gurwell works at the University of Kentucky and has a faculty appointment.

“The addition of APPs to the neurology care team has been a boon in providing the high-quality care to neurology patients,” said Safdieh. “This was recognized by the AAN with the creation of a new category of membership for APPs, and the

AAN is working to integrate more APPs on committees and subcommittees.

Our appointment of Julie Gurwell to our publication’s Editorial Board reflects the Academy’s desire to more formally recognize the vital role played by APPs and the unique insights they can share to guide us to greater understanding of the benefits they offer neurologists and their patients.” 

Gurwell

AANnews • September 2018 25

Education & Research

Apply for Education Research Opportunities by October 1 The AAN is offering two exciting funding opportunities for 2019. The deadline to apply for both awards is October 1, 2018.

Education Research Grant Offers $5,000 to $10,000 to fund education research projects based on the proposal and merits of the project.

“Education research” is defined as the qualitative and quantitative study of hypothesis-driven observations or interventions on the acquisition of knowledge or training.

Apply at AAN.com/view/ERG.

Medical Education Research Training Fellowship Offers $65,000 for one year, and up to $10,000 of the fellowship funds may be used for tuition to support formal education in

education research methodology at the applicant’s institution or elsewhere. “Medical education research” is defined as medically oriented education research with the goal of developing efficient and effective psychosocial and behavioral interventions to improve teaching, learning, and health care practice to ultimately impact patient and family outcomes. Apply at AAN.com/view/ERTF. 

October 1 Is Application Deadline for 2019 Research Program Opportunities The AAN is committed to making a profound difference in the lives of researchers, in turn making a difference in the lives of patients with brain disease. The ambitious 2019 AAN Research Program offers opportunities ranging from $130,000 to $450,000 and designed all types ofNCP research across all career levels and discovery stages. Pave your own pathway to improving patient care by 18Axon Ad—Half Pagefor Horizontal> NJ, Placed in Neurology Neurology Clinical Practice by the October 1, 2018, deadline. Visit AAN.com/view/ResearchProgram today.  applyingJournal, for oneorof the many opportunities 8.25 x 5.4375 +0.125 bleed, 4C

Meet MOC Part IV clinical module activity and eight credits of Part II self-assessment Get real-time data feedback for quality improvement and assessment

What is the Axon Registry®?

Use neurology specialty and subspecialty measures

MIPS

This free AAN US member benefit is a clinical quality improvement registry exclusively for neurology.

Use for government reporting requirements

Learn more at AAN.com/view/Axon.

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Take Advantage of Continuum for Comprehensive Review of Headache Disorders From migraine and cluster headache to secondary headache syndromes and headaches due to low and high intracranial pressure, the latest issue of Continuum: Lifelong Learning in Neurology® will provide an update across headache disorders, according to Peter J. Goadsby, MD, PhD, guest editor of this issue.

“The issue has interesting new data on the pathophysiology and treatments of these conditions,” Goadsby said. “It covers topics ranging from migraine pathophysiology, migraine treatment, pediatric headache, cluster headache, and headache in pregnancy. Readers will be able use the information learned from this issue in their daily practice.”

Goadsby

Topics include: Preventive Therapy of Migraine Todd J. Schwedt, MD, FAAN

Neuralgias Stewart J. Tepper, MD, FAHS

Headaches Due to Low and High Intracranial Pressure Deborah I. Friedman, MD, MPH, FAAN

Secondary Headache Syndromes Denise E. Chou, MD

The Migraine Postdrome Pyari Bose, MD, MRCP; Nazia Karsan, MBBS, MRCP; Peter J. Goadsby, MD, PhD

Headache in Pregnancy Matthew S. Robbins, MD, FAAN, FAHS

Acute Treatment of Migraine Bert B. Vargas, MD, FAAN

Cluster Headache and Other Trigeminal Autonomic Cephalalgias Mark Burish, MD, PhD

Common Legal Considerations When Moving to a New Medical Practice Joseph S. Kass, MD, JD, FAAN; Rachel V. Rose, JD, MBA

The Migraine Premonitory Phase Nazia Karsan, MBBS, MRCP; Pyari Bose, MD, MRCP; Peter J. Goadsby, MD, PhD The Migraine Aura Andrew Charles, MD

Unusual Headache Disorders Amaal Jilani Starling, MD, FAHS

Pediatric and Adolescent Headache Amy A. Gelfand, MD

All of the articles have corresponding interviews on Continuum® Audio, which is now included in a subscription to Continuum®.

AAN members receive a deep discount on Continuum and Continuum Audio—only $349 a year, a $700 value. Subscribe now by contacting Wolters Kluwer at (800) 361-0633, (301) 223-2300 (international), or Shop.LWW.com/continuum. Junior members who are transitioning to neurologist memberships can receive a 50-percent discount on the already low member rate for the Continuum and Continuum Audio subscription. 

ABPN to Offer Certification in Neurocritical Care The American Board of Psychiatry and Neurology (ABPN) has received approval from the American Board of Medical Specialties (ABMS) to offer certification in Neurocritical Care.

The AAN and the Neurocritical Care Society requested that the ABPN submit the application for the new subspecialty to the ABMS. “Neurocritical Care has grown substantially since it offered its first certification and accreditation through the United Council of Neurologic Subspecialties in 2007, now with 69 accredited training programs and 1,374 certified diplomates,” said William D, Freeman, MD, FAAN, chair of the AAN Critical Care and Emergency Neurology Section. “With this growth, the subspecialty had reached the level and quality that warrants ABPN certification.”

The ABPN will submit a proposal to the Accreditation Council for Graduate Medical Education (ACGME) for accreditation recognition of Neurocritical Care.

There will be a six-year practice pathway for neurologists certified in Neurocritical Care by the UCNS or another organization, who have completed a fellowship in Neurocritical Care through UCNS or another organization, or who document required practice experiences. The practice pathway will start at the time the first exam is offered, which is planned for 2020 or 2021.

The UCNS will offer its 2018 Neurocritical Care recertification examination and 2019 initial certification examination as scheduled and transition current diplomates who wish to retain their UCNS certification to a continuous certification model. UCNS will also continue to offer accreditation of training programs.

For more information, visit ABPN.com. 

AANnews • September 2018 27

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AAN.com/careers

Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added.

General Child Neurology Faculty Position. The Division of Pediatric Neurology at Nationwide Children's Hospital and the Department of Pediatrics at The Ohio State University College of Medicine is seeking a General Child Neurologist to join our team. U.S News and World Reports ranks Neurology and Neurosurgery at Nationwide Children’s Hospital among the top ten programs nationally. In 2017, there were over 17,000 neurology outpatient visits across the Nationwide Children’s Hospital medical system. The Division of Pediatric Neurology consists of 28 outstanding pediatric neurologists and offers fellowships in Clinical Neurophysiology, Neuromuscular Genetic Therapeutics, and Headache.

The neurology faculty provides dedicated neurocritical care coverage, inpatient/ED consultations, and runs a full service 6-bed Epilepsy Monitoring Unit. Over the past 5 years, the Division of Pediatric Neurology at Nationwide Children’s Hospital has averaged over 14 million dollars annually in extramural research funding. Qualified candidates for this position must have completed a residency in Child Neurology and be board certified or board eligible in Neurology with Special Qualifications in Child Neurology, possess strong clinical skills and a demonstrated commitment to teaching and research. Named to the Top 10 Honor Roll on U.S. News & World Report’s 2017-18 list of “America’s Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric healthcare systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents. Nationwide Children’s has a staff of nearly 13,000 providing state-of-the-art pediatric care during more than 1.4 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities in the US, supporting basic, clinical, translational, and health services research at Nationwide Children’s.

The Research Institute encompasses three research facilities totaling 525,000 square feet dedicated to research. If you or any of your colleagues are interested in applying or discussing this opportunity, please contact: Anup Patel, MD Section Chief of Neurology, Nationwide Children's Hospital, Associate Professor Neurology and Pediatrics, The Ohio State University College of Medicine, Anup.Patel@NationwideChildrens.org Neurology opportunity near 4 major metro areas. Practice neurology in an Academic Medical Center affiliated with Medical school. Primarily outpatient neurology opportunity in new medical building. Opportunity to join growing Neurology department of 8 Neurologists. Faculty members including General, Pediatric, Neuromuscular, Movement, Epilepsy and Vascular. Accredited Neurophysiology Center on site.

Multidisciplinary team includes Radiologists, Pharmacists, Nursing, Dietitians, Physical, Occupational and Speech Therapists. New Neurology Residency Program. Excellent starting salary, full benefits and sign-on bonus. H1b candidates and 2019 J1 candidates accepted. Educational stipend available. An outdoor enthusiast’s haven. Enjoy the scenic shores of a historic river. Take in the four-season views while mountain hiking.

Enjoy a sunset cruise under the stars. The region’s best skiing at your doorstep. Year-round family fun, A down-to-earth place to live combined with amazing cultural sensations, NCAA Division One Intercollegiate Sports Teams, Excellent Public and Private Schools, Short Distance to 4 Major Metro Areas, Grand prize winner America’s Best Communities Competition. Mention Code 171116—N. Minimum Requirements: MD or DO Medical Degree. Eligible to be state licensed in the United States.

United States Residency and/or Fellowship training. To apply for this job, contact Rob Rector at rrectorweb@phg.com, (404) 591-4218.

Neurology opportunities—Minneapolis/St. Paul, MN at Fairview Health Services. Fairview Health Services/HealthEast (Minneapolis/ St. Paul), an award-winning nonprofit health system (Fairview.org) has multiple Neurology opportunities. Fairview is one of the most comprehensive and geographically accessible systems in the state, serving the greater Twin Cities metro area and north-central Minnesota. Our progressive and passion-oriented culture allows our Neurologists to work together in offering the full continuum of highly technical and specialized neurological health services. Practice Details: Join an established team of Neurology providers dedicated to offering high-quality, comprehensive neurological care and education. Practice Neurology in either outpatient or inpatient settings, or a combination of both at our Hospitals and Clinic locations located in Minneapolis/St. Paul and surrounding suburban communities. Provide a full spectrum of adult and young adult Neurology.

Enjoy our strong primary care referral base. Opportunity to practice and further develop clinical interests such as clinical neurophysiology with special interest in stroke, electromyography (EMG), electroencephalography (EEG), and botox injections. Our staff includes nurses with specialized neurological training and highly skilled registered electro diagnostic technologists. Opportunity to provide Inpatient Neurology/Stroke coverage. Call coverage is dependent on each practice location. Fully integrated Electronic Medical Record (EPIC). Income Details/Benefits: Market competitive salary guarantee with ability to exceed on production compensation program with comprehensive benefits package that includes generous time off, annual CME allowance, malpractice insurance, a retirement plan, relocation & more. Sign-on bonus offered. The Twin Cities area is a vibrant metropolitan area with a population of 3.5 million, home to 20 Fortune 500 companies, nationally recognized educational system, major universities, professional sporting teams, fine dining and numerous arts and cultural activities.

For additional information, please contact Jill Herrera, recruit1@fairview. org, (800) 842-6469, www.fairview.org/careers Pediatric Neuro-immunologist Faculty Position. The Division of Pediatric Neurology at Nationwide Children's Hospital and the Department of Pediatrics at The Ohio State University College of Medicine is seeking a Pediatric Neuro-immunologist to join our team. US News and World

Reports ranks Neurology and Neurosurgery at Nationwide Children’s Hospital among the top ten programs nationally. In 2017, there were over 17,000 neurology outpatient visits across the Nationwide Children’s Hospital medical system. The Division of Pediatric Neurology consists of 28 outstanding pediatric neurologists and offers fellowships in Clinical Neurophysiology, Neuromuscular Genetic Therapeutics, and Headache.

The neurology faculty provides dedicated neurocritical care coverage and inpatient/ED consultations. Strong collaboration with Rheumatology exists with the potential for developing a center of excellence in Neuroimmunology and an active infusion center. Over the past 5 years, the Division of Pediatric Neurology at Nationwide Children’s Hospital has averaged over 14 million dollars annually in extramural research funding.

Qualified candidates for this position must have completed a fellowship in Neuro-immunology and be board certified in Neurology with Special Qualifications in Child Neurology, possess strong clinical skills and a demonstrated commitment to teaching and research. Named to the Top 10 Honor Roll on US News & World Report’s 2017-18 list of “America’s Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric healthcare systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents.

Nationwide Children’s has a staff of nearly 13,000 providing state-ofthe-art pediatric care during more than 1.4 million patient visits annually.

As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the US, supporting basic, clinical, translational, and health services research at Nationwide Children’s. The Research Institute encompasses three research facilities totaling 525,000 square feet dedicated to research. If you or any of your colleagues are interested in applying or discussing this opportunity, please contact: Anup Patel, MD Section Chief of Neurology, Nationwide Children's Hospital, Associate Professor Neurology and Pediatrics, The Ohio State University College of Medicine, Anup.Patel@NationwideChildrens.org

is seeking a Pediatric Movement Disorder Specialist to join our team.

U.S. News and World Reports ranks Neurology and Neurosurgery at Nationwide Children’s Hospital among the top ten programs nationally.

In 2017, there were over 17,000 neurology outpatient visits across the Nationwide Children’s Hospital medical system. The Division of Pediatric Neurology consists of 28 outstanding pediatric neurologists and offers fellowships in Clinical Neurophysiology, Neuromuscular Genetic Therapeutics, and Headache. The neurology faculty provides dedicated neurocritical care coverage and inpatient/consultations. With collaboration with Neurosurgery, a deep brain stimulation program (DBS) has been established. Over the past 5 years, the Division of Pediatric Neurology at Nationwide Children’s Hospital has averaged over 14 million dollars annually in extramural research funding. Qualified candidates for this position must have completed a fellowship in Movement Disorders and be board certified in Neurology with Special Qualifications in Child Neurology, possess strong clinical skills and a demonstrated commitment to teaching and research. Named to the Top 10 Honor Roll on US News & World Report’s 2017–18 list of “America’s Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric healthcare systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents. Nationwide Children’s has a staff of nearly 13,000 providing state-of-the-art pediatric care during more than 1.4 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the US, supporting basic, clinical, translational, and health services research at Nationwide Children’s. The Research Institute encompasses three research facilities totaling 525,000 square feet dedicated to research. If you or any of your colleagues are interested in applying or discussing this opportunity, please contact: Anup Patel, MD, Section Chief of Neurology, Nationwide Children's Hospital, Associate Professor Neurology and Pediatrics, The Ohio State University College of Medicine, Anup.Patel@NationwideChildrens.org

Enjoy Great Lifestyle of Coastal SE Virginia with No Call at Virginia Neurology and Sleep Centers. Located in Chesapeake, Virginia.

Established, reputable outpatient neurology practice in need of a BC neurologist with EMG interest and experience. Monday-Friday 9 am–5pm, no hospital call or inpatient responsibilities, fully EHR. Located in a growing metropolitan area in Southeastern Virginia with a beautiful climate, low cost of living, and excellent public and private schools (including universities). Cordial work environment. Excellent compensation and benefits package. Interested and qualified candidates please email CV to: Kathy Glenn, kglenn@vasleepneurology.com, (757) 410-2804.

Well established multi-specialty group seeking Neurologist in outpatient clinic in Northern California. Dignity Health Medical Group – Sierra Nevada, a service of Dignity Health Medical Foundation, is a well-established multi-specialty group featuring Cardiology, ENT, Neurology, ObGyn, Oncology, Internal Medicine and Family Practice.

We are aligned with Dignity Health, the fifth largest healthcare system in the country and the largest hospital provider in California, as well as Sierra Nevada Memorial Hospital. Our Grass Valley Group, located less than 60 miles from Sacramento, is currently recruiting a Neurologist.

This opportunity offers: Join an existing Neurologist in our outpatient clinic, Adult and geriatric patients, 80% outpatient/20% inpatient, Surgery referred out, 1:4 ER and inpatient call with tele-medicine robot available for neurology consults, hospital is a Certified Advanced Primary Stroke Center, affiliated with the Dignity Health Neurological Institute, Catchment area of 99,000 people with 24% 65 years of age or older, Traditional employment model with: Competitive salary guarantee period, Productivity and quality incentives, Attractive benefits package (comprehensive healthcare coverage, free medical insurance, 401K, paid malpractice, CME allowance, etc.), Generous time off. The natural beauty of Nevada County, combined with the rich history and economic vitality of the area, provides an appealing quality of life that is highly valued by residents and visitors alike. Grass Valley, the largest city in western Nevada County, has a population of just over 12,000 people. Although Grass Valley and the other cities of Nevada County offer a small-town feel, the conveniences and offerings of major metropolitan areas (Sacramento, San Francisco & Reno) are only a short drive away. Our charming historic towns offer fine dining and wine tasting, museums and art galleries, antiques, shopping and a range of cultural attractions. A year-round climate of moderate weather with warm summers and short winters offer outstanding recreational opportunities, including fishing, whitewater rafting, hiking, biking, boating, hunting, skiing, golfing, gold panning and camping. For more information, please contact: Physician Recruitment, (888) 599-7787, providers@dignityhealth.org, www.dignityhealth.org/ physician-careers

Live and work in the Beautiful California Eastern Sierra We are looking for a compassionate and dedicated Neurologist to establish a new practice within our growing Specialty Clinic. Our Specialty Clinic is attached to our Hospital which is a progressive, patient-centered, and quality driven 17-bed Critical Access Hospital and Rural Health Clinic with advanced technology, modern facilities, and superb medical staff. We are a financially sound, award winning District Hospital with over 400 talented team members serving the health-care needs of Mammoth Lakes' residents and guests. Sound like a good place to work? It is. Our recent Physician Satisfaction Survey scored in the 90th percentile of hospitals. Join our new and growing Specialty Clinic by engaging in impactful work in this rural community with a high need for a local Neurologist. This is a rare opportunity to make a difference in an underserved area while working in a highly professional environment.

This position provides a flexible work environment and schedule with highly competitive compensation. Bilingual in Spanish is a plus. Not only is this a dream job opportunity, but Mammoth Lakes is paradise for any year-round outdoor enthusiast. During winter you can ski and snowboard the legendary Mammoth and June Mountains or take off into the wilderness on your cross-country skis. Spring is our fishing opener where the town of Mammoth Lakes really gets its name and our abundance of alpine lakes are filled with trophy trout. The sharp and craggy granite peaks of the Sierra Nevada Range also form a dramatic backdrop for meadows brightly colored by wildflowers. Then the summer melts away the snow, opening thousands of miles of trails and even the road to Yosemite National Park just a 45-minute drive from town. You’ll never tire of finding secret alpine lakes, lush aspenlined streams and forested hideaways tucked away in the mountains.

From the Pacific Crest and the John Muir Trails to short day hikes, there’s something for everyone in the Eastern Sierra. Do you prefer to travel on two wheels? If so, miles and miles of quiet mountain roads and epic road bike climbs are calling your name. Prefer the dirt? We’ve got plenty of cross country and downhill trails. You can take the lift up to 11,000 feet and plummet down some black diamond bike trails on Mammoth Mountain. Or take the beginner trails with the whole family.

You can even bike to work at Mammoth Hospital on our many local bike paths. We also have excellent schools and a local community college along with a burgeoning theater and music community. Bluegrass jams or professional violinist duets? Yep, we got ‘em both. It’s tough to find that small town feel with so many amenities and Mammoth has it all.

But that’s not it. There are just too many amazing outdoor features to list. Mammoth Hospital gives employees the work life balance they need to enjoy where they live. Come work at Mammoth Hospital and make this amazing place your home so you can begin exploring! To apply for this job, contact Sarah Vigilante at sarah.vigilante@mammothhospital. com, (760)924-4045. Apply URL: www.mammothhospital.com/employment

Neurohospitalist at HCA—Redmond Regional Medical Center. HCA’s Redmond Regional Medical Center is recruiting a Neurohospitalist to join their established Hospitalist program of 14. Redmond Regional Medical Center is located in Rome, GA—a beautiful college town located 1-hour NW of Atlanta. Key details: 15 shifts per month (12-hour shifts), 1 week of night rotation every 12th week, 7 on/7 off schedule, No Home call, Competitive salary + benefits package, Candidates must be board eligible/board certified Apply now for more details, Park, park.meadors@ hcahealthcare.com, (615) 969-7275.

AANnews® Classified Advertising he AAN offers a complete package of print, online, and T in-person recruitment advertising opportunities. Visit careers.

AAN.com for all AAN options, rates, and deadlines. d copy for the November 2018 print edition of AANnews must A be submitted by October 1, 2018. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the right to T decline, withdraw, or edit advertisements at its discretion.

Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.

Pediatric Movement Disorder Specialist Faculty Position. The Division of Pediatric Neurology at Nationwide Children's Hospital and the Department of Pediatrics at The Ohio State University College of Medicine

AANnews • September 2018 29

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BRIEF SUMMARY OF PRESCRIBING INFORMATION

Please see package insert for full Prescribing Information INDICATIONS AND USAGE AIMOVIG is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS None.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of AIMOVIG has been evaluated in 2,537 patients with migraine who received at least one dose of AIMOVIG, representing 2,310 patient-years of exposure. Of these, 2,057 patients were exposed to 70 mg or 140 mg once monthly for at least 6 months, 1,198 patients were exposed for at least 12 months, and 287 patients were exposed for at least 18 months.

In placebo-controlled clinical studies (Studies 1, 2, and 3) of 2,184 patients, 787 patients received at least one dose of AIMOVIG 70 mg once monthly, 507 patients received at least one dose of AIMOVIG 140 mg once monthly, and 890 patients received placebo during 3 months or 6 months of double-blind treatment. Approximately 84% were female, 91% were white, and the mean age was 42 years at study entry.

The most common adverse reactions (incidence ≥ 3% and more often than placebo) in the migraine studies were injection site reactions and constipation.

Table 1 summarizes the adverse reactions that occurred during the first 3 months in the migraine studies (Studies 1, 2, and 3).

Adverse Reactions Occurring with an Incidence of at Least 2% for Either Dose of AIMOVIG and at Least 2% Greater than Placebo During the First 3 Months in Studies 1, 2, and 3 AIMOVIG 70 mg Once Monthly N = 787 %

AIMOVIG 140 mg Once Monthly N = 507 %

N = 890 %

Injection site reactionsa

6

5

3

Constipation

1

3

1

<1

2

<1

Adverse Reaction

Cramps, muscle spasms

Placebo

a Injection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema.

In Studies 1, 2, and 3, 1.3% of patients treated with AIMOVIG discontinued double blind treatment because of adverse events. The most frequent injection site reactions were injection site pain, injection site erythema, and injection site pruritus.

Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation, including neutralizing antibodies, is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to erenumab-aooe in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

The immunogenicity of AIMOVIG has been evaluated using an immunoassay for the detection of binding anti-erenumab-aooe antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.

In controlled studies with AIMOVIG, the incidence of anti-erenumab-aooe antibody development was 6.2% (48/778) in patients receiving AIMOVIG 70 mg once monthly (2 of whom had in vitro neutralizing activity) and 2.6% (13/504) in patients receiving AIMOVIG 140 mg once monthly (none of whom had in vitro neutralizing activity). The neutralizing anti-erenumab-aooe antibody positive rate may be underestimated because of limitations of the assay. Although these data do not demonstrate an impact of anti-erenumabaooe antibody development on the efficacy or safety of AIMOVIG in these patients, the available data are too limited to make definitive conclusions.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women. No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation (see Data). Serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

Data Animal Data In a study in which female monkeys were administered erenumab-aooe (0 or 50 mg/kg) twice weekly by subcutaneous injection throughout pregnancy (gestation day 20 - 22 to parturition), no adverse effects on offspring were observed. Serum erenumab-aooe exposures (AUC) in pregnant monkeys were approximately 20 times that in humans at a dose of 140 mg once monthly.

Lactation Risk Summary There are no data on the presence of erenumab-aooe in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AIMOVIG and any potential adverse effects on the breastfed infant from AIMOVIG or from the underlying maternal condition.

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

Geriatric Use Clinical studies of AIMOVIG did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

AIMOVIG™ (erenumab-aooe) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 USA U.S. License No. 1080 Marketed by: Amgen Inc. (Thousand Oaks, CA 91320), and Novartis Pharmaceuticals Corporation (East Hanover, NJ 07936) Patent: http://pat.amgen.com/aimovig/ © 2018 Amgen Inc. All rights reserved. v1 05/2018

enough already. it’s time to help prevent migraine.

Aimovig™ is the first and only FDA-approved therapy specifically designed to help prevent migraine by targeting and blocking the calcitonin gene-related peptide receptor (CGRP-R).1 • Aimovig™ reduced monthly migraine days.1 • The most common adverse reactions in clinical studies (≥ 3% of Aimovig™-treated patients and more often than placebo) were injection site reactions and constipation.1 • In 3- and 6-month clinical studies, up to 95% of patients stayed on Aimovig™.1 – Less than 2% of patients receiving Aimovig™ discontinued due to adverse events.

• Patients will have access to Aimovig Ally™— a range of personalized product support services designed to help them start and stay on therapy as prescribed.

Give patients less days marked by migraine with Aimovig™.

Learn more about Aimovig™ and how to get your Hypothetical patient.

next patient started at AimovigHCP.com/GetStarted

Indication Aimovig™ is indicated for the preventive treatment of migraine in adults.

Important Safety Information • The most common adverse reactions in clinical studies (≥ 3% of Aimovig™-treated patients and more often than placebo) were injection site reactions and constipation.

Please see a brief summary of the Prescribing Information on the adjacent page.

Reference: 1. Aimovig™ (erenumab-aooe) prescribing information, Amgen.

© 2018 Amgen Inc. All rights reserved. USA-334-80644