VOLUME 31 · ISSUE 11 · NOVEMBER 2017
Y O U R M O N T H LY A A N M E M B E R S H I P M A G A Z I N E
Experts to Outline Findings, Clinical Implications at 2018 Frontiers in Neuroscience Plenary Session Six expert speakers will outline their recent findings, along with clinical implications, during the Frontiers in Neuroscience Plenary Session to be held Wednesday, April 25, from 9:15 a.m. to 11:30 a.m. during the AAN Annual Meeting in Los Angeles, April 21 to 27. The Dynamics of the Unconscious Brain Under General Anesthesia Emery N. Brown, MD, PhD, Harvard Medical School Does Connectomics Make Sense? Jeff Lichtman, MD, PhD • Harvard Medical School Biology of Bedtime: Understanding Circadian Rhythms and Sleep Amita Sehgal, PhD • University of Pennsylvania Combining Patient-derived Cell and Animal Models to Uncover Epilepsy Mechanisms and Precision Therapies Jack M. Parent, MD • University of Michigan
Emery N. Brown, MD, PhD
Jeff Lichtman, MD, PhD
Amita Sehgal, PhD
Jack M. Parent, MD
Alan Evans, PhD
Emmanuelle Waubant, MD, FAAN
BigBrain: A High-resolution 3D Digital Human Brain Atlas Alan Evans, PhD • McGill University Leveraging the Study of Pediatric MS to Identify Risk Factors for the Disease Emmanuelle Waubant, MD, FAAN • USCF Learn more about what’s in store for you and your career at the 2018 Annual Meeting, register, and book your hotel all at AAN.com/view/AM18. •
THIS ISSUE 6 7 9 19
2018 Neuro Film Festival Now Accepting Submissions Register by November 6 for Technology Webinar Baffled by QPP? Free Support May Help You Free Online Resources Can Help You Meet Year-end CME and MOC Requirements
Registration Now Workload, Threats to Open for 2018 Annual Professionalism Top Meeting in Los Angeles Causes of Burnout Among Neurologists Registration is now live for the 2018 Annual Meeting in Los Angeles. You won’t want to miss the world’s largest and most exciting gathering of neurologists and neurology professionals in the equally exciting film and entertainment capital of the world. Whether you’re a clinician, educator, researcher, resident, or student—and no matter what your subspecialty area of interest—the 2018 Annual Meeting is serving up what you need to put your career in the spotlight.
Neurologists who were asked to share their thoughts on physician burnout described workload most often as a cause, followed by threats to professionalism and regulatory hassles, according to a new study by the AAN. The study results were published in the September 20, 2017, online issue of Neurology ®, and in print on October 17, 2017.
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Table of Contents COVER Experts to Outline Findings, Clinical Implications at 2018 Frontiers in Neuroscience Plenary Session Registration Now Open for 2018 Annual Meeting in Los Angeles Workload, Threats to professionalism Top Causes of Burnout Among Neurologists
3 AAN Is Working Hard to
Modify ABPN Maintenance of Certification (MOC)
MEET YOUR LEADER
4 Brett M. Kissela, MD, MS, FAAN
5 December 8 Is Housing Deadline for Breakthroughs in Neurology and New Career Essentials Conferences
6 2018 Neuro Film Festival Now Accepting Submissions
6 Applications Open for
Exhibit Opportunities During 2018 Annual Meeting
7 Register by November 6 for Technology Webinar
8 Academy Publishes Updated
Stroke and Stroke Rehabilitation Measures
8 Podcast Central
Official Publication of the American Academy of Neurology
May Help You
10 Apply by December 11 for 2018 Palatucci Advocacy Leadership Forum
10 Capitol Hill Report 18 Pennsylvania Member Scores Advocacy Trifecta
19 Free Online Resources Can
Help You Meet Your Year-end CME and MOC Requirements
20 Earn up to 224 CME with Annual Meeting On Demand
20 UCNS Issues Neuro-oncology
Certifications and Recertifications
23 Seeking Applications for 2018 24 AAN Leaders Represent Academy in Kyoto
24 Maintain Essential Education and Science, Incomparable Support by Renewing Your Membership Today
AMERICAN BRAIN FOUNDATION 26 For All You Have Done, Thank You
CAREERS | 28
A record number of applications were received for the 2018 AAN Research Program, which offered five new awards and 14 other opportunities ranging from $130,000 to $450,000 and designed for all types of research across all career levels and discovery stages. To help medical students get excited about the field of neurology, the AAN is celebrating the first annual Neuroscience Is…™ Rewarding Day on November 30, 2017, in honor of the November 30, 1840, birthday of Wilhelm Henrich Erb, MD, who is credited with popularizing the reflex hammer widely used in today’s neurological exam. For more information, visit AAN.com/view/NeuroscienceIsRewarding. • AANnews • November 2017
The Vision of the AAN is to be indispensable to our members. The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. Contact Information American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415 Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:
Website: AAN.com For advertising rates, contact: Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins Phone:
Diversity Leadership Program
9 Baffled by QPP? Free Support
AAN Executive Director Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela Babb, CAE Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designers: Siu Lee and Jim Hopwood Email: aannews@AAN.com AANnews is published monthly by the American Academy of Neurology for its 32,000 members worldwide. Access this magazine and other AAN publications online at AAN.com/go/elibrary. The American Academy of Neurology’s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
AAN Is Working Hard to Modify ABPN Maintenance of Certification (MOC) We have often heard from our members about the excess burden of the current ABPN MOC process including the re-certification examination and the Part IV requirements. Well, we are happy to inform you that changes are happening. I am also proud to tell you that the AAN is playing a leading role in these MOC reform efforts. The American Board of Psychiatry and Neurology recently announced changes to its maintenance of certification program. The ABPN is expanding the Self-assessment options for all ABPN diplomates, which basically means the Axon Registry® is now on the list of approved products or opportunities for diplomates to use in meeting the Self-assessment component of MOC. The ABPN said it will now waive eight hours of SelfAssessment in a three-year CMOC block when a diplomate participates in an ABPN-approved registry. The Axon Registry is approved by the ABPN for this waiver. By participating in the Axon Registry, AAN members already can satisfy the MOC Performance in Practice (Part 4) Clinical Component. I’m pleased to say these changes make the AAN’s Axon Registry an even greater benefit to our members, who already can save considerable time by using our registry to report quality data for the Merit-based Incentive Payment System. I encourage members to participate in the Axon Registry to help ease the burden of MOC. Visit AAN.com/view/axon to learn more about the registry and sign up, and go to AAN.com/cme-and-moc/online-learningprograms for free MOC study resources. More recently, we heard very promising news from the ABPN. We understand that the ABPN is working on a new pilot alternative for Part III (Cognitive Examination) that will be developed during the next year. In this pilot, diplomates will be given the opportunity to complete repeated self-assessment activities based upon specific literature references selected by a committee of peer diplomates. We were asked to nominate a member to this ABPN pilot meeting, and I’m pleased that our AAN President Elect James C. Stevens, MD, FAAN, will represent neurology so our voice will be part of this discussion. ABPN intends to share the details by year-end, and we will keep you informed of developments. It is important that you also know the AAN is playing a key role in an effort to engage certifying boards in dialogue with national specialty and state medical societies regarding maintenance of certification and physician selfregulation. In July, we hosted a planning meeting at the AAN Headquarters in Minneapolis with six other specialty societies and five state medical societies. This meeting led to a letter to the American Board of Medical Specialties (ABMS) signed by 32 specialty societies and 41 state medical societies.
Specialty Societies, state medical societies, and the American Board of Medical Specialties. They stated: “Our national medical specialty societies and our state medical societies are now sharing what we see as the issues and, potential unintended consequences of the current MOC program and an opportunity to collectively address these concerns…. After all, this is about physician self-regulation and Ralph L. Sacco, MD, MS, FAHA, FAAN not MOC. This is about keeping patients first and doing all we can to ensure high-quality patient care. Some boards have already recognized the problems and are responding. Together, we must fix the problem both in the short term and long term. We, the undersigned, propose a meeting of the leadership of the certifying boards, medical specialty societies, and state medical societies to discuss this crisis and plan a solution.” I am happy to report that the meeting will take place on December 4, 2017, and the AAN will be there. The societies will host a summit with representatives from ABMS and specialty boards, the Accreditation Council for Graduate Medical Education, Federation of State Medical Boards, Council of Medical Specialty Societies, and American Medical Association. The goal of the summit is to gain agreement with the certifying boards that they must collaborate with the societies in the development of a meaningful MOC process or risk the loss of professional self-regulation. The AAN recognizes these hassles of recertification and regulatory reporting draw you away from your patients and family and can contribute to burnout. That’s why we advocate on your behalf with ABPN and the Centers for Medicare & Medicaid Services, and why we strive to alleviate these burdens with beneficial tools—like the Axon Registry—and resources, such as our free suite of Neuro products to help you prepare for MOC. The AAN is working hard and doing all we can to help our members reduce regulatory hassle and improve wellness. Hang in there—change (not winter) is coming! •
Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN firstname.lastname@example.org @DrSaccoNeuro on Twitter
The letter was written to ABMS to strengthen the collaborative dialogue between the Council of Medical
AANnews • November 2017
Meet Your Leader
Brett M. Kissela, MD, MS, FAAN Brett M. Kissela, MD, MS, FAAN, is professor and chair of the Department of Neurology and Rehabilitation Medicine at the University of Cincinnati. Since 2008, he has been co-director of the Stroke Recovery Center at Drake and a member of the University of Cincinnati Stroke team since 2000. He was elected by Academy members to the AAN and AAN Institute Boards of Directors in April 2017. Kissela also is a Government Relations Committee member, a graduate of the 2010 class of the Palatucci Advocacy Leadership Forum (PALF), multi-year participant in Neurology on the Hill, and recipient of the AAN’s Michael S. Pessin Stroke Leadership Prize.
How did you first get involved as a volunteer on committees/ subcommittees and what moved you to participate? I got involved almost by accident. I was a new residency program director and became aware of the AAN’s Consortium of Neurology Program Directors. This group was incredibly valuable to me at that time in my career, especially because many excellent and established program directors brought me in and took me under their wing. Soon after I began attending the meetings of this group, I found myself being elected to be the leader! Thereafter, I began to volunteer for other duties on AAN committees and subcommittees, and also participated in some of the earliest Leadership Development Programs. At each stage, I found participation to be professionally and personally satisfying. Volunteering with the AAN serves to improve the good of our profession, which I feel strongly about. I have always found my AAN roles to be enjoyable because they are productive, and this is because we have excellent AAN staff who ensure that volunteers’ time is well used. I have especially enjoyed my interactions with the AAN staff and colleagues around the country. It is incredibly valuable to have a network of friends and colleagues across the country in all types of practice settings. Why did you wish to be on the Board of Directors? As above, I have very much enjoyed my volunteer duties with the AAN, and have been impressed with the structure and function of the organization. I am a local leader as a department chair, and
AANnews • November 2017
strive to be a “servant leader.” I hope that I can bring value to the Board and the AAN membership.
to “decode” the structure and there are many, many opportunities to get involved.
What experiences and viewpoints do you bring to this role?
Out of touch? No, not in my opinion. I have been impressed with the organization’s attentiveness to all issues in neurology, and the impetus to be responsive to membership needs. A member might feel that the AAN doesn’t perfectly align with their opinion on a topic, but it is almost a certainty that the organization has thoughtfully discussed multiple viewpoints and come to its position on that topic. I have only been on the Board since April, but this has certainly been my experience with the Board thus far.
Every day I participate in four missions—education, clinical care, research, and administration. I have the background of an educator (former residency program director and fellowship director) who is passionate about recruiting and teaching our future colleagues. I am a vascular neurologist who is clinically active in inpatient care and stroke call, as well as outpatient clinics with a special interest in stroke recovery. I am a researcher with a very active research portfolio related to stroke epidemiology, stroke recovery, and research infrastructure (I have a large role within our local CTSA award). Finally, I am the chair of our Department of Neurology and Rehabilitation Medicine at the University of Cincinnati. I feel strongly about being a servant leader, in that my job is to help all members of our department succeed professionally. In addition to the above experiences, within the AAN I am currently serving on the Government Relations Committee and have been able to put my PALF training to work in advocating during Neurology on the Hill as well as locally. From your experiences as an AAN leader, what is one of the more common misperceptions members may have about the Academy? “The AAN is huge and out of touch.” Huge? Actually, it is a fairly large organization. However, it is not hard
In your view, how does the AAN benefit the field of neurology most? The AAN is devoted to bringing value to each member, and hopefully succeeds with publications, educational activities including the Annual Meeting, advocacy, member education (do you know about MACRA?), practice tools like the Axon Registry, and support of education and research. But most importantly, we are a professional organization. The membership target is all neurologists— so the AAN is our professional network. At the largest level, the AAN is working to advance our field within the broad field of medicine. How should members evaluate the success of the AAN and the Board of Directors in supporting their careers and in neurology in general? You should assess if you are being listened to, and look to see what value the organization brings to you personally as well as to the whole profession. •
December 8 Is Housing Deadline for Breakthroughs in Neurology and New Career Essentials Conferences December 8 is your last chance to secure your room through the official AAN housing block for the upcoming Breakthroughs in Neurology and new Career Essentials: Foundation for Your Future conferences. Both conferences are set to take place concurrently the weekend of January 12 through 15 at the beautiful Caribe Royale Orlando in Florida.
12 through 15. From the latest practice management advice to help preparing for ABPN board recertification—and the latest science and education from top experts— Breakthroughs in Neurology has you covered. Visit AAN.com/view/Breakthroughs to learn more, register, and book your hotel. •
Scheduled for January 13 to 15, the AAN’s newest, family-friendly conference is targeted towards early career neurologists in private practice and academia. This conference offers an excellent opportunity for early career neurologists to learn things they weren’t taught in residency that can help lay the foundation for a successful career, as well as earn up to 8.5 valuable CME credits. Learn more, register, and book your hotel today at AAN.com/view/CareerEssentials.
Breakthroughs in Neurology
Experience top neurology programming led by more than 14 experts in the field, earn up to 25.25 CME (11.25 of which qualify for self-assessment CME), and receive ample opportunities to interact with faculty and colleagues January
Registration Now Open for 2018 Annual Meeting in Los Angeles Continued from cover Visit AAN.com/view/18AM today and get ready to experience these not-to-be-missed highlights—and a whole lot more!
Highlights: Seven Cutting-edge Plenary Sessions Hear from more than 40 leading researchers presenting the latest advances in neuroscience—one each day beginning Saturday evening: nn Hot Topics Plenary Session nn Presidential Plenary Session nn Contemporary Clinical Issues Plenary Session nn Clinical Trials Plenary Session nn Frontiers in Neuroscience Plenary Session nn Controversies in Neurology Plenary Session nn Year in Review Plenary Session
Lively Neuroscience in the Clinic Sessions These sessions will feature a mix of scientists and clinicians actively engaged in lively case discussions to integrate scientific research with clinical application. Scientists will introduce and
provide background on a case, including presentation of abstracts, and clinicians will apply the case to a patient. All will come together for audience Q&A. Featured topics include: nn Antisense Oligonucleotide (ASO) Therapy nn Opioid Use and Abuse: The Overlapping Neurobiology of Pain and Addiction, and the Path Toward Better Treatments nn Challenges in Genetic Diagnoses in Neurology nn Treatment of Progressive Multiple Sclerosis nn REM Sleep Behavior Disorder— Past, Present, Future nn Neurologic Complications of Cancer Immunotherapy: A New Frontier in Neuroinflammation nn Autism Myth Busters
Flexible, Dynamic Experiential Learning Areas Get ready to experience interactive, flexible, and totally dynamic new ways
of exploring, engaging, and learning throughout each day of the meeting. Experiential learning areas will offer a variety of real-world experiences focused on research, advocacy, health and wellness, career guidance, education, practice improvement, and more designed to engage you intellectually, emotionally, and socially while serving up fresh ideas to help you personally and professionally. Areas include: nn HeadTalks nn Research Corner: Moving Neurology Forward nn Advocacy to Action: Empowering Patients and Physicians nn Maximize Your Value: Improve Your Neurology Practice nn Navigating Your Career: Choose a Track, Stay on Track, Change Tracks nn Live Well: Taking Care of Your Patients Starts with Taking Care of You •
AANnews • November 2017
2018 Neuro Film Festival Now Accepting Submissions The AAN’s ninth annual Neuro Film Festival® is now accepting submissions until March 2, 2018. The popular online video contest aims to build awareness, demonstrate the importance of neuroscience research, and encourage more young people to pursue careers in neuroscience. We know you or your patients have a story to tell. Is it a personal story of you or a loved one living with brain disease? Are you studying neuroscience in school or looking at neurology as a career? Are you working to raise awareness and funding for the need of more brain disease research funding? Or are you fascinated by the wonders of the brain? We want to hear it!
Four Categories…Four Chances to Win! One Grand Prize winning video from each of the following categories will receive $1,000: 1. Why I think Neuroscience Is Cool Tell us why the brain is fascinating (for students ages 13–18 only) 2. Why I think Neuroscience Is Rewarding Tell us how discovery opens doors for (college students, medical school students, neurology residents) 3. Why I think Neuroscience Is Essential Tell us why research is key (for families, patients, neurologists) 4. Why I think Neuroscience Is Critical Tell us why advocacy makes an impact (for advocates, neurologists, neurology professionals, government, patient groups, families)
Since its inception, more than 500 videos have been accepted into the Neuro Film Festival—garnering nearly 165,000 views on the festival’s YouTube channel—each relaying its own unique story about the devastating effects of neurologic disease. To learn more about the contest, get inspiration for topics within each category, and submit an entry, visit NeuroFilmFestival.com. Encourage your patients to tell their stories, too! •
Applications Open for Exhibit Opportunities During 2018 Annual Meeting The Exhibit Hall during the AAN Annual Meeting is a not-to-be-missed opportunity for organizations you might work with to showcase products, information, and services of particular interest to the neurology community. Just as the meeting presents many new and unique opportunities for neurologists, so too does it provide new and unique opportunities for industry partners, hospital networks, and non-profits to connect and share with more than 14,000 anticipated attendees. Please help us get the word out to smaller organizations that may be less familiar with our meeting but would benefit from exhibiting at the 2018 meeting in Los Angeles, April 21 through 27. Applications are now open at http://bit.ly/2yrbgfw. •
Register by November 6 for Technology Webinar You may still have time to register for this practice management webinar to see how you can more effectively use technology in your practice to gain greater efficiency. And if you miss the live webinar on November 7, you still can access the recording of this and all other 2017 webinars to help improve your practice.
iNeurology: Best IT Practices November 7, 2017 12:00 p.m.–1:00 p.m. ET
Melissa Yu, MD
Deadline to Register: November 6
Director: Melissa Yu, MD, and Seth Lefberg Upon completion, you should be able to: nn Understand the core functionalities of electronic
nn Use health information technology to effectively
report on payer programs
nn Identify tools to improve patient care
Even though 2017 is coming to an end, you can access recordings of all of this year’s AAN practice management webinars to gain the valuable insights and tools you need to navigate through the ever-changing health care landscape— and receive year-end CME credits! Single webinars are $99 but AAN members get the greatest value with the $189 subscription to all 10 live one-hour webinars. All webinars include access to presentation slides and recordings. Physicians receive 1 AMA PRA Category 1 Credit™ per webinar; non-physicians receive a certificate of completion. Visit AAN.com/view/PMW17 to learn more and register. •
FREE Webinar Preps You for 2018 Rule Changes The AAN wants you to get off on the right foot for 2018, so it is offering “New Year, New Rules: Preparing for 2018,” a FREE webinar on changes you can expect to see to Medicare fees, MACRA reporting, and other aspects of care management. Join directors Lyell K. Jones, MD, FAAN, and William Henderson, FACMPE, on December 5, 2017, from 12:00 p.m. to 1:00 p.m. ET. The deadline to register at AAN.com/view/PMW17 is December 4. •
January 12–15, 2018 Orlando, Florida
Get a year-in-review of the latest science and education Earn up to up to 25.25 CME, 11.25 of which qualify for self-assessment CME Housing Deadline: December 8, 2017 Early Registration Deadline: January 3, 2018
Register Today AAN.com/view/Breakthroughs Translating Today’s Discoveries Into Tomorrow’s Clinics AANnews • November 2017
Academy Publishes Updated Stroke and Stroke Rehabilitation Measures The AAN, in partnership with the American College of Radiology and American Academy of Physical Medicine and Rehabilitation, has redefined how we measure and improve stroke care. A cross-organizational work group updated the stroke and stroke rehabilitation quality measurement set originally developed by the American Medical Association and its Physician Consortium for Performance Improvement. The new measurement set was published online in Neurology ® on September 13, 2017, and in the October 10 print issue. A multi-disciplinary work group reviewed the prior measurement set and voted to retire 13 measures. One measure was created to directly assess potentially avoidable complications for patients admitted for care. Five new measure bundles were created, each consisting of a number of time-specific interventions that should be delivered to every patient every time during the care processes, so that
implementing them together results in better outcomes than when implemented individually. Bundles were created to address intravenous fibrinolytic treatment, acute stroke endovascular treatment, endovascular and imaging, inpatient acute ischemic stroke care, and outpatient acute ischemic stroke care. Past measures addressing patient nutritional preferences and rehabilitation services were updated. New measures were created to improve care for carotid imaging, high and moderate intensity statin therapy, cognitive impairment, and establish uniform assessment of functional outcomes following recanalization therapy. A short 17-minute webinar is available detailing this innovative approach. Visit AAN.com/practice/quality-measures to watch the video and learn more about the measures, why they were created, how they will be used, and how to calculate performance. •
15 mi lli Ov an on d er d g ow row nlo ing ads ... !
Your Guide to New and Recent AAN Podcasts
Neurology ® Podcasts Visit Neurology.org to listen to Neurology podcasts and earn 0.5 AMA PRA Category 1 CME Credits™ by answering the multiple-choice questions in the online podcast quiz. Interviews based on articles from Neurology ® Clinical Practice, Neurology ® Genetics, and Neurology ® Neuroimmunology & Neuroinflammation are excluded from the CME program.
Available by November 1 nn Neurology: Infliximab for the Treatment of Central Nervous System Sarcoidosis: A Multi-institutional Series Stacey Lynn Clardy, MD, PhD, and Siddharama Pawate, MD, MBBS nn Neurology: Multiparametric MRI Changes Persist Beyond Recovery in Concussed Adolescent Hockey Players Christopher C. Giza, MD; Kathryn Y. Manning, BSc, MSc; and Ravi Menon, MD nn Neurology: Midlife Systemic Inflammatory Markers Are Associated with Late-life Brain Volume: The ARIC study Jeffrey M. Burns, MD, MS, and Keenan A. Walker, PhD nn Neurology: Genetics: This Variant Alters Protein Function, But Is It Pathogenic? Michelle L. Mauermann, MD, and Massimo Pandolfo, MD nn Neurology: Clinical Practice: Persistent Focal Enhancement of the Cisternal Segment of Oculomotor Nerve in
Heather D. Harle, MD, and Ihtesham A. Qureshi, MD
AANnews • November 2017
Baffled by QPP? Free Support May Help You Are you managing a small practice or providing care in an underserved or rural setting? And are you befuddled by the requirements of the MACRA Quality Payment Program? If you can say “yes” to those questions, you may benefit from some free support and technical assistance from the QPP-SURS at QPP.cms.gov/docs/QPP_Technical_ Assistance_Resource_Guide.pdf. QPP-SURS is a free resource for small (up to 15 providers), underserved, and rural providers. The support is available through 11 regional organizations that offer hands-on training and assistance to those who call or email. QPP-SURS works with practices to assess their needs and offers individualized guidance to help them successfully participate in QPP. Support offered by QPP-SURS includes: nn Selection of quality measures and activities to report
for each performance category under MIPS
nn Reporting for MIPS nn Engagement in quality improvement nn Optimization of health information technology nn Evaluation of options for joining an AAPM
The AAN has connected with many QPP-SURS regional organizations; all have a “no wrong door” policy—if they can’t help you they’ll put you in touch with someone who can— and typically respond to questions within one business day. AAN member: “Service is a godsend” “Jane” is the practice manager for a solo practitioner and AAN member based in Chattanooga, TN. She does all of the administrative work for the practice except accounts payable and payroll. Between 35 to 50 percent of the practice’s patients use Medicare, so the impact of MACRA changes have been keenly felt by the clinic—and especially by Jane.
Seeking help to properly navigate some of the MACRA paperwork, Jane attended two 2.5 hour seminars, but she said, “I left feeling just as stupid as when I started. I was #92 on the question and answer section, and they never even got to me.” Given the large number of questions, Jane clearly wasn’t the only person baffled by the new requirements. Then Jane heard about QPP-SURS through emails from the Centers for Medicare & Medicaid Services. She decided to contact Qsource, the technical assistance provider in her region, to seek help selecting measures to report for the Advancing Care Information (ACI) category. Jane was so pleased with the help that Qsource provided that she has since called back with dozens of questions. “Someone always responds to my questions within 24 hours,” Jane said. “If they don’t know the answer, they research and follow up with me. Qsource also has facilitated conference calls with me and our EHR vendor and interpreted our QRUR reports.” Other resources Qsource has provided include links to CMS websites, templates for reporting, and “tips and tricks” to make attestation easier, such as keeping a spreadsheet of records. Jane says some of the tips she’s learned “maybe would have crossed my mind down the line, but when you’ve got so many things to think about, you don’t think of it. The QPP-SURS providers only focus on MACRA/MIPS, so they know all of the tricks. I think this service is a godsend and I can’t believe it’s free for all small, underserved, and rural Medicare clinicians.” So, if QPP has you befuddled or bewildered—be happier! Go to QPP.cms.gov/docs/QPP_Technical_ Assistance_Resource_Guide.pdf, find your regional technical assistance provider, and access the free expert help that will benefit your practice and your peace of mind! •
AANnews • November 2017
Apply by December 11 for 2018 Palatucci Advocacy Leadership Forum Only a few weeks remain to apply for the weekend that will change your life. The Palatucci Advocacy Leadership Forum will be held May 17 through 20, 2018, and your application must be submitted by December 11. Don’t miss this opportunity to learn how to become an advocacy leader in your clinic, institution, or community. Acquire skills that you can apply both professionally and personally to enrich your work and reinvigorate your sense of purpose. Visit AAN.com/view/PALF to learn more. •
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. For several years, the AAN has supported congressional efforts to create US postage stamps to raise awareness and funds for Alzheimer’s disease. The Postal Service recently announced it would create an Alzheimer’s postage stamp. Congress failed to renew federal funding for the Children’s Health Insurance Program (CHIP) before it expired on September 30. The AAN sent an action alert to request members to ask Congress to act to ensure coverage for more than nine million children. The AAN signed onto a letter led by the American Medical Association urging Congress to enact legislation to allow CMS to continue a flexible approach to MACRA implementation. AAN Government Relations Committee (GRC) member Donn Dexter, MD, FAAN, recently held a successful medical provider event for Rep. Ron Kind (D-WI), a member of the House Ways & Means Health Subcommittee. GRC member Sarah Song, MD, MPH, successfully led the recent first annual meeting of the Illinois State Neurological Society, with 95 attendees and nine exhibitors. AAN Board member and GRC Vice Chair James N. Goldenberg, MD, FAAN, was an AAN-sponsored speaker on MACRA. GRC member Janice Wiesman, MD, published an article in Practical Neurology titled “NeuroAdvocacy: Why Lobbying Matters.” AAN Board member Jonathan P. Hosey, MD, FAAN, will serve on a health care roundtable convened by Rep. Matt Cartwright (D-PA) to discuss the future of the Affordable Care Act. AAN members Allan Levey, MD, PhD, and Bradley Hyman, MD, PhD, will serve on the Advisory Council on Alzheimer’s Research, Care and Services, a group that convenes quarterly to advise the HHS secretary on federal programs that affect people with Alzheimer’s disease. •
AANnews • November 2017
QUIETING MS Quietly
for your patients with relapsing MS
*AUBAGIO is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and treatment discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.1,2
INDICATION AUBAGIO® (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. IMPORTANT SAFETY INFORMATION WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY • Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. • Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for 6 months after starting AUBAGIO. If drug-induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or activated charcoal. AUBAGIO is contraindicated in patients with severe hepatic impairment. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. • AUBAGIO is contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposure lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant. Please see additional Important Safety Information and Brief Summary of Full Prescribing Information, including boxed WARNING, on the following pages.
THINK BEYOND RELAPSES IN THE MANAGEMENT OF RMS
MAKE AN IMPACT ON DISABILITY PROGRESSION NOW TRE
IMPORTANT SAFETY INFORMATION (continued) CONTRAINDICATIONS • Patients with severe hepatic impairment. • Pregnant women and females of reproductive potential not using effective contraception. • Patients with a history of hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. • Co-administration with leflunomide. WARNINGS AND PRECAUTIONS • Hepatotoxicity: Patients with pre-existing acute or chronic liver disease, or those with serum ALT >2 times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. In clinical trials, if ALT elevation was >3 times the ULN on 2 consecutive tests, patients discontinued AUBAGIO and underwent accelerated elimination. Consider additional monitoring if co-administering AUBAGIO with other potentially hepatotoxic drugs; monitor patients who develop symptoms suggestive of hepatic dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine). • Teratogenicity: AUBAGIO may cause fetal harm when administered in pregnant women. Teratogenicity and embryo-fetal lethality occurred in animal reproduction studies in multiple animal species at plasma teriflunomide exposures similar to or lower than that in humans at the maximum human recommended dose of 14 mg/day. AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception. Women who become pregnant while taking AUBAGIO may enroll in the AUBAGIO pregnancy registry by calling 1-800-745-4447, option 2. • Procedure for Accelerated Elimination of Teriflunomide: Teriflunomide is eliminated slowly from the plasma—it takes an average of 8 months, or up to 2 years, to reach plasma concentrations <0.02 mcg/mL. Elimination may be accelerated by administration of cholestyramine or activated charcoal, but this may cause disease activity to return in patients who were responding to AUBAGIO.
Please see additional Important Safety Information and Brief Summary of Full Prescribing Information, including boxed WARNING regarding hepatotoxicity and use in pregnancy, on the following pages.
Start or switch to AUBAGIO (teriflunomide) 14 mg—the only oral DMT with a proven impact on disability progression in 2 Phase III trials ®
The majority of patients remained free from disability progression* with AUBAGIO 14 mg1
80 84 AN ESTIMATED
OVER 108 WEEKS (P =0.03)1†
OVER 108 WEEKS (P <0.05)1†
DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; RMS=relapsing forms of MS. *Disability progression was a secondary endpoint in TEMSO and TOWER.6,7 † Based on Kaplan-Meier estimates.1 TEMSO: A double-blind, placebo-controlled trial in patients with relapsing forms of MS (N=1088). Patients were randomized to receive AUBAGIO 14 mg (n=359), AUBAGIO 7 mg (n=366), or placebo (n=363) once daily for 108 weeks.6 TOWER: A double-blind, placebo-controlled trial in patients with relapsing forms of MS (N=1169). Patients were randomized to receive AUBAGIO 14 mg (n=372), AUBAGIO 7 mg (n=408), or placebo (n=389) once daily with results for up to 40 months of treatment.7
• The estimated proportion of patients with sustained disability progression: —TEMSO: 20.2%, 21.7%, and 27.3% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively1 —TOWER: 15.8%, 21.1%, and 19.7% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively1 • AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression versus placebo in either trial1 • Sustained disability progression was defined as at least a 1-point increase from baseline EDSS score ≤5.5 (or at least a 0.5-point increase for those with a baseline EDSS score >5.5) sustained for at least 12 weeks1 • AUBAGIO 14 mg and 7 mg achieved a significant relative reduction in risk of relapse in TEMSO (31% for both doses; P<0.05) and TOWER (36% and 22%, respectively; P<0.05)1
• Bone Marrow Effects/Immunosuppression Potential/Infections: Decreases in white blood cell counts, mainly of neutrophils and lymphocytes, and platelets have been reported with AUBAGIO. Thrombocytopenia, including rare cases with platelet counts less than 50,000/mm3, has been reported in the postmarketing setting. Obtain a complete blood cell count within 6 months before starting treatment, with further monitoring based on signs and symptoms of bone marrow suppression. AUBAGIO is not recommended for patients with severe immunodeficiency, bone marrow disease, or severe uncontrolled infections. Tuberculosis (TB) has been observed in clinical studies of AUBAGIO. Before starting treatment, screen patients for latent TB infection with a tuberculin test. Treatment in patients with acute or chronic infections should not be started until the infection(s) is resolved. Administration of live vaccines is not recommended. The risk of malignancy, particularly lymphoproliferative disorders, or infection may be increased with the use of some medications with immunosuppressive potential, including teriflunomide. • Hypersensitivity and Serious Skin Reactions: AUBAGIO can cause anaphylaxis and severe allergic reactions. Signs and symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Cases of serious skin reactions, including Stevens-Johnson syndrome and a fatal case of toxic epidermal necrolysis, have been reported with AUBAGIO. Very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms have also been reported with leflunomide. If a severe skin reaction develops with AUBAGIO, stop treatment and begin accelerated elimination. In such cases, patients should not be re-exposed to teriflunomide. • Peripheral Neuropathy: Peripheral neuropathy, including polyneuropathy and mononeuropathy, has been reported with AUBAGIO. Age >60 years, concomitant neurotoxic medications, and diabetes may increase the risk. If peripheral neuropathy is suspected, consider discontinuing treatment and performing accelerated elimination. • Increased Blood Pressure: Blood pressure increases and hypertension have occurred with AUBAGIO. Measure blood pressure at treatment initiation and manage any elevations during treatment. • Respiratory Effects: Interstitial lung disease (ILD), including acute interstitial pneumonitis, has been reported with AUBAGIO. ILD may be fatal and may occur acutely at any time during therapy with a variable clinical presentation. If discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure. (continued on back)
MAKE AN IMPACT ON DISABILITY PROGRESSION—START OR SWITCH TO AUBAGIO 1
The only oral DMT with a proven impact on disability progression in 2 Phase III trials1,4,5 • An estimated 80% of patients in TEMSO and 84% of patients in TOWER remained free from disability progression over 108 weeks with AUBAGIO® (teriflunomide) 14 mg1 • AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression versus placebo in either trial1 • Sustained disability progression was defined as at least a 1-point increase from baseline EDSS score ≤5.5 (or at least a 0.5-point increase for those with a baseline EDSS score >5.5) sustained for at least 12 weeks1
AUBAGIO kept a range of RMS patients free from relapse1 • AUBAGIO 14 mg and 7 mg achieved a significant relative reduction in risk of relapse in TEMSO (31% for both doses; P<0.05) and TOWER (36% and 22%, respectively; P<0.05)
One pill, once a day, taken with or without food1
• Health care professionals should run certain tests before prescribing AUBAGIO and should monitor patient liver enzyme levels monthly for the first 6 months
AUBAGIO is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and treatment discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.1,2
IMPORTANT SAFETY INFORMATION (continued) Adverse Reactions: The most frequent adverse reactions (≥10% and ≥2% greater than placebo) with AUBAGIO 7 mg and 14 mg and placebo, respectively, were headache (18% and 16% vs 15%), ALT increased (13% and 15% vs 9%), diarrhea (13% and 14% vs 8%), alopecia (10% and 13% vs 5%), and nausea (8% and 11% vs 7%). Drug Interactions: Monitor patients when teriflunomide is coadministered with warfarin, or with drugs metabolized by CYP1A2, CYP2C8, substrates of OAT3 transporters, substrates of BCRP, or OATP1B1/1B3 transporters. Use in Specific Populations: Women who wish to become pregnant should discontinue AUBAGIO and undergo an accelerated elimination procedure. Use of effective contraception should be continued until plasma concentrations of teriflunomide are <0.02 mcg/mL. Nursing mothers should not use AUBAGIO. AUBAGIO is detected in human semen. To minimize any possible fetal risk, men not wishing to father a child and their female partners should use effective contraception. Men wishing to father a child should discontinue therapy and either undergo accelerated elimination or verify plasma teriflunomide concentration is <0.02 mcg/mL. Please see additional Important Safety Information on the previous pages and Brief Summary of Full Prescribing Information, including boxed WARNING regarding hepatotoxicity and use in pregnancy, on the following pages. References: 1. AUBAGIO (teriflunomide) [package insert]. Cambridge, MA: Genzyme Corporation; November 2016. 2. Data on file, Sanofi/Genzyme. Summary of safety HMR1726teriflunomide. December 5, 2013. 3. Ziemssen T, De Stefano N, Pia Sormani M, Van Wijmeersch B, Wiendl H, Kieseier BC. Optimizing therapy early in multiple sclerosis: An evidence-based view. Mult Scler Relat Disord. 2015;4(5):460-469. 4. Tecfidera (dimethyl fumarate) [package insert]. Cambridge, MA: Biogen Inc.; February 2016. 5. Gilenya (fingolimod) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2016. 6. O’Connor P, Wolinsky JS, Confavreux C, et al; for the TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293-1303. 7. Confavreux C, O’Connor P, Comi G, et al; for the TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(3):247-256.
©2017 Genzyme Corporation. All rights reserved. AUBAGIO, Sanofi, and Genzyme registered in U.S. Patent and Trademark Office. GZUS.AUBA.15.01.0246(4) February 2017
AUBAGIO® (teriflunomide) tablets, for oral use
Brief Summary of Prescribing Information WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY • Hepatotoxicity Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1)]. If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3)]. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. • Risk of Teratogenicity AUBAGIO is contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with AUBAGIO in females of reproductive potential. Advise females of reproductive potential to use effective contraception during AUBAGIO treatment and during an accelerated drug elimination procedure after AUBAGIO treatment. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.1), and Clinical Pharmacology (12.3) in the full prescribing information].
1 INDICATIONS AND USAGE AUBAGIO® is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 2 DOSAGE AND ADMINISTRATION The recommended dose of AUBAGIO is 7 mg or 14 mg orally once daily. AUBAGIO can be taken with or without food. Monitoring to assess safety • Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions (5.1)]. • Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms of infection [see Warnings and Precautions (5.4)]. • Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions (5.4)]. • Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential [see Warnings and Precautions (5.2)]. • Check blood pressure before start of AUBAGIO treatment and periodically thereafter [see Warnings and Precautions (5.7)]. 4 CONTRAINDICATIONS AUBAGIO is contraindicated in/with: • Patients with severe hepatic impairment [see Warnings and Precautions (5.1)]. • Pregnant women and females of reproductive potential not using effective contraception. AUBAGIO may cause fetal harm [see Warnings and Precautions (5.2 and 5.3) and Use in Specific Populations (8.1)]. • Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5)]. • Coadministration with leflunomide [see Clinical Pharmacology (12.3) in the full prescribing information]. 5 WARNINGS AND PRECAUTIONS 5.1 Hepatotoxicity Severe liver injury including fatal liver failure and dysfunction has been reported in some patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. In placebo-controlled trials, ALT greater than three times the ULN occurred in 61/1045 (5.8%) and 62/1002 (6.2%) of patients receiving AUBAGIO 7 mg and 14 mg, respectively, and 38/997 (3.8%) of patients receiving placebo, during the treatment period. These elevations occurred mostly within the first year of treatment. Half of the cases returned to normal without drug discontinuation. In clinical trials, if ALT elevation was greater than three times the ULN on two consecutive tests, AUBAGIO was discontinued and patients underwent an accelerated elimi-
nation procedure [see Warnings and Precautions (5.3)]. Of the patients who underwent discontinuation and accelerated elimination in controlled trials, half returned to normal or near normal values within 2 months. One patient in the controlled trials developed ALT 32 times the ULN and jaundice 5 months after initiation of AUBAGIO 14 mg treatment. The patient was hospitalized for 5 weeks and recovered after plasmapheresis and cholestyramine accelerated elimination procedure. AUBAGIO-induced liver injury in this patient could not be ruled out. Obtain serum transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO. Consider additional monitoring when AUBAGIO is given with other potentially hepatotoxic drugs. Consider discontinuing AUBAGIO if serum transaminase increase (greater than three times the ULN) is confirmed. Monitor serum transaminase and bilirubin on AUBAGIO therapy, particularly in patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. If liver injury is suspected to be AUBAGIO-induced, discontinue AUBAGIO and start an accelerated elimination procedure [see Warnings and Precautions (5.3)] and monitor liver tests weekly until normalized. If AUBAGIO-induced liver injury is unlikely because some other probable cause has been found, resumption of AUBAGIO therapy may be considered. 5.2 Teratogenicity AUBAGIO may cause fetal harm when administered to a pregnant woman. Teratogenicity and embryo-fetal lethality occurred in animal reproduction studies in multiple animal species at plasma teriflunomide exposures similar to or lower than that in humans at the maximum human recommended dose (MHRD) of 14 mg/day [see Use in Specific Populations (8.1)]. AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception [see Contraindications (4) and Warnings and Precautions (5.3)]. 5.3 Procedure for Accelerated Elimination of Teriflunomide Teriflunomide is eliminated slowly from the plasma [see Clinical Pharmacology (12.3) in the full prescribing information]. Without an accelerated elimination procedure, it takes on average 8 months to reach plasma concentrations less than 0.02 mg/L, although because of individual variations in drug clearance it may take as long as 2 years. An accelerated elimination procedure could be used at any time after discontinuation of AUBAGIO. Elimination can be accelerated by either of the following procedures: • Administration of cholestyramine 8 g every 8 hours for 11 days. If cholestyramine 8 g three times a day is not well tolerated, cholestyramine 4 g three times a day can be used. • Administration of 50 g oral activated charcoal powder every 12 hours for 11 days. If either elimination procedure is poorly tolerated, treatment days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly. At the end of 11 days, both regimens successfully accelerated teriflunomide elimination, leading to more than 98% decrease in teriflunomide plasma concentrations. Use of the accelerated elimination procedure may potentially result in return of disease activity if the patient had been responding to AUBAGIO treatment. 5.4 Bone Marrow Effects/Immunosuppression Potential/Infections Bone Marrow Effects A mean decrease compared to baseline in white blood cell (WBC) count of approximately 15% (mainly neutrophils and lymphocytes) and in platelet count of approximately 10% was observed in placebo-controlled trials with 7 mg and 14 mg of AUBAGIO. The decrease in mean WBC count occurred during the first 6 weeks and WBC count remained low during treatment. In placebo-controlled studies, neutrophil count <1.5×109/L was observed in 12% and 16% of patients receiving AUBAGIO 7 mg and 14 mg, respectively, compared with 7% of patients receiving placebo; lymphocyte count <0.8× 109/L was observed in 10% and 12% of patients receiving AUBAGIO 7 mg and 14 mg, respectively, compared with 6% of patients receiving placebo. No cases of serious pancytopenia were reported in premarketing clinical trials of AUBAGIO but rare cases of pancytopenia and agranulocytosis have been reported in the postmarketing setting with leflunomide. A similar risk would be expected for AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. Cases of thrombocytopenia with AUBAGIO, including rare cases with platelet counts less than 50,000/mm3, have been reported in the postmarketing setting. Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms suggestive of bone marrow suppression. Risk of Infection / Tuberculosis Screening Patients with active acute or chronic infections should not start treatment until the infection(s) is resolved. If a patient develops a serious infection consider suspending treatment with AUBAGIO and using an accelerated elimination procedure. Reassess the benefits and risks prior to resumption of therapy. Instruct patients receiving AUBAGIO to report symptoms of infections to a physician. AUBAGIO is not recommended for patients with severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections. Medications like AUBAGIO that have immunosuppression potential may cause patients to be more susceptible to infections, including opportunistic infections. In placebo-controlled studies of AUBAGIO, no overall increase in the risk of serious infections was observed with AUBAGIO 7 mg (2.2%) or 14 mg (2.7%) compared to placebo (2.2%). However, one fatal case of klebsiella pneumonia sepsis occurred in a patient taking AUBAGIO 14 mg for 1.7 years. Fatal infections have been reported in the postmarketing setting in patients receiving leflunomide, especially Pneumocystis jiroveci pneumonia and aspergillosis. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness which, in addition to rheumatoid disease, may predispose patients to infection. In clinical studies with AUBAGIO, cytomegalovirus hepatitis reactivation has been observed. In clinical studies with AUBAGIO, cases of tuberculosis have been observed. Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or with a blood test for mycobacterium tuberculosis infection. AUBAGIO has not been studied in patients with a positive tuberculosis screen, and the safety of AUBAGIO in individuals with latent tuberculosis infection is unknown. For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with AUBAGIO.
Vaccination No clinical data are available on the efficacy and safety of live vaccinations in patients taking AUBAGIO. Vaccination with live vaccines is not recommended. The long half-life of AUBAGIO should be considered when contemplating administration of a live vaccine after stopping AUBAGIO. Malignancy The risk of malignancy, particularly lymphoproliferative disorders, is increased with the use of some immunosuppressive medications. There is a potential for immunosuppression with AUBAGIO. No apparent increase in the incidence of malignancies and lymphoproliferative disorders was reported in the AUBAGIO clinical trials, but larger and longer-term studies would be needed to determine whether there is an increased risk of malignancy or lymphoproliferative disorders with AUBAGIO. 5.5 Hypersensitivity and Serious Skin Reactions AUBAGIO can cause anaphylaxis and severe allergic reactions [see Contraindications (4)]. Signs and symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Cases of serious skin reactions, including cases of Stevens-Johnson syndrome (SJS) and a fatal case of toxic epidermal necrolysis (TEN), have been reported with AUBAGIO. In patients treated with leflunomide, the parent compound, very rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Inform patients of the signs and symptoms of anaphylaxis and angioedema and signs and symptoms that may signal a serious skin reaction. Inform patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, or hepatic dysfunction) may be drug-related. Instruct patients to discontinue AUBAGIO and seek immediate medical care should these signs and symptoms occur. Discontinue AUBAGIO, unless the reactions are clearly not drug-related, and begin an accelerated elimination procedure immediately [see Warnings and Precautions (5.3)]. In such cases, patients should not be re-exposed to teriflunomide [see Contraindications (4)]. 5.6 Peripheral Neuropathy In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), occurred more frequently in patients taking AUBAGIO than in patients taking placebo. The incidence of peripheral neuropathy confirmed by nerve conduction studies was 1.4% (13 patients) and 1.9% (17 patients) of patients receiving 7 mg and 14 mg of AUBAGIO, respectively, compared with 0.4% receiving placebo (4 patients). Treatment was discontinued in 0.7% (8 patients) with confirmed peripheral neuropathy (3 patients receiving AUBAGIO 7 mg and 5 patients receiving AUBAGIO 14 mg). Five of them recovered following treatment discontinuation. Not all cases of peripheral neuropathy resolved with continued treatment. Peripheral neuropathy also occurred in patients receiving leflunomide. Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy. If a patient taking AUBAGIO develops symptoms consistent with peripheral neuropathy, such as bilateral numbness or tingling of hands or feet, consider discontinuing AUBAGIO therapy and performing an accelerated elimination procedure [see Warnings and Precautions (5.3)]. 5.7 Increased Blood Pressure In placebo-controlled studies, the mean change from baseline to the end of study in systolic blood pressure was +2.3 mmHg and +2.7 mmHg for AUBAGIO 7 mg and 14 mg, respectively, and -0.6 mmHg for placebo. The change from baseline in diastolic blood pressure was +1.4 mmHg and +1.9 mmHg for AUBAGIO 7 mg and 14 mg, respectively, and -0.3 mmHg for placebo. Hypertension was an adverse reaction in 3.1% and 4.3% of patients treated with 7 mg or 14 mg of AUBAGIO compared with 1.8% for placebo. Check blood pressure before start of AUBAGIO treatment and periodically thereafter. Elevated blood pressure should be appropriately managed during treatment with AUBAGIO. 5.8 Respiratory Effects Interstitial lung disease, including acute interstitial pneumonitis, has been reported with AUBAGIO in the postmarketing setting. Interstitial lung disease and worsening of pre-existing interstitial lung disease have been reported during treatment with leflunomide. Interstitial lung disease may be fatal and may occur acutely at any time during therapy with a variable clinical presentation. New onset or worsening pulmonary symptoms, such as cough and dyspnea, with or without associated fever, may be a reason for discontinuation of therapy and for further investigation as appropriate. If discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure [see Warnings and Precautions (5.3)]. 5.9 Concomitant Use with Immunosuppressive or Immunomodulating Therapies Coadministration with antineoplastic, or immunosuppressive therapies used for treatment of multiple sclerosis has not been evaluated. Safety studies in which AUBAGIO was concomitantly administered with other immune modulating therapies for up to one year (interferon beta, glatiramer acetate) did not reveal any specific safety concerns. The long term safety of these combinations in the treatment of multiple sclerosis has not been established. In any situation in which the decision is made to switch from AUBAGIO to another agent with a known potential for hematologic suppression, it would be prudent to monitor for hematologic toxicity, because there will be overlap of systemic exposure to both compounds. Use of an accelerated elimination procedure may decrease this risk, but may also potentially result in return of disease activity if the patient had been responding to AUBAGIO treatment [see Warnings and Precautions (5.3)]. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: • Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1)] • Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4)] • Hypersensitivity and Serious Skin Reactions [see Contraindications (4) and Warnings and Precautions (5.5)] • Peripheral Neuropathy [see Warnings and Precautions (5.6)] • Increased Blood Pressure [see Warnings and Precautions (5.7)]
AUBAGIO® (teriflunomide) tablets, for oral use • Respiratory Effects [see Warnings and Precautions (5.8)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 2047 patients receiving AUBAGIO (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female. The average age was 37 years. Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for AUBAGIO patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea. The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo treatment arms, respectively). Table 1. Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis AUBAGIO AUBAGIO 7 mg 14 mg Placebo Adverse Reaction (N=1045) (N=1002) (N=997) Headache 18% 16% 15% Increase in Alanine aminotransferase 13% 15% 9% Diarrhea 13% 14% 8% Alopecia 10% 13% 5% Nausea 8% 11% 7% Paresthesia 8% 9% 7% Arthralgia 8% 6% 5% Neutropenia 4% 6% 2% Hypertension 3% 4% 2% Cardiovascular Deaths Four cardiovascular deaths, including three sudden deaths, and one myocardial infarction in a patient with a history of hyperlipidemia and hypertension were reported among approximately 2600 patients exposed to AUBAGIO in the premarketing database. These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between AUBAGIO and cardiovascular death has not been established. Acute Renal Failure In placebo-controlled studies, creatinine values increased more than 100% over baseline in 8/1045 (0.8%) patients in the 7 mg AUBAGIO group and 6/1002 (0.6%) patients in the 14 mg AUBAGIO group versus 4/997 (0.4%) patients in the placebo group. These elevations were transient. Some elevations were accompanied by hyperkalemia. AUBAGIO may cause acute uric acid nephropathy with transient acute renal failure because AUBAGIO increases renal uric acid clearance. Hypophosphatemia In clinical trials, 18% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels of at least 0.6 mmol/L, compared to 7% of placebo-treated patients; 4% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels at least 0.3 mmol/L but less than 0.6 mmol/L, compared to 0.8% of placebo-treated patients. No patient in any treatment group had a serum phosphorus below 0.3 mmol/L. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of AUBAGIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hypersensitivity reactions, some of which were severe, such as anaphylaxis and angioedema [see Warnings and Precautions (5.5)] • Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome [see Warnings and Precautions (5.5)] • Thrombocytopenia [see Warnings and Precautions (5.4)] • Interstitial lung disease [see Warnings and Precautions (5.8)] • Pancreatitis 7 DRUG INTERACTIONS Effect of AUBAGIO on CYP2C8 substrates Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on warfarin Coadministration of AUBAGIO with warfarin requires close monitoring of the international normalized ratio (INR) because AUBAGIO may decrease peak INR by approximately 25%. Effect of AUBAGIO on oral contraceptives AUBAGIO may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on CYP1A2 substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo. In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required [see Clinical Pharmacology (12.3) in the full prescribing information].
Effect of AUBAGIO on organic anion transporter 3 (OAT3) substrates Teriflunomide inhibits the activity of OAT3 in vivo. In patients taking AUBAGIO, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required [see Clinical Pharmacology (12.3) in the full prescribing information]. Effect of AUBAGIO on BCRP and organic anion transporting polypeptide B1 and B3 (OATP1B1/ 1B3) substrates Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo. For a patient taking AUBAGIO, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking AUBAGIO [see Clinical Pharmacology (12.3) in the full prescribing information]. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AUBAGIO during pregnancy. Healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2 Risk Summary AUBAGIO is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data. Human data are not available at this time to inform the presence or absence of drug-associated risk with the use of AUBAGIO during pregnancy. In animal reproduction studies in rat and rabbits, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum human recommended dose (MHRD) of 14 mg/day [see Data]. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. The background risk of major birth defects and miscarriage in the indicated population is unknown. Clinical Considerations Women who wish to become pregnant should discontinue use of AUBAGIO and undergo an accelerated elimination procedure to decrease the plasma concentration of teriflunomide to less than 0.02 mg/L (0.02 mcg/mL). Effective contraception should be used until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Human plasma concentrations of teriflunomide less than 0.02 mg/L (0.02 mcg/mL) are expected to have minimal embryofetal risk [see Contraindications (4) and Warnings and Precautions (5.3)]. If the patient becomes pregnant while taking this drug, stop treatment with AUBAGIO, inform the patient of the potential risk to the fetus, and perform the accelerated drug elimination procedure to achieve plasma concentrations of less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) in the full prescribing information]. Refer the patient to an obstetrician/gynecologist, preferably experienced in reproductive toxicity, for further evaluation and counseling [see Warnings and Precautions (5.2, 5.3)]. Data Animal Data When teriflunomide (oral doses of 1, 3, or 10 mg/kg/day) was administered to pregnant rats throughout the period of organogenesis, high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death were observed at doses not associated with maternal toxicity. Adverse effects on embryofetal development were observed following dosing at various stages throughout organogenesis. Maternal plasma exposure at the no-effect level (1.0 mg/kg/day) for embryofetal developmental toxicity in rats was less than that in humans at the maximum recommended human dose (MRHD, 14 mg /day). Administration of teriflunomide (oral doses of 1, 3.5, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and embryofetal death at doses associated with minimal maternal toxicity. Maternal plasma exposure at the no-effect dose (1.0 mg/kg/day) for embryofetal developmental toxicity in rabbits was less than that in humans at the MRHD. In studies in which teriflunomide (oral doses of 0.05, 0.1, 0.3, 0.6, or 1.0 mg/kg/day) was administered to rats during gestation and lactation, decreased growth, eye and skin abnormalities, and high incidences of malformation (limb defects) and postnatal death were observed in the offspring at doses not associated with maternal toxicity. Maternal plasma exposure at the no-effect dose for pre- and postnatal developmental toxicity in rats (0.10 mg/kg/day) was less than that in humans at the MRHD. In animal reproduction studies of leflunomide, embryolethality and teratogenic effects were observed in pregnant rat and rabbit at or below clinically relevant plasma teriflunomide exposures (AUC). In published reproduction studies in pregnant mice, leflunomide was embryolethal and increased the incidence of malformations (craniofacial, axial skeletal, heart and great vessel). Supplementation with exogenous uridine reduced the teratogenic effects in pregnant mice, suggesting that the mode of action (inhibition of mitochondrial enzyme dihydroorotate dehydrogenase) is the same for therapeutic efficacy and developmental toxicity. At recommended doses in humans, teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. 8.2 Lactation Risk Summary It is not known whether this drug is excreted in human milk. Teriflunomide was detected in rat milk following a single oral dose. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AUBAGIO and any potential adverse effects on the breastfed infant from AUBAGIO or from the underlying maternal condition.
AUBAGIO® (teriflunomide) tablets, for oral use 8.3 Females and Males of Reproductive Potential Pregnancy Testing Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential. Advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.1)]. Contraception Females Females of reproductive potential should use effective contraception while taking AUBAGIO. If AUBAGIO is discontinued, use of contraception should be continued until is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL). Females of reproductive potential who wish to become pregnant should undergo an accelerated elimination procedure. Effective contraception should be used until it is verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Males AUBAGIO is detected in human semen. Animal studies to specifically evaluate the risk of male-mediated fetal toxicity have not been conducted. To minimize any possible risk, men not wishing to father a child and their female partners should use effective contraception. Men wishing to father a child should discontinue use of AUBAGIO and either undergo an accelerated elimination procedure or wait until verification that the plasma teriflunomide concentration is less than 0.02 mg/L (0.02 mcg/mL) [see Warnings and Precautions (5.3)]. Infertility Administration of teriflunomide to male rats resulted in no adverse effects on fertility. However, reduced epididymal sperm count was observed [see Nonclinical Toxicology (13.1) in the full prescribing information]. Effects of AUBAGIO on fertility in humans have not been evaluated. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of AUBAGIO did not include patients over 65 years old. 8.6 Hepatic Impairment No dosage adjustment is necessary for patients with mild and moderate hepatic impairment. The pharmacokinetics of teriflunomide in severe hepatic impairment have not been evaluated. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3) in the full prescribing information]. 8.7 Renal Impairment No dosage adjustment is necessary for patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3) in the full prescribing information]. 10 OVERDOSAGE There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects. In the event of clinically significant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination [see Warnings and Precautions (5.3)].
Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 A SANOFI COMPANY November 2016 TER-BPLR-SA-NOV16
Pennsylvania Member Scores Advocacy Trifecta The AAN counts on its members to be strong advocates for neurology. Literally hundreds of members have participated in Neurology on the Hill (NOH), the Palatucci Advocacy Leadership Forum (PALF)—or both, like Amtul Farheen, MD, FAAN. A neuromuscular subspecialist at St. Luke’s University Health System, PA, Farheen got her first taste of advocacy by way of her state neurological society.
again, and even take that energy to your local communities. Neurology on the Hill was a great experience and it was the first time I learned about advocacy and subsequently got deeply involved in it. The AAN staff is phenomenal in training and laying out all we need to know about federal and state advocacy before we go to the Hill. My favorite part is going to the Capitol with green scarves and bow ties with several neurologists at varying stages of their career, all with one goal of advocating for patients and the Amtul Farheen, field of neurology and making our voices heard at MD, FAAN Capitol Hill. I have learned that our legislators and their staffs are really nice people and want to listen to us and value our opinion.”
“I received an email in late summer of 2015 from the then-president of the Pennsylvania Neurological Society, Dr. Partha Thirumala, for interested volunteers to serve on the PNS board or help organize its annual meeting. PNS is an organization dedicated to education and advocacy. I felt this was a great opportunity to serve the field of neurology in my state and I promptly responded and was willing to help in any way I could. I was nominated for the secretary/ treasurer position and I received immense support from PNS at every step.” Her experience with the society was illuminating to Farheen, and she’s seen the benefits of advocacy on a local, grassroots level. “I think it is important for every neurologist, regardless of their career stage, to be involved with their local and state neurological societies,” she said. “It helps us advocate for our patients and our profession and get involved with educational activities as well. It helps us bring a change in our local communities and also connects us with exceptional physicians in the field who are working for a noble cause. My favorite part of being involved with PNS was playing a key role in arranging its 2016 annual meeting and being able to do grassroots advocacy during the meeting. Our congressman cosponsored the FAST Act and we invited him to speak to us. This also helped to build our long-term relationship with the congressman’s office.” Not long after, Farheen’s mentors recommended she get involved in the AAN’s Neurology on the Hill. “I first applied in the fall of 2015 and I was accepted and went to the Capitol in February 2016. Once you go to Neurology on the Hill, there is such a force in the air that you want to do this again and
While there are innumerable issues that neurologists can support, Farheen has found two that particularly resonate with her. “I think the AAN puts forth real key issues in neurology like the FAST Act, research in neurology, and drug pricing, all of which are critical concerns. However, I think the FAST Act is most important to me as I believe ‘time is brain’ and teleneurology could prevent significant disability by saving time.” But on a more local level, Farheen is involved in building a relationship between her neurology department and the Muscular Dystrophy Association to facilitate setting up empowerment workshops for CMT and neuromuscular patients in her county in Pennsylvania. Seeking help focusing her goals and tactics, Farheen applied for and was accepted into the 2017 Palatucci Advocacy Leadership Forum. “PALF was an exceptional training,” she said. “I have been able to use the skills learned from journalists in our media workshops when I was approached by a local reporter for a phone interview. The legislative training has helped me sharpen my advocacy skills. Also, creating relationships and networking with all the PALF graduates is invaluable.” Farheen takes her commitment to advocacy one step further by donating to BrainPAC (donations to BrainPAC are limited to US members only). “It is the only political action committee that is dedicated solely to neurology. I feel it is an important tool to help educate legislators about critical issues facing us neurologists, our field, and our patients.” Farheen offers this advice to AAN members: “Get involved and build relationships with your local legislative members. It helps us feel engaged and reduces burnout while at the same time it helps advocate for our patients and our profession.” NOH, PALF, and BrainPAC—it’s an advocacy trifecta. And thanks to the passionate advocacy of Farheen and hundreds like her, we’re all winners. • Amtul Farheen, MD, FAAN, and AAN Board Member Jonathan P. Hosey, MD, FAAN (left) met with Republican Rep. Charlie Dent (PA-15) during Neurology on the Hill.
AANnews • November 2017
Free Online Resources Can Help You Meet Your Year-end CME and MOC Requirements Preparing for your year-end CME and MOC requirements? The AAN has a variety of quality, convenient online resources that can be accessed from virtually anywhere—home or office—that are included free with your AAN membership! nn NeuroPISM
Online performance improvement program meets the ABPN MOC Part 4 Performance in Practice component requirements in addition to offering 20 CME credits. nn NeuroSAE®
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Earn .5 AMA PRA Category 1 Credit when you listen to weekly podcasts from Neurology and answer the accompanying online questions. Visit AAN.com/cme-and-moc/ online-learning-programs to get started earning your important CME before the year is out. •
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AANnews • November 2017
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UCNS Issues Neuro-oncology Certifications and Recertifications The United Council for Neurologic Subspecialties (UCNS) has issued new certifications and recertifications in Neuro-oncology. A total of 33 people received certification and 20 people received recertification. UCNS certification is a measure of expertise demonstrating that these physicians are properly trained and experienced in Neuro-oncology.
“We were happy to see that a high percentage of physicians who were due for recertification chose to take the exam, which demonstrates their commitment to lifelong learning and shows that they continue to find value in their UCNS certifications.” For a list of the newly certified and recertified diplomates, visit UCNS.org. •
“We now have 240 physician diplomates certified in Neuro-oncology, the highest distinction of expertise in this neurologic subspecialty,” said Matthew E. Fink, MD, FAAN, chair of the UCNS Certification Council.
Are You Getting Your AANe-news? Don’t miss the latest news headlines from your Academy! As an exclusive member benefit, you should be receiving AANe-news ™ the second and fourth Wednesday of each month if your email address is on file. If not, be sure to set your email filter to accept firstname.lastname@example.org as a friendly address. Or update your email address at AAN.com/MemberProfile.
It’s Not Spam... It’s AANe-news! 20
AANnews • November 2017
CME Tracker Available for UCNS Diplomates UCNS diplomates can use the organization’s CME tracker to keep track of credits needed to maintain certification. The online tool is available for diplomates, but is not required. AAN members may use the AAN’s NeuroTrackerTM for the same purpose. To request access to or log in to the UCNS CME tracker, visit “Login” in the upper right corner at UCSN.org. •
Ad Page Approximately one-third of people with Parkinson’s in the U.S. experience OFF periods.1-3 For people with Parkinson's, unexpected symptoms can affect their ability to move and engage in usual activities.4 In a 2014 survey of > 3,000 people with Parkinson's, two-thirds of respondents reported having more than two hours of OFF time per day.5
1. Statistics on Parkinson’s. Parkinson's Disease Foundation. http://www.pdf.org/en/parkinson_ statistics. Accessed July 2017. 2. Ahlskog JE et al. Mov Disord. 2001;16(3):448-458. 3. Decision Resources. Parkinson’s Disease (Report: January 2015). 4. Hechtner MC et al. Parkinsonism Relat Disord. 2014;20:969-974. 5. The Michael J. Fox Foundation Survey of Parkinson’s Patients’ Off Time Experience, July 2014. ACORDA THERAPEUTICS® and the stylized ACORDA THERAPEUTICS® logo are registered trademarks of Acorda Therapeutics, Inc. ©2017 Acorda Therapeutics, Inc. All rights reserved.
Workload, Threats to Professionalism Top Causes of Burnout Among Neurologists Continued from cover The qualitative study complements the quantitative study on neurologist burnout published earlier this year. Both analyzed responses to a 2016 AAN survey of US members on burnout, career satisfaction, and well-being. While the first study looked at the answers to multiple choice questions and found that 60 percent of neurologists experienced at least one symptom of burnout, this new study took a deeper dive, examining neurologists’ written responses to an open-ended question at the end of that survey. “It is a top priority of the AAN to understand all possible causes of burnout as we continue to develop mitigation strategies for our members,” said lead author Janis Miyasaki, MD, FAAN, of the University of Alberta in Edmonton and treasurer of the AAN. “The findings of this study further characterize burnout through the voices of neurologists and provide strategic direction for advocacy as well as for programs that aim to prevent and mitigate neurologist burnout while promoting well-being and engagement.” For this study, the authors evaluated 676 free text responses to the final question on the 2016 survey, “Is there anything else you would like to share with the AAN regarding burnout and well-being?”
Using inductive data analysis, researchers identified four categories of comments: 1. Policies and people affecting neurologists 2. Workload and work-life balance 3. Engagement, professionalism, and work domains specific to neurology 4. Solutions, advocacy, and other Key findings were that when neurologists described burnout, they mentioned workload most often followed by erosion of professional identity as well as insurance and regulatory hassles as roadblocks to providing care. Neurologists also said that the amount of clerical and patient workload led to increased work hours or work brought home, resulting in poor work-life balance. They identified electronic health records as a significant source of strain, saying that more time spent “charting,” specifically clicking boxes to satisfy third-party payers, reduced their ability to engage fully with a patient during a visit. The insights from this study enhance understanding of the responses to the other survey questions about burnout, creating another tool the AAN will use as it continues to create programs to reduce burnout for neurologists and work to reduce regulatory hassles as it advocates on their behalf in Washington, DC, and around the nation. To learn more about tips, tools, and strategies to help mitigate burnout, visit AAN.com/LiveWell. •
Live Well Lead Well Taking Care of Your Patients Starts with Taking Care of You
AANnews • November 2017
Seeking Applications for 2018 Diversity Leadership Program December 18 is the deadline to apply for the prestigious and interactive, all-expenses paid 2018 AAN Diversity Leadership Program. Up to 10 participants will be selected for this nine-month program to engage with AAN leadership and staff, develop their leadership skills, and contribute to a group project to present to the AAN Board of Directors. The Diversity Leadership Program is a crucial aspect of the AAN’s strategy intended to identify, mentor, and engage AAN members from underrepresented minority groups. The program is designed to: nn Provide leadership opportunities
The Diversity Leadership Program has been invaluable to me and went beyond developing me as a leader. This program has allowed me to feel valued as a member, a neurologist, an educator, and as a person. My involvement with the AAN has helped me find wellness and inspiration in many of the things I have done (and will do) professionally. The Diversity Leadership Program has been instrumental in my career, and I hope this program continues. I am thankful that I have had such support from the AAN and that the AAN is invested in diversity and inclusion. —Rachel Salas, MD, FAAN Johns Hopkins University, 2015 Diversity Leadership Program Graduate
nn Provide participants with
mentoring and group coaching to enhance their career development and expand their professional networks
nn Encourage and develop a more diverse membership that
is equipped to lead
nn Demonstrate to the recipients the long-term benefits of
neurology: African American/Black, Hispanic/Latino, American Indian, Native Hawaiian, or Alaska Native ethnicity. Visit AAN.com/view/Diversity for application requirements and to apply by December 18. •
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 are encouraged to apply. Applicants must be a US AAN member and from an underrepresented minority group in
AANnews • November 2017
AAN Leaders Represent Academy in Kyoto AAN leadership attended the 23rd World Congress of Neurology in Kyoto, Japan, in September. Representing the Academy were President Ralph L. Sacco, MD, MS, FAHA, FAAN; Immediate Past President Terrence L. Cascino, MD, FAAN; and Executive Director/CEO Catherine M. Rydell. Cohosted by the Japanese Society of Neurology and Asian and Oceanian Association of Neurology, the event’s theme was “Defining the Future of Neurology.” Sacco was the regional representative and the AAN’s delegate to the general assembly meeting, where new officers and trustees were elected. Cascino shared his work and insights on neurologist burnout and well-being, a focus for him during his recent presidency. •
Along with participating in the traditional kagami biraki ceremony to open a barrel of sake, AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN, also chaired the North American Regional Symposium that addressed Treatments and Prevention of Common Neurological Disorders.
Immediate Past President Terrence L. Cascino, MD, FAAN, addressed the topic of burnout and well-being at the conference.
Maintain Essential Education and Science, Incomparable Support by Renewing Your Membership Today It’s time to renew your membership for 2018. Remember: Only your AAN membership provides a single source for all the career support and education you need to thrive throughout your professional lifetime. By renewing today, you will continue to: nn Access complimentary AAN online programs to earn CME and help meet
nn Be the first to know about the latest scientific research and news
affecting the neuroscience community
nn Access member-only resources including clinical practice
guidelines and publications, including Neurology ® journal
nn Connect with a network of more than 32,000 neurologists
and neuroscience professionals worldwide
nn Save big on Annual Meeting registration, Continuum®,
and other AAN products and services
nn Contribute to public policy issues by representing your issues
at the federal, state, and local level
Find the full list of member benefits on AAN.com/Benefits or visit AAN.com/Dues to renew your 2018 membership today. •
AANnews • November 2017
Solve the case of his lifetime Identifying the link can lead to a crucial diagnosis1-5 Hereditary ATTR amyloidosis is an inherited, rapidly progressive disease that causes sensory-motor polyneuropathy that may be accompanied by autonomic or cardiac symptoms, eventually robbing patients of function—and even their lives. With increased research and development in hATTR amyloidosis, now it is more critical than ever to be aware of red-flag symptom clusters and investigate potential cases.
See the connections at: InvestigateRedFlagSymptoms.com
Not an actual patient.
References: 1. Conceição I, González-Duarte A, Obici L, et al. “Red-flag” symptom clusters in transthyretin familial amyloid polyneuropathy. J Peripher Nerv Syst. 2016;21(1):5-9. 2. Hanna M. Novel drugs targeting transthyretin amyloidosis. Curr Heart Fail Rep. 2014;11(1):50-57. 3. Adams D, Coelho T, Obici L, et al. Rapid progression of familial amyloidotic polyneuropathy: a multinational natural history study. Neurology. 2015;85(8):675-682. 4. Damy T, Judge DP, Kristen AV, et al. Cardiac findings and events observed in an open-label clinical trial of tafamidis in patients with non-Val30Met and non-Val122lle hereditary transthyretin amyloidosis. J Cardiovasc Transl Res. 2015;8(2):117-127. 5. Mohty D, Damy T, Cosnay P, et al. Cardiac amyloidosis: updates in diagnosis and management. Arch Cardiovasc Dis. 2013;106(10):528-540.
© 2017 Alnylam Pharmaceuticals, Inc. All rights reserved. 05.2017
For All You Have Done, Thank You As the season of thanksgiving begins, the American Brain Foundation would like to sincerely thank the many members of the AAN and Academy staff for your financial support. We appreciate your support and we are leveraged for success because of your donations online, on our new crowdfunding site, of members’ honoraria, during dues renewal, in response to our letters, and through our employee giving campaign. Our challenges are big, and there is much research to fund, and we thank you for your endorsement of our work! Visit our crowdfunding site at AmericanBrainFoundation.org to see the initial projects and learn how you can submit a project to be funded—or discover research that deserves your support. The American Brain Foundation also has a strong track record of partnership with organizations to fund specific brain disease research. So much vital work would be left undone without the generosity of these funding partners. Please join us in expressing our deep gratitude for their philanthropy. The ALS Association Alzheimer’s Association American Academy of Neurology American Epilepsy Society American Heart Association Consortium of Multiple Sclerosis Centers Epilepsy Foundation International Headache Society Mary E. Groff Charitable Trust McKnight Brain Research Foundation
AANnews • November 2017
Muscle Study Group Muscular Dystrophy Association Myasthenia Gravis Foundation of America National Ataxia Foundation National Multiple Sclerosis Society Parkinson’s Foundation Society of Vascular and Interventional Neurology Tourette Association of America William Randolph Hearst Foundation •
Mark Your Calendar for Laughter! Michael Pritchard, American comedian and nationally acclaimed keynote speaker and motivator, will highlight the American Brain Foundation’s Commitment to Cures event at the AAN Annual Meeting on Wednesday, April 25, 2018, at the JW Marriott in Los Angeles. Sponsorship opportunities are available now, and tickets will be available in December. Visit AmericanBrainFoundation. org/news-events for more information. •
Letâ€™s All Commit To Outsmarting Brain Disease. The American Brain Foundation is the central driving force behind bringing all neurologists, researchers, patients, and caregivers together to help generate funding for and awareness of brain disease.
By examining the whole brain, we get the whole picture. Because we believe itâ€™s all connected. So a cure for one disease could be a cure for others.
Mission: The American Brain Foundation brings researchers and donors together to defeat brain disease. For more information, visit www.AmericanBrainFoundation.org
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.
Neurologist Androscoggin Valley Hospital is seeking a fulltime Neurologist in rural Northern NH. We offer an unsurpassed quality of life with lower overall cost of living and no income or sales tax. We also offer the opportunity to spend more time with and get to know each of your patients on a more personal level. The pace of the day at AVH is reasonable and cases include, but are not limited to, the usual mix of stroke, headache, dementia, seizure disorders, gait disturbance, tremor, multiple sclerosis, Parkinson’s disease, carpal tunnel syndrome, back pain with radiculopathy, and neurovascular disease. This unique opportunity offers you autonomy and leadership with the reassurance of Dartmouth Hitchcock Medical Center just a few hours away, with 38 Neurology team members, and Littleton Regional Hospital only an hour away with its own Neurologist on staff. Further, AVH is part of the North Country Healthcare system. The neurologist at AVH sees patients 4 days per week from 8 a.m. to 5 p.m. Office time is also used for the performance of neurology diagnostics, such as NCS and EMG’s. Interpretation of NCS, EMG’s, and EEG’s is conducted after office hours or on the neurologist’s fifth day of the week. A The fifth day of the week is available as an administrative day with time allotted, as needed, for the neurologist to complete other clinical work when not seeing patients in the clinic or hospital. There is no call requirement for the Neurologist at AVH. This is a salaried position with a productivity inventive plan and the opportunity to earn up to an additional $15,000 annually in good citizenship incentives. Generous vacation, health/ dental, CME funds, retirement account, and other benefits provided. Commencement Bonus available. Candidates must be currently competent in the performance of NCS/ EMG studies and the interpretation of NCS, EMG, and EEG studies. More specifically, candidates must have at least 6 months full-time or its equivalent of supervised training in electrodiagnostic medicine (residency or fellowship), interpreted at least 200 EMG’s and 200 NCS under the supervision of an experienced electrodiagnostic medicine consultant, interpreted at least 250 EEG’s under the supervision of an expert electroencephalographer, and (if not coming directly from post graduate training to AVH/
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AANnews • November 2017
LRH) must have maintained competence by showing evidence that he/she has performed at least 50 EMG interpretations annually over last two years, 200 NCS interpretations annually over last two years, and 50 EEG interpretations annually over last two years. AVH performs about 7 EEG’s, 10 EMG’s, and 10 NCS per month. To qualify for clinical privileges at AVH and LRH, a physician must have completed a (full) neurology residency in United States (ACGME approved) or Canada; have sufficient, recent neurology experience; and be currently clinically competent. Board certification in one’s specialty is required within 5 years of completion of residency training. Required skills/ expertise include management of common neurology conditions for adults and comfort working in a small, rural community with only two neurology colleagues. Special interest and expertise in one or two areas of neurology preferred. Interest, experience, and clinical training in care of adolescents (>age 12 or age 16) or children (>age 6) would be a plus but is not required. Neurologic care of patients under age 18 may also be limited to specific diagnoses. We will consider selected new residency graduates as candidates for this position as well as H-1B and J-1 visa candidates. Excellent spoken English and interpersonal skills are required. If you are interested in this opportunity, please reply with complete CV to email@example.com Neurologist Exceptional opportunity for hardworking, motivated general and/or subspecialty-trained neurologist(s) to join a large private, busy, well-respected adult neurology practice. Our diverse practice consists of 18 neurologists, six neuropsychologists and includes eight offices in suburban Maryland (Montgomery County) and Washington, DC plus a high-end sleep lab. The practice size and geographic range served allow us to foster the development of subspecialty practices (i.e. Neuroophthalmology, Neuromuscular disease, etc.), so those with such expertise are enthusiastically sought. Additionally, we are an out-patient practice with very limited hospital call which affords our medical team a much improved work-life balance. An excellent compensation and, benefit package plus early
partnership are available. Please send CV and letter of interest to: The Neurology Center, PA, c/o Ezra D. Cohen, MD, 1201 Seven Locks Road, Suite 101 Rockville, MD 20854 or via email to firstname.lastname@example.org. Please visit our website at neurologycenter.com. Fellowship in Neuroimaging Winchester Neurological Consultants, Inc., in conjunction with Virginia Commonwealth University and Winchester Medical Center, is offering a clinical Neuroimaging Fellowship for BC/BE neurology graduates that can be completed in one or two years. Located approximately an hour from Washington, DC, our United Council of Neurologic Subspecialties fully accredited fellowship offers extensive training in the performance and interpretation of diagnostic inpatient and outpatient MRI, CT, Doppler, TCD, and myelography— utilizing four state of the art MRI scanners and four multislice CT units. Responsibilities include supervision and interpretation of imaging, assisting with acute stroke protocols, and direct patient care. Availability: immediate. Research interests are encouraged. Salary is $60,000.00 per year plus benefits. CV’s should be emailed to email@example.com
AANnews® Classified Advertising T he AAN offers a complete package of print, online, and in-person recruitment advertising opportunities. Visit AAN.com/Careers for all AAN options, rates, and deadlines.
d copy for the January 2018 print edition of A AANnews must be submitted by December 1, 2017. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the T right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.
Fill Your Open Job The hottest jobs meet the top candidates at the AAN Neurology Career Center.
Dates and Deadlines SUN 5
Application Deadline: Neurology on the Hill
Registration Deadline: RITE® (Residency In-service Training Examination) AAN.com/view/RITE
Early Registration Deadline: 2018 AAN Breakthroughs in Neurology Conference Orlando, FL AAN.com/view/Breakthroughs
NOVEMBER 7 Webinar: iNeurology: Best IT Practices
(Register by November 6) AAN.com/view/PMW17
NOVEMBER 30 Submission Deadline: Frank A. Rubino Award for Excellence in Clinical Neurology Teaching AAN.com/view/FrankRubino Submission Deadline: A.B. Baker Teacher Recognition Award AAN.com/view/ABBaker Submission Deadline: Clerkship Coordinator Recognition Award AAN.com/view/ClerkshipCoordinator Submission Deadline: Clerkship Director Innovation Award AAN.com/view/ClerkshipInnovation Submission Deadline: Clerkship Director Teaching Award AAN.com/view/ClerkshipTeaching Submission Deadline: Medical Student Scholarship to the Annual Meeting AAN.com/view/MedStudentScholarship
Application Deadline: UCNS Fellowship Training Program Accreditation UCNS.org/index.cfm
DECEMBER 5 Free Webinar: New Year, New Rules: Preparing for 2018 (Register by December 4) AAN.com/view/PMW17
DECEMBER 8 Housing Deadline: Breakthroughs in Neurology Conference AAN.com/view/Breakthroughs Housing Deadline: Career Essentials Conference AAN.com/view/CareerEssentials Submission Deadline: Resident Scholarship to the Annual Meeting AAN.com/view/ResidentScholarship Submission Deadline: Fellow Scholarship to the Annual Meeting AAN.com/view/FellowshipScholarship Submission Deadline: Program Director Recognition Award AAN.com/view/ProgramDirectorAward
Early Registration Deadline: Career Essentials Conference Orlando, FL AAN.com/view/CareerEssentials
JANUARY 12–15 2018 AAN Breakthroughs in Neurology Conference Orlando, FL AAN.com/view/Breakthroughs
JANUARY 13–15 Career Essentials Conference Orlando, FL AAN.com/view/CareerEssentials
SAVE THE DATES APRIL 21–27, 2018
Submission Deadline: Program Coordinator Recognition Award AAN.com/view/ ProgramCoordinatorAward
AAN Annual Meeting, Los Angeles
Application Deadline: Palatucci Advocacy Leadership Forum AAN.com/view/PALF
DECEMBER 18 Application Deadline: Diversity Leadership Program AAN.com/view/Diversity
AANnews • November 2017
A deeper look at the science behind migraine
Beyond the actual pain of migraine is the everyday impact on patientsâ€™ lives. Today, a growing understanding of the CGRP neuropeptide brings new insights to the science behind the migraine experience. CGRP = calcitonin gene-related peptide.
Le a rn m o re a t
scienceofm ig ra i ne.co m
ÂŠ 2017 Amgen Inc. All rights reserved. USA-334-053710
Published on Oct 19, 2017