VOLUME 31 · ISSUE 9 · SEPTEMBER 2017
Y O U R M O N T H LY A A N M E M B E R S H I P M A G A Z I N E
2018 Annual Meeting Abstract Submission Opens This Month Your work could be seen by more than 14,000 neurologists, neuroscientists, and researchers from around the world if your abstract is selected for the 2018 AAN Annual Meeting, to be held in Los Angeles, CA, April 21 through 27. Online abstract submission opens September 7 at AAN.com/view/18Abstracts and submissions are due no later than 11:59 p.m. CT on Monday, October 23. Because the Annual Meeting is a multi-disciplinary event that attracts attendees from around the globe, abstracts will be accepted in all facets of neurology and neuroscience and could be chosen for Neuroscience in the Clinic sessions, “Best Of” sessions, scientific platform or poster sessions. For more information, contact firstname.lastname@example.org or (612) 928-6088.
“This is an excellent opportunity to showcase your work and share your expertise with over 14,000 of your peers! I look forward to receiving your abstract submissions.” —Natalia S. Rost, MD, MPH, FAAN, FAHA Chair, AAN Science Committee
Medicare Proposed Save the Date: Fee Schedule Reflects Breakthroughs in AAN’s Successful Input Neurology Conference The Centers for Medicare & Medicaid Set for January 12–15 Services (CMS) recently released its Medicare Proposed Fee Schedule, and again the AAN had an impact on shaping the draft regulations to help reduce the burden on neurologists. The AAN met with Health and Human Services Secretary Tom Price, MD, and officials with CMS to advocate for these three specific changes. CMS listened and the proposed fee schedule is proof our regulatory advocacy efforts are working on behalf of our members.
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Mark your calendars for the 2018 Breakthroughs in Neurology Conference, set to take place January 12 through 15 at the Caribe Royale in Orlando, FL. This popular conference will offer a unique and convenient opportunity to earn valuable CME credits in one weekend while getting a year-in-review of the best neurology science and education.
Continued on page 25
THIS ISSUE 6 23 30
Master Quality Improvement Using EHR or Axon Registry Apply or Nominate Colleagues for Prestigious AAN Scientific Awards New Scholarships Offer $1.65 Million for Research in Cognitive Aging and Age-related Memory Loss
SUPER-REFRACTORY STATUS EPILEPTICUS (SRSE) IS
A CRITICAL PUZZLE OF CLINICAL COMPLEXITY 1-3 SRSE is a life-threatening form of status epilepticus (SE) that continues or recurs for >24 hours despite multiple therapeutic interventions (first-, second-, and third-line agents).3,4
Ad Page THE BURDEN OF SRSE IS HIGH5 Approximately 65% to 70% of patients with refractory SE or SRSE will die or be left with neurological deficits1,6 Outcomes of refractory seizures worsen with longer duration of uncontrolled seizure activity,7 including risk of neuronal death,7-9 neuronal injury,7-9 and alteration of neuronal networks3,4 Limited evidence exists to guide treatment decisions for patients with SRSE after third-line treatment failure3,4,10
Visit SRSE.com to learn more. References: 1. Delaj L, Novy J, Ryvlin P, Marchi NA, Rossetti AO. Refractory and super-refractory status epilepticus in adults: a 9-year cohort study. Acta Neurol Scand. 2017;135(1):92-99. 2. As reviewed in Bayrlee A, Ganeshalingam N, Kurczewski L, Brophy GM. Treatment of super-refractory status epilepticus. Curr Neurol Neurosci Rep. 2015;15(10):66. 3. As reviewed in Shorvon S, Ferlisi M. The treatment of super-refractory status epilepticus: a critical review of available therapies and a clinical treatment protocol. Brain. 2011;134(Pt 10):2802-2818. 4. As reviewed in Hocker S, Tatum WO, LaRoche S, Freeman WD. Refractory and super-refractory status epilepticus â€“ an update. Curr Neurol Neurosci Rep. 2014;14(6):452. 5. Beg JM, Anderson TD, Francis K, et al. Burden of illness for super-refractory status epilepticus patients. J Med Econ. 2017;20(1):45-53. 6. As reviewed in Ferlisi M, Shorvon S. The outcome of therapies in refractory and super-refractory convulsive status epilepticus and recommendations for therapy. Brain. 2012;135(Pt 8):2314-2328. 7. Scholtes FB, Renier WO, Meinardi H. Generalized convulsive status epilepticus: causes, therapy, and outcome in 346 patients. Epilepsia. 1994;35(5):1104-1112. 8. As reviewed in Payne TA, Bleck TP. Status epilepticus. Crit Care Clin. 1997;13(1):17-38. 9. As reviewed in Meldrum B. Excitotoxicity and epileptic brain damage. Epilepsy Res. 1991;10(1):55-61. 10. Glauser T, Shinnar S, Gloss D, et al. Evidence-based guideline: treatment of convulsive status epilepticus in children and adults: report of the Guideline Committee of the American Epilepsy Society. Epilepsy Curr. 2016;16(1):48-61.
ÂŠ 2017 Sage Therapeutics, Inc.
Official Publication of the American Academy of Neurology
PUBLICATION The Vision of the AAN is to be indispensable to our members. The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. Contact Information American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415 Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:
Website: AAN.com For advertising rates, contact: Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins Phone:
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
Table of Contents
2018 Annual Meeting Abstract
Submission Opens This Month
Medical Student Diversity Program
23 Apply or Nominate Colleagues for
Save the Date: Breakthroughs
24 Neurology Podcast Marks
Reflects AAN’s Successful Input in Neurology Conference Set for January 12–15
4 AAN Task Force Takes on High Drug Costs
MEET YOUR LEADER
5 James N. Goldenberg, MD, FAAN
6 Master Quality Improvement Using EHR or Axon Registry
6 Practice Management Questions? Just Ask email@example.com
7 Use New Quality Measurement
Set for Inpatient and Emergency Care
7 Help Expel Concussion from School Sports
10 AAN Publications Reap New Awards
12 Capitol Hill Report
14 Palatucci Forum Project Helps
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.
22 Applications Now Open for
Medicare Proposed Fee Schedule
Designers: Siu Lee and Jim Hopwood
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.
RESEARCH & AWARDS
Prestigious AAN Scientific Awards 10th Anniversary
27 Preparing for Fall ABPN MOC Exam? This Online Resource Can Help
28 UCNS: Recognizing the
Importance of Emerging Subspecialties
29 Enhanced Resident Leadership Program Application Opens This Month
29 Prepare Now for October 16–22 Neurology Career Week
AMERICAN BRAIN FOUNDATION
30 New Scholarships Offer $1.65
Million for Research in Cognitive Aging and Age-related Memory Loss
CAREERS | 31 DATES AND DEADLINES | 31
Produce Foundation Crowdfunding Platform
NEWS BRIEFS Chair Natalia S. Rost, MD, MPH, FAAN, and members of the AAN Science Committee met with representatives from the BRAIN Initiative to discuss mutually beneficial collaborations in research. The Brain Initiative is a public-private collaboration developed by the White House in 2013 to support the development and application of innovative technologies that can create a dynamic understanding of brain function. A new NeuroLearn: Lumbosacral Plexus online learning course is now available. The new course offers three CME credits and allows members to learn how to accurately diagnose a mononeuropathy (e.g., fibular neuropathy), lumbosacral plexopathy, or radiculopathy on the basis of a bedside clinical examination rather than relying on electrodiagnostic or imaging studies. Visit AAN.com to learn more. •
AANnews • September 2017
AAN Task Force Takes on High Drug Costs I think it is safe to say that many of our members who treat patients are aware of the high cost of many of the neurologic drugs in the United States. We understand that these costs— even with insurance—can have a severe economic impact on our patients and certainly drive up the expense of health care in this country. Many of us have heard our patients and their families express dire concerns about whether they could continue to take an effective medication that is controlling their condition and helping them maintain a high quality of life. Other patients do not take medicines as prescribed because of the high cost of a prescription. This is particularly true for patients with chronic neurological conditions that often require life-long therapy. Your Academy has been aware of this, too. Earlier this year, the AAN approved a position statement on Prescription Drug Prices (you can read this at AAN.com/view/positionstatement). As the document points out, many therapies for neurologic disease are among the most expensive in the US. Neurologists also are limited by few, if any, therapies available in a particular class of medications. For example, the recently approved therapies for Duchenne muscular dystrophy and spinal muscular atrophy are expected to cost $300,000 and $750,000 in the first year of treatment, respectively. These medications likely will require many years of therapy starting at a very young age. There are very few families who can afford such drugs. Additionally, some drugs that have even been approved for many years, are available as generics, or have multiple options available have greatly increased in price. Setting aside the financial enormity of such a burden, stratospheric price tags for these and other medications can be emotionally devastating to patients and family caregivers just as they need to have a laser-beam focus on treating the physical aspects of their disorder. Then, add insult to injury when patients learn that their medications—if available in Canada or overseas—may be considerably less expensive and they are unable to access this cheaper cost.
A couple decades ago in Washington, politicians aligned with the pharmaceutical industry ensured that the federal government would be unable to negotiate drug pricing under Medicare’s Part D coverage. Rather than being able to bring the weight of its purchasing power to bear on these unchecked prices, Medicare, the country’s largest single-payer health care system, has seen its costs balloon to Ralph L. Sacco, MD, MS, FAHA, FAAN unsustainable levels. The Centers for Medicare & Medicaid Services has projected that drug costs in the US will rise to $406 billion at the end of this decade from $272 billion in 2013, driven in part by higher priced “specialty” drugs. In Congress, the AAN has advocated for several pieces of legislation that are consistent with our position, including the Improving Access to Affordable Prescription Drugs Act introduced by Minnesota Sen. Al Franken to address the main areas of concern outlined in the AAN’s position statement: price negotiation, transparency, and importation. We also have been working with the National MS Society on their transparency goals regarding drug pricing. But we must do more for our patients and our profession to address the ongoing issue of high drug costs. This summer, I appointed a new Neurology Drug Pricing Task Force, led by Nicholas E. Johnson, MD, our able chair of the AAN Government Relations Committee. Its charge is to study the environment of drugs for neurologic disease and propose ways for the AAN to proactively address the challenges associated with ultra-high drug costs, including implications at the governmental, institutional, physician, and patient levels. Evaluation of other professional and patient-advocacy organization positions and opportunities for collaborations with other organizations will also be considered. We must work with our partners and address this major problem together. The task force held the first of its bimonthly conference calls in July, and will produce recommendations to the AAN Board of Directors in the coming months. We will communicate the results of their work to you, and we will call on you through email AAN Action Alerts to support legislation that accomplishes the goals outlined by the Academy in our Prescription Drug Prices position statement. Stay tuned and thanks for your continued efforts to promote the highest quality patient-centered neurologic care. •
Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN firstname.lastname@example.org @DrSaccoNeuro on Twitter
Meet Your Leader
James N. Goldenberg, MD, FAAN James N. Goldenberg, MD, FAAN, CPI, FAPCR, is currently in private practice at the Medical Specialists of the Palm Beaches Neurology in Atlantis, FL, where he served as president and chairman of the board of directors. He is also a principal investigator at JEM Research in Atlantis. He is affiliated assistant professor of neurology at the Leonard M. Miller School of Medicine at the University of Miami, and serves as Alumni Association founding president and on the advisory council for the University of Miami Department of Neurology. He is immediate past president of the Palm Beach County Medical Society, and he established the Physicians’ Leadership Academy of South Florida. He serves on the Florida Medical Association Board of Governors. How did you first get involved as a volunteer on committees/ subcommittees and what moved you to participate? I spent the first 15 years of my career focusing on my practice and my family. My prime goals were to be the best neurologist I could be for my patients and the best parent/spouse I could be for my family. I used whatever time I could spare to serve my hospital and community on several committees and boards. I began to feel the need to advocate for my fellow physicians and my patients on a broader scale. I saw an advertisement for the Palatucci Advocacy Leadership Forum (PALF) and applied. That training changed the trajectory of my career. I met a very talented group of staff members, fellow physicians, and facilitators. I realized that advocacy requires involvement and engagement. After PALF, I expressed interest in a new committee that was forming at that time. I was appointed to the Registry Committee and I’ve been excited to help develop this new project. Why did you wish to be on the Board of Directors? I have found my engagement with the Academy to be one of the most satisfying experiences of my career. Personally, I felt a bit helpless as the shifting health care landscape evolved. Through volunteering on committees, I began to feel involved in a meaningful way. The sense of helplessness was
replaced with a sense of purpose. I wanted to use that renewed energy to serve my profession. What experiences and viewpoints do you bring to this role? First and foremost, I bring almost 25 years of private practice experience to this role. I have practiced in several settings, from a two-person neurology group to a large multi-specialty group. In the multi-specialty group setting, I had the privilege of leading 80 physicians (including six neurologists) as we prepared for many changes, including value-based medicine. In addition, I have board service experience in the hospital setting and organized medicine at the local and state levels. From your experiences as an AAN leader, what is one of the more common misperceptions members may have about the Academy? I hear from our community private practice members that the Academy is an academic organization. Historically this may be true. In recent years, the Academy has made a strong effort to ensure private practitioners have a meaningful role at all levels of Academy leadership. A suite of leadership training opportunities now includes a program specifically designed for private practitioners. The challenge for private practitioners is to find time to engage, volunteer, and perhaps travel. I assure you the return on investment is positive.
In your view, how does the AAN benefit the field of neurology most? The AAN’s advocacy efforts are outstanding. From our advocacy staff in Minneapolis to our team on the ground in Washington, DC, we are represented by a talented and intelligent team. There are many opportunities for Academy members to personally become involved with advocacy. If members are not able to participate in advocacy activities, the opportunity to contribute to our political action committee, BrainPAC, is an effective means of advocacy by proxy. How should members evaluate the success of the AAN and the Board of Directors in supporting their careers and in neurology in general? The Academy’s mission is to be indispensable to its members. I think each member should reflect on whether this is true. Members should feel that the Academy communicates with them about issues that are important to them in the form and fashion they find most desirable and convenient. When a member encounters a difficult situation in the practice of neurology, it would be a sure measure of success if they turned to the Academy for solutions to those problems. •
AANnews • September 2017
Master Quality Improvement Using EHR or Axon Registry Quality improvement is one of the key factors in the new Quality Payment Program (QPP) established by CMS for physicians participating in the Merit-based Incentive Payment System (MIPS). Whether you are participating in MIPS or simply want to ensure your practice is identifying and reaching its quality improvement goals, using an EHR or the AAN’s Axon Registry ® can help simplify your quality reporting—and this webinar can show you how.
Webinar: Using the EHR or Axon Registry to Drive Quality Improvement October 10, 2017, from 12:00 p.m.-1:00 p.m. ET Deadline to Register: October 9 Director: Anup D. Patel, MD Upon completion, you should be able to: nn Discuss the basics of quality improvement methodology nn Understand principles of electronic health records and
nn Implement QI projects using electronic health record or
Axon Registry data
changing health care landscape. 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 if you miss the live event. 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. •
Anup D. Patel, MD
AAN practice management webinars provide the valuable insights and tools you need to navigate through the ever-
Still Time to Register for September Webinar! Register by September 11 at AAN.com/view/pmw17 for the upcoming webinar “Open Your Heart, Open Your Notes: A Guide to Patient Engagement,” offered on Tuesday, September 12, at 12:00 p.m. ET. •
Practice Management Questions? Just Ask email@example.com To help AAN members in small and solo practices quickly get the answers they need to help their practices thrive, the Academy has created a new email address: firstname.lastname@example.org. This convenient address is one of several recommendations made by the Small and Solo Practice Task Force. The AAN has a wealth of knowledge available to members, from a robust range of practice management resources online at AAN.com/view/practice to staff expertise. If you have practice management questions you can’t find answers to—whether concerning CPT or ICD-10 codes, payer issues, health information technology, or others—your email to email@example.com will result in a response within one business day. For immediate assistance, please contact Member Services at firstname.lastname@example.org. •
AANnews • September 2017
Got Questions? Clip and Save! AAN practice guidelines: email@example.com Axon Registry®: firstname.lastname@example.org MACRA/QPP/MIPS: email@example.com Practice management: firstname.lastname@example.org
Use New Quality Measurement Set for Inpatient and Emergency Care A new quality measurement set was developed through a partnership with the American Academy of Neurology, Neurohospitalist Society, and Neurocritical Care Society. It was published online ahead of print in Neurology® on July 21, 2017. These measures, created by a multidisciplinary workgroup, are focused on care for patients with critical conditions such as seizures, Guillain-Barré syndrome, and brain death. The Inpatient and Emergency Measures are: nn Documentation of Brain Death nn Reduction of Urinary Catheters for
Patients with Neurological Conditions
nn Delirium Risk Factor Screening and
nn Non-pharmacological Treatment
nn Status Epilepticus Treatment with
nn Immunosuppressive Treatment
nn EEG for Status Epilepticus and Coma
of Delirium for GBS
nn Immunosuppressive Therapy for
nn Status Epilepticus Identification
and Seizure Cessation
nn Discussion and Documentation of
nn Discussion and Documentation of
Goals of Care
nn Treatment of Bacterial Meningitis
View the published executive summary at Neurology and the full measure set on AAN.com. For more information, email Erin Lee at email@example.com or call (612) 928-6020. •
Help Expel Concussion from School Sports Nationally, more than one million athletes experience a concussion each year. As schools reopen across the country and young athletes don their uniforms and gear, the AAN encourages members to join the pep team for sports concussion awareness and proper treatment. Visit AAN.com/concussion to: nn Review the AAN Sports Concussion Guidelines nn Share with your patients the Patient Summary and
Quick Reference Sheet
nn Download the AAN Sports Concussion Quick Check
app and urge your patients (and/or their parents) to download the app. •
Hundreds Receive Latest Updates at Sports Concussion Conference More than 360 neurologists, coaches, athletic directors, and others concerned about brain injury attended the AAN’s Sports Concussion Conference in Jacksonville, FL, in July. •
AANnews • September 2017
Medicare Proposed Fee Schedule Reflects AAN’s Successful Input Continued from cover
One of the key goals of MACRA was to consolidate and streamline the Physician Quality Reporting System (PQRS), Meaningful Use (MU), and Value-based Payment Modifier (VM) into a single system. In regulations to create the new Merit-based Incentive Payment System (MIPS), CMS made several changes in the earlier programs but those changes do not affect payments until 2019. The AAN urged CMS to make retroactive modifications in the 2016 PQRS, MU, and VM requirements to reflect the policies in the Merit-based Incentive Payment System (MIPS) and reduce the penalties for physicians in 2018. CMS responded with several positive proposals.
PQRS and Meaningful Use Quality Reporting nn Previously in 2016, physicians were required to report
nine measures across three National Quality Strategy Domains, with one cross-cutting measure included.
nn In this rule, CMS proposes to revise 2016 PQRS and MU
quality reporting requirements to only require physicians to report six measures with no domain or cross-cutting measure requirements.
nn This proposal aligns the PQRS CY2016 and Meaningful
Use quality reporting requirements with the new quality reporting requirements for physicians under MIPS.
Value Modifier CMS proposes to: nn Hold all groups and solo practitioners who met 2016
PQRS reporting requirements harmless from any negative VM payment adjustments in 2018.
nn Halve penalties for those who did not meet PQRS
requirements to -2 percent for groups with 10 or more eligible professionals, and to -1 percent for smaller groups and solo practitioners.
nn Reduce the maximum upward payment adjustment to
two times an adjustment factor that is set at the rate needed to keep penalties and bonuses budget neutral. Drop its earlier proposal to publicly report 2016 value modifier data on its Physician Compare website.
Other important areas of the proposed fee schedule include:
AANnews • September 2017
David A. Evans, MBA
Bruce H. Cohen, MD, FAAN
Appropriate Use Criteria (AUC) nn The Protecting Access to Medicare Act (PAMA)
required CMS to create a program that effective January 1, 2017, would have denied payment for advanced imaging services unless the physician ordering the service had consulted appropriate use criteria.
nn CMS previously had delayed implementation until
2018, but now—in response to pressure from the AAN and other specialties—the agency is proposing to further delay the requirement until January 1, 2019.
nn This first year of reporting would be regarded as
an opportunity for testing and education and would not affect payment to the physician providing the image. Those who wished to begin testing earlier could participate in a voluntary reporting period expected to begin on July 2018.
“The AAN was successful on several fronts in their advocacy for members this year,” said David A. Evans, MBA, chair of the Practice Management and Technology Subcommittee. “I was most pleased to see their success in getting a delay in the implementation of Appropriate Use Criteria. This had the potential for immense disruption in neurologists’ workflow and increased administrative burden on providers. There has been uncertainty around the rollout of the program by CMS and an overall lack of readiness by all stakeholders, including EHR vendors, health care systems of all sizes, and—most concerning—solo/small/ private practices with limited resources.”
Evaluation and Management (E/M) Guidelines nn CMS calls for a multi-year effort to revise the
Evaluation and Management Guidelines to accompany a desire to reduce administrative burden to physicians.
nn CMS suggests a focus on eliminating guidelines related
to history and physical examination, with greater importance placed on medical decision making and time spent performing the service.
“CMS has asked to revise the E/M guidelines, to deemphasize the importance of the bullet points of the history and physical exam, and focus on medical decision making,” said Bruce H. Cohen, MD, FAAN, chair of the AAN’s Coding Subcommittee and AAN advisor to the AMA CPT Editorial Panel. “By changing documentation guidelines, the goal is re-focus physicians on what is the most important part of the E/M encounter—caring for the patient, and not the chart. How this will ultimately affect physician reimbursement is yet to be seen, but the benefits that lead to less burdensome documentation will allow more time to focus on the patient’s needs. The AAN has already started participating in the process and will be at the table as these new guidelines are being developed.”
Request for Information (RFI) on CMS Flexibilities and Efficiencies nn CMS invites comment on ideas for regulatory,
subregulatory, policy, practice, and procedural changes to improve the health care system by reducing unnecessary burdens for clinicians, other providers, patients, and their families.
nn CMS will not respond to the RFI comment submissions
in the final rule that will be issued in November, but will consider the input in developing future regulatory proposals and sub-regulatory guidance.
Telehealth nn CMS seeks comments on a number of codes related
nn The agency also is proposing to eliminate the
requirement for modifier for telehealth services.
nn CMS is seeking information regarding ways that it
might further expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies.
The AAN will submit a comment letter in response to the proposals by September 11. The announcement of the final rule is expected in November. •
14 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 September 1 nn Neurology: Longitudinal Diffusion Changes Following Postoperative Delirium in Older People Without Dementia Pearce J. Korb, MD; Michele Cavalleri, MD, PhD; and David C. Alsop, PhD nn Neurology: National Randomized Controlled Trial of Virtual House Calls for Parkinson Disease Jeffrey B. Ratliff, MD, DO; and E. Ray Dorsey, MD, MBA nn Neurology: Medication-overuse Headache: an Entrenched Idea in Need of Scrutiny Alexander Menze, MD, and Ann I. Scher, PhD nn Neurology: Genetics: ExACtly Zero or Once: a Clinically Helpful Guide to Assessing Genetic Variants in Mild Epilepsies James Kiely, MD, PhD, and Samuel F. Berkovic, AM, MD, FAA, FRACP, FRS
AANnews • September 2017
Neurology Now won a Clarion Award in the category Magazine Feature Article, External Publication (Circulation between 100,000 and 500,000) Lifestyle, for an article about open notes, “Going on Record: Patients Have a Right to Their Medical Records but Often Don’t Know How to Access Them. Electronic Systems and a Concept Known as Open Notes Are Changing That,” available at http://bit.ly/NNOpenNotes. The Clarion Awards competition is sponsored by the Association of Women in Communications. It is judged by a panel of journalists and journalism professors, as well as marketing and communications professionals. Want to learn more about Open Notes? Register for the AAN practice management webinar CHP: 16 Axon Registry Ad—Half Page Horizontal> AN “Open Your Heart, Placed in AANnews Open Your Notes: A Guide to Patient Engagement,” offered 8.25 x 5.25on +0.125 bleed, 4C 12. Read more details on page 6. • September
THE OFFICIAL NEWS SOURCE OF THE AMERICAN ACADEMY OF NEUROLOGY
STROKE RISK: New recommendations on blood pressure targets
EPILEPSY: Is screening for genetic risks for phenytoin complications cost-effective?
AUTISM: A new primate model
Lead Crisis in Flint Exposes Continuing Risk to Children Nationwide
SEAfOOD fOUnD nEUROPROTECTIvE fOR ALzhEIMER’S In ThOSE wITh RISK GEnE
What Neurologists Should Know and What They Can Do About It
BY SUSAN FITZGERALD
BY DAN HURLEY
O P E N N OT ES
ating at least one seafood meal a week can help protect the brains of persons at heightened risk for Alzheimer’s disease, and there seems to be no downside from the levels of mercury found in fish, according to an analysis of autopsied brain tissue from 286 elderly persons who had filled out food diaries as part of a longitudinal study on aging and memory. The Rush University study found that the benefits of eating seafood applied only to people who carried the apolipoprotein E4 (APOE e4) gene, which is linked to an elevated risk of Alzheimer’s disease. For persons who did not have the genetic variant, seafood consumption did not afford protection against the amyloid deposits and neurofibrillary tangles indicative of Alzheimer’s. “We found that seafood consumption was associated with higher brain levels of mercury, but that mercury was not correlated with brain neuropathologies of
A 10-year-old is shown here being screened for blood-lead levels at a local elementary school in Flint, MI.
ith half a million young children nationwide known to have blood-lead levels as high as those recorded during the ongoing
crisis in Flint, MI, neurologists are being urged to consider and, when appropriate, test for the toxic metal in the process of reaching a differential diagnosis.
Continued on page 4
Continued on page 14
Researchers Find the C4 Gene Is Involved with Synaptic Pruning and Associated with Schizophrenia BY JAMIE TALAN
ive years ago, scientists searching for genetic clues to schizophrenia found a major signal in a large neighborhood on chromosome 6 — the major histocompatibility complex (MHC). But there were hundreds of genes in that region, and no one knew how to pinpoint the gene or genes responsible for increasing the risk for the debilitating mental illness. BY RICHARD LALIBERTE Now, a team of scientists at Harvard Medical School has successfully designed novel techniques ThE C4 GEnE on chromosome 6 towers and used data from tens of thousands of DNA samfar above other risk-associated areas on from theback Psychiatric Genomics smallples incident in the 1970sConsortium lingered with Tom A MOVEMENT IS BORN
Patients have a right to their medical records but often don’t know how to access them. Electronic systems and a concept known as open notes are changing that.
Continued on page 18
schizophrenia’s genomic “skyline.”
Delbanco, MD, for decades. Dr. Delbanco, now pro- Thirty years later, that exchange led Dr. Delbanco and colleague fessor of medicine at Harvard Medical School and Jan Walker, RN, assistant professor of medicine at Harvard and Beth Israel Deaconess Medical Center in Boston, and Beth Israel, to co-found a movement that is changing the rules a young primary care physician at the time, was taking a his- about medical records and, many experts contend, establishing tory from a new patient. “My patient was having trouble with a new standard of care—fully transparent clinical notes. his marriage, difficulty at work, losing his cool with his kids, “The idea is simple,” says John Santa, MD, director of dissemination at OpenNotes (OpenNotes.org), a had out-of-control blood pressure—and nonprofit organization that Dr. Delbanco and said he drank a couple of beers a day,” Dr. Walker established to advance the initiative. Delbanco recalls. “Give patients easy—and that means elecAs he pondered the red flags this combitronic—access to the notes clinicians write nation raised, Dr. Delbanco became aware about them. This includes not only visit sumthat the patient across from him, who was maries that contain medical facts and what a printer by profession, could read what the doctor wants you to do, but also what the he was writing upside down, so his cliniclinician thinks, perceives, and cares about.” cal thoughts were no longer private. “I’m A patient’s right to those records was trying to figure out whether I should write written into federal law with the 1996 ‘possible alcohol abuse,’ because I think Health Insurance Portability and Accountyou probably drink more than a couple of ability Act (HIPAA). “But we’ve made it as beers a day,” Dr. Delbanco recalls explaindifficult for patients as possible,” Dr. Deling. “The patient was silent for a moment INSIGHT Tom Delbanco, MD, realized banco says. Note seekers often have to wait and then said, ‘You’d better write it down.’” access to doctors’ notes helps patients. days or weeks for a records department to What transpired might seem like a minor snippet of conversation. But it ran against the norms of tra- fulfill a request. They may be required to pick up records in ditional medical practice: Doctors took notes about patients but person or pay a copy fee for each page. Some are given a CD didn’t share them and certainly didn’t invite patients to help that many computers aren’t equipped to play or have to read write them. “That moment really struck me,” Dr. Delbanco says. records with a clerk standing over their shoulder. “[OpenNotes] “It didn’t make sense to me that patients didn’t see what we is making it easier for patients to do what they have a right to do wrote about them.” anyway,” Dr. Delbanco explains.
DECEMBER 2016 / JANUARY 2017
ALL IMAGES COURTESY RED HAT VIA THE OPEN PATIENT: REDHAT.COM/EN/OPEN-SOURCE-STORIES/OPEN-PATIENT
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Driving quality improvement and demonstrating the value of neurology. The AAN’s new Axon Registry® provides a seamless, discrete collection of timely data that can show quality improvement by individual neurologists and collectively confirm the crucial value of neurologists in the care of patients with brain disease.
Learn more and participate: AAN.com/view/axon
AANnews • September 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
Capitol Hill Report AAN Board Member Brett M. Kissela, MD, MS, FAAN, was asked to guest write Capitol Hill Report to give his firsthand impressions of testifying on behalf of the AAN on the FAST Act before a congressional committee in July. Below is his account. Within the AAN, I am currently a member of the Board of Directors and serve on the Government Relations Committee. I am a stroke neurologist who serves as professor and chair of Neurology and Rehabilitation Medicine at the University of Cincinnati (UC). I am also a proud member of our UC Stroke Team, where we take acute stroke calls to serve the entire Cincinnati metropolitan region, including 27 hospitals. For several years, we have used telemedicine to evaluate patients at outlying hospitals, and recently have begun to implement telemedicine at our urban and suburban hospitals too. We have made this move because telemedicine is a tool that allows rapid visual assessment for optimal decision making about appropriate acute stroke therapies. Time is brain, and telemedicine saves valuable time, leading to better outcomes for our patients. The AAN first proposed that Congress expand Medicare reimbursement for telestroke to non-rural areas in early 2015. Since then, the AAN efforts via Neurology on the Hill, grassroots advocacy, and DC lobbying have been extraordinarily successful in gaining congressional support for the Furthering Access to Stroke Telemedicine (FAST) Act (H.R. 1148/S. 431). In addition to the legislation passing the Senate Finance Committee as part of the CHRONIC Care Act, S. 870, it now has 128 cosponsors in the House. This level of support caught the eye of the House Energy and Commerce (E&C) Committee, which has jurisdiction over many health care issues. The E&C Committee invited 17Concussion Awareness Page testimony Horizontal> AN the AANAd—Half to present in favor of the FAST Act last week.
Placed in AANnews 8.25 x 5.25 +0.125 bleed, 4C
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AAN Board Member Brett M. Kissela, MD, MS, FAAN, (right) with House Energy and Commerce Health Subcommittee Chair Michael Burgess, MD, (R-TX).
I was honored to represent the AAN before the E&C Health Subcommittee led by Chair Michael Burgess, MD, (R-TX), and Ranking Member Gene Green (DTX). Frankly, after I accepted, I was a little scared and intimidated by participation in such an important and very formal process. Luckily, I had participated in the Palatucci Advocacy Leadership Forum in the past and thus have had some training for such an occasion. I presented for my allotted five minutes on our personal success of using telestroke at UC, giving examples of stroke patients that have been able to return to normal life after being treated with tPA. I was impressed by the knowledge of the committee members and their level of support for telestroke. Many mentioned H.R. 1148 in their opening statements and their questions allowed me to expand my description of the benefits of tPA and telestroke. Rep. Griffith, the House author of H.R. 1148, focused on the costs of the bill, and I was able to explain the cost savings of telestroke in helping patients avoid expensive long-term care. I want to thank the AAN advocacy staff for arranging this great opportunity. In addition to testifying before the committee, I attended a fundraiser for an Ohio member of Congress with a contribution from BrainPAC; met Sen. Sherrod Brown (D-OH), a supporter of the Senate version of the FAST Act; and visited the offices of my other members of Congress, Sen. Rob Portman (R-OH) and Rep. Steve Chabot (R-OH). We cannot complain about changes affecting our profession if we don’t stand up and advocate for ourselves. Please consider participating in AAN advocacy efforts as you see fit—consider applying for the Palatucci Advocacy Leadership Forum or Neurology on the Hill, or respond to our email action alerts to contact your members of Congress. If I can do it, so can you! To learn more about how you can get involved advocating for neurology, visit AAN.com/public-policy. •
Empower Your Patients
Available from all major booksellers or order online at AAN.com/view/NeurologyNowBooks
Palatucci Forum Project Helps Produce Foundation Crowdfunding Platform “I had a concept in mind and did not know where to start,” said Eugene L. Scharf, MD. “However, I knew the Palatucci Advocacy Leadership Forum (PALF) and colleagues at the forum would be able to help. This was my first interaction with the AAN, I was totally impressed with the organization.” Scharf’s idea was to research and develop an executive summary outlining the proposed creation of an online crowdsourced funding exchange hosted by the American Brain Foundation, where charitable donors could support available research topics by selecting personally meaningful research efforts. Scharf, then a resident at the Mayo Clinic in Rochester, MN, applied for the 2014 PALF and—fortunately—was accepted into the advocacy class, where he acquired a host of new skills. “PALF offers a host of sessions that were immensely valuable to my specific project,” Scharf said. “Probably the most valuable was getting used to SMART objectives because these helped me create a physical roadmap for achieving this goal.” As it happened, the American Brain Foundation was looking at creating some type of crowdfunding platform, as well. Former AAN President Robert C. Griggs, MD, FAAN, chair of the Research Advisory Committee that developed guidelines for researcher applications and for the scientific review of applications, heard of Scharf’s interest in this area and connected him with the Foundation staff. It was a fortuitous coincidence, and the training Scharf received at PALF helped him join forces with the fundraisers. “The American Brain Foundation is a very professional and cutting-edge organization. Their leadership also was interested in creating a crowdfunding platform as well. PALF training taught me how to pursue the proper contacts and share our mutual visions. They were welcoming of a collaborator.” Site development began in spring 2016, and approximately one year later, in April 2017, the American Brain Foundation crowdfunding website was launched. “The American Brain
Foundation is now crowdfunding neuroscience research. Go to americanbrainfoundation.org and be part of the cure.” The new online neuroscience research crowdfunding platform allows members of the public to search for and give money to research projects addressing brain diseases. The platform is part of the American Brain Foundation’s new strategic plan to reach out to the public for support. Scharf found the experience both challenging and broadening. “An idea in your head seldom resembles itself when it becomes a reality. Relinquishing some of the creative control was a challenge. In turn, I gained exposure to multiple aspects of development in which I had no prior background, such as website development, e-commerce, and marketing.” Scharf attended this year’s Palatucci Forum as an advisor to share his passion with others. Based on his experience with this project, what advice would Scharf give his fellow AAN neurologists? “I would say to my colleagues looking for a new perspective or a way to breakthrough an idea, the Palatucci Forum is an effective venue for bringing your idea from concept to reality. You also will meet many new colleagues and be a part of a tightly knit and supportive alumni group.” If you need assistance and guidance on a project you have in mind that would enhance the delivery of neurologic care in your community or improve other aspects of the neurology profession, visit AAN.com/public-policy/palatucciadvocacy-leadership-forum to learn more about this exclusive AAN program and watch for applications to open this October for the 2018 Palatucci Advocacy Leadership Forum. •
Eugene L. Scharf, MD
AANnews • September 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
Research & Awards
Applications Now Open for Medical Student Diversity Program Applications are now open at AAN.com/view/DiversityProgram for the 2018 Medical Student Diversity Program. The deadline to apply is October 6, 2017. The program provides medical students from underrepresented and underserved populations who are in good standing at a United States medical school the opportunity to attend the 2018 Annual Meeting where they will be paired with a mentor who will provide unique opportunities to network, receive guidance on career planning, and learn more about the field of neurology. Preference is given to second- and third-year students. Program winners will receive: nn Four nights hotel during the 70th AAN Annual Meeting
in Los Angeles, CA (arriving Friday, April 20, and departing on Tuesday, April 24)
nn Airfare up to $650 per diem nn Annual Meeting registration, including the
opportunity to work with their mentor to select tailored education and scientific programs
nn Mentorship by an established neurologist nn Acknowledgement at the Faculty and Trainee
nn A certificate of recognition
Learn more about application requirements and apply
SC: 16 Online MOC Page Horizontal> AN todayAd—Half at AAN.com/view/DiversityProgram. ced in AANnews 5 x 4.5 +0.125 bleed, 4C
Recertification Approaching? Neurology MOC Prep Course Now Available Anytime, Anywhere •
Online: Available 24/7, offering easy access to syllabi, audio interviews, and a self-assessment exam. Earn up to 15 self-assessment CME upon completion. • In-Person: Offered at the Breakthroughs in Neurology conference and AAN Annual Meeting.
AANnews • September 2017
Apply or Nominate Colleagues for Prestigious AAN Scientific Awards Application Deadline: October 25 Have you or someone you know been conducting research that may be advancing the field of neurology? If so, now is the time to start thinking about applying—or nominating a colleague—for one of 25 AAN awards to be presented at the 2018 AAN Annual Meeting in Los Angeles, CA, April 21 through 27. Online applications are available at AAN.com/view/18Awards, and the application deadline is October 25. Prestigious AAN awards honor the best research and achievements by neurologists and neuroscientists around the globe with prizes and other compensation, such as complimentary travel expenses and registration for the Annual Meeting. AAN awards recognize scientists at all stages of their careers for a variety of activities.
Senior Author Awards
Recognizes an individual for outstanding work in the field. nn John Dystel Prize for Multiple Sclerosis Research nn Sheila Essey Award: An Award for ALS Research nn Mitchell B. Max Award for Neuropathic Pain nn Lawrence C. McHenry: An Award for the History of Neurology nn Movement Disorders Research Award nn Neuroendocrine Research Award nn Neuro-oncology Scientific Award nn Potamkin Prize for Research in Pick’s, Alzheimer’s, and Related Diseases nn Irwin Schatz Award for Autonomic Disorders nn Sleep Science Award
Young Investigator Awards
Recognizes scientific contributions from promising young investigators. nn Dreifuss-Penry Epilepsy Award nn Norman Geschwind Prize in Behavioral Neurology nn Harold Wolff-John Graham Award: An Award for Headache/Facial Pain Research nn Wayne A. Hening Sleep Medicine Investigator Award nn Neuro-oncology Investigator Award nn Neuro-oncology Scientific Award nn Michael S. Pessin Stroke Leadership Prize nn Irwin Schatz Award for Autonomic Disorders nn Bruce S. Schoenberg International Award in Neuroepidemiology nn Jon Stolk Award in Movement Disorders for Young Investigators
Encourages clinical and translational research in neuroscience by physicians in clinical neurology training programs. nn Alliance Awards: Founders nn Alliance Awards: S. Weir Mitchell
Medical Student Essay Awards
Stimulates interest in the field of neurology as an exciting and challenging profession through highly competitive awards for the best essay. nn Medical Student Essay Award— Extended Neuroscience Award nn Medical Student Essay Award— Saul R. Korey Award nn Medical Student Essay Award— Roland P. Mackay Award nn Medical Student Essay Award— G. Milton Shy Award
Neuroscience Research Prize for High School Students—October 9 Application Deadline Encourages high school students to explore the world of the brain and nervous system through laboratory research.•
Research & Awards
Neurology Podcast Marks 10th Anniversary First aired in September 2007, the AAN’s Neurology ® Podcast has been downloaded more than 14 million times—and the number continues to grow. Neurology Podcast Editors Ted M. Burns, MD, and Andrew M. Southerland, MD, selected some of the more notable podcasts to highlight for the occasion: “It’s impossible to select favorite podcasts out of a list of more than 1,200 interviews—around 250 hours—done over the decade. But below is a list of perhaps some of our more memorable moments. As always, we thank our podcast team, our panel of interviewers, those whom we’ve interviewed, and especially all our listeners. It’s been a great 10-year ride and we look forward to the next 10.” Sample the deep wisdom and far-ranging insights of some of the world’s most eminent neurologists in these compelling podcasts. With each podcast, listeners can earn 0.5 AMA PRA Category 1 CME Credits™ by answering the multiple-choice questions related to Neurology content in the online Podcast Quiz. September 4, 2007: “Relevance of the Antibody Index to Diagnose Lyme Neuroborreliosis Among Seropositive Patients.” Our first podcast back in the days when nobody even knew what a podcast was! September 18, 2007: “Limbic Encephalitis as a Precipitating Event in Adult-onset Temporal Lobe Epilepsy.” The first podcast of Robert A. Gross, MD, PhD, FAAN! Who knew what great things lay ahead? June 3, 2008, and July 6, 2010: Interviews with the great Robert J. Joynt, MD, FAAN, the late dean and chair at the University of Rochester, about his career and other topics. December 2, 2008: “The US Health Care System, Part 1: Our Current System and Its Problems.” Marc R. Nuwer, MD, PhD, FAAN, and Thomas R. Swift, MD, FAAN, discuss the US health care system in context of the 2008 election. February 3, 2009; March 3, 2009; April, 12, 2011: Interviews with the legendary stroke neurologist C. Miller Fisher, MD. February 17, 2009: “Teaching the Next Generation of Neurologists.” A focus on neurology training with Mitchell S.V. Elkind, MD, MS, MPhil, FAAN, highlighting the great work of the Neurology Resident & Fellow Section. November 9, 2010: “Retrospective Analysis of NMDA Receptor Antibodies in Encephalitis of Unknown Origin.” An early interview with Josep Dalmau, MD, PhD, on NMDA encephalitis, a relative newcomer to the scene at the time.
AANnews • September 2017
January 4, 2011: “The Past, Present, and Future of Neurology in the United States.” An interview with former Neurology editors Lewis P. Rowland, MD, FAAN; Robert B. Daroff, MD, FAAN; and Robert C. Griggs, MD, FAAN, on the first paper published in the journal, as well as the history of neurology and advice for our younger listeners. September 6, 2011: “A Man’s Reach Must Exceed His Grasp.” 60th anniversary of the Neurology journal. Robert C. Griggs, MD, FAAN, interview. November 6, 2012: “Neurodegenerative Causes of Death Among Retired National Football League Players.” A controversial and timely topic, especially today. September 24, 2013: “The Complexities of Acute Stroke Decisionmaking.” Brett M. Kissela, MD, MS, FAAN, interviews the great Louis R. Caplan, MD. October 29, 2013: An interview with neurologist and podcaster Lara Marcuse, MD, about her own personal experience being a patient.
Ted M. Burns, MD
Andrew M. Southerland, MD
and rehabilitation experience. September 2015: Oliver Sacks Tribute: Interviews with Oliver Sacks, MD. Lesson of the week interviews from January 2011. September 27, 2016: “The Terrorist Inside My Husband’s Brain.” Susan Schneider-Williams, widow of Robin Williams, discusses her husband’s life before and during his battle with Lewy body disease. February 14, 2017: An interview with the CEO and President of Mayo Clinic, John Noseworthy, MD, FAAN, about the US health care system, his late 2016 meeting with President Trump, and his own career in MS care and research.
September 23, 2014: “Concussed.” An interview with Ben Utecht, former NFL player and past spokesman for the American Brain Foundation, about his concussions and worries about developing CTE.
May 2017: “Responsible Opioid Prescribing.” Four special episodes produced in response to the ongoing opioid epidemic in the US and around the world.
November 25, 2014: Andrew M. Southerland, MD, interviews novelist Esmerelda Santiago on her own stroke
Just about any interview with Alberto J. Espay, MD, FAAN, especially one of his interviews about a hot topic from the AAN Annual Meetings. •
Save the Date: Breakthroughs in Neurology Conference Set for January 12–15 Continued from cover Registration will open September 5. Visit AAN.com/conferences/breakthroughs-in-neurology for more information.
Friday, January 12
Saturday, January 13
8:00 a.m.–10:00 a.m. Multiple Sclerosis (Autoimmune) Director: TBD
8:00 a.m.–10:00 a.m. Epilepsy Director: Katherine Noe, MD
Infectious Disease (Zika) Director: Marie Francisca Grill, MD
Neuromuscular Director: Madhu Soni, MD
10:15 a.m.–11:45 a.m. Getting Paid in the Future: Quality, Accountable Care Organizations (ACOs), Patient-centered Medical Homes, and Value-based Purchasing Director: Allison L. Weathers, MD, FAAN, and David A. Evans, MBA
9:45 a.m.–10:15 a.m. Exhibits
11:30 a.m.–1:00 p.m Exhibits 11:45 a.m.–12:45 p.m. Presentation Stage: Is There a Neurologist on this Flight? Speaker: TBD 1:15 p.m.–3:15 p.m. Neuroscience in the Clinic: Multiple Sclerosis (Autoimmune) Director: Eric Klawiter, MD Neuroscience in the Clinic: Infectious Disease (Zika) Director: Kiran Thakur, MD 3:30 p.m.–5:00 p.m. Hot Topics Session nn Lysosomal Proteins as
a Therapeutic Target in Neurodegeneration—TBD
nn Antisense Oligonucleotide
Treatment (ASO) and SMA: Results of Clinical Trials—TBD
10:15 a.m.–11:45 a.m. Building Care Teams (Doctors, Advanced Practice Providers, Pharmacists, Emotional Support, and Patient Navigators) Director: Brad C. Klein, MD, MBA, FAAN 11:30 a.m.–1:00 p.m. Exhibits 11:45 a.m.–12:45 p.m. Presentation Stage: “Ask Me Anything” Panel Discussion Speakers: TBD 1:15 p.m.–3:15 p.m. Neuroscience in the Clinic: Epilepsy Director: Amy R. Brooks-Kayal, MD, FAAN Neuroscience in the Clinic: Neuromuscular Director: TBD
Study—TBD nn Resumption of Oral
Anticoagulation After Intracerebral Hemorrhage Is Associated with Decreased Mortality and Favorable Functional Outcome—TBD
nn High Drug Prices: The Elephant
in the Clinic—TBD
5:00 p.m.–6:00 p.m. ABPN Maintenance of Certification Informational Session
Sunday, January 14 8:00 a.m.–5:00 p.m. Neurology MOC Prep Course Director: Ralph F. Józefowicz, MD, FAAN
Monday, January 15 8:00 a.m.–12:00 p.m. Neurology MOC Prep Course, Continued Director: Ralph F. Józefowicz, MD, FAAN • Content is current as of August 14, 2017, and is subject to change.
3:30 p.m.–5:00 p.m. Contemporary Clinical Issues Session nn Nusinersen in Infants Diagnosed with Spinal Muscular Atrophy (SMA): Study Design and Initial Interim Efficacy and Safety Findings from the Phase 3 International ENDEAR
nn Population-based Comprehensive
Epilepsy Care in Ontario, Canada: A Model Network—O. Carter Snead III, MD, FAAN
nn Multiple Sclerosis—TBD
5:00 p.m.–6:00 p.m. Exhibit Hall Opening Reception
AANnews • September 2017
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.
Preparing for Fall ABPN MOC Exam? This Online Resource Can Help “While the AAN is not responsible for and does not mandate MOC, it is continually working on new ways to support members across their professional lives, including providing tools and resources to help members successfully meet the ABPN’s MOC requirements.” —Ralph F. Józefowicz, MD, FAAN Chair, Online Neurology MOC Prep Course
Let the AAN’s exclusive online Neurology MOC Prep Course help you prepare for this fall’s ABPN MOC examination in clinical neurology. Available at your convenience, 24/7, when and where you need it, the handy online course covers 14 topics addressing the most heavily weighted categories on the ABPN MOC Content Outline in Clinical Neurology and offers easy access to syllabi, audio interviews, a self-assessment exam, and up to 15 Self-assessment CME.
How it works: nn Read syllabi highlighting new developments on each topic
over the past several years
nn Listen to condensed audio interviews from syllabi authors nn Complete the self-assessment exam nn Earn a minimum score of 70 percent to claim up to
15 Self-assessment CME credits
Features: nn Written by neurologists for neurologists
Neurology MOC Prep Course Coming to January Breakthroughs in Neurology If you prefer a live learning experience, the in-person Neurology MOC Prep Course offering 11.25 Self-assessment CME credits is set to take place during the 2018 AAN Breakthroughs in Neurology Conference coming to the Caribe Royale in Orlando, FL, January 12 through 15. Visit AAN.com/conferences/breakthroughs-in-neurology for more information and to register. •
nn Content selected to reflect the ABPN content outline for
the cognitive expertise component (Part 3) of MOC
nn Syllabi cover new and updated science and therapies nn Audio interviews allow for on-the-go listening nn 100 multiple-choice questions help you determine your
strengths and areas for improvement
nn Exam feedback by subspecialty areas and suggestions
for further reading
nn Performance results compared to other neurologists nn Convenient online format—take on your own time,
at your own pace
Get started at AAN.com/view/MOCPrep. •
The American Academy of Neurology is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. MOC is not an American Academy of Neurology mandated initiative and the AAN has no control over MOC. Maintenance of Certification (MOC) is a requirement of the American Board of Medical Specialties (ABMS) and the ABPN. For more information, visit ABPN.com or AAN.com/cme-and-moc.
AANnews • September 2017
UCNS: Recognizing the Importance of Emerging Subspecialties The United Council for Neurologic Subspecialties (UCNS) has been accrediting training programs and certifying physicians in emerging neurologic subspecialties since 2006. Since that time, UCNS has established a reputation for excellence in accreditation through peer review of fellowship training programs and demonstration of expertise for physicians who are properly trained and experienced in a subspecialty area of practice through certification. The trend of subspecialization in the field of neurology started evolving in the late 1990s. Recognizing this trend, five leading organizations in the field of neurology—the American Academy of Neurology, American Neurologic Association, Association of University Professors in Neurology, Child Neurology Society, and the Professors of Child Neurology— began setting the foundation for UCNS. The UCNS formally incorporated in 2003 as a separate nonprofit organization with a mission to promote high-quality patient-centered care through accreditation of training programs and certification of physicians in neurologic subspecialties, with a vision of helping small neurologic subspecialties develop credibility and grow. Since that time, numerous neurologic subspecialties have emerged and are now viable training and career choices for physicians, and the UCNS has accredited 187 training programs and certified more than 2,700 diplomates in nine recognized subspecialties.
The Process for Subspecialty Recognition The pathway for an emerging neurologic subspecialty to being formally recognized by the UCNS begins with an application from a subspecialty sponsoring organization that demonstrates that the field requires a discrete body
of knowledge. Recognition of a subspecialty occurs after rigorous review by the UCNS Board of Directors, comprised of representatives from the five UCNS founding parent organizations, representatives from the UCNS subspecialty sponsoring organizations, and liaisons who sit on the board from the Accreditation Council for Graduate Medical Education and the American Board of Psychiatry and Neurology. Once a subspecialty is recognized, the process of developing the initial certification examination and training program standards begins. The certification and accreditation processes are overseen by the Certification Council and Accreditation Council, both populated by leaders in the field of neurology appointed by the five parent organizations. An examination committee is established and is comprised of experts identified by the sponsoring organization charged with writing the examination that will test the knowledge and competency of physicians seeking certification in the subspecialty. The training program curriculum and standards proposed by the sponsoring organization are finalized using educational content submitted by the subspecialty. The proven UCNS process guides subspecialties in establishing standardization for fellow education and physician testing and provides the oversight that assures compliance and credibility of the certification and accreditation standards. Recognized subspecialties have seen growth in their fields and outside validation from groups such as the LeapFrog Group and National Uniform Claim Committee. Increasingly, hospitals are using UCNS certification as a qualifier for physician employment. More information for becoming a UCNS-recognized subspecialty may be found at UCNS.org/go/membership. •
Find Your Next Job
Fill Your Open Job
The hottest jobs meet the top candidates at the AAN Neurology Career Center.
AANnews • September 2017
Enhanced Resident Leadership Program Application Opens This Month Are you an adult neurology or child neurology resident in the US or Canada with the motivation, drive, and potential to be a future leader of the Academy? If so, then the Enhanced Resident Leadership Program is for you! This program will provide recipients with the opportunity to augment their education, training, and networking by attending the 2018 AAN Annual Meeting in Los Angeles, CA. Recipients will receive: nn Five nights’ hotel stay at the 2018 AAN Annual Meeting
Recipients will be required to take part in the following opportunities to engage with AAN leadership:
nn Airfare up to $700
nn One all-day programming with fellow recipients
nn Annual Meeting registration and the opportunity
nn Faculty and Trainee Reception
to select education and scientific programs based on their specific needs
nn A certificate of recognition nn Acknowledgment at the Faculty and Trainee Reception
nn Touchpoint phone calls with AAN leader mentors
Applications open this month at AAN.com/view/ResidentLead and the deadline to apply is September 1. •
during the Annual Meeting.
Prepare Now for October 16–22 Neurology Career Week The AAN provides assistance and resources to members seeking new jobs or needing help with other employment matters. The always popular Neurology Career Week will be held October 16 through 22, and members can access personalized advice on their CV or interviewing skills, as well as search hundreds of open positions from leading employers across the country. Get ready now for Career Week and make the most of your job search with these opportunities:
Complimentary CV Review—A $195 Value
Create or Update Your Job Seeker Profile—Win $500
nn Your curriculum vitae is the first way prospective
nn Target your search with the largest job site specifically for
nn Submit your CV to firstname.lastname@example.org by October 1 to
nn View complete rules and eligibility at
employers judge you. Give yourself the competitive advantage with a professional evaluation of your CV, courtesy of the Neurology Career Center. register for a professional CV review.
nn Act now—offer is limited to the first 100 AAN members.
All CVs submitted will be returned with tips and comments by November 1.
Complimentary Professional Interview Coaching Session—A $250 Value nn In preparation for Neurology Career Week,
complimentary interview coaching sessions are available to the first 25 members who sign up.
nn Polish your interviewing skills and land your
nn Reserve your space by emailing
email@example.com. You will be contacted within two business days to arrange a date and time for your session, subject to availability.
neurologists! Create or update your job seeker profile by October 22, and you’ll be entered in a drawing for a chance to win $500. AAN.com/careers/career-events. •
New Scholarships Offer $1.65 Million for Research in Cognitive Aging and Age-related Memory Loss The McKnight Brain Research Foundation, the American Brain Foundation, and the American Academy of Neurology have established new awards that will advance research in cognitive aging to benefit people with agerelated memory loss. Through a generous $1.65 million grant given to the American Brain Foundation from McKnight, the new McKnight Clinical Translational Research Scholarships in Cognitive Aging and Age-Related Memory Loss will provide up to 10 early career clinicians who are interested in devoting significant research time with $150,000 over two years in stipend and research-related costs. The scholarships will be awarded over five years, from 2018 to 2022. Applications for the first two scholarships are now open at AAN.com/view/ResearchProgram and the application deadline is October 1, 2017. “The population is growing daily, and by the year 2030 it is estimated that nearly 25 percent of the 360 million Americans will be 65 or older, with millions suffering from some form of memory loss,” said J. Lee Dockery, chair of the McKnight Brain Research Foundation board of trustees. “Finding the answer to this important component of health can have an immense beneficial influence on every member of society in helping them age successfully.” “The American Brain Foundation is thrilled to be in a partnership with the McKnight Brain Research Foundation with the goal of increasing innovative research on
AANnews • September 2017
memory loss in aging,” said Robert C. Griggs, MD, FAAN, chair of the Foundation’s Research Advisory Committee. “The Foundation has funded more than 200 Clinical Research Training Scholarships across a broad spectrum of diseases of the brain.” Added Dockery, “The partnership between the McKnight Brain Research Foundation and the Robert C. Griggs, MD, FAAN American Brain Foundation, in collaboration with the American Academy of Neurology, has enormous potential to advance the understanding, alleviation and treatment of cognitive decline and memory loss specific to the process of aging.” The McKnight Brain Research Foundation promotes research and investigation of the brain in the fundamental mechanisms that underlie the neurobiology of memory with clinical relevance to the problems of age-related memory loss. For more information about the McKnight Brain Research Foundation, visit www.tmbrf.org. The American Brain Foundation was founded 25 years ago. Its mission is to bring researchers and donors together to defeat brain disease. Learn more at 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. 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, D.C., our United Council of Neurologic Subspecialties fully accredited fellowship offers extensive training in the performance and interpretation of diagnostic inpatient and outpatient MRI, CT, Doppler, TCD, and myelography—utilizing four state of the art MRI scanners and four multi-slice CT units. Responsibilities include supervision and interpretation of imaging, assisting with acute stroke protocols, and direct patient care. Availability: immediate. Research interests are encouraged. Salary is $60,000.00 per year plus benefits. CV’s should be emailed to firstname.lastname@example.org Neurologist The Wien Center for Alzheimer’s Disease and Memory Disorders at Mount Sinai Medical Center in Miami Beach has an exciting opportunity for a BC/BE Neurologist with a special focus on memory disorders. The Wien Center for Alzheimer’s Disease and Memory Disorders was established 30 years ago, during which period it has evaluated, diagnosed and treated over 15000 patient’s, in addition to providing public education and memory screening services for the community. The Wien
Center is engaged in many collaborative studies, the most important of which is the NIA, NIH-funded Alzheimer’s Disease Research Center (1Florida ADRC), which is a consortium of leading centers doing Alzheimer’s research in Florida, administered by the University of Florida. The Wien Center leads and operates the Clinical Core of the 1Florida ADRC, in which it conducts the following procedures: Annual clinical and neuropsychological evaluations, Structural and Functional MRI studies, Amyloid PET imaging and Clinico-pathological correlation. The Wien Center is a one of a kind center, based in Miami Beach, which is a site for various multicenter clinical trials, including Alzheimer’s prevention trials and the Alzheimer’s Disease Neuroimaging Initiative (ADNI). The Center also administers several programs funded by the State of Florida, including a Memory Disorders Clinic, a Memory Screening Program, the State of Florida Dementia Brain Bank, and an Alzheimer’s Caregiver Program. Since 2003 the Wien Center has hosted the annual Mild Cognitive Impairment Symposium, which has been attended by approximately 200 scientists and clinicians from around the world every year. The Symposium agenda includes extended discussion periods following presentations by national and international experts in fields such as neurology, psychiatry, neuropsychology, radiology, epidemiology, genetics and molecular biology. The
successful appointee will join a multidisciplinary team with experience in the diagnosis, management and the use of multimodal imaging of patients with memory complaints, mild cognitive impairment and dementia. She/he will have a unique opportunity to engage in observational as well as interventional research studies. EOE/AA/Drug-Free. Please visit us online at: www.msmc.com and email resume 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 November 2017 print edition of A AANnews must be submitted by October 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.
Dates and Deadlines SUN 3
Early Registration Deadline: Fall Conference AAN.com/view/Fall
Application Deadline: 2018 Clinical Research Training Scholarships AAN.com/view/ResearchProgram
Webinar: iNeurology: Best IT Practices
SEPTEMBER 12 Webinar: Open Your Heart, Open Your Notes: A Guide to Patient Engagement (Register by September 11) AAN.com/view/pmw17
(Register by November 6)
Webinar: Using the EHR or Axon Registry® to Drive Quality Improvement (Register by October 9) AAN.com/view/pmw17
OCTOBER 16–22 Neurology Career Week AAN.com/careers
OCTOBER 20–22 2017 AAN Fall Conference Las Vegas, NV AAN.com/view/fall
OCTOBER 23 Deadline: Call for Abstracts
OCTOBER 25 Application Deadline: AAN Awards
AAN.com/view/18Awards AANnews • September 2017
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Published on Aug 17, 2017