VOLUME 32 · ISSUE 4 · APRIL 2018
IT'S NOT TOO LATE TO REGISTER More than 3,000 Abstracts It’s not too late to attend the world’s most innovative neurology conference. Online registration is still available at AAN.com/view/ AM18 and on-site registration will be available beginning Friday, April 20, at 4:00 p.m. in the Los Angeles Convention Center. The meeting’s all-inclusive registration rate is your ticket to most everything the meeting has to offer, all week long and at no additional cost to you, letting you customize your week to make the experience all yours. Don’t miss this opportunity to join a diverse group of neurologists, neuroscientists, and neurology professionals from around the globe to experience the best education programming, scientific breakthroughs, and invaluable networking opportunities in the world of neurology. Look for new and innovative programs, events, and other opportunities all week long designed to engage and nourish your mind, body, and spirit. Continued on page 10
2018 AAN Award Winners Announced
Learn How to Integrate APPs into Your Practice
Congratulations to the winners of the 2018 AAN awards. Most of these recipients will be celebrated with presentations of their awards during the Annual Meeting in Los Angeles, and some will present papers at the following noted times. The American Academy of Neurology thanks the American Brain Foundation for its support through philanthropy of the American Academy of Neurology’s awards program.
Advanced practice providers, like physician assistants and nurse practitioners, share the responsibility for patient care, as well as sharing liability risks with their supervising physician. These professionals can be a key component in developing a more successful and efficient practice. This webinar will provide communication techniques and strategies to build your practice’s care team to create a healthy environment for yourself, your APPs, and your patients.
Continued on page 11
9 Empower Yourself at Annual Meeting
19 Emerging Leaders Program Turns Skeptic to Believer
Continued on page 21
26 New Continuum Addresses Spinal Cord Disorders
THE FIRST FDA-APPROVED TREATMENT FOR ADULTS WITH TARDIVE DYSKINESIA
PRECISELY FOCUSED on tardive dyskinesia (TD), so you can help your patients focus on what matters most
Not an actual patient
A convenient once-daily treatment for adults with TD1 INGREZZA 80 mg provided rapid and significant reductions in TD severity by 6 weeks1,2 —with continued reductions in TD severity through 48 weeks1,3 Generally well tolerated in clinical trials across a broad range of TD patients1,2 Selectively inhibits VMAT2, with no appreciable binding affinity for dopaminergic (including D2) or serotonergic receptors1 Offers convenient, once-daily dosing without complex titration1
S I G N U P F O R N E W S A N D U P DAT E S AT W W W. I N G R E Z Z A H C P.C O M / R E G I S T E R VMAT2, vesicular monoamine transporter 2.
Important Information INDICATION & USAGE
INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.
IMPORTANT SAFETY INFORMATION WARNINGS & PRECAUTIONS Somnolence INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
QT Prolongation INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the adjacent page for brief summary of Prescribing Information and visit www.INGREZZAHCP.com for full Prescribing Information. REFERENCES: 1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2017. 2. Hauser RA, Factor SA, Marder SR, et al. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017:174(5):476-484. 3. Factor SA, Remington G, Comella CL, et al. The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. J Clin Psychiatry. 2017.
©2017 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US-0287v3 02/18
for oral use
Brief Summary: for full Prescribing Information and Patient Information, refer to package insert. INDICATIONS AND USAGE
INGREZZA is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.
WARNINGS AND PRECAUTIONS
Somnolence INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA. QT Prolongation INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. In patients taking a strong CYP2D6 or CYP3A4 inhibitor, or who are CYP2D6 poor metabolizers, INGREZZA concentrations may be higher and QT prolongation clinically significant. For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary. For patients taking a strong CYP3A4 inhibitor, reduce the dose of INGREZZA to 40 mg once daily. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
Endocrine Disorders: blood glucose increased General Disorders: weight increased Infectious Disorders: respiratory infections Neurologic Disorders: drooling, dyskinesia, extrapyramidal symptoms (non-akathisia) Psychiatric Disorders: anxiety, insomnia During controlled trials, there was a dose-related increase in prolactin. Additionally, there was a dose-related increase in alkaline phosphatase and bilirubin, suggesting a potential risk for cholestasis.
Drugs Having Clinically Important Interactions with INGREZZA Table 2: Clinically Significant Drug Interactions with INGREZZA Monoamine Oxidase Inhibitors (MAOIs) Clinical Implication:
Prevention or Management: Examples: isocarboxazid, phenelzine, selegiline Strong CYP3A4 Inhibitors Clinical Implication:
The following adverse reactions are discussed in more detail in other sections of the labeling: • Somnolence • QT Prolongation 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 practice.
Prevention or Management: Examples: Strong CYP2D6 Inhibitors
The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose, dose escalation, dose reduction), including 445 patients. Patients were 26 to 84 years of age with moderate to severe tardive dyskinesia and had concurrent diagnoses of mood disorder (27%) or schizophrenia/schizoaffective disorder (72%). The mean age was 56 years. Patients were 57% Caucasian, 39% African-American, and 4% other. With respect to ethnicity, 28% were Hispanic or Latino. All subjects continued previous stable regimens of antipsychotics; 85% and 27% of subjects, respectively, were taking atypical and typical antipsychotic medications at study entry. Adverse Reactions Leading to Discontinuation of Treatment A total of 3% of INGREZZA treated patients and 2% of placebo-treated patients discontinued because of adverse reactions. Common Adverse Reactions Adverse reactions that occurred in the 3 placebo-controlled studies at an incidence of ≥2% and greater than placebo are presented in Table 1. Table 1: Adverse Reactions in 3 Placebo-Controlled Studies of 6-week Treatment Duration Reported at ≥2% and >Placebo INGREZZA (n=262) (%)
Placebo (n=183) (%)
Concomitant use of INGREZZA with strong CYP2D6 inhibitors may increase the exposure (Cmax and AUC) to valbenazine’s active metabolite compared with the use of INGREZZA alone. Increased exposure of active metabolite may increase the risk of exposure-related adverse reactions.
Prevention or Management:
Consider reducing INGREZZA dose based on tolerability when INGREZZA is coadministered with a strong CYP2D6 inhibitor.
paroxetine, fluoxetine, quinidine
Anticholinergic effects (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention)
Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder)
Headache Akathisia (akathisia, restlessness)
Strong CYP3A4 Inducers Clinical Implication:
Prevention or Management: Examples: Digoxin
General Disorders Somnolence (somnolence, fatigue, sedation) Nervous System Disorders 1
Gastrointestinal Disorders Vomiting Nausea Musculoskeletal Disorders Arthralgia 1
Within each adverse reaction category, the observed adverse reactions are listed in order of decreasing frequency.
Other Adverse Reactions Observed During the Premarketing Evaluation of INGREZZA Other adverse reactions of ≥1% incidence and greater than placebo are shown below. The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
Concomitant use of INGREZZA with strong CYP3A4 inhibitors increased the exposure (Cmax and AUC) to valbenazine and its active metabolite compared with the use of INGREZZA alone. Increased exposure of valbenazine and its active metabolite may increase the risk of exposure-related adverse reactions. Reduce INGREZZA dose when INGREZZA is coadministered with a strong CYP3A4 inhibitor. itraconazole, ketoconazole, clarithromycin
Variable and Fixed Dose Placebo-Controlled Trial Experience
Concomitant use of INGREZZA with MAOIs may increase the concentration of monoamine neurotransmitters in synapses, potentially leading to increased risk of adverse reactions such as serotonin syndrome, or attenuated treatment effect of INGREZZA. Avoid concomitant use of INGREZZA with MAOIs.
Concomitant use of INGREZZA with a strong CYP3A4 inducer decreased the exposure of valbenazine and its active metabolite compared to the use of INGREZZA alone. Reduced exposure of valbenazine and its active metabolite may reduce efficacy. Concomitant use of strong CYP3A4 inducers with INGREZZA is not recommended. rifampin, carbamazepine, phenytoin, St. John’s wort1
Concomitant use of INGREZZA with digoxin increased digoxin levels because of inhibition of intestinal P-glycoprotein (P-gp).
Prevention or Management:
Digoxin concentrations should be monitored when co-administering INGREZZA with digoxin. Increased digoxin exposure may increase the risk of exposure related adverse reactions. Dosage adjustment of digoxin may be necessary.
The induction potency of St. John’s wort may vary widely based on preparation.
Drugs Having No Clinically Important Interactions with INGREZZA Dosage adjustment for INGREZZA is not necessary when used in combination with substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4/5 based on in vitro study results.
Human Experience The pre-marketing clinical trials involving INGREZZA in approximately 850 subjects do not provide information regarding symptoms with overdose. Management of Overdosage No specific antidotes for INGREZZA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. If an overdose occurs, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org). For further information on INGREZZA, call 84-INGREZZA (844-647-3992). Distributed by: Neurocrine Biosciences, Inc. San Diego, CA 92130 INGREZZA is a trademark of Neurocrine Biosciences, Inc. CP-VBZ-US-0203v2 09/17
AANnews · April 2018
Cover It's Not Too Late to Register 2018 AAN Award Winners Announced
Tools & Resources What Is Your Plan for Scoring MIPS Points in 2018? · · · · · · 21
Podcast Central · · · · · · · · · 22
Learn How to Integrate APPs into Your Practice President’s Column Summit Examined Issues in Academic Neurology, How the AAN Can Help · · · · · · · · ·5 Through Their Eyes Recollections of Past AAN Presidents · · · · · · ·6 Conferences & Community Hot Topics Program Examines How Dramatic Changes in Stroke Care Will Impact Workforce, Staffing · · · ·9 Empower Yourself at Annual Meeting · · · · · · · · · · ·9 Post-program Opportunities to ‘Continue the Conversation’ with Faculty, Directors · · · · · · 11 Joint American Heart Association/American Stroke Association Session to Examine Disparities · · · · · · · 18 Emerging Leaders Program Turns Skeptic to Believer · · · · 19 2018 Sports Concussion Conference Set for Indianapolis · · · · · · · · · · · · 20
Axon Registry Makes MIPS Reporting Easy for Practice Manager · · · · · · 22 AAN Publishes New Neuro-oncology Quality Measurement Set · · · · · · · · 23 Better Health Outcomes Is Focus of New Neurology: Clinical Practice · · · · · · · · · 23 Education & Research Shulman Selected for AAN President’s Award · · · · · 25 Become UCNS Certified or Maintain Your Certification · · · 26 Neurology Press Releases Garner Media Attention · · · · · 26 New Continuum Addresses Spinal Cord Disorders · · · · · 26 American Brain Foundation Crowdfunding Site Celebrates Year of Growth, Looks to the Future · · · · · · · 27 Policy & Guidelines Capitol Hill Report · · · · · · · · 28 Careers · · · · · · · · · · · · · · · 35 Dates & Deadlines · · · · · · · · · 37
The Vision of the AAN is to be indispensable to our members. The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. Contact Information
For advertising rates, contact:
American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415
Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins
Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:
Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com
The AAN mourns the passing of neurologist Sir Roger Bannister, MD, on March 3. The Academy honored Bannister in 2005 with its first Lifetime Achievement Award. “While the world may remember him as the first athlete to break the four-minute mile, we can all be proud to note that he called the award from the AAN his most prized possession,” said Executive Director and CEO Catherine M. Rydell, CAE. Seven companies have joined the AAN Industry Roundtable as first-time members for 2018: Abbott, Bayer, Celgene, CSL Behring, Greenwich Biosciences Inc, Ionis Pharmaceuticals, and Sarepta Therapeutics. The Industry Roundtable provides a forum for the AAN and industry representatives to share ideas and resources and collaborate on opportunities to support neurology and serve people with neurologic disease. In late February, Anthem Inc. reversed its decision to reduce reimbursement for E/M services billed by the same provider for the same date of service using modifier 25. This decision was made in response to feedback from medical societies such as the AAN. The Academy supported both a specialty society coalition that opposed changes and the American Medical Association resolution to oppose this policy.
AAN Executive Director: Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela Babb, CAE Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designers: Siu Lee and Jim Hopwood Email: email@example.com
AANnews is published monthly by the American Academy of Neurology for its 34,000 members worldwide. Access this magazine and other AAN publications online at AAN.com/go/elibrary. The American Academy of Neurology ’ s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
Summit Examined Issues in Academic Neurology, How the AAN Can Help Academic neurology departments, like many other constituents of the AAN, are facing many challenges today to support the under-funded missions of clinical care, education, and research. As the birthplace of many neurologists, neurology departments are the place where students get their first exposure to the field, residents begin their training, fellows differentiate into subspecialists, and faculty careers develop. The challenges that are facing all of us include the ever-changing health care reforms, research funding cuts, neurology work force issues, graduate medical education funding cuts, reduced reimbursement for services, and increasing regulatory burden. As a sitting chair of a neurology department, I have personally felt the pressures and sometimes felt alone in coming up with solutions to respond to these challenges. We believe the time is right to come together to discuss the state of neurology and academic medicine, and to develop tangible solutions in support of the future of academic neurology. The AAN has developed an Academic Medicine Initiative and been actively seeking new ways to maximize the effectiveness of our ongoing support for academic neurology. Paramount to this initiative is strengthening the AAN’s relationship with chairs, understanding the needs of academic neurology departments, and efficiently identifying unmet needs of chairs and their departments and effectively addressing them. I am delighted to report that on March 5 in Chicago, the AAN hosted the first-ever Neurology Department Chair Summit, in collaboration with our colleagues at the American
Neurological Association (ANA) and the Association of University Professors of Neurology (AUPN). Attendees included more than 100 chairs from across the country as well as the chairs and vice chairs of the AAN’s Education and Science Committees.
Simply put, many attendees didn’t know what’s already being done by our organizations. Others were aware of what’s not being done, and many had ideas on what should be done. The sense was that there have been gaps in what we provide department chairs, and that we—the AAN, ANA, and AUPN—need to do more. The goal of this summit was to identify the current gaps, share best practices, and create a roadmap for moving forward. The desired outcome of the summit was to have fresh, focused ideas that the AAN and our colleagues can create programming around.
Current Academic Department Support from AAN, ANA, and AUPN Barbara Vickrey, MD, MPH, immediate past-president of ANA; Karen Johnston, MD, president of AUPN; and I were pleased to discuss current support provided by our organizations to Continued on page 15
AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN, opened the meeting of more than 100 neurology department chairs
Claudia F. Lucchinetti, MD, chair of neurology at the Mayo Clinic in Rochester, MN, spoke.
AANnews • April 2018 5
Through Their Eyes
Recollections of Past AAN Presidents Roger N. Rosenberg, MD, FAAN / President 1991–1993 Francis. I. Kittredge, Jr., MD, JD, FAAN / President 1999–2001 During 2018, AANnews® celebrates the history of the Academy during its 70th anniversary with a series of interviews of past presidents. The following excerpt is from a 2017 joint interview with Roger N. Rosenberg, MD, FAAN (RR), and Francis. I. Kittredge, Jr., MD, JD, FAAN (FK), conducted by AANnews editor Tim Streeter (TS). Rosenberg and Kittredge, along with then-President Lewis P. (Bud) Rowland, MD, FAAN, were instrumental in the launch of what is now known as the American Brain Foundation. TS: I’d like to take you back to the 1990s and The Decade of the Brain. Did the Academy benefit from that? RR: Yes, The Decade of the Brain in the 2000s had an effect. It had a major educational effect. It got people really interested in the brain. It increased the budget of the NIH. Those are very important. It was education not only of our colleagues in medicine and science, but the public. The public has an insatiable interest, as Dr. Kittredge said. We did not have good therapies for multiple sclerosis then; we do now. Parkinson’s then, we didn’t; we do now. Stroke then, we do now. The public is involved in this. They are our advocates with the Congress, the congressional appropriations, which has driven the ability to do more research. That is why we have to preserve the NIH budget now, which is under some concern. An increase in the budget for neurologic disease benefits everybody. No matter what your political persuasion may be. We have to deal with and develop new therapies for stroke and Alzheimer’s disease. These are democratic diseases. They affect everybody of any persuasion. We need to benefit the American people. I think The Decade of the Brain was the start and it had a real effect in terms of increasing the NIH budget of mobilizing the public at large from an education point of view and it just continues. The budget now of the NIH is 32 billion dollars. NINDS and NIH, the mental health institutes are up, and we are getting answers to neurologic disease. Look at what has happened in terms of stroke: tPA and endarterectomy and stents. It has had a practical effect. The Decade of the Brain really focused the public’s education on the brain in a very concerted way for the first time. It had a real benefit. Now we see the dividends from that investment. TS: Dr. Kittredge, you came into the presidency at the end of The Decade of the Brain. Did you see any effects? Did you have something to build off of during your presidency from that?
John Whitaker, MD; Sen. Mark Hatfield (R-OR); and Francis J. Kittredge, Jr., MD, JD, FAAN, in Washington, DC, 1992.
FK: I thought that The Decade of the Brain, as Roger said, was amazingly exciting. I mean, they expanded funding for NINDS by 100 percent. They doubled the budget over that 10-year period. The unfortunate thing is that after 2001, the budget has been sort of flatlined. There is an integration that occurs that starts with the basic sciences and NIH is primarily interested in that. If we don’t have the basic science going on at NIH and we don’t have the translational science going on in the university system in the neurology departments, and that kind of thing, then industry does not then follow up with the clinical applications and development of new target drugs. These are so closely linked and industry, as I understand it, has been pulling back from funding research on their part because of the fact that it is so difficult, expensive, and time-consuming to go ahead and introduce new drug products that are calculated, as Roger was saying, that have identified targets in the genome in the neuropathophysiology, if you will, that could be identified and targeted with new products because of the cost. There is a cost-benefit ratio to the investors and the people in the drug companies that really, I think, is at risk to some extent with that. You can’t really go ahead and cut our basic science research budget and expect that we are going to have new treatments and new cures for brain disease or any other group of diseases. You really need a guarantee or an assurance that you are going to maintain your budget at an inflation-adjusted level so that you don’t have to give up research programs because you don’t have the money. RR: …Dr. Kittredge and I were very active in starting a program which we called the [American Academy of Neurology] Education and Research Foundation, very much so. Dr. Kittredge and I had the view that, as he indicated, in order to get people to want to go in to do research after a
Stanley B. Prusiner, MD; AAN President Roger N. Rosenberg, MD, FAAN; Francis H.C. Crick, OM FRS; and William H. Oldendorf, MD, at the 1992 Annual Meeting.
AANnews • April 2018
residency, they weren’t prepared. They need fellowship support. They needed research grants. To go from a residency into a research program and to write grants and become independent without any formal training was extremely difficult. I do remember in 1991, 1990, going to Jan Kolehmainen, who at the time was the executive director, and indicated we need to do something to develop the needs for post-residency fellowship training to get people to go into research. We talked about a development office and I really said, “No, we need to move forward with a foundation of some sort. Something independent and dynamic.” I shared my thoughts with Dr. Kittredge and with Bud Rowland, who was the president at the time. We went forward and we established the AAN Education and Research Foundation. I was delighted to be the president as it began, but Dr. Kittredge was the first chair of the foundation.
RR: It is funding millions of dollars and dozens of wonderful fellowships. TS: More than 20 million dollars it has given away. RR: Dr. Kittredge, Dr. Rowland, and I feel pleased about that; that, that mission has been accomplished and wonderful people are now in academic medicine and doing science and research to help life for us all. FK: We created, I think in a sense, the seed corn for academic neurology. RR: I think so. FK: Because the interesting thing was these folks came out of their foundation fellowship and were successful at a very high level of getting an RO1 grant from NIH and that was something, at least some years ago, where 95 to 98 percent of them were in academic neurology. As a matter of fact, the chairman at Harvard, here, was one of our first fellows. RR: It’s terrific. It really—it goes on and on and on in terms of what it is— FK: It’s just the ripple effect has been phenomenal.
Rosenberg and Kittredge spoke during the Hall of Presidents presentation at the 2017 Annual Meeting.
FK: I was the first president. RR: First president of the foundation and he moved it forward and established it and was responsible for its success. FK: It is interesting because the conversation started during Bud Rowland’s term and Bud established a committee of the board that was the financial development committee of the board of trustees or the executive board of the Academy and Roger was on the committee and I chaired it and Steve Ringel was on the committee and we came back with two recommendations. The first was that we start a foundation, as Roger says, and the second was to go ahead and start a publishing company to take over the journal and develop other publications for the Academy that would go ahead and provide additional revenue. The foundation was started, I remember it vividly, sitting at a board meeting with Bud Rowland, who was sitting there, and Bud had an interesting comment and we were talking about money and at the time Audrey Penn was the deputy director at NINDS and was in charge of translational research. She was pushing that. But, as we said, “Well, what are we going to do with the money when we raise it?” Bud says, “I think we ought to go ahead and start clinical fellowships,” and that was the genesis of our clinical fellowship program, which is usually a two-year program after residency in a specialty or in a subject that is of interest.
Visit AAN.com/view/AANhistory to read the complete transcript of the interview with Rosenberg and Kittredge and learn how they were inspired to become neurologists and champions of brain research.
Academy Staff Celebrates Anniversary Many of the AAN’s nearly 200 employees were on hand or dialed into the Minneapolis headquarters on March 13 to celebrate the 70th anniversary of the date of the Academy’s 1948 incorporation. Staff enjoyed a presentation on AAN history incorporating archival photos and insightful quotes from past Academy leaders—and, of course, a birthday cake! Pictured with the cake are executive staff members Chief Business Development Officer Chris Becker; Executive Director and CEO Catherine M. Rydell, CAE; Chief Communications Officer Angela Babb, CAE, APR; General Counsel Bruce Levi, JD; Deputy Executive Director Christine E. Phelps.
RR: It has been a great success. The synergism among all of us a great success. Now it is the American Brain Foundation. TS: Right.
AANnews • April 2018 7
In Multiple Sclerosis, when it comes to Brain Preservation
Grey Matters, Too
Learn more at MSBrainPreservation.com
ÂŠ 2018 Celgene Corporation All rights reserved. 02/18 USII-CELG180027b
Conferences & Community
Hot Topics Program Examines How Dramatic Changes in Stroke Care Will Impact Workforce, Staffing The Hot Topics in Stroke Education and Practice course at the Annual Meeting will how highlight dramatic changes in the management of acute ischemic stroke (AIS) will impact the workforce, residency, staffing, and other aspects of the neurology profession and practice. The course will be Monday, April 23, from 3:30 p.m. to 5:30 p.m. The management of acute ischemic stroke (AIS) has witnessed a dramatic transformation over the past few years. These changes are based on the 2017 DAWN study, 2018 DEFUSE-3 study, and American Heart Association and the American Stroke Association’s new guidelines for early management of AIS, which the AAN recently affirmed, with
recommendations to treat eligible patients for up to 24 hours with thrombectomy.
“Evaluating and treating stroke will be an essential skill of any future neurologic practice, and this course will examine how these seismic changes will impact the organization and delivery of acute stroke care services in terms of human, organizational, and financial costs,” said Pierre Fayad, MD, FAHA, FAAN, director of the course.
For more information about the DEFUSE-3 trial, attend the Clinical Trials Plenary Session on Tuesday, April 24, at the Annual Meeting.
Empower Yourself at Annual Meeting Experiential Learning Areas Practice management and advocacy are not mutually exclusive—and neither are this year’s Advocacy to Action and Maximize Your Value Experiential Learning Areas. These two popular Annual Meeting destinations will share the same stage in the South Lobby of the Los Angeles Convention Center to provide the most powerful and effective tips and tools to equip you for success.
Advocacy to Action
Maximize Your Value
When neurology succeeds, we all succeed, and this highly interactive area will empower you to:
When you succeed, your patients succeed, and this resource-rich area will offer the guidance you’re seeking:
Find out how you can initiate your own advocacy efforts Learn about—and provide input on—the AAN’s important legislative priorities Visit the Polling Station to tell us what matters most to you—your voice can make a difference! Snap a photo at our selfie station and upload it to social media to promote #AANadvocacy Participate in Bow Tie Tuesday! Wear your own green bow ties and scarves, and learn how to get involved in Neurology on the Hill
Hear from experts about the latest AAN guidelines and quality measurement sets to ensure you are providing best-treatment practices Meet with staff from the AAN’s Axon Registry® and technical vendor FIGmd to put Axon’s quality improvement data to work for you
Hear talks about small and solo practice management, reimbursement, quality improvement, best practices for EHR technology, and communication on care teams Enjoy networking and roundtable events designed for small and solo practitioners and business administrators Visit AAN.com/view/ELA for a full program schedule.
Learn about the available tools and resources to help you succeed in the evolving Quality Payment Program Educate yourself about neurologists’ compensation and know how to increase your own revenue and value through coding and technology
Network with alumni of the Palatucci Advocacy Leadership Forum Become familiar with some of today’s most controversial topics impacting your practice—like high drug pricing and marijuana Visit AAN.com/view/ELA for a full program schedule. AANnews • April 2018 9
Conferences & Community
It's Not Too Late to Register
Continued from cover
Education Highlights Specialty Tracks If your schedule won’t allow you to stay for the whole meeting, maximize your time in Los Angeles and get the most out of a shorter trip with these specialty tracks that will take place on consecutive days:
Child Neurology–Sunday to Tuesday Neuro-rehabilitation–Wednesday to Friday Neuro-infectious Disease–Wednesday to Friday Neuro-oncology–Tuesday to Thursday Pain and Palliative Care–Sunday to Tuesday Sleep–Sunday to Tuesday
Career-focused Tracks This year’s tracks are geared toward neurohospitalists, those starting a new practice, and others who are interested in business basics, and advanced practice providers who are new to neurology. Expanded Experiential Learning Areas A robust lineup of opportunities will have you interacting, exploring, and learning outside the classroom. Expanded Spanish-language Curriculum Look for programming on a variety of topics in a variety of formats, including education courses and experiential learning areas—taught entirely in Spanish.
Scientific Highlights Presidential Lecture by Francis S. Collins, MD, PhD, National Institutes of Health: “California Dreaming: BRAIN and Precision Medicine in 2018” Joint American Heart Association/American Stroke Association Session A two-hour program will examine disparities in stroke care including bridging racial and ethnic disparities in the management of stroke and breakthroughs in engaging minority and rural communities in stroke studies. BRAIN Initiative Session This program will feature the latest findings from the NIH Brain Research through the Advancing Innovative Neurotechnologies (BRAIN) Initiative, a large-scale
AANnews • April 2018
effort aimed at revolutionizing our understanding of the human brain. Launched in 2013 by President Obama as a “moonshot to explore the frontiers of the mind,” this program seeks development of the technologies and insights to facilitate preventions, treatments, and cures of brain disorders. Controversies in Neurology Plenary Session—Based on Member Suggestions! For the first time, AAN members weighed in what they would like to see presented at this year’s session. Two member-chosen topics have been selected for presentation this year. Come hear about: Would You Let Your Child Play Contact Sports? and Should the Neurologist Be Primarily Responsible for Taking Care of Patients with Functional Disorders? New E-poster Set-up Twelve semi-private viewing areas will allow for a more interactive and dynamic engagement and discussion with presenters. Look for 12 different E-posters each day!
Additional Highlight Special Presentation by Bennet Omalu, MBBS, MPH, MBA; and Steven DeKosky, MD, FAAN, FACP As chronicled in the 2015 film “Concussion,” find out how Omalu and DeKosky changed American football, professional sports, and how the world perceives traumatic brain injury when together they confirmed the first case of dementia pugilistica/chronic encephalopathy in an American football player.
Post-program Opportunities to ‘Continue the Conversation’ with Faculty, Directors Annual Meeting attendees will be given a new opportunity to connect with faculty, directors, and other attendees via 30-minute, small-group conversations at the conclusion of select courses. The new pilot program, “Continuing the Conversation,” will offer audience members opportunities to connect one-on-one with directors in another room after the program, where they can ask questions of the directors― no more standing in line after the program!
This year’s sessions are: Sunday, April 22, 5:30 p.m.–6:00 p.m. following the day’s C26, C44, and C58 Neuro-ophthalmology courses Director: Nancy Newman, MD, FAAN Monday, April 23, 3:00 p.m.–3:30 p.m. following C70 Evaluating Tremor in the Office Director: Vicki Shanker, MD
2018 AAN Award Winners Announced
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2018 AAN ADVANCED PRACTICE PROVIDER SCHOLARSHIP
ASSOCIATION OF INDIAN NEUROLOGISTS IN AMERICA LIFETIME ACHIEVEMENT AWARD
AWARD FOR CREATIVE EXPRESSION OF HUMAN VALUES IN NEUROLOGY
This award is sponsored by the APP Work Group and Practice Committee of the American Academy of Neurology. Recipients: L aura Dixon, DNP, APRN, FNP-BC, Louisville, KY Tara M. Biller, ARNP, FNP-BC, Seattle, WA Consortium of Neurology APPs Meeting / Monday, April 23, 8:00 a.m. Founders Sponsored by the American Academy of Neurology and endowed by the former American Academy of Neurology Alliance. Recipient: Ezequiel Gleichgerrcht, MD, Charleston, SC S9: Epilepsy/Clinical Neurophysiology (EEG) I / Sunday, April 22, 3:30 p.m. S. Weir Mitchell Sponsored by the American Academy of Neurology and endowed by the former American Academy of Neurology Alliance. Recipient: Eric C. Landsness, MD, PhD, St. Louis, MO S17: Sleep / Monday, April 23, 3:30 p.m.
AMERICAN ACADEMY OF NEUROLOGY PRESIDENT’S AWARD This award is given by the American Academy of Neurology president for outstanding service to the AAN and the profession of neurology. Recipient: Lisa M. Shulman, MD, FAAN, Baltimore, MD
AMERICAN BRAIN FOUNDATION CHAIR’S AWARD Sponsored by the American Brain Foundation. Recipient: Richard P. Essey, San Francisco, CA Commitment to Cures Gala, JW Marriott Hotel / Wednesday, April 25, 6:00 p.m.
Sponsored by the American Brain Foundation. Recipient: V inay Chaudhry, MD, MBA, CPE, FRCP, FAAN, Baltimore, MD AINA Annual Meeting, InterContinental Hotel / Monday, April 23, 3:30 p.m.
This award is sponsored by the Ethics, Law, and Humanities Committee, a joint committee of the American Academy of Neurology, the American Neurological Association, and the Child Neurology Society. Recipient: Madaline B. Harrison, MD, Charlottesville, VA The 9 o’clock Patient
A.B. BAKER AWARD FOR LIFETIME ACHIEVEMENT IN NEUROLOGIC EDUCATION Funded by an endowment created by matching funds from the A.B. Baker Family Trust and Novartis Pharmaceuticals. Recipient: Steven Galetta, MD, FAAN, New York, NY
COMMITMENT TO CURES AWARD Sponsored by the American Brain Foundation. Recipient: D eMaurice Smith, Executive Director, NFL Players Association, Washington, DC Continued on page 12
AANnews • April 2018 11
Conferences & Community
2018 AAN Award Winners Announced 2018 ENHANCED RESIDENT LEADERSHIP PROGRAM The AAN is grateful to the following 2018 Enhanced Resident Leadership Program supporter: The Allergan Foundation. Recipients: M alik Adil, MBBS, Ochsner Clinic Foundation Kyle M. Blackburn, MD, UT Southwestern Ana G. Cristancho, MD, PhD, Children’s Hospital of Philadelphia Neil Datta, MD, Hartford Hospital Preston Douglas, MD, Loyola University Medical Center Amber Hetrick, MD, Indiana University School of Medicine Marina Khrizman, DO, Nationwide Children’s Hospital Noah Levinson, MD, University of Pennsylvania Ashley Rawls, MD, Medical University of South Carolina Stasia Rouse, MD, Loyola University Medical Center Jonathan Santoro, MD, Stanford University Jessica Schulte, MD, Columbia University Robert C. Stowe, MD, Baylor College of Medicine Lauren Treat, MD, Children’s Hospital Colorado Leena E. Youssefian, MD, Stony Brook Medicine
DREIFUSS-PENRY EPILEPSY AWARD
Sponsored by the American Academy of Neurology and endowed by members of the American Academy of Neurology Epilepsy Section; Abbott Laboratories, Inc.; Cephalon, Inc.; Cyberonics, Inc.; Elan Pharmaceuticals, Inc.; GlaxoSmithKline; Novartis Neuroscience; Ortho-McNeil Neurologics; Pfizer Inc; Shire US, Inc; and UCB Pharma. Recipient: Kathryn A. Davis, MD, MS, FAES, Philadelphia, PA S19: Epilepsy/Clinical Neurophysiology / Monday, April 23, 3:30 p.m.
JOHN DYSTEL PRIZE FOR MULTIPLE SCLEROSIS RESEARCH
Sponsored by the American Academy of Neurology and National Multiple Sclerosis Society and made possible through a special contribution from the John Dystel Multiple Sclerosis Research Fund at the National Multiple Sclerosis Society. Recipient: F rederik Barkhof, MD, PhD, Amsterdam, Netherlands S8: Progressive MS Therapies and Age-dependent Factors in MS Therapy / Sunday, April 22, 3:30 p.m.
AANnews • April 2018
Continued from page 11
SHEILA ESSEY AWARD: AN AWARD FOR ALS RESEARCH
Sponsored by the American Academy of Neurology, the American Brain Foundation, and the ALS Association and supported through the philanthropy of the Essey Family and the ALS Association. Recipient: Timothy M. Miller, MD, PhD, St. Louis, MO S25: Advances in Amyotrophic Lateral Sclerosis / Tuesday, April 24, 3:30 p.m.
NORMAN GESCHWIND PRIZE IN BEHAVIORAL NEUROLOGY
Sponsored by the American Academy of Neurology and endowed through Dr. Geschwind’s family, friends, and colleagues; Pfizer Inc; and the Society for Behavioral and Cognitive Neurology. Recipient: Zachary Miller, MD, San Francisco, CA S34: Behavioral and Cognitive Neurology / Wednesday, April 25, 3:30 p.m.
WAYNE A. HENING SLEEP MEDICINE INVESTIGATOR AWARD
Sponsored by the American Academy of Neurology and endowed by UCB, Inc., Lilly USA, Elite Home Medical & Respiratory, Inc., Raleigh Neurology Associates, and friends of Dr. Wayne A. Hening. Recipient: Yo-El Ju, MD, MSCI, St. Louis, MO S17: Sleep / Monday, April 23, 3:42 p.m.
INTERNATIONAL SCHOLARSHIP AWARD
Sponsored by the American Academy of Neurology. Recipients: D r. Chiseko Ikenaga, Tokyo, Japan Dr. Marianna Spatola, Barcelona, Spain Dr. Mariano Marrodan, Buenos Aires, Argentina Dr. Gerard Raimon M. Saranza, Manila, Philippines Dr. Joseph Kamtchum Tatuene, Blantyre, Malawi Dr. Chen-chen Tan, Qingdao, China Dr. Kaushik Gowthaman, Chennai, India Dr. Divya M. Radhakrishnan, New Delhi, India Dr. Fabiola De Marchi, Novara, Italy Dr. Arunmozhimaran Elavarasi, New Delhi, India Dr. Clare Angeli Enriquez, Manila, Philippines Dr. Federico Eberbach, Buenos Aires, Argentina Dr. Vafa Alakbarzade, Plymouth, United Kingdom Dr. Sankaranarayanan Muthukani, Tamilnadu, India Dr. Elison Sarapura, Lima, Peru Dr. Susanna M. Zuurbier, Amsterdam, Netherlands Dr. Jiangtao Zhang, Beijing, China Dr. Zemen Tadesse Abu, Addis Ababa, Ethiopia Dr. Irina Sharinova, Moscow, Russia Dr. Nada Abdelhameed Elsaid, Mansoura, Egypt
MITCHELL B. MAX AWARD FOR NEUROPATHIC PAIN
MOVEMENT DISORDERS RESEARCH AWARD
LAWRENCE C. MCHENRY AWARD: AN AWARD FOR THE HISTORY OF NEUROLOGY
NEURO-ONCOLOGY INVESTIGATOR AWARD
Sponsored by the American Academy of Neurology and endowed by the United States Cancer Pain Relief Committee, the Mayday Fund, and friends of Dr. Mitchell Max. Recipient: David M. Simpson, MD, FAAN, New York, NY S7: Pain and Palliative Care / Sunday, April 22, 3:30 p.m.
Sponsored by the American Academy of Neurology. Recipient: Bart T.H. Lutters, BSc, Utrecht, Netherlands S39: History of Neurology / Thursday, April 26, 1:00 p.m.
2018 MEDICAL STUDENT DIVERSITY SCHOLARSHIPS
The AAN is grateful to the following 2018 Medical Student Diversity Annual Meeting Scholarship supporter: The Allergan Foundation. Recipients: Nadir Bilici, University of Pennsylvania Perelman School Lauren B. Davis, MS, Ed, Children’s Hospital of Philadelphia Maria E. Diaz Ortiz, University of Pennsylvania Perelman School Gabriella Garcia, Temple University Claudia I. Martinez, University of Texas Francis May, Case Western Reserve University Monique Montenegro, Mayo Medical School, Rochester Monika Pyarali, Baylor College of Medicine Joshua Vandeburgh, Western Michigan University Gregory Vurture, New York University Langone Health
MEDICAL STUDENT ESSAY AWARDS
Sponsored by the American Academy of Neurology. Extended Neuroscience Award Recipient: T his award was not given for 2018 G. Milton Shy Award in Clinical Neurology Recipient: Benjamin Wissel, Cincinnati, OH P2.468: Functional Neurological Disorders in Parkinson Disease / Monday, April 23, 5:30 p.m. Roland P. Mackay Award in Historical Aspects Recipient: Yi Tong, Montreal, Quebec, Canada P2.469: Ghost in the Machine: Historical Aspects of Irreversible Brain Injury and Brain Death / Monday, April 23, 5:30 p.m. Saul R. Korey Award in Experimental Neurology Recipient: Kristen Martin, Burlington, VT P2.470: Discovery of Novel Recessive Genes in a Consanguineous Cohort Using Genotype-phenotype Correlations / Monday, April 23, 5:30 p.m.
Sponsored by the American Academy of Neurology, the Parkinson’s Foundation, and the American Academy of Neurology Movement Disorders Section and endowed by the Parkinson’s Foundation. Recipient: Irene Litvan, MD, FAAN, La Jolla, CA S18: Movement Disorders: Ataxia and Tremor / Monday, April 23, 3:30 p.m. Sponsored by the American Academy of Neurology and supported by friends of Dr. Jerome Posner. Recipient: Milan Chheda, MD, St. Louis, MO S23: Biologic and Clinical Discoveries in Neuro-oncology / Tuesday, April 24, 1:00 p.m.
NEURO-ONCOLOGY SCIENTIFIC AWARD
Sponsored by the American Academy of Neurology and supported by friends of Dr. WK Alfred Yung. Recipient: Scott R. Plotkin, MD, PhD, Boston, MA S23: Biologic and Clinical Discoveries in Neuro-oncology / Tuesday, April 24, 1:12 p.m.
NEUROENDOCRINE RESEARCH AWARD
Sponsored by the American Academy of Neurology and supported by friends of Dr. Andrew Herzog. Recipient: Ellen M. Mowry, MD, FAAN, Baltimore, MD Neuroendocrinology Section Meeting / Wednesday, April 25, 8:15 a.m.
NEUROSCIENCE RESEARCH PRIZE
Funded by the American Academy of Neurology. Recipients: Alex Remnitz, Armonk, NY P1.468: Behavioral Lateralization and Scototaxis Unaltered by Near Future Ocean Acidification Conditions in Poecilia Latipinna (Sailfin Molly) / Sunday, April 22, 4:00 p.m. Recipients: Jackie Stochel, Yorktown Heights, NY P1.469: Utilizing Drug Intervention to Inhibit Delayed Neuronal Death by Migrainous Spreading Depolarizations / Sunday, April 22, 4:00 p.m. Recipients: Sarah Hoffman, Ossining, NY P1.470: Exacerbated Alzheimer’s Disease Pathology in Female Hippocampus and Frontal Cortex of Tg6799 Mice and Humans Relative to Males / Sunday, April 22, 4:00 p.m. Continued on page 14
AANnews • April 2018 13
Conferences & Community
2018 AAN Award Winners Announced CHILD NEUROSCIENCE RESEARCH PRIZE
Sponsored by the American Academy of Neurology and the Child Neurology Society. Recipient: Amy Shteyman, Great Neck, NY The Language of Facial Expressions: A Neuroimaging Study on How a Smile Is Generated and Perceived by Another Person Child Neurology Society Meeting / Sunday, April 22, 5:30 p.m.
MICHAEL S. PESSIN STROKE LEADERSHIP PRIZE
Sponsored by the American Academy of Neurology and endowed by Dr. Pessin’s family, friends, and colleagues. Recipient: G len Jickling, MD, MSC, FRCP(C), Edmonton, AB, Canada S10: Intracerebral and Subarachnoid Hemorrhage / Sunday, April 22, 3:30 p.m.
MRIDHA SPIRIT OF NEUROLOGY HUMANITARIAN AWARD
Sponsored by the American Brain Foundation and funded through the philanthropy of Dr. and Mrs. Mridha. Recipient: Aaron L. Berkowitz, MD, PhD, Boston, MA Global Health Section Meeting / Tuesday, April 24, 12:00 p.m.
POTAMKIN PRIZE FOR RESEARCH IN PICK’S, ALZHEIMER’S, AND RELATED DISEASES
Sponsored by the American Academy of Neurology and the American Brain Foundation and funded through the philanthropy of the Potamkin family. Recipient: David A. Bennett, MD, Chicago, IL S2: Clinical Trials and Therapeutic Approaches in Neurodegenerative Diseases / Sunday, April 22, 1:00 p.m.
PUBLIC LEADERSHIP IN NEUROLOGY AWARD Sponsored by the American Brain Foundation. Recipient: Temple Grandin, PhD, Fort Collins, CO
SAFETY AND QUALITY AWARD
Sponsored by the American Academy of Neurology. Recipients: L ily Grossmann, MD, Boston, MA, Continuous Anesthesia Protocol for MRI and LP in Children Yi Li, MD, PhD, Worcester, MA, Utilization of Ultrasound Guided Lumbar Puncture to Improve the Efficacy and Outcome in an Overweight Patient Population Michael Robers, MD, Phoenix, AZ, Improving the Time for Physician Acknowledgement of Send out Labs
AANnews • April 2018
Continued from page 13 Mauricio Villamar, MD, Lexington, KY, Improvement in Time to Administration of Second-line Antiseizure Medications After Implementation of an Inpatient Status Epilepticus Alert Protocol
IRWIN SCHATZ AWARD FOR AUTONOMIC DISORDERS Sponsored by the American Academy of Neurology and endowed by Lundbeck, Inc. Recipient: David S. Goldstein, MD, PhD, Boston, MA S12: Autonomic Disorders / Monday, April 23, 1:00 p.m.
BRUCE S. SCHOENBERG INTERNATIONAL AWARD IN NEUROEPIDEMIOLOGY Sponsored by the American Academy of Neurology and endowed by GlaxoSmithKline, Inc. Recipient: Fred Sarfo, MD, PhD, Kumasi, Ghana S4: Neuroepidemiology: Neurodegeneration, Epilepsy, Cerebrovascular Disease Risks / Sunday, April 22, 1:00 p.m.
SLEEP SCIENCE AWARD
Sponsored by the American Academy of Neurology and the Sleep Section and endowed by Cephalon, Inc. Recipient: Bradley F. Boeve, MD, Rochester, MN S17: Sleep / Monday, April 23, 3:54 p.m.
JON STOLK AWARD IN MOVEMENT DISORDERS FOR YOUNG INVESTIGATORS
Sponsored by the American Academy of Neurology and endowed by Kyowa Pharmaceutical, Inc., Lineberry Research, Quintiles, Dr. Dennis Gillings, and VelaPharma. Recipient: Nandakumar Narayanan, MD, PhD, Iowa City, IA S30: Movement Disorders: Dystonia, Chorea, and Other Disorders / Wednesday, April 25, 1:00 p.m.
H. RICHARD TYLER AWARD
Sponsored by the American Academy of Neurology and the American Academy of Neurology History Section. Recipient: Andrew J. Solomon, MD, Burlington, VT
KENNETH M. VISTE, JR., MD, PATIENT ADVOCATE OF THE YEAR AWARD
Sponsored by the American Academy of Neurology and endowed by gifts from Dr. Viste’s colleagues, friends and patients. Recipient: Oleg Chernyshev, MD, PhD, Shreveport, LA
HAROLD WOLFF-JOHN GRAHAM AWARD
Sponsored by the American Academy of Neurology and endowed by Endo Pharmaceuticals. Recipient: William R. Renthal, MD, PhD, Boston, MA S43: Migraine / Thursday, April 26, 3:30 p.m.
Summit Examined Issues in Academic Neurology, How the AAN Can Help Continued from page 5 neurology academic departments and medical students, and answer questions about these current offerings. Among the valuable AAN resources I shared was the Axon Registry®; the number of academic departments enrolled in Axon is small and I called for all academic departments to participate. I also shared how advanced practice providers (APPs) are now the fastest growing group of AAN members and we are developing resources to help fully integrate them into the neurology care team. I also provided background on the AAN Academic Medicine Initiative.
S. Andrew Josephson, MD, FAAN, conducted a breakout session on “Maximizing Billing.”
Issues Facing Academic Departments This discussion focused on the outcomes of a survey that was sent to the chairs to ask what issues they are facing. It came as no surprise that revenue to support the mission of academic departments came up as the number one concern for chairs. Moreover, we worked to identify gaps and opportunities where the ANA, AUPN, and AAN can provide solutions in areas including: funding the education mission, pipeline and recruitment, research, and institutional change/integration. There is a concern that we need to focus on undergraduates and excite them about neurology before they are captivated by another specialty
Models for Revenue Generation for Departments: Making the Case to Hospital Administrators We discussed the data and analyses that would be instrumental in making the case to hospital administrators and other health system leaders for transfer of resources to neurology, based on the hospital-based downstream revenue driven by neurologists and neurologic care. We also looked at ways to maximize billing and the growing impact of therapeutics, including infusion, procedures such as endovascular neurology, and comprehensive stroke centers.
Discussion and Prioritization Toward the end of the day, we discussed the gaps and opportunities identified by the breakout groups during the meeting. There were ideas on what the AUPN, ANA, and AAN could possibly do on these topics. We heard that we need more data, toolkits, and greater participation in the AAN’s Neurology Compensation and Productivity Survey. If we could get more data on faculty compensation for certain subspecialties that could be very helpful in making the case to administrators. More education was requested on coding, models where neurologists could get reimbursed for reading images, and more education and resources for APPs to help optimize their participation in the neurology practice. There were requests for new models for growing revenue and providing support for K programs for
young investigators. And we need to continue advocating for our workforce pipeline and moving neurology training to the third year of medical school for all, not fourth year. We also discussed the importance of continuing to advocate for more funding for neurology research at the NIH and encouraging policies that support the continued investment into novel therapeutics by industry. The Chair Summit was a definite success and is only the beginning of our on-going efforts to support all aspects of academic medicine. The recommendations that came from this meeting and more will be summarized and prioritized to consider next steps. I am so grateful to the chairs, volunteers, and staff who helped develop a responsive agenda, led a number of panel discussions, and contributed greatly to the lively discussions in the breakout groups. I am very happy to have seen the amazing engagement, collegiality, and willingness to collaborate and learn from each other. We will build on our momentum to revitalize academic neurology, and I’m proud that the AAN is helping to lead the way.
Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN firstname.lastname@example.org @DrSaccoNeuro on Twitter
AANnews • April 2018 15
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Conferences & Community
Joint American Heart Association/American Stroke Association Session to Examine Disparities The American Heart Association and American Stroke Association are partnering with the AAN to host a two-hour program during the Annual Meeting that will examine disparities in stroke care. The director is Bruce Ovbiagele, MD, MSc, FAAN, and the session will take place on Wednesday, April 25, from 3:30 p.m. to 5:30 p.m.
Bridging Racial and Ethnic Disparities in the Management of Stroke
Breakthroughs in Engaging Minority and Rural Communities in Stroke Studies
3:30 p.m.–3:45 p.m. State of Racial and Ethnic Disparities in Stroke
4:30 p.m.–4:45 p.m. Learning About Your Community (and Establishing a Community Advisory Board)
3:45 p.m.–4:00 p.m. What More Can be Done to Address Racial and Ethnic Disparities in Stroke? 4:00 p.m.–4:15 p.m. Avenues to Engage in Stroke Disparities Research 4:15 p.m.–4:30 p.m. Obstacles and Opportunities in Stroke Care Access Among Racial and Ethnic Minorities
4:45 p.m.–5:00 p.m. Captivating the Community and Sustaining Ties 5:00 p.m.–5:15 p.m. Building Trust with Your Community Through Communication 5:15 p.m.–5:30 p.m. Dissemination of Results and Presenting Information
Pre-order and save up to $1,100 off the regular price. Annual Meeting On Demand is a comprehensive digital library with more than 500 hours1 of presentations recorded from the 2018 Annual Meeting. Access presentations plus syllabi for 200+ programs within 24 hours from the completion of the live presentation. With Annual Meeting On Demand you can: • Watch like you’re there in person with slides and synchronized audio • Learn at your desk, in your car, or on the go with online access on any computer or mobile device • Download PDFs of slides and MP3 files for even greater flexibility in accessing your content • Earn credits with integrated CME testing right in your media player • Participate without an internet connection by using your complimentary hard drive2
Order by April 20, 2018, to secure your savings. Online: Orders.OnDemand.org/AAN/ad Phone: (800) 501-2303 (US Only) or (818) 844-3299 Mention Offer Code : 181LAAADAAN600 1 2
For even greater savings, register to attend the Annual Meeting at AAN.com/view/register and select Gold Registration.
Specific presentations within a session may not be available or may be audio only if the presenter has confidential patient information or otherwise declines to be recorded. Hard drive does not include all the functionality available online, such as Advanced Search, MP3/PDF Downloads, Bookmarks, Recently Viewed and CME testing.
Conferences & Community
Emerging Leaders Program Turns Skeptic to Believer If five years ago you had told 2014 Emerging Leaders Program graduate Jeffrey C. McClean II, MD, FAAN, that one day he would be overseeing all of the Academy’s leadership programs as vice chair of the Leadership Development Committee and physician lead for both the Emerging Leaders and Transforming Leaders Programs, he might not have believed you. But today, when asked how the training he received during the prestigious six-month experience got him to where he is today, he doesn’t mince words: “None of this would have been possible without Emerging Leaders! In short, it has been the single most impactful experience of my professional career.” Back in 2013, McClean was one of only 12 young AAN members less than 10 years out of residency who were carefully chosen to participate in the second Emerging Leaders program. He was selected because of his commitment to the professional, community, and society leadership and was looking to develop and grow his interests and skills to apply them to long-term involvement with the Academy. “To be honest, I started the program as something of a skeptic,” admitted McClean, “so I was very pleasantly surprised at how amazing the experience was. The quality of the training was truly outstanding, and the opportunity to learn and develop these skills along with such an exceptional group of neurologists was inspirational.” Participants in McClean’s class were paired with mentors who helped them explore their leadership identity, set a course for long-term leadership growth, improve communication skills, and develop specific strategies to engage others to achieve professional and team goals. “I was paired with the perfect mentor, Dr. Ralph Józefowicz, a nationally recognized leader who had already accomplished much of what I aspired to. Years after completing the program, he remains an invaluable advisor and advocate.” The tangible skills the Emerging Leaders Program provides are numerous. Specifically, McClean credits the program with helping him adapt to being a more successful leader while simultaneously remaining true to his vision and values. “The most important skill I developed is the ability to tailor my approach based on the goal I am trying to achieve, as well as the individuals I am leading. The awareness I’ve gained of my own strengths and weaknesses, coupled with the ability to perceive those of others, allows me to approach challenging situations more effectively.”
for neurologists at various stages of their careers to develop as leaders.” When asked if he would recommend the AAN Leadership Programs to others, McClean doesn’t hesitate. “I recommend the AAN Leadership Programs all the time!” Learn more about Emerging Leaders and apply for the 2018-2019 program at AAN.com/view/EmergingLeaders.
The Emerging Leaders Program is supported in part by grants from Allergan, Inc., Lilly, Lundbeck LLC, Sanofi Genzyme, and Supernus Pharmaceuticals, Inc.
Leadership Program Applications Now Open! The following programs are now open for application through June 4. Visit AAN.com/view/lead to learn more and apply for one of the following career-changing programs: Emerging Leaders—a six-month program for members who are less than 10 years out of residency Transforming Leaders—a 10-month intensive training program for members who are 10 or more years out of residency Practice Leadership—a seven-month program for neurologists in solo or small practice Women Leading in Neurology—a 10-month program designed specifically for women to strengthen communication and leadership skills and to address topics such as gender bias in medicine
“I believe that strong physician leadership is absolutely essential for the health of our profession and to ensure the best care for our patients,” said McClean in talking about what motivates him in his new leadership role with the AAN’s Leadership Development Committee. “Despite this, very few of us have been trained to lead effectively. These programs are great for the individual participants, but more importantly, they are ensuring we have a strong pool of neurologist leaders for the future. My proudest achievement is how far we have come in creating a groundbreaking and successful array of opportunities
AANnews • April 2018 19
Conferences & Community
2018 Sports Concussion Conference Set for Indianapolis NCAA to Co-host Presentation and Reception Over one million athletes experience a concussion each year in the United States, with the issue attracting significant media attention in recent years. Rapid advances in our understanding of concussion have emerged and to help you stay up-to-date on the latest prevention, diagnosis, and treatment information, the AAN is hosting the 2018 Sports Concussion Conference this July 20 through 22 at the JW Marriott in Indianapolis, IN. Indianapolis is home to the National Collegiate Athletic Association (NCAA) and NCAA Sport Science Institute, offering a special opportunity for the AAN to collaborate with the NCAA on some unique programming, including a networking reception at the NCAA Hall of Champions and a session on the NCAA-DOD CARE Consortium. “The NCAA is a member-led organization dedicated to the well-being and lifelong success of college athletes and fits well with the AAN Sports Concussion Conference’s focus to bring attendees the very latest in sports concussion safety, prevention, and treatment,” said Brian W. Hainline, MD, FAAN, chief medical officer of the NCAA and co-chair of the Sports Concussion Conference along with David W. Dodick, MD, FAAN, professor of neurology at Mayo Clinic.
The NCAA-DoD CARE Consortium In 2014, the NCAA and the Department of Defense began a Cooperative Research and Development Agreement to jointly study concussion, which resulted in the NCAA-DoD Grand Alliance and includes a Mind Matters Challenge and the CARE Consortium. Set for Friday, July 20, from 3:45 p.m. to 5:30 p.m., this session will provide a backdrop for the historic rationale of CARE—the largest, prospective, clinical and advanced research concussion study every performed—while presenting emerging information that has already started to shape the concussion landscape. Faculty include:
SPORTS CONCUSSION JULY 20–22, 2018 INDIANAPOLIS, IN
Better understand the current state of concussion pathophysiology, diagnosis, and management Learn about the latest technologies for diagnosis and management Discover emerging issues in post-concussion syndrome diagnosis and advances in treatment approaches Discuss issues of long-term sequelae from athletic brain trauma Earn up to 20 CME/CE credits Added Dodick, “We are confident this collaborative research effort will uncover important insights and rapidly influence the clinical approach to concussion diagnosis and management.”
Early Registration and Hotel Deadline: June 14 Book your hotel and save with significant early registration discounts before June 14, 2018. Visit AAN.com/view/ ConcussionConference to secure your spot today.
Historic Rationale: Brian W. Hainline, MD, FAAN, Indianapolis, IN Clinical Research Core: Thomas W. McAllister, MD, Indianapolis, IN Advanced Research Core: Michael McCrea, PhD, Milwaukee, WI
Networking Reception at the NCAA Hall of Champions Join your colleagues on Friday, July 20, at the NCAA Hall of Champions for a special networking reception co-hosted by the AAN and NCAA. The event will feature a welcome address by Hainline and offer an opportunity for attendees to network and share knowledge and experiences. In addition to these programs, Sports Concussion Conference attendees can expect to:
AANnews • April 2018
Seeking Concussion Abstracts by May 7 The Sports Concussion Conference is accepting scientific abstract submissions on topics related to sports concussion. Accepted abstracts will be presented in the general poster sessions. Submission of previously presented work is encouraged if it is of interest to the field. Submit your research by May 7 at AAN.com/view/ConcussionConference.
Tools & Resources
What Is Your Plan for Scoring MIPS Points in 2018? We’re entering the third month of 2018—have you chosen your performance measures for MIPS? Remember, most physicians will need to score 15 points in 2018 to avoid a five-percent negative payment adjustment in 2020.
Are you still not sure how you will be reporting? Consider using MIPSwizard and receive $100 off as part of your AAN membership! Visit MIPSwizard at Medconcert.com/ AAN2017 to learn more.
Fortunately, there are multiple ways for you to “get to 15.” You can report six Quality measures; visit AAN.com/view/ MIPSTool to find neurology-specific Quality measures. Consider reporting these measures because you can get a higher score since neurology measures are not topped out and they may be more relevant to your practice. You can report two Improvement Activities; visit AAN.com/view/TipSheet to see Improvement Activities you can consider. Small practices (15 or fewer clinicians) get five bonus points automatically, so it’s even easier to get to 15!
Learn How to Integrate APPs into Your Practice Building Better Care Teams: Integrating APPs into Your Practice
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The AAN’s practice management webinars provide the valuable insights and tools you need to navigate through the ever-changing health care landscape— Deadline to Register: April 30 and receive year-end CME credits! Single webinars Faculty: Charles Zollinger, MD, FAAN; Emma Fields, Zollinger are $99 but AAN members get the greatest value with PA-C; and Seth Lefberg the $189 subscription to all 10 live one-hour webinars. All webinars include access to presentation slides and Remember, many of the 2018 practice management webinars recordings. Physicians receive 1 AMA PRA Category 1 Credit™ will include a panel to provide more perspectives on the per webinar; non-physicians receive a certificate of completion. information presented. Also, members who subscribe to the Visit AAN.com/view/pmw18 to learn more and register, or complete series of webinars can access a Synapse online contact Jessica Nickrand at email@example.com. community page to ask further questions, whether they participate live or watch the recorded webinar.
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AANnews • April 2018 21
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Tools & Resources
PODCAST CENTRAL 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 April 1 Neurology: Genetics: The Mitochondrial Disease Patients’ Diagnostic Odyssey: Results of A Survey Jason L. Crowell, MD, and John L.P. Thompson, PhD Neurology: Clinical Practice: Ask a Neurologist: What Primary Care Providers Ask, and Reducing Referrals Through eConsults Heather D. Harle, MD, and Ana C. Bradi, MD Neurology: Clinical Reasoning: A Young Woman with Symmetric Weakness and Behavioral Disturbance Daniel J. Ackerman, MD, and Jon Rosenberg, MD Neurology: Practice Guideline Recommendations Summary: Disease-modifying Therapies for Adults with Multiple Sclerosis Stacey Lynn Clardy, MD, PhD, and Alexander Duart Rae-Grant, MD
AANnews • April 2018
Axon Registry Makes MIPS Reporting Easy for Practice Manager The Axon Registry ® completed its first year of submission as a Qualified Clinical Data Registry (QCDR) for the Meritbased Incentive Payment System (MIPS) for reporting year 2017. There were over 300 providers that submitted data for 2017. The Axon Registry is a quality improvement specialized registry that can be used for many purposes. On top of being able to submit Quality, Advancing Care Information, and Improvement Activities for MIPS, the Axon Registry can be used for benchmarking against peers and receiving credit for MOC Part IV Clinical Module and waiving eight credits of Part II Self-assessment. The ease of use for the MIPS portal within the Axon Registry dashboard made for a smooth transition to MIPS for 2017 for many providers. One practice participating in the registry, Neurology Specialists of Norfolk, VA, has found the Axon Registry to be very helpful for MIPS submission. Practice manager Wendy Van Fossen was impressed by how quick data selection was. “I checked [the MIPS dashboard] out, more for informational purposes, and went through the process for one of my physicians. It was so easy, I kept going. I did the reporting for all 12 of my physicians in less than two hours.” When she had questions, she was able to work with staff from FIGmd to get them answered. Van Fossen explained, “They were able to answer my questions and I was comfortable with the process. I was delighted with how well my physicians scored.” When reporting for MIPS through the Axon Registry for reporting year 2018, practices will be provided with 35 neurology-specific measures to report for quality. Categorization of quality measures includes ALS, child neurology, cross-cutting, dementia, depression, DSP, epilepsy, falls, headache, multiple sclerosis, ophthalmology, Parkinson’s disease, and sleep. Physicians are given the ability to select their top six measures for submission and immediately see the CMS score they will receive. Practices can also submit data for Advancing Care Information and attest to Improvement Activities. Reporting for the MIPS program can be a daunting task, but the AAN is working diligently to provide easy-to-use solutions, including the Axon Registry. Learn more about the registry at AAN.com/view/Axon. For more information on how to join, contact registry staff at email@example.com.
AAN Publishes New Neuro-oncology Quality Measurement Set The AAN, in partnership with the Society of NeuroOncology, has developed and released a new quality measurement set on neurooncology. Five new measures were created: Multidisciplinary Care Plan Development for Primary Brain or Spine Tumor
Chemotherapy Education and Informed Consent for Brain Tumor Patients
Molecular Testing in Accordance with World Health Organization Classification of Tumors of the Central Nervous System
Intra-operative or Post-operative MRI for Gliomas
Measures are intended to improve the quality of care for patients receiving neuro-oncology care. View the published executive summary at Neurology ®, the full measurement set, and tools on AAN.com. For more information, contact Amy Bennett at firstname.lastname@example.org or call (612) 928-6072.
Venous Thromboembolism Events (VTE) Following Primary Brain Tumor Surgery
Better Health Outcomes Is Focus of New Neurology: Clinical Practice The April/May issue of Neurology ®: Clinical Practice examines the ongoing negotiation for better health outcomes in patients with chronic neurologic conditions. Articles of interest include “Uncertainties from a worldwide survey on antiepileptic drug withdrawal after seizure remission,” an analysis of global survey results regarding antiepileptic drug discontinuation after epilepsy remission reflects the lack of evidence for optimal strategies in most types of epilepsy and highlights inconsistencies in practice; “Achieving high-value care for all and the perverse Incentives of 340B Price Agreements,” along with an accompanying editorial, discusses the intentions of the 340B Pharmacy Benefit Program and the consequences for our ability to deliver quality care for all patients; and “Stroke code simulation benefits advanced practice providers similar to neurology residents” examines the value of this simulation for these important members of the neurology care team. Neurology: Clinical Practice, published six times a year, is available in print (for US members only), online, and for the iPad and Android. Visit Neurology.org/cp for more information.
Neurology ® Podcasts:
20 Minutes Pack a Punch! Download the latest podcast at Neurology.org/N
AANnews • April 2018 23
A study conducted in Italy of 617 people with Parkinson’s found that approximately 50% experienced symptoms of OFF within 5 years of diagnosis.1 OFF periods can occur throughout the day, can be unexpected and may appear more often over time.1-3 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.4
OFFmatters.com PD5817 7/17
1. 2. 3. 4.
Stocchi F et al. Parkinsonism Relat Disord. 2014;20(2):204-211. Stacy M et al. Mov Disord. 2005;20(6):726-733. Stacy M et al. www.medscape.org/viewarticle/701955. 2009. Accessed April 2017. 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.
Education & Research
Shulman Selected for AAN President’s Award Lisa M. Shulman, MD, FAAN, will receive the 2018 AAN President’s Award from Ralph L. Sacco, MD, MS, FAHA, FAAN, at the Annual Meeting.
book Parkinson’s Disease: A Complete Guide for Patients and Families, now in its third edition and translated in three languages. She is also a member of the Neurology Now ® editorial board and been active in helping plan the annual Brain Health Fair. From 1999 to 2000, she served as the AAN Neurology Public Policy Fellow in Washington, DC.
“Dr. Shulman has worked tirelessly to further the mission of the AAN in so many ways,” said Sacco. “She has served on the AAN Board of Directors from Shulman 2007 to 2017 as a member, secretary, and treasurer, and been an exemplary Board member and steward Her major research interest is the impact of chronic of the AAN finances. Her able input has helped guide us in so neurologic diseases such as Parkinson’s disease on daily many committees including Legislative Affairs, Joint Finance, function and quality of life. She is author or editor of 200 books, Long Range Planning, Health Reform Task Force, Practice chapters, and peer-reviewed publications. Improvement, and Publications. She has accomplished all of “Dr. Shulman has also joined our fight to raise funds to support these tasks with enthusiasm and energy.” research to cure brain disease,” Sacco said. “She has been Shulman, who is the Eugenia Brin Professor of Parkinson’s a vocal member of the American Brain Foundation’s Board Disease and Movement Disorders and the Rosalyn Newman of Trustees since 2013, helping to define their strategic plan. Distinguished Scholar in Parkinson Disease at the University Please join me in congratulating Lisa for her amazing service of Maryland, has also worked to champion enhanced patient to the AAN and the American Brain Foundation.” education and including patient-reported measurements in outcome assessments. Since 2007, she has been the editor-inchief of Neurology Now ® Books and co-author of the reference
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Education & Research
Become UCNS Certified or Maintain Your Certification Deadlines are approaching to apply for certification or recertification in three subspecialties through the United Council for Neurologic Subspecialties (UCNS). In Behavioral Neurology & Neuropsychiatry, the deadline to apply for both certification and recertification is May 1. The exams will be held the week of November 12–16. In Autonomic Disorders, the deadline to apply for certification is May 1, and the exam will be held the week of November 5–9. In Neurocritical Care, the deadline to apply for recertification is July 2. The exam will be held the week of December 3–7.
Visit UCNS Booth at Annual Meeting For answers to your questions about UCNS certification and accreditation, visit the UCNS booth at the Annual Meeting. Staff will be available to answer your questions at Booth #1114 during Exhibit Hall hours.
To apply, visit UCNS.org.
Neurology Press Releases Garner Media Attention The AAN issues weekly press releases on Neurology ® journal studies. During the winter, Neurology and the AAN were mentioned by many major news outlets on air and in print. The December AAN press release “Will a Salad a Day Keep Memory Problems Away?” was covered by NPR Morning Edition, CBS Evening News, Forbes, and more than 100 other news outlets. A December press release on the updated AAN guideline on mild cognitive impairment, “Guideline: Exercise May Improve Thinking Ability and Memory,” also featured in December, was covered by The Boston Globe, U.S. News & World Report, Los Angeles Times, Medscape, MedPage Today, and Newsweek. The January press release “Grinding Your Teeth? Botulinum Toxin May Help” was featured during an entire segment of Good Morning America. It was also covered by United Press International, the Chicago Tribune, and HealthDay.
New Continuum Addresses Spinal Cord Disorders Spinal Cord Disorders is the April issue of Continuum: Lifelong Learning in Neurology ®. The guest editor is Brent P. Goodman, MD, who said, “This Continuum® issue provides an update and review of the various conditions that affect the spinal cord. These conditions are reviewed by expert authors with perspectives that span a spectrum of neurologic specialties and are critical to the discussion of these remarkably diverse and often complex disorders.” Topics in this Continuum include: Approach to Myelopathy / Tracey A. Cho, MD, FAAN; Shamik Bhattacharyya, MD, MS Vascular Disorders of the Spinal Cord / Christopher L. Kramer, MD Metabolic and Toxic Myelopathies / Robert N. Schwendimann, MD, FAAN Infectious Myelopathies / Marie F. Grill, MD Neoplastic Myelopathies / Jing Wu, MD, PhD; Surabhi Ranjan, MBBS Immune-Mediated Myelopathies / Dean M. Wingerchuk, MD, FRCP(C)
AANnews • April 2018
Hereditary Myelopathies / Peter Hedera, MD, PhD
is now included in a subscription to Continuum.
Traumatic Spinal Cord Injury / Alejandro A. Rabinstein, MD, FAAN
AAN members receive a deep discount to Continuum and Continuum Audio for a subscription price of only $349. Subscribe now by contacting Wolters Kluwer at (800) 361-0633, (301) 223-2300 (international), or Shop.LWW.com/continuum. Junior members who are transitioning to neurologist memberships can receive a 50-percent discount on the already low member rate for the Continuum and Continuum Audio subscription.
Myelopathies Due to Structural Cervical and Thoracic Disease / Amro Maher Stino, MD; Samantha J. LoRusso, MD Disorders of the Cauda Equina / Brent P. Goodman, MD Liability for Referrals to Other Physicians / Joseph S. Kass, MD, JD, FAAN All of the articles have corresponding interviews on Continuum® Audio, which
American Brain Foundation
Crowdfunding Site Celebrates Year of Growth, Looks to the Future The American Brain Foundation’s crowdfunding platform at AmericanBrainFoundation.org marks its one-year anniversary this month. Launched in as part of the Foundation’s strategic plan to better engage and build public support, the site is the first multi-disorder neuroscience crowdfunding website of its kind, offering a unique opportunity for visitors to search for and learn about current research in many areas of brain disease and either support a specific research project that compels them, or make a general donation to support all efforts. Fundamental to the crowdfunding’s success is presenting the right projects to the right audiences at the right time. This year, the Foundation is focusing its efforts on educating the public about and promoting each individual research project, as well as the platform itself. The new crowdfunding marketing strategy is grounded in the Foundation’s ‘Cure One, Cure Many’ philosophy—one that envisions how advances in a cure for one
brain disease will lead to advances in research and cures for others. This philosophy sets the Foundation apart from other organizations raising money for a single brain disease. To coincide with March 2018 Multiple Sclerosis Awareness Month, the Foundation partnered with the National Multiple Sclerosis Society and Weizmann Institute of Science on a month-long crowdfunding campaign that highlighted two MS research projects, researcher updates, patient stories, and corresponding current events across social media, email, and cross-promotions. Crowdfunding is a unique and innovative way to support the mission to bring researchers and donors together. Follow the American Brain Foundation’s Facebook page, Twitter @ABFBrain and visit AmericanBrainFoundation.org/Crowdfundfor-cures to join the giving and follow the projects that matter most to you.
AANnews • April 2018 27
Policy & Guidelines
Capitol Hill Report Capitol Hill Report presents regular updates on legislative and regulatory actions and how the Academy ensures that the voice of neurology is heard on Capitol Hill. It is emailed to US members twice monthly and is posted at AAN.com/view/HillReport. Below are some recent highlights.
Your Neurology Advocates Visit 297 Capitol Hill Offices! At the end of February, 211 AAN member advocates from 49 states, accompanied by two patients, one caregiver, and Academy staff, made the annual pilgrimage to Neurology on the Hill. AAN advocates visited 297 congressional offices, posted 1,878 tweets using #NOH18, which produced 3.043 million shared social media impressions―a 66-percent increase in impressions over last year―and took lots of pictures of everyone with members of the House and Senate. Some legislators posted about their visits with the AAN members. They got to see a lot of enthusiasm and activism for neurology! Thanks to the successful efforts of the AAN and its members, the primary “ask” for recent NOH events—the FAST Act to strengthen stroke teleneurology across the country—was finally enacted into law in February. This accomplishment enabled the advocates to personally thank members of Congress who helped pass the legislation. And it also allowed the AAN to put forward an updated list of priorities for congressional action. Top on the advocates’ list was asking Congress to support legislation to reform drug pricing to ensure patients have access to needed medications. This included a request that lawmakers support the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act, a bill that requires transparency from pharmaceutical
AANnews • April 2018
companies when they plan to increase drug prices more than 10 percent within a year. “High drug costs can have a severe economic impact on our patients and certainly drive up the expense of health care in our country,” said AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN. “The AAN and its Neurology Drug Pricing Task Force believe action must be taken by lawmakers to ensure that prescription medications are accessible for patients with complex, chronic neurologic conditions.” The AAN’s advocates also asked lawmakers for increased funding for the National Institutes of Health (NIH), including new funding for research on non-opioid treatments for pain. More research is needed to understand the impact of pain medications on the brain, so therapies can be developed to promote healing and recovery. Additionally, the Academy advocated for continued support and funding for the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative.
To address regulatory burden, advocates asked their members of Congress to support the Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018, which encourages greater adoption and use of electronic prior authorization (ePA) in Medicare Part D. Widespread adoption of ePA will streamline communication between the payer, physician, and pharmacy, improve patient care, and potentially result in fewer prior authorization requests.
BrainPAC raised a record-breaking $71,740 from 134 donors. This year, 81 percent of NOH attendees contributed to BrainPAC compared to 58 percent last year. View the 2018 NOH Photo Album on the American Academy of Neurology Facebook page to enjoy more pictures of the visit. You can see who you recognize, either AAN member, representative, or senator.
AANnews • April 2018 29
BECAUSE RELAPSING MS AFFECTS MORE THAN HER. . .
NEWLY DIAGNOSED PATIENTS DESERVE THE #1 PRESCRIBED ORAL RMS THERAPY 1,2*†
Tecfidera® (dimethyl fumarate) is indicated for adults with relapsing forms of multiple sclerosis.
Important Safety Information
TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Patients experiencing signs and symptoms of anaphylaxis and angioedema (which have included difficulty breathing, urticaria, and swelling of the throat and tongue) should discontinue TECFIDERA and seek immediate medical care. Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA in a clinical trial. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. The symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. At the first sign or symptom suggestive of PML, withhold
TECFIDERA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. TECFIDERA may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had lymphocyte counts <0.5x109/L. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months. In these patients, the majority of lymphocyte counts remained <0.5x109/L with continued therapy. A complete blood count including lymphocyte count should be obtained before initiating treatment, 6 months after starting, every 6 to 12 months thereafter and as clinically indicated. Consider treatment interruption if lymphocyte counts <0.5x109/L persist for more than six months and follow lymphocyte counts until lymphopenia is resolved. Consider withholding treatment in patients with serious infections until resolved. Decisions about whether or not to restart TECFIDERA should be based on clinical circumstances. Clinically significant cases of liver injury have been reported in
IN THE DEFINE‡ CLINICAL TRIAL, PATIENTS WERE:
LESS LIKELY TO EXPERIENCE
A RELAPSE3§ TECFIDERA: 27% (n=410) Placebo: 46% (n=408) [P<0.0001] Based on proportion of patients relapsed (PPR)||
LESS LIKELY TO EXPERIENCE
TECFIDERA: 16% (n=410) Placebo: 27% (n=408) [P=0.0050]
84% OF PATIENTS IN THE DEFINE TRIAL WERE FREE OF DISABILITY PROGRESSION VS 73% OF PLACEBO PATIENTS3
IN A SEPARATE ANALYSIS, THE NEWLY DIAGNOSED PATIENTS FROM THE PIVOTAL TRIALS WERE:
LESS LIKELY TO EXPERIENCE
TECFIDERA: 0.073 (n=221) Placebo: 0.233 (n=223) [P<0.0001]
STUDY DESIGN: This post hoc analysis of integrated data from DEFINE and CONFIRM# was conducted to examine the efficacy and safety of TECFIDERA in 678 newly diagnosed patients (59% of patients in DEFINE and 71% in CONFIRM were treatment-naive4,5). The newly diagnosed population included patients who had been diagnosed with RRMS within 1 year prior to study entry and were naive to MS disease-modifying therapy. The analysis included clinical and neuroradiological efficacy endpoints as well as basic safety data, or adverse events. This study was not designed in advance to analyze the endpoints presented in the subgroup of newly diagnosed patients.1 Most common adverse events reported in patients receiving TECFIDERA compared with placebo included flushing, nasopharyngitis, headache, diarrhea, nausea, upper abdominal pain, and abdominal pain.3
Important Safety Information (cont’d)
patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients. Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected. TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% of patients taking TECFIDERA reported flushing, which was mostly mild to moderate in severity. Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization. Taking TECFIDERA with food may reduce flushing. Alternatively, administration of non-enteric coated aspirin prior to dosing may reduce the incidence or severity of flushing. TECFIDERA may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of TECFIDERA patients and <1% of placebo patients discontinued due to GI events. The incidence of serious GI events was 1%. The most common adverse reactions associated with TECFIDERA
versus placebo are flushing (40% vs 6%) and GI events: abdominal pain (18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%). A transient increase in mean eosinophil counts was seen during the first two months. TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant while taking TECFIDERA to enroll in the TECFIDERA pregnancy registry by calling 1-866-810-1462 or visiting www.TECFIDERApregnancyregistry.com. For additional Important Safety Information, please see adjacent Brief Summary of full Prescribing Information. *TECFIDERA is approved for adult patients only. † Based on prescriptions. ‡ Determination of Efficacy and Safety of Oral Fumarate in RelapsingRemitting MS.4 § Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted for at least 24 hours and were accompanied by new objective neurologic findings.4 || PPR is the percentage of patients who had one or more relapses over the course of the trial.4 ¶ Disability progression is defined as at least a 1-point increase from baseline EDSS of ≥1.0, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.3 # Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis.5 References: 1. Gold R, Giovannoni G, Phillips JT, et al. Mult Scler. 2015;21(1):57-66. 2. IMS data September 27, 2013-December 8, 2017. 3. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 4. Gold R, Kappos L, Arnold DL, et al. N Engl J Med. 2012;367:10981107. Erratum in: N Engl J Med. 2012;367:2362. 5. Fox RJ, Miller DH, Phillips JT, et al. N Engl J Med. 2012;367:1087-1097. Erratum in: N Engl J Med. 2012;367:1673. © 2018 Biogen. All rights reserved. 02/18 TEC-US-2505
Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use Brief Summary of Full Prescribing Information 1 INDICATIONS AND USAGE TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Discontinuation of TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of TECFIDERA with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3)]. TECFIDERA should be swallowed whole and intact. TECFIDERA should not be crushed or chewed and the capsule contents should not be sprinkled on food. TECFIDERA can be taken with or without food. 2.2 Blood Tests Prior to Initiation of Therapy Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy [see Warnings and Precautions (5.3)]. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with TECFIDERA [see Warnings and Precautions (5.4)]. 3 DOSAGE FORMS AND STRENGTHS TECFIDERA is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with “BG-12 120 mg” in black ink on the body. The 240 mg capsules have a green cap and a green body, printed with “BG-12 240 mg” in black ink on the body. 4 CONTRAINDICATIONS TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Anaphylaxis and Angioedema TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue TECFIDERA and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema. 5.2 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA for 4 years while enrolled in a clinical trial. During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years) while taking TECFIDERA [see Warnings and Precautions (5.3)]. The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms. Cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with
other MS medications associated with PML. Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis. It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients. 5.3 Lymphopenia TECFIDERA may decrease lymphocyte counts. In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. Six percent (6%) of TECFIDERA patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with TECFIDERA or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years) [see Warnings and Precautions (5.2)]. In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5x109/L with continued therapy. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts. Obtain a CBC, including lymphocyte count, before initiating treatment with TECFIDERA, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of TECFIDERA in patients with lymphocyte counts less than 0.5x109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if TECFIDERA is discontinued or interrupted due to lymphopenia. Consider withholding treatment from patients with serious infections until resolution. Decisions about whether or not to restart TECFIDERA should be individualized based on clinical circumstances. 5.4 Liver Injury Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients. Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials [see Adverse Reactions (6.1)]. Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected. 5.5 Flushing TECFIDERA may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials, 40% of TECFIDERA treated patients experienced flushing. Flushing symptoms generally began soon after initiating TECFIDERA and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued TECFIDERA for flushing and <1% had serious flushing symptoms that were not lifethreatening but led to hospitalization. Administration of TECFIDERA with food may reduce the incidence of flushing. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3)]. 6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema (5.1), Progressive multifocal leukoencephalopathy (5.2), Lymphopenia (5.3), Liver Injury (5.4), Flushing (5.5) [see Warnings and Precautions].
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea. Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients received TECFIDERA with an overall exposure of 2244 person-years [see Clinical Studies (14)]. The adverse reactions presented in the table below are based on safety information from 769 patients treated with TECFIDERA 240 mg twice a day and 771 placebo-treated patients. Table 1: Adverse Reactions in Study 1 and 2 reported for TECFIDERA 240 mg BID at ≥2% higher incidence than placebo
Flushing Abdominal pain Diarrhea Nausea Vomiting Pruritus Rash Albumin urine present Erythema Dyspepsia Aspartate aminotransferase increased Lymphopenia
TECFIDERA N=769 %
Placebo N=771 %
40 18 14 12 9 8 8 6 5 5 4 2
6 10 11 9 5 4 3 4 1 3 2 <1
Gastrointestinal TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with TECFIDERA. Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both TECFIDERA and placebo and were balanced between groups. There were no elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with TECFIDERA or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy. Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received TECFIDERA and been followed for periods up to 4 years with an overall exposure of 4603 person-years. Approximately 1162 patients have received more than 2 years of treatment with TECFIDERA. The adverse reaction profile of TECFIDERA in the uncontrolled clinical studies was consistent with the experience in the placebo-controlled clinical trials. 6.2 Post Marketing Experience The following adverse reaction has been identified during post approval use of TECFIDERA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Liver function abnormalities (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN) have been reported following TECFIDERA administration in post marketing experience [See Warnings and Precautions (5.4)].
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TECFIDERA during pregnancy. Encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of TECFIDERA in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. [see data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day. In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD. Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD. 8.2 Lactation Risk Summary There are no data on the presence of DMF or MMF in human milk. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TECFIDERA and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of TECFIDERA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 10 OVERDOSE Cases of overdose with TECFIDERA have been reported. The symptoms described in these cases were consistent with the known adverse event profile of TECFIDERA. There are no known therapeutic interventions to enhance elimination of TECFIDERA nor is there a known antidote. In the event of overdose, initiate symptomatic supportive treatment as clinically indicated. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Inform patients that they will be provided two strengths of TECFIDERA when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow TECFIDERA capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration (2.1)].
Anaphylaxis and Angioedema Advise patients to discontinue TECFIDERA and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.1)]. Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received TECFIDERA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.2)]. Lymphocyte Counts Inform patients that TECFIDERA may decrease lymphocyte counts. A blood test should be obtained before they start therapy. Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions (5.3), Adverse Reactions (6.1)]. Liver Injury Inform patients that TECFIDERA may cause liver injury. Instruct patients treated with TECFIDERA to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions (5.4)]. Flushing and Gastrointestinal (GI) Reactions Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI reactions. Advise patients experiencing flushing that taking TECFIDERA with food or taking a non-enteric coated aspirin prior to taking TECFIDERA may help [see Adverse Reactions (6.1)]. Pregnancy and Pregnancy Registry Instruct patients that if they are pregnant or plan to become pregnant while taking TECFIDERA they should inform their physician. Encourage patients to enroll in the TECFIDERA Pregnancy Registry if they become pregnant while taking TECFIDERA. [see Use in Specific Populations (8.1)]. 41347-09 Manufactured by: Biogen Cambridge, MA 02142 TECFIDERA is a trademark of Biogen. ÂŠ 2013-2017 Biogen 2/18
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Southern Connecticut Neurology Position—One Hour to NYC An independent private practice with three office locations in southern Connecticut is seeking an Adult Neurologist to join them in a well-established, busy 7 physician Adult and Pediatric Neurology group. One hour from New York City. Minutes from Long Island Sound. Very reasonable call, generally not required to go to the hospital at night. Yale University affiliated hospital is stroke certified and ED physicians are well versed on stroke management. Excellent neuroradiology and neurosurgery coverage and the tertiary care center is nearby. Great opportunity for rewarding clinical practice. EMG/EEG training preferred but not essential. Interested applicants please send your CV with a cover letter to email@example.com or call Pam Truedson at (203) 690-5090. Exceptional Quality of Life & Practice Environment in Beautiful Hendersonville, NC—UNC Health Care Affiliated Hospital Join busy, established neurologist, and PA-C, in outpatient practice at Pardee Neurology Associates. Opportunity for team-oriented BC Neurologist for hospital-employed practice in one of the most beautiful regions in the southeast. Large number of medical specialists on-site for consults.
EEG/EMG, state-of-the-art radiology center with carotid duplex ultrasound, 64 Slice CT Angiography, MRI Angiography, PET/CT and Neuroradiologist availability. Full spectrum inpatient & outpatient rehab for neurological conditions. Gait clinic in development. Opportunity for participation in regional and state stroke collaboratives. Epic EMR with dragon. Practice call requirement for inpatient consults. Office adjacent to 222-bed Pardee Hospital located in Hendersonville, NC. Excellent referral network, established Hospitalist program for inpatient admissions. Access to regional neurotrauma center via medical air or ground ambulance. Employed position offers a competitive base salary with wRVU production incentive, annual bonus for attaining Quality Measures, comprehensive benefits package, retirement plan with matching contribution plus hospital base contribution, life insurance provided at 2x base salary, CME/Due allowances, Paid Time Off (PTO), sign on, relocation assistance. No Visa sponsorship. No Recruitment or Placement Firm Inquiries. For consideration send CV to: Lilly Bonetti, FASPR, Pardee Hospital 800 N. Justice Street, Hendersonville, NC; (828) 694-7687 firstname.lastname@example.org; http:// www.pardeehospital.org
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AANnews • April 2018 37
A deeper look at the science behind migraine
Beyond the actual pain of migraine is the everyday impact on patientsâ€™ lives. Today, a growing understanding of the CGRP neuropeptide brings new insights to the science behind the migraine experience. CGRP = calcitonin gene-related peptide.
Le a rn m o re a t
scienceofm ig ra i ne.co m
2018 April AANnews