VOLUME 32 · ISSUE 8 · August 2018
2019 AWARDS AVAILABLE THIS MONTH Apply by October 24 Have you or someone you know been conducting research that may be advancing the field of neurology? If so, now is the time to start thinking about applying—or nominating a colleague—for one of the prestigious AAN awards to be presented at the 2019 AAN Annual Meeting in Philadelphia, May 4 through 10. Online applications will be available later this month at AAN.com/view/19Awards, and the application deadline is Wednesday, October 24. Prestigious AAN awards honor the best research and achievements by neurologists and neuroscientists around the globe with prizes and other compensation, such as complimentary travel expenses and registration for the Annual Meeting. AAN awards recognize scientists at all stages of their careers for a variety of activities.
Look for 2019 Annual Meeting Abstract Submissions to Open in September
The deadline to submit scientific abstracts for presentation in poster or platform sessions during the 2019 Annual Meeting will be Monday, October 22. Watch for submission details next month!
Save $200 on Fall Conference Registration Before August 22
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Continued on page 20
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Webinar Illustrates Axon Registry Benefits for Large Institutions
›
Improving Patient Access, Engagement, and Care August 21, 2018 • 12:00 p.m.–1:00 p.m. ET Deadline to Register: August 20 Faculty: Allison L. Weathers, MD, FAAN, and Radhika Sampat, DO You can purchase this single webinar for $99, or subscribe to the complete series of 2018 webinars for only $189—that’s
12 Neurology Advocate’s AAN Training Leads to Memory and Cognition Program
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27 New Endowment
Reinvigorates Raymond D. Adams Fellowship
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In Multiple Sclerosis–
THE ART OF BRAIN PRESERVATION Adding Grey to the Palette Completes the Picture
GREY MATTERS, TOO
Learn more about Multiple Sclerosis at MSBrainPreservation.com/art © 2018 Celgene Corporation All rights reserved. 03/18 USII-CELG180067
AANnews · August 2018
CONTENTS
NEWS BRIEFS
Cover 2019 Awards Available This Month Save $200 on Fall Conference Registration Before August 22 Webinar Helps Improve Patient Access, Engagement, and Care President’s Column Board Task Force Reports Recommend Steps on Key Issues · · · · · · · · · · · · · 4 Through Their Eyes Recollections of Past AAN Presidents · · · · · · 6 Tools & Resources Certification Helps Practicing Physicians with MIPS—Is It Worth It? · · · · · · · · · · · · · · 8 Now Available: 2017 MIPS Scores and Payment Adjustments · · · · · · · · · · · · 9 Webinar Illustrates Axon Registry Benefits for Large Institutions · · · · · · · · ·9 New Brain & Life Examines Parkinson’s, Concussion, and Chronic Pain · · · · · · · · · 10 Enhance Your Practice with Neurology Compensation and Productivity Report · · · · · 10 Understand Evidenced-based Medicine with EBM Online · · · 11 Podcast Central · · · · · · · · · 11
Policy & Guidelines Neurology Advocate’s AAN Training Leads to Memory and Cognition Program · · · · · 12 Capitol Hill Report · · · · · · · · 13
Conferences & Community New History Wall, Videos Welcome Board Members · · · 19 AAN Attends EAN Annual Meeting · · · · · · · · · 20 Education & Research New SIGN Framework to Further Engage, Unify Chapters · · · · · · · · · · 22 UCNS Welcomes New Board Members · · · · · · 22 UCNS to Develop New Continuous Certification Model · · · · · · · 23 UCNS Accredits New Training Programs · · · · · · · 25 Academy Rolls Out New Academic Year Membership for Students, Interns, and Juniors · · · · · · · · · · · 25 American Brain Foundation New Endowment Reinvigorates Raymond D. Adams Fellowship · · · · · · · · 27 Our Donors Make a Difference! · · · · · · · · · · · 27 Careers · · · · · · · · · · · · · · · 28
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
Email:
memberservices@aan.com
Website: AAN.com
In response to the administration’s “zero-tolerance” policy to criminally prosecute any illegal immigrants crossing the US-Mexico border, the AAN supported the American Medical Association’s policy to “oppose the practice of separating migrating children from their caregivers in the absence of immediate physical or emotional threats to the child’s well-being.” The redesigned AAN.com has won the Digital Health Award Merit Prize for Best Website for the spring 2018 competition. The award program is organized by the Health Information Resource Centers, a clearinghouse for professionals who work in consumer health fields.
Dates & Deadlines · · · · · · · · 28
The Vision of the AAN is to be indispensable to our members.
Phone: (800) 879-1960 (toll free) (612) 928-6000 (international)
Catherine M. Rydell, CAE, AAN executive director and CEO, serves on the American Board of Medical Specialties (ABMS) Continuing Board Certification: Vision for the Future Commission and recently attended the second meeting of the commission. The commission continues to hear presentations from stakeholder organizations and individuals. AAN members are encouraged to register for updates on the commission’s work at visioninitiative.org. Discussion will continue at meetings scheduled for August, October, and January. It is anticipated that a draft report will be available for stakeholder comments in November, with the final report presented to ABMS in February 2019.
Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com
AAN Executive Director: Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela Babb, CAE Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designers: Siu Lee and Jim Hopwood Email: aannews@aan.com
AANnews is published monthly by the American Academy of Neurology for its 34,000 members worldwide. Access this magazine and other AAN publications online at AAN.com/go/elibrary. The American Academy of Neurology ’ s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
President’s Column
Board Task Force Reports Recommend Steps on Key Issues In June, the Board of Directors of the AAN and AAN Institute gathered at our headquarters in Minneapolis for our annual summer meeting. Our Board is fully engaged and helping the AAN make progress to address key issues facing our profession. Among the agenda items were reports from three of our Board task forces, which I would like to summarize for you here so you are up-to-speed on some of the Academy’s efforts on your behalf.
Health Care Disparities Task Force Co-chaired by Brett Kissela, MD, FAAN, and Charlene Gamaldo, MD, FAAN, the Health Care Disparities Task Force was charged with developing a strategic approach to further our understanding of the current state of health care disparities amongst individuals with neurological conditions; reduce disparities in the health outcomes of neurological patients; and raise awareness of implicit biases and the impact on patient outcomes. The task force recommended a number of approaches to address some key strategic goals that will help the AAN address health care disparities: Better understand health care disparities in neurologic care Increase awareness, knowledge, attitudes, and behaviors regarding health care disparities among neurology providers Increase the diversity of our neurology work force Advocate for policies that decrease disparities The next steps for this task force include determining collaboration and ownership of the recommendations across the AAN committees and a follow-up report to the Board on progress toward implementing the recommendations. These broad strategies will greatly help us improve neurologic care for all of our patients.
Wellness Task Force Past President Terrence L. Cascino, MD, FAAN, has been a champion for the prevention of burnout and promotion of wellness in our profession. He currently chairs the Wellness Task Force, which he formed in 2015, and it has racked up remarkable accomplishments. For example, the Study Group within this task force has published three papers on the prevalence and causes of burnout among current and future AAN member neurologists, and another paper is currently under review. The Resident Group, charged with developing strategies to help mitigate or prevent burnout specific to trainee (resident and fellow) issues, published a paper in 2017, produced three recorded webinars on resident well-being, and is in
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AANnews • August 2018
the process of developing a toolkit for residency programs. This group has been reconstituted as part of the Graduate Education Subcommittee of the Education Committee. The Mitigation Group’s efforts to develop Sacco strategies to help enhance wellness led to the creation of Live Well, Lead Well: A Well-being and Resiliency Program for Neurologists. The group helped create the Live Well webpage at AAN.com/LiveWell, which provides a central hub for wellness resources and has attracted more than 6,200 users since July 2016. Our wellness campaign marketing objectives achieved 52-percent awareness among US neurologists of the AAN’s initiatives and resources to help mitigate burnout and improve well-being by end of June 2017 (the goal was 50 percent), and 70 percent of US neurologist members who responded said they have tried to improve their well-being by the end of June 2017 (the goal was 10 percent). The Wellness Task Force recommends that the AAN: Coordinate wellness efforts through the AAN committee structure Collaborate with other organizations to mitigate burnout and promote well-being Develop additional resources to address the issue of burnout and well-being at the organizational level and evolve the Live Well, Lead Well Leadership Program Develop and disseminate personalized mitigation resources for trainees and program directors Continue to evaluate well-being and career satisfaction among AAN members, including important subgroups of our membership
Business Innovation Task Force As we shared with you in the 2017 Annual Report, the AAN is in excellent financial health. To make further progress and create resources to address all of the AAN goals, as well as these new priorities, we need to continue to think of ways to finance our programs without increasing your dues. We continue to seek ways to deliver more value to you for your dues dollar. Currently, 88 cents of every dollar of your dues payment is returned back to you in member benefits. We are constantly looking for innovative ways to maximize our revenues and seek new income-generating opportunities. Back in 2000, we established a for-profit subsidiary, AAN Enterprises, Inc., to do just that. It had a good run, but we closed it in 2013 in a shift of priorities and strategies. This year, we have closed The AAN Store for similar reasons. Late last year, I appointed
the Business Innovation Task Force, chaired by James N. Goldenberg, MD, FAAN, to develop a more clearly defined process to create and evaluate new approaches of producing additional revenue to support our mission. Dr. Goldenberg’s report of the task force focused on establishing a more cohesive, standardized structure for evaluating and prioritizing business opportunities. The task force recommends renaming the Academy’s Business Development division to the “Center for Business Innovation” (CBI), which more appropriately reflects responsibilities and aligns with recommendations. It also recommends the AAN establish a Business Innovation Subcommittee (BIS) that reports to the Finance Committee. The BIS would work with the CBI to develop and implement the highest value business innovation opportunities focused on: new business development opportunities; investment-required opportunities; and opportunities that are considered but not pursued for various reasons by divisions within the AAN. Along with creating this new structure, the work ahead includes establishing processes and procedures. The Board accepted the reports and recommendations from all three task forces, and referred their reports and recommendations to Executive Director/CEO Catherine M. Rydell, CAE, for review by the Executive Staff in consultation with the president to determine which recommendations are able to be implemented. We are extremely fortunate to have the diverse insights, talents, and experiences that the volunteer members of these and other task forces, committees, and subcommittees of the AAN share in their collaboration with one another and with the Board of Directors. Their commitment and professionalism give the Board and our membership full confidence in their efforts and the staff’s ability to address their recommendations in their plans and activities. I want to personally thank all the AAN members and staff who work every day to make this organization rise to any challenge and take progressive steps to make the future better for our patients and our profession.
Ralph L. Sacco, MD, MS, FAHA, FAAN President, AAN
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AANnews • August 2018 5
Through Their Eyes
Recollections of Past AAN Presidents Sandra F. Olson, MD, FAAN AAN President 2003−2005 AANnews celebrates the history of the Academy during its 70th anniversary with a series of interviews of past presidents. The following excerpt is from a 2017 interview with Sandra F. Olson, MD, FAAN (SO), conducted by AANnews® editor Tim Streeter (TS). Olson has the distinction of being the first woman elected president of the AAN. During her term, the advocacy activities of the Academy grew to include Neurology on the Hill and the Palatucci Advocacy Leadership Forum. TS: You became, in 2003, the first woman president of the Academy. Why you, and why then? SO: It's interesting. I've asked myself the same questions. I think me, because again I had been very active, I had been on the committees. I was involved with the different aspects of the Academy, and I think at that time they thought that I was worthy to be the president and was nominated and became the president. I don't like to think that it was just because I was a woman, and they looked around and said, “Jeez Louise! It's about time we have a woman. Whom can we nominate?” If it were that, I wouldn't want to do it of course. At that time, I sort of felt like I was the right person at the right time. I was the woman, yes, but I just happened to be somebody who had been working with the Academy
and involved in that and that was the time. TS: You had the right skill set. SO: Well, I like to think so. I guess they thought so too. TS: You have a reputation of being the consummate advocate for neurology. Where does that passion come from? SO: It's because I love the profession, and I think it's the greatest profession. I think it's the greatest area of medicine. It was for me. I never knew anything else other than being a neurologist, and I just like to spread the word. I like to exhibit that passion to the young people, to the students and the residents that I've dealt with through the years. And to recruit them into neurology because I just think it's so rewarding. As I said, I wouldn't do anything else…. TS: In 2003, the Academy launched two big advocacy programs: Neurology on the Hill and the Palatucci Advocacy Leadership Forum. How important are these activities to not only the Academy, but to the members who participate in them? SO: I think they're very important, and I think that is shown by the fact that more and more people want to participate in Neurology on the Hill. I've participated; I participated in the last one. I was a Palatucci fellow, and I think that as the Academy realized that we had to grow leaders, and that we had to become very active in advocating for neurology in our patients, that this just caught on. And I also think that people have also felt threats and they want to do something about it. And so, they, like you said, they went to the Hill. We went to the Hill and presented our cases to the Congress people.
Olson advocating in the 1980s with Stephen M. Sergay, MB BCh, FAAN; Ludwig Gutmann, MD, FAAN; and James Anthony, MD. President Elect Olson received the gavel as the new president from outgoing President Stanley Fahn, MD, FAAN, at the 2003 Annual Meeting in Hawaii.
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And really tried to make the point of neurology, and what the needs were, and why they needed neurologists and needed us. As I said, that's something that has really caught on…. TS: When Obamacare was proposed and being debated in Congress, the Academy didn't take a firm position on that. SO: No. TS: It didn't take a firm position on the AHCA, which was recently proposed by the Trump administration. But we came up with a set of health care reform principles. Is there a point, in your experience, where the Academy really has to take a firm stand and say, “This is right” or “This is wrong,” even though it's going to alienate some of our members? SO: That's a difficult question or a difficult stand to take for an organization. As you know, the AMA came out and endorsed Obamacare, which caused a big controversy. And I think in the long run there were a lot of people involved perhaps in
And get fairly reimbursed for it, which is always something neurology has kind of been advocating because we're such a cognitive specialty. It’s easy to measure that an operation has been done and the gall bladder has been removed. That's pretty black and white. It's not so easy in neurology to recognize that a half an hour that you spend with an Alzheimer’s patient and their family is really going to deliver any goods. You can't measure that, and so that's where it's a little different with neurology. TS: You can't cure them, but you can help improve their quality of life. SO: Right, and there are things that we can cure. I mean, you can get an epileptic under complete control, and eventually get them off their meds. Is that a cure? Well, yes. You can take a migraine patient who is really suffering and get them on the right medications and improve their quality of life immensely. Those are joyous things. There are other folks like a Parkinson patient; you can get them up and walking and let them go to the bathroom when they have to. That's a big deal for some of these folks and the same with an MS patient. Again, you feel a great sense of accomplishment when you see that and when you have the patients tell you, “Well, now I can walk down the street.” TS: It's hard to quantify, isn't it for the CMS or insurance providers? SO: That's right. It is. It's very hard to quantify…. TS: What advice would you give to a young Academy member who wanted to get more involved? SO: Okay. First of all, you can apply to be on a committee, and put your name in for a committee you think you would like being on and where you could make a contribution. That's wide open and or you can make it known to the powers that be or whatever; lobby for yourself a little bit. Study the issues; see where you want to go.
the decision making who were not happy with it. But I can’t speak to it, I wasn't on the board so I really don't know. It's just sort of what you hear, and I think again those decisions are often driven by a few people who feel very passionate about one thing or the other. As far as the Academy taking a stand on that, that would be up to the board and to the leadership if they thought it was the right thing to do. But again, you have a great diversity of opinions with regards to these issues. Great diversity and as you know they're often very polarized. Some people think there should clearly be a single payer government run system, à la England and other countries. There are other people that wouldn't want the government doing anything about health care. I feel it's kind of in-between in some way, and to me the best solution has not yet been worked out, but that's just my personal opinion. Hopefully it will be. Hopefully it will evolve and everybody will get the care they deserve, and physicians will be able to take care of people.
It's very important when you're on a committee to (A) show up, and (B) do the homework. People have asked me so many times, “Well, what's the secret, Dr. Olson?” First of all, you have to show up and second of all you have to be aware of what it is. And if you don't like that committee and what they're doing, well, okay, shift gears. Speak up, you don't have to go along with what everybody says. It's very disheartening to be on a committee and have a member who never says anything, never contributes, never has an opinion, or asks a question. You want to say, “Why are you here?” That's a negative aspect of things. There's so many positive aspects, so young folks sign up. We send out that email, join. TS: Simple enough, isn't it? SO: Join. Come to the meetings. Visit AAN.com/view/AANhistory to read the complete transcript of Olson’s interview and learn about her early years in medical school and how she was inspired by another AAN president, her mentor Kenneth M. Viste, Jr., MD, FAAN.
AANnews • August 2018 7
Tools & Resources
Certification Helps Practicing Physicians with MIPS—Is It Worth It? Just what you wanted to hear: There is a new certification program for physicians. What you need to know: This voluntary certification program helps you automatically attain the necessary 15 credits for Improvement Activities under the Merit-based Incentive Payment System (MIPS)! The National Committee for Quality Assurance, a private nonprofit organization dedicated to improving health care quality, designed the Patient-Centered Specialty Practice (PCSP) to extend the popular Patient-Centered Medical Home (PCMH) concept to specialists, including neurologists. Specialists who are committed to improving patient access, facilitating communication with primary care and other providers, and coordinating care can receive recognition under this program. About 85 neurologists have achieved recognition under this program to-date, including AAN member Daniel Ackerman, MD. His group practice, located in Bethlehem, PA, is part of St. Luke’s University Health Network, which is comprised of more than 315 sites and 10 hospitals in Pennsylvania and parts of New Jersey. The group sees both urban and rural patients and a “healthy mix” of payers; approximately 50 percent of the patients are on Medicare. Ackerman’s group practice is comprised of 29 neurologists, two neuropsychologists, seven physical medicine/rehab physicians, and 18 advanced practice providers. His practice manager is Laura Dobrosielski-Hetrick. Together, they shared their experiences with certification for PCSP. First of all, how does PCSP help with MACRA/MIPS participation? PCSP recognition means we get full marks on Improvement Activities. This means we get 15 points automatically, which is the performance threshold for 2018. Additionally, we’ve experienced improvements in the quality of care we deliver, which allows us to improve performance on quality measures and maximize use of our EHR. Why and how did you decide to pursue PCSP certification? The health system made the decision to pursue certification. They started with the PCMH model first on the primary care practice (PCP) side. After one to two years, they started reaching out to specialty practices about the benefits of the model. It was a process. We tried to find a workaround in our electronic medical records using Epic. As far as reimbursement, they have started giving a bump in reimbursement for Medicare. The physicians benefit from working more efficiently. What changes were necessary to achieve recognition? We kicked off implementation with informal meetings with providers. There were some growing pains initially. For example, physicians were required to sign forms that indicated they
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AANnews • August 2018
participated in team huddles, and there was resistance to this. But the benefits far outweigh the process it took to get there. The PCSP process requires you to implement protocols and that makes things extremely seamless now. You do notice that the practice is functioning differently, but it’s not an interruption or a bother. That transition happened quickly. It didn’t require a lot of physician time. A lot of the changes were done or engineered by practice admins and by working with medical assistants and other staff to ensure they were practicing to the top of their license. Much of it was put into play without providers having to step in or micromanage. It sounds like practice administrators and support staff play a major role in implementing PCSP. Can you think of any limitations for a small or solo practitioner interested in implementing the model? In a smaller practice or community setting, where a neurologist might be working with multiple PCPs affiliated with different systems, it could be challenging to implement, but it’s absolutely worth doing. In fact, it may be a good thing to do in a small practice. We faced some challenges in communicating this change across all the providers in our practice. Those communication barriers are essentially not there in a small practice. We’re large, so standardization was a challenge. But in a smaller setting, the changes would be the way the practitioner would want to see his or her practice run. What are some of the benefits and outcomes you’ve seen since receiving PCSP recognition? One of the things on the outpatient side is that the PCSP requires you to have same-day appointments in every practitioner’s schedule. Initially, our reaction was like “no one can do this.” But then we figured it out. Before PCSP, access had been six to eight months out for headache providers and now it’s down to 12 weeks. And we now have patients that are coming in within 24 to 48 hours. These are the high-need patients who might have gone to the ED in the past if access wasn’t available with their neurologist. PCSP empowers all staff members to function at the highest level of their license. Currently, our practice has standing orders for medical assistants to facilitate memory testing. They have all been trained. Medical assistants are also measuring gait and giving B12 injections. This allows physicians and APPs to be more efficient with their time and see the patients that most need to see them. That is a satisfier for the staff. It’s now an expectation. They’ve seen visits become more timely and efficient. They have a call schedule for scheduling/clinical calls. Our nurses are triaging and functioning to higher extent as well. The acuity of what’s expected is diminished. We’ve surveyed patients and are hearing that they appreciate the new model of care. When feedback isn’t great, it challenges
us to think about how we’re doing things and whether we could do them better. Earlier this week, a patient wanted to speak to a manager and all they wanted to say was that the neurology office was the best. This person’s visit was exceptional and efficient. We also are hearing positive feedback from primary care providers. They no longer feel like they’re on an island. PCSP made it easy to align with PCPs and provide them with a basic sense of how to do neuro prep so when they refer patients to us we have more information and background. This makes the initial visit we have with our patients better.
With the shortage of neurologists, if we do a good job of communicating with PCPs, they’ll feel more comfortable managing stable neurologic patients that are referred back to them. They know they can always open the communication channels. This opens up access for neurologists to see the right patients. Would you recommend other neurologists pursue PCSP recognition? Yes, absolutely. To learn more, visit NCQA.org and search for “Patient-Centered Specialty Practice.”
Now Available: 2017 MIPS Scores and Payment Adjustments 2017 Merit-based Incentive Payment System (MIPS) performance feedback and final scores are now available online on the Quality Payment Program (QPP) portal found at qpp.cms.gov/login. You can access your final score by visiting the site and logging in using your Enterprise Identity Management (EIDM) credentials.
payment adjustments to achieve required budget neutrality. Note that because the performance threshold was low in 2017, the maximum payment adjustments are likely to be much lower than four percent allowed by law. In other words, even if you scored the maximum 100 points, you may not receive a four percent payment adjustment in 2019.
Everyone who scored more than three points in 2017 will receive a neutral or positive payment adjustment of up to four percent to payments for the covered professional services they furnish in 2019. Physicians who scored above 70 points will receive an additional payment adjustment factor for exceptional performance.
If you feel your score does not accurately capture your performance, you may request a targeted review through the same QPP portal where scores were located. All targeted review requests must be submitted by September 30, 2018.
Payment adjustments are assigned on a sliding scale, so the higher your score, the larger the positive payment adjustment. All positive payment adjustments must be balanced by negative
For help interpreting your score or payment adjustment, email macra@aan.com or qpp@cms.hhs.gov. Responses are provided in one business day.
Webinar Illustrates Axon Registry Benefits for Large Institutions To illustrate the usefulness of the AAN’s Axon Registry ® for larger organizations like academic centers and hospitals, the AAN presented a webinar customized to institutional environments and their needs. The webinar is now available online for any AAN member to listen to at AAN.com/view/Axon. AAN President Ralph L. Sacco, MD, MS, FAHA, FAAN, whose institution was an early user of the Axon Registry, explained its purpose and goals. Lyell K. Jones, MD, FAAN, chair of the Registry Committee, reviewed the benefits of joining Axon and how registry implementation works, particularly with Epic. Salim I. Dib, MD, FAAN, neurologist at University of Miami, discussed that institution’s experience with Axon Registry and lessons learned. Highlighted benefits for large groups include: Benchmarking capability nationally
Neurology-specific measures available nowhere else but through the AAN Real-time transparency into the quality of care your group provides Ability to use data in negotiations with commercial payers Improving the efficiency and consistency of your documentation MOC Part IV and Part II credit
the best possible care. I encourage you to improve your competitive advantage with the Axon Registry. Measure the performance of your practice and improve the quality of your care for your patients to overall positively impact your bottom line.” To learn more about the Axon Registry or to receive a recording of the webinar, email registry@aan.com or call (612) 928-6167.
Sacco explained, “We need to do everything we can to monitor quality performance data, improve metrics, and ensure our patients are receiving
AANnews • August 2018 9
Tools & Resources
New Brain & Life Examines Parkinson’s, Concussion, and Chronic Pain The August/September issue of the AAN’s new Brain & Life™ (formerly Neurology Now ®) features a cover story on 60 Minutes correspondent Lesley Stahl, whose husband, Aaron Latham, a novelist, screenplay writer, and journalist, has Parkinson’s disease. Stahl talks about how boxing and deep brain stimulation surgery help him manage his symptoms. Also in this issue is a feature on Bennet Omalu, MBBS, MPH, MBA, a neuropathologist who identified and named chronic traumatic encephalopathy, a form of brain damage, in retired NFL players. Since then, he has written a book, Truth Doesn’t Have a Side (due out in paperback in August); consulted on the Will Smith movie Concussion based on his story; and continues to speak out about brain damage risks. Omalu shares his ongoing concerns about brain damage in athletes, especially players under the age of 18. Primeros xilios PA R A LO G Í A NEURO 2018 O VERAN
Another feature takes an in-depth look at living with chronic pain, including the latest thinking on opioids and other methods of treating pain, including cognitive behavioral therapy and meditation.
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Brain & Life and its companion patient website BrainandLife.org made their debut in April. The magazine and website provide the same trusted, expert information for patients, families, and caregivers as Neurology Now did. Also publishing in August is the second quarterly issue of Brain & Life™ en Español, featuring Bull actor Christopher Jackson. This free Spanish-language version of the magazine will be sent to AAN member offices in areas with large Hispanic and Latino populations to distribute to their patients, and additional copies will be mailed to our subscribers. Quantities of Spanish copies can be requested or changed at BeGreen@ WasteFreeMail.com.
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Enhance Your Practice with Neurology Compensation and Productivity Report The AAN’s 2017 Neurology Compensation and Productivity Report is still available to help you enhance your practice. The report is free if you participated in the 2017 survey. If you did not participate, you can download a free Executive Summary that will help you understand the breadth and depth of data available for you to use, and then purchase the report for half the price non-AAN members must pay. There was no survey or report done for 2018. Instead, the Academy gathered feedback from members and is making some big improvements to refine survey questions, simplify the format so it is less timeconsuming, and maximize the value for AAN members. The new survey will be available in the first quarter of 2019. All US members are encouraged to participate to help increase the sample size and quality of the report participants receive. Visit AAN.com/view/2017NeuroReport to download the free 2017 Executive Summary and access the report.
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AANnews • August 2018
2018
Brain & Life magazine is a free resource to AAN members in the United States to distribute to patients, who also can subscribe for free. If you need to adjust the number of copies you receive for your patients or update your clinic address, visit BrainandLife.org or email BeGreen@WasteFreeMail.com.
“The AAN's online evidence-based medicine course is comprehensive and user-paced,” said Don B. Smith, MD, FAAN, member of the eLearning Subcommittee and AAN EBM methodologist. “It covers topics ranging from formulating evidence-answerable questions to conducting a meta-analysis. It teaches how to search for relevant evidence, how to assess for bias, how to calculate and evaluate effect sizes, and how to assess the generalizability of evidence. It also explores weighting the risks and benefits of a proposed treatment according to a patient's values. AAN members have found the course to be a great value. Check it out!” For a number of years, the Academy’s EBM training was available only to residents and program directors. The latter have found the program useful to teach EBM concepts in an easy-to-understand manner, supplement/replace EBM instruction in journal club or clinical rounds, and monitor residents' progress and track their scores. And course completion statistics can be a barometer for meeting ACGME core competencies. Learn more and sign up (or sign your residents up) for this free AAN member benefit at AAN.com/view/EBMOnline.
Webinar Helps Improve Patient Access, Engagement, and Care continued from cover
less than $19 per webinar! All webinars are now available in the new AAN Online Learning Center and feature: Convenient one-hour live webinar sessions from 12:00 p.m.–1:00 p.m. ET On-demand access to webinar recording and presentation slides if you miss the live event 1 AMA PRA Category 1 Credit™ per webinar for physicians, or certificate of completion for non-physicians Visit AAN.com/view/pmw18 to learn more and register, or contact Jessica Nickrand at jnickrand@aan.com.
Over 17
EBM Online is available in the Academy’s new Online Learning Center. The program: Smith Contains five hours of on-demand courses in 10 modules Uses common, real-life neurologic clinical examples Allows learners to review core concepts and diagnostic and statistical tools at their own pace and convenience
downloads... a n o nd illi
ing ow gr
The AAN has converted and refined its popular classroom evidence-based medicine training into a convenient ondemand, self-paced online program that is free to all AAN members.
m
Understand Evidenced-based Medicine with EBM Online
PODCAST CENTRAL Your Guide to New and Recent AAN Podcasts
Neurology Podcasts
Visit Neurology.org/podcast to listen to Neurology ® podcasts and earn 0.5 AMA PRA Category 1 CME Credits™ by answering the multiple-choice questions in the online podcast quiz. Interviews based on articles from Neurology ® Clinical Practice, Neurology ® Genetics, and Neurology ® Neuroimmunology & Neuroinflammation are excluded from the CME program.
Available by August 1
Neurology: Diagnosing Cerebral Ischemia with Door-to-thrombolysis Times Below 20 Minutes James V. Berthaud, MD, MPH, with Olli S. Mattila, MD, and Perttu J. Lindsberg, MD, PhD, FAHA, FESO Neurology: The Efficacy of Non-pharmacologic Intervention for Orthostatic Hypotension Associated with Aging Chenjie Xia, MD, and James Frith, MB ChB, PhD Neurology: Silent Infarct Is a Risk Factor for Infarct Recurrence in Adults with Sickle Cell Anemia Justin A. Sattin, MD, and Lori C. Jordan, MD, PhD Neurology: How Early Can We Diagnose Alzheimer’s Disease (And Is It Sufficient)? The 2017 Wartenberg Lecture Jeffrey M. Burns, MD, MS, and Ronald C. Petersen, MD, 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: Genetics: The Mitochondrial Disease Patients’ Diagnostic Odyssey: Results of a Survey Jason L. Crowell, MD, and John L. P. Thompson, PhD
AANnews • August 2018 11
Policy & Guidelines
Neurology Advocate’s AAN Training Leads to Memory and Cognition Program When Glen R. Finney, MD, first engaged in neurology advocacy, he was a senior resident applying to participate in the AAN’s first Neurology on the Hill visit in 2003. It changed his life, and the ripple effect for neurology patients has been enormous as Finney’s activism grew over the years. Now, his commitment has resulted in a new Memory and Cognition Program at Geisinger Health System in Wilkes-Barre, PA. And Finney currently chairs the Executive Committee of the AAN’s BrainPAC, the country’s only political action committee devoted solely to neurology. “It was empowering to meet other neurologists passionate about making a difference in neurology care,” Finney said of his first Neurology on the Hill experience. “I was inspired to apply for the Donald M. Palatucci Advocacy Leadership Forum, the first leadership program at the AAN, and had the good fortune to be accepted into their second ever class of advocacy trainees.” One of the strengths of the AAN’s Palatucci Forum is helping participants develop an achievable action plan for their advocacy projects. “My first idea for an action plan to come out of the program was to advance cognitive rehabilitation for behavioral neurology patients. That idea was a bit ahead of its time,” Finney acknowledged. “So, my second idea was to advocate for the importance of a good neurology history and examination as essential to the care of neurology patients. I honed my skills in media communications and in planning out objective, measurable, achievable goals in advocacy. I have continued throughout my career to advocate for classic neurologic skills, coupled with cutting-edge technology, as the key to providing neurology care of value to patients.”
In subsequent years, Finney returned to the Palatucci Forum several times as an advisor and faculty member, sharing his insights and skills with new classes of advocates. He also has continued to journey to Washington, DC, for numerous Neurology on the Hill events. He became further engaged at the committee level. “Through the relationships that were developed serving with the Academy’s Legislative Affairs Committee, Government Relations Committee, and the BrainPAC Executive Committee—which I’ve had the honor to chair since May 2017—I have been able to reach out to federal policymakers and staff to inform them of the ongoing importance of preserving our time with our patients to provide the vital history and examination needed for neurology to sing.” Along the way, Finney was offered a marvelous opportunity— and challenge—that took him from a comfortable position as behavioral neurology division chief at the University of Florida department of neurology in Gainesville, FL, to Pennsylvania— and new advocacy opportunities. “Geisinger Health System, a few years ago, recognized the critical need for cognitive care for patients, especially with the aging of the population. When they recruited me to found
Neurology ® Podcasts:
20 Minutes Pack a Punch! Download the latest podcast at neurology.org/podcast 12
AANnews • August 2018
the Geisinger Memory and Cognition Program, it was on the premise of providing high-value multidisciplinary care including the time to do detailed neurologic history and examination and developing integrated cognitive rehabilitation services as part of the vision for 21st century cognitive care. The successes in advocacy I had prior to coming to Geisinger, the skills in communications and action planning taught by the Academy, have all allowed for me to articulate and advance a vision of high-value care for patients and families with cognitive disorders or at risk for such. I have been able to bring to life my action plans in the formation of the Geisinger Memory and Cognition Program and its flagship site, the Geisinger Memory and Cognition Center in Wilkes-Barre, where we have ensured a comfortable and uplifting space to provide care to patients and their families with a multidisciplinary team. We now have services that include behavioral neurology, neuropsychology, speech language pathology, social work, a driving simulator, and gait analyzer. The need for these services is huge, so we have only just begun to grow!” Finney put his media training skills to use as the center opened to the community. Talking with local ABC television affiliate WNEP, he explained the need in a cogent soundbite: "We have the oldest population in the state of Pennsylvania right here, and Pennsylvania has the second oldest population in the nation, which means here in northeastern PA, this is one of the oldest populations throughout the country." The April ribbon-cutting ceremony for the new center included Rep. Matt Cartwright (D-PA) as a key participant. “Rep. Cartwright’s attendance highlighted the visibility that advocacy brings to the needs of neurology patients and families,” said Finney. Whether advocating to members of Congress or within a health care institution, Finney’s passion for doing what’s right for his patients has demonstrated the value of AAN programs. “I am thankful to have the skills, experience, and relationships that 15 years of involvement in American Academy of Neurology advocacy have fostered in me to move this vision forward, and to have the support of the unique and incredible health care organization that is the Geisinger Healthcare System in which to see that vision realized.”
(Left to right) David Avila, MD; Anowar Hossain, MD; Rep. Matt Cartwright; Glen R. Finney, MD; Neil R. Holland, MBBS, FAAN; and Maya Lichtenstein, MD.
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. Join Me in Local Advocacy through Neurology off the Hill Guest Author Partha Thirumala, MD, MS, FACNS, FAAN Recently, I had the pleasure of hosting Rep. Keith Rothfus (R-PA) at the University of Pittsburgh Medical Center. After meeting with Rep. Rothfus several times before both in Washington, DC (as part of Neurology on the Hill) and at his district office, this visit gave me the opportunity to highlight my day-to-day work and the type of care we provide to patients in his district. A site visit is an especially useful advocacy tool, as it builds a stronger relationship between you and your member of Congress and allows them to witness firsthand the importance of neurology in their community. During the site visit with Rep. Rothfus, I was able to show him the Multiple Sclerosis Center, which treats more than 2,500 patients in Pittsburgh. By discussing the process and challenges of treating MS, I highlighted the patient experience, and their struggles with affording their prescription drugs. One of our patients was able to explain to Rep. Rothfus the burden of affording their treatments, and the unrestrained increasing costs. Monthly out-of-pocket costs for MS patients rose from a mean of $7 in 2004 to $303 in 2016. The site visit allowed me to highlight AAN priority legislative issues such as high drug pricing and regulatory burden, but more importantly it strengthened my relationship with Rep. Rothfus, so that I can be a resource for him in the future. As members of Congress debate and vote on legislation that affects our health care system, it is essential they understand the neurologist perspective. The AAN helps coordinate and schedule site visits as a part of Neurology off the Hill, a program which encompasses all local advocacy. Most of these activities occur during August, when the House of Representatives will be leaving Washington, DC, for a month-long recess. I encourage my fellow AAN members to engage in district meetings (meeting at a congressperson’s local office), site visits, local fundraisers, town hall meetings, roundtable discussions, and other community events. If you are interested in participating in Neurology off the Hill, please email advocacy@aan.com.
AANnews • August 2018 13
BECAUSE RELAPSING MS AFFECTS MORE THAN HER. . .
NEWLY DIAGNOSED PATIENTS DESERVE THE #1 PRESCRIBED ORAL RMS THERAPY 1,2*†
Indication
Tecfidera® (dimethyl fumarate) is indicated for adults with relapsing forms of multiple sclerosis.
Important Safety Information
TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Patients experiencing signs and symptoms of anaphylaxis and angioedema (which have included difficulty breathing, urticaria, and swelling of the throat and tongue) should discontinue TECFIDERA and seek immediate medical care. Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA in a clinical trial. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. The symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. At the first sign or symptom suggestive of PML, withhold
TECFIDERA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. TECFIDERA may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had lymphocyte counts <0.5x109/L. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months. In these patients, the majority of lymphocyte counts remained <0.5x109/L with continued therapy. A complete blood count including lymphocyte count should be obtained before initiating treatment, 6 months after starting, every 6 to 12 months thereafter and as clinically indicated. Consider treatment interruption if lymphocyte counts <0.5x109/L persist for more than six months and follow lymphocyte counts until lymphopenia is resolved. Consider withholding treatment in patients with serious infections until resolved. Decisions about whether or not to restart TECFIDERA should be based on clinical circumstances. Clinically significant cases of liver injury have been reported in
49
38
IN THE DEFINE‡ CLINICAL TRIAL, PATIENTS WERE:
%
LESS LIKELY TO EXPERIENCE
A RELAPSE3§ TECFIDERA: 27% (n=410) Placebo: 46% (n=408) [P<0.0001] Based on proportion of patients relapsed (PPR)||
%
LESS LIKELY TO EXPERIENCE
DISABILITY PROGRESSION3¶
TECFIDERA: 16% (n=410) Placebo: 27% (n=408) [P=0.0050]
84% OF PATIENTS IN THE DEFINE TRIAL WERE FREE OF DISABILITY PROGRESSION VS 73% OF PLACEBO PATIENTS3
IN A SEPARATE ANALYSIS, THE NEWLY DIAGNOSED PATIENTS FROM THE PIVOTAL TRIALS WERE:
71
%
LESS LIKELY TO EXPERIENCE
DISABILITY PROGRESSION1
TECFIDERA: 0.073 (n=221) Placebo: 0.233 (n=223) [P<0.0001]
STUDY DESIGN: This post hoc analysis of integrated data from DEFINE and CONFIRM# was conducted to examine the efficacy and safety of TECFIDERA in 678 newly diagnosed patients (59% of patients in DEFINE and 71% in CONFIRM were treatment-naive4,5). The newly diagnosed population included patients who had been diagnosed with RRMS within 1 year prior to study entry and were naive to MS disease-modifying therapy. The analysis included clinical and neuroradiological efficacy endpoints as well as basic safety data, or adverse events. This study was not designed in advance to analyze the endpoints presented in the subgroup of newly diagnosed patients.1 Most common adverse events reported in patients receiving TECFIDERA compared with placebo included flushing, nasopharyngitis, headache, diarrhea, nausea, upper abdominal pain, and abdominal pain.3
Important Safety Information (cont’d)
patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients. Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected. TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% of patients taking TECFIDERA reported flushing, which was mostly mild to moderate in severity. Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization. Taking TECFIDERA with food may reduce flushing. Alternatively, administration of non-enteric coated aspirin prior to dosing may reduce the incidence or severity of flushing. TECFIDERA may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of TECFIDERA patients and <1% of placebo patients discontinued due to GI events. The incidence of serious GI events was 1%. The most common adverse reactions associated with TECFIDERA
versus placebo are flushing (40% vs 6%) and GI events: abdominal pain (18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%). A transient increase in mean eosinophil counts was seen during the first two months. TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant while taking TECFIDERA to enroll in the TECFIDERA pregnancy registry by calling 1-866-810-1462 or visiting www.TECFIDERApregnancyregistry.com. For additional Important Safety Information, please see adjacent Brief Summary of full Prescribing Information. *TECFIDERA is approved for adult patients only. † Based on prescriptions. ‡ Determination of Efficacy and Safety of Oral Fumarate in RelapsingRemitting MS.4 § Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted for at least 24 hours and were accompanied by new objective neurologic findings.4 || PPR is the percentage of patients who had one or more relapses over the course of the trial.4 ¶ Disability progression is defined as at least a 1-point increase from baseline EDSS of ≥1.0, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.3 # Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis.5 References: 1. Gold R, Giovannoni G, Phillips JT, et al. Mult Scler. 2015;21(1):57-66. 2. IMS data September 27, 2013-December 8, 2017. 3. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 4. Gold R, Kappos L, Arnold DL, et al. N Engl J Med. 2012;367:10981107. Erratum in: N Engl J Med. 2012;367:2362. 5. Fox RJ, Miller DH, Phillips JT, et al. N Engl J Med. 2012;367:1087-1097. Erratum in: N Engl J Med. 2012;367:1673. © 2018 Biogen. All rights reserved. 02/18 TEC-US-2505
Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use Brief Summary of Full Prescribing Information 1 INDICATIONS AND USAGE TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Discontinuation of TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of TECFIDERA with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3)]. TECFIDERA should be swallowed whole and intact. TECFIDERA should not be crushed or chewed and the capsule contents should not be sprinkled on food. TECFIDERA can be taken with or without food. 2.2 Blood Tests Prior to Initiation of Therapy Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy [see Warnings and Precautions (5.3)]. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with TECFIDERA [see Warnings and Precautions (5.4)]. 3 DOSAGE FORMS AND STRENGTHS TECFIDERA is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with “BG-12 120 mg” in black ink on the body. The 240 mg capsules have a green cap and a green body, printed with “BG-12 240 mg” in black ink on the body. 4 CONTRAINDICATIONS TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Anaphylaxis and Angioedema TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue TECFIDERA and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema. 5.2 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA for 4 years while enrolled in a clinical trial. During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years) while taking TECFIDERA [see Warnings and Precautions (5.3)]. The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms. Cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with
other MS medications associated with PML. Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis. It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients. 5.3 Lymphopenia TECFIDERA may decrease lymphocyte counts. In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. Six percent (6%) of TECFIDERA patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with TECFIDERA or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years) [see Warnings and Precautions (5.2)]. In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5x109/L with continued therapy. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts. Obtain a CBC, including lymphocyte count, before initiating treatment with TECFIDERA, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of TECFIDERA in patients with lymphocyte counts less than 0.5x109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if TECFIDERA is discontinued or interrupted due to lymphopenia. Consider withholding treatment from patients with serious infections until resolution. Decisions about whether or not to restart TECFIDERA should be individualized based on clinical circumstances. 5.4 Liver Injury Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients. Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials [see Adverse Reactions (6.1)]. Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected. 5.5 Flushing TECFIDERA may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials, 40% of TECFIDERA treated patients experienced flushing. Flushing symptoms generally began soon after initiating TECFIDERA and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued TECFIDERA for flushing and <1% had serious flushing symptoms that were not lifethreatening but led to hospitalization. Administration of TECFIDERA with food may reduce the incidence of flushing. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3)]. 6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema (5.1), Progressive multifocal leukoencephalopathy (5.2), Lymphopenia (5.3), Liver Injury (5.4), Flushing (5.5) [see Warnings and Precautions].
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea. Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients received TECFIDERA with an overall exposure of 2244 person-years [see Clinical Studies (14)]. The adverse reactions presented in the table below are based on safety information from 769 patients treated with TECFIDERA 240 mg twice a day and 771 placebo-treated patients. Table 1: Adverse Reactions in Study 1 and 2 reported for TECFIDERA 240 mg BID at ≥2% higher incidence than placebo
Flushing Abdominal pain Diarrhea Nausea Vomiting Pruritus Rash Albumin urine present Erythema Dyspepsia Aspartate aminotransferase increased Lymphopenia
TECFIDERA N=769 %
Placebo N=771 %
40 18 14 12 9 8 8 6 5 5 4 2
6 10 11 9 5 4 3 4 1 3 2 <1
Gastrointestinal TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with TECFIDERA. Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both TECFIDERA and placebo and were balanced between groups. There were no elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with TECFIDERA or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy. Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received TECFIDERA and been followed for periods up to 4 years with an overall exposure of 4603 person-years. Approximately 1162 patients have received more than 2 years of treatment with TECFIDERA. The adverse reaction profile of TECFIDERA in the uncontrolled clinical studies was consistent with the experience in the placebo-controlled clinical trials. 6.2 Post Marketing Experience The following adverse reaction has been identified during post approval use of TECFIDERA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Liver function abnormalities (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN) have been reported following TECFIDERA administration in post marketing experience [See Warnings and Precautions (5.4)].
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TECFIDERA during pregnancy. Encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of TECFIDERA in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. [see data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day. In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD. Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD. 8.2 Lactation Risk Summary There are no data on the presence of DMF or MMF in human milk. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TECFIDERA and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of TECFIDERA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 10 OVERDOSE Cases of overdose with TECFIDERA have been reported. The symptoms described in these cases were consistent with the known adverse event profile of TECFIDERA. There are no known therapeutic interventions to enhance elimination of TECFIDERA nor is there a known antidote. In the event of overdose, initiate symptomatic supportive treatment as clinically indicated. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Inform patients that they will be provided two strengths of TECFIDERA when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow TECFIDERA capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration (2.1)].
Anaphylaxis and Angioedema Advise patients to discontinue TECFIDERA and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.1)]. Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received TECFIDERA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.2)]. Lymphocyte Counts Inform patients that TECFIDERA may decrease lymphocyte counts. A blood test should be obtained before they start therapy. Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions (5.3), Adverse Reactions (6.1)]. Liver Injury Inform patients that TECFIDERA may cause liver injury. Instruct patients treated with TECFIDERA to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions (5.4)]. Flushing and Gastrointestinal (GI) Reactions Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI reactions. Advise patients experiencing flushing that taking TECFIDERA with food or taking a non-enteric coated aspirin prior to taking TECFIDERA may help [see Adverse Reactions (6.1)]. 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. © 2013-2017 Biogen 2/18
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AANnews • August 2018
Conferences & Community
New History Wall, Videos Welcome Board Members The summer meeting of the AAN and AAN Institute Board of Directors began with a walk through time: a multimedia overview of 70+ years that saw the rise of the American Academy of Neurology, from its inception in 1946 and formal launch in 1948 to an association now supporting 34,000 neurology professionals worldwide. The new history wall includes a photo-rich timeline of key events and leaders in the Academy’s history, portraits of all 35 AAN presidents, and video excerpts from a series of interviews conducted in 2017 with 10 past presidents. The video display can be updated with additional audio-video files from the AAN’s archives and new interviews. The history wall welcomes staff and members to the Academy headquarters’ fifth floor, which includes a cafeteria and deck area, staff meeting rooms, and the board room.
Free Helmets Help Heads Stay Healthy The AAN again held its annual bicycle helmet giveaway in June, distributing 1,000 helmets to the public outside AAN headquarters in conjunction with the Mill City Farmers Market themed day focusing on healthy brain foods. The public began lining up 45 minutes before the 8:00 a.m. start, and the line was soon around the block. Copies of Brain & Life™ magazine also were handed out. In acknowledgment of the day, Minneapolis Mayor Jacob Frey proclaimed it Brain Health Awareness Day in the city. This is the seventh year the AAN has hosted this community event, and it received media coverage from five local TV stations and the Mill City Times, along with extensive social media exposure. To extend its impact on Minnesotans’ brain health, the AAN also donated an additional 1,000 helmets to the Minneapolis Police Department Bike Cops for Kids, St. Paul-Ramsey County Public Health, Extended Learning Summer School/MPS, Nice Ride, Brain Injury Alliance Minnesota, and Hennepin County Health Care for the Homeless.
AANnews • August 2018 19
Conferences & Community
AAN Attends EAN Annual Meeting AAN leadership was on hand at the European Academy of Neurology Congress in June, representing our 1,565 European members. From left to right: Membership Director Christi L. Kokaisel, MBA, CAE; President Ralph L. Sacco, MD, MS, FAHA, FAAN; Executive Director/CEO Catherine M. Rydell, CAE; and Chief Communications & Membership Officer Angela M. Babb, CAE, APR.
Save $200 on Fall Conference Registration Before August 22 continued from cover education courses and breakthrough scientific research from the record-setting Annual Meeting and added them to the program. In addition to their popularity, these new programs were selected based on their innovative formats and complementary curriculum. The result promises to be the most robust Fall Conference yet—in the compact three-day format attendees find so convenient. Get ready to experience the next generation of Fall Conference programming: visit AAN.com/view/Fall for full program descriptions and to secure your early registration savings before August 22.
Meeting-At-A-Glance Friday, October 26
8:00 a.m.–9:30 a.m. Neurology Update I: Dementia and Movement Disorders Practice Management I: Coding for Complex and Chronic Patients Critical Care EEG Monitoring 10:00 a.m.–11:30 a.m. Neurology Update II: Neuroinfectious Disease and Neuro-otology Practice Management II: Teleneurology: What You Need to Know Multiple Sclerosis Overview: Clinical Advances 11:30 a.m.–1:00 p.m. Lunch in Exhibit Hall 1:00 p.m.–2:30 p.m. Neurology Update III: Headache and Sleep Practice Management III: Using Integrated Care Models in Your Practice Neuroscience in the Clinic: Stress and Neurologic Diseases: What Is It, and What Is the Provider to Do? 1:00 p.m.–4:30 p.m. Skills Workshop: Management of Acute Seizure and Acute Stroke (Additional Fee Required)
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AANnews • August 2018
3:00 p.m.–4:30 p.m. Neurology Update IV: Autoimmune Neurology and Multiple Sclerosis Practice Management IV: Small and Solo Practice Essentials Controversies in Neurology Plenary Session 4:00 p.m.–6:00 p.m. Exhibit Hall Opening Reception
Saturday, October 27 8:00 a.m.–9:30 a.m. Neurology Update V: Sports Neurology and Palliative Care Practice Management V: Improving Patient Engagement Case Studies: Unusual Movement Disorders 10:00 a.m.–11:30 a.m. Neurology Update VI: Stroke and Neurocritical Care Practice Management VI: Being a Provider in the Era of APMs Clinical Pearls: Learning from Complex Cases—Simple Lessons That Apply to Everyday Problems 11:30 a.m.–1:00 p.m. Lunch in Exhibit Hall 1:00 p.m.–2:30 p.m. Continuum® Test Your Knowledge I: A Multiple-choice Question Review Neuroscience in the Clinic: Intertwined Epidemics: Opioids and Chronic Pain
1:00 p.m.–5:00 p.m. Leadership Challenges in Practice Skills Workshop: Clinical Uses of Botulinum Toxin for Dystonia (Additional Fee Required) 3:00 p.m.–4:30 p.m. Continuum Test Your Knowledge II: A Multiple-choice Question Review Neurology Year in Review Plenary Session 5:00 p.m.–6:00 p.m. Maintenance of Certification Information Session
Sunday, October 28 7:15 a.m.–8:45 a.m. Neurology Update VII: Neuromuscular Diseases Practice Management VII: Improve Your Quality, Improve Your Value What Do I Do Now: Emergency Inpatient Management of Migraine and Other Headache Disorders 9:00 a.m.–11:00 a.m. Skills Workshop: Clinical Usefulness of Botulinum Toxin for Spasticity (Additional Fee Required) 9:00 a.m.–10:30 a.m. Neurology Update VIII: Epilepsy and Pregnancy Neuroscience in the Clinic: Amyotrophic Lateral Sclerosis
Non-motor symptoms of OFF periods affecting the lives of people with Parkinson’s may include anxiety, mood changes, fatigue, irritability and cognitive dysfunction.1,2 Unexpected symptoms can affect everyday life, for example, reduction in mobility and avoidance of activities. 3 Symptom variability among patients can make recognition of OFF periods challenging for clinicians.4
OFFmatters.com
1. 2. 3. 4.
Stacy M et al. Mov Disord. 2005;20(6):726-733. Witjas T et al. Neurology. 2002;59(3):408-413. Hechtner MC et al. Parkinsonism Relat Disord. 2014;20(9):969-974. Pahwa R et al. Curr Res Med Opin. 2009;25(4):841-849.
ACORDA THERAPEUTICS® and the stylized ACORDA THERAPEUTICS® logo are registered trademarks of Acorda Therapeutics, Inc. ©2017 Acorda Therapeutics, Inc. All rights reserved. PD5818 7/17
Education & Research
New SIGN Framework to Further Engage, Unify Chapters A new framework for Student Interest Group in Neurology (SIGN) chapters is being rolled out this summer. The standardizations are designed to further engage chapters in the exploration of the field of neurology and participation with the AAN, as well as unify process and standards for the more than 130 chapters nationwide. “With these changes, we really hope to deepen engagement with our SIGN chapters and offer more meaningful opportunities for medical students and potential future neurologists to learn about all the exciting career opportunities in this fast-growing, highdemand field,” said AAN Education Committee Member Justin Jordan, MD, MPH. In addition to receiving a new logo and more informative and interactive web pages on AAN.com, as part of the new revamp all chapters will now participate in select core-content programming and opportunities to receive additional funding. Program highlights include: New Required Lecture Series To ensure that all chapters are presenting information on key topics in neurology, each SIGN chapter is now required to present the following core topics during the academic year: What Is Neurology? Clinical Career in Neurology; What’s New in Neurology? Recent Discoveries and Research Careers; Life as a Neurologist―Lifestyles in Neurology Careers; and Community Engagement and Advocacy. Additional suggested topics include Residency― How to Apply; Research―Engaging in Opportunities; Financial Planning; and Wellness/Life and Work Balance.
plan of events and a membership roster will have the opportunity to apply for additional funding. To learn more, visit AAN.com/view/SIGN. Members of the SIGN chapter at San Juan Bautista School of Medicine in Puerto Rico.
New Funding Opportunities As in the past, each US and Canadian chapter has $400 to use toward food and/or chapter resources on a modified academic year, which runs August 1 to July 31. Chapters that complete the four core topics and provide a year-long
UCNS Welcomes New Board Members The United Council for Neurologic Subspecialties recently elected three new members to its Board of Directors. They are: Paul G. Fisher, MD, chief of the division of child neurology at the Stanford Neuroscience Health Center, Palo Alto, CA, was elected to serve a second three-year voting board term representing the Child Neurology Society. Barbara Schildkrout, MD, will serve a two-year voting term representing the subspecialty of Behavioral Neurology & Neuropsychiatry and was nominated by the American Neuropsychiatric Association and Society for Behavioral and Cognitive Neurology.
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AANnews • August 2018
Schildkrout is a UCNS diplomate, certified in Behavioral Neurology & Neuropsychiatry since 2012, and is an assistant professor of psychiatry at Harvard Medical School in Boston, MA. Jaishri Blakeley, MD, will serve a two-year non-voting term representing Neuro-oncology. UCNS-certified in Neuro-oncology since 2009, Blakeley was nominated by the AAN Neurooncology Section. She is an associate professor in the department of neurology, neurosurgery and oncology at Johns Hopkins Hospital in Baltimore, MD.
The UCNS Board of Directors has nine voting members. The five founding parent organizations, the AAN, American Neurological Association, Professors of Child Neurology, Child Neurology Society, and Association of University Professors of Neurology, have permanent seats with one vote each. The four other seats are for representatives of UCNS member subspecialties with voting privileges rotating amongst the subspecialties. Meetings of the UCNS Board are also attended by representatives of the Accreditation Council for Graduate Medical Education and the American Board of Psychiatry and Neurology serving as liaisons. In addition, the executive directors of the parent organizations attend meetings in an ex-officio capacity.
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UCNS to Develop New Continuous Certification Model The United Council for Neurologic Subspecialties (UCNS) plans to develop a new continuous certification model to replace the current recertification process. After evaluating examples of alternative models of continuous certification and gathering feedback from UCNS diplomates, the UCNS Board of Directors decided to embark on the new process that will align with lifelong learning, provide online knowledge assessments, and offer a continuous certification model. Ralph F. Józefowicz, MD, FAAN, chair of the UCNS Board, said, “The field of medicine is advancing at a fast pace. The objective of maintenance of certification is to ensure that physicians are keeping up with the advances in their subspecialty field to provide the best possible patient care. We believe this can be achieved through a process that actively facilitates lifelong learning and the knowledge assessed by a means that is not burdensome for the physician.” The UCNS Certification Council has been charged with outlining a new continuous certification process that includes: Certification requirements that are delivered and completed on a manageable and annual basis to replace the current 10-year process/high-stakes examination Involvement of sponsoring organizations and their subspecialty experts in identifying the topics and information that is relevant to lifelong learning for their field Identification of resources that are credible, accessible, and affordable and reflect the fundamental knowledge needed to stay up-to-date in the subspecialty field
All recertification examinations scheduled for 2018 will take place as planned. No recertification examinations will be administered in 2019 during the new continuous certification development phase. The goal is to implement a new continuous certification process in 2020. As per UCNS policy, diplomates with certificates expiring in a year when no recertification is offered will have their certification extended to the next examination or until the new recertification program is in place. All 2019 initial certification examinations will take place as scheduled. For more information, visit UCNS.org or contact Todd Bulson, Senior Manager, Certification, at tbulson@ucns. org or (612) 928-6067 with questions.
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Need Help Seeing New Ways to Improve Your Practice? The latest online 2017 Neurology Compensation and Productivity Report offers eye-opening information to help you succeed. Use the customizable dashboard to compare your practice data to local and national colleagues. Determine if you are being compensated fairly relative to your peers, and use the data to demonstrate your value to payers and deliver quality patient care. Get better visibility with the 2017 Neurology Compensation and Productivity Report at AAN.com/view/2017NeuroReport. AANnews • August 2018 23
Education & Research
UCNS Accredits New Training Programs The United Council for Neurologic Subspecialties (UCNS) has approved accreditation for four new fellowship training programs. The programs and directors are:
Neurocritical Care
Headache Medicine
Wake Forest Baptist Medical Center (Kyle Hobbs, MD)
University of Washington School of Medicine (Natalia Murinova, MD, MHA) Children’s Health System of Dallas/ University of Texas Southwestern, Dallas (Tonia Sabo, MD)
Neuro-oncology Sylvester Comprehensive Cancer Center/University of Miami (Deborah Heros, MD)
There are now 197 UCNS-accredited training programs. For more information about applying for accreditation, visit UCNS.org. Applications received by the December 1, 2018, deadline will be reviewed for accreditation in the spring of 2019.
Academy Rolls Out New Academic Year Membership for Students, Interns, and Juniors To better align with the academic cycle and provide the best membership value, the Academy recently moved all Student, Intern, and Junior membership categories to an academic year cycle, running July 1 through June 30.
Current members paid through December 31, 2018, can extend Publishing: 18their Brainmembership & Life Ad—Half Page Horizontal> AN year to June 30, 2019, through the academic
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at the prorated amount of $80. Members in these categories of membership whose memberships are paid for by their program do not need to take any further action. For questions about the change, contact AAN Member Services at MemberServices@aan.com, (800) 879-1960, or (612) 928-6000 (International).
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FREE Patient and Caregiver Magazine and Website! This popular AAN resource provides expert content your patients and their caregivers rely on. Place in your waiting room and share with your patients!
BrainandLife.org
Cure One, Cure Many We bring researchers and donors together to defeat brain disease. The American Brain Foundation invests in research for all brain diseases, because advances in a cure for one brain disease will lead to cures for others. This is how we will reach our vision of a world with cures for brain disease.
Make a gift in honor of a loved one or caregiver at
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American Brain Foundation
New Endowment Reinvigorates Raymond D. Adams Fellowship In the summer of 2001, the American Brain Foundation (then known as the AAN Foundation) received a surprise call from a former student of Raymond D. Adams, emeritus Bullard Professor of Neuropathy at Harvard Medical School and emeritus chief of neurology service at the Massachusetts General Hospital. The former student, who preferred to remain anonymous, was interested in supporting a research fellowship to honor the neurology giant he so admired. From that conversation sprang a chain of events that culminated in the Raymond D. Adams Clinical Research Training Fellowship in 2004. Adams
Through the generosity of that same donor, another recent gift has been realized to secure the endowment to support additional scholarships in the name of the beloved teacher and friend, legendary neurologist and diagnostician, and tireless academician who estimated to have “trained over 250 academic neurologists in [his] time."
AAN members are invited to add their support to the new endowment to help fund the next generation of neurologists. To learn more and to make a donation, contact Shelly Rucks at srucks@americanbrainfoundation.org or (612) 928-6318.
Our Donors Make a Difference! The American Brain Foundation sat down with American Academy of Neurology staff member Grant Niver, Program Manager, State Affairs, to learn why supporting the Foundation is so important to him. Foundation: Why have you chosen to support the American Brain Foundation? Niver: I’m supporting the American Brain Foundation in honor of my mom, Roberta, who courageously lives with Parkinson’s disease. Foundation: What are your hopes for the research that the American Brain Foundation is funding? Niver: Simple—breakthroughs. Breakthroughs not just for a cure, but advanced therapies and treatments for the millions of people currently living with neurologic diseases. Foundation: The American Brain Foundation supports all brain disease research because we believe if we cure one, we’ll cure many. What does this mean to you as a donor?
Grant Niver and his mom, Roberta, joined the Parkinson’s Action Network in Washington, DC, in 2015, to help advocate for more research funding.
Niver: It’s a significant reason why I believe strongly in supporting the Foundation. The Foundation allows research dollars to be as impactful as possible. My contribution not only benefits millions of people with neurologic diseases but increases the chances for a breakthrough (and one day a CURE!) in Parkinson’s.
Neurology Disputes & Debates:
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Comment on Neurology® journal articles and read what others are saying at Neurology.org/N
AANnews • August 2018 27
AAN.com/careers
Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added. Multiple Neurology Openings in Greater Cincinnati/Northern Kentucky Come join a growing, well-respected group with the full support of our award-winning hospital system, St. Elizabeth Healthcare. St. Elizabeth Physicians offers a competitive compensation and benefits package. Working at St. Elizabeth Physicians allows you to enjoy Kentucky’s natural charm while all that metropolitan greater Cincinnati has to offer is just minutes away. Northern Kentucky is on the banks of the Ohio River and boasts affordable costs of living, award-winning schools, colleges and professional sports, exceptional fine arts and the distinction of being sixth in the nation for its number of Fortune 500 Company headquarters. The Cincinnati area was also recently named one of the trendiest cities in the nation by Realtor.com. Progressive 5-member physician/1 NP neurology division of St. Elizabeth Physicians is seeking to add two neurologists; one for neurohospitalist position and one for traditional in- and outpatient practice. St. Elizabeth Physicians is a financially successful, multi-specialty group consisting of 372 physicians, 116 advanced practitioners, and over 1,100 associates serving more than 340,000 patients in 116 conveniently located sites in Kentucky, Ohio and Indiana. In partnership with our five St. Elizabeth Hospitals, together we are transforming how healthcare is delivered in our region. Beginning in 2019, a partnership with the University of Kentucky will also result in a local medical school. St. Elizabeth is a proud member of the Mayo Clinic Care Network. This network provides access to proven protocols, eConsults and unparalleled experience. It supports our mission to ensure our patients receive comprehensive and compassionate care—anywhere. Join St. Elizabeth Physicians where our associates ranked us in the top 4% of the country for overall satisfaction. St. Elizabeth Physician is an Equal Opportunity Employer and values the diversity of our associates. If you are interested in joining this highly-talented group of physicians, please contact Dante Gapultos at dante.gapultos@stelizabeth.com or (859) 344-5505.
call schedules • Open to all sub specialties (except sleep medicine) o Cognitive, headache and movement disorder training a plus Benefits and Lifestyle: • High income potential with competitive base compensation and production incentives • Excellent benefits package • Financial security with working for a top ranked, financially secure hospital system • Area is well known for the top ranked (nationally) public and private schools • Less than an hour drive to historic Philadelphia • Wonderful cultural opportunities • Short drive to beaches, mountains, New York City and Washington, DC Main Line Health (MLH) is a not-for-profit health system serving portions of Philadelphia and its western suburbs. At its core are four of the region’s respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s premier facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital; Mirmont Treatment Center for drug and alcohol recovery; and Main Line Health HomeCare & Hospice, a home health service. Main Line Health also consists of Main Line HealthCare, one of the region’s largest multi-specialty physician networks, and the Lankenau Institute for Medical Research, a non-profit biomedical research organization located on the campus of Lankenau Medical Center. Main Line Health is also comprised of five outpatient health centers located in Broomall, Collegeville, Exton, Concordville and Newtown Square. Main Line Health Hospitals, with more than 10,000 employees and 2,000 physicians, are the recipients of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence, and being named among the nation’s best employers by Forbes magazine. Main Line Health is among the area’s leaders in medicine, providing advanced patient-centered care, education and research to help our community stay healthy. Forward CV to: Rose Caione Physician Recruiter caioner@mlhs.org (484) 580-4146.
Opportunity to Join A Well-Regarded Health System in Suburban Philadelphia Main Line Health System, located in the beautiful western suburbs of Philadelphia has opportunities for neurologists looking to join a well-regarded health system. Opportunities: • Outpatient opportunities or combination of outpatient/neuro-hospitalist position • Enjoy the benefits of working in a well-established, employed practice • Diverse neurologic patient mix • Enjoy the support of respected and top-level primary care, hospitalists and other specialists within Main Line Health community • Reasonable
Neurohospitalist opening affiliated with teaching hospital with new Neurology Residency Program Medical school affiliated Academic Medical Center. Opportunity to join growing Neurology department of 8 Neurologists. Faculty members including General, Pediatric, Neuromuscular, Movement, Epilepsy and Vascular. 7 days on 7 days off schedule with opportunity for outpatient clinic. Accredited Neurophysiology Center on site. Multidisciplinary team includes Radiologists, Pharmacists, Nursing, Dietitians, Physical, Occupational and Speech Therapists. Comprehensive benefits package including
malpractice. Excellent starting salary and sign-on bonus. Academic Appointment. Educational stipend available. Named one of 150 Great Places to Work in Healthcare—Becker´s Hospital Review. Excellent Public and Private Schools. NCAA Division I Intercollegiate Sports Teams. Driving distance for skiing, water sports, hiking, etc. Short Distance to 4 Major Metro Areas. Expanding Downtown Area, Concert Halls and a Theater Community. Mention code 180418 NHO. Email: jpolver1@phg.com Pediatric Neurology opening affiliated with teaching hospital with new Neurology Residency Program Opportunity to join two practicing Pediatric Neurologists. Join medical school Department of Neuroscience including Neurology, Neurosurgery & Neurophysiology. Faculty members including Child & Adult Neurologists, as well as Functional, Pediatric & Spine Neurosurgeons. Established, Accredited Long-term Epilepsy Monitoring Unit. 36 Bed NICU; 12 Bed Pediatric ICU Level III Center. New, $30 Million Pediatric Hospital Expansion. Clinical Research Interest Encourage. Excellent starting salary, full benefits and sign-on bonus. Educational stipend available. An outdoor enthusiast´s haven. Enjoy the scenic shores of a historic River. Take in the fourseason views while mountain hiking. Enjoy a sunset cruise under the stars. The region´s best skiing at your doorstep. Year-round family fun. A down-to-earth place to live combined with amazing cultural sensations. NCAA Division One Intercollegiate Sports Teams. Mention code 180420 CHN. Email jpolver1@phg.com
AANnews® Classified Advertising The AAN offers a complete package of print, online, and
in-person recruitment advertising opportunities. Visit careers.AAN.com for all AAN options, rates, and deadlines. Ad copy for the October 2018 print edition of AANnews must be submitted by September 1, 2018. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the right to T decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.
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AUGUST 1
Deadline: UCNS Neuroimaging Certification and Recertification Examinations Application UCNS.org/go/subspecialty/neuroimaging/ certification
AUGUST 21
Webinar: Improving Patient Access, Engagement, and Care (Register by August 20) AAN.com/view/pmw18
AUGUST 22
Early Registration Deadline: Fall Conference AAN.com/view/Fall
AUGUST 31
Deadline: AAN/AAN Institute Board of Directors Nominations AAN.com/view/BOD
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SEPTEMBER 20
OCTOBER 1
Deadline: Fall Conference Advance Registration and Hotel AAN.com/view/Fall
Deadline: 2019 Research Program AAN.com/view/ResearchProgram
SEPTEMBER 25
Deadline: Abstract Submission for 2019 Annual Meeting AAN.com/view/19Abstracts
Webinar: Using Guidelines and Quality Measures to Become a Better Neurologist (Register by September 24) AAN.com/view/pmw18
OCTOBER 22
OCTOBER 23
Webinar: How Does Health Services Research Help Me? (Register by October 22) AAN.com/view/pmw18
OCTOBER 24
Deadline: Awards Application
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OCTOBER 26–28
Fall Conference, Las Vegas, NV AAN.com/view/Fall
BRIEF SUMMARY OF PRESCRIBING INFORMATION
Please see package insert for full Prescribing Information INDICATIONS AND USAGE AIMOVIG is indicated for the preventive treatment of migraine in adults. CONTRAINDICATIONS None. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of AIMOVIG has been evaluated in 2,537 patients with migraine who received at least one dose of AIMOVIG, representing 2,310 patient-years of exposure. Of these, 2,057 patients were exposed to 70 mg or 140 mg once monthly for at least 6 months, 1,198 patients were exposed for at least 12 months, and 287 patients were exposed for at least 18 months. In placebo-controlled clinical studies (Studies 1, 2, and 3) of 2,184 patients, 787 patients received at least one dose of AIMOVIG 70 mg once monthly, 507 patients received at least one dose of AIMOVIG 140 mg once monthly, and 890 patients received placebo during 3 months or 6 months of double-blind treatment. Approximately 84% were female, 91% were white, and the mean age was 42 years at study entry. The most common adverse reactions (incidence ≥ 3% and more often than placebo) in the migraine studies were injection site reactions and constipation. Table 1 summarizes the adverse reactions that occurred during the first 3 months in the migraine studies (Studies 1, 2, and 3). Adverse Reactions Occurring with an Incidence of at Least 2% for Either Dose of AIMOVIG and at Least 2% Greater than Placebo During the First 3 Months in Studies 1, 2, and 3 AIMOVIG 70 mg Once Monthly N = 787 %
AIMOVIG 140 mg Once Monthly N = 507 %
N = 890 %
Injection site reactionsa
6
5
3
Constipation
1
3
1
<1
2
<1
Adverse Reaction
Cramps, muscle spasms
Placebo
a Injection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema.
In Studies 1, 2, and 3, 1.3% of patients treated with AIMOVIG discontinued double blind treatment because of adverse events. The most frequent injection site reactions were injection site pain, injection site erythema, and injection site pruritus. Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation, including neutralizing antibodies, is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to erenumab-aooe in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. The immunogenicity of AIMOVIG has been evaluated using an immunoassay for the detection of binding anti-erenumab-aooe antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.
In controlled studies with AIMOVIG, the incidence of anti-erenumab-aooe antibody development was 6.2% (48/778) in patients receiving AIMOVIG 70 mg once monthly (2 of whom had in vitro neutralizing activity) and 2.6% (13/504) in patients receiving AIMOVIG 140 mg once monthly (none of whom had in vitro neutralizing activity). The neutralizing anti-erenumab-aooe antibody positive rate may be underestimated because of limitations of the assay. Although these data do not demonstrate an impact of anti-erenumabaooe antibody development on the efficacy or safety of AIMOVIG in these patients, the available data are too limited to make definitive conclusions. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women. No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooe throughout gestation (see Data). Serum erenumab-aooe exposures in pregnant monkeys were greater than those in humans at clinical doses. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data In a study in which female monkeys were administered erenumab-aooe (0 or 50 mg/kg) twice weekly by subcutaneous injection throughout pregnancy (gestation day 20 - 22 to parturition), no adverse effects on offspring were observed. Serum erenumab-aooe exposures (AUC) in pregnant monkeys were approximately 20 times that in humans at a dose of 140 mg once monthly. Lactation Risk Summary There are no data on the presence of erenumab-aooe in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AIMOVIG and any potential adverse effects on the breastfed infant from AIMOVIG or from the underlying maternal condition. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of AIMOVIG did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
AIMOVIG™ (erenumab-aooe) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 USA U.S. License No. 1080 Marketed by: Amgen Inc. (Thousand Oaks, CA 91320), and Novartis Pharmaceuticals Corporation (East Hanover, NJ 07936) Patent: http://pat.amgen.com/aimovig/ © 2018 Amgen Inc. All rights reserved. v1 05/2018
enough already. it’s time to help prevent migraine.
Aimovig™ is the first and only FDA-approved therapy specifically designed to help prevent migraine by targeting and blocking the calcitonin gene-related peptide receptor (CGRP-R).1 • Aimovig™ reduced monthly migraine days.1 • The most common adverse reactions in clinical studies (≥ 3% of Aimovig™-treated patients and more often than placebo) were injection site reactions and constipation.1 • In 3- and 6-month clinical studies, up to 95% of patients stayed on Aimovig™.1 – Less than 2% of patients receiving Aimovig™ discontinued due to adverse events.
• Patients will have access to Aimovig Ally™— a range of personalized product support services designed to help them start and stay on therapy as prescribed.
Give patients less days marked by migraine with Aimovig™.
Learn more about Aimovig™ and how to get your Hypothetical patient.
next patient started at AimovigHCP.com/GetStarted
Indication Aimovig™ is indicated for the preventive treatment of migraine in adults.
Important Safety Information • The most common adverse reactions in clinical studies (≥ 3% of Aimovig™-treated patients and more often than placebo) were injection site reactions and constipation. Please see a brief summary of the Prescribing Information on the adjacent page. Reference: 1. Aimovig™ (erenumab-aooe) prescribing information, Amgen.
© 2018 Amgen Inc. All rights reserved. USA-334-80644