2022 November AANnews

2023 ANNUAL MEETING REGISTRATION NOW OPEN!

Join Us In Person or Online

The 2023 AAN Annual Meeting is coming to Boston April 22–27, and whether you join us in person or online, this year’s lineup is sure to have something for everyone. You can expect a fresh program of top-tier education, the very latest scientific discoveries, and an abundance of opportunities to connect with friends and colleagues from around the globe.

Plus, with 2023 marking 75 years since the founding of the AAN in 1948, you can also join us for a special 75th Anniversary celebration during the opening party on Sunday, April 23, and via various opportunities throughout the week.

Visit AAN.com/AM to learn more and to secure your spot.

It’s Time to Renew Your Membership for 2023

Retain Access to the Best Neurology Resources

Renew your AAN membership today so you can go into the new year with uninterrupted access to the highest quality resources—when you need them—from the world’s largest and most trusted community of neurology professionals. Your robust AAN membership benefits package is valued at up to $4,000 and provides you with exclusive access to*:

350+ online courses, videos, and exams

Top scientific resources, including 48 issues per year of Neurology ®, the most widely read and highly cited peerreviewed journal

Free Neurology: Education Online Journal Debuts

Neurology ® Education, the latest in the family of Neurology ® journals, has posted its first issue. This online-only, peer-reviewed journal publishes original research articles, reviews, and editorials on evidence-based teaching methods and curriculum innovations. It provides the academic community with a forum to exchange ideas that enhance neurologic and clinical neuroscience education. The journal is free for readers and no article processing or open access fees are charged to authors.

Thank

to the supporters of the

Leadership Program

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

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

Contact Information

American Academy of Neurology

201 Chicago Avenue

Minneapolis, MN 55415

Phone: (800) 879-1960 (toll free) (612) 928-6000 (international)

Email: memberservices@ aan.com Website: AAN.com

For advertising rates, contact: Michael J. O’Brien II

Account/Relationship Manager

Wolters Kluwer

Phone: (978) 578-4514

Email: Michael.Obrien @ wolterskluwer.com

November Highlights

8 Need End-of-year CME? Check out These AAN Education Opportunities!

If you’re looking to meet your end-of-year CME requirements, then look no further. Only AAN members have free and discounted access to a variety of exclusive online CME and selfassessment resources. Browse all the convenient programs and get started fulfilling your requirements today at AAN.com/learn

10

Apply by January 20, 2023, for AAN Health Care Equity Scholarship

The AAN is proud to offer the Health Care Equity Scholarship Program. Scholarship recipients will participate in a multifaceted year-round program to continue personal development and create a roadmap aimed at mitigating health care disparities.

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AAN Chief Executive Officer: Mary E. Post, MBA, CAE Editor-in-Chief: Melissa W. Ko, MD, MBA, CPE, FAAN

Managing Editor: Angela M. Babb, MS, CAE, APR

Editor: Tim Streeter

Writers: Ryan Knoke and Sarah Parsons

Designer: Siu Lee

Email: aannews@ aan.com

AANnews® is published monthly by the American Academy of Neurology for its 38,000 members worldwide. Access this magazine and other AAN publications online at AAN.com.

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The inclusion of advertisements and/or promotions of Sponsors and other Internet sites or resources that offer content, goods, or services on the Website does not imply endorsement of the advertised/promoted products or services by AAN.

Bruno

Women Leading in Neurology Program Transforms Graduate’s Career

“I was so thrilled to be selected for the 2021 Women Leading in Neurology (WLN) Program, but at the time, I had no idea this one program would change my career in such a transformative way,” said Michiko Kimura Bruno, MD, FAAN.

News Briefs

Two New Communities Available on Synapse

Artificial Intelligence Community

A new Artificial Intelligence in Neurology Community has launched on SynapseSM AAN Member Communities. The community is an open forum for AAN members interested in exploring how AI will shape the field of neurology. Already over 130 members are participating in discussions about AI/machine learning research, publications, ethics, and possible collaborations. Join the conversation at AAN.com/memberprofile/sections/join

Associate Professor Community

Over the past year, the AAN has worked to identify ways to support the needs of associate professors. In response to suggestions, associate professors now have a dedicated, private Synapse

networking and sharing information with other

AAN Advocacy Focuses on Prior Authorization Process: How You Can Help Now

Some of the most frustrating complaints I have heard voiced by neurologists and patients alike over the years are related to enduring the prior authorization (PA) process used by insurers to evaluate whether care is medically necessary and covered. Physicians, who average 41 such reviews a week—translating to almost two business days of physician and staff time according to a 2021 AMA survey, say it is a waste of time and inefficient use of health care dollars. Patients, who end up waiting to attain health care services such as imaging or to take prescribed medication, complain that delays in their care are sometimes so prolonged that it compromises their health or they give up in frustration. According to the Regulatory Relief Coalition, the process takes between two to 14 days, but for 15 percent of physicians, it can take from 15 to more than 31 days.

Brad C. Klein, MD, MBA, FAAN, who chairs the AAN Medical Economics and Practice Committee, knows all too well how the system consumes resources for neurologic practices. He cites the recent case of a patient for whom he prescribed ubrogepant (Ubrelvy) after failing triptan therapies which were on formulary. After an initial submission online, the insurance company requested additional information and required multiple duplicate resubmissions in both paper and electronic format subsequently. The process, which should have taken 10 minutes to complete, took 3.5 hours over several weeks instead. Sadly, it is being repeated in practices across the country on a daily basis.

Klein

The AAN has worked for many years to advance PA reform with Congress and the federal administration. We have engaged in many discussions with key stakeholders to champion the Improving Seniors’ Timely Access to Care Act of 2021 (S. 3018/H.R. 3173), which would establish an electronic prior authorization (ePA) program; standardize and streamline the PA process for routinely approved services; reduce the amount of time an insurer is allowed to consider such requests; and ensure that they are reviewed by qualified medical personnel. The bill, advanced by the House Ways and Means Committee on July 27, 2022, and backed by the AAN and its coalition partners, has become one of the most supported bipartisan bills in Congress. It was selected for the priority agenda of two Neurology on the Hill events, and I am happy to report that this bill was passed in the House on September 14, 2022, and now awaits Senate action.

“Members may think that since it only pertains to Medicare Advantage plans, the legislation is not impactful,” said Dr. Klein. However, approximately 28.4 million beneficiaries now choose Medicare Advantage plans—45 percent of the Medicare population—which has doubled over the last decade. Between the passage of this law, which Dr. Klein hopes is imminent, and some successes with state efforts, progress is being made.

Dr. Klein has tried in the past to get Gold Card access endorsed in Pennsylvania, where he practices, to exempt from PA physicians who are compliant and have a very low denial rate. He would like to see that and other initiatives

achieved including: standardization of policies across payers; assurance that patients can remain on medications that are working despite formulary changes; commitment by payers that formulary and authorization policy cannot change more than once yearly; increased transparency and a streamlined internet-based user interface to find policies and relevant criteria to obtain approvals in real time; and the removal of gag rules precluding pharmacies from informing patients about cost-saving sites like GoodRx.

Examples like the one Dr. Klein shared help in legislative advocacy. Shannon M. Kilgore, MD, FAAN, who serves on the AAN Board of Directors, said, “The AMA has created the website https://fixpriorauth.org/ to collect patient and physician stories regarding adverse events related to delays in care which helped lead to the passage of the bill in the House.” Dr. Kilgore, who is the vice chair of the AAN delegation to the AMA House of Delegates, ensures collaboration between the two organizations along with other AAN members. She said,

AAN resources for neurologists

The AAN has created resources at AAN.com/practice/ prior-authorization to assist clinicians undergoing the prior authorization process such as insurance and prior authorization checklists. More recently, a PA Work Group of the Coding and Payment Policy Subcommittee created two disease-specific PA templates for CGRP inhibitors and botulinum toxin.

What you can do to help

Contact your Senate offices at AAN.quorum.us/ campaign/42488

If you or your patients have stories that demonstrate the hazards of prior authorization, share them on https://fixpriorauth.org

Learn more about how BrainPAC helps advocate for this and other issues important to neurology at BrainPAC.org

Kilgore

Avitzur

“Working with the AMA increases our chance of success on desired reform, which may be more difficult for the much smaller field of neurology to do alone.”

In the past, efforts to advocate directly with payers on PA failed to lead to substantive changes. It is clear that only legislative actions can ensure lasting change. Derek Brandt, director of Congressional Affairs at the AAN, said, “We were thrilled to have the Improving Seniors’ Timely Access to Care Act pass the House unanimously in September, but much more work is needed to get this bill over the finish line.” He urges AAN members who want to help get this done before Congress adjourns in December to contact their Senate at offices AAN.quorum.us/ campaign/42488. “We also expect many state bills focused on

prior authorization to be considered early next year when local legislatures come back into session,” Brandt added. Because local advocacy can have a huge impact on an issue like this, he encourages members who would like to help advocate for change in their regions to connect with their state neurologic and medical societies, which typically coordinate such efforts within their states.

Brandt

PRACTICE

Orly Avitzur, MD, MBA, FAAN President, AAN oavitzur@aan.com @OrlyA on Twitter

Clinics Creatively Adapt to Staffing Shortages

The AAN continues to reach out to neurology business administrators from across the country to learn what unique solutions they are finding to manage the ongoing staffing crisis sparked by COVID-19. Recently, the Academy asked, “How have you established an appropriate staff/provider ratio?” Just over one-third of respondents indicated their staffing ratio was 1:1, and another one-third indicated it was 2:1.

While several practices indicated staff support a specific physician, Pam E. Bolling, administrative director at Florida Neurology Group in Fort Myers, has had to alter their model due to staffing challenges. “We usually have one medical assistant (MA) staff supporting one provider. However, given staffing challenges, we had to pivot our model and created work teams. We now have one MA navigator who monitors the providers’ schedules and distributes charts to rooming staff, four MAs rooming patients, two MAs prepping charts, one MA dedicated to medication refills, one MA calling patients, and one MA floating to fill in where needed. This is working very successfully, and now our team of 10 MAs can support our 15 providers.”

Additionally, practices have had to think differently about roles and responsibilities of support staff, especially given the

popularity of a hybrid work environment. When thinking about developing your staff-toprovider ratio, Jose M. Rocha, MHL, director of the central business office at Performance Medical Management in Medley, FL, recommends, “Consider how on-site and remote staff can complement one another. Review what services or tasks can really be done before the office encounter. For example, digital demographic information, exchange of IDs and insurance cards, verification of insurance, explanation of amount due at time of service, and collection of copayment.”

Check the Managing Staffing Challenges site at AAN.com/practice/ staffing-challenges for other important things to consider when developing your staffing ratio.

The June, August, and September editions of AANnews feature additional creative solutions. Connect with the AAN on social media at #AAN and @AANMember

Rocha

Stay Current on Correct Diagnosis Coding for Dementia

Effective October 2022, neurology clinicians have new guidelines to follow and additional codes to consider when selecting the appropriate diagnosis code for dementia. The expansion of dementia codes will include the state and severity and identification of behavioral and psychological symptoms of dementia. While there are current codes for dementia with and without behavioral disturbances, the rationale for the requested changes is the need for additional detail on associated disorders such as psychotic disorders, mood disorders, and anxiety. The changes are part of the Centers for Disease Control and Prevention’s semi-annual updates to the ICD-10 code set and apply to all insurers.

The updated guidelines specify that documentation must clearly include the severity of the patient’s condition (unspecified, mild, moderate, or severe) and “requires the provider’s clinical judgment and codes should be assigned only on the basis of provider documentation unless otherwise instructed by the classification. If the documentation does not provide information about the severity of the dementia, assign the appropriate code for unspecified severity.”

The ICD-10 Coordination and Maintenance Committee, which is responsible for the code set, provided the following clarification when assigning the stage:

Mild dementia: “Clearly evident functional impact on daily life, affecting mainly instrumental activities. No longer fully independent/requires occasional assistance with daily life activities.”

Moderate dementia: “Extensive functional impact on daily life with impairment in basic activities. No longer independent and requires frequent assistance with daily life activities.”

Severe dementia: “Clinical interview may not be possible. Complete dependency due to severe functional impact on daily life with impairment in basic activities, including basic self-care.”

Other updates include the ability to report conditions such as vascular dementia, dementia in other diseases, and unspecified dementia. For specific coding questions, contact AAN staff at

Use New Telehealth Tips for Specialty Exams

Given the continued use of telehealth since the beginning of the pandemic, the AAN has produced two specialized guides to help you perform virtual exams for patients with a neuromuscular or vestibular disorder. The new “Telehealth Exam Tips for Patients with a Neuromuscular Disorder” and “Telehealth Exam Tips for Patients with a Vestibular Disorder” can be found at AAN.com/telehealth, which includes additional telehealth resources.

Despite the common belief that vestibular exams are not possible in a real-time audiovisual setting, the guide’s primary author Daniel R. Gold, DO, noted, “When paired with a targeted history, accurate diagnosis is usually possible. At the very least, virtual evaluation allows for effective and efficient triage, and appropriate referrals can be made to vestibular physical therapy, audiology, or otolaryngology.”

Similarly, the neuromuscular exam guide aims to promote confidence with the virtual exam by including evidencebased considerations for virtual cranial nerve and motor assessments.

Although the legislative and regulatory future of telehealth remains uncertain, the authors designed the content of these guides to be relevant for practitioners regardless of their practice location and patient population. 

AAN Partners with Epilepsy Foundation on CDC Program

November is National Epilepsy Awareness Month, and the AAN is proud to partner with the Epilepsy Foundation in support of its cooperative agreement with the CDC Epilepsy Program “Improving Epilepsy Education, Systems of Care, and Health Outcomes through National and Community Partnerships.” The goals of this initiative are to improve health, social participation, and quality of life for people with epilepsy; reduce stigma; and increase access to health services, community resources, and selfmanagement supports.

AAN.com/EpilepsyResources to find a list of epilepsy resources for physicians, patients, caregivers, and the public.

MIPS Value Pathways: A New Road to Quality Health Care

The Centers for Medicare & Medicaid Services will launch a new track in 2023 within the Quality Payment Program called MIPS Value Pathways (MVP), which builds off the traditional MIPS pathway. CMS hopes to transition clinicians reporting MIPS toward Alternative Payment Models (APMs) over time. There will be opportunities from year to year to update MVPs and in time CMS hopes the pathways will demonstrate improvements in specific conditions and across specialties. CMS has suggested that it will sunset traditional MIPS by 2027.

CMS has finalized one stroke MVP and proposed two new MVPs for neurology anticipated to go into effect January 1, 2023:

ƒ “Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes MVP,” which was finalized last year, focuses on the clinical theme of providing fundamental prevention and treatment of those patients at risk for, or that have had, a stroke.

ƒ

“Optimal Care for Patients with Episodic Neurological Conditions MVP” focuses on the clinical theme of promoting quality care for patients suffering from episodic neurologic conditions.

ƒ “Supportive Care for Neurodegenerative Conditions MVP” focuses on the clinical theme of promoting quality care for patients with cognitive-based neurological disorders such as dementia, Parkinson’s disease, and amyotrophic lateral sclerosis.

The AAN provided feedback to CMS on the components of these MVPs. It is notable that there are so many options available for neurology, much more so than other specialties.

AAN.com/qpp

Members should look to the AAN for more information about 2023 MVPs after details are finalized this month. These changes may not immediately impact you or your practice but could potentially in the future, so the AAN has created two helpful overviews—“Understanding MIPS Value Pathways” and the more specific stroke-related “Understanding MIPS Value Pathways: Neurology MVPS”—to help you learn more about the changes in reporting requirements so you’re prepared for when this affects you or your practice.

Visit AAN.com/qpp

see all the tools and resources available

an AAN member.

Registry Helps Members Prepare for MIPS Submission in 2023

One of the benefits of the Axon Registry® is providing AAN members with a solution for submitting Merit-based Incentive Payment System (MIPS) reporting to the Centers for Medicare & Medicaid Services. MIPS submission through the Axon Registry offers reporting for three out of the four components of the MIPS program: Quality, Improvement Activities, and Promoting Interoperability. The fourth component, Cost of Care, uses Medicare claims data to calculate performance, which means clinicians and groups do not have to submit additional data to meet this component. Submitting for MIPS via the Axon Registry is free for any Axon Registry participant. As CMS signals a switch from the current MIPS program to MIPS Value Pathways (MVP), the Axon Registry can be a tool to help you understand MVPs.

For MIPS submission, CMS requires practices to submit six quality measures, including one outcome measure or, if no outcome measures apply, the practice must submit a high-priority measure. The AAN recommends practices choose 10 quality measures that are relevant to their patient populations to ensure that at least six of those measures have the required performance data.

The Axon Registry staff provides support to practices throughout the year, including confirming the accuracy of the data on the Axon Registry dashboard and assistance submitting quality measures for MIPS.

Early enrollment in the Axon Registry is recommended for practices wanting to use MIPS submission.

interested in joining the Axon Registry for MIPS submission must do so by the June 30 deadline. Practices that register after June 30 are not guaranteed to be prepared for MIPS submission. To learn more, visit AAN.com/Axon. Contact registry @ aan.com with questions.

Need End-of-year CME? Check out These AAN Education Opportunities!

If you’re looking to meet your end-of-year CME requirements, then look no further. Only AAN members have free and discounted access to a variety of exclusive online CME and self-assessment resources. Browse all the convenient programs and get started fulfilling your requirements today at AAN.com/learn

Free with Membership*

ƒ

Neurology Question of the Day Mobile App

Earn up to 29 self-assessment CME per year by answering short daily questions on topics from multiple neurology subspecialties.

ƒ NeuroSAE®

Complete all editions to earn up to 16 self-assessment CME per year with shorter exams now available quarterly to help neurologists meet the American Board of Psychiatry and Neurology self-assessment and lifelong learning component (part 2) for Continuing Certification.

ƒ Neurology®

Earn CME credits by reading two editor-selected articles per week and completing corresponding online exams.

ƒ AAN Patient Safety Education Program

Learn to identify potential patient safety risks and how to mitigate these risks and improve patient safety and earn 4 self-assessment CME.

Discounted with Membership

ƒ 2022 AAN Conferences—Available On Demand

Listen to on-demand recordings of any or all the AAN’s 2022 conferences including:

Ž Annual Meeting On Demand—200+ CME

Ž Summer Conference On Demand—up to 25.25 CME

Ž Fall Conference On Demand—up to 51.5 CME

Ž APP Neurology Education Series—up to 8 CME

ƒ NeuroReady®

Preparing for the neurology boards? Up for recertification? Onboarding as an APP? Looking for a solid foundational knowledge in neurology? Get ready with these convenient online courses. Choose from the Board Prep Edition, Continuing Certification Edition (up to 15 SA-CME), and

Advanced Practice Provider Edition (up to 12 SA-CME). Group discounts available.

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Continuum® and Continuum® Audio

Earn up to 20 AMA PRA Category 1 Credits™ toward self-assessment CME with each issue of the AAN’s official CME journal. Supplement with Continuum Audio to listen to conversations with Continuum authors and earn CME.

*Free access may vary by membership type

Track Your Progress with NeuroTracker!

Add and edit both your AAN and non-AAN credits, activities, and more—all in a convenient one-stop-shop for tracking CME, self-assessment, Improvement in Medical Practice (PIP), and professional development activities! With NeuroTracker, you can:

Enter your non-AAN activities and credits and upload documentation (certificate of attendance, etc.) to centralize all your information in case of an ABPN audit

View your faculty/director/co-chair evaluations from recent AAN activities

Track your professional activities such as committee work, faculty, and published AAN article

Download and print AAN CME transcripts

Audit report for non-AAN credits entered

View your self-assessment report from select AAN conferences

Note: The AAN is not a certifying board, and members are required to contact the ABPN for the most up-to-date information on individual CC requirements, i.e., ABPN Physician Portal. 

UCNS Approves Neonatal Neurocritical Care for Neurologic Subspecialty Recognition

The United Council for Neurologic Subspecialties (UCNS) has approved Neonatal Neurocritical Care (NNCC) for subspecialty recognition and will soon be accrediting training programs and certifying physicians in this rapidly evolving neurology subspecialty. NNCC provides complex diagnostic testing and

prognostication required to care for the neurologically compromised maternal/ fetal dyad, preterm, or term newborn, and the developing child after discharge from the Neonatal Intensive Care Unit.

The NNCC subspecialty application was sponsored, prepared, and submitted by the Newborn Brain Society (NBS).

The UCNS and NBS are currently identifying subspecialty experts to develop and finalize the subspecialty standards and requirements for fellowship training program accreditation and the certification criteria for physicians.

For more information, visit UCNS.org

December 9 Is Last Day to Register for RITE

The deadline to register for the AAN’s 2023 RITE® (Residency In-service Training Examination) is quickly approaching. Visit AAN.com/RITE before December 9 to secure your residents’ spots. As a reminder, in order to receive the memberonly registration rate of $240, AAN membership dues must be paid, and new member applications (when applicable) must be completed for all Junior members sitting for the exam in advance of exam registration. To check the status of your residents’ AAN membership, please use the personalized link that you used to renew your membership or contact AAN Member Services at (800) 879-1960 or memberservices @aan.com for assistance.

The RITE exam will be administered February 14 through 20, 2023. Each exam question is accompanied by discussions and references for additional study. Some reminders for programs:

ƒ The RITE again will be delivered via a web-based platform, allowing programs flexibility for residents to use their own computers and sit for the exam in a time/location that aligns with your institution’s testing environment and associated guidelines.

ƒ While you will register residents for a specific day during the 5-day testing window February 14–20, 2023, residents are free to take the exam at any time during the testing window.

Institutions are encouraged to follow their own social distancing procedures and limit the number of residents sitting for the exam at one time to ensure safe in-person exam administration.

Preparation Resources for Your Residents

Help your residents prepare for the RITE with the AAN’s convenient online resources: NeuroSAE ( AAN.com/NeuroSAE ) and NeuroReady: Board Prep Edition ( AAN.com/NeuroReadyBP). For questions or information about special pricing on these programs, contact theRITE

aan.com

visit AAN.com/RITE

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.

Latest Advocacy News

ƒ The 2023 Neurology on the Hill application is now open! Join us in Washington, DC, March 5–7, to lay the groundwork for tomorrow’s successes. You don’t need a background in public policy, just passion for making a positive change! The application closes November 21.

ƒ Building on the success of the 2022 Neurology on the Hill, we’re excited to announce H.R. 3173, Improving Seniors’ Timely Access to Care Act, has passed the House of Representatives. Continue this momentum and encourage your senator to pass this bill.

ƒ The AAN recently welcomed Kelly McCone, MPA, Senior Congressional Affairs Manager, to its Washington, DC, office. McCone will contribute to the AAN’s federal advocacy efforts, with a primary focus on congressional relations. McCone joins the team with experience in federal affairs both on and off Capitol Hill.

Issue in Focus

The 2022 midterm elections are right around the corner! On Tuesday, November 8, we’ll head to the polls and choose, among other offices, who will represent us in the United States House and Senate. Between redistricting and retirements, this election will have a huge impact on neurology in the next few years. That’s why, regardless of your party affiliation, it’s so important that you remember to vote!

As you know, it’s not always as simple as walking in the polling place and voting. Are you registered at the correct address? Do you need any identifying information in your state? Can you vote early or absentee? These laws differ state by state, but you can find all the information you need at the National Association of Secretaries of State “Can I Vote” website at nass.org/can-I-vote

Apply by January 20, 2023, for AAN Health Care Equity Scholarship

Inclusion is the reason the AAN was founded. To be an organization that is the home for all neurologists. It is what makes us stronger. To support our goal of being a fully inclusive, deliberately diverse, and anti-racist organization and our core values of Inclusion, Diversity, Equity, Anti-racism, and Social Justice (IDEAS), we are excited to share progress and updates with you.

The AAN is proud to offer the Health Care Equity Scholarship Program. Scholarship recipients will participate in a multifaceted year-round program to continue personal development and create a roadmap aimed at mitigating health care disparities. Selected participants will be part of the third cohort and will develop a project or initiative at their institution addressing or identifying a health care disparity. Participants also will have opportunities to engage with the cohort members, program alumni, and AAN leaders while continuing

Wellness: What Does It Mean to You?

to strengthen their knowledge around health care disparities.

Scholarship recipients will be required to complete a postprogram evaluation and demonstrate their future commitment to inclusion, diversity, equity, anti-racism, and social justice.

AAN members in the US and Canada are eligible to apply for the 10 scholarship spots open for this program by January 20, 2023. To learn more about the components and benefits of the scholarship program or to apply, visit AAN.com/IDEAS 

With the rising rates of physician burnout and early retirement due to the COVID-19 pandemic, the shortage of neurologists is likely higher than the AAN estimate from several years ago of 11 percent at the time and reaching as high as 19 percent by the end of this decade. As a result, the Academy has made reducing burnout and increasing wellness among our members a top priority.

We know that wellness doesn’t just mean yoga and stacking stones. Wellness is all-encompassing. It could be about collaborating with colleagues to promote a healthy workplace culture. Or focusing on what makes you grateful—whether it’s friends, family, your health, or even your patients.

Because your health matters, your Academy is working to reimagine what

wellness means—or could mean—and to rekindle your passion for neurology by preventing future burnout and restoring your resiliency through a variety of resources, events, tips and tricks, and more that will help you thrive both at work and at home.

So, join the conversation on Twitter, tag @AANmember, and tell us what wellness means to you. 

It’s Time to Renew Your Membership for 2023 continued from cover

Trusted AAN clinical practice guidelines, free member publications, and award-winning patient education resources to help you provide up-to-date care

Savings of 30 percent or more on industry-leading in-person and virtual conferences

Opportunity to exchange diverse insight and ideas among 38,000 colleagues from 138 countries representing all facets and subspecialties through more than 60 SynapseSM Member Communities

The chance to add your voice to impactful legislation and regulatory advocacy at the US federal and state level to transform the field of neurology and ensure access to care for patients

More

Visit AAN.com/membership/memberbenefits to see all the ways your membership provides the resources you need to succeed! For more information, contact AAN Member Services at memberservices @ aan.com, (800) 8791960, or (612) 928-6000 (international).

*Benefits vary by member type.

Women Leading in Neurology Program Transforms Graduate’s Career

Bruno’s initial motivation to apply for the program was to create the first multidisciplinary movement disorders center in Hawaii at her institution, the Queen’s Medical Center in Honolulu, as well as start a research program on racial and urban-rural disparity to improve access to care for all people in Hawaii. “After being in private practice for many years, I had a vision of what was needed in the community,” she said. “But I did not feel confident on how I could get there. I did not view myself as a natural leader (if there is even one!) and did not feel I had the skill to build a comprehensive program with many moving parts.”

That was all about to change once Bruno entered the program. “Going in, I thought we would be ‘taught’ a skill, like learning how to play a new musical instrument or new sport,” she said. “I could say that at least that was not what happened to me.”

Like so many graduates of the AAN Leadership Development Programs, Bruno is quick to credit the force behind her transformative process to that of her coaches and mentors: Joanne L. Smikle, PhD, and Caroline M. Tanner, MD, PhD, FAAN, who “pushed me to have a deep reflection and an honest assessment about myself first. After that, the ability to reflect extended into assessing the situation and others.”

As part of the program, Bruno and her fellow colleagues learned about skills like mindfulness and emotional intelligence, “Specificially for me, the transformative experience was developing ‘self-awareness,’ she said. “What I learned about myself was that I feared conflicts and disagreements. But leadership is about working with others; communicating my vision and building a team to achieve something bigger than ourselves. And when we work with others, conflicts and disagreements will inevitably arise. What changed was that rather than avoiding them, I started to assess the situation, and view challenges as opportunities. To do this, I had to first acknowledge my emotion ‘as is’ and try to understand my own bias and motivations. Once I recognized them, I could refocus on my values, priorities, and goals and come up with the best appropriate next steps.”

With Tanner’s guidance, Bruno was able to restart her important research project. “In this short period of time—less than a year and half since meeting her—I had three abstracts accepted, three papers published, and received a three-year grant from the Michael J. Fox Foundation, which allowed us to

hire a research coordinator and do more research,” she said. “We also received certification as Hawaii’s first Parkinson’s Foundation’s Comprehensive Care Center, and we finally convinced the hospital to approve purchase of MR-guided focused ultrasound. We will be starting a movement disorder fellowship. And I am happy to report that we are building the multidisciplinary movement center that I dreamt of! I wake up excited to go to work to see what awaits me.”

Bruno says her colleagues now view her as an effective leader and she has been invited to take part in various leadership opportunities not only within her department and hospital, but within her community.

Added Bruno, “The WLN program taught me to see the complex world in a new lens. I learned to be resilient even in the face of small failures and setbacks. I learned to make challenges into opportunities. I learned how to use team members’ strength. And above all, I met nine wonderful fellow women neurologists who I can confide to and will be my lifelong friends.”

you to the organizations supporting this program in part:

AstraZeneca Rare Disease

Inc.

Biosciences, Inc.

“I was so thrilled to be selected for the 2021 Women Leading in Neurology (WLN) Program, but at the time, I had no idea this one program would change my career in such a transformative way.”

—Michiko Kimura Bruno, MD, FAAN Bruno

2023 Annual Meeting Registration Now Open! continued from

2022 Attendees Weigh in on Their Favorite Meeting Moments

“ It’s one of the best conferences in the whole country, really in the whole world. You can really get information on many conditions all in one meeting. I practice general neurology, so I need to cover many areas.”

Luis J. Forastieri, MD, Solo practitioner neurologist, Caguas, Puerto Rico

“

I’m really enjoying meeting a lot of likeminded people and the diversity, both geographically and in experience—students, program directors, residents, fellows, catching up with alumni from my program who are doing residency in the US.”

Ibrahim Laswi, Third-year medical student, Weill Cornell Medicine—Qatar

“ I love it. Everyone has been really kind and welcoming. I’m overwhelmed by how much amazing opportunity there is and everything going on here. Everything you could think of in neurology. I even saw a session on neurology and poetry. You have the creative and the intellectual.”

Khadija Awais, MBBS, Resident, University of Tennessee, Memphis, First-time attendee

“

It’s the mecca of neurological meetings and being active in the community is important to us. We heard it was the fun conference. We heard it was the best one when we were in medical school. There’s a talk on the Neurology of Wine Tasting—how could you not? It combines learning with fun.”

From left, Fellow Anuj Dhir, MD, and residents Joaquin Vizcarra, MD, and David Landzberg, MD, Emory University, Atlanta, First-time attendees

“

[Highlights include] The plethora of information and opportunity to learn. The vast array of topics and opportunity to learn about so many diseases.”

Alicia Harvey, PharmD, Miramar, Florida, First-time attendee 

FOR PATIENTS WITH CERTAIN VHL-ASSOCIATED TUMORS

DISCOVER WELIREG TM THE FIRST AND ONLY SYSTEMIC TREATMENT 1,2

WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Simple, once-daily, oral dosing

• The recommended dosage is 120 mg once daily until progression of disease or unacceptable toxicity. WELIREG may be taken with or without food.

Not actual size.

1x daily

SELECTED SAFETY INFORMATION

WARNING: EMBRYO-FETAL TOXICITY

• Exposure to WELIREG during pregnancy can cause embryo-fetal harm.

• Verify pregnancy status prior to the initiation of WELIREG.

• Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

Before prescribing WELIREG, please read the additional Selected Safety Information on the following pages and the adjacent Brief Summary of the Prescribing Information, including the Boxed Warning about embryo-fetal toxicity.

WELIREG

TUMOR SHRINKAGE ACROSS CERTAIN TUMORS IN PATIENTS WITH VHL DISEASE

49%

ORRa

(95% CI, 36–62) (n=30/61)b

All responses were partial responses (complete response, 0%)b

Median DOR was not reached (range of ongoing responses: 2.8+ to 22+ months)

56% of patients who responded (n=17/30) maintained a response that lasted ≥12 months

Patient Subgroups

With CNS hemangioblastomas (n=24)

63%

ORRa (95% CI, 41–81) (n=15/24)c

Complete response, 4%; partial response, 58%

Median DOR was not reached (range of ongoing responses: 3.7+ to 22+ months)

73% of patients who responded (n=11/15) maintained a response that lasted ≥12 months

With pNET (n=12)

83%

ORRa (95% CI, 52–98) (n=10/12)c

Complete response, 17%; partial response, 67%

Median DOR was not reached (range of ongoing responses: 11+ to 19+ months)

50% of patients who responded (n=5/10) maintained a response that lasted ≥12 months

Complete response defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response defined as ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline.3

Median DOR could not be estimatedd since the majority of patients who responded to treatment maintained their response (did not experience disease progression per RECIST v1.1) at the time of data cutoff.4

aMeasured by radiology assessment using RECIST v1.1 as assessed by IRC.

bAll patients with a response were followed for a minimum of 18 months from the start of treatment.

cNumber of patients with measurable solid lesions, based on IRC assessment. dBy Kaplan-Meier method.

+ Denotes ongoing response.

DOR = duration of response; RECIST v1.1 = Response Evaluation Criteria

In Solid Tumors v1.1; ORR = objective response rate; CI = confidence interval.

STUDY DESIGN: Patients (N=61) had VHL-associated RCC diagnosed based on a VHL germline alteration and with at least 1 measurable solid tumor (as defined by RECIST v1.1) localized to the kidney. Patients had other VHL-associated tumors, including CNS hemangioblastomas and pNET. CNS hemangioblastomas and pNET in these patients were diagnosed based on the presence of at least 1 measurable solid tumor in brain/spine or pancreas, respectively, as defined by RECIST v1.1 and identified by central independent review committee (IRC). The study excluded patients with metastatic disease. Patients received WELIREG 120 mg once daily until progression of disease or unacceptable toxicity. Median age of patients was 41 years (range 19 to 66 years). Of the 61 patients included in the study, 3.3% were age 65 years or older, and 53% were male. Ninety percent were White, 3.3% were Black or African-American, 1.6% were Asian, and 1.6% were Native Hawaiian or other Pacific Islander. Eighty-two percent had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 16% had an ECOG PS of 1, and 1.6% had an ECOG PS of 2; and 84% had VHL Type I Disease. The median diameter of RCC target lesions per IRC was 2.2 cm. Median time from initial radiographic diagnosis of VHL-associated RCC tumors that led to enrollment to the time of treatment with WELIREG was 17.9 months (range: 2.8 to 96.7 months). Seventy-seven percent of patients had prior surgical procedures for RCC. The major efficacy end point for the treatment of VHL-associated RCC was ORR measured by radiology assessment using RECIST v1.1 as assessed by IRC. Additional efficacy end points included DOR and time to response (TTR).

Learn more at www.welireghcp.com

SAFETY

Anemia

• WELIREG can cause severe anemia that can require blood transfusion. In Study 004, anemia occurred in 90% of patients and 7% had Grade 3 anemia. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months). In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, anemia occurred in 76% of patients and 28% had Grade 3 anemia.

• Monitor for anemia before initiation of and periodically throughout treatment. Closely monitor patients who are dual UGT2B17 and CYP2C19 poor metabolizers due to potential increases in exposure that may increase the incidence or severity of anemia.

• Transfuse patients as clinically indicated. For patients with hemoglobin (Hb) <9 g/dL, withhold WELIREG until Hb ≥9 g/dL, then resume at reduced dose or permanently discontinue depending on the severity of anemia. For life-threatening anemia or when urgent intervention is indicated, withhold WELIREG until Hb ≥9 g/dL, then resume at a reduced dose or permanently discontinue.

• The use of erythropoiesis stimulating agents (ESAs) for treatment of anemia is not recommended in patients treated with WELIREG.

Hypoxia

• WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. In Study 004, hypoxia occurred in 1.6% of patients. In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, hypoxia occurred in 29% of patients; 16% were Grade 3 hypoxia.

• Monitor oxygen saturation before initiation of and periodically throughout treatment. For decreased oxygen saturation with exercise (eg, pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose. For decreased oxygen saturation at rest (eg, pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a health care provider.

Embryo-Fetal Toxicity

• Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman.

• Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Adverse Reactions

• In Study 004, serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

• WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

• Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

• Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

• The most common adverse reactions (≥25%) were decreased hemoglobin (93%), anemia (90%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

• In Study 001, a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose, the following additional adverse reactions have been reported: edema, cough, musculoskeletal pain, vomiting, diarrhea, and dehydration.

Drug Interactions

• Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

• Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

Lactation

• Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

• WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

• Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

• Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown.

Pediatric Use

• Safety and effectiveness of WELIREG in pediatric patients under 18 years of age have not been established.

Before prescribing WELIREG, please see the adjacent Brief Summary of the Prescribing Information, including the Boxed Warning about embryo-fetal toxicity.

Summary

the

Information for

40 mg tablets, for oral use

WARNING: EMBRYO-FETAL TOXICITY

• Exposure to WELIREG during pregnancy can cause embryo-fetal harm.

• Verify pregnancy status prior to the initiation of WELIREG.

• Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective.

INDICATIONS AND USAGE

WELIREG is indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of WELIREG is 120 mg administered orally once daily until disease progression or unacceptable toxicity. WELIREG should be taken at the same time each day and may be taken with or without food.

Advise patients to swallow tablets whole. Do not chew, crush, or split WELIREG prior to swallowing.

If a dose of WELIREG is missed, it can be taken as soon as possible on the same day.

Resume the regular daily dose schedule for WELIREG the next day. Do not take extra tablets to make up for the missed dose.

If vomiting occurs any time after taking WELIREG, do not retake the dose. Take the next dose on the next day.

Dosage Modifications for Adverse Reactions

Dosage modifications for WELIREG for adverse reactions are summarized in Table 1.

The recommended dose reductions are:

• First dose reduction: WELIREG 80 mg orally once daily

• Second dose reduction: WELIREG 40 mg orally once daily

• Third dose reduction: Permanently discontinue Table 1: Recommended Dosage Modifications for Adverse Reactions

Adverse ReactionSeverity

Hemoglobin <9 g/dL or transfusion indicated

Dosage Modification

• Withhold until hemoglobin ≥9g/dL.

• Resume at reduced dose or discontinue depending on the severity of anemia.

Anemia

Life-threatening or urgent intervention indicated

Decreased oxygen saturation with exercise (e.g., pulse oximeter <88%)

• Withhold until hemoglobin ≥9g/dL.

• Resume at a reduced dose or permanently discontinue.

• Consider withholding until resolved.

• Resume at the same dose or at a reduced dose depending on the severity of hypoxia.

The use of erythropoiesis stimulating agents (ESAs) for treatment of anemia is not recommended in patients treated with WELIREG. For patients treated with WELIREG who develop anemia, the safety and effectiveness for use of ESAs have not been established. Randomized controlled trials in patients with cancer receiving myelosuppressive chemotherapy with ESAs have shown that ESAs increased the risks of death and serious cardiovascular reactions, and decreased progressionfree survival and/or overall survival. See the prescribing information for ESAs for more information.

Hypoxia

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

In Study 004, hypoxia occurred in 1.6% of patients. In another clinical trial [Study 001 (n=58)] in patients with advanced solid tumors who received the same dosage of WELIREG, hypoxia occurred in 29% of patients, including Grade 3 hypoxia in 16%.

Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same dose or at a reduced dose.

For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening hypoxia or for recurrent symptomatic hypoxia, permanently discontinue WELIREG.

Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.

Embryo-Fetal Toxicity

Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of belzutifan to pregnant rats during the period of organogenesis caused embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations at maternal exposures ≥0.2 times the human exposures (AUC) at the recommended dose of 120 mg daily. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with WELIREG and for 1 week after the last dose, since WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed elsewhere in the labeling:

• Anemia

• Hypoxia

Clinical Trials Experience

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

The safety of WELIREG was evaluated in an open-label clinical trial (Study-004) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney. Patients received WELIREG 120 mg orally once daily. The median duration of exposure to WELIREG was 68 weeks (range: 8.4 to 104.7 weeks).

Hypoxia

Decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated

Life-threatening or recurrent symptomatic hypoxia

Other Adverse Reactions Grade 3

Grade 4

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Anemia

• Withhold until resolved.

• Resume at reduced dose or discontinue depending on the severity of hypoxia.

• Permanently discontinue.

• Withhold dosing until resolved to ≤ Grade 2.

• Consider resuming at a reduced dose (reduce by 40 mg).

• Permanently discontinue upon recurrence of Grade 3.

• Permanently discontinue.

Serious adverse reactions occurred in 15% of patients who received WELIREG, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

Permanent discontinuation of WELIREG due to adverse reactions occurred in 3.3% of patients. Adverse reactions which resulted in permanent discontinuation of WELIREG were dizziness and opioid overdose (1.6% each).

Dosage interruptions of WELIREG due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.

WELIREG can cause severe anemia that can require blood transfusion. In Study 004, anemia occurred in 90% of patients and 7% had Grade 3 anemia. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months). In another clinical trial [Study 001 (n=58)] in patients with advanced solid tumors who received the same dosage of WELIREG, anemia occurred in 76% of patients and 28% had Grade 3 anemia. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. Closely monitor patients who are dual UGT2B17 and CYP2C19 poor metabolizers due to potential increases in exposure that may increase the incidence or severity of anemia.

Transfuse patients as clinically indicated. For patients with hemoglobin <9g/dL, withhold WELIREG until ≥9g/dL, then resume at reduced dose or permanently discontinue WELIREG, depending on the severity of anemia. For life threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥9g/dL, then resume at a reduced dose or permanently discontinue WELIREG.

Brief Summary of the Prescribing Information for WELIREG™ (belzutifan)

mg tablets,

oral use

2 summarizes the adverse reactions reported in patients treated with WELIREG in Study 004.

Table 2: Adverse Reactions Occurring in ≥10% of Patients Who Received WELIREG in Study 004 Adverse Reaction

WELIREG N=61

Grades*

Blood and Lymphatic

Anemia

General

Fatigue†

System

Gastrointestinal

Nausea

Eye Disorders

impairment#

Infections

Upper respiratory tract infectionÞ

Thoracic and Mediastinal

Musculoskeletal and Connective Tissue

Arthralgia

Vascular

Hypertension

and Nutrition

increased

per

CTCAE

and asthenia

headache and migraine

dizziness and vertigo

3-4

Hormonal Contraceptives

Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

Based on findings in animal studies, WELIREG can cause fetal harm when administered to a pregnant woman. There are no available data on the use of WELIREG in pregnant women to inform the drug-associated risk. In an animal reproduction study, oral administration of belzutifan to pregnant rats during the period of organogenesis caused embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations at maternal exposures ≥0.2 times the human exposure (AUC) at the recommended dose of 120 mg daily (see Data). Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. 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.

Data

Animal Data

In a pilot embryo-fetal development study, pregnant rats received oral doses of 6, 60, or 200 mg/kg/day of belzutifan during the period of organogenesis. Belzutifan caused embryo-fetal lethality at doses ≥60 mg/kg/day (approximately 1 time the human exposure at the recommended dose based on AUC). Reduced fetal body weights, fetal rib malformations, and reduced skeletal ossification occurred at doses of 6 and 60 mg/kg/day (approximately ≥0.2 times the human exposure at the recommended dose based on AUC).

Lactation

Risk Summary

There are no data on the presence of belzutifan or its metabolites in human milk or their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

WELIREG can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

Contraception

Females

abdominal discomfort, abdominal pain, abdominal pain upper and abdominal pain

visual impairment, vision blurred, central retinal

occlusion and retinal

bronchitis, sinusitis, upper respiratory tract infection, and viral upper respiratory infection

3 summarizes the laboratory abnormalities in Study 004.

Table 3: Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients Who Received WELIREG in Study 004

Laboratory Abnormality*

Chemistry

Increased creatinine

Grades 1-4

Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective.

Males

Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

WELIREG (n=61)

Infertility

Grades 3-4

Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential. The reversibility of the effect on fertility is unknown.

Pediatric Use

glucose

4.9 Increased ALT

0 Increased AST

calcium (corrected)

phosphate

Hematology

0

Safety and effectiveness of WELIREG have not been established in pediatric patients. Geriatric Use

Of the patients who received WELIREG in Study 004, 3.3% were ≥65 years old. Clinical trials of WELIREG did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.

Renal Impairment

Decreased hemoglobin

7 Decreased leukocytes

denominator used to calculate

Other Clinical Trials Experience

0

In Study 001 (NCT02974738), a clinical trial in patients with advanced solid tumors (n=58) treated at the recommended dose in which the median age of enrollment was 62.5 years (range 39-75) and the median number of prior therapies for cancer was 3 (range 1-9), the following additional adverse reactions have been reported following administration of WELIREG at the recommended dosage: edema, cough, musculoskeletal pain, vomiting, diarrhea, and dehydration.

DRUG INTERACTIONS

Effects of Other Drugs on WELIREG UGT2B17 or CYP2C19 Inhibitors

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions of WELIREG. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

Effect of WELIREG on Other Drugs

Sensitive CYP3A4 Substrates

Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A substrates, which may reduce the efficacy of these substrates. The magnitude of this decrease may be more pronounced in patients who are dual UGT2B17 and CYP2C19 poor metabolizers. Avoid coadministration of WELIREG with sensitive CYP3A4 substrates, for which minimal decrease in concentration may lead to therapeutic failures of the substrate. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information.

No dosage modification of WELIREG is recommended in patients with mild (eGFR 60-89 mL/min/1.73 m2 estimated by MDRD) and moderate (eGFR 30-59 mL/min/1.73 m2) renal impairment. WELIREG has not been studied in patients with severe (eGFR 15-29 mL/min/1.73 m2) renal impairment.

Hepatic Impairment

No dosage modification of WELIREG is recommended in patients with mild [total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or total bilirubin >1 to 1.5 x ULN and any AST] hepatic impairment. WELIREG has not been studied in patients with moderate or severe hepatic impairment (total bilirubin >1.5 x ULN and any AST).

Dual UGT2B17 and CYP2C19 Poor Metabolizers

Patients who are dual UGT2B17 and CYP2C19 poor metabolizers have higher belzutifan exposures, which may increase the incidence and severity of adverse reactions of WELIREG. Closely monitor for adverse reactions in patients who are dual UGT2B17 and CYP2C19 poor metabolizers.

OVERDOSAGE

There is no specific treatment for WELIREG overdose. In cases of suspected overdose, withhold WELIREG and institute supportive care. Grade 3 hypoxia occurred at dosages of 120 mg twice a day and Grade 4 thrombocytopenia occurred at dosages of 240 mg once daily (approximately 2 times the recommended dosage).

For more detailed information, please read the Prescribing Information. uspi-mk6482-t-2108r000 Revised: 08/2021

Copyright © 2022 Merck & Co., Inc., Kenilworth, NJ, USA and its affiliates All rights reserved.

Free Neurology: Education Online Journal Debuts continued from cover

Editor Roy E. Strowd III, MD, MEd, MS, FAAN, said, “We are tremendously excited about the first issue of Neurology: Education. This issue includes an important editorial from Dr. Sharon Lewis on the status of pipeline programs in neurology and their importance in addressing equity, diversity, and inclusion in the field.”

Strowd said the issue will appeal to neurological educators at multiple levels of instruction. “The curriculum innovation articles present new approaches to an inter-institutional online seminar series for teaching fellows, a comparison of life-actors vs mannequins for teaching neurological emergencies to residents, and how to train neurology faculty to complete quality narrative evaluations. Three

education research articles focus on the theme of how to develop the next generation of neurologists by developing interest in neurology early for pre-health and medical students.”

Accompanying this issue are commentaries on the Neurology: Education blog, including an inaugural “The Learner Perspective” editorial which presents a learner’s experience in going through one of the educational interventions described in this issue.

Read the new issue or learn more about Neurology: Education and how to submit articles at Neurology.org/NE. Comments, feedback, and questions can be sent to NEjournal @ neurology.org

AMERICAN BRAIN FOUNDATION

Spotlight on Next Generation Research Grant Recipient: Sanjana Shellikeri, PhD

Shellikeri

Improves

Real is Real

StudyComparing

Patients

Manikin

Sanjana Shellikeri, PhD, is a 2022 Next Generation Research Grant recipient for her work developing speech assessment tools that will better enable doctors to screen patients for speech impairment indicative of ALS, Parkinson’s, and Lewy body dementia. By developing screening tools based on “real life” natural speech, Shellikeri’s research

help physicians

more accurate prognoses and specific treatments to manage

About Next Generation Research Grants

Offered in collaboration with the AAN, the Foundation’s Next Generation Research Grants fund and support a broad range of innovative research across many different areas of neurologic disease, in turn advancing a more comprehensive view of the brain and enabling the identification of new biomarkers, risk factors, treatments, and cures. To date, the Next Generation Research Grants have provided millions of dollars to fund the innovative research of promising early-career investigators— with more than 86 percent of past recipients going on to secure funding from the NIH and other national entities.

NOVEMBER

Opportunity for BC/BE Neurologist with MS Fellowship to Develop and Grow MS Practice—Mercy Health Services —Baltimore, Maryland

A multispecialty Neurology group in Baltimore is looking to hire a multiple sclerosis neurologist to join our group of 4 neurologists at Mercy Medical Center. We are seeking a physician that is excited about developing and growing a MS practice. This is your opportunity to focus on your neurology subspecialty, Multiple Sclerosis, and make a real difference in your community. You will be busy immediately as there is an excellent primary care and neurology referral base. There is a significant demand for this specialty in our area. There is very strong subspecialty support and a full range of services available for patients and referrals. This position is primarily an outpatient position. Candidates must be board certified or board eligible in neurology and have either training or experience with multiple sclerosis to qualify. In addition to a competitive

DECEMBER

compensation, you will be offered medical/dental/vision benefits, life insurance, long-term disability, a retirement plan with match, CME stipend, vacation time, and a wonderful work environment. For more information, please call Mary Beth Coyne at (410) 659-2824 or send your CV to mcoyne@ mdmercy.com. Join a collegial group of neurologists in Baltimore, Maryland. Subspecialty focus on multiple sclerosis neurology. Must be board eligible/certified in neurology with a multiple sclerosis fellowship. On-site infusion center, MRI, CT, other imaging in satellite, multispecialty location. Mercy Medical Center is located in downtown Baltimore, but also offers services in our satellite locations in Baltimore County, Anne Arundel County and Howard County. On site infusion and MRI at our Baltimore County location, this will be the primary location for this physician. Baltimore is a culturally diverse community that offers all of the amenities of a large city. This position offers the ability to really make a difference in the community.

JANUARY

January 20

January 31

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 January 2023 print edition of AANnews must be submitted by December 1, 2022. The same deadline applies to changes/cancellations.

The American Academy of Neurology reserves the right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.

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