Highlights from a Mid-Year Forum 2019 session on drug policy changes from the Trump administration, moderated by American Academy of Ophthalmology President George Williams, MD.
Abstract
As American consumers call for lower cost pharmaceutical drugs, federal policymakers are committed to identifying solutions to slow rising drug spending. The administration and Congress are considering new policies that could have substantial impacts for ophthalmology, with expensive Medicare Part B drugs a top target.
The session at Mid-Year Forum 2019 focused on the administration’s drug policy changes, as well as congressional initiatives to address challenges in this arena. Important perspectives were shared, by the Department of Health and Human Services, Centers for Medicare & Medicaid Services, ophthalmology and the broader stakeholder community, on how to ensure patient access to critical treatments while also controlling costs and maintaining incentives to promote pharmaceutical innovations.
Background Information
As American consumers call for lower-cost pharmaceutical drugs, federal policymakers are committed to identifying policy solutions to slow rising drug spending. The Administration and Congress are considering new policies that could have substantial impacts for ophthalmology, with expensive Medicare Part B drugs a top target. As these policies are implemented and considered, the Academy is working to educate the membership on the potential impact while simultaneously advocating against federal policy that is not in the best interest of ophthalmology patients.
Summary of Comments from Guest Speakers
George Williams, MD, president, American Academy of Ophthalmology
Moderator
Dr. Williams opened the session by outlining the purpose of Mid-Year Forum for attendees and thanking participants for their willingness to discuss important challenges and issues related to drug spending. Dr. Williams introduced Rep. Kurt Schrader (D-Ore.) to provide his perspective on congressional efforts to address drug prices.
Rep. Kurt Schrader, Energy & Commerce Committee, United States House of Representatives
Rep. Schrader pointed out that while the media is focused on hot political topics, he and his colleagues in Congress are working on solutions to important issues, including drug pricing. He discussed his own efforts to promote bills to increase competition, end gaming by drug manufacturers, and to make drugs more affordable. He highlighted that the Energy & Commerce Committee, which he is a member of, recently passed six bills out of the committee on the issue of drug pricing. Rep. Schrader also mentioned his work to address issues impacting ophthalmology, including drug shortages. He closed his remarks taking questions from the audience on global budgeting, addressing high deductibles and pharmacy benefit managers.
Perspective on Trump Administration Drug Spending Proposals
Joel White, president and CEO of Council for Affordable Health Coverage
Mr. White highlighted various actions by the administration on drug spending, including new proposed rules and regulations. He informed attendees that both political parties were invested in addressing drug prices and that a major legislative package could happen this year. He highlighted actions that have occurred that impact ophthalmology, including Medicare Advantage step therapy authority in Part B, Food and Drug Administration clearing the generic backlog and eliminating pharmacy gag-clauses. Mr. White also highlighted potential actions related to Average-Sale Price (ASP) and linking drug pricing to costs internationally.
Drug Spending and Perspective of Retina Specialists
Sunil Gupta, MD, CEO, USRetina
Dr. Gupta opened by highlighting need and ongoing efforts to improve quality, affordability and access. He discussed efforts within ophthalmology to advance all three, including new treatments for macular degeneration, the IRIS registry and prevention of blindness. Ophthalmology has shown clear efforts to address affordability without government mandates and has also focused on improved outcomes. Dr. Gupta also discussed step therapy and how it is counter-productive to providing quality care to Medicare beneficiaries. He encouraged attendees to continue advocating for the profession of ophthalmology and against proposals that would negatively impact our patients.
Industry Perspectives on Drug Development and Pricing
Mark Blumenkranz, MD, MMS, chairman and professor emeritus, Byers Eye Institute, Stanford University
Dr. Blumenkranz opened his talk by discussing several headwinds and tailwinds that are impacting drug pricing and drug spending in 2020 and beyond. This included discussion of public and media perception of drug makers and market, as well as ophthalmology drugs coming off patent and new biologics coming to market. He discussed the evolving landscape of anti-VEGF therapies, including biosimilars attempting to come to market. He also discussed that many companies who sought to bring a new ophthalmology therapy to market have failed, despite heavy investments in development.
AAO Advocacy and Perspectives on Drug Spending
David Glasser, MD, Academy Secretary for Federal Affairs
Dr. Glasser highlighted the challenge of drug spending under Medicare, informing attendees that prescription drug spending was expected to grow 6.3% annually through 2026. He stated that ophthalmology has multiple drugs at the top for costs within Medicare Part B, which is why regulatory and legislative action on Part B is impacting ophthalmology. He outlined various solutions that have been proposed that impact ophthalmology, including prior authorization, step therapy, moving Part B drugs to Part D and reviving the competitive acquisition program.
Dr. Glasser told attendees that these efforts are top priorities for the Academy’s advocacy efforts. Dr. Glasser closed with a brief discussion of generic drug shortages and how pricing is linked to those issues.
High Priority Objectives
- Continue to educate the Academy membership about new drug pricing policies that impact ophthalmologists and their patients.
- Continue the Academy’s engagement with Congress and the administration on challenges and new proposals related to drug spending.
Read the full Mid-Year Forum 2019 Report: View as webpages or as a PDF (360 KB).