In this issue: Measures to increase gene therapy access, new state 340B data, proposed CMS changes, and more.

December 3, 2024

Welcome to NPC This Week! We hope you'll join us each week for a look-ahead at the policy, research, and industry conversations that matter to the future of biopharmaceutical innovation. The DMs are open if you have suggestions — and please share with your network.

- Michael Pratt, Devon Bortz, and Haley McKeefer

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NPC Highlights

Potential Measures to Widen Gene Therapy Access: Many patients face challenges in accessing innovative cell and gene therapy treatments. Laura Joszt of Managed Healthcare Executive recently reviewed a new NPC analysis that holistically examines these unique circumstances and offers potential solutions to address access barriers.

• Employers Struggle With Coverage: Employers are still grappling with fitting innovative gene therapies into both traditional and novel models of reimbursement in order to widen access for enrollees, Bloomberg Law reports.

Value Viewpoint: In her latest "Value Viewpoint," NPC Chief Strategy Officer Kimberly Westrich spotlights a Value in Health article that estimates the indirect costs associated with Alzheimer’s disease and a literature review examining how increased costs to patients, through copays, co-insurance, and deductibles, impact how use and access healthcare services. Notably, authors found that increased "utilization management" isn't driving more efficient — or value-based — healthcare. 

Industry News

340B in Minnesota: Minnesota hospitals participating in the federal 340B Drug Pricing Program generated at least $630 million in net revenue last year, according to afirst-of-its-kind report from the Minnesota Department of Health.

• More Context: Due to a gap in state statute, Minnesota was not able to gather data on office-administered Part B drugs from providers. Thus, the state characterized the topline figure of $630 million in profits as a “significant underestimate.”

CMS Proposes to Codify IRA Provisions: The Centers for Medicare & Medicaid Services has proposed numerous changes to Medicare Part D for contract year 2026, including codifying guidance provisions from the Inflation Reduction Act (IRA) to establish the Medicare Prescription Payment Plan. Additionally, the agency proposed that Part D plan sponsors must provide enrollees with broad access to generics, biosimilars, and “any other lower-cost drugs” to incentivize reduced costs when “medically appropriate.”

• Coverage of GLP-1s: Among the proposed changes, CMS proposed to expand coverage of anti-obesity drugs.

ICYMI

Makary Nominated as FDA Commissioner: POLITICO reports that President-elect Donald Trump will nominate Dr. Martin Makary, a surgeon at the Johns Hopkins Hospital, to lead the FDA. STAT News and Endpoints News share reactions from scientists and industry executives.

Changes to User Fee Cycle: Pink Sheet’s Sarah Karlin-Smith explores how the incoming Trump administration could revisit the FDA’s prescription drug user fee cycle to “lessen the influence” of the process on agency activities.

Oz Nominated as CMS Administrator: Trump will nominate Dr. Mehmet Oz, a TV personality and licensed surgeon, to be the head of CMS. Bloomberg Law and MM+M explore how the nomination may shape the future of the agency, including possible impacts on the Medicare DPNP.

Concentration in Commercial Insurance Markets: The American Medical Association released its annual report on concentration in commercial insurance markets, which can limit competition and consumer choice in medical coverage. Authors found that nearly a decade after their first report was published in 2014, 95% of metropolitan statistical area-level markets were highly concentrated in 2023, per federal standards. 

New Research on Medigap and Medicare Advantage: New research published in Health Affairs Scholar suggests that beneficiaries who receive a physician-administered drug are more likely to disenroll from Medicare Advantage in favor of traditional coverage through Medicare Part D and the Medigap program. The findings suggest that Medicare Advantage coverage falls short for patients with greater medical needs and that guaranteed access to Medigap may impact patient access to physician-administered drugs.

Advocates Push for Copay Accumulators Rule: Advocates with the HIV + Hepatitis Policy Institute are urging the current Administration to bar insurers from using copay accumulators before January.

“We Shouldn't Need to Be Insurance Experts”: In an op-ed for USA Today, caregiver Kelsey Denham shares her family’s story of navigating the complex system of insurance coverage for her son’s neurology care.

Mark Your Calendar

January 13-16: NPC President and CEO John O’Brien will speak at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. This premier investment symposium connects global industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community.