Spotlight on Market Access

Drugs in the Medicare price negotiation process will be at a disadvantage in Part D plans because their lack of manufacturer rebates and discounts will mean lower profits for plans and more pressure on premiums relative to competitors.

The realization is more dreary news for products that end up in the crosshairs of the Inflation Reduction Act (IRA) pricing process, even though the law requires Part D plans to cover negotiated drugs. There is no requirement that plans put those products on a preferred formulary tier, nor are there limits on utilization management tools like prior authorization or step therapy that plans can impose.

When then-President Barack Obama signed the Affordable Care Act (ACA) into law on March 23, 2010, he established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved almost 50 biosimilars, with about one-fifth of those gaining interchangeable status. That distinction, however, has been increasingly under fire, most recently in President Biden’s fiscal year (FY) 2025 budget, which proposes eliminating the interchangeability designation entirely. That could help boost uptake of biosimilars, resulting in prescription drug savings, say some industry experts.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

When the FDA approved Novo Nordisk’s Wegovy (semaglutide) for reducing the risk of serious heart problems, it paved the way for Medicare Part D plans to cover the drug. Industry experts also predict that the drug’s expanded indication will pressure more commercial insurers and their plan-sponsor clients to cover the pricey — and increasingly popular — medication.

“The pressure is just going to be too much” for commercial plans to avoid broadening their GLP-1 coverage, says Debra Devereaux, principal and chief pharmacy/clinical officer at Rebellis Group. However, she cautions that there may not be many significant coverage-policy changes this year.

Artificial intelligence (AI), drug shortages and cell and gene therapies are just a few of the areas on which the FDA is focusing during a major reorganization. Those were some of the topics that FDA Commissioner Robert Califf, M.D., discussed with Mike Tuffin, president and CEO of AHIP, at the insurer trade group’s 2024 Medicare, Medicaid, Duals & Commercial Markets Forum, held March 12 through 14 in Baltimore.

When asked his vision for the FDA in 2024 and beyond, Califf responded that 2024 priorities were different because it’s an election year, and the agency’s priorities are “tied to the administration that’s in place.”

Founded in Dayton, Ohio, in 1989, CareSource is a not-for-profit health insurer that serves Medicaid, Medicare-Medicaid dual eligibles and Affordable Care Act (ACA) exchange members in six states, though Ohio remains its largest market. The insurer in recent years has faced a rocky road growing its Medicaid presence — it lost out on an Iowa contract, and its successful bid in Mississippi is held up by a legal standoff. CareSource has a pending Medicaid bid in Kansas but may be looking to the exchanges for faster expansion. The insurer in February struck an affiliation deal with Brookfield, Wis.-based Common Ground Healthcare Cooperative, one of the few remaining ACA CO-OP plans, which are governed by their members. Common Ground currently serves about 60,000 members.