Spotlight on Market Access

Cigna Corp.-owned Express Scripts removed 43 medications from its 2023 National Preferred Formulary, while the other two major PBMs — CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx — cut 23 and 19 drugs from their formularies in 2023, respectively. Since 2014, the three PBMs have dramatically increased the number of excluded drugs, but the growth rate of exclusions has slowed for the second year in a row.

On Sept. 1, CMS will publish its list of 10 Medicare Part D drugs that it has chosen for negotiations for 2026, the first year that negotiated prices will be in effect via the Inflation Reduction Act (IRA). But a lot of unknowns exist around the law, including how CMS will determine the drugs up for negotiation. During an Evercore ISI webinar held Jan. 30, analysts broke down this aspect of the IRA and shared the drugs and manufacturers they expect to be impacted.

“We are looking at an escalating number of drugs subject to negotiation starting in 2026,” noted Tobin Marcus, policy analyst at Evercore ISI. “There’s been some misunderstanding about the fact that these numbers are cumulative.” So while 2026 will have 10 drugs up for negotiation, 2027 will have an additional 15 Part D drugs for a total of 25 for the year. The following year will see an additional 15 Part D and Part B drugs, and then starting in 2029 and later years, 20 more Part D and Part B agents will be up for negotiation.

With more than 1 million members, Blue Cross and Blue Shield of Louisiana is the largest Blues affiliate in its home state and the second-largest insurer overall, behind UnitedHealthcare. Founded in 1934 as the Hospital Service Association of New Orleans, BCBSLA is now the 19th largest Blues insurer in the U.S. While the majority of its customers are employer groups, the insurer also offers coverage on the Affordable Care Act exchanges in Louisiana, as well as Medicare Advantage (MA) plans. It dominates Louisiana’s individual and group risk-based commercial markets, holding 88.5% and 74.5% of overall market share, respectively. Cigna Corp.’s Express Scripts currently serves as BCBSLA’s pharmacy benefits manager.

The FDA’s accelerated approval pathway will see major changes following December’s passage of the Consolidated Appropriations Act, 2023 (2023 CAA), the latest version of the annual legislation that funds the federal government. Experts say that the changes should force drugmakers to be more diligent about proving the clinical value of their early-stage pharmaceuticals — as long as the FDA uses its enforcement powers.

Stakeholders across the health care system have criticized the FDA’s approach to accelerated approval in recent years. The agency’s critics say that it has taken a lax approach, granting accelerated approval to drugs of dubious clinical value, which ultimately costs the health care system billions. In particular, the FDA’s move to grant accelerated approval to Biogen Inc.’s Alzheimer’s drug Aduhelm (aducanumab) faced criticism from researchers, medical practitioners, health systems and insurers. In addition, a recent congressional report documented ethical lapses by agency employees during the accelerated approval process for Aduhelm, and the HHS Office of Inspector General is currently investigating the agency’s decision.

The pharmaceutical industry likely will continue to battle challenges posed by a variety of factors in 2023, including global economic issues, competition and the Inflation Reduction Act (IRA). The biosimilars space in particular is expected to undergo a change as the world’s top selling drug, AbbVie Inc.’s Humira (adalimumab), finally faces competition from a number of companies. But industry experts tell AIS Health, a division of MMIT, that they expect a number of positive developments in the space in 2023.