The List of PBM Formulary Exclusions Got Longer in 2023

Tony Hagen 
Managed Healthcare Executive

Pharmacy benefit managers say they exclude high-cost drugs and have alternatives on their formularies. Critics say exclusions narrow patient options and may put effective medication financially out of reach.

The number of drugs excluded from the three largest pharmacy benefit manager (PBM) formularies reached an all-time high in 2023, despite concerns that profits are being put ahead of patient access. This year, CVS Caremark, Optum Rx and Express Scripts — which together handle 80% of all prescriptions in the United States — each have roughly 600 medications on their standard formulary exclusion lists, according to Adam Fein, Ph.D., CEO of Drug Channels Institute. Fein said the 600 level is a high water mark, although there is some leveling off in the upward trend in the number of drugs that are not on formularies.

Exclusions leave patients with fewer options for treatment unless they can afford the out-of-pocket costs of buying drugs that are not covered by the insurer. What is even more disturbing are the trends within the trend of formulary exclusions, critics say.

“Now PBMs are often excluding medicines for conditions where it is particularly important for patients and physicians to have multiple treatment options, such as oncology and autoimmune disorders,” said a 2022 report from Xcenda, a consulting firm owned by AmerisourceBergen. In 2016, each of the big three PBMs excluded only two oncology medicines. In 2022, CVS Caremark, Express Scripts and Optum Rx excluded 30, 38 and
29 cancer medications, respectively.

Many of the excluded products may be generics or biosimilars with lower list prices, which the PBMs push aside in favor of the brand medicines. Observers state that rebates offered by brand manufacturers are often to blame for this practice, although patients may get stuck with higher copays in the end.

“These formularies have important real-world consequences for patients,” Fein wrote in a blog post. He pointed to the restricted availability of rapid-acting insulin products. This year, the big three PBMs have settled on a favorable formulary placement for Eli Lilly and Company’s Humalog (insulin lispro injection) and Humulin (human insulin injection) or Novo Nordisk’s NovoLog (insulin aspart injection) and Novolin (human insulin injection), but “no major formulary prefers the low list-price versions of the branded products.”

In the long-acting insulin category, Viatris Inc has launched the biosimilar Semglee (insulin glargine-yfgn) and a lower-priced identical unbranded biosimilar. Still, the majority (52%) of new-to-brand commercial prescriptions (patients taking the drug for the first time) in 2022 were written for the reference product, Sanofi’s Lantus (insulin glargine), according to Fein. “Presumably, Sanofi’s rebating practices have slowed biosimilar adoption,” Fein said.

This is the year that biosimilars of Humira (adalimumab) finally arrive on market, and the medical community will be watching closely to see how many of these get on the PBMs’ preferred formularies. Amgen launched Amjevita (adalimumab-atto) in late January at two list prices. CVS Caremark said Humira will remain the preferred product on its formulary, with Amjevita on the nonpreferred brand tier. Express Scripts and Optum Rx spokespeople said the companies were still weighing their options.

In an analysis of drug formulary exclusions published last year in Health Science Journal, the authors noted that individuals with drug coverage governed by Express Scripts 2022 National Preferred Formulary were often left without access to any version of an excluded drug. “Overall, 42% of Express Scripts’ 2022 formulary exclusions mandate(d) a non–therapeutically equivalent medicine based on differences in active ingredient (and) formulation or no therapeutic alternative,” wrote lead author Robert Popovian, M.S., Pharm.D., a consultant and senior health policy fellow at the Progressive Policy Institute.

Such exclusions can force patients and their providers into therapeutic choices that may have harmful clinical or financial consequences, wrote Popovian and his colleagues. Roughly half of the 2022 exclusions by the big three offered no clear economic or medical benefit to patients, their report stated.

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