Since the FDA’s approval of the first biosimilar in 2015, the agency has approved almost 40 more agents. However, their adoption in the U.S. market has been slow. A recent study, published in the journal BioDrugs, found that biosimilars were covered more restrictively than their reference biologics in 19.4% of coverage decisions made by select commercial health plans.
The study examined 1,181 coverage decisions made by 17 commercial health plans as of August 2021 from the Tufts Medical Center Specialty Drug Evidence and Coverage database, which included 19 commercially available biosimilars for seven biologic reference products used in treating 28 conditions.
The researchers found that plans were more likely to exclude coverage or impose restrictions on biosimilars that are used for pediatric patients and those that treat diseases with a high prevalence. The first biosimilars to enter the market and the ones offering savings of $15,000 or more per patient annually were much less likely to be restricted. Furthermore, health plans whose pharmacy benefits were managed by the three largest pharmacy benefit managers — CVS Health Corp.’s Caremark, Cigna Corp.’s Express Scripts, and UnitedHealth Group’s Optum Rx — were less likely to impose greater restrictions on biosimilars.
A March report from Health Care Cost Institute showed that the uptake of biosimilars remained low among people with employer-sponsored insurance between 2019 and 2021. The report focused on seven drug products that had approved and launched biosimilars over the study period and found that biosimilars made up one-third or less of all drug administrations in five of the seven drug classes studied.
The study noted that the preference for reference products over biosimilars can drive up health care spending due to the price differences between biologics and biosimilars. For all seven drugs studied, the biologic price was at least 20% higher than the prices of associated biosimilars.
As of May 2023, the 41 FDA-approved biosimilars in the U.S. are for 11 reference products. Under the medical benefit, the majority of commercial lives have coverage for biosimilars with utilization management restrictions, according to coverage policy analysis data from MMIT Analytics (MMIT is the parent company of AIS Health).
Amgen Inc.’s Amjevita (adalimumab-atto) landed on the U.S. market in January this year and became the first of several biosimilars to Humira — the top-selling drug in the world — that will finally be available to patients. Under the pharmacy benefit, most commercial enrollees still have better access to Humira compared to Amjevita.
This infographic was reprinted from AIS Health’s biweekly publication RADAR on Drug Benefits.