Spotlight on Market Access

For nearly all services and functions, employers had higher levels of satisfaction than health plans in 2024. The ratings differ significantly in delivery of promised services, contract and service flexibility, and responsiveness and issue resolution.

Many respondents said their PBMs have strategies for new and upcoming biosimilars in 2024 and acknowledged the importance of having such strategies. Yet they expressed mixed feelings about their PBMs’ Humira biosimilar strategy, with 10% indicating they were dissatisfied and just 16% saying they were very satisfied.

The last of the so-called Big Three PBMs recently joined the others in offering a new private-label subsidiary when it unveiled upcoming changes to its commercial formularies. Those units, which are largely focused on biosimilars and generics, may offer benefits to pharma companies partnering with them, but such arrangements also pose potential risks as the offerings are already drawing scrutiny.

On Jan. 1, 2025, UnitedHealth Group’s Optum Rx will place Nuvaila-labeled biosimilars of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine and AbbVie Inc.’s Humira (adalimumab) on various tiers of three of its commercial formularies for a zero-dollar copay. In partnership with Amgen Inc. for its interchangeable Wezlana (ustekinumab-auub), Wezlana for Nuvaila will be available in both high-wholesale acquisition cost and low-WAC versions.

When the FDA approved the first injectable treatment for HIV pre-exposure prophylaxis (PrEP), the agency hailed the therapy as “an important tool in the effort to end the HIV epidemic” due to its every-two-months regimen, lessening the burden of oral treatments that were taken every day. But a new injectable agent may soon be approved that reduces that treatment burden to twice a year.

Gilead Sciences, Inc. revealed on Sept. 12 that twice-yearly treatment with its lenacapavir in a second Phase III trial reduced HIV infections by 96% compared with background HIV incidence. In addition, among the 2,180 participants in the lenacapavir group in the PURPOSE 2 trial, there were two incident cases, meaning that 99.9% of the participants did not acquire HIV infection.

In recent years, commercial health plans have increasingly opted to place both biosimilars and their reference biologics on preferred tiers in their formularies, according to a recent Health Affairs study.

The researchers analyzed coverage and market share for seven biologics — also known as “originator products” — and 20 corresponding biosimilars from the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the IQVIA Longitudinal Access and Adjudicated Data Set from August 2017 to August 2022. The study categorized the payers’ coverage policies as:

Over the last few years, the FDA has taken multiple steps to level the playing field between biosimilars and interchangeable biosimilars. More recently, it proposed draft guidance that would do away with switching studies for interchangeability status. Commenters on that guidance were mostly supportive — with some even backing interchangeability for all biosimilars — and others asked for clarification on a range of issues, including what information the FDA needed to make a determination of interchangeability. Meanwhile, one group derided the guidance as an “ill-advised and inappropriate move.”

Based on the agency’s experience with biosimilars and interchangeable biosimilars, the FDA on June 20 published the draft guidance “Considerations in Demonstrating Interchangeability With a Reference Product: Update.” Since the initial interchangeability guidance — published on May 19, 2019 — the FDA’s “experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product. Accordingly, FDA’s scientific approach to when a switching study or studies may be needed to support a demonstration of interchangeability has evolved.”