Radar on Specialty Pharmacy

At the beginning of next year, the last of the Big Three PBMs will join the others in offering a new private-label subsidiary. Those units, which are largely focused on biosimilars and generics, have the potential to boost biosimilar competition and improve pricing, but such arrangements also are drawing scrutiny, most recently from the Senate Finance Committee.

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.

After taking several steps to prepare — including releasing a fact sheet, posting a technical frequently asked questions for pharmacies and launching an informational website for health care providers — CMS on Sept. 30 issued a final National Coverage Determination on Medicare coverage of HIV pre-exposure prophylaxis (PrEP). Effective immediately, coverage for PrEP will be under Medicare Part B — including oral agents previously covered under Part D — where it will be available at no cost to beneficiaries, a move that should increase adherence to treatment, industry experts say.

“At face value, moving coverage to Part B helps ensure that all Medicare recipients will have access to the HIV PrEP, as opposed to depending upon patients with stand-alone or carved-out prescription benefits to access PrEP through their prescription benefit,” observes Winston Wong, Pharm.D., president of the W-Squared Group. “I don’t believe there is any question of coverage since CMS issued an NCD, which mandates all Part D plans meet the minimum coverage requirements; however, I don’t believe carve-out prescription benefits for retirees are required to provide comparable coverage to CMS.”

In the seven years since the approval of the first chimeric antigen receptor T-cell (CAR-T) therapy, the agents have proved to be effective in the treatment of non-Hodgkin lymphoma. But the one-time-use agents come with risks, including the potentially fatal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), so the FDA requires patients remain near their treatment center for four weeks after administration, which can be onerous for patients. But a recent study finds that side effects were rare after the first two weeks post-infusion, perhaps helping lead to less of a burden for patients.

An article in Blood Advances, a journal of the American Society of Hematology, revealed the findings of a retrospective study of 475 patients who received three CD19-directed CAR-Ts at nine different centers: Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. subsidiary Kite Pharma, Inc., Novartis Pharmaceuticals Corp.’s Kymriah (tisagenlecleucel) and Breyanzi (lisocabtagene maraleucel) from Juno Therapeutics, Inc., a Bristol Myers Squibb company.

Recently publicized data from a late-stage clinical trial for an HIV pre-exposure prophylaxis (PrEP) therapy showed promise for twice-yearly treatments, potentially boosting compliance, according to industry experts. Although the Affordable Care Act mandated that all nongrandfathered group and individual health plans must offer no-cost PrEP coverage, compliance continues to be a problem, research reveals.

When the FDA approved the first injectable treatment for 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.