Spotlight on Market Access

With the FDA’s February 2021 approval of Bristol Myers Squibb’s Breyanzi, followed by another nod for the drugmaker’s Abecma just a few weeks later, there are now five chimeric antigen receptor T-cell (CAR-T) therapies on the market. Since they require administration at approved treatment centers, CAR-T drugs are most often covered under the medical benefit, though coverage under the pharmacy benefit isn’t unheard of. Among the most advantaged therapies are Novartis’ Kymriah, which holds covered or better status for more than 80% of all insured lives under the medical benefit, and Gilead Sciences’ Tecartus, following behind at 76%. The graphics below show how all five CAR-T therapies are covered under the pharmacy and medical benefit.

A new entrant to the ulcerative colitis therapeutic class brings a new mechanism of action. However, according to payers responding to a survey by Zitter Insights, the treatment, Bristol Myers Squibb’s Zeposia (ozanimod), may have some challenges breaking into the space.

On May 27, the FDA gave an additional indication to Zeposia for the treatment of adults with moderately to severely active ulcerative colitis. It is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for this indication. The agency initially approved the capsule on March 26, 2020, for relapsing forms of multiple sclerosis (MS). Three other oral S1Ps are approved for MS: Gilenya (fingolimod) and Mayzent (siponimod), both from Novartis Pharmaceuticals Corp., and new entrant Ponvory (ponesimod), from the Janssen Pharmaceutical Companies of Johnson & Johnson.

The FDA in February accepted a New Drug Application under priority review for Incyte Corp.’s ruxolitinib cream for the treatment of atopic dermatitis. Meanwhile, there are currently more than 10 agents in Phase III trials for this indication. Among the medications that are on the market, Sanofi and Regeneron’s Dupixent (dupilumab) and Pfizer Inc.’s Eucrisa (crisaborole) are competing for preferred status after topical corticosteroids, topical calcineurin inhibitors and phototherapy. Most medications are covered under the pharmacy benefit, with the exception of Dupixent. More than half of payer pharmacy benefit formularies do not require step therapy or prior authorization for atopic dermatitis medications.

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors.

Change is coming to drug reimbursement under the Medicare and Medicaid programs: CMS is set to implement a new Medicaid rule providing flexibility for value-based drug purchasing and is considering how best to incorporate value-based purchasing into parts of the Medicare program, a panel of experts said recently.