Spotlight on Market Access

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.

UnitedHealthcare (UHC), the health insurance unit of UnitedHealth Group, Inc., is the largest health insurer in the U.S., offering products across all sectors. Nationally, UHC is the top insurer in the group risk, administrative services only (ASO) and Medicare Advantage (MA) markets. As of March 2021, United controls a whopping 26.7% of the national MA market, and has expanded its presence significantly year over year since 2018.