Radar on Specialty Pharmacy

A recently approved product in 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.

An earlier version of this story incorrectly said that per Prime Therapeutics LLC’s recommendation, one health plan shifted to oncology biosimilars from the reference drugs and realized hundreds of millions of dollars in savings. The plan realized millions in savings. This version has been corrected.

As payers continue to look for ways to tackle the rising spending on specialty drugs, Prime Therapeutics LLC is launching a medical drug management program. Known as MedDrive, the offering will be rolled out in phases, with the initial one focused on increasing the use of biosimilars.

PBMs have used formulary exclusions as an effective way to negotiate with manufacturers for several years. However, at least one payer has gotten more aggressive with its tactics to get members to move from an excluded drug to one with preferred status, dangling a financial incentive for members. That effort is facing pushback from several medical associations, but if it proves to be successful, other companies could follow suit, suggest industry experts.

PBMs began implementing formulary exclusion lists about 10 years ago, and specialty drugs have made up an increasing number of the excluded products. As of early 2021, each of the Big Three — CVS Health’s Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx — was excluding more than 400 products.

Multiple myeloma, an incurable blood disease that starts in the bone marrow and can be a relatively rare cancer, has an array of products available to treat it, and new agents — including the first gene therapy for the disease — continue to gain FDA approval. However, as the therapies are different types of drugs, management of the space can be challenging.

Winston Wong, Pharm.D., president of W-Squared Group, points out that about 20 therapies are available to treat multiple myeloma. As of April, the National Institutes of Health listed more than 200 clinical trials, many for gene therapies, he adds. “Thus, the already crowded and complicated field of treatment options is only going to get more crowded,” he tells AIS Health, a division of MMIT.

✦ The U.S. Supreme Court denied a petition from Novartis AG’s Sandoz unit to review the 2020 Federal Circuit decision to uphold two patents of Amgen Inc.’s Enbrel (etanercept). The FDA approved Sandoz’s Enbrel biosimilar, which is known as Erelzi (etanercept-szzs), on Aug. 30, 2016, but the Supreme Court’s decision means Enbrel biosimilars will not be able to launch until 2029. The FDA approved another Enbrel biosimilar, Samsung Bioepis Co., Ltd.’s Eticovo (etanercept-ykro), on April 25, 2019. Novartis says that estimates indicate that a biosimilar of Enbrel could save the U.S. health care system around $1 billion per year.

✦ Viatris Inc. expects the FDA to approve two of its insulin products as interchangeable biosimilars this summer, the company said during its May 10 conference call to report first-quarter 2021 earnings. The company — formed in 2020 through the combination of Mylan N.V. and Pfizer’s Upjohn business — said its insulin glargine, whose reference drug is Sanofi’s Toujeo, and insulin aspart, whose reference drug is Novo Nordisk’s NovoLog/NovoRapid, are on track to be approved as interchangeable in July. As of early June, the FDA has approved 29 biosimilars, but none have the interchangeable designation. Insulins became eligible for biosimilar status when the FDA transitioned certain protein products approved under the Federal Food, Drug, and Cosmetic Act to the Public Health Service Act on March 23, 2020.