Radar on Specialty Pharmacy

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.

✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma. The agency gave the application priority review, and the review was conducted through the Real-Time Oncology Review (RTOR) pilot program. The FDA first approved the programmed cell death-1 (PD-1) inhibitor on Sept. 4, 2014. The recommended dose of Keytruda is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The list price for the every-three-weeks dosing is $9,869.94; for every six weeks, it’s $19,739.88.

✦ May 14: The FDA approved Apellis Pharmaceuticals, Inc.’s Empaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who are treatment naïve, as well as people switching from any C5 inhibitors, including Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz). Empaveli is the first C3 inhibitor for PNH. The agency gave the drug priority review, as well as fast track and orphan drug designations. The recommended dose is 1,080 mg twice weekly via subcutaneous infusion using an infusion pump. The drug’s annual wholesale acquisition cost is $458,000.

Although there are more than 20 FDA-approved disease-modifying therapies (DMTs) for multiple sclerosis (MS), companies continue to bring new products to market. Zitter Insights found that the majority of payers expect to manage the newest entrant, the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod), to label.

On March 19, the FDA approved Ponvory to treat adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The approval was based in part on the Phase III OPTIMUM study, which showed the product reduced annual relapses by 30.5%, compared with Sanofi’s Aubagio (teriflunomide). It also reduced brain lesions by more than 50%.