Radar on Specialty Pharmacy

Prime Therapeutics LLC recently unveiled that it had signed a value-based agreement for a relatively new multiple sclerosis (MS) drug with a complicated treatment regimen and high price tag.

In early June, the PBM said it had signed a deal with EMD Serono, Inc. for Mavenclad (cladribine) by which Prime would be financially compensated based on the rate at which members discontinue the therapy or switch to another MS drug over the typical course of treatment.

When the FDA approved Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) in early May, the tablet became the first treatment approved for a specific type of non-small cell lung cancer (NSCLC). Commercial payers have indicated a willingness to cover the drug within the first six months of launch, according to data from Zitter Insights.

The agency gave Tabrecta accelerated approval for the treatment of adults with metastatic NSCLC whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping (METex14) (see story, p. 3). The agency also approved Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic.

When the FDA approved Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) on May 6, it was the first of seven approvals in non-small cell lung cancer (NSCLC) through May 29 (RSP 6/20, p. 8). While these will offer more options for people with certain forms of the condition, more treatments are still needed, says one industry expert, and the pipeline is full of an array of therapies.

Lung cancer is the second most common cancer in both men and women, according to the American Cancer Society. NSCLC makes up 84% of all lung cancers, while small cell lung cancer makes up about 13%.

As the COVID-19 pandemic continues to spur huge changes throughout the health care system, CMS’s current and future alternative payment models have not been immune. In early June, the Center for Medicare & Medicaid Innovation (CMMI) unveiled changes to the programs, including to the Oncology Care Model (OCM).

The changes that CMMI has implemented so far are the following:

✦The model has been extended for one year through June 2022.

As more and more high-cost therapies come onto the U.S. market, payers are looking for ways to be able to cover those treatments for their members who need them. Value-based purchasing (VBP) arrangements are an option, but they do not come without challenges. CMS last month issued a proposed rule aimed at making it easier for manufacturers to offer these contracts by addressing one hurdle: Medicaid best price.

Drugmakers have long cited Medicaid best price — which determines how rebates are calculated in the Medicaid Drug Rebate Program — as an impediment to their ability to offer VBP deals to both commercial and government payers. Specifically, since manufacturers need to sell their drugs to Medicaid at the lowest price they offer another purchaser, companies have said that if they have to provide a large discount due to patients’ failing to meet certain contract-stipulated outcomes, that they will have to make a drug available to Medicaid programs at a much lower price than they are comfortable with.