Radar on Specialty Pharmacy

On July 24, President Donald Trump signed four executive orders aimed at lowering what Americans pay for prescription drugs. Industry experts questioned how much of an impact two of the orders — one on low price insulin and one on drug importation — ultimately would have. And the other two — a most-favored nation order, presumably impacting Medicare Part B only, and an end to rebates within Medicare Part D — have received pushback from the pharma and PBM industries, respectively. Some industry sources have speculated that the orders are targeted to show Americans less than 100 days before the next presidential election that the administration is following up on the promise to make drugs affordable.

“The four orders that I’m signing today will completely restructure the prescription drug market, in terms of pricing and everything else, to make these medications affordable and accessible for all Americans,” declared Trump while unveiling the orders.

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.