Radar on Specialty Pharmacy

✦ Feb. 3: The FDA gave accelerated approval to Merck KGaA unit EMD Serono, Inc.’s Tepmetko (tepotinib) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. The agency gave the drug priority review and breakthrough therapy and orphan drug designations. The therapy was approved under the FDA’s Real-Time Oncology Review pilot program. Dosing for the tablet is 450 mg via two 225 mg tablets once daily. The list price of a 30-day supply is $20,898. Visit www.tepmetko.com.

✦ Feb. 5: The FDA approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B. The agency gave the CD19-directed chimeric antigen receptor T cell (CAR-T) therapy orphan drug, regenerative medicine advanced therapy and breakthrough therapy designations. The list price for the one-time treatment is $410,300. Visit www.breyanzi.com.

Therapeutic interventions have evolved from people taking a pill every day to treat a condition to the one-time cell and gene therapies aimed at halting disease progression or even curing a disease. The rise of these innovative new products means that payers need more information than ever in order to properly assess treatments, as well as updated reimbursement models.

“The science is moving at lightning speed, and what we thought was previously impossible has now become a reality with some of the newer gene therapies and other novel drug approvals,” observes Reta Mourad, Pharm.D., a senior director on the access experience team at PRECISIONvalue. “As we learn more about diseases and develop a deeper understanding down to the genetic and molecular level, we are able to see advances in therapies that were unheard of,” for example with chimeric antigen receptor T cell (CAR-T) therapies, the first of which were approved in 2017.

The FDA recently approved the first long-acting regimen for the treatment of HIV in adults. The dosing schedule could help with adherence in a condition where that is particularly crucial. However, some potential challenges exist with the medication, including whether health plans actually will cover it.

On Jan. 21, the FDA approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine) for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in people who are virologically suppressed on it with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.

As the U.S. surpasses 500,000 deaths from the COVID-19 pandemic, people with cancer continue to unsurprisingly be hesitant to visit a provider office or hospital for treatment. So, Cancer Treatment Centers of America (CTCA) is working with CVS Health to bring therapies into certain patients’ homes, helping keep immunocompromised people safer and allowing them to continue much-needed cancer treatment.

Multiple studies have shown how the pandemic has affected all aspects of cancer care, from screening and diagnostic workups to actual oncology treatments, follow-up services and patient support (RSP 6/20, p. 1). “The COVID-19 pandemic created new challenges for immunocompromised patients with cancer looking for ways to safely continue their care while minimizing their exposure to the virus,” explains Sree Chaguturu, M.D., senior vice president at CVS Health and chief medical officer at CVS Caremark. “CTCA is seeing a 50% reduction in infusions, and, while a slight delay in treatments may have been appropriate at the pandemic’s onset, data is now pointing to increased mortality risk with every month of delayed care. There is a critical need for providing in-home therapy where possible to safely treat patients who are immunocompromised.”

With the FDA’s approval of Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space. However, with more of these therapies in the pipeline, payers should take a closer look at these therapies and their management of them, say industry experts.

On Feb. 5, the FDA approved Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B (see brief, p. 8). The agency gave the CD19-directed CAR-T therapy orphan drug, regenerative medicine advanced therapy and breakthrough therapy designations.