Radar on Specialty Pharmacy

In a reverse course from its stance a year ago, CMS recently finalized a rule allowing nongrandfathered individual and group market plans to not count manufacturer copayment assistance toward members’ annual deductible and out-of-pocket responsibilities. Known as copay accumulator programs, they began appearing on the pharmaceutical industry’s radar a couple of years ago — and Zitter Insights research reveals their popularity is showing no sign of slowing.

Traditionally, when a manufacturer provides copay assistance for one of its drugs, that dollar amount would count toward the patient’s deductible and out-of-pocket maximum. Once people hit their annual limit, their insurer picks up their prescription costs for the rest of the year. But copay accumulator programs prevent those manufacturer-provided funds from applying to the deductible and out-of-pocket max. Instead, when members have used all of the copay assistance available to them, their payments then start counting toward their deductible and out-of-pocket costs.

Since 2015, three cyclin-dependent kinase (CDK) 4/6 inhibitors have come onto the U.S. market as treatments for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. A recently released poster from AllianceRx Walgreens Prime in collaboration with Duquesne University School of Pharmacy shows that people taking the therapies have high adherence, low rates of stopping treatment and low side effects.

Breast cancer is the second most commonly diagnosed cancer in women in the U.S. HR+/HER2- is the most common form of the condition, making up about 60% of breast cancer diagnoses. The National Comprehensive Cancer Network designates the CDK 4/6 inhibitors with an aromatase inhibitor or fulvestrant as category 1 first-line therapies for HR+/HER2- advanced or metastatic breast cancer.

With the novel coronavirus putting immunocompromised people in particular at risk and hospitals focusing on treating people with COVID-19, many people with cancer are experiencing disruptions in their treatment. And as studies show people forgoing diagnostic tests such as mammograms and colonoscopies, industry experts worry that as we emerge on the other side of the pandemic, there will be an uptick in these procedures — as well as an increase in people receiving a cancer diagnosis that’s at an advanced stage.

“COVID-19 has had a major impact upon all aspects of the health care industry,” says Winston Wong, Pharm.D., president of W-Squared Group. “Cancer care is no exception.”

✦ Ontruzant (trastuzumab-dttb) launched on April 15. Merck & Co., Inc. will commercialize the Herceptin (trastuzumab) biosimilar in the U.S. per a deal with Samsung Bioepis Co., Ltd. Ontruzant is available in 150 mg single-dose vials and 420 mg multiple-dose vials. The wholesale acquisition cost for the 150 mg vial is $1,325, and the WAC for the 420 mg vial is $3,709. Both are discounts of 15% off Herceptin’s list price. Merck will market and distribute it in the U.S. until the drugmaker spins off Ontruzant and other products to a new yet-to-be named, independent, publicly traded company, which is expected to occur in the first half of 2021. Visit www.merckconnect.com/ontruzant.

✦ Teva Pharmaceuticals USA, Inc. and its parent company Teva Pharmaceutical Industries Ltd. filed a lawsuit (No. 1:20-cv-00808) against the FDA and HHS over the decision not to transition Copaxone (glatiramer acetate) from the Public Health Service Act to the Federal Food, Drug, and Cosmetic Act (RSP 3/20, p. 4). On March 23, 100 products made the transition as mandated by the Biologics Price Competition and Innovation Act. Teva is claiming that the FDA’s decision is “arbitrary, capricious, and contrary to law, and it thus should be set aside under the Administrative Procedure Act.” View the lawsuit at https://bit.ly/3b8Porb.

✦ April 8: The FDA granted an additional approval to Pfizer Inc. subsidiary Array BioPharma Inc.’s Braftovi (encorafenib) in combination with Lilly USA, LLC’s Erbitux (cetuximab) for the treatment of adults with metastatic colorectal cancer with the BRAFV600E mutation, as detected by an FDA-approved test (see brief below), after prior therapy. The agency initially approved the capsule in June 2018 (RSP 7/18, p. 10). The recommended dose for the new use is 300 mg once daily in combination with Erbitux. Website GoodRx lists the price of two bottles, each with 90 75 mg capsules, as more than $12,400. Visit www.braftovi.com.

✦ April 13: The FDA approved AstraZeneca and Merck & Co., Inc.’s Koselugo (selumetinib) for people at least 2 years old with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. The agency gave the kinase inhibitor breakthrough therapy, rare pediatric disease and orphan drug designations. AstraZeneca received a priority review voucher under the rare pediatric disease designation program. Recommended dosage of the capsule is 25 mg/m2 twice daily. Multiple news outlets report that the drug’s monthly list price for an average patient will be $12,500. Visit www.koselugo.com.