Radar on Specialty Pharmacy

✦ May 6: The FDA gave accelerated approval to Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping (METex14) as detected by an FDA-approved test. The agency also approved Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for this use. The recommended dose for the tablet is 400 mg twice daily. The list price for a 28-day supply is $17,950. Visit www.us.tabrecta.com and https://bit.ly/2Sp4MJo.

✦ May 8: The FDA gave accelerated approval to Eli Lilly and Co. subsidiary Loxo Oncology, Inc.’s Retevmo (selpercatinib) to treat adults with metastatic rearranged during transfection fusion-positive NSCLC; people at least 12 years old with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy; and people at least 12 years old with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory. Dosing is weight-based. The drug’s list price is $20,600 for 30 days of treatment. Visit www.retevmo.com.

A longtime pharma industry expert spoke with AIS Health about their experience as someone with cancer during a pandemic. They asked to remain unidentified:

AIS Health: What kind of cancer do you have, and when were you diagnosed?

Source: I have non-small cell lung cancer with adenocarcinoma, Stage IV, diagnosed in May 2018.

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs. Additional products may be available soon, as the pipeline for the condition boasts several candidates.

According to the National Institute of Neurological Disorders and Stroke, muscular dystrophy consists of a group of more than 30 genetic diseases in which people lose muscle mass and strength over time. DMD, which mainly affects boys and is caused by a lack of dystrophin, is the most common form of the condition, accounting for about half the cases. Onset of the progressive disease is between 3 years old and 5 years old. Most boys with the condition will not be able to walk by the time they’re 12 years old. They will experience declining heart and lung functions and will require a respirator. People with the condition usually die in their 40s.

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.