Radar on Specialty Pharmacy

Community oncology practices already have been hit hard for a number of years, and the COVID-19 pandemic may make the situation worse. But as hospitals try to keep immune-compromised people out, this could result in a shift to these community practices for cancer care, say some industry experts.

A recently released Community Oncology Alliance (COA) practice report shows that from January 2008 through April 2020, 1,748 community oncology clinics and/or practices have shut down, been acquired by hospitals, undergone mergers, sent patients elsewhere or faced financial struggles.

✦ The Association for Accessible Medicines (AAM) filed an amicus brief May 13 in support of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) remaining law if the Affordable Care Act (ACA) is invalidated. The BPCIA established the 351(k) biosimilar pathway, and AAM asserted that the legislation is “a functionally independent part” of the ACA. If the BPCIA is invalidated, “a decade of progress by AAM and its members would be lost,” stated the brief. View the brief at https://bit.ly/2zWVDlf.

✦ With its first-in, first-out accounting methodology for specialty drug pricing, Navitus Health Solutions saved plan sponsors an average of 8% on those drugs in 2019 before price hikes due to inflation, according to its 2019 Drug Trend Report, released on May 18. Among other findings, the company’s specialty pharmacy, Lumicera Health Solutions, saved plan sponsors more than $1.5 million through its split-fill program. Download the report at www.navitus.com.

✦ 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.