Radar on Specialty Pharmacy

✦ A federal circuit court ruled July 6 that Amgen Inc. gave adequate notice to Roche Group unit Genentech USA, Inc. before commercializing its Mvasi (bevacizumab-awwb), a biosimilar to Genentech’s Avastin (bevacizumab). The U.S. Court of Appeals for the Federal Circuit upheld an opinion (No. 1:19-cv-00602-CFC) from the U.S. District Court for the District of Delaware that Amgen had complied with the provision of the Biologics Price Competition and Innovation Act (BPCIA) requiring biosimilar companies to provide 180 days’ notice to the innovator company notifying the innovator of their intent to commercially market a biosimilar. Genentech claimed that Amgen had not done this for supplements to its Mvasi application and had filed an emergency motion and a motion for a temporary restraining order. According to the ruling, “Amgen notified Genentech of its intent to commercially market its biological product, Mvasi, on October 6, 2017. Despite its later supplements to its applications adding a manufacturing facility and changing its drug product label, Amgen’s biological product, Mvasi, did not change. Genentech, therefore, had notice of Amgen’s intent to commercially market Mvasi as required.” View the decision at https://bit.ly/3gAULCw.

✦ Mylan N.V. said June 18 that a district court had invalidated a Biogen patent for its multiple sclerosis drug Tecfidera (dimethyl fumarate). The move clears the way, said Mylan, for it to launch its dimethyl fumarate product after the FDA approves it. The drug’s action date is Nov. 16, and Mylan said it is working with the FDA to move up that date. Mylan said it believes its application is one of the first filed for this product, and thus it expects to receive 180 days of marketing exclusivity once it launches. According to Fierce Pharma, Biogen will appeal the decision. View the decision at http://freepdfhosting.com/05a5211020.pdf.

✦ May 29: The FDA expanded the label of Eli Lilly and Co.’s Cyramza (ramucirumab) to include, in combination with erlotinib, the first-line treatment of people with metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 (L858R) mutations. Dosing is 10 mg/kg via intravenous infusion every two weeks with daily erlotinib. The monthly list price for this indication is $11,103. Visit www.cyramza.com.

✦ June 10: The FDA gave another indication to Bristol-Myers Squibb Co.’s Opdivo (nivolumab) for people with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. The recommended dose is a 240 mg intravenous infusion every two weeks or 480 mg every four weeks. Website Drugs.com lists the price of a 240 mg/24 mL vial as $6,879.49. Visit www.opdivo.com.

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.