Radar on Specialty Pharmacy

✦ On Aug. 17, 2018, the FDA gave accelerated approval to Bristol-Myers Squibb Co.’s programmed death-1 (PD-1) inhibitor Opdivo (nivolumab) for the treatment of people with metastatic small cell lung cancer whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy (RSP 9/18, p. 8). That approval was based on surrogate endpoints from the Phase I/II CheckMate -032 trial. However, the subsequent trials CheckMate -451 and CheckMate -331 did not meet their primary endpoints of overall survival, so in consultation with the FDA, the company has withdrawn this indication from the U.S. market. Bristol-Myers is advising people being treated with Opdivo for this indication to consult with their health care provider. Visit https://bit.ly/3o2gNlN.

✦ Pfizer Inc. launched its granulocyte colony-stimulating factor Nyvepria (pegfilgrastim-apgf) in the U.S. on Dec. 15 following its June 10, 2020, approval (RSP 7/20, p. 8), according to AmerisourceBergen Corp. It is the fourth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) on the U.S. market, joining Mylan N.V.’s Fulphila (pegfilgrastim-jmdb), Coherus BioSciences, Inc.’s Udenyca (pegfilgrastim-cbqv) and Ziextenzo (pegfilgrastim-bmez) from Sandoz Inc., a Novartis AG unit. Visit www.nyvepria.com and view AmerisourceBergen’s biosimilars pipeline report at https://bit.ly/3mZwYPD.

✦ Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, as well as primary progressive MS. Twice-yearly dosing via a shorter two-hour infusion is now available for people who have not experienced any serious infusion reactions. The initial dose is administered as two 300 mg two-and-a-half-hour infusions two weeks apart and then subsequent doses are 600 mg every six months. The agency initially approved the drug for subsequent infusions of three-and-a-half hours. The drug’s annual list price is $65,000, according to its website. Visit www.ocrevus.com.

✦ Dec. 16: The FDA approved MacroGenics, Inc.’s Margenza (margetuximab-cmkb) in combination with chemotherapy for the treatment of adults with metastatic human epidermal growth factor receptor 2-positive breast cancer who have received at least two anti-HER2 regimens, with at least one of them for metastatic disease. Dosing is via a 120-minute intravenous infusion at 15 mg/kg for the first dose and then over a minimum of 30 minutes every three weeks. The company says it expects the drug to be available in March. Visit www.margenza.com.

As expected by some in the pharma industry, judges in two U.S. district courts have temporarily blocked implementation of the administration’s most-favored-nation (MFN) model that was set to take effect Jan. 1. While some industry stakeholders agree that changes are needed to drug pricing policies, many of them maintain that this approach is the wrong way to go about it and hailed the decision. As of press time, it’s unclear what steps either the outgoing administration of President Donald Trump or the incoming administration of President-elect Joe Biden will take next.

Published as an Interim Final Rule with Comment Period (85 Fed. Reg. 76180, Nov. 27, 2020), the MFN model would “test whether more closely aligning payment for Medicare Part B drugs and biologicals…with international prices and removing incentives to use higher-cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries” (RSP 12/20, p. 1).

While the COVID-19 pandemic and pharma’s efforts to counter it were the top pharma concerns in 2020, that wasn’t the only innovation within the specialty pharmacy arena. AIS Health spoke with a variety of industry experts on various trends over the past year.

What were some of the most notable developments within the specialty pharmacy industry in 2020, and why?

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) last month, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

HAE is a rare but potentially fatal condition that causes swelling in various parts of the body, including the hands, feet, intestinal tract, face, larynx and trachea.