Radar on Specialty Pharmacy

People being treated for advanced prostate cancer now have a new oral option, offering patients the ability to not have to visit a provider for administration — an especially welcome alternative during the COVID-19 pandemic. Industry experts point to an array of reasons as to why the new drug should expect to get a lot of use. And a recent Zitter Insights survey indicates that the majority of oncologist respondents likely will prescribe it, with many saying they expect to favor it over the current standard of care.

On Dec. 18, the FDA approved Myovant Sciences GmbH’s Orgovyx (relugolix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, to treat adults with advanced prostate cancer (RSP 1/21, p. 8). Dosing for the drug is a loading dose of 360 mg on the first day of treatment and then 120 mg of the tablet once daily.

The pharmaceutical industry has undergone an unprecedented burst of innovation lately, led — but by no means limited to — the race to develop a vaccine to counter the COVID-19 pandemic, and this trend is showing no signs of slowing, with oncology, orphan drugs, cell and gene therapies leading the way. But with this innovation come premium prices, and though the previous administration issued a flurry of rules and executive orders focused on drug pricing, there was not much concrete action in this area. President Joe Biden has multiple issues to deal with, so it remains to be seen what he’ll do here in the upcoming year. AIS Health spoke with multiple industry experts to get their opinions on what we may see over the next year within the specialty drug space.

What do you expect to see on the issue of drug prices in 2021? Do you anticipate any legislation passing?

David Root, vice president of government affairs at Prime Therapeutics LLC: “We anticipate that the incoming Biden administration will be focused on combating the pandemic through public health measures and deployment of new vaccines and therapeutics and that this focus may take attention away from other issues. The incoming administration will also need to decide whether to retain the Trump administration’s proposed most-favored-nation proposal and the rebate rule.…Given how tight control of the Senate will be and narrower margins in the House, is it likely that only more targeted drug pricing issues reach the president’s desk. The FDA user fees programs need to be reauthorized in the next Congress and that may also bring attention to drug pricing issues.”

✦ 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).