Radar on Specialty Pharmacy

As more health systems are creating their own specialty pharmacies, two major players in the space are coming together. In mid-January, Shields Health Solutions unveiled a deal to purchase ExceleraRx Corp. for an undisclosed amount. The new company could provide these entities with more leverage when it comes to payer networks and manufacturer distribution.

Shields is a specialty pharmacy integrator that partners with health systems to help them create and grow a hospital-owned specialty pharmacy program. Excelera is a network of specialty pharmacies among its members, which are integrated delivery networks and academic medical centers. Created by Minneapolis-based Fairview Health Services almost a decade ago (RSP 5/14, p. 1), the group now consists of almost 30 members.

As of the beginning of February, the FDA had approved 29 biosimilars. For various reasons, mostly patent litigation by reference drug companies, only 20 of those products actually have launched onto the U.S. market. But as the biosimilars market has yet to demonstrate its full potential, it certainly seems to be picking up steam. In a report released in October, the IQVIA Institute for Human Data Science projected that over the next five years, biosimilars could hit $80 billion in aggregate sales and provide savings in excess of $100 billion in aggregate. AIS Health spoke with a variety of industry experts on what we’ve seen over the past year and what we might expect looking forward.

The available products span seven reference drugs consisting of three supportive care drugs — two biosimilars of Neupogen (filgrastim), one of Epogen/Procrit (epoetin-alfa) and four of Neulasta (pegfilgrastim) — three oncology brands — three biosimilars of Rituxan (rituximab), two of Avastin (bevacizumab) and five of Herceptin (trastuzumab) — and one tumor necrosis factor inhibitor, Remicade (infliximab), which has three biosimilar versions on the market.

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.