The Sandoz's and Boehinger Ingelheim's Humira biosimilars will join Amgen's Amjevita on the formulary of UnitedHealth Group's PBM. Cyltezo may have a marketing edge because of its interchangeability designation.
One of the lingering doubts about biosimilars has been whether pharmacy benefit managers (PBM), especially the big three — Optum Rx, CVS Caremark and Express Scripts — would include them on their formularies, leading to coverage and prescriptions, or would the PBMs stick with the brand-name reference products because of rebates and other discounts that can reward the companies financially for sticking with drugs that have higher list prices.
Some doubt remains, partly because the PBM industry that is inscrutable in many ways. But today’s news that Optum Rx is going to add two more Humira (adalimumab) biosimilars may be a sign that formulary placement is receding as an obstacle to biosimilar prescribing and use.
Optum Rx announced this morning that it is going to include Sandoz’s Hyrimoz (adalimumab-adaz) and Boehinger Ingelheim’s Cyltezo (adalimumab-adbm) to its formulary at parity with Humira. Optum Rx, the PBM arm of the health services giant UnitedHealth Group, had previously put Amgen’s Amjevita (adalimumab-atto) on its formulary after it came on the market early this year.
"Optum Rx's decision to add Cyltezo to its formulary could benefit millions of Americans, improving access to a crucial medicine that has been a safe and effective treatment for many inflammatory conditions for the last two decades," said Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim, in a press release today.
“As an industry leader driving competition and biosimilar access, we are bringing unprecedented choice and value in this highly utilized but historically very expensive drug class,” said Heather Cianfrocco, Optum Rx’s CEO, said in a press release.
Optum Rx’s decision to cover three biosimilars was expected. Cianfrocco announced in late 2022 that the PBM would cover Amjevita and two others. The fresh news today was that Cyltezo and Hyrimoz got the nod.
Cyltezo may have a marked marketing advantage over the other Humira biosimilars because it is the only one so far with the interchangeable designation from the FDA. The designation means patients in trials have switched back and forth between Humira and the biosimilar without safety or and efficacy problems occurring. Surveys of doctors have found that they are more comfortable prescribing a biosimilar with the interchangeable designation.
Humira, once the world's top selling drug, still generated approximately $20 billion in revenue for AbbVie in 2022. It has powerful anti-inflammatory effects and is used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis and other autoimmune diseases that are caused by a dysregulated immune system that has inflammatory aspects.
Through patent litigation and other means, AbbVie managed to keep Humira biosimilars off the market for years, but this year by virtue of a series of legal settlements between AbbVie and the biosimilar makers, the floodgates opened. Amgen got a jump on the competition with Amjevita. In July, five more Humira biosimilars are expected to come on the market in addition to Cyltezo and Hyrimoz.