The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack, stroke, cancer, blood clots and death to the labels of the Janus kinase (JAK) inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib). The move follows the agency’s review of a large, randomized safety clinical trial of Xeljanz. The FDA also is limiting the approved uses for all the drugs to certain people who have not responded to or cannot tolerate at least one tumor necrosis factor (TNF) inhibitor. While some payers may already have had TNF inhibitors as a first step, they need to make sure that they have utilization management strategies in place to help ensure these drugs are used in the second-line setting, recommend industry experts.
The FDA approval of the first biosimilar for ocular use is poised to bring savings to a costly class, particularly in Medicare. However, ophthalmologists’ and retinologists’ lack of experience with biosimilars is a potential roadblock to these drugs’ uptake. Payers should focus on provider education and outreach ahead of these drugs’ launches in order to ease concerns about their use, say industry experts.
Biosimilars are finally starting to bring down the prices of their innovator products across a range of indications, research shows. The FDA often approves biosimilars across some or all of the innovator drug’s indications even if applicant companies have not conducted studies in those uses. But two professional societies have been pushing back against payers’ allowance of two Avastin (bevacizumab) biosimilars in untested ocular indications.
Walgreens Boots Alliance recently revealed that it is making a majority investment in Shields Health Solutions through its subsidiary Walgreen Co. The deal will expand Walgreens’ position within the growing hospital-based specialty pharmacy space.
Shields is a specialty pharmacy integrator that partners with health systems to help them create and grow a hospital-owned specialty pharmacy program. The hospitals own the pharmacies while Shields manages them.
✦ Sept. 15: The FDA granted another indication to BeiGene, Ltd.’s Brukinsa (zanubrutinib), giving it accelerated approval for the treatment of people with relapsed or refractory marginal zone lymphoma following treatment with at least one anti-CD20-based regimen. The agency first approved the drug on Nov. 14, 2019. The recommended dose of the capsule is 160 mg twice daily or 320 mg once daily. Website Drugs.com lists the price of 120 80 mg capsules as more than $14,094.00.
✦ Over the past five years, biosimilars created competition that resulted in savings of $9.8 billion. That’s according to Amgen Inc.’s 2021 Biosimilar Trends Report, its eighth edition. The therapies also have the potential to save people out-of-pocket costs of $238 million in the nine classes in which the agents have been approved. The drugs are launching with wholesale acquisition costs that are generally between 15% and 37% less than those of their reference products.