The FDA is requiring revisions to the labels of Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib) following the agency’s review of a large, randomized safety clinical trial of Xeljanz. The trial compared Xeljanz with tumor necrosis factor (TNF) inhibitors in people with rheumatoid arthritis and showed an increased risk of blood clots and death with a lower dose of Xeljanz. A prior study showed the same results but only at a higher dose. While Olumiant and Rinvoq were not studied, they are also Janus kinase (JAK) inhibitors indicated for inflammatory conditions, so the FDA says they might have similar risks. The agency also is limiting all of the drugs’ approved uses to people who have not responded to or cannot tolerate one or more TNF inhibitors.

A group of 16 patient-advocacy organizations wrote a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure requesting that they enact a zero-copay policy for Medicare Part B beneficiaries taking a biosimilar. “These therapies represent an opportunity to improve the health and well-being of millions of Americans and, at the same time, save U.S. taxpayers billions in health care costs,” wrote the organizations, which include the Crohn’s & Colitis Foundation and International Myeloma Foundation. They noted that almost 15% of Part B enrollees pay a 20% coinsurance for reference biologics, and supplemental insurance covers only a portion of that amount. Implementing such a policy would result in savings up to $3.3 billion in out-of-pocket costs and as much as $5.2 billion in taxpayer dollars over 10 years, they wrote.

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