Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.
Some gene therapies could be big winners under the changes the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to Medicare’s new technology add-on program (NTAP) for its fiscal 2025 inpatient prospective payment system.
With credit card fees taking a sizable bite of their billings, many U.S. health care providers are fighting back by offering patients cash discounts. But when a drug company covers card processing fees for its distributors to pass on to their provider clients so they can pay for so-called “buy-and-bill” Medicare Part B drugs with a credit card at cash prices, it’s fraud if those concessions aren’t figured into the drug’s average sales price – at least that’s what the U.S. Department of Justice is claiming in a complaint it released April 10 against Regeneron Pharmaceuticals Inc.
Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.
In finalizing its 2025 Medicare Advantage and Part D rule, the U.S. Centers for Medicare & Medicaid Services (CMS) all but did away with the coverage differences between biosimilars and interchangeables.
Following the U.S. FDA’s March 11 approval of Novo Nordisk A/S’ glucagon-like peptide 1 receptor agonist, Wegovy (semaglutide), to reduce the risk of major adverse cardiovascular events such as heart attack and stroke, the Centers for Medicare & Medicaid Services (CMS) has issued guidance ensuring coverage.
When it comes to whether Medicare Part D should cover the new anti-obesity drugs, the U.S. Centers for Medicare & Medicaid Services and lawmakers may be caught between the math and public pressure.
At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted nine accelerated approvals last year, up from six in 2022. But the proportion of novel drugs with accelerated approval was 16% both years. And when compared with the 12 drugs in 2020 and the 14 that received accelerated approval in 2021, last year’s crop was a little lackluster. However, a deeper look at the 2023 class of accelerated approvals shows a historic milestone. For the first time since the path was created in 1992, the number of novel biologics getting accelerated approval at CDER outpaced the number of small-molecule drugs.
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
One down, eight to go. That’s the scorecard for the constitutional challenges to mandatory Medicare drug price negotiations now that a U.S. federal court has dismissed a suit filed by the Pharmaceutical Research and Manufacturers of America, the National Infusion Center Association and the Global Colon Cancer Association.
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