Wegovy (semaglutide) has racked up another indication. The U.S. FDA approved the injectable for reducing risk of major adverse cardiovascular events such as death, heart attack or stroke and for long-term weight management. The approval expands the drug’s potential. The mighty glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S was already approved for those age 12 and older who are obese and for some overweight adults with weight-related problems.
The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.
The U.S. Congress has passed a continuing resolution (CR) for the fiscal 2024 budget, an exercise that has become all too common as a substitute for a full suite of spending bills in an era of growing deficits.
One of the more significant enforcement actions to date in 2024 is the $13 million hit taken by the owner of a clinical lab in New Jersey for allegations of payment of kickbacks for unnecessary testing, suggesting that this new year will be a robust one for federal fraud enforcement in the U.S.
The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.
In keeping with a provision in the Inflation Reduction Act, the U.S. Department of Health and Human Services will not implement a final rule removing the anti-kickback safe harbor for the rebates drug companies pay pharmacy benefit managers until Jan. 1, 2032.
In July, Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd.) became the first amyloid-targeting drug to win traditional approval from the U.S. FDA, after getting accelerated approval in January based on the surrogate endpoint of plaque removal.
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.
In another step that blurs the distinction between biosimilars and interchangeables, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing a rule to give Medicare Part D plans more flexibility to substitute biosimilars for the reference biologics so Medicare beneficiaries can have timelier access to the lower-cost drugs. The rule would permit the plans to treat the biosimilar substitutions as “maintenance changes” that don’t require prior Medicare approval. Such changes would enable the substitutions to apply to all enrollees – and not just those who begin the therapy after the effective date of the change.
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