US Medicare rejects routine coverage of warfarin genetic testing
This article was originally published in Scrip
The US Medicare programme is proposing to pay for pharmacogenomic testing to predict a patient's response to warfarin only when conducted as part of an appropriately designed clinical trial.
You may also be interested in...
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.
Clinicians and sponsors want the US FDA to open up antibacterial labeling to include more data on efficacy against resistant pathogens and in other body sites, but regulatory restrictions may require a workaround in the form of rapid, peer-to-peer communications about the data on new products.
US FDA’s 'consistent with labeling' guidance prompts more sponsors to consider comparative promotional claims, but any minimization of product safety issues still runs the risk of enforcement, legal experts say; Office of Prescription Drug Promotion’s research agenda on consumer understanding of Rx ad claims could result in an attempt to limit comparative claims.