Dendreon vs. CMS:Controversy Is Bigger Than One Product
This article was originally published in RPM Report
It appeared as though the controversy over the level of efficacy and benefit from the prostate cancer immunotherapy Provenge ended when the drug was approved by FDA at the end of April. The FDA approval may have just been the halfway point in the product's route through government agencies to the commercial market. Now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
You may also be interested in...
Modification to ‘reasonable and necessary’ definition in MCIT final rule offers new avenue for drug manufacturers to get products covered in Part B. The Biden Administration will have to decide whether it will keep the Trump regulation unchanged.
CMS is proposing to deny coverage of Lilly’s Alzheimer’s “rule-out” diagnostic Amyvid. The decision is important for biopharma manufacturers for several reasons, both as a demonstration that the agency really will refuse to pay for FDA approved drugs—and for how CMS thinks it can actually use its authority to encourage research on effective AD therapies.
Sanofi is responding to critics of the Zaltrap price with a 50% discount. Is this a “watershed” moment for cancer drug prices? Probably not. The real test will come when payors resist a price on a drug with a proven therapeutic advantage – and when the drug really matters to the sponsor.