We here at drugwonks.com are all for â€œeffectiveâ€ from a patient-centric standpoint (â€œeffectiveâ€ meaning â€œmost effective in treating a given patient). But we are highly dubious of people hijacking the word to mean â€œcost effectiveâ€ (like in â€œevidence-based medicineâ€ aka â€œhealth technology assessmentâ€ aka â€œrational use of medicine.)
It is, therefore, with pleasure that we pass along the following report from todayâ€™s edition of Drug Industry Daily(http://www.fdanews.com/did/5_192/cms/60829-1.html)
The future of the Centers for Medicare & Medicaid Services' (CMS) plan to share prescription drug plan data with the FDA in an effort to base Medicare reimbursement on product comparisons is in doubt as the agency determines whether it has the legal authority to share this information, an industry source says.
The CMS has been working with the FDA to develop this new program as a means to ensure the most effective products are covered by Medicare's Part D plan. While CMS Administrator Mark McClellan, the program's primary advocate, is leaving in October, that is not the reason why the program is in trouble, the source said.
The CMS is worried that, while the law gives it the authority to use Part D data for payment purposes, it may not be able to use this information to make comparisons between competing drugs. The CMS is also unsure whether it is able to provide the FDA this data for postmarket surveillance, as it originally planned.