FDA Drug Reviews Could Benefit From Insights Into What Payers Want, OND Chief Says
Peter Stein believes sponsors could have a role in “educating” the US FDA’s divisions and medical review staff about how registration trials can address payer data demands.
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US FDA Wades Into Reimbursement Issues With Upcoming Stakeholder Meeting On Alzheimer’s Drug Coverage, Evidence Challenges
Convened by the Duke-Margolis Health Policy Center, the meeting later this month will not be open to the public. But the center expects to continue to engage with stakeholders on the issues in the coming weeks and months.
To aid its value assessments, ICER is interested in helping FDA understand the importance of patient-relevant outcomes and consistent endpoints across trials of drugs for the same disease.
US Centers for Medicare and Medicaid Services concludes structural changes to existing payment systems to accommodate the high cost of Novartis’ Kymriah and Gilead’s Yescarta are still “premature.”