Cost effectiveness and outcomes drive value for payers, Cigna‘s Chief Medical Officer Alan Muney said. While some medical device companies assume an FDA approval will mean a definite reimbursement nod from payers, these two forces drive a sometimes wrongheaded “gap of hopefulness” for the industry. (See his discussion of why device companies need to think like payers above.)
“The FDA decides on safety and effectiveness,” Muney said during a panel presentation at Advamed 2013. “But the FDA doesn’t do the cost effectiveness comparisons.”
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Short of that gap being closed, manufacturers should work to show significantly better outcomes than other products on the market or offer a lower cost for the same outcome, he said. (That’s not to say that a much more expensive device that lowers the total cost of care wouldn’t be reimbursed–that kind of expense is justifiable, he noted.)
“The guiding principle for reimbursement is the new technology really has to satisfy the outcomes. . . . You can’t just look at effectiveness any more,” he said.