Amgen Faces New ICER Roadblock To Repatha Reimbursement
The Institute for Clinical and Economic Review is lowering the value-based pricing benchmark for Amgen's PCSK9 inhibitor based on the results of the FOURIER cardiovascular outcomes trial – which was positive overall but did not show a reduction in CV mortality.
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ODYSSEY outcomes study homes in on value of PCSK9 inhibition for the subgroup of patients with LDL of at least 100 mg/dL, a potentially large market, but how much will payers ease restrictions in exchange for a lower price?
Labeling for reduction of cardiovascular risk may help a bit with payers, but the "twin problem" of pricing and lack of patient adherence is likely to continue to present hurdles for reimbursement.
Amgen's report of higher sales and news of priority review for an outcomes benefit claim for Repatha bode well, but a negative JAMA editorial is another knock on the PCSK9 inhibitor class.