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emerged in other cardiac drug studies, they write. “If long term benefits have in fact been overestimated in the current model (as they clearly were in an earlier version of this model), huge price reductions would be necessary for PCSK9i therapy to provide acceptable value by conventional benchmarks of cost-effectiveness.”
The authors of the editorial are Daniel Mark of Duke University Clinical Research Institute, Ilana Richman of the Yale University School of Medicine, and Mark Hlatky of Stanford University School of Medicine.
Amgen’s Ofman defended the assumption that preventing cardiac events, as recorded in FOURIER, should translate into survival, saying that the Fonarow study made “conservative assumptions.”
There is another point of divergence in the Fonarow and Kazi studies. When they modeled cost savings from evolocumab, the former factored in productivity—the economic cost of a heart attack victim not going to work, for example. Kazi says his group’s study sticks to just the medical costs saved—the hospital stay, the follow-on procedures—by avoiding a cardiac event.
The Fonarow study acknowledges that the current annual list price ($14,523) is not cost-effective for people with less elevated cholesterol levels. FOURIER, for example, accepted people with cholesterol levels all the way down to 70 mg/dl. For them, evolocumab should come in at just under $10,000 a year to be worth prescribing, the study says.
It might already do that. The problem is, no one beyond Amgen and the companies paying for the drug actually know. Amgen has said, as drug companies often do, that the list price is not a real-world price because of rebates and discounts negotiated in secret with insurance companies and their agents. The evolocumab discounts that Amgen has negotiated are undisclosed; the Fonarow study, to which Amgen contributed industry data, tabbed the average industry rebate at 29 percent.
Amgen has also said it would refund costs if a patient suffers a heart attack or stroke while on evolocumab. Ofman said “several” of its more than 20 contracts with insurers have refunds built in. He said that all patients under those contracts, regardless of individual cholesterol level or risk, would qualify for refunds.