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Amgen’s Heart Data Don’t Impress Drug-Price Evaluation Group

Xconomy San Francisco — 

The drug-price evaluator that the drug companies love to hate has weighed in again, this time casting a skeptical eye on the price of a next-generation heart medicine from Amgen (NASDAQ: AMGN).

The group known as ICER, which stands for Institute for Clinical and Economic Review, released a report today that said Amgen’s evolocumab (Repatha) has not shown it can make a difference in deaths due to cardiovascular disease. ICER said it would soon recommend an even lower price for evolocumab that would reflect its reduced value. The list price is about $14,000 a year; it’s unclear how much of a discount Amgen is willing to provide in negotiations with insurers and their agents. The company recently began offering payers who lower access barriers refunds if patients on their plans taking evolocumab suffer a heart attack or stroke.

Two years ago, ICER estimated the drug’s value between $5,400 and $7,735 a year, but that estimate was based on an assumption that a long-term study of 27,000 patients would show the drug would not just reduce heart attacks and strokes, but would keep people from dying. ICER said in today’s report it would revise its estimate “in coming months.”

Amgen reported data from the long-term study, called FOURIER, this March, hoping to convince more doctors to prescribe evolocumab and more insurers to cover it. The company plans to release more data from the study later this year.

Evolocumab generated $141 million in revenue in 2016, well short of initial expectations. Its rival drug, alirocumab (Praluent), fared about as badly, with $116 million in 2016 sales.

ICER came under fire last year from the drug industry. The CEO of the Biotechnology Innovation Organization trade group accused ICER of being a front for insurance companies. Amgen has pushed back a few times, as its drugs for multiple myeloma have also gotten the ICER treatment. Last month, even before ICER published its update, Amgen blasted the agency’s coming report and the methods it has used to determine value. ICER was using a methodology that “advocates for arbitrary and paternalistic willingness-to-pay thresholds while doing little to help the healthcare system understand the impact of new technology in a truly usable way,” Amgen argued, adding that it “urge[d] ICER to apply methodologically sound and clinically useful techniques” instead.

Amgen didn’t respond to requests for comment on today’s ICER report by press time, but we’ll update this post with any feedback from the company.

Amgen’s evolocumab, and alirocumab, from Sanofi and Regeneron Pharmaceuticals (NASDAQ: REGN), were approved by the FDA in 2015 to reduce cholesterol in patients who are not getting enough benefit from the standard of care, called statins, or who cannot take them because of side effects. Insurers have refused to cover most prescriptions at first blush, demanding proof a patient truly needs the expensive next-generation drug instead of a low-cost generic.

Both drugs are PCSK9 inhibitors—injectable antibodies administered once or twice a month. They block a protein, called proprotein convertase subtilisin/kexin type 9, which interferes with the body’s clearance of so-called bad cholesterol from the bloodstream. The drugs showed a striking ability to lower cholesterol levels in clinical studies and were hailed as a big medical advance.

At the time of the FOURIER data release, cardiologists acknowledged the drug’s benefit in reducing cardiac events but were skeptical that the data could nudge payers to widen their coverage.

In an editorial that accompanied the FOURIER data publication in the New England Journal of Medicine, Dutch endocrinologist Robin Dullaart noted that the study was “rather short.” More testing is needed to determine how effective PCSK9 blockers are in high risk patients, as well as those who start treatment just after a heart attack or stroke, Dullaart wrote.

Partners Regeneron and Sanofi are due to report long-term data for alirocumab by the end of 2017 from a study of more than 18,000 patients called Odyssey Outcomes.

“The longer outcomes trial for alirocumab may shine additional light on the concerns about cardiovascular mortality,” ICER’s report says.

Shares of Amgen dipped 0.27 percent to $164.44 apiece on Tuesday.

Ben Fidler contributed to this report.