The much-anticipated results of the FOURIER study showed that Amgen’s Repatha (evolocumab) significantly reduces the risk of certain adverse cardiovascular (CV) events, such as myocardial infarction (MI) and stroke, but not the risk of CV death. The results also suggest that decreasing LDL cholesterol levels below current targets may benefit high-risk patients.

Insurers have been reluctant to cover Repatha—despite the drug’s demonstrated ability to lower LDL cholesterol even in patients who are being optimally treated with statins—at least in part because of Repatha’s $7,000-per-year price tag (the list price, before discounts, is $14,000 per year). According to FiercePharma, citing Symphony Health data, last year commercial insurers refused nearly three out of four coverage requests for Repatha and the other approved PCSK9 inhibitor, Sanofi and Regeneron Pharmaceuticals’ Praluent (alirocumab), and Medicare’s coverage denial rate was 61 percent. Payers said there were no data to quantify the drugs’ effects on CV risks, so the drugmakers initiated clinical trials to produce that data. (The Praluent ODYSSEY Outcomes trial is scheduled for completion in December.)

FOURIER included 27,564 adults with a history of CV disease who were receiving optimized statin therapy and were at high risk for a recurrent event. The patients continued their statin therapy and added Repatha or placebo to their regimen for a median follow-up period of 26 months.

The primary endpoint was a composite of CV death, MI, stroke, hospitalization for unstable angina or coronary revascularization. Compared with placebo, Repatha led to a significant 15 percent reduction in the risk for the combined events in the primary endpoint. Individually, there was a 27 percent reduction in the risk for MI, a 21 percent reduction in the risk for stroke and a 22 percent reduction in the risk for coronary revascularization, but no observed effect on CV death or hospitalization for unstable angina. The magnitude of the risk reductions increased in the second year of treatment. No new safety concerns were identified.

The lead researcher, Dr. Marc Sabatine, said a longer treatment period with Repatha could reveal a reduction in CV death risk, Reuters reported.

The trial results were published online March 17 by The New England Journal of Medicine.

Our Take: Amgen hopes the results will convince payers to cover Repatha, but some analysts believe the lack of a CV death benefit might outweigh the risk reductions in other CV events, should payers re-evaluate their stance on the drug. To sweeten the deal, Amgen said it would refund the cost of treatment if a patient experiences MI or stroke while taking Repatha as prescribed.

We have no idea how they would track that data or know whether the patient was taking the drug as prescribed.

Of note: Pfizer discontinued development of its PCSK9 inhibitor, bococizumab, in November. In light of the drug’s clinical data and the evolving market for lipid-lowering drugs, Pfizer said bococizumab was “not likely to provide value to patients, physicians or shareholders.”

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