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As expected, the , the second in a new class of lipid-lowering drugs -- PCSK9 inhibitors -- to become available in the U.S.
Drug-maker Amgen said evolocumab will be available in the U.S. next week.
As with alirocumab (Praluent), which was approved in July, evolocumab was approved for use in patients who fail to achieve LDL cholesterol lowering through diet and maximally-tolerated statin therapy in adults who require additional LDL cholesterol lowering, including patients with heterozygous or homozygous familial hypercholesterolemia.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11-4 in favor of approval for evolocumab, Amgen's entry in the PCSK9 derby, although there was some concern that clinical trials of the drug were short term -- the longest exposure to the drug was 7 months -- thus the panel said that outcomes studies should continue.
But for patients with homozygous familial hypercholesterolemia, the FDA advisors were unanimous in their support of evolocumab.
Sanofi and Regeneron Pharmaceuticals set the wholesale acquisition price for alirocumab on the U.S. market at $1,120 every 28 days for both the 75 mg and 150 mg doses, a price that was higher than anticipated by market watchers. Steven D. Pearson, MD, president of the Institute for Clinical and Economic Review (ICER), an independent nonprofit research institute in Boston focused on comparative effectiveness and cost effectiveness, told 51˶ that he anticipated that payers would negotiate for a lower price.
Amgen said the U.S. Wholesale Acquisition Cost (WAC) price of Repatha is $542.31 for one 140 mg single-use prefilled SureClick autoinjector or prefilled syringe, or $14,100 annually for the every two weeks administration.
The company said it would make a single monthly injection available next year. “Until then, Amgen anticipates monthly administration predominately for HoFH patients. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance.â€
Anthony C. Hooper, executive vice president of Global Commercial Operations addressed the cost issue saying, “… we will be working with payers and other purchasers to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilization. By partnering with payers to implement these programs, we can help ensure that all appropriate patients who could benefit from Repatha will have access to this important new therapy.â€
Evolocumab made headlines last spring when results of the LAPLACE-2 trial and the DESCARTES trial were presented at the American College of Cardiology and simultaneously published by The New England Journal of Medicine.
LAPLACE-2, which used a complicated randomization scheme, demonstrated dramatic reductions in LDL whether injected once a month or twice a month. It was also effective if given on top of a statin or ezetimibe, or administered as monotherapy.
In the DESCARTES trial, the monoclonal antibody cut LDL by a placebo-adjusted 48% to 62% from baseline across patient populations ranging from background management with diet alone to high-dose atorvastatin (Lipitor) plus ezetimibe (all P<0.001).
From the American Heart Association: