By Jonathan D. Rockoff and Betsy McKay 

Shares in Amgen plunged Friday, after the biotech released positive data on the heart-health benefits from its cholesterol-lowering drug Repatha that nevertheless failed to persuade Wall Street that health plans would begin easing access to the expensive drug.

The stock's 6.4% drop underscored a mounting challenge for drug companies after securing regulatory approval for a new medicine: getting health plans to pay for it.

Researchers found, in a study following 27,564 patients over 2.2 years, that Repatha reduced the risk of deaths, heart attacks and strokes by 20% compared with standard treatment with statin drugs. Repatha lowered the risk of a wider array of heart-related events by 15%.

The risk reduction, although significant, may still not be enough for health plans to ease the tight restrictions on use of a drug that lists for more than $14,500 a year, according to analysts.

"It is likely that the majority of restrictions," on coverage such as requiring prior authorization, "will remain," Barclays' Geoff Meacham wrote in a research note.

To persuade health plans and drug-benefit managers to pay for Repatha, Amgen offered to refund the cost to payers for patients who suffer a heart attack or stroke. About 4.9% of trial subjects suffered one of the events, Peter Bach, director of Memorial Sloan Kettering Cancer Center's Center for Health Policy and Outcomes, said after reviewing the trial data.

"Now that Repatha has proven a meaningful reduction in cardiovascular events, we expect payers to remove onerous barriers" to patient access said Joshua Ofman, an Amgen senior vice president.

Amgen has been striking so-called value-based reimbursement deals with health plans like Cigna and Harvard Pilgrim Health Care that tie the payments the company receives to the benefits to patients.

Repatha, among the new injectable cholesterol-fighting agents known as PCSK9s, was approved in 2015 after studies showed it cut levels of bad cholesterol. Unclear was whether that LDL-cholesterol reduction also reduced the risk of heart-related events, such as heart attacks and strokes.

Without such evidence, health plans have limited access to Repatha as well as rival drug Praluent, from Sanofi SA and Regeneron Pharmaceuticals Inc., in favor of much-cheaper statins pills. Shares in Sanofi and Regeneron also fell Friday.

Amgen said last month that Repatha had met the goals of its study, but released the specific findings only on Friday at a medical meeting.

Amgen is "very confident" that doctors will view the results as "practice-changing" and incorporate Repatha into their care of patients whose cholesterol remains high despite treatment with a statin or who can't tolerate a statin, said Sean Harper, Amgen's chief of research and development.

Stephen Kopecky, professor of cardiovascular diseases at the Mayo Clinic in Rochester, Minn., cautiously praised the results. "It really is incredible that the drug could do even more than statins," he said. "But if you look at it, there are still a lot of people having troubles. This wasn't one of these results where you say, 'wow, this is an incredible reduction.'"

He prescribes the drug for patients who can't be helped by statins or other cholesterol-lowering drugs and said he would likely stick with that prescribing pattern. "I'm not sure this is going to change my practice pattern much. We need to be judicious, because of price and because we want patients to remember that it's not just about the drug," he said, noting patient also need to stick to a healthful lifestyle.

In making its case to the payers, Amgen may point to the study's finding that the risk reduction improved after giving Repatha six months. After a year's treatment, patients taking Repatha were at a 25% lower risk of heart-related events, Dr. Harper said.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com and Betsy McKay at betsy.mckay@wsj.com

 

(END) Dow Jones Newswires

March 17, 2017 13:50 ET (17:50 GMT)

Copyright (c) 2017 Dow Jones & Company, Inc.
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