Amgen's Repatha Study Shows Reduced Risk of Heart Attack, Stroke -- 2nd Update
March 17 2017 - 2:05PM
Dow Jones News
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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