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 Highly anticipated results from a 27,500-patient trial of Amgen
Inc's Repatha will be presented on Friday at the meeting in
Washington, informing doctors and investors of just how much the
expensive injectable drug cut the risk of heart attack, stroke and
death in people with heart disease already taking maximum doses of
cholesterol-lowering statins, such as Lipitor.
Insurers and pharmacy benefit managers have been rejecting some 75
percent of prescriptions written for the new medicines while
awaiting proof of their clinical value. They prefer to keep patients
on cheap, generic statins already shown to prevent heart attacks.
Repatha and a competing drug, Praluent from Regeneron
Pharmaceuticals Inc and Sanofi SA , have list prices of over $14,000
a year, before discounts and rebates.
They belong to a class of medicines called PCSK9 inhibitors that
were approved on their ability to dramatically lower "bad" LDL
cholesterol. But with a raging debate over high U.S. prescription
drug prices, there has been pressure for hard data to justify the
cost of medicines that may have to be taken for life.
The high rejection rate has severely constrained sales of the
potential multibillion-dollar products, which were just $58 million
for Repatha and $41 million for Praluent in the fourth quarter.
Rejections have frustrated cardiologists trying to get these new
drugs for patients whose cholesterol remains dangerously high
despite taking the most potent statins, and for those unable to
tolerate them.
"What I care about is there are patients for whom the PCSK9 is
absolutely vital," said Dr. Leslie Cho, head of preventive
cardiology and cardiac rehabilitation at the Cleveland Clinic.
Industry analysts said they hope to see at least a 20 percent
reduction of major adverse heart events from Repatha, and that
anything less might be viewed as disappointing to investors.
Dr. Jorge Plutzky, director of the vascular disease prevention
program at Brigham and Women's Hospital in Boston, said a risk
reduction greater than 20 percent would be very hard for insurers to
ignore. But, he added, "any statistically significant reduction in
cardiovascular events would be important to me."
Amgen shares rose 3 percent last month, when it announced the
Repatha trial had succeeded without providing details.
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AWAITING APPEAL DECISION
Regeneron expects to have results from Praluent's large
cardiovascular outcomes trial by year end. Whether Praluent will
still be available depends on an appeal of a U.S. court ruling that
found it infringed Repatha patents.
Praluent was allowed to remain on the market pending the appeal
decision, which could take into account the benefit to society of
competition that lowers drug prices.
New prescriptions have been higher for Repatha since the January
court ruling. In the week ended March 3, there were 1,288 written
for Repatha and 892 for Praluent, according to data reported by
analysts.
But interviews with physicians found they were not taking Praluent's
uncertain future into account when selecting which to prescribe.
Those decisions were driven by preferences of individual patients'
health insurer or PBM, they said. Insurers negotiate discounts with
each drugmaker and then offer the cheaper one to patients with a
lower co-payment.
Express Scripts Holding Co , the nation's largest PBM, declined to
speculate on how much clinical benefit must be demonstrated before
making it available to more patients.
(Reporting by Bill Berkrot in New York; Editing by Lisa Shumaker)
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