"We're seeing a lot of patients who either don't qualify or their
physicians are not providing (needed) information," said Everett
Neville, a vice president of Express Scripts, the largest pharmacy
benefit manager in the United States.
Neville, in an interview, said Express Scripts and insurers had
rejected a surprisingly high number of prescriptions for the two
injectable drugs, Praluent from Regeneron Pharmaceuticals and Sanofi,
and Amgen Inc's Repatha.
They were approved during the summer and belong to a new class of
medicines called PCSK9 inhibitors that can slash "bad" LDL
cholesterol by more than 60 percent.
The products each cost more than $14,000 a year and are meant for
patients with a hereditary form of high cholesterol and those with
cardiovascular disease.
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Before getting their prescriptions filled, patients in Express
Scripts plans are asked for documentation of their diagnosis, their
cholesterol levels, diet and whether they are already taking maximum
levels of standard cholesterol treatments called statins, which
include Pfizer Inc's Lipitor.
Neville predicted the number of rejected prescriptions for Praluent
and Repatha will eventually drop sharply as doctors prescribe them
more narrowly.
Express Scripts, which administers drug benefits for employers and
health plans and also runs large mail-order pharmacies, in July said
Praluent and Repatha are viewed as breakthrough medicines but could
wreak financial havoc on its clients.
But Neville, speaking on the sidelines of the PSA Pharmaceutical
Strategy Conference in New York, said sales of the drugs have been
at the low end of its expectations.
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"We feel very confident we can manage this and this won't mess up
our clients' budgets in 2016." But Neville said that could change in
2017, when results from a large study will show if Praluent
significantly reduces the risk of heart attack and stroke.
If it does, analysts say that could strengthen the argument for
giving it to a wider patient population. Repatha is undergoing a
similar large study.
Express Scripts has become a vocal critic of highly priced
medicines, including Sovaldi, an $84,000 hepatitis C treatment from
Gilead Sciences Inc. A rival treatment from AbbVie Inc was approved
late last year, and Express Scripts successfully pressured both
companies to lower prices.
(Reporting by Ransdell Pierson; Editing by Chris Reese and David
Gregorio)
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