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 Repatha belongs to a potent new class of drugs known as PCSK9
inhibitors that are extremely effective at lowering "bad" LDL
cholesterol.
But the National Institute for Health and Care Excellence (NICE)
cost watchdog said on Wednesday the question as to whether this
would reduce heart attacks and strokes remained unanswered, given a
lack of long-term clinical outcomes studies.
NICE, which decides if treatments should be paid for on the National
Health Service (NHS), also said in its draft guidance that analyses
presented by Amgen had limitations that "called into question the
reliability of the cost-effectiveness results".
Amgen said it was disappointed by the decision, since the evidence
"strongly indicates that high cholesterol is linked to heart attacks
and strokes", and it aimed to provide more data and analyses to
demonstrate the cost-effectiveness of Repatha.
The British list price for Repatha is 4,448.60 pounds ($6,769) for a
year's treatment, which is less than half the U.S. list price of
more than $14,000. NICE said Amgen had also offered the NHS a
further undisclosed discount.
Regeneron Pharmaceuticals and Sanofi have a rival product called
Praluent that has not yet been assessed by NICE.
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The high price of PCSK9s has already stirred controversy in the
United States, where Express Scripts, the largest manager of
prescription drug plans for U.S. employers and health plans,
recently reached discount deals for the medicines.
(Reporting by Ben Hirschler, editing by Louise Heavens and David
Evans)
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