Independent group finds
new cholesterol drugs far too costly
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[September 09, 2015]
By Bill Berkrot
(Reuters) - An independent non-profit
organization that evaluates clinical and cost effectiveness of new
medicines said announced prices for a just-approved class of potent
cholesterol lowering drugs were far too high, according to a draft
report released on Tuesday.
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The Boston-based Institute for Clinical and Economic Review (ICER)
said its analyses indicated "that the price that best represents the
overall benefits" the drugs may provide patients would be between
$3,615 and $4,811 a year, a 67 percent discount off the list prices.
"Even if these drugs were used in just over 25 percent of eligible
patients, then employers, insurers, and patients would need to spend
on average more than $20 billion a year for these drugs," ICER
president Steven Pearson said in a statement.
It would take a further price reduction to an annual cost of $2,177
in order to not have to try to limit patient use to keep overall
health care cost growth within bounds, ICER concluded.
The new injectable cholesterol fighters belong to a class known as
PCSK9 inhibitors that in clinical trials lowered levels of "bad" LDL
cholesterol by about 55-60 percent in patients who could not reduce
their levels enough with inexpensive, widely-used statins, such as
Lipitor, or those who could not tolerate statins. Ongoing studies
will determine if they actually cut heart attacks as statins have
been shown to do.
Praluent from Regeneron Pharmaceuticals and Sanofi has a U.S. price
of $14,600 for a year of treatment. Amgen Inc set an annual price of
$14,100 for its Repatha.
Depending on how they are used in practice, it has been estimated
that between 3.5 million and 15 million Americans could be eligible
for treatment, ICER said.
"There are serious questions regarding the price at which these
drugs would represent a sensible value to patients and to the health
care system," the report said. ICER found that the two drugs appear
to have equivalent overall effectiveness for most patient groups.
The drugs were initially approved for use in patients with a
hereditary form of extreme high cholesterol and those with heart
disease.
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Amgen said it disagrees with ICER’s methodology, assumptions and
preliminary conclusions. "We are concerned that ... its short term
budgetary focus will be used to create access barriers to innovative
medicines like Repatha for appropriate patients," Amgen spokeswoman
Kristen Neese said in an emailed statement.
Regeneron said it needs to better understand the methodology used in
the ICER analysis and called for a robust peer review process. "We
are committed to providing affordable medicines and ensuring access
to Praluent for patients who are prescribed the therapy," Regeneron
spokeswoman Hala Mizra said.
The PCSK9 drugs have been in the crosshairs of U.S. pharmacy benefit
managers, such as Express Scripts and CVS Health. They hope to gain
significant discounts for customers by offering the drugmakers
preferential usage status in exchange for lower prices, as they have
done with expensive new hepatitis C treatments.
Further entry of PCSK9 drugs from Pfizer and others could also lead
to lower prices as competition intensifies.
(Reporting by Bill Berkrot; Editing by Grant McCool)
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