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 The unusual move is the latest salvo in the war on escalating U.S.
healthcare costs, with insurers using aggressive tactics to extract
steep price discounts from drugmakers, even for the newest
medications, and controlling patient access to the most expensive
drugs.
CVS, in a letter published in the latest edition of the Journal of
the American Medical Association, said current guidelines, which
include a formula for assessing heart disease risk rather than
specific targets for levels of "bad" LDL cholesterol, do not provide
clarity on how to choose the best, and most cost effective, therapy.
CVS says LDL targets are needed now that the U.S. Food and Drug
Administration has approved Praluent, a potent new drug from
Regeneron Pharmaceuticals Inc and Sanofi SA that works by blocking a
protein called PCSK9 that helps LDL cholesterol stay in the
bloodstream. An FDA decision on a second PCSK9 inhibitor, Amgen
Inc's Repatha, is expected later this month.
CVS and other pharmacy benefit managers are concerned about the cost
of the PCSK9s compared with older cholesterol fighters such as
statins, which are available as generics for less than $50 a month.
Praluent, given by injection, has a list price of almost $15,000 a
year.
Both Praluent and Repatha, in combination with statins, have been
shown to lower cholesterol by around 60 percent compared with
statins alone.
"The current cholesterol management guidelines do not provide
clarity as to how these expensive new medications could fit in the
treatment paradigm, potentially resulting in some scenarios where a
prescriber could consider a PCSK9 inhibitor for a low-risk patient,”
Dr. William Shrank, chief scientific officer at CVS, said in a
statement.
The latest treatment guidelines, issued in 2013 by the American
College of Cardiology and the American Heart Association, overturned
decades of practice in which doctors screened patients for high
cholesterol, then sought to reduce LDL to a specific level.
The new guidelines dropped an emphasis on specific targets for LDL
levels. Instead, they suggest that an individual patient's risk of
developing heart disease rather than an LDL number should be used to
determine the need for more intensive treatment.
Dr. Troyen Brennan, chief medical officer for CVS, said that if the
guidelines are not changed, CVS will use its own targets, which will
vary depending on patient history. "We expect patients to first use
statins," he said. "If they can't use statins, or can't make (LDL)
targets, then they would use PCSK9 inhibitors."
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Some prominent cardiologists have questioned the 2013 guidelines,
but the ACC and AHA have shown little appetite to return to LDL
targets. "LDL may or may not correlate to cardiovascular outcomes,"
Dr. Kim Allan Williams, president of the ACC, told Reuters last
week.
Williams said on Monday, "The potential of this new class of drugs
is exciting, and we look forward to data from the clinical trials in
progress that could demonstrate whether these new
cholesterol-lowering drugs will benefit a wider group of patients.
In the meantime, ... any changes to them (guidelines) must be
supported by evidence."
The AHA said in response to a request for comments, "We continually
weigh our recommendations against current science and update our
guidance accordingly."
When Praluent was approved last month, Williams said the ACC
recommended that doctors limit prescribing PCSK9 inhibitors "to the
very high risk, hard-to-treat groups approved by the FDA." In
addition, he said patients should otherwise follow the current
cholesterol guidelines, which recommend lifestyle changes and, if
needed, statins for most patients with or at risk of heart disease.
CVS estimates that about 73 million Americans have elevated
cholesterol.
"PCSK9 inhibitors will be used chronically — generally for the
remainder of the lives of treated patients," CVS said in its letter.
"As a result, most payers, both government and commercial, are
probably considering thoughtful ways to rationalize the use of these
medications."
(Editing by Leslie Adler)
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