08-10-2015, 10:56 PM
Mon Aug 10, 2015 4:33pm EDT
By Deena Beasley
(Reuters) -
CVS Health Corp, the second largest manager of drug benefit plans for U.S. employers and insurers, asked heart specialists on Monday to revamp guidelines for treating patients with high cholesterol after the launch of new, expensive medications.
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 which 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.
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."
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.
AHA and ACC officials did not have immediate
comment Monday on CVS's call for changes to
their cholesterol guidelines.
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)
***Opinion***
This is ObamaCare hard at work ... Let's put a pricetag on human life ... If you can afford it, we have it, but if you expect the healthcare system to keep you alive ..... Well good luck with that!!
By Deena Beasley
(Reuters) -
CVS Health Corp, the second largest manager of drug benefit plans for U.S. employers and insurers, asked heart specialists on Monday to revamp guidelines for treating patients with high cholesterol after the launch of new, expensive medications.
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 which 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.
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."
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.
AHA and ACC officials did not have immediate
comment Monday on CVS's call for changes to
their cholesterol guidelines.
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)
***Opinion***
This is ObamaCare hard at work ... Let's put a pricetag on human life ... If you can afford it, we have it, but if you expect the healthcare system to keep you alive ..... Well good luck with that!!