CVS wrote a letter that was published in the latest edition of the Journal of the American Medical Association in which it said that current guidelines, which include a formula for assessing heart disease risk rather than specific targets for levels of "bad" LDL cholesterol, aren’t clear on how to choose the best, and most cost-effective, therapy.
CVS said LDL targets are needed now that the FDA has approved Regeneron Pharmaceuticals Inc. and Sanofi SA's Praluent, a new drug that blocks a protein called PCSK9.
"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.
CVS and other pharmacy-benefit managers are concerned about the cost of the PCSK9s compared with older cholesterol fighters.
The latest treatment guidelines from 2013 overturned decades of practice in which doctors screened patients for high cholesterol, then sought to reduce LDL to a specific level.
Dr. Troyen Brennan, CVS' chief medical officer, said that if the guidelines are not changed, CVS will use its own targets, which will vary depending on patient history.
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