PCSK9 inhibitors necessitate an update to heart guidelines, CVS Health says
CVS Health urged the American College of Cardiology and the American Heart Association to rewrite their guidelines to include specific cholesterol targets as the pharmacy benefit manager seeks to manage costs for a new class of cholesterol-lowering drugs known as PCSK9 inhibitors.
The viewpoint was published in JAMA on Monday.
The authors say the guidelines need to be rewritten because they were issued prior to the release of Merck's outcomes trial for Vytorin—dubbed Improve-It—as well as the availability of PCSK9 inhibitors, like Sanofi's and Regeneron's recently approved Praluent.
Merck's Improve-It trial showed an outcomes benefit in patients with high cholesterol who were taking Vytorin, a mix of a non-statin, ezetimibe and simvastatin. It was one of the first trials to show that a non-statin combined with a statin could reduce the incidence of heart attack and stroke.
“The guidelines were established when statins were the primary treatment for hyperlipidemia,” the CVS Health executives wrote in the commentary. “The dilemma presented by the introduction of the PCSK9 inhibitors reinforces the need to update guidelines on a regular basis, or at least offer clarification when new data emerge.”
Setting guidelines around specific LDL targets would allow clinicians and payers to create management strategies for people with high cholesterol, they argued. “Clear guidelines and targets would be attractive to support rational clinical decision-making, particularly as increasing evidence emerges about the optimal role of PCSK9 inhibitors,” they said.
CVS Health, which operates one of the nation's largest pharmacy benefit managers, publicly expressed concern about the potential costs of PCSK9 inhibitors months before Praluent was approved. Praluent is expected to cost $14,600 before discounts. Although the FDA gave the drug a narrower indication than expected, CVS and other PBMs contend that low-risk patients may be prescribed expensive PCSK9 inhibitors rather than first undergoing treatment with a low-cost statin.