CVS Health medical officials seek changes in cholesterol guidelines

CVS Health has urged healthcare professionals to reconsider guidelines used in assessing which patients should use new cholesterol-lowering medications. Three top CVS medical officials expressed their opinion in a commentary published in JAMA on Aug. 10.

Last month, the FDA approved alirocumab, an injectable drug intended to lower cholesterol and the first commercially available proprotein convertase subtilisin kexin type 9 (PCSK-9) inhibitor. The FDA is expected to approve another PCSK-9 inhibitor (evolocumab) by Aug. 27.

Although clinical trials have shown alirocumab significantly reduces low-density lipoprotein (LDL) cholesterol, the drug is also expensive at an annual cost of nearly $15,000.

The CVS officials mentioned that more than 73 million adults in the U.S. have elevated LDL cholesterol and that patients need to take the PCSK-9 inhibitors for the rest of their lives. They urged that health insurers and government payers promote the use of statins, which are much cheaper. However, they noted guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) released in 2013 dissuaded clinicians from treating patients to a specific LDL cholesterol target.

They wrote that the guidelines “inadvertently limited the ability of payers to employ typical utilization management tools. The authors of the guidelines may not have contemplated this challenge in 2013, when little clinical evidence was available for this new class of medications.”

The CVS officials who wrote the letter were William H. Shrank, MD, MSHS; Jane F. Barlow, MD, MPH; and Troyen A. Brennan, MD, JD.

With the introduction of PCSK-9 inhibitors, the CVS officials said the industry might want to return to lipid goals to determine which patients should receive the drugs. Instead of focusing on LDL cholesterol targets, the ACC/AHA guidelines apply a 10-year atherosclerotic cardiovascular disease risk score to determine who should receive treatment.

The PCSK-9 drug manufacturers are currently evaluating the drugs’ effects on long-term clinical outcomes and whether they help prevent or delay major adverse cardiovascular events such as MI, ischemic stroke and death due to cardiovascular disease. Guidelines may change based on those results, according to the CVS officials.

“In the meantime, a rational, step-wise approach that again utilizes specific LDL [cholesterol] target levels would help,” they wrote. “In the absence of such an approach, clinicians will be forced to simultaneously consider multiple competing priorities in clinical decision-making: efficacy, safety, evidence quality, as well as responsible stewardship of limited health care budgets. Clear guidelines and targets would be attractive to support rational clinical decision making, particularly as increasing evidence emerges about the optimal role of PCSK-9 inhibitors.”