CVS Health institute experts call for retooled cholesterol treatment guidelines in JAMA

WOONSOCKET, R.I. — Experts from the CVS Health Research Institute, writing Monday in the Journal of the American Medical Association (JAMA), are calling for a reconsideration of treatment guidelines for high cholesterol as PCSK9 inhibitors hit the market.

According to the CVS Health Institute experts, PCSK9 inhibitors, the new injectable high cholesterol drugs — the first of which was approved in late July — complicate the existing American College of Cardiology/American Heart Association guidelines. Because they were written when statins were the most common — and cost-effective — treatment for high cholesterol, experts wrote about their concern that PCSK9 treatment would be an expensive treatment prescribed to patients for whom it might be unnecessary.

“As PCSK9 inhibitors become available, 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," said Dr. William H. Shrank, chief scientific officer at CVS Health. “There is a need for consensus around management strategies for patients with high cholesterol given that the cost differential between proven older therapies and this new class of drugs is substantial. In fact, if used broadly, PCSK9 inhibitors would likely be the most costly class of medications we've seen thus far." 

CVS Health’s numbers estimate that a PCSK9 inhibitor treatment regimen would cost over $14,000 per patient per year. Given that high cholesterol is a chronic condition, the authors expressed concern about the cost over time as well. The article in JAMA mentioned also that the Food and Drug Administration noted the lack of outcomes evidence with PCSK9, and larger-scale trials are currently underway.

“As we work to encourage cost-effective use of these new cholesterol-lowering medications for our PBM clients, guidelines that incorporate specific LDL targets would be important to help determine where PCSK9 inhibitors best fit,” added co-author Troyen A. Brennan, MD, Chief Medical Officer at CVS Health. "Given the changing market dynamics, we are encouraging an evaluation of treatment guidelines that will provide clear guidance for clinicians and will also enable effective utilization management programs to help control health care costs while achieving desired health outcomes.”

More information from CVS Health can be seen in the infographic below.