6 reasons cholesterol drug guidelines must change

In a commentary published online first August 10 in the Journal of the American Medical Association (JAMA), experts from CVS Health Research Institute encouraged the cardiology community to review and reconsider current treatment guidelines for the management of high cholesterol. 

Related:5 things to know about cholesterol-lowering PCSK9 inhibitors

The top 6 reasons that the changes are needed, according to CVS Health are:

• As a new class of high-cost cholesterol lowering drugs – PCSK9 inhibitors – comes to market, current American College of Cardiology/American Heart Association (ACC/AHA) guidelines could complicate treatment choices and inhibit utilization management tools to manage costs. “…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, MD, chief scientific officer at CVS Health.

• The cost differential between proven older therapies and PCSK9 inhibitors is substantial, according to Shrank. “In fact, if used broadly, PCSK9 inhibitors would likely be the most costly class of medications we've seen thus far." 

• FDA recently approved Praluent (alirocumab), the first PCSK9 inhibitor, for treatment of high cholesterol in July, 2015, and approval of a second therapy is expected soon. Praluent will cost more than $14,000 annually per patient and will most likely be taken chronically for the duration of a patient's life, amplifying strain on the healthcare system.

• ACC/AHA’s 2013 guidelines were established when statins, a highly effective, low-cost treatment option, were the primary treatment for high cholesterol and the only treatment with proven improved outcomes. As a result, budgetary effects of the guidelines on patients and payors was limited, according to the commentary. The CVS Health authors write that there is likely to be substantial enthusiasm about PCSK9s in the marketplace and caution that the current guidelines do not provide clarity on how to choose the best evidence-based therapy to achieve cost-effective clinical outcomes,” according to a CVS Health statement.

• "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," said co-author Troyen A. Brennan, MD, chief medical officer at CVS Health.

• FDA advisory panels, which met earlier in the year, noted the lack of outcomes data for this new class of medicines and the need for more broad evaluation to assess potential adverse effects. In addition, large-scale clinical trials are under way that will provide greater insight into the long-term clinical outcomes.

Read next: The first PCSK9 inhibitor approval: 5 lessons