Guidelines that incorporate specific cholesterol targets would help to determine optimal use of PCSK9 inhibitors and enable effective utilization management
WOONSOCKET, R.I., (August 10, 2015) – In a commentary published online first today in the Journal of the American Medical Association (JAMA), CVS Health (NYSE: CVS) Research Institute experts encouraged the cardiology community to review and reconsider current treatment guidelines for the management of high cholesterol. As a new class of high-cost cholesterol lowering drugs, known as 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.
"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 MD, MSHS, 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."
In 2013, ACC/AHA guidelines abandoned the longstanding principle that physicians should treat patients to a specific cholesterol target based on their cardiovascular risk and instead recommended more aggressive management of cholesterol with high-dose, high-potency medications if a patient was at elevated risk for cardiovascular disease. The 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, so budgetary effects of the guidelines on patients and payors was limited. However, 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.
"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."
The U.S. Food and Drug Administration (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. In the U.S., more than 73 million adults have elevated LDL-C, a major contributor to cardiovascular disease, a leading cause of death and disability. 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 health care system. The 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, and large-scale clinical trials are under way that will provide greater insight into the long-term clinical outcomes.
The CVS Health Research Institute is focused on contributing to the body of scientific knowledge related to pharmacy and health care through research collaborations with external academic institutions, participation in federally-funded research, analysis and sharing of CVS Health data sources and coordination of pilot programs and initiatives. CVS Health Research Institute findings support a continuous quality improvement environment, which encourages product innovation and development to benefit CVS Health patients, clients and their members.
To read the commentary in JAMA, click the following link: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2015.10017
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