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CVS Health Urges Reconsideration of Cholesterol Management Guidelines

Specific cholesterol targets would help determine optimal use of costly PCSK9 inhibitors

With a new class of high-cost cholesterol-lowering drugs coming to market, current American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of high cholesterol could complicate treatment choices and inhibit utilization management tools to control costs, the CVS Health Research Institute warns in a commentary published online in the Journal of the American Medical Association. CVS Health is encouraging the cardiology community to review and reconsider current cholesterol treatment.

“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 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 payers 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 [pharmacy benefit manager] 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 FDA approved alirocumab (Praluent, Regeneron/Sanofi), the first PCSK9 inhibitor, for treatment of high cholesterol in July 2015. An FDA decision on a second PCSK9 inhibitor, Amgen’s Repatha, is expected later this month. In the U.S., more than 73 million adults have elevated LDL-C.  Praluent will cost more than $14,000 annually per patient and will most likely be taken 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.

Brennan told Reuters that CVS Health, the number two manager of drug-benefit plans for U.S. employers and insurers, will wait until a second new PCSK9 inhibitor is approved by regulators before negotiating for price discounts or adding either of the pricier drugs to its list of covered medications. The company wants to see the type of patients who should be given the newer drug under the FDA label.

Sources: CVS Health; August 10, 2015; and Reuters; August 9, 2015.

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