In a commentary published online Monday in the Journal of the American Medical Association (JAMA), the CVS Health experts said that as PCSK9 inhibitors — a new class of high-cost, cholesterol-lowering drugs — come to market, current American College of Cardiology/American Heart Association (ACC/AHA) guidelines could complicate treatment choices and inhibit utilization management tools to rein in 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,” co-author William Shrank, chief scientific officer at CVS Health, said in a statement. “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 principle that doctors should treat patients to a specific cholesterol target based on their cardiovascular risk and 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; as a result, budgetary effects of the guidelines on patients and payors was limited, according to CVS Health.
Yet the authors said enthusiasm about PCSK9s in the marketplace is likely to be substantial, and they cautioned that the current guidelines aren’t clear about 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,” stated co-author Troy Brennan, 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 Food and Drug Administration last month approved Praluent (alirocumab), the first PCSK9 inhibitor, for treatment of high cholesterol, and the 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 health care system.
CVS Health said 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 gauge potential adverse effects, and large-scale clinical trials are under way that will provide greater insight into the long-term clinical outcomes.
In the United States, more than 73 million adults have elevated LDL-C, a major contributor to cardiovascular disease, a leading cause of death and disability.