CVS Attempts to Control PCSK9 Costs

Debate continues around eligibility requirements for pricey new high cholesterol drug class.

On the heels of the debate that raged around costly new hepatitis C drugs comes the next battle in the specialty pharmacy landscape.

Last month, the FDA approved Regeneron & Sanofi’s proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, Praluent, with Amgen’s Repatha expected to be approved soon as well. Praluent was announced to have a cost of $14,600 annually. With such a price point, if the drugs were to be broadly approved for the approximately 2.3 million people who could potentially use PCSK9 inhibitors, it could cost up to approximately $23.3 billion annually, according to pharmacy benefit manager Prime Therapeutics.

As a result of the potentially astronomical price tag, pharmacy benefit manager CVS Health urged the American College of Cardiology (ACC) and the American Heart Association (AHA) to revise guidelines for cholesterol-treatment to include previously disregarded numerical targets for LDL cholesterol.

"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."

The previous ACC/AHA guidelines recommended treating patients for specific cholesterol targets based on cardiovascular risk. These guidelines were abandoned for more aggressive cholesterol management with highly effective statins in patients with an elevated cardiovascular disease risk.

When low-cost statins were the primary treatment for high cholesterol, there was a limited financial impact from these guidelines on patients and payors. With the arrival of PCSK9s, CVS warns that the current guidelines are not clear in determining the optimal therapy for cost-effective clinical outcomes.

Concerns persist among PBMs that without numerical benchmarks, physicians would have more freedom to prescribe the costly PCSK9s over statins, which have less expensive generic options. CVS officials told Reuters that they will hold off on coverage for Praluent, while waiting to see how Repatha's official label defines the size of the recommended treatment population.

Meanwhile, a recent study by Prime analyzing claims data of more than 3 million commercially insured members found that 1 in 5 (80%) individuals with established cardiovascular disease were adherent to their high dose statin regimen, as per ACA/AHA recommendations.

“Because PCSK9s have not been proven to prevent heart attacks and their long term safety has not yet been established, we feel compelled to help our clients optimize statin therapy prior to the initiation of PCSK9s,” said David Lassen, chief clinical officer at Prime. “We believe this is the right thing to do clinically for our members and the responsible thing to do as we manage the total cost of care.”

Ultimately, the tug-of-war for the cost and treatment guidelines of PCSK9s could have a similar outcome to the battle over the new hepatitis C antiviral drugs, which saw exclusive formulary decisions largely influenced by price discounts.

"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 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."