PCSK9 Inhibitor—An Important Breakthrough in Controlling Cholesterol, But at What Price?

Cardiovascular disease (CVD) remains a common—and costly—problem in US health care that is continuing to grow. By 2020, it is estimated that 38.7% of the population will have some form of CVD, with total direct medical costs associated with it more than $470 billion. According to statements from the American Heart Association, that number will only continue to rise, and by 2030, total direct medical costs for CVD will be a staggering $818 billion

(Heidenreich PA, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933-944). 

During a recent AMCP Nexus session, John Watckins, PharmD, MPH, BCPS, pharmacy manager, formulary development, Premera Blue Cross; Dan Danielson, MS, RPh, pharmacy manager, clinical services, Premera Blue Cross; and Jody Allen, BS, PharmD, FASHP, vice president, clinical account management, Express Scripts, discussed PCSK9 inhibitors as an emerging cholesterol treatment. Cholesterol is a major risk factor for CVD with increasing prevalence. 

The Cost of PCSK9 Inhibitors

PCSK9 inhibitors are a new class of drug that lower low-density lipoprotein-cholesterol (LDL-c) levels. Currently, Praluent (alirocumab) injection and Repatha (evolocumab) injection have been approved by the US Federal Food and Drug Administration to treat patients who are not able to control their LDL-c with current treatment options, including diet and statins. Clinical trials showed 50% to 70% reductions in LDL-c with PCSK9 inhibitors when compared to placebos, according to the presentation. 

PCSK9 inhibitors, however, carry a high price tag. The average wholesale acquisition cost is approximately $14,000, while the cost of Entresto, a recently approved heart failure drug, is only $4560. 

According to the presentation, the cost-effective price of PCSK9 inhibitors would need to be between $3600 and $4800 and the affordable price around $2177 (PCSK9 inhibitors for treatment of high cholesterol. Action guide and resource compendium. Institute for Clinical and Economic Review. Online. Updated November 2015).

Payer Considerations

During the presentation, Allen said that there are a number of things that payers should consider when it comes to PCSK9 inhibitors. 

Early concerns include a lack of cardiovascular outcomes data, the potential for overutilization, and cost. 

While PCSK9 inhibitors are an important breakthrough in controlling cholesterol, the presenters said, clinical management will be critical because the high cost associated with them could overwhelm patients and benefit plans. 

The speakers concluded that there are still a number of assumptions that are required to be made concerning PCSK9 inhibitors. Best estimates, accoridng to them, suggest that PCSK9 inhibitors are overpriced, given their estimated clinical value. 

Because PCSK9 inhibitors are unaffordable at current prices, this may drive unprecedented benefit cost increases.—Kelsey Moroz