PCSK9 Inhibitors Should Cost 85% Less, ICER Reports

A draft report on the value-based price benchmark for the newly approved PCSK9 inhibitors for lowering bad cholesterol found that Repatha and Praluent should cost approximately 85% less than their list prices.

The Institute for Clinical and Economic Review (ICER)’s PCSK9 Inhibitor Therapies for High Cholesterol: Effectiveness, Value, and Value-Based Price Benchmarks provides prices that reflect the estimated improvements in long-term patient outcomes and a threshold for new drug costs that does not exceed growth in the overall national economy.

“Patients, clinicians, insurers — everyone needs good information in order to make the best decisions about the use and pricing of new drugs,” Steven D. Pearson, MD, MSc, the founder and president of ICER, said in a statement. “Our goal is to meet that need and in doing so not shy away from analyzing cost-effectiveness and potential budget impact.”

With between 3.5 and 15 million Americans potentially eligible to be considered for treatment with PCSK9 inhibitors, which have a list price of more than $14,000 a year, ICER sought to determine the true price at which these drugs would “represent a sensible value to patients and to the health care system.”

The report assessed comparative effectiveness research and value of both Praluent and Repatha in patients with familial hypercholesterolemia, patients with established cardiovascular disease, and patients at elevated risk for cardiovascular disease. The review was based on 25 clinical trials and 2 published systematic reviews and meta-analyses.

After evaluating the comparative clinical effectiveness and comparative value of the PCSK9 inhibitors for patients with elevated low-density lipoprotein cholesterol (LDL-C), the report determined that the 2 drugs have very similar effects and in the absence of a head-to-head trial, it is impossible to determine if one lowers cholesterol more than the other.

Overall, the ICER team reported that the PCSK9 inhibitors not only provide substantial or incremental net health benefit for all the patient populations studied, but the drugs appear to be very well tolerated thus far. However, it is important to note that the majority of studies lasted less than 6 months.

According to the report, treatment with PCSK9 inhibitors generates cost-effectiveness ratios that exceed the commonly-accepted $100,000 per quality-adjusted life year (QALY). In order to meet that threshold, the drugs would need price reductions of 63% to 82% to reach between $3615 and $4811. These prices represent what best represents the overall benefits these drugs may bring to patients.

Overall, the draft value-based price benchmark for both Repatha and Praluent should actually be $2177, which represents a full 85% discount. This $2177 price tag represents the level at which doctors and insurers would not have to try to limit patient use in some way.

“Our draft report therefore suggests that $2177 is the price that should serve as an alarm bell—if the cost is more than $2177 a year, drug companies, doctors, insurers, and other parties may need to work together to determine ways to limit the use of these drugs, find savings in other parts of the health care system, or adopt other measures to help make these drugs more affordable,” Mr Pearson concluded.