- The Institute for Clinical and Economic Review (ICER) has released a new draft report, titled "PCSK9 Inhbitor Therapies for High Cholesterol Effectiveness, Value, and Value-Based Price Benchmarks."
- Based on ICER cost-benefit analysis, Sanofi/Regeneron's Praluent (alirocumb) and Amgen's Repatha (evolocumab) should cost between $3,615 and $4,811—between 65% and 70% lower than drugs' list prices of more than $14,000.
- Additional analyses conclude that in order for these drugs to come down to a level at which physicians and payers would not need to limit patient access, the cost would need to be $2,177 per year.
The ICER has taken available evidence for Praluent and Repatha and analyzed it under different utilization scenarios, both in terms of cost-effectiveness and potential budget impact. Based on ICER estimates in which 3.5 million to 15 million Americans would take a PCSK9 inhibitor in order to lower hard-to-control hypercholesterolemia, with a list price of $14,000, it would be budget-busting. According to the ICER's analysis, if only 25% of eligible patients used one of the PCSK9 inhibitors, it would cost an average of $20 billion per year—a recurring cost, year in and year out.
Of course, this is just one analysis, and it should be taken with a grain of salt. The market for PCSK9 drugs could deviate significantly from ICER's assumptions, and deals with insurers and government health programs could offset the patient access problems—or place significant limits on access—delineated by the organization.
The latter movement is already underway when it comes to PCSK9s. Earlier this month, Aetna and United Healthcare, two major insurers, issued guidelines under which patients could be covered for treatment with PCSK9 inhibitors. As expected, the guidelines are strict and mandate "medical necessity" as the starting point for a conversation. In addition, patients who want to take either Praluent or Repatha will be taking it as second- or third-line therapy after treatment with high-potency statins (and ezetimbe in the case of Aetna) have failed.