Report: Regeneron Blasts ICER's Analysis of PCSK9 Prices

Regeneron's CEO said ICER's methodology wasn't scientific. The nonprofit said analysis of a drug based on what people can afford to pay is the point of its work.

The CEO of Regeneron Pharmaceuticals squared off Thursday with a leader of a non-profit that recently deemed its new cholesterol drug way too expensive, according to a report in Reuters.

Regeneron was first in the US market with a PCSK9 inhibitor, which was approved in July 2015 with a list price above $14,000 a year per patient. The company’s therapy, alirocumab (Praluent), is being jointly marketed with Sanofi.

Not long after the approval, the Institute for Clinical and Economic Review (ICER) issued a report that said alirocumab and its competitor, Amgen’s evolocumab (Repatha), should cost about 67% less than the list price, based on what Americans could afford.

Regeneron CEO Leonard Schleifer said ICER’s analysis “wasn’t scientific” while taking part in the Financial Times US Healthcare & Life Sciences Summit. Reuters quoted him as saying, “They did all the calculations and they said it’s X, which is OK. I could have lived with that,” he said. But, “they said society can’t afford X, so we are going to say it’s one-third X.”

ICER Chief Operating Officer Sarah Edmond responded that taking budget impact into account is a major point of the group’s work. She said Regeneron was “attacking the science of an independent nonprofit whose entire mission is tied to opening the black box of pricing,” according to the Reuters report.

The nonprofit responded further on its morning blog, saying, “Mr. Schleifer objects to the budget impact portion of ICER’s analysis. However, in the world of finite resources, if we don’t consider how a new treatment might impact the ability to provide existing treatments for other conditions, we are not looking at the overall value of the drug.”

ICER is not the only group that thinks the drugmakers set the price of PCSK9 inhibitors too high. Pharmacy benefits managers (PBMs) reacted harshly to the prices set for the competing drugs last summer, and since then PBMs and health plans have negotiated discounts or exclusive agreements, and set up strict controls to limit use to only the most at-risk patients.

This week, Cigna announced it had reached value-based agreement with both Amgen and Sanofi-Regeneron to link reimbursement to how well the drug performs with its patients.