Regeneron CEO Says Critique of the Company’s New Cholesterol Lowering Therapy Was Non-Scientific

Speaking yesterday at the Financial Times U.S. Healthcare & Life Sciences Summit, Leonard Schleifer, chief executive officer of Regeneron Pharmaceuticalssharply criticized the results of a report written by Boston-based Institute for Clinical and Economic Review (ICER) regarding its pricing for its new cholesterol medication.

On Sept. 8, 2015, ICER published a draft report on “Effectiveness, Value, and Pricing Benchmarks for PCSK9 Inhibitors for High Cholesterol.” The two drugs it evaluated was Regeneron and Sanofi‘s Praluent and Amgen‘s Repatha.

The report stated, in part, that, “there is remaining uncertainty about the interpretation of the existing evidence on the clinical effectiveness of these drugs for different types of patients. In addition, with a list price over $14,000 per year, there are serious questions regarding the price at which these drugs would represent a sensible value to patients and to the health care system.”

The report further went on to calculate that more appropriate prices that “best represents the overall benefits these drugs may bring to patients would be between $3,615 and $4,811, representing a 67 percent discount off the list price.”

Schleifer argued that the report’s numbers were not scientific. “They did all the calculations and they said it’s X, which is ok. I could have lived with that. But … they said society can’t afford X, so we are going to say it’s one-third X. They had value-based pricing, but they just decided that, well, we can’t afford it. That wasn’t scientific. There was no intellectual honesty there.”

ICER’s chief operation officer, Sarah Emond, was also on the same panel, and responded by saying, “You’re attacking the science of an independent non-profit whose entire mission is tied to opening the black box of pricing.”

Regeneron’s Praluent was the first PCSK9 inhibitor to hit the market, launching in July 2015. Amgen’s Repatha followed shortly after that.

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