Regeneron CEO pushes back on pricing criticism of new gen cholesterol meds

If the new-gen cholesterol fighters are to achieve the lofty sales expected from them, makers Amgen ($AMGN) and partners Sanofi ($SNY) and Regeneron ($REGN) must overcome the pushback over the perception they cost too much. Regeneron CEO Leonard Schleifer has decided to take that on with some pushback of his own.

At a health conference Thursday, Reuters says Schleifer criticized a price analysis by Institute for Clinical and Economic Review (ICER) on the PCSK9 inhibitors, saying it simply wasn’t scientific, instead deciding itself what the country’s health system could afford to pay. The ICER review concluded the drugs do lower cholesterol but that their list prices would need to be 67% less to be cost effective. Payers and others have used ICER reviews in their arguments against drug pricing.

“They did all the calculations and they said it's X, which is OK. I could have lived with that,” Reuters quoted Schleifer as saying. “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 COO Sarah Edmond, who was on a panel with the Regeneron exec, took issue with Schleifer’s characterization, Reuters said, accusing him of attacking a group whose mission is to open “the black box of pricing."

The list prices on both PCSK9 drugs top $14,000, and though they’ve cut “bad” LDL cholesterol significantly in clinical trials, there’s no proof yet that the meds reduce the risk of heart attacks, strokes and other cardiovascular problems. With that outcomes data due later this year and next, payers have been diligent about restricting the drugs’ use to certain patients.

But Schleifer instead pointed to the value-based pricing contracts it announced this week with Cigna as an indicator of what can work with the new meds. Cigna stuck deals on both Praluent, from Sanofi and Regeneron, and Repatha, from Amgen. Cigna gets bigger discounts on the PCSK9 inhibitors if they don’t deliver the goods for patients.

Cigna’s deal is a way to open up access to patients while limiting its costs. Cigna will track patients who use Repatha or Praluent to see whether they rack up similar reductions in LDL cholesterol as patients in clinical trials did. If the drugs work as expected, then the insurer can theoretically anticipate saving money on CV complications down the road, giving Cigna a payoff on its drug investments. If not, then it collects a bigger discount as a consolation prize. And in the process, it will collect data on medical and pharmacy claims to study whether its PCSK9 patients are reaping CV benefits.

- read the Reuters story

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