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

Regeneron CEO Says Critique of the Company's New Cholesterol Lowering Therapy Was Non-Scientific May 13, 2016
By Mark Terry, Breaking News Staff

Speaking yesterday at the Financial Times U.S. Healthcare & Life Sciences Summit, Leonard Schleifer, chief executive officer of Regeneron Pharmaceuticals , sharply 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 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.

Amgen and Regeneron were not only battling on the marketplace, but in court. In March, a Delaware district court came down on Amgen’s side in defense of two patents being contested by Sanofi and Regeneron. The jury ruled that the patents for Repatha were valid. Praluent uses a similar mechanism of action. The basis of the Sanofi’s and Regeneron’s claims was that Amgen’s patents for antibodies that targeted PCSK9 were so broad as to be meaningless.

Part of the pricing issue for both drugs is that the current standard of treatment for high cholesterol is statins, which typically cost about $50 per month. For most patients statins are considered very effective.

Amgen inked an exclusive deal with CVS Health (CVS), which blocked Praluent being used by CVS’s Pharmacy Benefit Management business and its patients. CVS argued that the two drugs were “therapeutically equivalent.”

Sanofi and Regeneron picked up a deal with UnitedHealth Group, which made Praluent the preferred access drug, and essentially forces patients to use Praluent for 12 weeks before their doctor can subscribe Repatha to them.

And although the lawsuit was sort of settled, damages have not been. On April 4, writing for The Motley Fool, Brian Feroldi said, “Damages have not yet been announced, but Amgen isn’t just looking for a big check or even royalty payments on sales. Instead, it’s going whole hog and trying to get Praluent removed from the market. While it’s hard to know what kind of chances Amgen has at getting the drug pulled completely, it does show that Amgen really isn’t playing around, and even if the courts determine that a royalty payment will suffice, losing the court case clearly puts Regeneron and Sanofi in a bind.”

After the panel discussion was over, ICER took to its blog to get in a final comment, 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.”

The American Journal of Managed Care (AJMC) also noted that “ICER is not the only group that thinks the drug makers set the price of PCSK9 inhibitors too high. Pharmacy benefit 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.”

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