Commercialization, Pricing

Sanofi/Regeneron’s one-two punch on PCSK9 price and health data wins a key convert as Express Scripts creates exclusive formulary deal

Just 7 weeks after Sanofi $SNY and Regeneron $REGN flagged pivotal data on a clear mortality benefit to be had from its PCSK9 cardio drug Praluent, they’re back with a chummy public selfie with Express Scripts that swaps a new discount price in exchange for a pledge to dismantle any hurdles that could prevent the PBM’s 20 million members from taking advantage of it.

Len Schleifer

Nobody’s talking specifics here, but in March Sanofi/Regeneron pledged to cut its price to $4,460 to $7,975 a year for payers who are willing to stop throwing up roadblocks to this drug, dropping to a price that on the low end is not much higher than the $10-a-day cost of the old generation of statins before they went generic. At the high end, it still marks a sharp drop from the $14,000 wholesale price that had been the market standard used to peg discounts against.

Salting that deal with new mortality benefits from longterm use, a goal that eluded rival Amgen, appears to be enough for at least one of the most prominent pharmacy players to see their way through to dropping the complex approval process that made this drug a nonevent on the bottom line. Express Scripts is giving Sanofi/Regeneron an exclusive place on their formulary — take that, Amgen — with a pledge to pass along the savings to its members through lower out-of-pocket expenses.

The blunt Regeneron CEO Len Schleifer said the deal was “designed to break the gridlock so that Praluent is finally able to reach patients most in need. U.S. cardiologists have experienced unprecedented challenges in securing access for Praluent for patients who were clearly appropriate, but were denied coverage. This agreement sets a new standard in industry and payer collaboration that we hope will serve as a model for how to make innovative medicines more accessible and affordable.” 

And ICER chief Steven Pearson offered his endorsement, happy to see some real negotiating on price and access. He noted:

Following a decades-long trend toward dysfunction and finger-pointing, the US health care system is beginning to address its drug pricing problem through the emergence of a ‘grand bargain.’ When a manufacturer is willing to responsibly price an innovative medicine in line with its clinical benefits, payers should reciprocate by removing the hurdles that can prevent patients from getting the drug.

Mike Suesserman

Sanofi/Regeneron and Amgen have been duking it out over who owns the patents on PCSK9, but both have been essentially sidelined by payers’ persistent refusal to hit a green light on these drugs. With physicians staring at a pile of paperwork and repeated denials, these companies never had a chance at the original high price they wanted to fetch. Reality dawned slowly, but the sun is coming up on a field that a host of analysts still resolutely believes is a blockbuster market in the making.

“We’ve been out on the market close to three years,” says Mike Suesserman, VP of the cardiometabolic and opthamology business unit at Regeneron. They’ve seen lots of feedback along the way and identified what the critical hurdles are. This deal, he says, addresses those hurdles.

“In that sense I think it’s a huge leap forward.”

You can bet that more such leaps forward are in the works as Amgen looks to strike back on the pharmacy front.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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