PCSK9 price-cut matchup is on, as Regeneron and Sanofi slash Praluent list tag 60%

It’s not often that a tit-for-tat pricing battle goes public in biopharma—and that sort of fight is perhaps even more rare for prerebate list prices.

But Regeneron and Sanofi are engaged in just that with their PCSK9 cholesterol drug rival Amgen. Effective for pharmacy orders in early March, they will slash the list price of their entrant, Praluent, by 60%, matching the $5,850 level Amgen has reached with head-to-head competitor Repatha.

"We hope that payers will do their part to help ensure savings are directly passed on to more patients, through lower out-of-pocket costs," Sanofi’s North America head of Primary Care Business Unit, Michelle Carnahan, said in a statement on Monday.

Launched in 2015, both Repatha and Praleunt carried original list prices of a bit more than $14,000 a year. But drug pricing watchdogs at the Institute for Clinical and Economic Review (ICER) argued at the time that the PCSK9 inhibitors needed to bear prices of $5,404 to $7,735 to be cost-effective, drawing counterattack from Amgen and Regeneron.

But in March 2018, Sanofi and Regeneron reported that Praluent reduced the risk of cardiovascular events by 15%, and in high-risk patients with high levels of LDL, the benefit was even greater. Trying to capitalize on those positive results to lock in market share, the pair made a first move toward a dramatically lower price, cutting Praluent’s postrebate net price to the range of $4,500 to $8,000—within ICER’s recommendation—and won themselves an exclusive spot on Express Scripts’ preferred formulary.

Amgen didn’t just sit around. Last October, in what may be a first for pharma, Amgen slashed the list price of Repatha by 60% to $5,850 per year. In an interview with FiercePharma at the time, Amgen EVP of global commercial operations Murdo Gordon said the rebates the company was paying to commercial insurers and PBMs didn’t lower patients’ costs, which many payers peg to a drug’s list price. Amgen could only fix that by cutting Repatha’s retail price.

Now, Regeneron and Sanofi have followed suit, and the two competitors are once again on the same price level.

"Offering a lower-priced Praluent will help lower seniors' out-of-pocket costs and thereby remove another barrier to receiving this important medicine," Regeneron helmsman Leonard Schleifer said in a statement. The team now estimates that Medicare patients’ out-of-pocket costs will drop to about $25 to $150 a month.

Praluent has been lagging behind Repatha in terms of sales. In 2018, it generated sales of €261 million ($295 million), versus the Amgen drug’s $550 million. Those numbers represent year-over-year increases of 56% and 72%, respectively, but are still relatively weak compared with analysts’ original excitement over the PCSK9 class.

Bernstein analyst Ronny Gal drew a gloomy outlook when Praluent’s net price first came down for Express Scripts, calling the deal a "capitulation" that’s almost as good as nixing megablockbuster sales potential for PCSK9 drugs.

Gordon, though, expressed optimism. While admitting that lower net prices will take a toll on Repatha numbers in the near term, "we expect to see a positive impact on volume growth and reported net sales over the longer timeframe," the Amgen exec said on the company’s fourth-quarter earnings call.

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