Regeneron/Sanofi to cut price of heart drug in Express Scripts deal

(Reuters) - Regeneron Pharmaceuticals Inc and Sanofi SA will cut the net price of their expensive cholesterol drug for Express Scripts Holdings Co customers in exchange for greater patient access, with some savings to be shared with consumers, the companies said on Tuesday.

The drug, Praluent, dramatically lowers bad LDL cholesterol and reduces the risk of heart attacks and death in high-risk heart patients.

But sales of Praluent and a rival Amgen drug, with list prices of more than $14,000 a year before discounts, have been constrained by onerous roadblocks to patient access by insurers. They reject about 70 percent of prescriptions written, the companies have said.

“I expect this to substantially increase the sales,” Regeneron Chief Executive Leonard Schleifer said of the deal.

The arrangement makes Praluent exclusive on the Express Scripts’ national formulary for the drug class known as PCSK9 inhibitors, meaning some customers of the largest U.S. pharmacy benefit manager (PBM) will not easily access Amgen’s Repatha.

Amgen said the decision impacts 2,000 Repatha patients out of the 39,000 people who take the drug. It said it has been negotiating with several payers and that it will fight to be included in other Express Scripts business, and that it is offering significant discounts.

Amgen shares were off 2.7 percent, or $4.70, at $174.48 while Regeneron shares fell 2 percent, or $5.59 to $$298.09.

Regeneron and Sanofi said in March they would be willing to lower Praluent’s price in exchange for easier patient access. They said pricing could be tied to an independent review by the Institute for Clinical and Economic Review (ICER), which put an appropriate Praluent price for highest risk patients at $4,500 to $8,000 a year.

The Praluent net price will be at the “low end” of the ICER range including double-digit rebates, said Express Scripts Chief Medical Officer Steve Miller.

Beginning July 1, doctors can submit just one form attesting that a patient with heart disease meets criteria for PCSK9 therapy, such as inability to sufficiently lower LDL with cheap statins, like Pfizer’s Lipitor.

“This ... addresses head-on the frustrations caused by complex pre-authorization requirements that hamstring physicians and put an important medicine out of reach from patients,” Michelle Carnahan, head of Sanofi’s North America cardiovascular business, said in a statement.

Starting next year, Express Scripts will pass along a portion of Praluent rebates it receives from the drugmakers to people in eligible health benefit plans, lowering out-of-pocket costs.

“This is a significant (price) reduction that the patients will also feel, not just the insurance companies or the employers,” Schleifer said.

He said talks were taking place with other insurers and PBMs about similar arrangements.

“I hope that this will spread like wildfire through the entire payer system,” Schleifer said.