(Adds details, background, updates share prices)
By Bill Berkrot
May 1 (Reuters) - Regeneron Pharmaceuticals Inc and Sanofi SA will slash the 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, has a list price of over $14,000 a year, but the new price, after discounts and double-digit rebates, is on the "low end" of a $4,500 to $6,600 range, Express Scripts Chief Medical Officer Steve Miller told Reuters.
That range was determined in March to be cost effective by the independent Institute for Clinical and Economic Review (ICER) for highest risk patients assuming the drug results in a sustained reduction in cardiovascular-related deaths.
Praluent, given by injection, 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 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.
But investors are less certain that big price concessions will result in an overall sales increase. Amgen shares were off 3.3 percent, or $5.81, at $168.67 while Regeneron shares fell 2.5 percent, or $7.59 to $296.09.
The new 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.
Express Scripts, the nation's largest manager of pharmacy benefit plans (PBM), said about 25 million people, or a third of its customers, are covered by the preferred formulary.
Miller said in a telephone interview that the new Praluent price includes "point of sale" discounts for consumers. Beginning in July, 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 told Reuters by telephone.
The Trump administration and members of Congress have demanded that PBMs pass on more of the rebates they receive to consumers outraged over rising costs at the pharmacy counter. Many Americans now have health plans with higher deductibles or co-payments, making them responsible for more of their medical costs.
Other insurers and PBMs, including UnitedHealth, and CVS Health, have announced plans to return at least some prescription drug rebates back to consumers.
Amgen said the formulary 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.
Regeneron and Sanofi said in March they would be willing to lower Praluent's price in exchange for easier patient access.
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 generic versions of Pfizer's Lipitor.
Regeneron's CEO 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. (Reporting by Bill Berkrot in New York and Deena Beasley in Los Angeles; editing by Marguerita Choy and James Dalgleish)