Express Scripts Holding Co, the largest manager of prescription drug plans for U.S. employers and health plans, said it has reached deals to cover two costly new cholesterol drugs and expects to spend no more than $750 million on them next year.

The injected drugs – Repatha from Amgen Inc and Praluent from partners Regeneron Pharmaceuticals Inc and Sanofi – each have list prices of more than $14,000 a year.

They were approved by U.S. regulators during the summer and belong to a new class of medicines called PCSK9 inhibitors that can slash “bad” LDL cholesterol by more than 60 percent.

Express Scripts, which has been a vocal critic of rising U.S. drug prices, would not comment on how much of a discount it had negotiated. It says total U.S. spending on the new drugs could reach $10 billion next year, far beyond Wall Street forecasts.

Express Scripts said its agreements with PCSK9 drugmakers include rebates, restrictions on who can receive the therapy, protections against price increases and a spending cap. It noted that drugmakers in the past would not provide a discount to insurers that limited a drug’s use.

“But this time, we have been able to put in place strong utilization management to make sure only patients that meet (U.S.) label criteria get on the drug and we get a discount on top of that,” said Chief Medical Officer Steve Miller. “We are confident that we have received the best price possible for both products, without needing to exclude either.”

The agreements are part of Express Scripts’ National Preferred Formulary list of drugs, which covers 25 million Americans.

Wall Street analysts forecast 2016 sales of between $157 million and $609 million for Repatha and between $211 million and $911 million for Praluent, with sales of each seen rising to $2.3 billion by 2020, according to Thomson Reuters Cortellis.

Express Scripts said that statins, many now available as low cost generics, remain the most appropriate therapy for the large majority of the more than 70 million Americans with high cholesterol.

U.S. health regulators have said that PCSK9 treatments should be used by a much smaller group of people with an inherited form of very high cholesterol, or people at high risk of heart attack or stroke who cannot control cholesterol with statins alone.

But the drugs may be used more widely over time. Amgen and Regeneron/Sanofi are conducting clinical trials to show that their PCSK9 medicines can lower the risk of heart attack, stroke and other serious heart problems.

If a study were to show that PCSK9s are a primary way to prevent serious heart problems, “obviously that increases the patient population enormously,” Miller said.

Amgen said in a statement that it continues “to engage constructively with other payers to enable patients to have access to Repatha,” while Sanofi/Regeneron said, “we are dedicated to establishing agreements with insurers.”



(Reporting By Deena Beasley; Editing by Steve Orlofsky)

Source: Reuters Health