Express Scripts secures price cut on new cholesterol drugs

Amgen, Sanofi and Regeneron have been forced to cut the cost of their new cholesterol drugs in negotiations with America's most powerful healthcare gatekeeper.

Express Scripts, the largest manager of prescription drug plans for US employers and health plans, and has just announced deals to control the cost of Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab), which have list prices of $14,000 each.

Express Scripts now expects to spend no more than $750 million on the drugs in 2016, far lower than industry forecasts, it says.

Nevertheless, analysts still predict the drugs will rapidly reach multi-billion dollar revenues – especially if they can eventually prove benefits in preventing heart attacks and strokes.

Thomson Reuters Cortellis forecasts both drugs will reach revenues of $2.3 billion by 2020.

Express Scripts has been the most vocal critic of pharma industry pricing, and last year took a stand against Gilead's pricing for hepatitis C drugs Sovaldi and Harvoni, excluding them from its coverage in favour of Abbvie's rival treatment Viekira Pak.

Express Scripts' senior vice president and chief medical officer Steve Miller said the deal on the cholesterol drugs meant this extreme action had been avoided.

"Aligned with our clients, we have achieved a more balanced marketplace, which has led to more collaborative discussions with manufacturers like Amgen, Regeneron and Sanofi, who share our interest in delivering innovative treatments to patients when clinically appropriate."

He added: "As a result, we are confident that we have received the best price possible for both products, without needing to exclude either."

Both drugs belong to the PCSK9 inhibitor class, and cut LDL cholesterol by more than 60 per cent in hard-to-treat patients.

The pharmacy benefits management (PBM) company would not disclose the exact terms of the agreements, but said they include rebates, restrictions on who can receive the therapy, protections against price increases and a spending cap.

Express Scripts says the deal represents the first time pharma firms have offered a discount to insurers who have limited a drug's use. It says it will use a robust monitoring system to ensure that only those patients who benefit from the drug continue to receive it, and that patients adhere to treatment.

The FDA licence for the PCSK9 drugs restricts their use to people with an inherited form of very high cholesterol, or those at high risk of heart attack or stroke who cannot control cholesterol with statins alone.

Now largely genericised, statins still offer effective and good-value treatment for most patients with high cholesterol, who total 70 million in the US.

But Amgen and Regeneron/Sanofi are hoping they can produce evidence to show their benefit in a much larger group of patients. Both drugs are being studied in trials to show that the PCSK9 medicines can lower the risk of heart attack, stroke and other serious heart problems.

Lower prices in Europe

The growing controversy in the US over drug prices has been fuelled by comparisons with Europe, where the new cholesterol drugs are much cheaper.

Repatha will be sold in the UK at a cost of $6,780 per year, less than half the $14,100 Amgen is charging for the drug in the US, with the price in other EU markets typically below $9,000.

However this doesn't mean the drug has escaped the attention of the UK's cost-effectiveness watchdog NICE – its ongoing review is expected to be finalised in April 2016, with a review of Praluent expected two months later.