Sanofi, Amgen Set to Get U.K. Access for Drugs With Discount

  • New cholesterol treatments cost $5,784 a year before discounts
  • Both medicines face tight restrictions from U.S. insurers

Sanofi and Amgen Inc. came a step closer to winning support for the use of their new cholesterol medicines within the U.K.’s public health-care system by offering discounts on the treatments for some patients who are at very high risk of heart attacks and strokes.

Amgen’s Repatha and Sanofi’s Praluent, which cost more than 4,000 pounds ($5,784) a person each year, can be used to help reduce cardiovascular risk in patients whose cholesterol hasn’t improved with lifestyle changes or other drugs, the National Institute for Health and Care Excellence said in draft guidelines published on Friday. The size of the discounts wasn’t disclosed.

The high cost of the injectable drugs -- which belong to a class of medicines known as PCSK9 inhibitors -- has led to tight restrictions for their use in the U.S., the largest market for prescription drugs. Amgen reported last week that about 77 percent of prescriptions for Repatha were being rejected, mostly because of hurdles in completing very detailed prior-authorization forms. Each of the two drugs, projected to top $180 million in sales this year, generated less than $20 million in the first quarter.

Undisclosed Discounts

The discounts negotiated with the two drugmakers for the U.K. -- which are kept confidential for competitive reasons -- are necessary to make the treatments cost effective, Professor Carole Longson, a director at NICE, said in the statement. Ezetimibe, the Merck & Co. medicine used as an alternative for those who can’t take older cholesterol-lowering drugs called statins, costs about 350 pounds a year.

A final recommendation by NICE typically forms the basis of funding decisions for National Health Service bodies across the country.

The discounted price “offers Praluent at a good value to the NHS,” a spokesman for the French drugmaker said, while declining to comment on the specific figures. A spokeswoman for Amgen also declined to give a discount figure.

Insurers and pharmacy-benefit managers have warned that the PCSK9 drugs could become one of the costliest classes ever because of their prices -- both are listed for more than $14,000 a year in the U.S. -- and the large number of people in the U.S. with high levels of bad cholesterol. For now, use of the drugs is limited to those with genetic conditions or who can’t tolerate other drugs such as statins, many of which have cheap generic versions.

Key Studies

Some of the restrictions may lift when the companies complete trials studying the effect of the drugs on reducing heart attacks and strokes. Amgen’s results are expected later this year and Sanofi’s also could be ready in the second half of this year, if the trial is stopped early because of the efficacy shown. Positive results would boost use of the drugs significantly.

Analysts estimate that Repatha’s sales will climb from about $185 million this year to more than $3 billion by 2022. Praluent is projected to generate $265 million in 2016, and grow to almost $3 billion over the next six years.

Sales in the first quarter reflect “the significant payer restrictions limiting the uptake of this innovative medicine,” Sanofi Chief Executive Officer Olivier Brandicourt told analysts on a conference call last Friday. “Both physicians and patients are confronted with significant administrative hurdles which are imposed by payers before providing access to this important new therapy.”

Competing Drugs

The insurance coverage has also been fiercely contested between the two companies.

Praluent, which was developed with Regeneron Pharmaceuticals Inc. and introduced in the U.S. in July, is covered by the U.S.’s biggest health insurer, UnitedHealth Group Inc., as well as Express Scripts Holding Co., Aetna Inc. and other insurers, giving more than 100 million people access to it. Amgen, meanwhile, won exclusive deals for Repatha from CVS Health Corp. and Harvard Pilgrim Health Care, and its medicine is also covered by Express Scripts and UnitedHealth.

Amgen will continue to hold discussions with insurers and to offer rebates “as we jostle for formulary positions,” Tony Hooper, Amgen’s executive vice president of global commercial operations, told analysts last week.

‘Extremely Frustrated’

“Talking to cardiologists, it’s clear that they are extremely frustrated at the moment,” he said. “We are spending quite a bit of time with payers at the moment, and helping them see the -- what I would imagine are the -- unintended consequences of a rather onerous paper-based prior-authorization system, which is resulting in so many patients not getting access to drug when they should.”

The U.K. panel’s support would mean the biologic treatments can be used by the NHS for patients with primary hypercholesterolemia or mixed dyslipidaemia, who are at higher risk for heart diseases because of a long-term buildup of fatty deposits in the arteries. Both medicines are given as self-administered injections once every two weeks.

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