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Amgen cholesterol drug wins U.S. approval for some patients

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(Bloomberg) — Amgen Inc. (NYSE:AMG) won U.S. approval for its powerful cholesterol-lowering drug Repatha for certain patients, making it the second in a new class of treatments to come to market.

The Food and Drug Administration (NYSE:FDA) limited sales of Repatha to people with hard-to-treat levels of bad cholesterol, according to a statement from the agency. The injection will cost $14,100 a year, Amgen said, and will be available in the U.S. next week.

See also: Battle over who gets $15,000 heart drug focuses on guidelines

Repatha belongs to a category of drugs known as PCSK9 inhibitors designed to help patients with ultra-high bad, or LDL, cholesterol who can’t get their condition under control with widely used statins such as Pfizer Inc.’s Lipitor. Sanofi and Regeneron Pharmaceuticals Inc. won approval on July 24 for their PCSK9 drug, Praluent.

Repatha was approved in the European Union on July 21 for patients with uncontrolled cholesterol who require additional intensive reduction of LDL cholesterol.

Expensive therapy 

Express Scripts Holding Co. (Nasdaq:ESRX), the U.S.’s largest manager of prescription drug benefits, said PCSK9s could be the most expensive therapies ever seen, costing as much as $100 billion a year “if not managed properly.” As many as 10 million Americans may have conditions that would make them eligible for the drugs.

The pharmacy manager said Thursday that it would make a decision on how to cover the new drugs in the next several weeks. It didn’t rule out excluding either Amgen’s or Sanofi and Regeneron’s treatment to force price concessions. In the meantime, it will cover both.

“Our preference would be that both Amgen and Sanofi/Regeneron provide our clients favorable pricing so that it would make sense for our national formulary to cover both products,” David Whitrap, an Express Scripts spokesman, said in an e-mail.

CVS Health Corp. (NYSE:CVS), the second-largest pharmacy benefit manager after Express Scripts, said it would also review both new drugs and try to negotiate favorable pricing.

Working with payers 

“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” said Anthony Hooper, Amgen’s vice president of global commercial operations. Amgen will work with health insurers and pharmacy managers on getting the drugs covered, and finding ways to charge based on how effective they are.

See also: CVS joins Express Scripts in targeting new cholesterol drugs

Sanofi and Regeneron’s Praluent is given every two weeks in either a 75-milligram or 150-milligram injection, each of which costs $560 per shot, or almost $15,000 a year. Amgen’s will have a list price of $542.31 per shot. The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Education (ASPE) estimates the annual PCSK9 cost to Medicare will be $27 billion, assistant secretary Richard Frank said in a presentation.

UnitedHealth Group Inc. (NYSE:UNH), the largest health insurer in the U.S., will require patients who want to start taking Praluent to already use a high-intensity statin such as AstraZeneca PLC’s Crestor or, if they can’t tolerate strong statins, a low-or moderate-intensity one such as Merck & Co.’s Zocor.

Aetna Inc. (NYSE:AET) put Praluent on a precertification list that requires patients first fail to get their cholesterol under control with two high-dose statins. The insurer also requires Praluent be used in combination with a statin at the maximum tolerated dose.

Both Repatha and Praluent have shown a significant effect on cholesterol in clinical studies, though their effects on the heart won’t be known until trials are completed in 2017. High cholesterol is linked to heart disease, the No. 1 killer of Americans. Heart disease is also a condition that can lead to disability and a need for long-term care (LTC) services.

—With assistance from Zachary Tracer in New York and Caroline Chen in San Francisco.


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