Express Scripts Will Cover Both PCSK9 Inhibitors

Express Scripts, the nation’s largest pharmacy benefit manager (PBM), will cover both versions of a new class of cholesterol-lowering drugs approved a month apart this summer, according to the company. Coverage will start October 12, 2015.

Adding the 2 PCKS9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha) comes amid concern about the drugs’ high cost and calls for the American Heart Association and American College of Cardiology to update clinical guidelines to reflect their presence in the market.

Right now, PBMs are taking on the gatekeeper role themselves, and both Express Scripts and CVS Health had said they would not automatically add the new class to the national preferred formulary until they had reviewed the FDA label and negotiated discounts over the announced wholesale prices. Sanofi-Regeneron set a price of $14,600 a year for Praluent when it was approved July 24, 2015, and Amgen followed with a price of $14,100 for Repatha after its August 27, 2015, approval.

Express Scripts announced it had achieved steep discounts as well as protections against future price increases for both drugs. While it declined to announce discount levels, it expects to spend $750 million for the 2 drugs in 2016. That amount is well below earlier forecasts but still puts the drug class among the most costly in the market.

“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,” said Steve Miller, MD, Express Scripts’ chief medical officer. “As a result, we are confident that we have received the best price possible for both products, without having to exclude either.”

Having 2 drugs hit the market at once no doubt helped negotiations, and the expected arrival of more entrants into this class will create more opportunities for price controls. Pfizer’s entrant could receive approval by next summer.

At the same time, both drugs are in the midst of long-term cardiovascular outcomes trials that could lead to expanded FDA labels. In the United States, the drugs are only indicated for those patients at highest risk for heart disease who have been unable to control cholesterol on maximally tolerated statins. (They will also be indicated for the much smaller group of patients with familial hypercholesterolemia). In Europe, both drugs won broader approval for patients who are statin intolerant, which will dramatically widen the pool of patients who may try them.

Express Scripts pointed out that the new class of biologics, which require injection every 2 weeks, may be unfamiliar to patients accustomed to taking a pill every day, and special education, training, and monitoring will be required.

Both drugs inhibit the proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that when blocked results in dramatically lower levels of low-density lipoprotein (LDL) cholesterol. PCSK9 stymies the liver from effectively eliminating LDL cholesterol on its own. When it was found that persons who lacked this enzyme had abnormally low cholesterol levels, researchers immediately recognized the therapeutic potential and began looking for ways to block PCSK9. Drugs in the class can reduce cholesterol levels up to 60%.

The total market for the 2 drugs, based on the FDA approval, has been estimated between 5 million and 10 million.