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

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(Bloomberg) — The fight is intensifying over which patients will get an almost $15,000-a-year cholesterol drug from Regeneron Pharmaceuticals Inc. (Nasdaq:REGN) and Sanofi (NYSE:SNY), with CVS Health Corp. (NYSE:CVS) calling for new treatment guidelines to make it clearer who should qualify.

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

In a commentary published online Monday in the Journal of the American Medical Association, three top medical officials from CVS are urging cardiologists to reconsider cholesterol-lowering guidelines from the American College of Cardiology and American Heart Association. They say that setting clear cholesterol levels for patients to reach would help doctors determine who needs the injectable drug and others like it, known as PCSK9 inhibitors.

Regeneron and Sanofi’s treatment, Praluent, is the first of the powerful new class of cholesterol-lowering drugs, which already are triggering a huge debate among insurers and employers worried about their potential costs. A competing drug from Amgen Inc. (Nasdaq:AMGN) could be approved by U.S. regulators by the end of this month. Already, insurers such as Aetna Inc. (NYSE:AET) and UnitedHealth Group Inc. (NYSE:UNH) are at odds over which patients can get coverage for Praluent.

See also: Amgen’s cholesterol drug recommended by European regulator panel

In addition to its drugstore business, CVS is the second-biggest pharmacy benefit manager (PBM) in the United States, working with insurers and employers to negotiate prices for medications. For that reason, its views are taken very seriously in the health industry.

Vague guidelines

In approving Praluent, the U.S. Food and Drug Administration (FDA) left it vague about who exactly should get the medicine, approving it for patients with atherosclerotic disease who need further reduction of cholesterol despite being on high doses of statin drugs such as Lipitor. The FDA didn’t define precisely what this means, creating potential for conflict between patients, doctors and insurers. The drug is also approved for patients with a genetic form of high cholesterol.

Setting a minimum cholesterol level for PCSK9s would be a shift for the influential cardiology organizations. Their current guidelines, written in 2013, moved away from recommending preset targets for bad cholesterol in favor of a broader strategy of looking at overall heart disease risk to determine treatment.

Without specific bad cholesterol targets, insurers could find it difficult to limit PCSK9 use to patients who need the drugs most, making expenses difficult to control, said Troyen Brennan, CVS’s chief medical officer, in the medical journal commentary he wrote with two colleagues.

If the PCSK9 drugs are used broadly, “the cost implications for payors and society could be extraordinary,” they wrote. “Reasonable utilization management can occur only with a return to reliance on lipid goals.”

Doctors’ judgment

Under the current guidelines, “it would be a simple, logical step” for a doctor to conclude that PCSK9 drugs should be used widely, even for patients with low risk of major heart events, Brennan said in an interview. After all, studies have shown that lowering LDL, or bad cholesterol, is generally better for heart health.

“We are basically trying to disrupt that kind of thinking,” Brennan said in an interview.

CVS’s larger competitor, Express Scripts Holding Co. (Nasdaq:ESRX), agreed that cholesterol guidelines need to become much more specific about how to define statin failure.

“I definitely think they are going to have to relook at the guidelines. The question is how do you define failure?” said Steve Miller, chief medical officer for Express Scripts, in an interview. “There is a lot of ambiguity in the current classification system.”

Insurer limits

Insurers already are putting different restrictions on who can get Praluent. Aetna, for example, will approve Praluent for heart disease patients whose bad cholesterol remains above 70 milligrams per deciliter despite trying two regimens containing both a statin and another type of cholesterol drug, according to a recent policy bulletin. The average American adult has an LDL of about 115, according to statistics compiled by the American Heart Association.

See also: PBM Resolves Drug Shift Investigation

Ed Pezalla, Aetna’s national medical director for pharmacy policy, agreed that numerical cholesterol guidelines are needed.

“Targets are what’s used by doctors and patients,” he said in an interview. “That’s what makes sense to them.”

UnitedHealth is somewhat more restrictive in who can get Praluent, according to a set of criteria posted on its website. It requires heart disease patients to have bad cholesterol that remains above 130 while on statin therapy to qualify for a PCSK9.

While sales of the drugs are expected to ramp up slowly, insurers expect they may eventually become one of the biggest-selling classes of treatments of all time. That’s because, unlike expensive new drugs for hepatitis C that cost $1,000 a pill but cure the disease in three months, patients who get on the new PCSK9 drugs are likely to stay on them indefinitely, potentially for the rest of their lives.

Statins alone

Kim Allan Williams, president of the cardiology college, said numerical LDL targets aren’t needed because the guidelines already make clear what type of bad cholesterol reduction should be expected from high doses of statins alone — generally about a 50 percent reduction.

To get a better price, Brennan said CVS may decide to cover only one of the PCSK9 drugs. The company has used such a strategy in other classes of drugs to extract a discount from one manufacture in exchange for excluding its competitors. Last week, CVS said it would begin excluding Viagra, from Pfizer Inc. (NYSE:PFE), next year, letting erectile-dysfunction patients use Cialis, from Eli Lilly & Co. (NYSE:LLY), instead.

A decision on PCSK9s will be made after the FDA rules on whether to approve Amgen’s drug in late August, Brennan said. Express Scripts’ Miller also said his company may cover only one PCSK9 drug if this approach yields a better price.

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