(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.
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.
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.
