Insurers are taking heat for their reluctance to cover a new class of PCSK9 inhibitors, some of which can cut cholesterol to the level of a 6-month-old baby, the New York Times reports. Cost is the issue. Amgen’s list price for its drug is $14,000 a year. Sanofi and Regeneron have developed drugs that act in a similar fashion; that is they can drive levels of LDL cholesterol to previously unheard of lows.
A study published in JAMA involved 968 patients tracked over 18 months. Some got a statin and some a statin plus the Amgen PCSK9 inhibitor, evolocumab. Patients taking only the statin saw LDL levels averaging 93, which is considered magnificent. But compare that to the patients taking the statin plus evolocumab; they averaged an LDL level of 36 and some saw LDL levels of 10.
Insurers may be more open to covering the drugs when the results of large clinical trials that measure their safety and mortality outcomes from heart disease are released. Those studies are expected to come within the next few months.
For now though, coverage is hard to come by, with insurers insisting on extensive documentation concerning a patient’s need for the drug. The New York Times: “Yet even when patients meet all the criteria for a PCSK9 inhibitor, insurers deny 80 to 90 percent of claims at first. In the end, only one in three or one in four qualified patients gets the drug….”
Source: New York Times