New Cholesterol Drugs Not Breaking The Bank– Yet

Sales of the new cholesterol-lowering PCSK9 inhibitors have been lower than some had anticipated, the nation’s largest pharmacy benefit manager, Express Scripts, disclosed in a Reuters news story.

The majority of prescriptions have been rejected by Express Scripts “because patients did not meet required medical criteria,” Reuters reported.

“We’re seeing a lot of patients who either don’t qualify or their physicians are not providing (needed) information,” a vice president of Express Scripts told the news service.

As I have previously reported, insurance companies, faced by the threat of explosive demand for the drugs, have established rigorous criteria to ensure that the drugs are used only when they are “medically necessary.”

So far, drug sales have been “at the low end of… expectations,” the Express Scripts executive told Reuters. “We feel very confident we can manage this and this won’t mess up our clients’ budgets in 2016.”

But that could change in 2017 when the large cardiovascular outcomes trials with the drugs are scheduled to finish. Demand for the drugs could explode if the trials are highly positive.

The two drugs, alirocumab (Praluent, developed by Regeneron and Sanofi) and evolocumab (Repatha, from Amgen), each have a wholesale acquisition cost of more than $14,000 a year. But the actual cost is in most cases substantially less, since companies have been playing the two drugs off each other to negotiate discounts.

An earlier Reuters story quoted Paul Ridker, MD, a cardiologist at the Brigham and Women’s Hospital in Boston: “The price tag is exceptionally high. The good news is three different companies and potentially as many as five may have products in this arena soon, and hopefully competition will bring us there.”

“This is the first time we are going to see the payers really exert their influence here as much as the physicians and the patients and that’s going to be an interesting twist for the story,” Ridker said.

Reuters also quoted Patrick O’Gara, MD, another Brigham cardiologist, who said that the drugs are not ready to be used in people who believe they are statin-intolerant. “Release of these medications in an unfiltered way to a large number of patents with statin intolerance is a very worrisome proposition at this point and time, looking ahead and thinking about cost,” said O’Gara.

Last month, as I reported at the time, the Institute for Clinical and Economic Review (ICER) released a draft report stating that the PCSK9 inhibitors were highly effective but far too expensive to be used without broad restrictions. The price of the drugs would need to fall to nearly $2,000 to be used without limitations.

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