Express Scripts: Strict prior-auth moves keep a tight lid on PCSK9 sales

Turns out, pharmacy benefits managers are doing fine at controlling their costs for the new generation of cholesterol drugs. How? By limiting scripts to patients who are actually eligible for the PCSK9 meds, which carry list prices of more than $14,000.

Express Scripts VP Everett Neville

Express Scripts ($ESRX) VP Everett Neville tells Reuters that his company has so far rejected most prescriptions for the drugs, Sanofi ($SNY) and Regeneron's ($REGN) Praluent and Amgen's ($AMGN) Repatha. Launched over the summer, the two drugs are FDA-approved to treat patients with a disease that causes extraordinarily high cholesterol levels and for high-risk patients who haven't fully responded to aggressive statin therapy.

So far, "[w]e're seeing a lot of patients who either don't qualify or their physicians are not providing [necessary] information," Neville told the news service. Sales of the drugs have been at the low end of Express Scripts' expected range, he said.

As Reuters notes, Express Scripts won't approve a PCSK9 script until patients have documented their diagnosis, their cholesterol levels, their current statin use--which should be at maximum doses--and provided information on their diets. Only then will the pharmacy benefits manager give its blessing, provided all the information matches its eligibility requirements.

Neville figures the number of rejections will drop as doctors learn to prescribe the drugs more narrowly, Reuters says.

At least for now, that is. The drugmakers would have liked to get the FDA green light for patients who don't tolerate statin therapy, but the agency held off on that until data from CV outcomes trials becomes available in 2017. If Praluent or Repatha proves effective at reducing heart attack and stroke, then millions more patients would be in line for therapy. Express Scripts' rival CVS Health has predicted huge costs associated with that sort of expansion.

Of course, what's good for Express Scripts isn't necessarily good for Sanofi, Regeneron and Amgen. Analysts see the size of the PCSK9 market at $10 billion to $20 billion, including statin-intolerant patients. If PBMs and other payers can keep prescriptions within the narrow FDA bounds, early uptake won't deliver as much to the drugmakers' sales as they might have hoped.

- see the Reuters news

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