Sanofi and Regeneron's next-gen cholesterol drug Praluent never lived up to early expectations, and its price tag was at least partly to blame. The cost petrified payers. Even before it—and its fellow PSCK9 med from Amgen—won FDA approval in 2015, pharmacy benefit managers (PBMs) rang alarms about the hundreds of billions the new PCSK9 class could cost the healthcare system.

But payers themselves weren't the only ones calling out costs after the drugs launched with stickers of more than $14,000. Self-appointed cost watchdog the Institute for Clinical and Economic Review (ICER) had just started assessing new drugs, and it said the companies would need to cut their prices by two-thirds to be cost-effective. 

Sanofi and Regeneron hit back. ICER had underestimated the cardiovascular risks patients faced, the partners said, and that in itself undercut Praluent's value. The group's process wasn't transparent, its estimate of the PCSK9 class' overall costs was "unrealistic" and its report ignored the "value and risk of innovation," they argued. Amgen tossed out its own litany of complaints.

It was only the beginning in that tug of war. Of 72 treatments assessed since ICER started a cost-effectiveness review program, the group has supported pricing on just 21, according to a chart compiled by Bernstein analysts in July. Since then, ICER has published reports endorsing pricing on two out of seven drugs, for a total of 23 endorsements in 79 reviews. It's still waiting on pricing decisions for three drugs, so the approval figure could climb. 

Drugmakers publicly balked at their products' verdicts dozens of times. Pharma advocates accused the group of shilling for the insurance industry—and PBMs, which sometimes praised ICER's work, didn't do much to dispel that idea.

But a funny thing happened: Signs of cooperation emerged. ICER not only revamped its appraisals to take pharma's concerns into account; some drugmakers themselves reached out. And some of the initial nos have since turned to yeses, including Praluent to treat high-risk high cholesterol patients.

Later, Sanofi and Regeneron would in fact approach ICER about pricing before launching their soon-to-be blockbuster immunology drug Dupixent. Indeed, over the last two years, many companies have been "rolling up their sleeves" to participate in the group's drug value reviews, said David Whitrap, ICER's vice president of communications and outreach.

ICER still has its critics, of course. But like it or not, with drug pricing a top issue going into the 2020 elections, there's no sign the group will back away from its role as self-appointed cost-effectiveness auditor.

ICER's origin

ICER emerged as a thorn in pharma's side in 2015 after it scored a $5.2 million grant from the Arnold Foundation and rolled out a program to scrutinize new drug prices. Suddenly, the organization—which had been evaluating everything from surgery techniques to talk therapy for depression—was drilling deep into pharma. Just months later, it unveiled its PCSK9 pricing slap-down. Dozens of evaluations would follow.

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