In the face of growing criticism over its efforts to place a value on new medicines, the Institute for Clinical and Economic Review is trying to strike back. Recently, the nonprofit took a conciliatory approach by soliciting suggestions for improving its methods, but this week it became more aggressive by trying to dispel what it calls the “myths” about its operations and motives.

The controversial organization released a manifesto on Tuesday that attempts to rebut its many critics, who have chastised ICER for purportedly having cozy relationships with insurers; failing to sufficiently take into account the views of patients; and not providing enough time for drug makers to respond to assessments, among other things.

“Unfortunately, some recent criticism has been fueled by a lack of knowledge about ICER, or even purposeful misinformation by a few vocal critics, who oppose a move toward pricing that is better aligned with the added value a drug, device, or treatment provides to patients,” the nonprofit wrote in explaining the reasons for issuing its paper.

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The move comes as ICER has played a behind-the-scenes, but increasingly significant, role in the US health care system over the past two years. In the absence of an official entity to determine the extent to which medicines are cost effective — a function that is played by government agencies in some other countries — ICER has managed to fill the void with its reports.

The first such report — about new hepatitis C drugs — caused a ruckus by stating the medicines were, essentially, overpriced. And its methods and conclusions have increasingly irritated various drug makers. Last April, for instance, Amgen (AMGN) openly challenged the way the nonprofit was handling its review of bone cancer drugs before a public discussion even took place.

Meanwhile, a recent survey found that even as health plans continue to criticize drug prices, they have not yet embraced several new tools that have been developed by different organizations, including ICER, for assessing value. Next year, for instance, 64 percent reported it’s unlikely they will rely on ICER reports, although 36 percent said they may do so.

ICER responded by pointing to still another survey from late last year by the Dymaxium consulting firm, which found 59 percent of payers reported using its reports for making clinical-effectiveness and cost-effectiveness decisions about medicines, such as determining product affordability. But these developments have clearly placed ICER on the defensive.

In its statement this week, ICER struck a more assertive tone and pointedly argued it was not founded by health insurers, a frequent complaint from its critics, and that most of its funding – about 70 percent — comes from philanthropic foundations. “We do not represent the interests of the insurance industry,” ICER stated. “Our reports follow the evidence.”

And while ICER acknowledged most of its reports found the list prices of new drugs are too high relative to other options, the nonprofit also maintained that “some reports have found that the list price of new drugs can be well-aligned with the added value for patients.” In other words, ICER was arguing some of its assessments favor drug companies. You can read the rest of its arguments right here.

To what extent its attempt to dispel the “myths” will be effective remains to be seen. Already, though, one organization is upset. The National Pharmaceutical Council, a policy research group that focuses on the value of medicines and represents drug makers, took offense that ICER noted its financial support for the nonprofit back in 2006. That’s when ICER started as a research organization.

And like many drug makers, not just insurers, the NPC is still an ICER member. But NPC argued its membership should not be confused with approving of everything ICER does. “To be clear, NPC’s engagement with ICER is not an endorsement of that organization or its value assessment framework,” NPC said in a statement, adding that as an ICER member, it can work toward “fostering solutions.”

While acknowledging ICER’s efforts to become more responsive, another group remains frustrated. Although ICER took issue with complaints that it “does not engage meaningfully” with patient groups, the Personalized Medicine Coalition, a group of drug makers, insurers, patient groups, and other institutions, told us the nonprofit is slow to provide sufficient time to respond to assessments.

This was one of the key complaints, in fact, that last month prompted ICER to solicit suggestions for improvements. ICER set a mid-September deadline for submissions. Whatever changes ICER later makes will be closely watched, although the nonprofit is not under any obligation to alter its approach.

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