- The Institute for Clinical and Economic Review, a non-profit research organization which has taken a number of pharmaceutical companies to task for high prices of new drugs, has begun to more aggressively push back against the industry's claims of bias.
- The group, known best by its acronym ICER, this week published a lengthy rebuttal to a number of accusations leveled against it by pharma companies angry at ICER's cost-effectiveness studies of their drugs.
- Over the past year, ICER has published several cost-effectiveness studies examining the prices and value of several categories of drugs, including treatments for hepatitis C, high cholesterol and multiple myeloma. Drugmakers have argued ICER's reviews are driven by the interests of insurers and fail to take the patient perspective into account.
As rising drug prices intensify public scrutiny of the pharma industry, ICER's cost-effectiveness evaluations of new drugs have drawn attention as a seemingly objective way to assess and compare the value of treatments.
Unlike some countries in Europe, there is no government body in the U.S. charged with weighing whether new drugs are cost-effective. Absent an official voice, ICER's assessments have been seized by some as a way to push back against higher drug prices. And drugmakers aren't happy about it.
Following a recent ICER assessment which judged many new multiple myeloma drugs to be overpriced, Bristol-Myers Squibb accused the organization of "fail[ing] to recognize the patient perspective" and said its methodology had "significant limitations."
Amgen, whose myeloma drug Kyprolis (carfilzomib) was similarly singled out by ICER, called the analysis "not clinically relevant."
PhRMA, a powerful trade association for the industry, has also spoken out against ICER. "The model developed by ICER uses methodology that is systematically biased against continued progress, devaluing advances through blunt budget caps and one-size-fits-all value thresholds," PhRMA said in a statement in May.
Initially, ICER responded by soliciting public input into its methodology. But in its newly published response, ICER has gone on the offensive.
"Unfortunately, much of the more recent criticism has been fueled by a lack of knowledge about ICER or even willful mischaracterization by those who oppose a move toward pricing in alignment with the added value for patients," the group said.
Specifically, ICER attempts to rebut criticisms it represents the interests of insurers seeking to cut costs and defends its methodology, which relies on a metric known as quality-adjusted life year (QALY).
ICER claims 70% of its funding currently comes from non-profit philanthropic foundations, with only 9% tied to contributions from health plans and provider groups. According to the group, the largest source of funding over its first three years was from the National Pharmaceutical Council, a policy research organization supported by many major biopharmaceutical companies.
But the NPC took issue with ICER's depiction of its relationship with the non-profit. "To be clear, NPC’s engagement with ICER is not an endorsement of that organization nor its value assessment framework," NPC said in a statement.
NPC has been a member of ICER since 2008 but recently has become more critical of ICER's methods.
ICER also argued its assessments are anchored in engagement with patients and advocacy groups and defended the QALY model as "the gold standard measure of how much better a treatment makes patients."
Criticism of ICER is unlikely to go away. BIO, an industry group for biotechs, has begun to take a more assertive public stance while PhRMA is reportedly gearing up for a major advertising campaign to shift the public narrative on drug pricing.
But it doesn't seem like ICER will back down either. "If prices do not come into alignment with value, a deeper crisis in patient access and societal affordability will occur, potentially creating a true threat to future innovation," the group said concluding its rebuttal.