- Bristol-Myers Squibb pushed back against a cost-effectiveness study of its multiple myeloma drug Empliciti, joining several other pharma companies who have publicly voiced criticism of the methods used by the Institute for Clinical and Economic Review (ICER).
- In its recent assessment of new multiple myeloma drugs, ICER recommended a 75% to 89% discount on the cost per vial of Empliciti. Other drugs such as Amgen's Kyprolis and Takeda's Ninlaro also should be discounted, the research institute said in its report.
- According to Bristol-Myers, however, ICER's methodology "failed to recognize the patient perspective," and had "significant limitations."
ICER's assessments have taken on greater significance lately as high drug prices continue to fuel criticism of the pharma industry. Last fall, the institute reviewed the new PCSK9 drugs Repatha and Praluent and it has previously done a value analysis on new hepatitis C treatments.
But drugmakers are criticizing ICER's approach. Regeneron CEO Leonard Schleifer called the group's approach unscientific in comments earlier this month discussing the review for Praluent, Reuters reported. And Amgen has said the assessment of its multiple myeloma drug Kyprolis may not be "clinically relevant," given ICER's omission of several factors.
Now Bristol-Myers has joined in. "In the spirit of putting patient needs first, we fundamentally disagree with ICER’s approach to value assessment, which led to the questionable conclusions outlined in its report," the company said.
Specifically, Bristol-Myers said the metric ICER used, quality-adjusted life years (QALY), could undervalue the benefit of treatment in older populations. Multiple myeloma is typically diagnosed in older individuals.
Inconsistencies between the draft and revised versions of the report illustrate the results' uncertainty, the company said.
Bristol-Myers' response also included a shot to payers, who have begun to look at ICER's reports as leverage in negotiations with drug companies. "These assessments should not be used for decision-making that determines access to innovative medicines," Bristol-Myers said.
Major industry association PhRMA also disagreed with ICER's conclusions and accused the organization as being too beholden to payer interests.
"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 that ignore the complex realities of optimally caring for cancer patients in an era of personalized medicine," PhRMA said in a statement.
However, given the opacity of drug pricing, reports like those from ICER will continue to draw attention as a way to gauge the cost-effectiveness of new drugs, whether pharma likes it or not.