UPDATED: BMS joins Amgen in blasting ICER myeloma report

Empliciti
Empliciti

Bristol-Myers Squibb ($BMS) and Amgen may be fierce competitors when it comes to their new gen cancer drugs Empliciti and Kyprolis for treating multiple myeloma. But they are certainly allies when it comes to one thing: their unhappiness with a report from a drug cost effectiveness group that says their drugs are not worth their prices for treating the disease.

BMS yesterday put out a statement taking issue with the methodology used in a report released this month by the Boston-based Institute for Clinical and Economic Review (ICER). Amgen ($AMGN) in April had lashed out at ICER even before the report was published. It has put together its own economic analysis for the value its drug, which yesterday it said has been published in The Journal of Medical Economics.

The drugmakers are upset over ICER’s draft report that graded a half-dozen treatment regimens, including Bristol-Myers Squibb's Empliciti, Amgen's Kyprolis and Takeda's Ninlaro, for cost-effectiveness. It found that even though their side effects tend to be fewer and patients live longer without their cancer progressing, the drug regimens were far less cost-effective than standard treatment with Celgene's Revlimid and dexamethasone.

According to the report, for patients who'd failed on one previous treatment, the premium for the newer cocktails over the Revlimid regimen ranged from $255,000 (Empliciti) to $391,000 (Ninlaro) per quality-adjusted life year (QALY), a common measure of cost-effectiveness. The group calculated similar differences in patients on their third round of therapy.

But both BMS and Amgen say the ICER report is flawed. BMS yesterday pointed out the ICER model has to draw some conclusions based on uncertainties “that even the organization itself acknowledges." It said the limitations of the report could set up “arbitrary barriers to patient access.”

“While assessments of cost-effectiveness may prove useful in comparing treatments, they have significant limitations,” BMS claimed. “Therefore, these assessments should not be used for decision-making that determines access to innovative medicines.”

In its own evaluation, Amgen found that Kyprolis, when used alongside Celgene's ($CELG) Revlimid and dexamethasone in patients whose disease had not progressed, presents an economic value "well below the benchmarks of $150,000 to $300,000 [per quality life year] cited as reasonable benchmarks for cancer in the U.S." 

ICER President Steven D. Pearson said in an emailed statement that ICER had gotten the "input of all the manufacturers of the drugs reviewed" in the report. "I don't think it came as much of a surprise to them--or to patients, clinicians, or insurers--that our report found that the evidence supports the clinical effectiveness of these drugs, but their list price is far too high to align well with the degree of patient benefit they provide."

He went on to say that ICER's methods are "transparent" and benchmarked against other sources and that the group also took comments from patients and clinicians on how to sustain the innovation that has brought important advances in myeloma care while not outstripping the resources needed to share the benefits of innovation among all patients in the health system. "The choice that manufacturers make when they price their drugs has to be a part of that conversation.  We do not feel that this broader challenge will be met if drug companies try to shoot the messenger bringing independent reviews of the evidence to the table."  

- here’s the BMS statement 
- here’s Amgen’s announcement

Related Articles:
New myeloma meds offer improvement, but are far too expensive: Report 
Facing a new assessment of Kyprolis, Amgen castigates cost-effectiveness team's methods

Editor's note: The story was updated with a comment from ICER.