BMS Piqued by ICER's HTA Report on New Myeloma Drugs, Publishes Response

Bristol-Myers Squibb (BMS) has challenged the recently released report by the Institute for Clinical and Economic Review (ICER) that evaluates the clinical and cost effectiveness of newer treatments for multiple myeloma (MM). In a press release, the company said “We fundamentally disagree with ICER’s approach to value assessment, which led to the questionable conclusions outlined in its report.”

The company’s new treatment for MM, elotozumab (Empliciti), was 1 of 3 agents approved right before the annual meeting of the American Society of Hematology (ASH) in December 2015. Elotozumab, daratumumab (Darzalex), and ixazomib (Ninlaro) were all reviewed during a joint session held by the FDA and ASH. Left with multiple choices, how best can clinicians choose the treatment for their patients in combination with the standard of care?

The ICER report focused on 6 different combination treatments to be used as second or third-line treatments in relapsed/refractory patients with MM. However, the report concluded that while some of these combinations are promising, it’s too early to determine their cost-effectiveness.

BMS has raised objections to several sections of the report, with the patient perspective in mind:

1. The report does not reflect the true value of health outcomes in cancer care. The press release claims that ICER’s cost-effectiveness thresholds raise barriers for patient access. Considering that the median age of patients diagnosed with MM is 69 years, quality-adjusted life years may not be an optimal measure of benefit.
2. It is based on uncertainties in comparative effectiveness research. ICER’s model is fraught with limitations, including:

• Inaccurate and incomplete assessments of costs and cost savings
• Use of immature data
• Differences between trial and real-world dosing regimens
• Incomplete evidence
• Uncertainty of point estimates

3. It does not adhere to established Health Technology Assessment (HTA) best practices. HTA should be based on a clear, transparent, sophisticated and, differentiated view of value. It should include a clear understanding of disease management and indirect benefits.

“While assessments of cost-effectiveness may prove useful in comparing treatments, they have significant limitations, and the lack of available mature data sources preclude the drawing of valid conclusions,” the release claims.