BMS  statement on ICER Ide-Cel evidence report

BMS today released the following statement following the issuance of a report from the Institute for Economic and Clinical Review (ICER), which examined the clinical effectiveness of idecabtagene vicleucel (ide-cel) in its determination of pricing recommendations.

“At BMS, we take great care to price our medicines based on the value they deliver, the scientific innovation they represent, economic factors that impact healthcare systems’ capacity to provide appropriate, rapid, and sustainable access to patients, and the investment necessary to develop them. ICER’s assessment of ide-cel was, in our view, limited by criteria that disregarded these broader dynamics and their impacts on price.

Even within the specified criteria of this review, ICER used inappropriate modeling of ide-cel’s overall survival data and a misguided view of retreatment, contributing to ICER’s flawed assessment of clinical and economic value.”

In its assessment, ICER attempted to correlate progression-free survival to overall survival.  Overall survival data is the clinical gold standard for measuring a patient’s response to a medicine. Public data and clinical expertise has shown ide-cel has demonstrated meaningful overall survival, as evidenced by the following:

• In the Phase 1 CRB-401 study of 62 patients with heavily pretreated relapsed and refractory multiple myeloma treated with ide-cel, the median overall survival was 34.2 months.
• Six clinical experts reviewed the ide-cel clinical data and provided independent estimates of overall survival, which should be a key consideration for a cost-effectiveness assessment.

Additional long term data on overall survival is expected soon.  Twelve month overall survival from the KarMMa trial published in the New England Journal of Medicine was 78% of 128 patients.  Further detail regarding these patient responses to ide-cel and its duration will be made available when the 2-year follow-up of patients from the original KarMMa study is shared in the coming months.

Ide-cel, approved by the U.S. FDA as Abecma, offers patients who have limited effective treatment options a potentially transformative individualized therapy with the potential for long-term disease control. There are limited data available regarding retreatment with Abecma.

BMS provided a detailed public response statement to ICER at its April 16, 2021, ICER’s Midwest Comparative Effectiveness Public Advisory Council (CEPAC) meeting.  The statement can be found here.

BMS provided a written summary to ICER for its Final Evidence Report and Meeting Summary.  The BMS summary can be found here.

Updated May 2021