A NICE appraisal committee has decided not to recommend axicabtagene ciloleucel for the treatment of relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma in adults after two or more systemic therapies.
The committee acknowledged that data from the ZUMA-1 study show good response rates, overall survival, and progression-free survival with axicabtagene. However, it noted that the published evidence for comparator treatments was limited.
Because ZUMA-1 was a single-arm study with no direct comparator data, the company provided results from the retrospective SCHOLAR-1 study comparing axicabtagene with salvage chemotherapy. SCHOLAR-1 included patients with primary refractory disease and patients with ECOG scores of 0-4. The committee determined that SCHOLAR-1 did not represent UK practice.
The uncertainty around the clinical effectiveness created uncertainty in cost estimates. Cost-effectiveness estimates provided by the company suggested an incremental cost-effectiveness ratio (ICER) of over £50,000 per quality-adjusted life year (QALY) gained. However, reanalysis of the data to take into account UK clinical practice returned an ICER of £100,000 per QALY gained, significantly above the threshold considered to be a cost-effective use of NHS resources.
The committee agreed that, based on current evidence, axicabtagene ciloleucel is not recommended for the routine treatment of relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma. The treatment was also found not to eligible for inclusion in the Cancer Drugs Fund.
NICE is now inviting feedback on the decision. The closing date for receipt of comments is 18 September 2018. The appraisal committee will meet again on 27 September.