Brentuximab vedotin for relapsed or refractory systemic anaplastic large cell lymphoma

STA: Brentuximab vedotin for relapsed or refractory systemic anaplastic large cell lymphoma (Single Technology Assessment for NICE) 

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) critically reviewed the company’s submission related to the clinical and cost-effectiveness of brentuximab vedotin for treating relapsed or refractory anaplastic large cell lymphoma (sALCL).  In terms of clinical effectiveness, the company’s submission focussed on the findings from one single single arm open label, non-randomised, phase II study (SG035-0004) with 58 patients with relapsed or refractory sALCL after treatment failure with at least one other therapy and an Eastern Cooperative Oncology Group (ECOG) performance status less than 2.  The primary clinical outcome in the study was objective response rate.  Secondary outcome data, namely progression free survival and overall survival were used to extrapolate the study’s findings and populate a partitioned survival economic model.  The committee’s preferred economic modelling assumptions resulted in a base case deterministic incremental cost-effectiveness ratio (ICER) of £18,324 per quality adjusted life year (QALY) gained.  The preferred probabilistic ICER was £20,399 per QALY gained.  The committee considered different assumptions surrounding extrapolation of PFS and OS data and noted the impact of alternative survival modelling methods on results. 

Outcome and translation

After consideration of all the evidence, NICE have issued the following recommendation in their Final Appraisal Determination for brentuximab vedotin:

“Brentuximab vedotin is recommended as an option for treating relapsed or refractory systemic anaplastic large cell lymphoma in adults, only if:

  • They have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and

  • The company provides brentuximab vedotin according to the commercial access agreement with NHS England.”

HERU researchers involved in this research project:  Graham Scotland, Dwayne Boyers and Elisabet Jacobsen

Publications

Boyers, D., Cruickshank, M., Jacobsen, E., Cooper, C., Fraser, C., Culligan, D. and Scotland, G. (2017) Brentuximab vedotin for relapsed or refractory systemic anaplastic large cell lymphoma, (NICE Technology Appraisal Guidance - TA478), Aberdeen Health Technology Assessment Group.