The aim of this project, which was commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, was to review the clinical and cost-effectiveness of Brentuximab vedotin for treating relapsed or refractory anaplastic large cell lymphoma (sALCL).The clinical effectiveness evidence submitted by the company (Takeda UK Ltd) responsible for manufacturing Brentuximab vedotin (Adcetris) consisted of one Phase II, open-label, single-arm, multi-centre trial examining the efficacy and safety of Brentuximab vedotin in patients with relapsed or recurrent sALCL after treatment failure of at least one prior therapy. The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company.

After taking into consideration the company submission and the findings of the ERG’s critique, NICE released clinical guidance (TA478, October 2017). Brentuximab vedotin is currently recommended as an option for treating relapsed or refractory systemic anaplastic large cell lymphoma only if (i) patients have an Eastern Cooperative Oncology Group performance status of 0 or 1 and (ii) the company provides Brentuximab vedotin in line with the commercial access agreement with NHS England.


Graham Scotland;




Boyers, D, Cruickshank, M, Jacobsen, E, Cooper, D, Fraser, C, Culligan, D, Scotland, G. Brentuximab vedotin for relapsed or refractory systemic anaplastic large cell lymphoma. Evidence Review Group report in support of NICE STA programme. University of Aberdeen: Health Services Research Unit; 2017. URL: