NICE Issues Technology Appraisal Guidance for Brentuximab Vedotin

Evidence-based recommendations on brentuximab vedotin for treating relapsed or refractory systemic anaplastic large cell lymphoma

NICE announced on 4 October 2017 that it issued technology appraisal guidance [TA478] on brentuximab vedotin (Adcetris) for treating relapsed or refractory systemic anaplastic large cell lymphoma in adults. In particular, it is recommended as an option for treating relapsed or refractory systemic anaplastic large cell lymphoma in adult patients, only if they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and if the company provides brentuximab vedotin according to the commercial access agreement with NHS England.

When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.

These recommendations are not intended to affect treatment with brentuximab vedotin that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Brentuximab vedotin has been available to patients in England through the Cancer Drugs Fund since April 2013 for relapsed or refractory systemic anaplastic large cell lymphoma.

The recommended dose is 1.8 mg/kg administered by intravenous infusion over 30 minutes every 3 weeks.

Brentuximab vedotin has a marketing authorisation for treating relapsed or refractory systemic anaplastic large cell lymphoma in adults, but it is most likely to be used in the NHS as first-line salvage therapy. At this point in the treatment pathway, the appropriate comparator is chemotherapy.

Evidence from the main clinical trial for brentuximab vedotin shows that it is effective based on response rates. However, the trial is not comparative, and therefore there is uncertainty about the full extent of the survival benefit from treatment with brentuximab vedotin.

The best available evidence comes from an unadjusted indirect comparison of brentuximab vedotin and chemotherapy, although there is still uncertainty about the robustness of the results because of the differences in age, stage of disease, and performance status in the groups compared.

The plausible estimates of cost effectiveness are below 30,000 GBP per quality-adjusted life year gained, and this was considered to be an acceptable use of NHS resources. However, because the clinical- and cost-effectiveness data are based on people with an ECOG performance status of 0 or 1, brentuximab vedotin is only recommended for this group.

The price of brentuximab vedotin is 2,500 GBP for a 50‑mg vial (excluding VAT; British national formulary accessed August 2017).

Takeda has agreed a commercial access agreement with NHS England in which a discount is applied at the point of purchase or invoice for brentuximab vedotin. The financial terms of the agreement are commercial in confidence.