Durvalumab can be used, within its marketing authorisation, as an option for neoadjuvant and adjuvant treatment with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy, then alone as adjuvant treatment, for resectable gastric or gastro-oesophageal junction adenocarcinoma in adults. Durvalumab can only be used if the company provides it according to the commercial arrangement (see section 2).
Durvalumab with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by durvalumab alone as adjuvant treatment must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. It must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that it provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for resectable gastric or gastro-oesophageal junction adenocarcinoma before surgery (neoadjuvant) and after surgery (adjuvant) is FLOT chemotherapy.
Clinical trial evidence shows that durvalumab plus FLOT chemotherapy as neoadjuvant and adjuvant treatment, then durvalumab alone as adjuvant treatment, increases how long people have before their cancer gets worse and how long they live compared with placebo plus FLOT chemotherapy as neoadjuvant and adjuvant treatment, then placebo alone as adjuvant treatment.
Although there are some uncertainties in the clinical-effectiveness evidence and the economic model, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, durvalumab can be used for neoadjuvant and adjuvant treatment with FLOT chemotherapy, then alone as adjuvant treatment.
For all the evidence, see the committee papers. For more information on streamlined evaluations, see NICE's technology appraisal and highly specialised technologies guidance manual.