Durvalumab can be used, within its marketing authorisation, as an option with gemcitabine and cisplatin for neoadjuvant treatment, and then alone for adjuvant treatment, of muscle-invasive bladder cancer in adults. Durvalumab can only be used if the company provides it according to the commercial arrangement.
Durvalumab with gemcitabine and cisplatin for neoadjuvant treatment, then alone for 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 muscle-invasive bladder cancer before surgery (neoadjuvant) is gemcitabine plus cisplatin. Usual treatment after surgery (adjuvant) is best supportive care. But if the cancer is at high risk of recurrence and the tumours express PD-L1 at a level of 1% or more, adjuvant nivolumab may be used.
Clinical trial evidence shows that risk of recurrence is lower with neoadjuvant durvalumab with gemcitabine plus cisplatin, then adjuvant durvalumab, than with neoadjuvant gemcitabine plus cisplatin alone. Adjuvant durvalumab has not been directly compared in a clinical trial with adjuvant nivolumab.
There are uncertainties in the economic model. But the most likely cost-effectiveness estimate is within the range that NICE considers an acceptable use of NHS resources. So, durvalumab can be used.