In July 2018 the European Medicines Agency restricted the use of atezolizumab for untreated urothelial carcinoma. It should now only be used in adults with high levels of PD-L1. For more information, see the summary of product characteristics for atezolizumab.
1.1 Atezolizumab is recommended for use within the Cancer Drugs Fund as an option for untreated locally advanced or metastatic urothelial carcinoma in adults when cisplatin-containing chemotherapy is unsuitable, only if:
their tumours express PD-L1 at a level of 5% or more and
the conditions of the managed access agreement for atezolizumab are followed.
1.2 This recommendation is not intended to affect treatment with atezolizumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation 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.
Why the committee made these recommendations
The recommendations only cover people with untreated PD-L1-positive locally advanced or metastatic urothelial carcinoma who cannot have cisplatin because more evidence became available after the committee meeting for people with disease that has progressed after platinum-containing chemotherapy. Separate guidance will be developed for this population when this evidence has been considered.
Atezolizumab has been studied in a clinical trial, but it has not been directly compared with other treatments. Clinicians think the trial results compare favourably with current treatments. Atezolizumab appears to be an effective treatment but it is difficult to establish the size of the clinical benefit compared with current treatments.
Atezolizumab meets NICE's criteria to be considered a life-extending end-of-life treatment. It is likely to extend people's lives by more than 3 months, but a lack of evidence comparing atezolizumab with other treatments means that this is uncertain.
The estimates of cost effectiveness are very uncertain. However, the most likely estimate based on the evidence that is available now is higher than what NICE normally considers acceptable for end-of-life treatments.
Atezolizumab has the potential to be cost effective, but more evidence is needed to address the clinical uncertainty. It can therefore be recommended for use within the Cancer Drugs Fund while further data are collected as part of a managed access agreement. Collecting further data from people taking part in the IMvigor 130 trial, which directly compares atezolizumab with other treatments, would help to address some of the uncertainties. In addition, other data collected during the managed access period may help to address some uncertainties.