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New HTA Decisions in England
October 2021
Drug name
TECENTRIQ® (atezolizumab)
Company
Roche
Decision date
30/09/2021
Therapeutic area
Cancer
Therapeutic sub area
Bladder cancer
Decision
Recommended (CDF)
Indication
Indicated for untreated locally advanced or metastatic urothelial cancer in adults whose tumours express PD‑L1 at a level of 5% or more and when cisplatin-containing chemotherapy is unsuitable.
Decision Detail
The company has a commercial arrangement (simple discount patient access scheme).
Summary
This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement to address uncertainties identified during the original appraisal. This guidance includes recommendations only for untreated PD L1 positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable. In the original appraisal, clinical-effectiveness evidence for atezolizumab came from IMvigor 210, a phase 2 single-arm study. The company did a simulated treatment comparison and network meta-analysis to compare atezolizumab with gemcitabine plus carboplatin. The committee in the original appraisal was concerned that the simulated treatment comparison was not robust and had concerns about the reliability and robustness of the network meta-analysis. To address the committee's concerns from the original appraisal, the company provided the clinical-effectiveness evidence for atezolizumab from IMvigor 130, a phase 3 randomised controlled trial. The trial included 1,213 adults with previously untreated locally advanced or metastatic urothelial cancer, who were eligible to receive platinum-based therapy. Only a subgroup of 93 people, which included people with untreated PD L1 positive (tumour expression of 5% or more) locally advanced or metastatic urothelial cancer and who were ineligible to have treatment with cisplatin, was relevant to this appraisal. This was the result of the restricted EMA marketing authorisation, which stated atezolizumab should only be used in adults with high levels of PD L1. The clinical evidence showed that atezolizumab was associated with a statistically significant improvements in overall survival and progression-free survival compared with platinum-based chemotherapy. The committee acknowledged that the small sample size was a result of the restricted marketing authorisation for atezolizumab for people with high levels of PD L1. The committee also noted that the survival data was 87% mature. The committee concluded that the data from IMvigor 130 was the most appropriate evidence for decision making. Atezolizumab meets NICE's criteria to be considered a life-extending treatment at the end of life. Using the committees preferred assumptions for decision making, the plausible ICER was considerably less than £50,000 per QALY gained. The committee recalled the uncertainty in the clinical evidence but noted the survival estimates were reasonably mature. It concluded the cost-effectiveness estimate for atezolizumab suggest it is an acceptable use of NHS resources for a life-extending treatment at the end of life. So, atezolizumab was recommended for routine use in the NHS.