Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Nivolumab shows moderate benefit over current care, with clinical trial evidence indicating a reduction in the risk of cancer recurrence compared to placebo. However, the lack of overall survival data limits the strength of this evidence.
Cost effectiveness
The ICER for nivolumab compared to best supportive care is £11,361 per QALY, which is within NICE’s acceptable range when platinum-based chemotherapy is unsuitable. However, uncertainties remain regarding its cost-effectiveness compared to platinum-based chemotherapy.
Quality of life
The treatment is reported to be well tolerated, with patient experts indicating that extending disease-free survival is important for quality of life. However, specific HRQoL data is limited.
Supporting Domains
Safety and Adverse Effects
Nivolumab has a very good safety profile with mostly mild or moderate adverse events reported. The treatment is generally well tolerated compared to traditional chemotherapy.
Comparator Selection
The primary comparator was placebo, with no direct comparison to platinum-based chemotherapy provided. While best supportive care is relevant, the absence of a robust comparison to standard care limits the strength of the evidence.
Patient Population and Subgroups
The trial population is representative of the intended patient population, particularly those with PD-L1 expression ³1%. However, there are some limitations regarding subgroup analyses.
Care Pathway Integration
Nivolumab can be integrated into existing care pathways with minor adjustments, as it is a new treatment option that fits within the current treatment landscape for urothelial cancer.
Resource Use and Cost Implications
The budget impact is manageable, particularly when considering the commercial arrangement that provides a discount. The treatment is expected to be resource-efficient when platinum-based chemotherapy is unsuitable.
Evidence Quality and Robustness
The evidence is based on a Phase 3 RCT (CheckMate 274) with a reasonable sample size, although there are some methodological concerns regarding the indirect treatment comparisons.
Uncertainty, Sensitivity, and Broader Impacts
There are significant uncertainties regarding the translation of disease-free survival to overall survival, and the indirect treatment comparison lacks robustness, which may impact broader implications.
