Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The clinical evidence from the IMpower010 trial indicates that atezolizumab reduces the relative risk of disease recurrence or death by 57% compared to active monitoring, with a hazard ratio of 0.43. However, the overall survival data is still immature, and the committee noted that while disease-free survival improvements are significant, the uncertainty surrounding overall survival limits the strength of the evidence.
Cost effectiveness
The cost-effectiveness estimates for atezolizumab are uncertain due to immature trial data and the company’s original economic model being deemed inappropriate. Although the potential for cost-effectiveness exists, the committee concluded that more evidence is needed to justify its routine use, resulting in a B++ rating.
Quality of life
The document does not provide specific data on HRQoL improvements associated with atezolizumab. While it is implied that the treatment may improve outcomes for patients, the lack of robust evidence or validated tools to measure HRQoL impacts leads to a rating of B++.
Supporting Domains
Safety and Adverse Effects
Atezolizumab has a very good safety profile with mostly mild or moderate adverse events reported. The committee noted that serious adverse events are rare, supporting a rating of A+ for safety and tolerability.
Comparator Selection
The treatment was compared against active monitoring, which is the standard of care following chemotherapy for NSCLC. This is an acceptable comparator choice, although the committee acknowledged some limitations in the evidence base.
Patient Population and Subgroups
The trial population is well-defined, focusing on adults with stage 2 to 3a NSCLC and PD-L1 expression. The committee noted that the population aligns with the intended use of the treatment, leading to a rating of A+.
Care Pathway Integration
Atezolizumab is positioned as the first immunotherapy available in the adjuvant setting for NSCLC, which integrates well into existing treatment pathways. Minor adjustments may be needed, but overall integration is feasible.
Resource Use and Cost Implications
While the treatment may have a manageable budget impact, the uncertainties in the economic model and the potential high costs associated with the treatment lead to a rating of B+.
Evidence Quality and Robustness
The evidence from the IMpower010 trial is robust but has limitations due to the immaturity of the data and the need for further analyses. This results in a B++ rating, indicating some concerns about the overall robustness of the evidence.
Uncertainty, Sensitivity, and Broader Impacts
There are significant uncertainties regarding the long-term outcomes and cost-effectiveness of atezolizumab, particularly due to the immaturity of trial data. This leads to a rating of B+.
