Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The clinical trial evidence from the ADRIATIC study shows that durvalumab significantly improves overall survival (55.9 months vs. 33.4 months for placebo) and progression-free survival (16.6 months vs. 9.2 months for placebo). This indicates a clear clinical advantage over the standard of care (active monitoring), fulfilling the criteria for a strong clinical benefit.
Cost effectiveness
The cost-effectiveness estimates for durvalumab are within the acceptable range for NHS resources, with the committee concluding that it provides value for money. The ICER is expected to be around or slightly above £20,000 to £30,000 per QALY gained, which is considered acceptable by NICE.
Quality of life
While the document does not provide extensive HRQoL data, the improvement in survival and the context of treating a devastating disease suggest a moderate positive impact on quality of life. The committee noted that the treatment addresses an unmet need, which supports the likelihood of HRQoL improvements.
Supporting Domains
Safety and Adverse Effects
The safety profile of durvalumab is described as acceptable, with manageable adverse events. The committee did not identify significant safety concerns that would undermine the treatment’s benefits, indicating a very good tolerability.
Comparator Selection
The comparator used in the clinical trial was active monitoring, which is the standard of care for this patient population. This is an appropriate choice, as it reflects the current treatment landscape for limited-stage small-cell lung cancer.
Patient Population and Subgroups
The trial population is broadly representative of the intended patient population with limited-stage small-cell lung cancer. The committee noted that the trial included patients who had undergone platinum-based chemoradiotherapy, which aligns with the marketing authorization.
Care Pathway Integration
Durvalumab can be integrated into existing care pathways with minor adjustments. The treatment is positioned as an addition to active monitoring, which is already part of the standard care for these patients.
Resource Use and Cost Implications
The economic model used by the company was deemed acceptable, and the committee agreed with the EAG’s estimates of resource use, which align with expected clinical practice. This indicates a manageable budget impact.
Evidence Quality and Robustness
The evidence base is supported by a robust Phase 3 RCT (ADRIATIC) with a well-defined patient population and clear outcomes. The committee found the trial design and data quality to be strong, with low risk of bias.
Uncertainty, Sensitivity, and Broader Impacts
While there are some uncertainties regarding long-term benefits and treatment effect waning, the committee concluded that the available evidence sufficiently supports the use of durvalumab, particularly given the unmet need in this patient population.
