Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Atogepant has shown a significant reduction in monthly migraine days compared to placebo in clinical trials, but there is no direct evidence comparing it with other preventive treatments. The committee noted that while atogepant is more effective than placebo, the uncertainty regarding its efficacy compared to other treatments like rimegepant limits the strength of the evidence.
Cost effectiveness
The cost-effectiveness estimates for atogepant compared to rimegepant fall within the acceptable range for Healthcare resources, with the committee concluding that it is a defensible option. The ICER is around £20,000 per QALY gained, which is considered acceptable by NICE.
Quality of life
The document indicates that atogepant may improve quality of life for patients with migraines, but specific HRQoL data is limited. The committee acknowledged that while there are potential benefits, the evidence is not robust enough to demonstrate significant improvements in validated HRQoL measures.
Supporting Domains
Safety and Adverse Effects
Atogepant has a favorable safety profile with mostly mild to moderate adverse events reported in clinical trials. The committee noted that serious adverse events are rare, indicating a good tolerability compared to existing treatments.
Comparator Selection
While atogepant was compared to placebo in trials, the lack of direct comparisons with other preventive treatments raises concerns. The committee acknowledged that indirect comparisons were made, but the uncertainty surrounding these results limits the robustness of the evidence.
Patient Population and Subgroups
The trials included a relevant patient population with chronic and episodic migraine, and the committee noted that the subgroup analysis for those who had failed multiple treatments was appropriate. However, there are some limitations in subgroup exploration.
Care Pathway Integration
Atogepant can be integrated into existing care pathways with minor adjustments. The committee noted that it could be prescribed in both secondary and primary care settings, which facilitates access for patients.
Resource Use and Cost Implications
The budget impact of atogepant is manageable, and the committee concluded that it would not impose a significant burden on healthcare resources, especially considering its lower costs compared to some injectable alternatives.
Evidence Quality and Robustness
The evidence base includes several clinical trials, but the reliance on indirect comparisons and the uncertainty in the network meta-analyses raise concerns about the robustness of the findings. The committee noted gaps in direct comparative evidence.
Uncertainty, Sensitivity, and Broader Impacts
There is a high level of uncertainty regarding the clinical effectiveness of atogepant compared to other treatments, which could impact its broader acceptance. The committee highlighted the need for further evidence to clarify these uncertainties.
