Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The clinical trial evidence indicates that solriamfetol significantly reduces excessive daytime sleepiness compared to standard care alone, as shown in the TONES 3 trial. However, the evidence does not demonstrate a clear improvement in quality of life, which limits the rating to moderate benefit.
Cost effectiveness
The cost-effectiveness estimates for solriamfetol are uncertain and likely exceed what NICE considers acceptable for Healthcare resources. The committee expressed concerns about the economic model and the assumptions made, resulting in a low cost-effectiveness rating.
Quality of life
While the reduction in excessive daytime sleepiness is acknowledged, the trials did not show a corresponding improvement in quality of life as measured by EQ-5D. The committee noted that the EQ-5D may not adequately capture the quality of life impact for this patient population, leading to a rating of no demonstrated benefit.
Supporting Domains
Safety and Adverse Effects
The safety profile of solriamfetol is generally acceptable, with most adverse events being mild or moderate. However, there are concerns regarding serious adverse events, which were noted but did not significantly undermine the overall safety assessment.
Comparator Selection
The comparator, CPAP, is appropriate as it represents the standard care for excessive daytime sleepiness due to obstructive sleep apnoea. The committee acknowledged that some patients may not tolerate CPAP, but overall, the selection of comparators was strong.
Patient Population and Subgroups
The trial population included patients who were adherent to primary therapy, which is representative of the intended patient population. However, there were some limitations in subgroup analyses, particularly regarding those who cannot tolerate CPAP.
Care Pathway Integration
The integration of solriamfetol into existing care pathways may require additional monitoring and adjustments, particularly in secondary care settings. This indicates a moderate impact on current practices.
Resource Use and Cost Implications
The resource implications of solriamfetol are significant, and the economic model suggests a high cost burden that may require restrictions. This raises concerns about the affordability of the treatment.
Evidence Quality and Robustness
The evidence base is supported by a well-conducted Phase III trial (TONES 3), although there are some methodological concerns and uncertainties regarding the economic model. Overall, the evidence is credible but not without limitations.
Uncertainty, Sensitivity, and Broader Impacts
There are significant uncertainties regarding the cost-effectiveness and quality of life benefits associated with solriamfetol. The committee noted that these uncertainties could restrict its use, leading to a moderate rating.
