Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Relugolix CT shows moderate benefit over current care, with clinical trial evidence indicating a significant reduction in dysmenorrhoea and non-menstrual pelvic pain compared to placebo. However, the lack of direct comparisons with standard treatments like GnRH agonists and surgery limits the strength of the evidence.
Cost effectiveness
The cost-effectiveness estimates for relugolix CT are within the acceptable range for Healthcare resources, suggesting it is a cost-effective option compared to existing treatments. The committee concluded that the ICERs are acceptable, supporting its economic viability.
Quality of life
The evidence suggests that relugolix CT improves quality of life for patients with endometriosis, as indicated by the significant reduction in pain levels. However, the data on HRQoL improvements are not extensively detailed, leading to a moderate rating.
Supporting Domains
Safety and Adverse Effects
Relugolix CT has a very good safety profile with mostly mild to moderate adverse events reported. The evidence indicates that serious adverse events are rare, supporting a strong tolerability rating.
Comparator Selection
While GnRH agonists are identified as relevant comparators, the absence of direct head-to-head trials with these treatments raises concerns about the robustness of the evidence. The committee noted that surgery could also be a relevant comparator, which was not included in the initial analysis.
Patient Population and Subgroups
The trial population is broadly representative of the intended patient population, with a focus on adults of reproductive age who have had prior treatments for endometriosis. However, there are some limitations in subgroup analyses.
Care Pathway Integration
Relugolix CT can be integrated into existing care pathways with minor adjustments, as it offers an oral administration route that is more convenient than injectable options. This enhances its feasibility in clinical practice.
Resource Use and Cost Implications
The resource implications of relugolix CT are manageable, with the potential for cost savings due to its oral administration and reduced need for hospital visits compared to injectable treatments.
Evidence Quality and Robustness
The evidence base is supported by two phase 3 RCTs, which provide strong data. However, the reliance on indirect comparisons and some methodological concerns limit the overall robustness.
Uncertainty, Sensitivity, and Broader Impacts
While there are uncertainties regarding the long-term effects and utility values used in the economic model, the overall context supports the use of relugolix CT, particularly given the unmet need in endometriosis treatment.
