ASSOCIATION BETWEEN EQ-5D AND MODERATE-TO-SEVERE VASOMOTOR SYMPTOM RESPONSE IN MENOPAUSE: A POST-HOC ANALYSIS OF THE OASIS 1/2 TRIALS
Author(s)
Landan Zhang, PhD1, Catia C Proenca, PhD2, Bernard Wilson, Health Economics1, Zoe Schaedel, Dr3, Susanna Weidlinger, Dr4.
1Bayer, Reading, United Kingdom, 2Bayer Consumer Care AG, Basel, Switzerland, 3Brighton and Hove Primary Care, Brighton, United Kingdom, 4University Hospital Inselspital, Bern, Switzerland.
1Bayer, Reading, United Kingdom, 2Bayer Consumer Care AG, Basel, Switzerland, 3Brighton and Hove Primary Care, Brighton, United Kingdom, 4University Hospital Inselspital, Bern, Switzerland.
OBJECTIVES: Vasomotor symptoms (VMS) associated with menopause are frequent, persistent, and reduce quality-of-life (QoL), with limited non-hormonal treatment options available. This analysis estimated EQ-5D-3L health state utility values associated with VMS, overall and in women with ≤1 year since menopause (≤1 year since amenorrhea), representing women at an earlier stage of symptom onset, to quantify the utility burden and subsequent improvement linked to at least 50% reduction in the frequency of moderate-to-severe VMS.
METHODS: This is a post-hoc analysis using data from the OASIS-1/2 trials (NCT05042362; NCT05099159) of elinzanetant versus placebo. EQ-5D-3L index (UK tariff, mapped from EQ-5D-5L using Hernández Alava et al. (2023)) [a standardized measure of health-related QoL anchored at 0 (death) and 1 (perfect health)] was modelled using mixed model repeated measures with a time-dependent covariate for VMS response (≥50% reduction in moderate-to-severe hot flash frequency; yes/no). Subgroup analyses in women ≤1 year since menopause were conducted by including a subgroup-by-response interaction.
RESULTS: 796 patients were included in the analysis, with 117 women ≤1 year since menopause; at baseline, mean utility was 0.820 overall and 0.810 within the subgroup. In the overall population, EQ-5D-5L was significantly associated with VMS response (yes: 0.854) vs. no: 0.831; difference 0.024, p<0.001). When including a subgroup by VMS response interaction, the magnitude of this difference by response status was higher among women ≤1 year since menopause (yes: 0.868 vs no: 0.816; difference 0.052, interaction p=0.001).
CONCLUSIONS: VMS have measurable impact on QoL. Decreasing the frequency of VMS is associated with a utility improvement. Women experiencing symptoms close to the start of menopause have lower baseline utility values and experience a pronounced utility improvement with elinzanetant treatment, suggesting a benefit in addressing symptoms early.
METHODS: This is a post-hoc analysis using data from the OASIS-1/2 trials (NCT05042362; NCT05099159) of elinzanetant versus placebo. EQ-5D-3L index (UK tariff, mapped from EQ-5D-5L using Hernández Alava et al. (2023)) [a standardized measure of health-related QoL anchored at 0 (death) and 1 (perfect health)] was modelled using mixed model repeated measures with a time-dependent covariate for VMS response (≥50% reduction in moderate-to-severe hot flash frequency; yes/no). Subgroup analyses in women ≤1 year since menopause were conducted by including a subgroup-by-response interaction.
RESULTS: 796 patients were included in the analysis, with 117 women ≤1 year since menopause; at baseline, mean utility was 0.820 overall and 0.810 within the subgroup. In the overall population, EQ-5D-5L was significantly associated with VMS response (yes: 0.854) vs. no: 0.831; difference 0.024, p<0.001). When including a subgroup by VMS response interaction, the magnitude of this difference by response status was higher among women ≤1 year since menopause (yes: 0.868 vs no: 0.816; difference 0.052, interaction p=0.001).
CONCLUSIONS: VMS have measurable impact on QoL. Decreasing the frequency of VMS is associated with a utility improvement. Women experiencing symptoms close to the start of menopause have lower baseline utility values and experience a pronounced utility improvement with elinzanetant treatment, suggesting a benefit in addressing symptoms early.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR111
Topic
Economic Evaluation, Patient-Centered Research
Topic Subcategory
Health State Utilities
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity), Reproductive & Sexual Health