OBJECTIVES: The P1vital® PReDicT Test was developed by P1vital Products Ltd as a digital tool to provide an early indication of response or non-response to antidepressant medication, helping reduce time to recovery. A randomised-controlled trial was conducted (2016-2019) in five European countries (DE,ES,F,NL,UK) to assess its clinical and cost-effectiveness in primary depression care.

METHODS: An incremental within-trial economic evaluation is ongoing to compare the value of the PReDicT Test with Treatment-As-Usual over 24 weeks. Resource use data were obtained using a new, multi-lingual Health Economics Questionnaire (HEQ) as an adaptive patient self-report online form measuring health and social care resource use, medication, informal care, productivity losses and socio-demographics. Between group differences in costs and outcomes using quality-adjusted life years (QALYs) based on the EQ-5D-5L, alternatively CALYs based on the OxCAP-MH capabilities (UK and D) are being assessed using a regression-based approach adjusted for missing data and country specifics.

RESULTS: Baseline mean age was 39 years, baseline QIDS score 16, 38% males. From the 913 (DE:130,ES:164,F:76,NL:54,UK:489) patients randomised, 24-week follow-up data were available for 534 patients. 24-week health economics instrument completion rates significantly varied between countries (DE:48%,ES:61%,F:86%,NL:70%,UK:55%). No significant differences between completers and non-completers were detected. Total median completion time for the three health economics instruments were 11min at baseline vs. 4 min at 24 weeks. This presentation will detail the final cost, outcome and cost-effectiveness results together with relevant methodological aspects.

CONCLUSIONS: To fully evaluate the value of the PReDicT Test, economic evaluation from a societal perspective is needed. The HEQ embedded in an adaptive online system shows considerably reduced data collection burden and data missingness. The great between-country variations in follow-up completion rates may reflect some substantial underlying system and depression care differences. These and other semantic, unit cost and outcome valuation heterogeneities will be addressed in sensitivity analyses.