Simon J1, Perić N1, Mayer S1, Deckert J2, Gorwood P3, Pérez V4, Reif A5, Ruhe H6, Veltman D7, Morriss R8, Bilderbeck A9, Dawson G9, Dourish C10, Dias R11, Kingslake J11, Browning M9, on behalf of the Predict Group .9
1Medical University of Vienna, Vienna, Austria, 2University Hospital of Wuerzburg, Wuerzburg, Germany, 3Université Paris-Descartes, Paris, France, 4Hospital del Mar, Barcelona, Spain, 5University Hospital Frankfurt, Frankfurt am Main, Germany, 6Radboud University, Nijmegen, Netherlands, 7VU University Medical Centre and Amsterdam Neuroscience, Amsterdam, Netherlands, 8University of Nottingham, Nottingham, UK, 9P1vital Ltd., Oxfordshire, UK, 10P1vital Ltd., Wallingford , OXF, UK, 11P1vital Products Ltd, Oxfordshire, UK
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.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Medical Devices, Mental Health