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Cost-effectiveness of pramipexole augmentation for acute phase and maintenance therapy of treatment-resistant depression compared to placebo augmentation: economic evaluation of the PAX-D randomised controlled trial

Lookup NU author(s): Dr Stuart WatsonORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2025 The Author(s)Background: Pramipexole augmentation of antidepressant treatment for treatment-resistant depression (TRD) has been shown to improve symptom burden over 12 weeks but with some adverse effects compared to placebo augmentation. We aimed to evaluate the cost-effectiveness of pramipexole augmentation for TRD. Methods: We conducted an economic evaluation as part of the PAX-D trial over 12 and 48 weeks. Two costing perspectives, National Health Service and Personal Social Services (NHS + PSS) and societal, were adopted. The primary outcome was quality-adjusted life year (QALY) based on the EQ-5D-5L. Secondary outcomes included year of full capability (YFC) based on the ICECAP-A, and capability-weighted life year (CWLY) based on the OxCAP-MH. Incremental cost-effectiveness ratios (ICERs), cost-effectiveness planes and cost-effectiveness acceptability curves were reported alongside sensitivity analyses. The trial was registered with ISCTRN (ISRCTN84666271) and EudraCT (2019-001023-13) and is complete. Findings: From the NHS + PSS perspective, mean incremental cost of pramipexole was £60 (95% CI: −£55, £176) over 12 weeks and £811 (95% CI: £110, £1513) over 48 weeks. The difference in QALY gained was 0.012 (95% CI: 0.003, 0.021) over 12 weeks and 0.090 (95% CI: 0.036, 0.144) over 48 weeks, equivalent to 4 (95% CI: 1, 8) and 33 (95% CI: 13, 52) days in perfect health. The ICER was £5069/QALY (95% CI: −£3642, £35,608) over 12 weeks and £9007/QALY (95% CI: £2,219, £27,258) over 48 weeks, representing over 90% probability of cost-effectiveness at £20,000/QALY threshold. From the societal perspective, pramipexole was on average cost saving and more effective over 48 weeks. Alternative analyses provided consistent conclusions. Interpretation: Pramipexole augmentation for TRD has demonstrated both clinical and cost-effectiveness. Further trials, directly comparing pramipexole to other augmentation strategies, will be useful in determining the position of this repurposed medication in the treatment pathway of depression. Funding: National Institute for Health and Care Research, Efficacy and Mechanism Evaluation Programme.

Publication metadata

Author(s): Laszewska A, Helter T, Baldwin A, Cleare AJ, Cowen PJ, Evans J, Huys QJM, Kurkar M, Lewis AC, Nixon N, Rastogi A, Watson S, Geddes JR, Browning M, Simon J

Publication type: Article

Publication status: Published

Journal: The Lancet Regional Health - Europe

Year: 2026

Volume: 61

Print publication date: 01/02/2026

Online publication date: 17/11/2025

Acceptance date: 31/10/2025

Date deposited: 01/12/2025

ISSN (electronic): 2666-7762

Publisher: Elsevier Ltd

URL: https://doi.org/10.1016/j.lanepe.2025.101533

DOI: 10.1016/j.lanepe.2025.101533

Data Access Statement: De-identified individual clinical trial participant-level data will be made available for sharing in ethically approved individual patient data synthesis and meta-analyses on receipt of an appropriate application and subject to approval by the PAX-D chief investigator (michael.browning@psych.ox.ac.uk).

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