Cost-effectiveness of pramipexole in addition to mood stabilisers for patients with treatment-resistant bipolar depression: Economic evaluation of the PAX-BD randomised controlled trial
- PMID: 40683533
- DOI: 10.1016/j.jad.2025.119937
Cost-effectiveness of pramipexole in addition to mood stabilisers for patients with treatment-resistant bipolar depression: Economic evaluation of the PAX-BD randomised controlled trial
Abstract
Background: People with bipolar disorders (BD) frequently experience depressive symptoms that do not respond to available treatment options. The resulting burden for people with BD and society is substantial. This study sought to explore the cost-effectiveness of pramipexole in combination with mood stabilisers for people with treatment-resistant bipolar disorder (TRBD).
Methods: We calculated mean incremental cost-effectiveness ratios (ICER) of pramipexole compared to placebo over 12 and 48 weeks from health and social care (NHS + PSS) and societal perspectives for 36 participants with TRBD. Quality-adjusted life years (QALY) were captured with the EQ-5D-5L as the primary outcome measure. We used capability well-being measures (ICECAP-A, OxCAP-MH) to assess the robustness of the results and multiple imputation and bootstrapping to address missing data and small sample size.
Results: We found that pramipexole is dominantly more effective and cost-saving from the NHS + PSS perspective with 86 % probability of being cost-effective at £30,000/QALY gained over 12 weeks and 93 % over 48 weeks. From the societal perspective, pramipexole was more effective but also more expensive with lower probability of cost-effectiveness (36 % over 12 weeks and 48 % over 48 weeks). Uncertainty around the mean ICERs was substantial due to the small sample size.
Limitations: The PAX-BD trial was conducted during the COVID-19 pandemic and terminated early, resulting in a limited generalizability of resource use outside the pandemic context and a small sample size.
Conclusions: Pramipexole is a cost-effective treatment option for TRBD from the NHS + PSS perspective, with statistically significant increases in health-related quality of life and capability well-being over extended periods.
Keywords: Bipolar disorder; Cost-effectiveness; Health economic evaluation; Pramipexole; Treatment-resistant bipolar disorder.
Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.
Conflict of interest statement
Declaration of competing interest Michael Berger reports being co-PI on a research grant with payments made to the Medical University of Vienna by the WWTF (Vienna Science and Technology Fund) and receiving a scholarship from the Austrian Science Fund. Thomas Chadwick reports payments from NIHR HTA and the following: Member of Programme Steering Committee (ODDESSI: Open Dialogue: Development and Evaluation of a Social Network Intervention for Severe Mental Illness – University College London); Chair of Data Monitoring and Ethics Committee (SCENE: Improving quality of life and health outcomes of patients with psychosis through a new structured intervention for expanding social networks – Queen Mary University of London); Member of Data Monitoring and Ethics Committee (SUMMIT: Supporting Mothers' Mental health with Interpersonal Therapy – University College London); member of Trial Steering Committee (SCHEMA: Secure Care Hospital Evaluation of Manualised (interpersonal) Art-psychotherapy: A Randomised Controlled Trial – Cardiff University). Richard Morriss reports payments made to institutions from the NIHR HTA programme, UKRI-MRC, UKRI-ESPRC, Wellcome Trust, Magstim plc, Electromedical Products Inc., P1Vital Ltd., and membership of 2 DMEC committees as personal payment from Novartis plc. Paul RA Stokes reports grant funding to his institution from NIHR as a co-applicant on the PAX-BD trial. Prof Stokes reports grant funding from the Medical Research Council UK, H. Lundbeck A/S and King's Health Partners made to his institution, funding from NIHR, non-financial support from Janssen Research and Development LLC for an MRC-funded study led by Prof Stokes, editorial honoraria and non-financial support from Frontiers in Psychiatry outside the submitted work. Prof Stokes is a member of the UK Advisory Council on the Misuse of Drugs (ACMD), and Specialty Chief Editor, Mood Disorders section, Frontiers in Psychiatry. Allan H Young reports the following: employed by Imperial College London; Honorary Consultant Psychiatrist (NHS UK); Editor of Journal of Psychopharmacology and Deputy Editor, BJPsych Open; Paid lectures and advisory boards for the following companies with drugs used in affective and related disorders: Flow Neuroscience, Novartis, Roche, Janssen, Takeda, Noema pharma, Compass, Astrazenaca, Boehringer Ingelheim, Eli Lilly, LivaNova, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, Sage, Neurocentrx; Principal Investigator in the Restore-Life VNS registry study funded by LivaNova.; Principal Investigator on ESKETINTRD3004: “An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression.”; Principal Investigator on “The Effects of Psilocybin on Cognitive Function in Healthy Participants”; Principal Investigator on “The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)”; Principal Investigator on “A Double-Blind, Randomized, Parallel-Group Study with Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy.” (Janssen); Principal Investigator on “ An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants with Major Depressive Disorder (MDD).” (Janssen); Principal Investigator on “A Randomized, Double-blind, Multicentre, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy.”; Principal Investigator on “ A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients with Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNR.” (Janssen); UK Chief Investigator for Compass; COMP006 & COMP007 studies; UK Chief Investigator for Novartis MDD study MIJ821A12201; Grant funding (past and present): NIMH (USA); CIHR (Canada); NARSAD (USA); Stanley Medical Research Institute (USA); MRC (UK); Wellcome Trust (UK); Royal College of Physicians (Edin); BMA (UK); UBC-VGH Foundation (Canada); WEDC (Canada); CCS Depression Research Fund (Canada); MSFHR (Canada); NIHR (UK). Janssen (UK) EU Horizon 2020. Stuart Watson reports honoraria payments from the British Association of Psychopharmacology mood disorders certificate teaching and NIHR HTA board funding. R. Hamish McAllister-Williams reports acting as TSC chair for the NIHR HTA funded SNAPPER trial, TSC member for UK MRC funded FORWARDS-2 study and DMC chair for the EU funded PReDicT study; Director of Education for British Association for Psychopharmacology; receiving support for meetings via Janssen-Cilag; receiving payments/consultation fees from LivaNova, Janssen-Cilag, Sage Therapeutics, P1Vital, Takeda and Lundbeck. Judit Simon reports being PI/co-I on research grants with payments made to the Medical University of Vienna from the CDG, NIHR, EC, ECNP, LBG, WWTF, FWF, and advisory honoraria received by the EBC. All other authors report no relevant conflict of interest.
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