Pyne, Sarah ORCID: https://orcid.org/0000-0003-0093-9125, Sach, Tracey H. ORCID: https://orcid.org/0000-0002-8098-9220, Lawrence, Megan, Renz, Susanne, Eminton, Zina, Stuart, Beth, Thomas, Kim S., Francis, Nick, Soulsby, Irene, Thomas, Karen, Permyakova, Natalia V., Ridd, Matthew J., Little, Paul, Muller, Ingrid, Nuttall, Jacqui, Griffiths, Gareth, Layton, Alison M. and Santer, Miriam (2023) Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): Economic evaluation alongside a randomised controlled trial. BMJ Open, 13 (12). ISSN 2044-6055
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Abstract
Objective This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks. Design Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial. Setting Primary and secondary healthcare, community and social media advertising. Participants Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment. Interventions Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment. Main outcome measures Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator's global assessment, IGA <3 vs ≥3)) and baseline variables (Acne-QoL symptom subscale score, resource use costs, EQ-5D score and use of topical treatments). Results Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence's threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis). Conclusions The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis. Trial registration number ISRCTN registry (ISRCTN12892056).
Item Type: | Article |
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Uncontrolled Keywords: | acne,adult dermatology,clinical trial,dermatology,health economics,health economics,medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700 |
Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Health Economics Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit |
Related URLs: | |
Depositing User: | LivePure Connector |
Date Deposited: | 10 Dec 2024 01:46 |
Last Modified: | 17 Dec 2024 01:42 |
URI: | https://ueaeprints.uea.ac.uk/id/eprint/97964 |
DOI: | 10.1136/bmjopen-2023-073245 |
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