Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial
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...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e073245.full |
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| author | Ingrid Muller Miriam Santer Beth Stuart Paul Little Matthew J Ridd Karen Thomas Nick Francis Kim S Thomas Gareth Griffiths Natalia V Permyakova Jacqui Nuttall Irene Soulsby Alison M Layton Tracey H Sach Sarah Pyne Susanne Renz Zina Eminton Megan Lawrence |
| author_facet | Ingrid Muller Miriam Santer Beth Stuart Paul Little Matthew J Ridd Karen Thomas Nick Francis Kim S Thomas Gareth Griffiths Natalia V Permyakova Jacqui Nuttall Irene Soulsby Alison M Layton Tracey H Sach Sarah Pyne Susanne Renz Zina Eminton Megan Lawrence |
| author_sort | Ingrid Muller |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-a2ad53dd8bc84d2ca75800e7cde0cda9 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-a2ad53dd8bc84d2ca75800e7cde0cda92025-08-20T03:52:29ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-073245Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trialIngrid Muller0Miriam Santer1Beth Stuart2Paul Little3Matthew J Ridd4Karen Thomas5Nick Francis6Kim S Thomas7Gareth Griffiths8Natalia V Permyakova9Jacqui Nuttall10Irene Soulsby11Alison M Layton12Tracey H Sach13Sarah Pyne14Susanne Renz15Zina Eminton16Megan Lawrence17Primary Care Research Centre, Faculty of Medicine, University of Southampton, Southampton SO16 5ST, UK2 Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK2 Queen Mary University of London, London, UKUniversity of Southampton, Medical School, Southampton, UKprofessor of primary care researchDivision of Injury Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA2 Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UKprofessor of applied dermatology research3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK11 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK6 Public Contributor, Primary Care Research Centre, University of Southampton, Southampton, Hampshire, UK8 Skin Research Centre, Hull York Medical School, University of York, York, North Yorkshire, UKprofessor of health economicsNorwich Medical School, University of East Anglia, Norwich, UK3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UKObjective 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).https://bmjopen.bmj.com/content/13/12/e073245.full |
| spellingShingle | Ingrid Muller Miriam Santer Beth Stuart Paul Little Matthew J Ridd Karen Thomas Nick Francis Kim S Thomas Gareth Griffiths Natalia V Permyakova Jacqui Nuttall Irene Soulsby Alison M Layton Tracey H Sach Sarah Pyne Susanne Renz Zina Eminton Megan Lawrence Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial BMJ Open |
| title | Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial |
| title_full | Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial |
| title_fullStr | Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial |
| title_full_unstemmed | Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial |
| title_short | Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial |
| title_sort | cost effectiveness of spironolactone for adult female acne safa economic evaluation alongside a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/13/12/e073245.full |
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