The University of Southampton
University of Southampton Institutional Repository

Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial

Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial
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, 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 100mg/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 [IGA <3 versus ≥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 (NICE) 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.
Adult, Humans, Female, Cost-Benefit Analysis, Spironolactone/therapeutic use, Cost-Effectiveness Analysis, Quality of Life, State Medicine, Acne Vulgaris/drug therapy, Quality-Adjusted Life Years, Adult dermatology, Clinical Trial, Dermatology, Acne, Health economics, HEALTH ECONOMICS
2044-6055
Pyne, Sarah
9f3f2284-d954-435c-a629-55edf67126af
Sach, Tracey H.
5c09256f-ebed-4d14-853a-181f6c92d6f2
Lawrence, Megan
e217da1e-b347-4129-b22f-0c8bae5eaf78
Renz, Susanne
4537317b-9305-464a-af38-5dd50ed70258
Eminton, Zina
44904d98-97be-4080-9a84-bf5742525f8e
Stuart, Beth
a51c80d3-5855-4672-b24f-8c65fd2e1444
Thomas, Kim S
75e143ff-868e-47dc-b892-c9745a7e496a
Francis, Nick
9b610883-605c-4fee-871d-defaa86ccf8e
Soulsby, Irene
96080278-1724-45a0-9066-5e2dfdde90af
Thomas, Karen
6d182191-c867-491d-aaca-cb1d92a87074
Permyakova, Natalia V.
f72b4f3b-d27e-4e64-ab46-298f312affdf
Ridd, Matthew J.
74f1634d-421f-46bd-8127-ec54d6f70224
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Muller, Ingrid
b532741c-7cd6-4834-b60d-90f9b9b12695
Nuttall, Jacqui
b4c18569-1ab8-4fb6-b72d-1a61ad271a1a
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Layton, Alison M.
5b851301-28e2-49f6-af30-a1bb7f35baa1
Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
Pyne, Sarah
9f3f2284-d954-435c-a629-55edf67126af
Sach, Tracey H.
5c09256f-ebed-4d14-853a-181f6c92d6f2
Lawrence, Megan
e217da1e-b347-4129-b22f-0c8bae5eaf78
Renz, Susanne
4537317b-9305-464a-af38-5dd50ed70258
Eminton, Zina
44904d98-97be-4080-9a84-bf5742525f8e
Stuart, Beth
a51c80d3-5855-4672-b24f-8c65fd2e1444
Thomas, Kim S
75e143ff-868e-47dc-b892-c9745a7e496a
Francis, Nick
9b610883-605c-4fee-871d-defaa86ccf8e
Soulsby, Irene
96080278-1724-45a0-9066-5e2dfdde90af
Thomas, Karen
6d182191-c867-491d-aaca-cb1d92a87074
Permyakova, Natalia V.
f72b4f3b-d27e-4e64-ab46-298f312affdf
Ridd, Matthew J.
74f1634d-421f-46bd-8127-ec54d6f70224
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Muller, Ingrid
b532741c-7cd6-4834-b60d-90f9b9b12695
Nuttall, Jacqui
b4c18569-1ab8-4fb6-b72d-1a61ad271a1a
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Layton, Alison M.
5b851301-28e2-49f6-af30-a1bb7f35baa1
Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc

Pyne, Sarah, Sach, Tracey H., 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), [e073245]. (doi:10.1136/bmjopen-2023-073245).

Record type: Article

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 100mg/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 [IGA <3 versus ≥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 (NICE) 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.

Text
bmjopen-2023-073245.R3_Proof_hi - Accepted Manuscript
Available under License Creative Commons Attribution.
Download (2MB)
Text
e073245.full - Version of Record
Available under License Creative Commons Attribution.
Download (1MB)
Text
Email acceptance
Restricted to Registered users only
Available under License Creative Commons Attribution.
Download (14kB)
Request a copy

More information

Accepted/In Press date: 5 December 2023
e-pub ahead of print date: 11 December 2023
Published date: 11 December 2023
Additional Information: Funding Information: We declare no support from any organisation other than the NIHR for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work; no other relationships or activities that could appear to have influenced the submitted work. LH has received consultancy fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work. THS was a member of NIHR HTA Efficient Study Designs-2, HTA Efficient Study Designs Board, HTA End of Life Care and Add-on-Studies, HTA Primary Care Themed Call Board and the HTA Commissioning Board between 2013 to December 2019. She is a steering committee member of the UK Dermatology Clinical Trials Network and Chair of the NIHR Research for Patient Benefit Regional Advisory Panel for the East of England. THS had no part in the decision-making for funding this study. Funding Information: We would like to thank all PPI contributors, participants, research and clinical staff, the NIHR Clinical Research Network, and the members of the Trial Steering Committee and Data Monitoring Committee for their support. The study was developed with support from the UK Dermatology Clinical Trials Network (UK DCTN). The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. The University of Southampton was the research sponsor for this trial. Funding Information: This study presents independent research funded by the National Institute for Health and Care Research (NIHR) under its Health Technology Assessment programme (16/13/02). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. This trial was registered prospectively with the ISRCTN registry ( ISRCTN12892056 ) and EudraCT (2018-003630-33).
Keywords: Adult, Humans, Female, Cost-Benefit Analysis, Spironolactone/therapeutic use, Cost-Effectiveness Analysis, Quality of Life, State Medicine, Acne Vulgaris/drug therapy, Quality-Adjusted Life Years, Adult dermatology, Clinical Trial, Dermatology, Acne, Health economics, HEALTH ECONOMICS

Identifiers

Local EPrints ID: 485039
URI: http://eprints.soton.ac.uk/id/eprint/485039
ISSN: 2044-6055
PURE UUID: 4be6b497-9044-435a-8bc4-027fe0d4fb5f
ORCID for Tracey H. Sach: ORCID iD orcid.org/0000-0002-8098-9220
ORCID for Nick Francis: ORCID iD orcid.org/0000-0001-8939-7312
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260

Catalogue record

Date deposited: 28 Nov 2023 17:53
Last modified: 21 Nov 2024 03:06

Export record

Altmetrics

Contributors

Author: Sarah Pyne
Author: Tracey H. Sach ORCID iD
Author: Megan Lawrence
Author: Susanne Renz
Author: Zina Eminton
Author: Beth Stuart
Author: Kim S Thomas
Author: Nick Francis ORCID iD
Author: Irene Soulsby
Author: Karen Thomas
Author: Natalia V. Permyakova
Author: Matthew J. Ridd
Author: Paul Little ORCID iD
Author: Ingrid Muller
Author: Jacqui Nuttall
Author: Alison M. Layton
Author: Miriam Santer ORCID iD

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×