Cost-effectiveness of testosterone treatment utilising individual patient data from randomised controlled trials in men with low testosterone levels

Rodolfo Hernández* (Corresponding Author), Nipun Lakshitha de Silva, Jemma Hudson, Moira Cruickshank, Richard Quinton, Paul Manson, Waljit S Dhillo, Siladitya Bhattacharya, Miriam Brazzelli, Channa N Jayasena

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Testosterone is safe and highly effective in men with organic hypogonadism, but worldwide testosterone prescribing has recently shifted towards middle-aged and older men, mostly with low testosterone related to age, diabetes and obesity, for whom there is less established evidence of clinical safety and benefit. The value of testosterone treatment in middle-aged and older men with low testosterone is yet to be determined. We therefore evaluated the cost-effectiveness of testosterone treatment in such men with low testosterone compared with no treatment.

METHODS: A cost-utility analysis comparing testosterone with no treatment was conducted following best practices in decision modelling. A cohort Markov model incorporating relevant care pathways for individuals with hypogonadism was developed for a 10-year-time horizon. Clinical outcomes were obtained from an individual patient meta-analysis of placebo-controlled, double-blind randomised studies. Three starting age categories were defined: 40, 60 and 75 years. Cost utility (quality-adjusted life years) accrued and costs of testosterone treatment, monitoring and cardiovascular complications were compared to estimate incremental cost-effectiveness ratios and cost-effectiveness acceptability curves for selected scenarios.

RESULTS: Ten-year excess treatment costs for testosterone compared with non-treatment ranged between £2306 and £3269 per patient. Quality-adjusted life years results depended on the instruments used to measure health utilities. Using Beck depression index-derived quality-adjusted life years data, testosterone was cost-effective (incremental cost-effectiveness ratio <£20,000) for men aged <75 years, regardless of morbidity and mortality sensitivity analyses. Testosterone was not cost-effective in men aged >75 years in models assuming increased morbidity and/or mortality.

CONCLUSIONS AND FUTURE RESEARCH: Our data suggest that testosterone is cost-effective in men <75 years when Beck depression index-derived quality-adjusted life years data are considered; cost-effectiveness in men >75 years is dependent on cardiovascular safety. However, more robust and longer-term cost-utility data are needed to verify our conclusion.

Original languageEnglish
Number of pages10
JournalAndrology
Early online date17 Jan 2024
DOIs
Publication statusE-pub ahead of print - 17 Jan 2024

Bibliographical note

ACKNOWLEDGEMENTS
Professor Graham Scotland (Health Services Research Unit and Health Economics Research Unit, University of Aberdeen, UK) for providing comments on an earlier draft of this article. The project was funded by the NIHR Health Technology Assessment Programme (project number: 17/68/01). The Section of Endocrinology and Investigative Medicine is funded by grants from the MRC and NIHR and is supported by the NIHR Biomedical Research Centre Funding Scheme and the NIHR/Imperial Clinical Research Facility. The views expressed are those of the author(s) and not necessarily those of the NHS, NIHR or Department of Health. Channa N. Jayasena was funded by NIHR post-doctoral fellowship and Waljit S. Dhillo by NIHR Senior Investigator Award.

Keywords

  • cost-effectiveness
  • economic people
  • hypogonadism
  • technology assessment
  • Testosterone

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