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

Ten-year excess treatment costs for testosterone compared with no treatment ranged between £2306 and £3269 per patient.

• Costs included testosterone treatment, monitoring, and cardiovascular complications.
• A cohort Markov model with a 10-year time horizon was used.
• Three starting age categories were defined: 40, 60, and 75 years.
• A cost-utility analysis comparing testosterone with no treatment was conducted following best practices in decision modelling.

Testosterone was cost-effective (ICER <£20,000) for men aged <75 years when Beck Depression Index-derived QALY data were used, regardless of morbidity and mortality sensitivity analyses.

• The incremental cost-effectiveness ratio threshold used was £20,000 per QALY.
• This finding held regardless of morbidity and mortality sensitivity analyses for men under 75.
• Clinical outcomes were obtained from an individual patient meta-analysis of placebo-controlled, double-blind randomised studies.
• Quality-adjusted life years results depended on the instruments used to measure health utilities.

Testosterone was not cost-effective in men aged >75 years in models assuming increased morbidity and/or mortality.

• Cost-effectiveness in men >75 years was dependent on cardiovascular safety assumptions.
• Morbidity and mortality sensitivity analyses were conducted to test robustness of findings.
• The finding reflects uncertainty around cardiovascular risk in older men with low testosterone treated with testosterone.
• The worldwide shift in testosterone prescribing towards middle-aged and older men with low testosterone related to age, diabetes, and obesity provided the clinical context.

The study population targeted middle-aged and older men with low testosterone levels, a group for whom evidence of clinical safety and benefit is less established.

• The study was motivated by a worldwide shift in testosterone prescribing towards middle-aged and older men, mostly with low testosterone related to age, diabetes, and obesity.
• The value of testosterone treatment in this population was described as 'yet to be determined.'
• The analysis was distinguished from organic hypogonadism, where 'testosterone is safe and highly effective.'
• Three starting age categories (40, 60, and 75 years) were modelled to capture different age-related risk profiles.

The choice of health utility measurement instrument materially affected the cost-effectiveness results for testosterone treatment.

• Quality-adjusted life years results 'depended on the instruments used to measure health utilities.'
• Beck Depression Index-derived QALY data yielded cost-effective results for men <75 years.
• Results varied across different utility measurement approaches, highlighting methodological sensitivity.
• The authors noted that 'more robust and longer-term cost-utility data are needed to verify our conclusion.'

A cohort Markov model incorporating relevant care pathways for individuals with hypogonadism was developed for a 10-year time horizon.

• The model compared cost utility (quality-adjusted life years) accrued and costs of testosterone treatment, monitoring, and cardiovascular complications.
• Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were estimated for selected scenarios.
• Clinical outcomes were derived from an individual patient meta-analysis of placebo-controlled, double-blind randomised studies.
• The analysis followed 'best practices in decision modelling.'