PMON260 Cost-Effectiveness of Testosterone Treatment for Men with Hypogonadism

BACKGROUND: Testosterone replacement therapy is the standard treatment for male hypogonadism (MH). Prescribing rates of testosterone in the UK have risen between 2001 and 2010 without an observable increase in the prevalence of hypogonadism, which may reflect increasing media awareness among men about hypogonadism. Currently, there is uncertainty about the safety and efficacy of testosterone treatment for MH, especially regarding its impact on cardiovascular risk, which has led to mandatory safety labelling in some countries. AIM: We conducted an economic evaluation of testosterone therapy in men with hypogonadism, using individual patient data (IPD) of safety and efficacy outcomes in over 3000 participants as part of an international collaboration of investigators of 17 existing placebo-controlled RCTs assessing the safety and efficacy of testosterone treatment for MH (TestES Consortium). METHODS: A cost-utility analysis of the use of testosterone treatment for MH was conducted using a cohort Markov model developed following best practice. The model care pathway was informed by existing clinical guidelines, the results of the TestES Consortium individual patient data (IPD) meta-analysis, and discussions with clinical and methodological experts. Five Markov states were included: no complications, post-Cardiac pathology, post-Peripheral Vascular System Pathology, post-Cerebrovascular System Pathology, and Death. All-cause mortality, cardiovascular and cerebrovascular complications, and utility weights were obtained from the TestES IPD analyses. The UK NHS and personal and social services perspective was adopted for costs. Ten-year and lifetime time horizons were considered with costs and effects discounted annually at 3.5% rate. The model was run probabilistically using 10,000 Monte Carlo simulations. Three starting ages were defined (40, 60, and 75 years). Mean total cost, mean QALYs and incremental cost-effectiveness ratios were calculated. RESULTS: Cost-effectiveness of testosterone treatment appears to be dependent on the relative risk (RR) of all-cause mortality - favouring TRT - and the methods used to derive health state utility scores (i.e., SF-6D or a mapping between Beck Depression Inventory -BDI- score and EQ-5D score) for testosterone treatment versus standard care. When the RR of mortality and the BDI utilities were used, ICERs remained below the £20,000 ($27,400) UK conventional threshold, irrespective of the cohort starting age. However, ICERs increased above the £20,000 threshold when the difference in all-cause mortality was dropped, and the SF-6D utility scores were used. CONCLUSIONS: We report the most in-depth economic analysis of male hypogonadism treatment to date. There remains limited data for generating preference-based health-related quality of life (HRQoL) weights for economic evaluation. Further clarity on the long-term cardiovascular safety of testosterone treatment in men with hypogonadism, and more in-depth mapping of clinical outcomes to generic preference-based measures of HRQoL will be crucial to inform robust estimates of the cost-effectiveness of testosterone treatment for MH. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.