Cost-effectiveness analysis of intra muscular testosterone undecanoate (IM-TU) as testosterone replacement therapy (TRT) for androgen deficiency in the aging male (ADAM) and diabetes mellitus type 2 (DM2) patients in Brazil

Abstract

Objectives: To determine the cost-effectiveness of TRT with IM-TU compared with placebo for patients with ADAM and DM2 in Brazilian Private Healthcare System. Methods: The study was a cost-effectiveness analysis based on Markov modeling. Epidemiological and efficacy data derived from a critical appraisal of the scientific literature. Only direct medical costs were considered. If available, costs of clinical events (CE) were obtained from burden of disease studies. If not, Brazilian official guidelines determined the resources used to treat the CE. Costs and benefits were discounted at 5% yearly. Outcomes were expressed as CE. Probability sensitivity analysis (PSA) was conducted to assess model robustness. Life time horizon was analyzed. Results: The systematic review showed that although the absence of studies directly evaluating the impact of IM-TU on cardiovascular events, their favorable influence on cardiovascular disease intermediate markers suggests that IM-TU may have clinically relevant effect in patients at risk, especially in patients with metabolic syndrome and/ or DM2. The analysis showed higher clinical benefits and costs for IM-TU. Considering 100 patients, 75.2CE and 140.0CE occurred with a spent of R$34,120 and R$23,489 with IM-TU and placebo, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of R$16,390/CE avoided. PSA demonstrated that in 83.2% of the simulations IM-TU was more effective with higher cost and in 16.8% of the simulations IM-TU was dominant compared to placebo. Conclusion: Our study demonstrated that IM-TU have clinically relevant effect in reducing CE being highly cost-effective for ADAM treatment in patients with DM2 at willingness-to-pay beyond R$19,016/CE avoided (Brazilian GDP per-capita).