Cost-Utility of Intramuscular Testosterone for Men and Male Adolescents With Organic Hypogonadotropic Hypogonadism in Brazil
Author(s)
Afonso Nogueira Simões Correa Neto, MD1, Mariana Andrades Fiorino Monteiro Novo, M.Sc2, Muriel Barros, M.Sc3, Suena Parahiba, M.Sc3, Bruna Marmett, M.Sc3, Gilson Dorneles, M.Sc3, Vania Santos Nunes-Nogueira, PhD, MD4, Julia Simoes Correa Galendi, PhD, MD5.
1Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil, 2Botucatu Medical School, University of the State of São Paulo (UNESP), Botucatu, Brazil, 3Escritório de Projetos, Hospital Moinhos de Vento, Porto Alegre RS, Brazil, Porto Alegre, Brazil, 4São Paulo State University, Medical School, Botucatu, Brazil, 5Associate Researcher, Botucatu Medical School, University of the State of São Paulo (UNESP), São Paulo, Brazil.
1Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil, 2Botucatu Medical School, University of the State of São Paulo (UNESP), Botucatu, Brazil, 3Escritório de Projetos, Hospital Moinhos de Vento, Porto Alegre RS, Brazil, Porto Alegre, Brazil, 4São Paulo State University, Medical School, Botucatu, Brazil, 5Associate Researcher, Botucatu Medical School, University of the State of São Paulo (UNESP), São Paulo, Brazil.
OBJECTIVES: Although intramuscular TRT is universally recommended in clinical guidelines for OHH management, patient access is limited due to recently rising prices of TRT and lack of coverage in the Brazilian Unified Health System (SUS). This cost-utility analyses aimed to assess the value of intramuscular testosterone replacement therapy (TRT) for adult and adolescent males with Organic Hypogonadotropic Hypogonadism (OHH) from the SUS perspective.
METHODS: A decision tree with Markov model with annual cycle and lifetime horizon was developed to compare TRT with no treatment. Health-state utilities were estimated in a Time Trade-Off study. Cost data were obtained from national databases: Management System for the Table of Procedures and Medicines at SUS for lab/imaging tests and Drug Market Regulation Chamber for medication prices. Transition probabilities were sourced from the literature. Deterministic and probabilistic sensitivity analyses were conducted.
RESULTS: TRT consistently led to Quality-Adjusted Life Years (QALYs) gains at higher costs, resulting in an incremental cost-effectiveness ratio (ICER) of R$2,774/QALY for adolescent males. For adults, the ICERs for the three approved formulations were: R$ 4,044.41/QALY for testosterone blend (decanoate, phenylpropionate, isocaproate, propionate); R$ 9,146.67/QALY for testosterone cypionate; R$ 5,201.39/QALY for testosterone undecanoate. Utility values in uncomplicated OHH states were the most influential parameter, followed by medication costs. Probabilistic analyses demonstrated that at a willingness-to-pay threshold of R$20,000/QALY, all formulations had a 100% probability of being cost-effective.
CONCLUSIONS: Our results show that TRT is cost-effective for the management of OHH, supporting their inclusion in the minimum benefit list of Brazilian SUS.
METHODS: A decision tree with Markov model with annual cycle and lifetime horizon was developed to compare TRT with no treatment. Health-state utilities were estimated in a Time Trade-Off study. Cost data were obtained from national databases: Management System for the Table of Procedures and Medicines at SUS for lab/imaging tests and Drug Market Regulation Chamber for medication prices. Transition probabilities were sourced from the literature. Deterministic and probabilistic sensitivity analyses were conducted.
RESULTS: TRT consistently led to Quality-Adjusted Life Years (QALYs) gains at higher costs, resulting in an incremental cost-effectiveness ratio (ICER) of R$2,774/QALY for adolescent males. For adults, the ICERs for the three approved formulations were: R$ 4,044.41/QALY for testosterone blend (decanoate, phenylpropionate, isocaproate, propionate); R$ 9,146.67/QALY for testosterone cypionate; R$ 5,201.39/QALY for testosterone undecanoate. Utility values in uncomplicated OHH states were the most influential parameter, followed by medication costs. Probabilistic analyses demonstrated that at a willingness-to-pay threshold of R$20,000/QALY, all formulations had a 100% probability of being cost-effective.
CONCLUSIONS: Our results show that TRT is cost-effective for the management of OHH, supporting their inclusion in the minimum benefit list of Brazilian SUS.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE313
Topic
Economic Evaluation, Health Technology Assessment
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)