Cost-effectiveness of romosozumab for severe postmenopausal osteoporosis at very high risk of fracture in Mexico.

Introduction: This study aims to assess the cost effectiveness of romosozumab versus teriparatide, both sequenced to denosumab, for the treatment of severe postmenopausal osteoporosis at very high risk of fractures in Mexican women. Methods: A Markov model was used to assess the relative cost effectiveness of 1 year of romosozumab versus 2 years of teriparatide, both sequenced to denosumab for a total treatment duration of 5 years. Outcomes for a cohort of women with a mean age of 74 years, a T-score -2.5 and a previous fragility fracture were simulated over a lifetime horizon. The analysis was conducted from the perspective of the Mexican healthcare system and used a discount rate of 5% per annum. To inform relative fracture incidence, the bone mineral density (BMD) advantage of romosozumab over teriparatide was translated into relative risks of fracture, using relationships provided by a meta-regression of osteoporosis therapy trials. Outcomes were assessed in terms of lifetime costs (2023 Mexican pesos), quality-adjusted life years (QALYs) and life-years gained (LYs). Results: Base case results showed that, compared with teriparatide/ denosumab, romosozumab/ denosumab reduced costs by $51,363 MXN per patient and yielded 0.03 additional QALYs and 0.01 LYs. Scenario analyses and probabilistic sensitivity analyses confirmed that results are robust to uncertainty in model assumptions and inputs. Conclusions: Results show that romosozumab/ denosumab produces greater health benefits at a lower total cost than teriparatide/ denosumab. ### Competing Interest Statement TAM, LG, EY and LMC are employed by Amgen. JPDM has served as a consultant for Amgen and has received research grants from them. ### Funding Statement Yes ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: N/A I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request