OBJECTIVES: Recent randomised studies have indicated that Hormone Replacement Therapy (HRT) does not reduce the risk of cardiovascular events neither in secondary nor in primary prevention. Evidence of the effect of HRT on breast cancer has been inconclusive, but now the general belief is that the risk of breast cancer increases. In line with the results found in the Women’s Health Initiative (WHI) the cost-effectiveness of HRT therapy, based on a societal perspective, was assessed for women with menopausal symptoms. METHODS: An individual state transition model populated Swedish data was used to estimate the cost-effectiveness of women with menopausal symptoms. The model consists of the following disease states: Coronary Heart Disease (CHD), Stroke, Venous thromboembolic events (VTE), breast cancer, colorectal cancer, hip fracture, vertebral fracture and wrist fracture. HRT therapy was modelled by its impact on the disease risks during therapy and possible effects after the cessation of therapy. The model calculates costs and health effects or quality adjusted life years (QALYs) with and without intervention. The resulting cost per gained QALY was compared to the value of a gained QALY, which was set to 65,000€. RESULTS: The cost per QALY gained for Swedish women with intact uterus and menopausal symptoms were estimated to 1404€, 1188€, and 1004€ when the therapy started at the age of 50, 55, and 60, respectively. The cost per QALY gained was found to be below the set value of a QALY at very low symptom related reductions in the quality of life. CONCLUSIONS: The results indicate that there is high probability that HRT is cost-effective for the treatment of women with menopausal symptoms