Health Technology Assessment on denosumab in the treatment of postmenopausal osteoporosis

Background: Denosumab is the first fully human monoclonal antibody inhibiting the activity and the development of osteoclasts in the treatment of postmenopausal osteoporosis. Objectives: The objective was to realize a HTA report on denosumab. Methods: A HTA report was realized considering epidemiological, economic, organizational, social and ethical aspects. A scientific literature review was conducted through electronic databases to evaluate epidemiological context and risk factors for osteoporosis. For the economic evaluation, a cost-effectiveness and a budget impact analysis were performed. To evaluate ethical implications, clinical benefits and patient needs were considered. Results: In Italy around 4.000.000 women are affected by osteoporosis, which is a social and economic priority due to the progressive aging of the population and to the non-optimal adherence to available treatments. Denosumab administered subcutaneously 60 mg every six months, is an effective treatment to reduce quickly, clinically relevant and consistent the incidence of vertebral, nonvertebral and hip fractures. Comparing with strontium ranelate, the Incremental Cost Effectiveness Ratio (ICER) was €69 per QALY and €18.047 per QALY in comparison with generic alendronate. The Budget Impact analysis has allowed us to estimate a reduction in costs for the National Health Service. Denosumab for administering property and safety, is indicated in outpatients treatment, involving General Practitioners. Ethical evaluation is on the whole positive, concerning efficacy, clinical benefits and patient needs. Discussion: The introduction of innovative drugs, such as denosumab, could allow more effective management of the disease in presence of equity of access to the drug throughout the whole country. Implications for health systems/professionals/patients/society: HTA application for denosumab represents an important instrument in health care decision making to produce a critical documentation about the real value of a product and its utilization in the Italian context.