1. The Prevention of Postmenopausal Osteoporotic Fractures: Results of the Health Technology Assessment of a New Antiosteoporotic Drug
- Author
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Maria Rosaria Gualano, Silvio Capizzi, Maria Lucia Specchia, Giuseppe La Torre, Chiara Cadeddu, Maria Luisa Di Pietro, Walter Ricciardi, Nicola Nicolotti, S Capri, Antonella Sferrazza, Flavia Kheiraoui, Maria Assunta Veneziano, and Chiara De Waure
- Subjects
Budgets ,Genetics and Molecular Biology (all) ,Drug ,medicine.medical_specialty ,Technology Assessment, Biomedical ,Article Subject ,Immunology and Microbiology (all) ,Cost-Benefit Analysis ,media_common.quotation_subject ,Osteoporosis ,MEDLINE ,lcsh:Medicine ,Antibodies, Monoclonal, Humanized ,Biochemistry ,General Biochemistry, Genetics and Molecular Biology ,Strontium ranelate ,Epidemiology ,Biochemistry, Genetics and Molecular Biology (all) ,medicine ,Humans ,Settore MED/42 - IGIENE GENERALE E APPLICATA ,Aged ,media_common ,Aged, 80 and over ,Bone Density Conservation Agents ,General Immunology and Microbiology ,Cost–benefit analysis ,business.industry ,lcsh:R ,Health Technology Assessment ,Health technology ,General Medicine ,Middle Aged ,medicine.disease ,Markov Chains ,Surgery ,Hospitalization ,Postmenopause ,Treatment Outcome ,Denosumab ,Italy ,Physical therapy ,Female ,business ,Osteoporotic Fractures ,Research Article ,medicine.drug - Abstract
Objective. The Health Technology Assessment (HTA) approach was applied to denosumab in the prevention of osteoporotic fractures in postmenopausal women.Method. Epidemiological, clinical, technical, economic, organizational, and ethical aspects were considered. Medical electronic databases were accessed to evaluate osteoporosis epidemiology and therapeutical approaches. A budget impact and a cost-effectiveness analyses were performed to assess economic implications. Clinical benefits and patient needs were considered with respect to organizational and ethical evaluation.Results. In Italy around four millions women are affected by osteoporosis and have a higher risk for fractures with 70,000 women being hospitalized every year. Bisphosphonates and strontium ranelate are recommended as first line treatment for the prevention of osteoporotic fractures. Denosumab is effective in reducing vertebral, nonvertebral, and hip/femoral fractures with an advantage of being administered subcutaneously every six months. The budget impact analysis estimated a reduction in costs for the National Health Service with the introduction of denosumab. Furthermore, the economic analysis demonstrated that denosumab is cost-effective in comparison to oral bisphosphonates and strontium ranelate. Denosumab can be administered in outpatients by involving General Practitioners in the management. Ethical evaluation is positive because of its efficacy and compliance.Conclusion. Denosumab could add value in the prevention of osteoporotic fractures.
- Published
- 2014