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.

De Waure, C., Specchia, M. L., Cadeddu, C., Capizzi, S., Capri, S., Di Pietro, M. L., Veneziano, M. A., Gualano, M., Kheiraoui,, La Torre, G., Nicolotti, N., Sferrazza, A., Ricciardi, G., The prevention of postmenopausal osteoporotic fractures: results of the health technology assessment of a new antiosteoporotic drug, <<BIOMED RESEARCH INTERNATIONAL>>, 2014; 2014 (N/A): 975927-975927. [doi:10.1155/2014/975927] [http://hdl.handle.net/10807/57163]

The prevention of postmenopausal osteoporotic fractures: results of the health technology assessment of a new antiosteoporotic drug

De Waure, Chiara;Specchia, Maria Lucia;Cadeddu, Chiara;Capizzi, Silvio;Di Pietro, Maria Luisa;Veneziano, Maria Assunta;La Torre, Giuseppe;Nicolotti, Nicola;Sferrazza, Antonella;Ricciardi, Gualtiero
2014

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.
Inglese
De Waure, C., Specchia, M. L., Cadeddu, C., Capizzi, S., Capri, S., Di Pietro, M. L., Veneziano, M. A., Gualano, M., Kheiraoui,, La Torre, G., Nicolotti, N., Sferrazza, A., Ricciardi, G., The prevention of postmenopausal osteoporotic fractures: results of the health technology assessment of a new antiosteoporotic drug, <<BIOMED RESEARCH INTERNATIONAL>>, 2014; 2014 (N/A): 975927-975927. [doi:10.1155/2014/975927] [http://hdl.handle.net/10807/57163]
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10807/57163
Citazioni
  • ???jsp.display-item.citation.pmc??? 5
  • Scopus 12
  • ???jsp.display-item.citation.isi??? 7
social impact