The prevention of postmenopausal osteoporotic fractures: results of the Health Technology Assessment of a new antiosteoporotic 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.

• Authors: Chiara de Waure, Maria Lucia Specchia, Chiara Cadeddu, Silvio Capizzi, Stefano Capri, Maria Luisa Di Pietro, Maria Assunta Veneziano, Maria Rosaria Gualano, Flavia Kheiraoui, Giuseppe La Torre, Nicola Nicolotti, Antonella Sferrazza, Walter Ricciardi
• Journal: BioMed research international (Biomed Res Int) Vol. 2014 Pg. 975927 ( 2014) ISSN: 2314-6141 [Electronic] United States
• PMID: 24689066 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Bone Density Conservation Agents
• Denosumab

Topics

• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Humanized (economics, therapeutic use)
• Bone Density Conservation Agents (economics, therapeutic use)
• Budgets
• Cost-Benefit Analysis
• Denosumab
• Female
• Hospitalization (economics)
• Humans
• Italy (epidemiology)
• Markov Chains
• Middle Aged
• Osteoporotic Fractures (drug therapy, economics, epidemiology, prevention & control)
• Postmenopause (drug effects)
• Technology Assessment, Biomedical (economics, ethics, organization & administration)
• Treatment Outcome