The management of the large patient population in Italy receiving long-term oral anticoagulation therapy (OAT) poses organizational challenges that are traditionally approached with a centralized procedure, relying on hospital-based clinics and/or GPs. However, the availability of near-patient testing devices for the monitoring of OAT effectiveness (international normalized ratio measurement) allows for alternative or complementary management models, in which adequately trained patients perform the test themselves and possibly make decisions about dosing adjustments (patient self-monitoring). Patient self-monitoring has been proven to be effective and safe, and is economically attractive. However, in order to assess its potential economic impact in Italy, there is a need for data on current treatment patterns and relative costs, which are currently not available.
To establish prevalent management patterns and costs incurred by Italian OAT patients.
An ad hoc questionnaire was developed and administered to OAT patients with the support of the main Italian OAT patients association. Returned questionnaires were checked for consistency and valid data were summarized. Resources used were costed according to published prices.
A total of 4722 valid questionnaires were returned from all over Italy. The prevalent OAT management model in this sample relied on hospital-based anticoagulation clinics. Significant earning losses, transportation costs and other out-of-pocket expenses were incurred by patients, with an estimated mean overall monthly cost of approximately €30 (year 2008 value). There was a wide distribution of costs in this population, depending mainly on monitoring frequency, home-to-clinic distance and employment status.
This study contributes to clarifying the organizational models of the Italian OAT population and delivers data on treatment patterns and costs that may be used when planning and evaluating alternative management options.
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This contribution represents an original work that has not been previously published nor simultaneously submitted for publication elsewhere. The manuscript has been approved by all authors and conforms to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals prepared by the International Committee of Medical Journal Editors.
All of the data, models and methodology used in this research come from published and publicly available sources and are not proprietary.
This study was funded by an unrestricted research grant from Roche Diagnostics, Monza (MI), Italy.
Paola Botrugno is an employee of Roche Diagnostics SPA. All other authors have worked as external consultants for Roche Diagnostics and are employees of AdRes Health Economics & Outcomes Research, which receives grants and payments from pharmaceutical companies including Roche. The publication of study results was not contingent on the sponsor’s approval. The sponsor had no role in the design and conduct of the study, collection, management, analysis and interpretation of the data, or preparation, review and approval of the manuscript. Viola Sacchi and Paolo De Luca contributed to data entry.
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Pradelli, L., Iannazzo, S., Zaniolo, O. et al. Organization and estimated patient-borne costs of oral anticoagulation therapy in Italy. Appl Health Econ Health Policy 8, 119–128 (2010). https://doi.org/10.2165/11313890-000000000-00000
- International Normalize Ratio
- Monitoring Frequency
- Monthly Cost
- Anticoagulation Clinic
- Target International Normalize Ratio