Abstract
Objectives:
The objective was to analyze adherence and current trends in utilization and prescription practice patterns of the anti-RANKL monoclonal antibody denosumab in the treatment of postmenopausal osteoporosis (OP).
Methods:
The prescription-based database of the General Health Insurance Company of the Czech Republic that covers approximately 60% of the Czech population (6 million) was used as the data source. Medication possession ratio (MPR) and persistence were calculated for all patients (both OP medication-naïve and medication-experienced) with postmenopausal OP from the start of their therapy with denosumab 60 mg per ml subcutaneous injection within a period between September 2011, i.e. first denosumab availability, and May 2014. Clinical data such as fractures, co-morbidities and co-medication were not analyzed.
Results:
A total of 7904 women treated with denosumab were analyzed; 93.8% of patients were identified as compliant (MPR ≥0.8) while 6.2% were non-compliant (MPR < 0.8). Persistence (base case, i.e. refill gap ≤30 days) was 59.1% after 12 months and 34.8% after 24 months. By 2013, i.e. within 2 years, denosumab became the second most utilized and most costly drug after oral bisphosphonates.
Conclusions:
Despite relatively high MPR and persistence rate observed in denosumab treatment, adherence enhancing strategies, focused on persistence in particular, are still needed. The uptake of denosumab has been rapid, its utilization keeps rising swiftly, and denosumab already represents a significant part of the osteoporosis therapy budget.
Transparency
Declaration of funding
There is no sponsorship to declare.
Author contributions: L.F. – study conception, data preparation and analysis, interpretation of the results, discussion, drafting and revising the manuscript; M.V. – study conception, literature research, algorithm of data handling, interpretation of the results, discussion, revising the manuscript.
Declaration of financial/other relationships
L.F. has disclosed that he was employed by the public health insurance fund, the General Health Insurance Company of the Czech Republic (GHIC CZ) at the time this study was conducted. M.V. has disclosed that she has no significant relationships with or financial interests in any commercial companies related to this study or article.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
We gratefully acknowledge cooperation and quantitative data provision by the General Health Insurance Company of the Czech Republic. The authors thank Michal Urbanek MSc for English editing. We are grateful to Prof. Jan J. Štepán, Prof. Vladimír Palička, and Prof. Pavel Horák for sharing their profound clinical experience in osteoporosis treatment.
Notes
* Prolia is a registered trade name of Amgen Europe BV, Breda, the Netherlands