ABSTRACT
Objective: To assess changes in the involvement of advisory bodies in the reimbursement decision-making process in Poland, and to evaluate variables that influenced HTA recommendations in the years 2013–2015.
Research design and methods: Two independent contributors reviewed the statements of the TC, recommendations issued by the president of the AOTMiT and reimbursement decisions of the MoH for the years 2013–2015. We collected data on the type of recommendations and variables influencing the HTA recommendations. Data were analysed using the χ2 test, trend test, kappa coefficient of agreement, and ordinal logistic regression.
Results: We collected 267 records including 263 statements of the TC and 265 HTA recommendations; the share of positive HTA recommendations changed from 73% in 2013 through 79% in 2014 to 42% in 2015. The kappa coefficient for the association between statements and recommendations decreased from 0.91 in 2013 through 0.86 in 2014 to 0.53 in 2015. The agreement between the reimbursement decisions of the MoH and the HTA recommendations was 0.29 in 2013, 0.22 in 2014 and 0.26 in 2015, which represents fair agreement.
Conclusions: Our study revealed a fair agreement between the AOTMiT recommendations and the MoH decisions; the association was especially weak in 2015.
Acknowledgements
We would like to thank Katarzyna Antoniewicz for participation in the process of data extraction, which was helpful to conduct the study.
Declaration of Interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose. Ethical approval was not required for this study as it was based on publicly available data and no patient-based data were included or analysed.
Author Contributions
Conception and design: PK; analysis and interpretation of the data: KM and PK; the drafting of the paper: PK and KM; revising the paper critically for intellectual content: WT. The final approval of the version to be published: PK, KM, WT; all authors agree to be accountable for all aspects of the work.
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