Kawalec Paweł, Malinowski Krzysztof Piotr
Jagiellonian University Medical College, Faculty of Health Sciences, Institute of Public Health, Kraków, Poland.
Jagiellonian University Medical College, Faculty of Health Sciences, Institute of Public Health, Kraków, Poland.
Health Policy. 2016 Nov;120(11):1240-1248. doi: 10.1016/j.healthpol.2016.09.021. Epub 2016 Oct 11.
The aim of the study was to assess the influence of public advisory bodies (the Transparency Council and the President of AOTMiT, the Polish Agency for Health Technology Assessment and Tariff System) involved in the process on final reimbursement decisions performed by the Ministry of Health.
We have analysed all statements of the Transparency Council as well as the President of the AOTMiT recommendations and final reimbursement decisions in Poland for the period of three years: 2012 till 2014. For each recommendation we collected data on decisions as well as potential additional requirements regarding the reimbursement; data was presented for the whole analysed period and separately for each year, to assess the general tendencies in the reimbursement decision-making in Poland. We collected all data accessible at February 2015. The kappa measurement of agreement was used to assess the compliance between statements, recommendations and reimbursement decisions.
We collected data on 238 drugs evaluated by the Agency. The compliance between the Transparency Council and the President of the AOTMiT was 95% and remained constant in the analysed period. The agreement between the President of the AOTMiT recommendations and final reimbursement decisions was only fairly represented by a kappa coefficient of 0.23 and decreased in the subsequent years. We observed an increasing proportion of positive-conditional recommendations, with the introduction of a risk sharing scheme being the most common condition of a reimbursement recommendation.
We observed that final reimbursement decisions did not reflect statements and recommendations issued by the advisory boards. Positive recommendations issued by the AOTMiT did not guarantee positive reimbursement status, and negative recommendations in some cases did not result in the lack of reimbursement.
本研究旨在评估参与该过程的公共咨询机构（透明度委员会以及波兰卫生技术评估与关税系统机构AOTMiT主席）对卫生部做出的最终报销决定的影响。
我们分析了透明度委员会的所有声明以及AOTMiT主席在2012年至2014年这三年期间在波兰提出的建议和最终报销决定。对于每项建议，我们收集了关于决定的数据以及与报销相关的潜在额外要求；数据呈现了整个分析期以及每年的情况，以评估波兰报销决策的总体趋势。我们收集了截至2015年2月可获取的所有数据。使用卡帕一致性测量来评估声明、建议和报销决定之间的一致性。
我们收集了该机构评估的238种药物的数据。透明度委员会与AOTMiT主席之间的一致性为95%，且在分析期内保持不变。AOTMiT主席的建议与最终报销决定之间的一致性仅由卡帕系数0.23大致体现，且在随后几年有所下降。我们观察到积极条件性建议的比例不断增加，引入风险分担计划是报销建议最常见的条件。
我们观察到最终报销决定并未反映咨询委员会发布的声明和建议。AOTMiT发布的积极建议并不能保证获得积极的报销状态，而在某些情况下，消极建议也并未导致报销的缺失。
