Relating Health Technology Assessment recommendations and reimbursement decisions in Poland in years 2012-2014, a retrospective analysis.

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.