Reimbursement Decisions for Innovative Drug Technologies in Poland: Duration of Reimbursement Processes and Impact of HTA Recommendation

OBJECTIVES: The purpose of this study is to evaluate duration of reimbursement processes and impact of HTA recommendation on the drug reimbursement decisions made by the Minister of Health in Poland.

METHODS: The analysis was carried out on two data sets: process covers all reimbursement applications regarding innovative drugs evaluated by the HTA Agency from January 1, 2021 to December 14, 2023 and analysis of all positive decisions published from March 2021 to January 2024. We analyzed over 250 applications for reimbursement for innovative drugs, most of them were already in the mature phase.

RESULTS: In the years 2021-2023, 254 unique applications for drug reimbursement have been submitted, among 226 mature processes, 80% were successful. By January 2024, 268 positive decisions were made, of which 76% concerned reimbursement under the drug program. The time from submitting the application for HTA assessment to reimbursement decisions made in 2021 was on average 616 days, the vast majority of processes (76%) lasted longer than a year. In 2023, in the drug program category the duration of the process was shortened to an average of 315 days. Among the positive reimbursement decisions from the last 3 years, only 13% were preceded by an unconditionally positive HTA recommendation, 13% were successful despite negative reimbursement recommendation, and the majority of drugs received a conditional recommendation - positive with conditions or negative with a chance in certain circumstances.

CONCLUSIONS: In Poland, the average duration of the reimbursement process has been shortened by 250 days over the last 3 years, ultimately, the process is to last one year. The vast majority of positive reimbursement decisions were based on a conditional HTA recommendation; the need to meet the condition included in the recommendation is particularly important in the context of the new reimbursement law.