Poland's Medical Fund Act: Progress of the New Fast-Track TLI Reimbursement Pathway

OBJECTIVES: To evaluate the progress of the new ‘fast-track’ TLI reimbursement pathway introduced in Poland’s 2020 Medical Fund Act.

METHODS: Data was gathered on the number of therapies recommended for inclusion in the high-level pharmaceutical technology innovation (TLI) list by the Agency for Health Technology Assessment and Tariff System (AOTMiT) in 2021-2024, the number chosen for the final annual lists by the Ministry of Health (MoH), and the number eventually gaining reimbursement, in order to assess the progress of the ‘fast-track ‘reimbursement pathway and its contribution to improving access to new orphan medicines.

RESULTS: Of the 44 medicines included by the AOTMiT in its draft TLI lists in 2021, 2022, 2023 and 2024, 70.5% were orphan drugs. The MoH selected 25 of these 44 medicines – or 56.8% – for the final TLI lists; 22 of these (88%) were orphan drugs. Only 14 of the drugs selected by the MoH for the final TLI lists have gained reimbursement through the TLI pathway, or 56%. One of the drugs selected for the TLI list gained reimbursement through the standard procedure, meaning that the total number of TLI-listed drugs to gain reimbursement is 15, or 60%, of which 12 (80%) are orphan drugs. However, these 15 account for only 34% of those drugs recommended by the AOTMiT for TLI listing.

CONCLUSIONS: This research indicates that the ‘fast-track’ TLI mechanism has helped to speed up and improve access to orphan drugs in Poland, but there remains widespread dissatisfaction at the limited number of therapies progressing to reimbursement under the much-vaunted system. Additionally, concerns over potentially punitive regulations applying at the end of reimbursement terms, and the AOTMiT’s data collection process accompanying TLI drugs, may be discouraging manufacturers from submitting reimbursement applications.