AOTMiT to Add Artificial Intelligence to Reimbursement Guidelines for the First Time

AOTMiT (Poland's Agency for Health Technology Assessment and Tariff System) is preparing the first update in nearly a decade to the HTA guidelines used to evaluate drugs and medical devices entering the reimbursement lists. Among the new chapters in the document, artificial intelligence will appear for the first time.

The process is led by the Guidelines Update Team, made up of the agency's own analysts along with invited HTA experts, patient representatives, academics and representatives of key institutions in the healthcare system. The work runs along two parallel tracks: one covering a general revision of the methodology for assessing medical technologies, the other focused on orphan drugs used in rare diseases.

Changes to the methodology

For orphan drugs, the agency is developing a multi-criteria analysis, known as MCDA, meant to supplement the current approach, which relies mainly on a cost-effectiveness threshold. The new method will factor in clinical efficacy, safety, patients' quality of life and budgetary impact on the system, as well as elements rarely formalized in Polish assessments until now, such as social aspects.

The HTA guidelines document itself, in force since 2016, is set to be expanded with entirely new chapters. The agency's deputy president announced that one of them will be devoted to artificial intelligence, alongside chapters on social perspectives, orphan drugs and vaccines.

Certain new chapters will be added, for example on artificial intelligence or social perspectives - Anna Kowalczuk, Deputy President of AOTMiT

Timeline for the work

The stakeholder survey on the new evaluation criteria began in November 2025. The agency plans to close the conceptual work on the MCDA criteria in June 2026, with a chance of finishing earlier in May. The next stage will be testing the new methodology on real reimbursement applications, with implementation of the revised guidelines planned for 2026.

We will complete all the work in June 2026. We might even manage it in May - Joanna Parkitna, Director of the Health Technology Assessment Department at AOTMiT

Where AI's role at the agency comes from

Adding a chapter on artificial intelligence to the HTA guidelines is not an isolated move. Back in April 2025, the agency set up an internal Team for AI and Data Hub Implementation, tasked with identifying and prioritizing areas where deploying AI tools makes sense, building analysts' competence in this area, and assessing the risks of using such solutions in the agency's decision-making processes.

The new chapter in the HTA guidelines is therefore meant to formalize the rules under which analysts and applicants will be able to use AI tools when preparing the clinical and economic analyses submitted to the agency, rather than handing the reimbursement decision itself over to an algorithm. Final recommendations will still be reviewed by the Rada Przejrzystości (the Transparency Council), and the decision to add a drug to the reimbursement list remains with the Minister of Health.

What this means for the market

For pharmaceutical companies and applicants submitting reimbursement documentation, the change means adapting HTA analyses to standards that had gone unupdated for a decade, likely including requirements on how AI tools are used and documented when preparing scientific evidence. For patients with rare diseases, the key development will be the new multi-criteria method, meant to give the agency more tools for assessing orphan drugs, which have often been rejected until now because of high costs relative to small patient populations.

The agency has not yet given a detailed timeline for public consultations on the full HTA guidelines document, nor a date for the final version, including the AI chapter, to take effect. What is known is that work on the criteria for orphan drugs is due to close by mid-2026, with testing of the new methodology starting right after.