Polish HTA Methodological Guidelines (AOTMiT)
These guidelines are used in Poland to assess health technologies for reimbursement decisions. They provide clear rules for evaluating clinical evidence and cost-effectiveness, aiming to make the assessment process more transparent and consistent with international standards like those in the UK.
At a glance
Use when
Conducting or preparing for a health technology assessment in Poland for reimbursement; aligning submissions with AOTMiT requirements; comparing HTA processes across European countries
Avoid when
Assessing technologies outside the Polish healthcare system without local adaptation; relying solely on these guidelines for patient-centered or organizational impact assessment
Inputs
Clinical trial data, real-world evidence, economic models, indirect comparison analyses
Outputs
HTA reports supporting reimbursement decisions, evidence quality assessments, cost-effectiveness analyses
How it works
Developed by the Polish Agency for Health Technology Assessment and Tariff System (AOTMiT), the 2016-updated guidelines specify requirements for indirect treatment comparisons, economic modeling inputs, and evidence appraisal. They align more closely with NICE methods, improving clarity and standardization, though some areas like pairwise meta-analysis lack detailed guidance.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Assumptions
- Submitted evidence is of sufficient quality and relevance; comparators are appropriately selected; economic models reflect Polish healthcare context
- Strengths
- Increased clarity and alignment with international standards like NICE; reduced discrepancies between assessors and applicants; structured approach to evidence evaluation
- Limitations
- Less detailed guidance on certain methods like pairwise meta-analysis; lack of standardized submission templates; limited guidance on patient and social aspects
- Also known as
- AOTMiT Guidelines, Polish HTA Guidelines
Questions this answers
- › How should clinical evidence be assessed for reimbursement in Poland?
- › What economic modeling standards are required by AOTMiT?
- › How are indirect treatment comparisons handled in Polish HTA submissions?
- › What are the key differences between Polish HTA guidelines and NICE methods?
- › How do the updated guidelines improve transparency in reimbursement decisions?
- › What discrepancies between AOTMiT and marketing authorisation holders were addressed by the update?
References & sources
Similar by meaning
- Irish HTA Guidelines (NCPE submission guidelines)
- Guidelines for the Economic Evaluation of Health Technologies in Ireland (HIQA)
- AIFA Guidelines for the economic evaluation of health technologies (P&R dossier, Chapter 9)
- INFARMED Methodology for Pharmacotherapeutic Assessment of Health Technologies (METOD-AFT)
- Polish MCDA tool for orphan-drug pricing and reimbursement
Beta record. Based on the original catalogue summary; primary-source enrichment pending.