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Market access for medical technologies in Poland

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Poland

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Key topics

There is only one key theme describing market access for medical technologies in Poland: 

  • Reimbursement: payment via the DRG-adjusted budget and fee-for-service (add-on reimbursement, unbundled payment categories) mechanisms

There is no separate funding (approval by the payer) aspect, as the coverage decision is made in parallel with the creation of the procedure code. Furthermore, there are no stand-alone health technology assessment activities in Poland, as HTA is an integral part of reimbursement decision-making. 

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Reimbursement

Poland has one of the most complicated reimbursement systems in Europe. Various payment mechanisms are implemented.

Hospitals that are part of the National Hospital Network (63% of all Polish hospitals in 2022) are reimbursed via the following payment mechanisms:

  • A budget adjusted for activity based on DRGs is used to finance the majority of (routine) hospital services
  • Certain services are financed separately, outside of the budget, using the DRG case-by-case payment or fee-for-service (add-on reimbursement) mechanism

In addition, certain highly specialized services/devices are paid for directly by the Ministry of Health (unbundled payment categories).

Hospitals that are not part of the National Hospital Network participate in tenders for contracts with the National Health Fund and are typically paid via DRG on a case-by-case basis.

Poland uses the Polish DRG system, which was historically adopted from the English HRG system. DRGs are determined by the combination of a procedure code (ICD-9-PL) and a diagnosis code (ICD-10-PL). The procedure coding nomenclature and the DRG system are released by the National Health Fund, although the DRG system is maintained by the Agency for Health Technology Assessment and Tariff System (AOTMiT).

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Specifics for IVD tests

There is no specific reimbursement framework for in-vitro diagnostic tests. Most IVD tests are funded using a global budget principle as part of the funding of the labs. 

A limited number of expensive IVD tests are reimbursed on a fee-for-service basis using add-on payment categories in the DRG system. 

MTRC has experience with more than 49 projects in Poland

News and insights

Multiple changes in the Prenatal Testing Program in Poland

In late October 2024, the Agency for Health Technology Assessment and Tariff System (AOTMiT) published several recommendations concerning the Prenatal Testing Program, specifically on removing alpha-fetoprotein and estriol testing and qualifying the placental growth factor (PlGF) test and free fetal DNA testing (cffDNA) as part of non-invasive prenatal diagnostics.

Health technology assessments initiated by the Agency for Health Technology Assessment and Tariff System (AOTMiT) in the fourth quarter of 2023 in Poland

In the fourth quarter of 2023, two new health technology assessments were initiated by the Agency for Health Technology Assessment and Tariff System (AOTMiT). The assessments belong to the cardiovascular and neurovascular technology groups.

New HTAs initiated in Poland

In early August 2023, the Polish Agency for Health Technology Assessment and Tariff System (AOTMiT) announced the start of the evaluation of several technologies in men’s health, neuromodulation and in-vitro diagnostics fields.

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