Multiple changes in the Prenatal Testing Program in Poland

In late October 2024, the Agency for Health Technology Assessment and Tariff System (AOTMiT) published assessment reports and several recommendations concerning non-invasive prenatal diagnostics within the scope of the Prenatal Testing Program.

The recommendations made by the President of the AOTMiT and the position of the Transparency Council concerning the changes in the guaranteed services within the scope of the Prenatal Testing Program include the following:

• To remove two tests (alpha-fetoprotein and estriol determination) from the list of guaranteed services as part of non-invasive prenatal diagnostics financed under the Prenatal Testing Program;
• Do not introduce the placental growth factor (PlGF) test to the list of guaranteed services within the scope of the Prenatal Testing Program in the following indications:
  • Assessing the risk of fetal trisomy as an additional test or alternatively to the PAPP-A test in a combined test (ultrasound, PAPP-A, free beta-hCG);
  • As an additional test in preeclampsia and fetal growth restriction (FGR);
• To introduce free fetal DNA testing (cffDNA) in non-invasive prenatal diagnostics as a guaranteed service within the scope of the Prenatal Testing Program. The test would be indicated to patients with an intermediate risk of fetal aneuploidy identified by a combined test in the first trimester of pregnancy (ultrasound, PAPP-A, free beta-hCG). Therefore, the cffDNA test would be used as an additional test (add-on).

The full details in Polish can be found here (alpha-fetoprotein determination), here (estriol determination), here (PlGF determination), and here (cffDNA determination).

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.