Communication from AOTMIT on submission of PICO information for joint clinical assessment
The Agency for Health Technology Assessment and Tariff System (AOTMiT) announces that due to the entry into force of Regulation (EU) 2021/2282 of the European Parliament and of the Council of December 15, 2021 on Health Technology Assessment and amending Directive 2011/24/EU[1], as of January 12, 2025, selected medical technologies are subject to Joint Clinical Assessment.
The regulation represents a significant step toward unifying health technology assessment procedures at the European Union level. A key step in joint assessments is the definition of the decision problem and the scope of the medical technology assessment to be carried out (population, intervention, comparators and health effects – PICO).
AOTMiT envisages the possibility for responsible entities for medical technologies to submit proposals for clinical assessment parameters (PICO) adapted to Polish conditions for inclusion in the Agency’s work.
Accordingly, entities whose medicinal products will be subject to joint clinical evaluation in the current year are invited to send PICO proposals to the e-mail address: PICOJCA@aotm.gov.pl.
[1] https://eur-lex.europa.eu/legal-content/PL/TXT/PDF/?uri=CELEX:32021R2282