Towards a more transparent HTA process in Poland: new Polish HTA methodological guidelines

Krzysztof Lach,Michal Dziwisz,Cécile Rémuzat,Mondher Toumi

doi:10.1080/20016689.2017.1355202

Abstract

ABSTRACTIntroduction: Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016.Methods: We identified key changes introduced by the update and, before guideline publication, analysed discrepancies between AOTMiT assessments and the submitting marketing authorisation holders (MAHs) to elucidate the context of the update. We compared the clarity and detail of the new guidelines versus those of the UK’s National Institute for Health and Care Excellence (NICE).Results: The update specified more precise requirements for items such as indirect comparison or input data for economic modelling. Agency–MAH discrepancies relating to the subjects of the HTA update were found in 14.6% of published documents. The new Polish HTA guidelines were as clear and detailed as NICE’s on topics such as assessing quality of evidence and economic modelling, but were less informative when describing (for example) pairwise meta-analysis.Conclusions: The Polish HTA guidelines update demonstrates lessons learned from internal and external experiences. The new guidelines adhere more closely to UK HTA standards, being clearer and more informative. While the update is expected to reduce Agency–MAH discrepancies, there remain areas for development, such as providing templates to aid HTA submissions.

Highlights

Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016
The interest in harnessing health technology assessment (HTA) in Poland has been growing in the last decade, with major milestones being (1) the establishment of the national HTA Agency (Agencja Oceny Technologii Medycznych i Taryfikacji; AOTMiT) in 2005, which plays the role of an advisor to the Ministry of Health (MoH); (2) issuing the first HTA methodological guidelines in 2007 [2]; and (3) subsequent updates of these guidelines in 2009 [3] and 2016 [4]
Compared with the older version, the new Polish HTA methodological guidelines are more precise with respect to the different components of an HTA report

Summary

Introduction

Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016. The interest in harnessing health technology assessment (HTA) in Poland has been growing in the last decade, with major milestones being (1) the establishment of the national HTA Agency (Agencja Oceny Technologii Medycznych i Taryfikacji; AOTMiT) in 2005, which plays the role of an advisor to the Ministry of Health (MoH); (2) issuing the first HTA methodological guidelines in 2007 [2]; and (3) subsequent updates of these guidelines in 2009 [3] and 2016 [4]. Cooperation between AOTMiT and other European HTA societies, for example the European network for Health Technology Assessment (EUnetHTA), has expedited the development of HTA and bolstered its use in Poland. The MoH may commission the AOTMiT to reassess health technologies and services funded by the national health insurance system, to revise their coverage status

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