HTAR (HTA-Regulation) Implementation in Austria: Revision of the existing methods manual and complementation with national decision support methods

Research area: HTA-methods & steering instruments

Internal Review: Claudia Wild, Reinhard Busse, Dimitra Panteli

Duration: June 2023 – April 2024
Language: English (with German summary)

Background:
In January 2022, the EU regulation on the EU-wide joint assessment of health technologies (Health Technology Assessment Regulation, HTAR) was adopted [1]. It will be legally binding in January 2025 after a transition period of three years [2]. Under the HTAR, cooperation in the evaluation, especially of medicinal products and medical devices, are regulated. It may provide a structure for carrying out joint HTA using state-of-the-art methods on the European level by producing methodologically rigorous and timely scientific assessments supporting evidence-based decisions on the national level [2].

In most EU member states, the national institutionalisation of HTA increasingly took place within the past two decades. The European Network for Health Technology Assessment (EUnetHTA) built the basis for scientific and technical cooperation between HTA bodies [3]. After establishing the EUnetHTA project (2006-2009), further activities, primarily in subsequent joint actions, contributed to building and upholding HTA capacity and trust [3]. Due to a high degree of overlap between the HTA methodology of EUnetHTA rapid relative effectiveness (REA) and assessments of HTA bodies [3], the use of these joint assessments at a national level ("national uptake") was feasible and reduced redundancies.

Within the latest project (EUnetHTA21), further deliverables in the form of, inter alia, extensive updates of existing guidance and new guidance for joint assessments were created to facilitate the implementation of the HTAR [4]. Currently, the Member State Coordination Group on HTA (HTACG) builds on the aforementioned deliverables from EUnetHTA and established subgroups aiming at developing both methodological and procedural guidance for HTAR. The HTACG also aims to ensure cooperation between EU bodies such as the European Medicines Agency (EMA), other Medical Device Coordination Group (MDCG) expert panels and the appropriate involvement of stakeholder organisations and experts in its work [5].

Although the core methodological guidance is generally well established within the EUnetHTA Core Model® [3, 4], some of the recommendations from EUnetHTA guidances leave room to decide between alternative methodological options.

Project Objective and Research Questions:
This project aims to support a national adaptation of EUnetHTA guidelines by identifying these EUnetHTA guidances with need for concretisation, describing alternative methodological options based on different methods manuals and supporting a decision on the most appropriate option for the AIHTA, with specific focus on assessments for the Austrian hospital benefit catalogue and the individual medical services (MEL) .

The following research questions (RQ) will, hence, be answered:

• RQ1: Which EUnetHTA guidances provide room to decide among alternative methodological options or are in need for concretisation?
• RQ2: How can these alternative methodological options described based on different methodological handbooks?
• RQ3: Which of these alternative methodological options are most suitable for Austrian rapid assessments supporting a decision on the annual revision of the hospital benefit catalogue?

Methods:
Identification of EUnetHTA guidances with room to decide among alternative methodological options: EUnetHTA guidelines will be systematically reviewed based on sections and sub-sections. One or more of the following criteria must apply to be considered a guideline recommendation with need for concretisation:

• Broadly defined guidance stating different options instead of giving clear guidance.
• The divergence between EUnetHTA guidelines and AIHTA methods paper or standard practice at AIHTA.
• General unclarity concerning what is proposed within a EUnetHTA guidance.

Synopsis of different alternative methodological options based on methodological handbooks: The following organisation's manuals are reviewed with a specific focus on the preferred alternative methodological option of the organisation. The following organisations/ documents will hereby be selected:

• IQWIG/ IQWIG methods handbook 6.0 [6].
• NICE/ HTA manual [7].
• Cochrane/ Cochrane Handbook [8].

Further, a focused search in the LIGHTS database [9]will be conducted to identify other methods handbooks. In this context, any official methodological guidance documents (e.g., manuals, handbooks) by European HTA organisations and EBM institutions are eligible.

Defining the most appropriate option among alternative approaches: After identifying guidances with need for concretisation and preferred alternative methodological option of different organisations, the results will be presented to experts from Austrian HTA organisations and the AIHTA team members. Depending on their feedback and willingness to cooperate within a broader methods manual, either a external review phase or a semi-structured discussion ideally using a voting system (e.g., DELPHI method) may then be used to decide on the most appropriate alternative methodological option to be used for the AIHTA reflecting both expert input from other HTA organisations and the lived practice of AIHTA systematic review authors.

Timeplan:

 

Time period	Deliverable
June, July 2023	Scoping and drafting protocol, identification of guidances with need for concretisation
August, September 2023	Synopsis of different alternative methodological options
October 2023	Drafting the report, presenting preliminary results to Austrian HTA organisation and coordination of methods paper
November 2023	Drafting preliminary version, optional: DELPHI method for Austrian concretisation
December 2023- February 2024	Peer-review
March – April 2024	Publication of revised AIHTA report/ methods manual

References:

[1]          European Commission EUR-Lex. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance). [cited 01.05.2023]. Available from: http://data.europa.eu/eli/reg/2021/2282/oj.

[2]          I. Imaz-Iglesia and C. Wild. EUnetHTA's contribution to the new legal framework for health technology assessment cooperation in Europe. Int J Technol Assess Health Care. 2022;38(1):e50. Epub 20220602. DOI: 10.1017/s026646232200037x.

[3]          F. B. Kristensen. Mapping of HTA methodologies in EU and Norway. 2017 [cited 20.05.2023]. Available from: https://health.ec.europa.eu/system/files/2018-01/2018_mapping_methodologies_en_0.pdf.

[4]          European Network for Health Technology Assessment (EUnetHTA). Joint HTA Work. Available from: https://www.eunethta.eu/jointhtawork/.

[5]          European Commission. Member State Coordination Group on HTA (HTACG). [cited 15.06.2023]. Available from: https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment/member-state-coordination-group-hta-htacg_en.

[6]          Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWIG). Allgemeine Methoden. Entwurf für Version 7.0. 2022 [cited 01.05.2023]. Available from: https://www.iqwig.de/methoden/allgemeine-methoden_entwurf-fuer-version-7.pdf.

[7]          National Institute for Health and Care Excellence (NICE). NICE health technology evaluations: the manual. Process and methods 2022 [cited 15.06.2023]. Available from: https://www.nice.org.uk/process/pmg36/resources/nice-health-technology-evaluations-the-manual-pdf-72286779244741.

[8]          J. Higgins, J. Thomas, J. Chandler, M. Cumpston, T. Li, M. Page, et al. Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Handbook for Systematic Reviews of Interventions. 2019. DOI: 10.1002/9781119536604.

[9]          J. Hirt, C. M. Schönenberger, H. Ewald, D. O. Lawson, D. Papola, R. Rohner, et al. Introducing the Library of Guidance for Health Scientists (LIGHTS): A Living Database for Methods Guidance. JAMA Netw Open. 2023;6(2):e2253198. Epub 20230201. DOI: 10.1001/jamanetworkopen.2022.53198.