HTAR (HTA-Regulation): Implementation in Austria

Research area: HTA-methods & steering instruments

Duration: May 2022 – December 2024
Language: German

Background: In January 2022, the EU regulation on the EU-wide joint assessment of health technologies (Health Technology Assessment Regulation, HTAR, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2021:458:FULL&from=EN) was adopted. It will be legally binding in January 2025 - after a transition period of 3 years. The HTAR is a first result and an input into an overall EU strategy for the reorganisation of the pharmaceutical market (Pharmaceutical Strategy). The HTAR primarily regulates the cooperation among European HTA institutions in the evaluation of medicinal products and medical devices. The aim is to pool HTA resources across Europe to produce high-quality and timely scientific assessments to support evidence-based decision-making at national level. This should facilitate earlier access to "real" innovations. In addition to efficiency gains in the production of assessments, transparency and traceability in the preparation of assessments should also be ensured by harmonising the methodology at a high qualitative level.

In preparation for the HTAR, method papers, document templates for assessments, but also for submissions from industry, processes and Standard Operating Procedures (SOPs) were defined in three EUnetHTA Joint Actions in recent years and are now finalised in a service contract (EUnetHTA21) so that the HTAR can be implemented smoothly. Although the HTAR does not interfere with national reimbursement decisions, it requires that member states contribute their priorities for the evaluation of products to the central steering body (Coordination Group). In highly decentralised countries, where many decisions are made regionally, but where the needs for health policy decisions also arise regionally, national coordination is a prerequisite for successful implementation of the HTAR. The advantage of HTAR for small countries (without corresponding HTA resources) is that high-quality assessments become available to support decision-making.

Project objectives and tasks: The project, which is scheduled to run for several years, aims to make the HTA Regulation applicable for Austria as well or – vice versa – to prepare Austria for the HTAR. This is to be achieved on the one hand by adapting the Austrian methods, but also the document structures, so that the national contextualisation of the European Assessments is complemented by corresponding high-quality methods, and on the other hand by creating the conditions for coordinating the regional needs of the Austrian decision-makers.

In this context, the following work (work packages, WP) is to be carried out in cooperation with all HTA provider institutions in the following 2 years.

1. WP 1: Raising awareness of HTAR and discussion of its importance for Austria for existing HTA work and processes.
2. WP 2: Establishment (further development) of the Austrian database for Austrian HTAs: Ö-POP (Planned and Ongoing Projects) Database.
3. WP 3: Revision of the existing methods manual and complementation with national decision support methods.
4. WP 4: Development of a concept for the coordination of the needs of regional decision makers in order to inform HTAR Coordination Group.

Methods: The following methods will be used to achieve the objectives:

WP 1: Lectures, seminars and discussions with Austrian stakeholders (users and providers of HTA):

• Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK)
• Representatives of the nine federal states
• Umbrella organisation of Austrian social insurances, Austrian social insurance institutions, especially the Austrian Health Insurance Fund (Österreichische Gesundheitskasse)
• Member institutions of the Austrian HTA network: DUK, IAVM, UMIT, PMU, GÖG

WP 2: Coordination of

• the regular (every 6 months) filling of the Ö-POP database by HTA providers,
• if perceived necessary, development of an Internet-based, searchable database, accessible to HTA providers and users (Austrian health policy decision-makers in the federal government, the regional health funds and hospital cooperations, social insurance funds).

WP 3: Revision of the existing methodological manual

• by reviewing and contrasting the European (EUnetHTA) methods papers with existing chapters,
• by mapping of needs for additional methods and according existing know-how in HTA-provider institutions: rapid assessments, health economic methods, overview of reviews, etc.
• Coordination of the preparation of methods chapters by HTA providers (DUK, MUW, ...)
• Participation in IHSI (International Horizon Scanning Initiative, pharmaceuticals) meetings and development of IHSI concept for medical devices in cooperation with IHSI partner institutions.

WP 4: Analysis of the decision-making processes and coordination requirements

• primarily in those institutions (regional hospital authorities) in which decisions on HTAR-relevant technologies are made (cost-intensive oncology drugs and ATMPs - EU implementation 2025-2028, medical devices in risk classes IIb and III).
• Identification of contact persons in departments on medical procedures and drug commissions.
• Piloting the collection of current requests for decision support and screen topics according to the need for speed/ possible postponement of answers, work intensity/ volume of requests, synthesis of (global) evidence vs. need for regional frame of reference.
• Designing of a possible process to coordinate national needs

           - for submitting topics, screening for EU potential or answering at national level or initiation of collaborative (voluntary) assessment and

           - for providing feedback to the EUnetHTA Coordination Group work plan or for disseminating the EUnetHTA assessments to the national decision-makers.

• Developing an estimate for staffing requirements for coordination and communication as well as for rapid response to regional or Austrian questions (potential modules for the tasks of a coordination unit).

Schedule and milestones:

Time period	Tasks
Work package 1: Awareness raising on HTAR
January 2022	Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK)
May 2022	Representatives of the nine federal provinces
June 2022	Austrian Social Insurance Institutions, DVSV and ÖGK
July 2022	Member institutions of the Austrian HTA Network: DUK, IAVM, UMIT, PMU, GÖG
Work package 2: Establishment (advancement) of the Austrian database for HTAs: Ö-POP
Twice p.a.: April 2022, Nov 2022	Coordination of regular (every 6 months) filling of the Ö-POP database by HTA providers
June to Aug 2022	Technical feasibility study for the development of an Internet-based, searchable database accessible to Austrian health policy-makers (federal government, provinces, social insurance funds)
2023	Ev.Development of an internet-based, searchable database, if necessary
Work package 3: Review and revision of the existing methods manual
June/ July 2022	Mapping of know-how and needs for complementary methods for rapid enquiries and contextualisation Rapid Assessments, Health Economic methods, Overview of Reviews
Sept 2022 to Sept 2023	Review of European (EUnetHTA) method papers and comparison with existing chapters of the method manual
2022, permanent	Participation in IHSI (pharmaceuticals) and development of IHSI concept (medical devices in cooperation with IHSI partner institutions)
Mid 2023	Coordination of the preparation of the complementary method chapters
Work package 4: Concept development for coordination of regional decision makers' needs and communication to EUnetHTA Coordination Group
tbd	Tbd:

References:

1. HTA-Regulation 2022: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2021:458:FULL&from=EN
2. Österreichisches Methodenhandbuch: https://aihta.at/uploads/tableTool/UllCmsPage/gallery/methodenhandbuch-aihta1.pdf
3. EUnetHTA21: https://www.eunethta.eu/eunethta-21/