Bewertung medizinischer Einzelleistungen – MEL 2025

2430
Research area: High tech medicine

Project leaders: Gregor Goetz

Project co-operation: AIHTA staff for individual reviews
Duration: November 2024 – March 2025


 
Suggested by: MoH
Publication: from July 15th 2025
 

Objective:
Each year, the Austrian Federal Ministry of Health (MoH) receives proposals from service-providers for inclusion of new medical procedures in the MoH catalogue of procedures as a prerequisite for reimbursement [1-3]. The procedures are prioritized by the Ministry of Health and the assessments contracted out to the Austrian Institute for Health Technology Assessment (AIHTA). The aim of this project is to evaluate the comparative efficacy and safety of these procedures to assist reimbursement decisions.

Methods:
The EUnetHTA Core Model® [4]and methodological guidance documents developed by the HTA-R [5]methods subgroup are used for all systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme [6].

Mapping the literature: A preliminary search for systematic reviews (SRs) is conducted. If a recent high-quality SR assessed with the ROBIS tool [7]is identified that uses the same in- and exclusion criteria, this SR may be used as a basis for the whole report.

Protocol: The respective PICO question is uploaded on the open science foundation (OSF) before data extraction begins [8]. All changes and ex-post decisions are documented and justified within the final report.

Systematic search: A systematic search is conducted for each topic using at least two medical databases. If at least one high-quality SR is identified, the systematic search of the identified SR may be updated.

Abstract- and Full-text screening: Two reviewers screen independently potentially relevant literature. Nested Knowledge [9]or other equivalent platforms [10]are used to assist these working steps.

Risk of bias (RoB) assessment: Key risk of bias tools defined by the LATITUDES Network [11]are used. Two reviewers are involved within this working step.

Data extraction: Two persons are involved within this working step. One reviewer extracts the data using pre-defined and piloted data-extraction tables and another reviewer verifies the extracted data.

Synthesis: A narrative synthesis is conducted using the GRADE approach [6]. Meta-analyses may be performed when appropriate conditions are met [12].

Stakeholder involvement: At least one clinical expert is involved within the respective SR. Manufacturers may be contacted primarily for relevant information on CE marking and ongoing studies.

References:

[1]          Mad P., Geiger-Gritsch S., Hinterreiter G., Mathis-Edenhofer S. and Wild C. Pre-coverage assessments of new hospital interventions on Austria: methodology and 3 years of experience. Int J Technol Assess Health Care. 2012;28(2):171-179. DOI: 10.1017/s0266462312000025.

[2]          Grössmann N., Wolf S., Rosian K. and Wild C. Pre-reimbursement: early assessment for coverage decisions. Wien Med Wochenschr. 2019;169(11-12):254-262. Epub 20190206. Vorab-Erstattung: Frühbewertungen für Erstattungsentscheidungen. DOI: 10.1007/s10354-019-0683-1.

[3]          Goetz G., Panteli D., Busse R. and Wild C. Reimbursement decisions for medical services in Austria: an analysis of influencing factors for the hospital individual services catalogue between 2008 and 2020. BMC Health Serv Res. 2022;22(1):205. Epub 20220215. DOI: 10.1186/s12913-022-07531-3.

[4]          European Network for Health Technology Assessment (EUnetHTA). HTA Core Model®. Available from: https://www.eunethta.eu/hta-core-model/.

[5]          European Commission (EC). Implementation of the Regulation on health technology assessment. Key documents [cited 11.11.2024]. Available from: https://health.ec.europa.eu/health-technology-assessment/key-documents_en?f%5B0%5D=topic_topic%3A227.

[6]          Guyatt G., Oxman A. D., Akl E. A., Kunz R., Vist G., Brozek J., et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64(4):383-394. Epub 20101231. DOI: 10.1016/j.jclinepi.2010.04.026.

[7]          Whiting P., Savovi? J., Higgins J. P., Caldwell D. M., Reeves B. C., Shea B., et al. ROBIS: A new tool to assess risk of bias in systematic reviews was developed. J Clin Epidemiol. 2016;69:225-234. Epub 20150616. DOI: 10.1016/j.jclinepi.2015.06.005.

[8]          Open Science Foundation (OSF). Future-proof your research. Preregister your next study. [cited 22.05.2024]. Available from: https://www.cos.io/initiatives/prereg.

[9]          Nested Knowledge Inc. Nested Knowledge [Software]. 2024.

[10]        Affengruber L., van der Maten M. M., Spiero I., Nussbaumer-Streit B., Mahmi?-Kaknjo M., Ellen M. E., et al. An exploration of available methods and tools to improve the efficiency of systematic review production: a scoping review. BMC Med Res Methodol. 2024;24(1):210. Epub 20240918. DOI: 10.1186/s12874-024-02320-4.

[11]        LATITUDES Network. Validity assessment tools for evidence synthesis: your one-stop-shop. [cited 16.01.2024]. Available from: https://www.latitudes-network.org/.

[12]        Deeks J. J., Higgins J. P. and Altman D. G. Chapter 10: Analysing data and undertaking meta-analyses. In: Higgins J. P. and Thomas J., editors. Cochrane Handbook for Systematic Reviews of Interventions Version 64, 2023.