Evidence-based reimbursement processes in Europe Part 1: Reimbursement decisions for medical procedures in Austria. An analysis of factors – besides clinical evidence – influencing reimbursement decisions for the hospital benefit catalogue

Research area: HTA-methods & steering instruments

Duration: September 2020 – November 2020
Language: English (with German summary)
Publication: https://bmchealthservres.biomedcentral.com/articles/

Background: Decision maker’s interest regarding, and willingness to implement, health technology assessment (HTA) – as a tool to support a decision on the basis of best available evidence [1]– grew over the past decades [2]. Countries increasingly established systematic approaches to assess the clinical evidence of medical procedures before widespread adoption into the healthcare system. In Austria, for instance, reimbursement of new ‘extra medical services’ (EMS; German: medizinische Einzelleistung) in hospitals is independently evaluated by the Austrian Institute for Health Technology Assessment (AIHTA/former Ludwig Boltzmann Institute for HTA)[3]. These assessments are based on systematic reviews regarding the comparative effectiveness and safety for each new intervention and are utilised as pre-coverage decision support [4].

One recent study [4]analysed 69 EMS appraisals (excl. update assessments) between 2008 and 2017 and found that in the majority of the cases, the evidence-based recommendations translated directly into reimbursement decisions. Yet, the analysis also showed that while 15 (21.7%) EMS were recommended by the conducted HTA reports, 25 (36.2%) EMS were finally included in the hospital benefit catalogue (either fully or with restriction). Consequently, there are also other factors influencing the final reimbursement decision: In 2016, a retrospective analysis of 78 medical device appraisals (time period: 2008-2015) was conducted to identify factors that impact on coverage decisions in Austria [5]. Despite low clinical evidence, some high-risk devices (for only a few patients) received a positive decision. Logistic regression analysis showed that there was no significant association between variables addressing the quality of the evidence and reimbursement decision for risk class III devices. High-risk device characteristics were found to be positive predictors for reimbursement within the group of medical devices for which no RCTs were available. For class II devices only, however, variables addressing the quality of the evidence were positive predictors for the reimbursement decision [5].

Yet, it is unclear a) in how far re-imbursement decisions were exclusively supported by clinical evidence in the past decade and b) what further factors influenced a positive re-imbursement decision besides clinical evidence.

Aims of the project and research questions: The project aims at identifying specific factors besides clinical evidence that play a pivotal role in the Austrian decision making process for medical procedures utilising medical devices. The following research questions (RQ) will be answered:

• RQ1: In how far were EMS appraisals based on clinical evidence in the past decade in Austria?
• RQ2: What other factors are taken into account in the reimbursement process in order to arrive at a decision deviating from the evidence-based recommendation?

Methods: EMS assessments and subsequent appraisals (focus on medical devices) for the annual maintenance of the hospital benefit catalogue in Austria between 2010 and 2020 will be analysed using a mixed methods approach.

In the first step, descriptive statistical methods will be used to analyse data of conducted EMS assessments and subsequent reimbursement decisions. First, Information from a dataset of the LBI-HTA/AIHTA for which data was gathered until 2016 will be inspected and information may be retrieved. Then a new complete dataset (incl. a detailed coding and analysis plan) will hereby be created by gathering information on EMS appraisals (e.g., information of HTA reports such as intervention, risk class of medical device and quality of evidence as well as the final reimbursement decision) of the past ten years.

In the second step, medical device appraisals deviating from the evidence-based recommendation will be identified. On the basis of these appraisals, semi-structured interviews with decision makers will be conducted to identify further variables that may influence the reimbursement of medical devices that lack sound scientific clinical evidence.

Timetable/ Milestones:

Period	Task
Mid September – Mid October	Inspection of data, gathering subsequent data, descriptive statistical analysis
Mid October – Mid November	Qualitative interviews with decision makers