HTA programme

How does the Health Technology Assessment (HTA) programme work? What phases does an HTA topic go through prior to a reimbursement decision being made? You can find detailed information on this here.

Overview of the development and use of HTA reports

Identifying topics

• Using the “Topic submission form”, anyone can propose topics at any time.
• The deadline for the submission of topics is 1 March each year.
• The following criteria are applicable for the selection of topics:
  • controversial efficacy or safety profile,
  • budgetary relevance of the service,
  • expected benefits of regulatory measures, and
  • feasibility of proposed improvements.
• A recommendation on the topics to be addressed is made by the Federal Medical Services Commission (ELGK) and the Federal Medicines Commission (EAK).

Pre-scoping

• Pre-scoping involves a preliminary analysis and definition of the question to be investigated.
• Pre-scoping provides the basis for the tender process and the commissioning of an external partner.

HTA protocol

• In the HTA protocol, the external partner defines the research question in detail and defines the methodology for the subsequent HTA report. The protocol is submitted to a review group, consisting of four or five independent experts, who evaluate the scientific quality of the report.
• The protocol is then submitted to stakeholders, such as health insurance associations, patient organisations, healthcare professional associations, professional societies, industry associations or other interested parties. Stakeholders are notified of the protocol 20 working days in advance and are given 20 working days to comment on the protocol.
• The finalised protocol is published, together with stakeholders’ comments, on the HTA projects page.

HTA report (assessment)

• In the HTA report, the external partner answers the research question by analysing the scientific evidence concerning efficacy, safety and cost-effectiveness, as well as legal, social, ethical and organisational aspects.
• The HTA report is submitted to a review group, consisting of four or five independent experts, who evaluate the scientific quality of the report.
• The HTA report is then submitted to stakeholders. Stakeholders are notified of the report 20 working days in advance and are given 20 working days to comment on the report.
• The finalised HTA report is published on the HTA projects page.

Appraisal

• The Federal Commissions appraise the HTA report and submit a recommendation to the Federal Department of Home Affairs (FDHA) or, in the case of medicines, to the FOPH.
  

Decision

• The FDHA or the FOPH decides whether mandatory reimbursement is terminated, restricted or continued. The decision is published.
  

Last modification 21.07.2023