In early February 2021, the final method and process frameworks of the Treatment Council (Behandlingsråd) were approved in Denmark. The Treatment Council is a new model for assessing treatments and health technologies, expected to become fully operational in early 2021.
The process framework describes the steps of evaluating treatment or technology by the Treatment Council, while the method framework describes the methods that the Secretariat and the Council must use in the evaluations.
Accordingly, the Treatment Council's assessment process will include the following steps:
- Determination of the suggestions
- Discussion with the applicant
- Sorting of the areas based on applications
- Selection of the topics
- Topics for evaluation
- Topics for major analyzes
- Establishment of professional committees
- Determination of the evaluation or analysis design
- Development of the assessment report
- Decision on recommendation
- The solution (medical device or health technology) is recommended for commissioning
- The solution is not recommended
- The solution is recommended within the framework of scientific research
A usual process for health technologies is expected to last 5-8 months from the day Treatment Council has received a complete application. A typical process for major analyzes (basic topics concerning, e.g., treatment regimens or approaches or organization of treatment) is expected to last up to 12 months from the day the Treatment Council has received a complete application. It is expected that the Treatment Council will have the capacity to develop approximately 15-25 evaluations and 2-3 major analyzes per year.
The Council can evaluate both new technologies as well as the technologies that are already widely used in the health care system. However, the Treatment Council's evaluation cannot be considered a prerequisite for new technology to enter the market.
The Treatment Council's Secretariat has now begun to prepare a process and method manual, the operational starting point for the Secretariat's and the Council's future work. The handbook is expected to be available for consultation in spring 2021.
The full details in Danish can be found here.
This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news).
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks). First EU issues of both newsletters are available for download free-of-charge.