In vitro diagnostics (IVDs) are tests that are performed on samples taken from the human body, such as blood, urine, or tissue. They can be used to diagnose diseases, monitor health conditions, or guide treatment decisions. IVDs are an essential part of modern health care, as they can provide accurate, timely, and cost-effective information for patients and health professionals.
However, getting an IVD reimbursed in the public health system of a country can be a challenging and complex process, as it requires demonstrating the clinical and economic value of the test compared to existing alternatives. Different countries have different systems and criteria for assessing and reimbursing IVDs, and manufacturers and sponsors need to be aware of the specific requirements and procedures of each market.
The Danish Treatment Council
The main body responsible for assessing and recommending new health technologies, including IVDs, for reimbursement in Denmark is the Danish Treatment Council (Behandlingsrådet). The Danish Treatment Council is a new independent body that was established in 2020 to replace the previous system of regional health technology assessment (HTA) committees. The Danish Treatment Council aims to ensure a more consistent, transparent, and evidence-based approach to the introduction and use of new health technologies in the public health system.
The Danish Treatment Council consists of 15 members, including a chairperson, a vice-chairperson, and 13 experts from various fields, such as clinical medicine, health economics, patient perspectives, ethics, and law. The members are appointed by the Minister of Health for a four-year term, based on nominations from relevant stakeholders, such as the Danish Regions, the Danish Medical Association, the Danish Patients’ Association, and the Danish Council of Ethics.
The Danish Treatment Council evaluates new health technologies based on four main criteria: clinical effectiveness, health economics, organizational and patient perspectives, and ethical and legal aspects. The Danish Treatment Council issues recommendations for the use of new health technologies in the public health system, which are then implemented by the Danish Regions, the five administrative units that are responsible for the provision and financing of health care services in Denmark.
The Danish Treatment Council publishes its recommendations and the underlying assessment reports on its website and in the national health technology catalogue (Sundhedsteknologikataloget), which is a database of all the health technologies that are reimbursed or under evaluation in the public health system. The Danish Treatment Council also monitors the implementation and impact of its recommendations and updates them as new evidence becomes available.
The dossier format
To apply for reimbursement of an IVD in Denmark, the manufacturer or sponsor of the test needs to submit a dossier to the secretariat of the Danish Treatment Council. The dossier is a comprehensive document that provides all the relevant information and evidence to support the clinical and economic value of the test. The dossier format for IVDs is based on the Danish Regions’ methodological framework, which consists of four main sections: introduction, clinical effectiveness, health economics, and organizational and patient perspectives.
The introduction section provides a general overview of the test, its intended use, its target population, its comparator, and its regulatory status. The introduction section also includes a summary of the main findings and conclusions of the dossier.
The clinical effectiveness section provides a systematic review of the available literature on the diagnostic accuracy, clinical validity, and clinical utility of the test. The clinical effectiveness section also includes a critical appraisal of the quality and relevance of the studies, a meta-analysis of the results, and a discussion of the strengths and limitations of the evidence.
The health economics section provides a health economic evaluation of the test, comparing its costs and consequences with those of the comparator. The health economics section also includes a description of the model structure, the data sources, the assumptions, the sensitivity analyses, and the results of the evaluation.
The organizational and patient perspectives section provides a qualitative analysis of the potential impact of the test on the organization and delivery of health care services, as well as on the experiences and preferences of patients and health professionals. The organizational and patient perspectives section also includes a description of the methods, the data sources, the findings, and the implications of the analysis.
The dossier should follow the template and guidance provided by the Danish Treatment Council, which are available on its website. The dossier should be written in Danish or English, and should include a list of references, a glossary of terms, and appendices with additional information and data.
The review process
The review process for an IVD in Denmark takes about 180 days (6 months) from the date of submission to the approval by the Danish Treatment Council. The review process involves the following steps:
- Submission of the dossier by the applicant to the secretariat of the Danish Treatment Council.
- Screening of the dossier by the secretariat to check the completeness and quality of the information provided. The secretariat may request additional information or clarification from the applicant if needed.
- Assessment of the dossier by an external expert group, which includes clinical specialists, health economists, patient representatives, and methodologists. The expert group reviews the dossier and provides input and feedback to the secretariat on the clinical and economic value of the test.
- Preparation of a draft assessment report by the secretariat based on the expert group’s input and feedback. The draft assessment report summarizes the evidence and the arguments for and against the use of the test in the public health system.
- Consultation of the draft assessment report with the applicant and relevant stakeholders for comments and corrections. The applicant and the stakeholders have 14 days to review the draft assessment report and provide their feedback to the secretariat.
- Finalization of the assessment report by the secretariat and submission to the Danish Treatment Council for decision making. The secretariat incorporates the feedback from the consultation and prepares the final assessment report for the Danish Treatment Council.
- Publication of the assessment report and the recommendation by the Danish Treatment Council on its website and in the national health technology catalogue. The Danish Treatment Council makes its decision based on the assessment report and the four main criteria. The decision can be either positive, conditional, or negative. A positive decision means that the test is recommended for reimbursement and use in the public health system. A conditional decision means that the test is recommended for reimbursement and use in the public health system under certain conditions, such as further data collection, monitoring, or evaluation. A negative decision means that the test is not recommended for reimbursement and use in the public health system.
Conclusion
Getting an IVD reimbursed in Denmark can be a rewarding but challenging process, as it requires demonstrating the clinical and economic value of the test in a rigorous and transparent manner. Manufacturers and sponsors of IVDs need to be familiar with the specific requirements and procedures of the Danish Treatment Council, which is the main body responsible for assessing and recommending new health technologies for reimbursement in Denmark. By following the dossier format and the review process of the Danish Treatment Council, manufacturers and sponsors can increase their chances of getting their IVD reimbursed and used in the Danish public health system.