Companion diagnostics are in vitro diagnostic tests that help identify patients who are likely to benefit from a specific therapy based on their biomarkers or genetic variations. They are essential for the practice of precision medicine, which aims to tailor treatments to individual characteristics and needs.
Standard IVDs are in vitro diagnostic tests that are used for various purposes, such as screening, diagnosis, monitoring, or prognosis of diseases or conditions. They are not necessarily linked to a specific therapy, but they may provide useful information for clinical decision-making.
In Belgium, both companion diagnostics and standard IVDs are subject to a reimbursement process that is overseen by the National Institute for Health and Disability Insurance (NIHDI). This process involves submitting a reimbursement dossier, undergoing an evaluation by the Federal Agency for Medicines and Health Products (FAMHP), meeting specific assessment criteria, and receiving a decision from NIHDI.
However, there are some differences between the reimbursement process for companion diagnostics and standard IVDs in Belgium. These differences are mainly related to the following aspects:
- The link between the diagnostic result and the treatment decision
- The alignment with the reimbursement status of the corresponding therapy
- The compliance with the new medical devices and in vitro diagnostics legislation
The link between the diagnostic result and the treatment decision
One of the main differences between companion diagnostics and standard IVDs is that companion diagnostics require a strong link between the diagnostic result and the treatment decision. This means that the companion diagnostic must demonstrate its clinical utility and effectiveness in guiding the selection of the most appropriate therapy for the patient.
Standard IVDs, on the other hand, do not necessarily have to show such a strong link, as they may have other clinical applications or purposes. For example, a standard IVD may be used to monitor the disease progression or response to treatment, rather than to select the treatment itself.
The alignment with the reimbursement status of the corresponding therapy
Another difference between companion diagnostics and standard IVDs is that companion diagnostics have to align with the reimbursement status of the corresponding therapy. This means that the companion diagnostic may face additional challenges in demonstrating its cost-effectiveness and economic impact, especially if the therapy is not reimbursed or has limited access in Belgium.
Standard IVDs, on the other hand, do not have to depend on the reimbursement status of a specific therapy, as they may be used for different therapies or indications. For example, a standard IVD may be used to diagnose a condition that can be treated with various options, rather than with a single therapy.
The compliance with the new medical devices and in vitro diagnostics legislation
A third difference between companion diagnostics and standard IVDs is that companion diagnostics have to comply with the new medical devices and in vitro diagnostics legislation that came into force in October 2022. This legislation transposes the EU MedTech regulations and introduces new requirements for the safety, performance, and quality of medical devices and IVDs, including companion diagnostics.
Standard IVDs, on the other hand, may have already been compliant with the previous legislation, or may have a longer transition period to adapt to the new requirements. For example, a standard IVD may have already obtained a CE marking and a valid certificate from a notified body or may have until May 2024 to do so.
How to apply for reimbursement of an IVD in Belgium?
The reimbursement process for an IVD in Belgium depends on the type and category of the IVD. There are four main categories of IVDs, based on the risk classification and the intended use:
- Category A: IVDs for self-testing or near-patient testing
- Category B: IVDs for screening, diagnosis or monitoring of transmissible diseases
- Category C: IVDs for screening, diagnosis or monitoring of non-transmissible diseases
In Belgium, the reimbursement of IVDs depends on the type of device, the type of test, and the setting where the test is performed.
Generally, there are two main categories of IVDs: those that are reimbursed by the National Institute for Health and Disability Insurance (NIHDI), and those that are not. The NIHDI is the public institution that manages the compulsory health insurance system in Belgium. The NIHDI determines the reimbursement criteria and tariffs for IVDs that are included in the nomenclature of health benefits, which is a list of medical services and products that are covered by the health insurance.
To apply for reimbursement of an IVD that is included in the nomenclature, the manufacturer or the distributor of the device must submit an application to the Technical Medical Council (TMC) of the NIHDI. The TMC is a consultative body that advises the NIHDI on the reimbursement of medical devices and other health benefits. The TMC evaluates the application based on the clinical and economic evidence of the device and issues a recommendation to the General Council of the NIHDI. The General Council is the decision-making body of the NIHDI that approves the reimbursement of health benefits. The reimbursement decision is then published in the Belgian Official Journal and becomes effective.
For IVDs that are not included in the nomenclature, such as self-tests or companion diagnostics, there is no reimbursement by the NIHDI. However, some of these devices may be reimbursed by the supplementary health insurance, which is offered by private or mutual insurers. The reimbursement conditions and rates vary depending on the insurer and the type of device. To apply for reimbursement of an IVD by the supplementary health insurance, the user of the device must contact their insurer and follow their specific procedures.
The Guideline on the Submission Processes for Performance Studies according to the IVDR in Belgium
The alignment with the reimbursement status of the corresponding therapy
Another difference between companion diagnostics and standard IVDs is that companion diagnostics have to align with the reimbursement status of the corresponding therapy. This means that the companion diagnostic may face additional challenges in demonstrating its cost-effectiveness and economic impact, especially if the therapy is not reimbursed or has limited access in Belgium.
Standard IVDs, on the other hand, do not have to depend on the reimbursement status of a specific therapy, as they may be used for different therapies or indications. For example, a standard IVD may be used to diagnose a condition that can be treated with various options, rather than with a single therapy.
The compliance with the new medical devices and in vitro diagnostics legislation
A third difference between companion diagnostics and standard IVDs is that companion diagnostics have to comply with the new medical devices and in vitro diagnostics legislation that came into force in October 2022. This legislation transposes the EU MedTech regulations and introduces new requirements for the safety, performance, and quality of medical devices and IVDs, including companion diagnostics.
Standard IVDs, on the other hand, may have already been compliant with the previous legislation, or may have a longer transition period to adapt to the new requirements. For example, a standard IVD may have already obtained a CE marking and a valid certificate from a notified body or may have until May 2024 to do so.
Conclusion
Companion diagnostics and standard IVDs are both subject to a reimbursement process in Belgium, but they have some differences in terms of the link between the diagnostic result and the treatment decision, the alignment with the reimbursement status of the corresponding therapy, and the compliance with the new medical devices and in vitro diagnostics legislation. These differences may pose different challenges and opportunities for diagnostics companies seeking reimbursement in Belgium.
Belgian guidelines and documents
• Guideline on Submission Processes of Performance Studies according to IVDR in Belgium (version 4.0). This document aims at providing guidance for the different submission processes for clinical investigations under the new regulation from a national point of view.
• Zip-folder structure for initial performance study applications including relevant templates • Template for the list of submitted documents – initial submission
• Template for the list of submitted documents – substantial modifications
• Application form – initial submission (duplicated section 3 – duplicated section 4 – duplicated section 5)
• Application form – substantial modifications
• Template List of GSPR