Navigating Belgium's medicine reimbursement process

Understanding Belgium’s medicine reimbursement process is crucial for pharmaceutical companies seeking approval for their products. At e&a consultants, we’re happy to share our expertise and present this concise overview of the procedure, outlining key steps such as dossier submission, the evaluation process, and the timeline from the scientific evaluation to the final ministerial decision. You can also visit our overview for the Luxembourg market. 

The basics of dossier submission

The reimbursement process for pharmaceuticals in Belgium is regulated by the Royal Decree of February 1, 2018. This decree sets out the requirements for submitting a dossier, including necessary content, evaluation parameters and timelines. It is essential for pharmaceutical companies to adhere to these legal frameworks, as failure to comply could lead to the rejection of their dossier. 

Pharmaceutical companies can submit a dossier for reimbursement once they have received a marketing authorisation for their product. The main authority overseeing this process is the CRM (Committee for the Reimbursement of Medicines), a sub-organ of the NIHDI (National Institute for Health and Disability Insurance). The entire process, from submission to decision, takes a standard 180 days, provided the dossier is admissible and there are no major delays. 

Understanding the evaluation process 

The reimbursement evaluation process can be divided into two key phases, each lasting 90 days: 

Assessment phase (first 90 days):   

The first phase focuses on the scientific evaluation of the medicine. During this period, the CRM assesses the studies provided by the company to demonstrate the medicine's effectiveness. They evaluate the quality of evidence and determine the medicine’s therapeutic value and its position within current treatment options. This phase aims to answer key questions, such as whether the medicine provides additional value over existing treatments and where it fits in the healthcare landscape. 

On the first day, the day that you submit your reimbursement dossier, you should also submit a price dossier to the FPS (Federal Public Service) Economy. They use this dossier to set the pricing in a parallel track to the scientific evaluation. 

Appraisal phase (second 90 days):   

After the scientific evaluation, the process moves into the economic phase, where the focus shifts to reimbursement proposals. During this phase, the NIHDI uses the price evaluation from the FPS Economy from phase 1 to move forward with pricing and reimbursement conditions and end up with a provisional proposal. 

Responding to evaluations and proposals 

Pharmaceutical companies have the opportunity to respond to both the scientific evaluation and the reimbursement proposal: 

Assessment phase response: 

After receiving the initial scientific evaluation, after about 60 days, companies have 20 days to respond. This response period allows companies to address any concerns or misunderstandings the CRM raises. It is common for the evaluation to include a series of questions or requests for clarification, which companies must address promptly. 

Appraisal phase response: 

Once the price and reimbursement conditions are proposed by the CRM, companies have 10 days to react. This phase focuses on the criteria that determine which patients will be eligible for reimbursement. The conditions are often stringent, requiring a specific diagnosis or other qualifying factors. For example, certain medicines may only be reimbursed for patients who have already tried other treatment options. 

After the appraisal phase and within 150 days of the procedure, the Minister of Social Affairs receives a formal advice from the CRM to make his decision. 

The role of the Minister of Social Affairs 

The final decision on medicine reimbursement lies with the Minister of Social Affairs. The CRM provides an advisory opinion, but the Minister has the ultimate authority to approve or deny the reimbursement request. The deadline for this decision is on day 180 of the process. 

Publication and implementation of the decision 

Once the minister’s decision is made, it is published in the Belgian Official Gazette the month after. However, the reimbursement does not take effect immediately. In most cases, the reimbursement becomes applicable on the first day of the month following publication. For example, if the decision is made in August and published in September, the reimbursement would take effect on October 1. 

Based on the NIHDI’s MORSE report, the average turnaround time between the dossier submission and the medicine reimbursement is almost one year. 

Additional considerations 

There are additional options available throughout the reimbursement process: 

Clock stop mechanism:   

At two key points during the process - after receiving the first scientific report and after receiving the reimbursement proposal - companies can request a "clock stop" if they need more time to respond. This mechanism pauses the timeline for up to 90 days. While we at e&a consultants typically avoid using the full clock stop period, it can be useful when external consultations with medical experts are necessary. 

Hearings:   

While all the communication mentioned above is written communication, companies may request a virtual hearing with the CRM during either the assessment phase or appraisal phase. This option allows them to present their arguments and is particularly useful when there are significant discrepancies between the company’s perspective and the evaluation. 

In some cases, like orphan medicines, companies may request a pre-submission hearing. This is particularly helpful when submitting an innovative medicine which introduces major changes in clinical practice.