Explaining the reformed reimbursement procedure in Belgium

In May 2024, a major reform of medicine reimbursement in Belgium was approved by the Parliament. This reform is now also published into the Belgian Official Gazette. But how will these changes impact pharma companies and patients? e&a consultants provides you with a handy overview.  

Important disclaimer: it is unclear how some of these changes will translate to practice. For that, we will have to wait for the royal decree to be published and for the practical government guidelines to emerge from it.  

Greater patient involvement in medicine reimbursement 

The new reform states that patients will be more closely included in the reimbursement process of medicine, a decision the e&a team strongly applauds. New reimbursement requests, for instance, will need to include patient experience data. We will have to wait for a clarifying royal decree for the practical interpretation of this concept. 

Patient involvement will also occur through patient representatives who would be able to communicate their needs and concerns to decision-makers. But it needs to be clarified in what way. Perhaps a patient platform will be set up to uniformly communicate patient organisations' interests. In any case, there will likely be close collaboration in the future between patient organisations and two key committees, the Commission for the Reimbursement of Medicines (CTG) and the Advisory Committee in case of temporary allowance for the use of medicine (CATT). 

A renewed system for fast access and early access programs  

The reform also introduces a lump sum compensation to facilitate early and fast medicine access in Belgium and help make much needed medicine more easily available to patients with life threatening diseases or chronic conditions. But when can you apply for early or fast access?  

To be granted early access, your medicine needs to be registered on the government’s Unmet Medical Need list and there must exist a Medical Need Program or Compassionate Use Program for your particular medicine.  

Fast access on the other hand speeds up medicine review and approval for urgently needed drugs which are ready to go to market. This can be granted to early access medicine or PRIME medicine.  

Requesting lump sum compensation for your fast or early access medicine will come with certain obligations:  

• You will need to collect and analyse real world data. 

• You must apply for a conventional medicine reimbursement as well. 

• You will need to continue making your innovative medicine available even if you are declined reimbursement. 

Exactly what pharma companies need to submit to receive lump sum compensation should become clear in the upcoming royal decree. 

The reimbursement procedure becomes more accessible 

Previously, you had to follow a specific reimbursement procedure based on how the government labelled your medicine. With the reform, pharma companies can decide whether their medicine has added value, influencing the reimbursement procedure timeline. In the case of no added value, for instance, you no longer need to follow the complete procedure but a shortened one of 90 days (and in some cases 60 days). However, it is important to note that an upcoming royal decree might add subcategories for medicine, which could impact the procedure timeline and evaluation.  

The reimbursement committee can decide if a) the medicine has added value, b) the medicine has no added value, or c) the medicine’s added value needs to be evaluated. The precise implications of these decisions are unclear without the royal decree, but this procedural change does seem positive. This change offers pharma companies more autonomy and seemingly speeds up the overall procedure, making it more accessible.