Since 2022, Belgium has streamlined its reimbursement process for Diagnostic and Care Products, Medical Nutrition, and Magistral Preparation Products. This blog breaks down how the CRPPP/CTFPV handles applications, what types of files exist, and what steps are involved — so you can confidently navigate the system and get your product covered.
What is CRPPP / CTFPV?
Since February 1, 2022, a new, transparent reimbursement procedure has been implemented by INAMI (Belgian National Institute for Health and Disability Insurance) for applications concerning Diagnostic and Care Products, Medical Nutrition, and Magistral Preparation Products.
These requests are now handled by the CRPPP (Commission de remboursement des produits et des prestations pharmaceutiques in French) or CTFPV (Commissie voor Terugbetaling van Farmaceutische Producten en Verstrekkingen in Dutch). Within this commission there are 3 working groups (WG):
- WG Medical Nutrition
- WG Diagnostic and Care Products
- WG Magistral Preparation Products
This single commission with 3 working groups replaces the responsibilities previously divided among three separate bodies:
- TRDVM / CTDMS (Technische Raad voor Diagnostische- en Verzorgingsmiddelen / Conseil Technique des moyens Diagnostiques et de Matériel de Soins)
- WG NUT / GT NUT (Werkgroep Medische Voeding / Groupe de Travail Nutrition)
- TFR / CTP (Technisch Farmaceutische Raad / Médical Conseil Technique Pharmaceutique)
Legal Framework & Scope
The procedure, conditions and timelines are defined in the Royal Decree of November 23, 2021.
The scope includes:
- Non-implantable Medical Devices (active dressings, diagnostic equipment, treatment equipment)
- Prestations with Medical Devices (medical oxygen gas and accessories, bandages and other plasters, sterile insulin syringes, …)
- Magistral Preparation Products with Medical Devices
- Medical Nutrition (e.g. food for special medical purposes, parental nutrition at home, home enteral tube feeding, …)
Types of Reimbursement
Three types or reimbursement exist:
- Lump sum that can partially or fully cover the costs for patients
- Maximum amount in EUR or units
- Percentage of the product price
Reimbursement varies according to the device/product concerned, existing frameworks, the commission responsible for the decision making.
Types of Application Files
Applications fall into three categories. There are different templates depending on the type of application/request.
- Administrative file
- Extension of the range of already reimbursed products or acts with medical devices
- No therapeutic added value or budgetary impact
- Examples: same product in a new flavour, or an addition of an existing product
- Semi-administrative file
- Extension of already reimbursed products or acts with medical devices
- Also has no added value or budgetary impact
- Examples: a different packaging or new pharmaceutical form
- File with added value
- Applies to a new product or version that claims therapeutic and/or social added value in comparison to existing alternatives
- Must demonstrate superiority compared to existing alternatives
The Reimbursement Procedure
Step-by-Step for semi-administrative and added-value files
- Admissibility Check
- Within 10 working days, the secretariat verifies if your application is complete.
- If admissible:
- You’re notified of the official Day 0 (the day after complete receipt).
- The timeline begins: max 370 days
- Evaluation by the Working Group
- File is assessed by a working group.
- You receive a provisional evaluation report within 60 days of Day 0.
- You have 20 days (extendable once by 60 days) to respond with comments/objections.
- A final evaluation report is sent within 110 days of Day 0.
- Working Group Recommendation
- A reasoned provisional recommendation is issued within 170 days.
- You have 20 days (extendable once by 60 days) to comment.
- If the recommendation matches your proposal, it becomes final. If objections were submitted, the working group reviews them and issues a final recommendation within 250 days of Day 0.
- Opinion of the Commission
- The Commission reviews the final recommendation.
- Day 310: Final Opinion sent to the Minister
- Minister’s Decision
- The Minister has 60 days to make a final decision.
- The Minister can deviate from the Commission’s opinion based on social or budgetary grounds.
Note: Reimbursement takes effect the first day of the month following the expiration of a period of ten days from the day following publication in the Official Gazette. Take into account the estimation of a maximum of 180 days for all the steps after CRPPP opinion.
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