Market Access · Pricing and Reimbursement
Pricing and Reimbursement (Market Access), Belgium and the Benelux.
Authorising a medicine is one decision. Pricing it and getting it reimbursed are others. MEDCOR supports you through both, so market access is planned alongside your regulatory work rather than after it.
When you need this
You need pricing and reimbursement support when a medicine is heading for the Belgian market and its price and patient access still have to be settled: a new launch, a change to a product already on the market, or a price or reimbursement position that needs revisiting.
This work often becomes urgent only once the marketing authorisation is secured. Planning it alongside the regulatory file keeps the launch date realistic, and the same conversation can cover both.
Two decisions, two authorities
The price
Medicine prices in Belgium are regulated. The FPS Economy oversees the maximum price of human medicines, so a price is applied for and agreed before launch, and later changes follow a set procedure.
The reimbursement
Whether health insurance pays for a medicine, and on what conditions, is decided through RIZIV/INAMI, the National Institute for Health and Disability Insurance (NIHDI). A file is submitted, the Commission for Reimbursement of Medicines (CRM) advises, and the Minister of Social Affairs decides.
What this covers
- 01Mapping the price and reimbursement route for your medicine in Belgium, and how it fits with your marketing authorisation timeline.
- 02Preparing and following up the price application with the FPS Economy.
- 03Preparing and following up the reimbursement file with RIZIV/INAMI, including the dossier for the Commission for Reimbursement of Medicines (CRM) and the reimbursement conditions.
- 04Support for vaccines, generics and other medicines, including how generic entry changes the position of an existing product.
- 05Looking after the position once the product is listed: price changes, reimbursement conditions and periodic reviews.
- 06Extending the plan to the Netherlands and Luxembourg where your launch includes them.
Vaccines, generics and other medicines
Vaccines
Vaccines can follow different routes from other medicines, from reimbursement to inclusion in public vaccination programmes. The first step is establishing which applies to your product.
Generics
A generic launch is shaped by the price and reimbursement position of the reference product. Pricing the entry correctly, and understanding what follows it, matters as much as the file itself.
Other medicines
Innovative, orphan, over-the-counter and established products each carry their own considerations. The work starts from your product and builds outwards.
How the work runs
Scoping call
A short conversation about the product, where it stands in authorisation and when you plan to launch. You leave knowing what is needed and what is not.
Route and plan
A written route for price and reimbursement: which applications go to which authority, what evidence each one needs, and how the timeline fits your launch.
Preparation and follow-up
The files are prepared, submitted and followed up with the authorities, and their questions are answered as they arise. Pricing work is familiar ground: Hendrik has advised on OTC pricing dossiers earlier in his career.
Common questions
What is pricing and reimbursement for a medicine?
Two separate decisions that together determine market access. Pricing sets the price a medicine may be sold at; reimbursement decides whether, and on what terms, health insurance pays for it. A medicine can be authorised yet still reach no patients until both are settled.
How are medicine prices set in Belgium?
The maximum price of a human medicine is regulated by the FPS Economy. A price is applied for and agreed before the medicine goes on the market, and any later change follows a set procedure.
Who decides whether a medicine is reimbursed in Belgium?
Reimbursement runs through RIZIV/INAMI. The Commission for Reimbursement of Medicines reviews the file, and the Minister of Social Affairs takes the decision.
How long does the reimbursement process take?
It varies with the medicine and the route, and a reimbursement file commonly runs to several months. Because it often begins in earnest only once the authorisation is secured, starting the groundwork early is what protects the launch date.
Are pricing and reimbursement handled separately?
They are two decisions, with two authorities, on two timelines. They are closely linked, though, so MEDCOR prepares them together to keep the price, the file and the launch plan consistent.
Do you work on vaccines and generics?
Yes, along with innovative, orphan and other medicines. Each has its own route: a vaccine may involve a public programme, a generic turns on the reference product's position. The first step is establishing which applies to yours.
Does pricing and reimbursement apply beyond Belgium?
Belgium is the core of this work. Where a launch extends to the Netherlands or Luxembourg, the same planning can be carried across the Benelux.
Can this be combined with regulatory support?
Yes, and it usually is. Market access planned alongside the regulatory file means one conversation and one plan cover the route from authorisation through to a reimbursed product.
Already working with MEDCOR on your regulatory affairs? Pricing and reimbursement can sit within the same engagement, with the MEDCOR network covering vaccines, generics and other medicines.
MEDCOR's other services
Planning a launch in Belgium?
Tell me where the product stands today and we will work out the price and reimbursement route together.
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