FAQ

The standard procedure takes up to 180 days and starts once you have submitted your reimbursement dossier to the Commission for Reimbursement of Medicine (CRM). If needed, your company can request additional time to answer questions by the CRM or formulate a reply to their reports. These clock stops, limited to 90 days each, can prolong the 180-day procedure and can be requested up to two times throughout the procedure.

The royal decree of 1 February 2018 provides a detailed overview of the reimbursement procedure and deadlines. You can consult it here.

The Minister of Economy determines the pricing of medicine based on several factors, of which the most important ones are:

- The cost-price structure of the medicine, which includes all costs incurred to make the drug available to Belgian patients

- The price of your medicine in other EU countries

- The prices of comparable pharmaceutical products on the Belgian market

For the maximum ex-factory price of a drug, the FPS economy is guided by the royal decree of 10 April 2014, where you can find more information on the pricing procedure and requirements for a correct pricing dossier.

A managed entry agreement (MEA) is a confidential agreement you enter into with the government in case there are clinical or budgetary uncertainties for your medicine at the time of application, e.g. it is not clear what the expenses will be for your drug or how many patients will need it, etc.

Have you submitted a reimbursement dossier for an orphan drug, a medicine with added value or a medicine that claims equal value to one currently in MEA? Then your dossier may end up in a MEA.

Whenever a medicine has been reimbursable for 12 years in Belgium, the basis of reimbursement may decrease. The amount is limited by the EU6 safety net. This means a decrease in price cannot go below the lowest price of these six reference EU countries: Germany, France, the Netherlands, Ireland, Finland and Austria. This safety net only applies to original medicines without a generic or biosimilar alternative on the market.

You can find more information on the EU6 safety net here.

First, you need to apply for a marketing authorisation with the Luxembourg authorities, even if you already have a European authorisation. Afterwards, you will receive a country of reference for the composition of your pricing or reimbursement dossier. For example, if your medicine is available on the Belgian market, Belgium can be your country of reference. Your request can be submitted once your product is available in the country of reference.

Reimbursement of medical devices in Belgium doesn't run through a single committee, it's handled by several specialised bodies within RIZIV/INAMI, depending on the type of product:

• CRPPP / CTFPV – the Commission for the Reimbursement of Pharmaceutical Products and Procedures handles diagnostic and care products, medical nutrition, and magistral preparation products. Since 2022, this commission operates through three working groups, which replaced the former Technical Council for Diagnostic and Care Devices, the Working Group on Medical Nutrition, and the Technical Pharmaceutical Council.
• CRIDMI / CTIIMH – the Commission for Reimbursement of Implants and Invasive Medical Devices handles the reimbursement of implants and invasive medical devices, such as neurostimulators or middle ear implants.
• TGR/CTM – The Technical Medical Council handles, among other things, the reimbursement of in vitro diagnostic (IVD) medical devices through the nomenclature. A specific example are histochemical tests that detect a particular mutation: these are also a form of companion diagnostics (CDx), but their reimbursement runs through the nomenclature and is therefore decided by this council.
• CDx working group – a separate, joint working group between the CRM and the TGR that ensures molecular companion diagnostics linked to a specific medicine are reimbursed simultaneously with that medicine.

Each committee issues an advice to the Minister of Social Affairs, who takes the final decision on whether a product is added to the list of reimbursable products and under what conditions.

Want to dig deeper into the CRIDMI/CTIIMH and CRPPP/CTFPV procedures, timelines and pricing challenges? Read our blog: CTIIMH & CRPPP-CTFPV: how MedTech reimbursement works in Belgium.

Radiopharmaceuticals are a category of their own. Belgium set up the Technical Council for Radioisotopes (TRRI/CTRI) in 2014, the advisory body that supports the Minister of Social Affairs on the reimbursement of radiopharmaceuticals.

A radiopharmaceutical is only eligible for reimbursement if it's explicitly listed on the list of reimbursable radiopharmaceutical products. The procedure is similar to that for ordinary medicines, and runs within a 90-day procedure: the company submits a dossier, the TRRI reviews it and formulates a proposal, and the Minister takes the final decision.

Just as with medicines, the FOD Economie / SPF Économie (Federal Public Service Economy) oversees pricing for certain medical devices, namely hearing aids and specific reimbursable implants. Not all reimbursable implants fall under this price control, only those listed in Annex 1 of the Royal Decree of 25 June 2014, specifically Category I.C implants under the ophthalmology and orthopaedics-and-traumatology headings, and Category I.G implants reimbursed in a specific way.

For these implants, every price determination or increase must be requested individually from the Price Service of SPF Economie, based on a dossier including:

• the product's CE certificate, together with the distribution and/or export notification filed with the FAGG (Federal Agency for Medicines and Health Products)
• the cost price structure, with a fully itemised justification
• information on market and competitive conditions