CTIIMH & CRPPP-CTFPV: how MedTech reimbursement works in Belgium

To bring an innovative medical technology to market in Belgium, you’ll need a good understanding of the complex reimbursement landscape. It’s important to know that MedTech follows distinct procedures depending on the nature of the device. Understanding these processes is key to ensuring market access and sustainable pricing.

Looking for more information on medicine reimbursement? Click here for an overview of procedures and regulations.

Which committees oversee MedTech reimbursement?

In Belgium, reimbursement for medical devices is managed by two key committees:

• CTIIMH (Commission for Transparency on Implants and Invasive and Human Material): responsible for implantable and invasive medical devices. The procedures, conditions, and timelines for these devices were formalised under the Royal Decree of 25 June 2014.
  
  
• CRPPP-CTFPV (Commission for the Reimbursement of Pharmaceutical Products and Medical Procedures): oversees non-implantable and non-invasive devices. The Royal Decree of 23 November 2021 defines the process, criteria, and timelines for reimbursement decisions in this category.

How does MedTech reimbursement differ from pharmaceuticals?

Unlike pharmaceuticals, where a company submits an application for each new medicine seeking reimbursement, medical devices could be aligned with already existing listings. The reimbursement process is split into two main pathways:

Automatic reimbursement via a chapter-based list:

• Some medical devices, such as an intraocular lens for cataract surgery, can be automatically reimbursed if they already fall under a recognized medical act (or in Dutch “verstrekking”).
• This means no separate reimbursement application is needed, and the prescribing physician attests the use of the device.

Individual submission to the CTIIMH for new or modified listings:

• If a device does not yet have a recognised procedure under the existing list, a company must submit a dossier to the CTIIMH to either create a new category or modify an existing one.
• Factors such as therapeutic value, cost, budget impact, and comparative effectiveness are assessed during this process.

What are the forms of reimbursement for MedTech?

The reimbursements may be based on a fixed lump sum (forfaitary amount), a ceiling amount, or in some cases, there may be no reimbursement at all. The level of patient involvement can vary, with some categories requiring a contribution from the patient, while others may be fully reimbursed by the healthcare system. The specific reimbursement conditions are determined by the category under which the device is classified, influencing both the cost and the patient's financial responsibility.

What is the nominative list?

For active implantable devices (such as pacemakers and neurostimulators), a nominative list exists where products are, in fact, explicitly named. This publicly available list provides greater transparency in reimbursement pricing compared to other MedTech categories.

Before submitting a dossier, companies often conduct preliminary discussions with the medical devices service at the National Institute for Health and Disability Insurance (RIZIV/INAMI) to determine the most appropriate reimbursement pathway.

What are the timeline and criteria for reimbursement decisions within CTIIMH and CRPPP-CTFPV?

Both CTIIMH and CRPPP-CTFPV follow structured, time-bound procedures:

• The standard decision timeline for CTIIMH is 255 days and for non-implantable devices under CRPPP-CTFPV is 240 days, with predefined deadlines at each stage.
• The key evaluation criteria include therapeutic value, pricing, budget impact, and cost-effectiveness.
• Additional challenges arise in determining whether a device qualifies as implantable and assessing the duration of its presence in the body. These are factors that influence reimbursement eligibility.

Collaboration and strategic planning: the key to success

Given the complexity of Belgium’s reimbursement landscape, continuous engagement with key stakeholders like BeMedTech, regulatory authorities, and market experts is essential. For MedTech companies looking to enter the Belgian market, understanding the pathways to reimbursement early and planning strategically can be the difference between successful market access and prolonged delays.