Blog Market Access Insights

Understanding the Early & Equitable Fast Access (EEFA) Framework in Belgium

Belgium has introduced the Early & Equitable Fast Access (EEFA) framework, a major step forward in enabling faster patient access to innovative therapies. This new procedure allows treatments to become available earlier through temporary reimbursement, even before the standard pricing and reimbursement process is completed.

Curious about how it works in practice? In our blog post, we break down the process, requirements, and key considerations for a successful application.

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Radiopharmaceutical reimbursement in Belgium: FAQs

Radiopharmaceutical products used for diagnosis or treatment can be reimbursed through the Belgian compulsory health insurance. Their reimbursement follows a specific procedure managed by the National Institute for Health and Disability Insurance (RIZIV/INAMI), with the Technical Council for Radioisotopes (TRRI/CTRI) playing a central advisory role.

We answer some frequently asked questions about the Belgian reimbursement pathway for radiopharmaceuticals.

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LIVV contributes to IHI COMPASS project

LIVV is part of the COMPASS Project, a major European initiative funded by the Innovative Health Initiative (IHI).

COMPASS brings together 62 organisations across 25 countries, including hospitals, universities, research centres, MedTech companies, SMEs, and patient organisations to advance cardio-oncology care.
The project aims to optimise cardiovascular health for cancer patients and survivors by developing an end-to-end, patient-centred care pathway. This includes:
• Predicting cardiotoxicity risk
• Detecting cardiovascular disease earlier
• Supporting personalised treatment decisions
• Enabling long-term monitoring through AI and real-world data
Cardiotoxicity, cardiovascular damage caused by cancer therapies, can occur during or even years after treatment, making this work critical for long-term patient outcomes.

At LIVV, we’re excited to contribute to this collaborative effort and help shape the future of integrated, data-driven healthcare.

Interested to know more about the COMPASS project?

Reimbursement of Implants and Invasive Medical Devices in Belgium: A Practical Guide

Reimbursement of implants and invasive medical devices in Belgium is managed through the compulsory health insurance system by the National Institute for Health and Disability Insurance (NIHDI/RIZIV-INAMI). Reimbursement is primarily governed through the Belgian List of reimbursable implants and invasive medical devices, commonly referred to as the Positive List, which defines reimbursable device categories, reimbursement conditions and reimbursement amounts.

Applications to introduce or modify reimbursement are evaluated by the Commission for Reimbursement of Implants and Invasive Medical Devices (CTIIMH/CRIDMI). Depending on the existing reimbursement framework, manufacturers or distributors may need to request a modification of the list, add an individual device to a nominative list, or pursue another applicable reimbursement pathway.

This practical guide explains how the Belgian reimbursement system for implants and invasive medical devices works, including the Positive List, nominative lists, reimbursement categories, CTIIMH/CRIDMI and the IRREQ application process.

Navigating the reimbursement process can be complex and time-consuming, especially when aligning with the evolving expectations of the CTIIMH/ CRIDMI. At LIVV, we specialize in guiding companies through every step of the reimbursement pathway. From dossier strategy and preparation to liaising with working groups and regulatory follow-up, we ensure your file is clear, compliant, and positioned for success.

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Why reimbursement shapes the future of cardiovascular care in Belgium

Life-saving cardiovascular devices, from pacemakers, valves to advanced stents, can only help patients if they are accessible. In Belgium, reimbursement policies play a crucial role in who gets access, which technologies hospitals adopt, and how care evolves. Learn why reimbursement is more than money, it’s the key to better care in Belgium.

📩 Contact us today to schedule a consultation and unlock your product’s reimbursement potential.

Patient Involvement in Drug Reimbursement in Belgium

On 1 April 2025, Belgium officially opened the door for patients to participate in decisions about the reimbursement of medicines. For the first time, the Commission for the Reimbursement of Medicines (CRM or CTG in Dutch) at the National Institute for Health and Disability Insurance (NIHDI or RIZIV/INAMI in Dutch/French) includes patient representatives in its procedures.

📩 Contact us today to schedule a consultation and unlock your product’s reimbursement potential.

Requesting Reimbursement for Diagnostic and Care Products, Medical Nutrition, and Magistral Preparation Products in Belgium

Since 2022, Belgium has streamlined its reimbursement process for diagnostic tools, medical nutrition, and magistral preparations.

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

Our blog breaks down how the CRPPP/CTFPV handles applications, what types of files exist, and what steps are involved.

Navigating the reimbursement process can be complex and time-consuming, especially when aligning with the evolving expectations of the CRPPP/CTFPV. At LIVV, we specialize in guiding companies through every step of the reimbursement pathway. From dossier strategy and preparation to liaising with working groups and regulatory follow-up, we ensure your file is clear, compliant, and positioned for success.
Don’t leave your reimbursement to chance, partner with LIVV for peace of mind and proven expertise.

📩 Contact us today to schedule a consultation and unlock your product’s reimbursement potential.

Visualizing Reimbursement Criteria for Digital Health Tools in Belgium and France

Poster presented at ISPOR Europe 2024 17-20 November 2024 in Barcelona Spain

Digital Health is a term that encompasses a broad and interdisciplinary field. A subgroup of Digital Health Technologies (DHTs) are Digital Health Applications (DHAs) typically referring to certified software that patients and healthcare providers use to support, monitor, or manage health conditions. In Europe, terminology and categorization vary between countries. Furthermore, also the regulatory requirements and reimbursement frameworks are different.

The objective of this project is to enhance the understanding of reimbursement frameworks for DHTs in Belgium and France by developing visual decisionsupport tools.
The aim is to support market access professionals and developers in navigating the reimbursement frameworks for a specific DHT on country level, comparing the DHT features and compliance with specific national reimbursement criteria, identifying gaps in the eligibility, and providing guidance.

Discover the poster

Navigating the Maze: Effective Go-to-Market Strategies for Digital Therapeutics

This short blog focuses on strategic approaches for the commercialization of digital therapeutics.

Read here

We also have a presentation on demand about this topic. Contact us for more information.

“Go-to-market for digital therapeutics“

In the rapidly evolving field of digital therapeutics (DTx), navigating the go-to-market (GTM) landscape is key to create commercially viable businesses. This talk will explore several commercialization pathways, including direct-to-consumer (D2C), pharmaceutical partnerships, and employer channels, while considering the regulatory, clinical, and market dynamics in the EU.  We will also explore the national pathways in Germany (DiGa) and France (PECAN). 

This presentation aims to provide a comprehensive overview of how DTx companies can leverage these strategies to achieve market penetration and scalability in a diverse regulatory environment like the EU, while addressing challenges such as evidence generation, reimbursement, and regional variations.

Introduction to Digital Health Technologies

Embark on a journey through the intricate world of Digital Health Technologies (DHTs) with this blog. We delve into their varied definitions and the categorization challenges these essential tools face.

Read here