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Reimbursement strategy

Identify reimbursement, payer and HTA barriers and define practical next steps.

Identify reimbursement, payer and HTA barriers and define practical next steps.

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White Paper: Market Access Landscape for Health Apps in Europe

Get insights from MTRC White Papers to explore practical strategies for navigating digital health reimbursement in Europe and discover how health app developers build effective strategies for market entry and scale 

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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Belgium expands reimbursement of health apps with a third care pathway

In Belgium, the reimbursement framework for health apps (applications mobiles médicales) is overseen by the National Institute for Health and Disability Insurance (INAMI/RIZIV). The supporting administrative framework, managed by industry associations beMedTech and Agoria, is the mHealthBelgium validation pyramid, which consists of three levels:

  • Level 1 – the app is a CE-certified medical device;
  • Level 2 – additional ICT criteria are fulfilled, and a reimbursement application is submitted to INAMI/RIZIV;
  • Level 3 – reimbursement within a specific care pathway is approved by INAMI/RIZIV.

Level 3 is subdivided into two sub-levels. At Level 3- (“light”), the app has not yet demonstrated sufficient socio-economic benefits and reimbursement is temporary while additional evidence is generated. At Level 3+ (“plus”), sufficient socio-economic benefits have been demonstrated and the app can be reimbursed on a permanent basis.

Before September 2026, two care pathways had already been established. A total of 12 health apps had reached Level 3+ and were reimbursed, with some apps reimbursed under more than one pathway:

  • Remote monitoring of oncology patients (six apps);
  • Remote monitoring in chronic heart failure (ten apps).

In September 2026, Cureety Techcare reached Level 3+ and was added to the existing “Remote monitoring of oncology patients” care pathway.

Furthermore, a new care pathway, “Remote monitoring by a physiotherapist,” was introduced, with moveUP becoming eligible for reimbursement. The moveUP app had already achieved Level 3+ status and was previously reimbursed within two existing care pathways.

Therefore, as of September 2026, three care pathways have been established, with a total of 13 reimbursed health apps.

Two additional care pathways are currently in development:

  • Holter monitoring for cardiac patients;
  • Remote monitoring for patients with obstructive sleep apnea (OSA).

What does it mean?

The latest developments indicate that Belgium is gradually expanding the scope of reimbursed digital health, both by adding new apps to existing pathways and by creating reimbursement opportunities for new clinical uses.

At the same time, access remains care-pathway specific. Reaching the technical and regulatory levels of the mHealthBelgium pyramid does not by itself create a general route to reimbursement: the app needs to be linked to a relevant reimbursed care pathway. This makes the development of new pathways particularly important for companies whose technologies currently fall outside oncology, chronic heart failure and physiotherapy monitoring.

The Belgian approach also places importance on evidence of socio-economic benefit. Permanent Level 3+ reimbursement is linked to demonstrating such benefit, while Level 3- provides a route for temporary reimbursement and further evidence generation. Evidence planning should therefore be considered as part of the reimbursement strategy rather than only after the technical requirements have been addressed.

Finally, the two pathways currently under development suggest that the reimbursed scope may continue to broaden. Developers of cardiac monitoring and OSA solutions in particular should follow these developments, as they may create new reimbursement opportunities.

This news is just one of about 300 market access news and updates collected by our team in the premium subscription service MTRC Access Intelligence every week from more than 80 organizations. Access our paid service to stay on top of all developments, specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, six-week, no-obligation trial.