How the EU HTA Regulation works
Regulation (EU) 2021/2282 on health technology assessment applies from 12 January 2025. It establishes the Member State Coordination Group on HTA (HTACG), made up of national and regional HTA bodies, which adopts joint work by consensus where possible, with one vote per Member State. The Commission acts as its secretariat through the HTA secretariat in DG SANTE, which provides administrative, technical and IT support and runs the HTA IT platform.[1, 2]
The HTACG works through four subgroups: joint clinical assessments, joint scientific consultations, identification of emerging health technologies, and methodological and procedural guidance. A stakeholder network, set up by the Commission, brings in patient organisations, health professionals, developer associations, payers and others to support that work on request. The detailed rules sit in implementing acts, including Implementing Regulation (EU) 2024/1381 on JCA of medicinal products and (EU) 2024/3169 on joint scientific consultations for medicinal products, with parallel acts for medical devices and in vitro diagnostics.
| From | Medicines in JCA scope |
|---|---|
| 12 January 2025 | New active substances for cancer, and advanced therapy medicinal products |
| 13 January 2028 | Designated orphan medicinal products are added |
| 13 January 2030 | All other medicinal products within the Regulation's scope |
A selection of high-risk medical devices and in vitro diagnostics is also in scope. See our EU JCA dossier service for the assessment itself.
- 12 January 2025Oncology and ATMPsNew active substances for cancer and advanced therapy medicinal products
- 13 January 2028Orphan medicinesAdded to the scope
- 13 January 2030All other medicinesAll other medicinal products within the Regulation's scope
Pricing and reimbursement remain national decisions; Member States give the JCA report due consideration.
Joint scientific consultations
A joint scientific consultation (JSC) lets a health technology developer discuss the design of its clinical development with EU HTA bodies before pivotal trials are fixed. A product is eligible where it is likely to be the subject of a future JCA, and developers of medicinal products may ask for the JSC to run in parallel with scientific advice from the European Medicines Agency. Requests go to the HTA secretariat and are handled through the HTA IT platform.
The value of a JSC depends on the questions put to it. Comparator choice, endpoints, population definitions and the data needed for later indirect comparisons are where early alignment matters most, because the JCA scoping will draw together the PICO needs of many Member States.
How Belgian reimbursement works
In Belgium, a company with a marketing authorisation and a maximum price from the FPS Economy applies for reimbursement to the Commission for Reimbursement of Medicines (CRM, in Dutch CTG) at INAMI-RIZIV. The CRM is an advisory body to the Minister of Social Affairs, with academic, insurer, pharmacist, physician, industry and patient members; industry and patient members do not vote. For a new medicine or indication, the CRM prepares an assessment report on efficacy, safety, added value over alternatives, the balance between benefit and cost to the insurance, and budget impact, then makes a reimbursement proposal.[3]
The Minister decides, after advice from the Inspector of Finance and with the agreement of the Budget Minister, and may depart from the CRM proposal only on social or budgetary grounds. The decision is due within 180 days of the complete application, and a positive decision takes effect once published as a ministerial decree. Applications claiming added therapeutic value (class 1) must include an economic evaluation.
Where evidence or price data are not yet sufficient for permanent listing, temporary reimbursement can run through an Article 81/111 agreement between INAMI and the company. Public parts cover price and reimbursement basis, budget risk compensation, the uncertainties identified by the CRM and evaluation requirements; the financial annex is confidential. In INAMI's 2026 analysis, 51 of the 87 innovative medicines reimbursed by 1 June 2026 were reimbursed under such a convention. Since 1 March 2026, the Early and Equitable Fast Access (EEFA) procedure also allows earlier access for medicines addressing an unmet need.[4]
Evidence and methods: the role of KCE
The Belgian Health Care Knowledge Centre (KCE) is a federal research centre that advises policymakers on health care and health insurance. It does not take reimbursement decisions. Its methods guidance, the Belgian guidelines for economic evaluations and budget impact analyses (third edition, KCE Report 400, 2025), applies to economic evaluations and budget impact analyses submitted to INAMI-RIZIV committees.[5]
- Perspective: health care payers (federal government, communities and patients) for costs.
- Technique: cost-effectiveness or cost-utility analysis, with the choice justified; QALYs weighted with a generic instrument such as EQ-5D using public preference values.
- Comparators: economically relevant comparisons on the efficiency frontier, based on head-to-head data where possible.
- Discounting: 3% for costs and 1.5% for outcomes.
- Uncertainty: probabilistic sensitivity analysis, with scenario analyses for structural and methodological choices.
- Budget impact: yearly impact up to steady state, at least three years, undiscounted.
Belgium does not use an explicit cost-effectiveness threshold, and KCE advises against citing thresholds from other countries.
How EU JCA interacts with Belgian reimbursement
A JCA report covers relative clinical effectiveness only. Member States keep full competence over their conclusions on added value and over pricing and reimbursement. Under Article 13, they must give due consideration to published JCA reports and must not request at national level information already submitted at Union level.
For a medicine in JCA scope, the Belgian dossier therefore has to sit alongside the JCA: the same clinical evidence, PICO choices and indirect comparisons, then the Belgian economic evaluation, budget impact and any agreement terms built on top. Inconsistencies between the two are visible to assessors.
What we deliver
- JCA readiness reviews and PICO simulation across Member States
- Joint scientific consultation briefing packages and question framing
- JCA-standard systematic literature reviews and indirect treatment comparisons
- JCA dossier drafting and responses during the assessment
- Belgian cost-effectiveness and budget impact models built to KCE guidelines, or adapted from global models
- Clinical and economic sections of CRM reimbursement applications
- Evidence plans for Article 81/111 agreements, including data collection to address CRM uncertainties
What assessors look for
- Comparators that reflect practice: a global model that omits relevant Belgian alternatives will not support a class 1 claim.
- Consistency with the JCA: national analyses that redefine populations or outcomes without explanation invite questions.
- Transparent indirect comparisons: assumptions, heterogeneity and effect modifiers stated, not buried.
- Belgian inputs: unit costs, discount rates and utilities aligned with KCE guidance rather than carried over from another reference case.
- A credible budget impact: uptake and displacement assumptions that can be traced and tested.
- Clear uncertainty: what remains unknown, and how an agreement or further data would resolve it.
Why Evidaxia
We have developed EU JCA dossiers for several companies, including PICO scoping, ITCs and NMAs, and our EU-level work is built to feed national processes, including Belgium's. Hasan Bari, our Founder and Managing Director, is a clinician and health economist and former NICE HTA Technical Lead and Analyst. We support teams working at EU level and in Belgium, applying that experience to the INAMI-RIZIV process.
References
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union. 2021 Dec 22;L458:1-32. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R2282
- European Commission. Implementation of the HTA Regulation [Internet]. Brussels: European Commission; [date unknown] [cited 2026 Oct]. Available from: https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment_en
- INAMI-RIZIV. Commission for Reimbursement of Medicines [Internet]. Brussels: INAMI-RIZIV; [date unknown] [cited 2026 Oct]. Available from: https://www.riziv.fgov.be/fr/l-inami/nos-organes/la-commission-de-remboursement-des-medicaments
- INAMI-RIZIV. Article 81/111 conventions [Internet]. Brussels: INAMI-RIZIV; [date unknown] [cited 2026 Oct]. Available from: https://www.inami.fgov.be/fr/programmes-web/medicaments-innovants-documents-publics-des-conventions-article-81-111
- Belgian Health Care Knowledge Centre (KCE). Belgian guidelines for economic evaluations and budget impact analyses. KCE Report 400 [Internet]. Brussels: KCE; 2025 [cited 2026 Oct]. Available from: https://kce.fgov.be/sites/default/files/2025-05/KCE400_Method_guidelines_economic_evaluations.pdf
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.