The Belgian National Institute for Health and Disability Insurance (RIZIV / INAMI – NIHDI) recently published a Questions and Answers document (Q&A) on the EU joint clinical assessment (JCA) and joint scientific consultation (JSC) procedures for medicines under the Regulation on Health Technology Assessment (HTA) (Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU) (see, attached copies of the Q&A in Dutch and French).

The Q&A clarifies the procedural and temporal relationship between the JCA procedure and the reimbursement procedures before the Commission for the Reimbursement of Medicines of NIHDI (Commissie Tegemoetkoming Geneesmiddelen / Commission de remboursement des medicaments – CRM). Further, it discusses a range of matters related to the role of NIHDI in the JSC procedure.

The publication of the Q&A follows the publication earlier this month of a Royal Decree that (i) integrates the JCA into the Belgian reimbursement procedures for medicinal products; and (ii) introduces a basis for the CRM considering in its medicines evaluation process assessments and reports prepared by recognised foreign organisations in the context of the EU HTA process (Koninklijk Besluit van 25 mei 2025 tot wijziging van het Koninklijk Besluit van 1 februari 2018 tot vaststelling van de procedures, termijnen en voorwaarden inzake de tegemoetkoming van de verplichte verzekering voor geneeskundige verzorging en uitkeringen in de kosten van farmaceutische specialiteiten / Arrêté royal du 25 mai 2025 modifiant l’Arrêté royal du 1er février 2018 fixant les procédures, délais et conditions en matière d’intervention de l’assurance obligatoire soins de santé et indemnités dans le coût des spécialités pharmaceutiques – the Royal Decree; see, attached copy).

As the HTA Regulation became operational on 12 January 2025, the Royal Decree entered into force with retroactive effect on the same date. The new rules are currently applied only to new oncology medicines and advanced therapy medicinal products. Selected high-risk medical devices will also be assessed under the new rules as of 2026 (subject to further regulatory changes). Orphan medicines will be added in January 2028 and, as of January 2030, the joint assessment work is expected to cover all new medicines (see, Van Bael & Bellis Life Sciences News & Insights of 22 October 2024, 28 October 2024, 19 December 2024, 27 January 2025 and 30 January 2025).