Presentation (CTI)

OBJECTIVES: The National Centre for Pharmacoeconomics (NCPE) is acting as Lead Assessor for the first published Joint Clinical Assessment (JCA) of tovorafenib for paediatric low-grade glioma and the second JCA of onasemnogene abeparvovec for 5q spinal muscular atrophy, which had not been published at the time of abstract submission. This study examined the early impact of JCA implementation on Ireland's reimbursement process, assessment requirements, and timelines
METHODS: The published JCA for tovorafenib was reviewed alongside changes to NCPE reimbursement procedures, HTA templates, and submission timelines. Areas of duplication between the European JCA and the national HTA process, together with opportunities to streamline assessments, were identified.
RESULTS: In Ireland, health technology developers (HTDs) may initiate the reimbursement process following Committee for Medicinal Products for Human Use (CHMP) opinion. Although both medicines had received CHMP opinion, neither was submitted at that stage, suggesting HTDs may be waiting for publication of the JCA report before initiating the national process. The published tovorafenib JCA provides a comprehensive clinical assessment but does not include several elements required for the Irish HTA, including national clinical guidelines, Ireland-specific PICOs, pivotal trial summaries, and a value statement on comparative effectiveness. However, much of this information is available within the HTD submission dossier, creating opportunities to reduce duplication. In addition, the comprehensive JCA assessment and early PICO scoping have the potential to streamline the Irish HTA.
CONCLUSIONS: Early experience suggests that the EU JCA will support national HTA in Ireland by reducing duplication. Although HTDs may delay reimbursement submissions until publication of the JCA report, this could be offset by more efficient national assessments. To maximise the benefits of the EU JCA, Irish HTA templates, submission requirements, timelines should be aligned with the JCA process, and the PICOs relevant to Ireland should be clearly identified.