Ireland’s NCPE applies EU Joint Clinical Assessment in first national HTA review

Ireland’s NCPE has completed the first national assessment for a medicine with an EU Joint Clinical Assessment (JCA), using the JCA report ahead of its public release. The case provides early insight into how EU-level assessments are being integrated into national decision-making processes.

The Baseline

• NCPE’s Rapid Review is the first national HTA to incorporate an EU Joint Clinical Assessment into its evaluation.
• The endorsed JCA for onasemnogene abeparvovec (Itvisma®) was used ahead of publication, reflecting parallel EU and national timelines.
• The NCPE recommended that the therapy not be considered for reimbursement at the submitted price, with both the JCA and national assessment informing the final decision by Ireland’s healthcare system.

The first national assessment for a medicine supported by an EU Joint Clinical Assessment (JCA) has been completed, providing an early indication of how the EU HTA Regulation (EU HTAR) is being applied at country level.

The JCA concerns Novartis’ Itvisma® (onasemnogene abeparvovec intrathecal), an advanced therapy medicinal product for the treatment of spinal muscular atrophy (SMA). The report was endorsed by the Member State Coordination Group on Health Technology Assessment (HTACG) at its 21st meeting on July 16, 2026, chaired by Roisín Adams (NCPE, Ireland) and co-chaired by Marco Marchetti (AGENAS, Italy).

In line with the EU HTAR, the European Commission will now carry out a procedural review to verify that the report, assessed by Ireland’s National Centre for Pharmacoeconomics (NCPE) with Haute Autorité de Santé (France) as co-assessor, complies with the applicable requirements. The report will be published following completion of this review.

At the same time, Ireland’s health technology assessment (HTA) body, the NCPE, has completed a Rapid Review for the therapy, becoming the first national HTA body to assess a medicine supported by a JCA. The Rapid Review was completed in 49 days, with the national decision issued 16 days after EU marketing authorization. This follows European Commission (EC) approval on June 30, 2026, marking the first gene replacement therapy in the EU for a broad population with SMA, including children aged two years and older, as well as adolescents and adults.

A Rapid Review is the first step in Ireland’s drug reimbursement process and is conducted for all medicines. It results in either a recommendation on reimbursement or a decision that a full HTA is required.

In this case, the NCPE concluded that a full HTA was not required but recommended that Itvisma not be considered for reimbursement at the submitted price. The NCPE assessment report, together with the JCA report, will now be used by the Health Service Executive (HSE), Ireland’s publicly funded healthcare system, as part of the final reimbursement decision, alongside the criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013.

The use of the JCA report within the Rapid Review process is notable given that the EU-level report has not yet been published. This reflects how JCAs are intended to operate within the framework, with endorsed reports made available to Member States and used in parallel with national procedures, rather than only after formal publication.

Commenting on the process, the NCPE noted:

“This is an example of how prompt application by Health Technology Developers with national processes for drugs with a JCA can facilitate the intended efficiencies of European collaboration at a national level.”

The case provides an early example of how timelines between EU-level assessment and national decision-making are beginning to align. It also illustrates how JCA outputs, including relative effectiveness estimates derived from indirect comparisons, can be incorporated into national evaluations at an early stage. As further JCAs are completed, similar examples are likely to provide additional insight into how EU-level clinical assessments are used in practice, particularly in relation to the sequencing of assessments, the timing of submissions, and the role of JCA outputs in national reimbursement decisions.