NCPE — First National HTA Using EU Joint Clinical Assessment Data

The NCPE completed a rapid review of onasemnogene abeparvovec intrathecal (Itvisma®), Novartis’s intrathecal gene therapy for spinal muscular atrophy (SMA), making this the first national HTA assessment completed for a medicine undergoing an EU Joint Clinical Assessment (JCA) under the EU HTA Regulation. The JCA report was endorsed by the Member State Coordination Group on […]

NCPE Director Questions Value of Early Access Proposals

In a separate RTÉ interview broadcast 21 June 2026, NCPE Director Professor Michael Barry questioned proposals for earlier access to new medicines ahead of full reimbursement assessment. He noted that for several rare disease drugs assessed this year, none had demonstrated an overall survival benefit, and argued that early access without a negotiated price reduction […]

Minister Signs Off End-to-End Review of Drug Approval System

Minister for Health Jennifer Carroll MacNeill announced on RTÉ’s Prime Time, broadcast 11 June 2026, that she has signed off the tender for an end-to-end review of Ireland’s system for approving access to and funding for new drugs and medical treatments. The Minister said she approved the tender details the previous week and that the […]

617-DAY ACCESS GAP — BLUETEQ CLOSES THE FINAL PHASE

New market opportunity for HSE: a single national platform for all Managed Access Protocols.

EU HTA Milestone — First Joint Clinical Assessment

The NCPE published on 4 May 2026 that the HTA Coordination Group approved the first-ever Joint Clinical Assessment report under the EU HTA Regulation. The NCPE Ireland acted as lead assessor, working with IQWiG Germany as co-assessor. The assessment covered tovorafenib (Ojemda®), an anticancer medicine for paediatric low-grade glioma. The report has been forwarded to […]

New Framework Agreement — FASPM 2026–2029

A new pricing and reimbursement Framework Agreement (FASPM) between the HSE and the Irish Pharmaceutical Healthcare Association (IPHA) came into effect in 2026. Key provisions include a commitment to a 180-day new medicines review, a new declining rebate structure (beginning at 9% for medicines added in 2026), new biosimilar rules, and a requirement for suppliers […]

New Framework Agreement on Supply and Pricing of Medicines (FASPM) 2026–2029

A new Framework Agreement on the Supply and Pricing of Medicines between the HSE and the Irish Pharmaceutical Healthcare Association (IPHA) took effect from 1 January 2026 and runs to 31 December 2029. Key provisions include: Horizon scanning: pharmaceutical companies must notify the HSE of new medicines 12–18 months in advance of expected launch. Rebate […]