Dáil Éireann Debate, Thursday - 6 July 2023
317. Deputy Pádraig O'Sullivan asked the Minister for Health the number of medicines assessments carried out by the NCPE that have been subject to external review or audit; the extent to which NCPE activity has been subject to audit to date; the governance and oversight procedures in place for the NCPE via the HSE's chief clinical officer and/or his Department; and if he will make a statement on the matter. [33220/23]
Amharc ar fhreagraThe NCPE was subject to audit in 2019 as part of a review commissioned by the Department of Health and conducted by Mazars examining the governance arrangements to support the HSE’s drug reimbursement process. In relation to staffing and governance the report highlighted that: “As their roles are so specialist, we reviewed the qualifications of the staff at the NCPE. We noted that the assessors in the NCPE have all completed or are in the process of completing a PHD programme in Pharmacoeconomics. This is a highly unique skill set and these individuals are highly valuable to this process. The calibre of the staff resources employed in the NCPE is testament to the strong governance in this process”.
The NCPE is involved in multiple international collaborations and has completed two joint Health Technology Assessments (HTAs), Zolgensma® and Libmeldy®, as part of the Beneluxa Initiative. Collaboration on HTA requires that there is a peer review process. The NCPE contribution to the Joint Assessments is reviewed by HTA experts from other countries.
The NCPE is highly regarded internationally and is playing a leading role in three international initiatives: the Beneluxa Initiative, International Horizon Scanning Initiative, and the European HTA Regulation. The Regulation on HTA entered into force in January 2022 and will fully apply as of January 2025. Its purpose is to strengthen the quality of HTA in the European Union and ensure efficiency in the evaluation of new medicines and technologies in a consistent way across member states. The HTA Coordination Group is the main governance body established under the HTA legislation and under which Joint Clinical Assessments and Joint Scientific Consultations for both pharmaceutical technologies and medical devices will be undertaken following established methodological procedures. The NCPE’s Head of HTA Strategy and External Engagement is the Chair of this Group.
All NCPE HTAs are disseminated to the HSE’S Chief Clinical Officer on completion. Therefore, there is full oversight of all HTAs completed by the NCPE.
