Irish HTA Guidelines (NCPE submission guidelines)
These guidelines outline how pharmaceutical companies should prepare and submit health technology assessment dossiers to Ireland's National Centre for Pharmacoeconomics, including what data and analyses are required.
At a glance
Use when
Preparing a pharmacoeconomic submission for a new medicine to the NCPE in Ireland
Avoid when
Assessing non-pharmaceutical technologies or when applying to HTA bodies outside Ireland
Inputs
Clinical trial data, health economic models, cost data, epidemiological data, quality-of-life inputs, Irish healthcare resource use
Outputs
Standardized HTA dossier compliant with NCPE requirements, including economic evaluation and budget impact analysis
How it works
The NCPE submission guidelines specify requirements for manufacturer submissions for pharmacoeconomic evaluation in Ireland, covering clinical effectiveness, safety, economic modelling, budget impact analysis, and patient-reported outcomes. They define a standardized reporting format and methodological expectations for evidence synthesis, cost-effectiveness analysis, and uncertainty assessment.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Patient and Social Aspects
- Categories
- AppraisalCost-effectiveness ModellingEvidence SynthesisReporting Standards & Best Practice
- Assumptions
- Submitted evidence is relevant to the Irish healthcare context; comparators are appropriate; long-term outcomes can be modelled using available data
- Strengths
- Provides clear, consistent standards for submissions; promotes transparency and comparability across assessments; aligned with Irish health system priorities
- Limitations
- May not accommodate innovative trial designs or real-world evidence easily; focused on pharmaceuticals, limiting broader HTA applicability
- Also known as
- NCPE submission guidelines, National Centre for Pharmacoeconomics Guidelines, Irish HTA submission requirements
Questions this answers
- › What clinical and economic evidence is required for a pharmaceutical HTA submission in Ireland?
- › How should cost-effectiveness analyses be structured for NCPE review?
- › What format should budget impact models follow?
- › Which patient-reported outcomes or quality-of-life data are needed?
- › How should uncertainty and sensitivity analyses be reported?
- › What are the methodological standards for evidence synthesis in Irish HTA submissions?
References & sources
- websitencpe.ie ↗
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.