Rapid review or full HTA? How new medicines reach reimbursement in Ireland
Every new medicine seeking public reimbursement in Ireland passes through the National Centre for Pharmacoeconomics. Whether it stops at a four-week rapid review or proceeds to a full health technology assessment shapes the evidence, the timeline and the commercial discussions that follow.
The decision architecture
Irish reimbursement is a statutory decision of the Health Service Executive (HSE). Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE must decide on an application to add a medicine to the Reimbursement List within 180 days of receiving it. Where the HSE needs more information, it must say what it requires, and the 180-day period is suspended until the applicant provides it.[1]
In reaching a decision, the HSE must have regard to nine criteria in Schedule 3 of the Act. They are the health needs of the public; the cost-effectiveness of meeting those needs with the item rather than other health services; the availability and suitability of items for supply; the costs, benefits and risks relative to therapeutically similar items, and the certainty of that evidence; the potential or actual budget impact; clinical need; the level of clinical supervision required; efficacy, effectiveness and added therapeutic benefit against existing treatment; and the resources available to the HSE.[2]
The National Centre for Pharmacoeconomics (NCPE) addresses three of these nine criteria: efficacy, effectiveness and added therapeutic benefit; cost-effectiveness; and budget impact.[3] That distinction matters. An NCPE recommendation is expert advice into a broader statutory judgement, not the decision itself.
The other actors each have a defined role:
- Corporate Pharmaceutical Unit (CPU): The interface between the HSE and industry on pricing and reimbursement applications. On receipt of an application, the CPU commissions the NCPE assessment.[3]
- HSE Drugs Group: Makes recommendations on reimbursement. Its recommendations go to the next HSE Leadership Team meeting, which takes the decision.[2, 3]
- National Cancer Control Programme (NCCP): For oncology medicines, the NCPE report from a full HTA is also sent to the NCCP.[3] Its Technology Review Committee reviews proposals for funding new cancer medicines, drawing on the NCPE critique, and its recommendations pass via the NCCP Director to the Drugs Group.[4]
Step one: the rapid review
The default first step is the rapid review. NCPE describes it as an assessment of all new medicines to determine whether a more in-depth evaluation is needed, and it aims to complete it in about four weeks.[3, 5] The Framework Agreement on the Supply and Pricing of Medicines (FASPM) 2026 to 2029 between the State and the Irish Pharmaceutical Healthcare Association (IPHA) states that the rapid review report will issue within four weeks of commissioning and validation of the dossier.[2]
The rapid review is not a formality. NCPE can reach one of five outcomes.[6]
| Rapid review outcome | What it means in practice |
|---|---|
| Full HTA recommended to assess clinical and cost-effectiveness compared with current standard of care | Uncertainty about comparative effectiveness or value needs a full model and dossier. |
| Full HTA recommended on the basis of the proposed price relative to currently available therapies | The price, rather than the evidence, triggers the full assessment. |
| Full HTA not recommended; NCPE recommends the medicine be considered for reimbursement | The application proceeds to HSE consideration without a full HTA. |
| Full HTA not recommended; NCPE recommends the medicine not be considered for reimbursement at the submitted price | A price that NCPE does not consider justified, without the need for a full assessment. |
| Full HTA not recommended until additional efficacy and/or safety data are submitted | The evidence base is judged insufficient for any assessment yet. |
What triggers a full HTA
NCPE states that a full HTA is generally needed for medicines that are high cost relative to potential comparators, those with a net impact on the drugs budget, and those where there is a query about comparative clinical efficacy or value for money.[3] Its patient-facing guidance puts it similarly: an HTA is carried out where there is a question about clinical or cost-effectiveness, and for all new medicines with a high cost compared with existing treatments or a high impact on the drugs budget.[5]
NCPE does not publish numerical cut-offs for "high cost" or "budget impact". In our experience, three questions predict the outcome of the rapid review reasonably well:
- Is the price per patient materially above the relevant Irish comparator? If so, the second rapid review outcome above is the likely result, whatever the strength of the clinical data.
- Is the budget impact non-trivial in the context of the indication? A low per-patient cost in a large population can trigger a full HTA as readily as a high cost in a small one.
- Does the comparative case rest on an indirect comparison, single-arm data or a surrogate endpoint? Each raises a "query in relation to comparative clinical efficacy", which is itself a trigger.
Our viewFor most innovative medicines, a full HTA should be the planning assumption rather than a contingency. The rapid review then becomes a test of whether the full HTA can be avoided, not the moment the Irish model is first built.
The full HTA: process and timelines
When a full HTA is required, the CPU commissions it and the company submits its dossier after a pre-submission meeting with NCPE.[3] The FASPM adds several planning requirements. Companies must notify the HSE of products expected to be submitted within the following 12 to 18 months, and confirm their intention to seek pricing and reimbursement no later than three months before submission to NCPE. NCPE will then establish the most appropriate assessment, which may be a rapid review or, in some cases, a full HTA, and may invite applicants to a focused pre-submission meeting to establish the data and approaches required.[2] In other words, a medicine can now be routed directly to a full HTA.
Timelines are in transition. NCPE's website describes a full HTA as taking approximately 18 weeks, excluding a clock-stop of approximately five weeks while the company responds to questions.[3] The FASPM states that NCPE will make every effort to complete its assessment within 90 days of validation, excluding periods awaiting information from the applicant, and that robust, mutually agreed clock-stop procedures apply to new applications from 1 January 2026.[2]
| Stage | Target under the FASPM 2026 to 2029 |
|---|---|
| Rapid review report | Within four weeks of commissioning and dossier validation |
| NCPE assessment of a submitted application | Every effort to complete within 90 days of validation, excluding clock-stops |
| HSE consideration of the assessment report | Within 14 days, against the 2013 Act criteria |
| Drugs Group recommendation to company | Notified in writing within 14 days of the recommendation |
| HSE decision after Drugs Group | Within 45 days of the recommendation, at the next Leadership Team meeting |
| Implementation after approval | Within 45 days |
| Managed Access Protocol, where required | Target of 90 days after the decision to develop and implement |
| End-to-end KPI | 270 days by Q4 2027; 180 days by Q1 2029 |
Source: FASPM 2026 to 2029, Schedules 3 and 4.[2]
The KPI targets are an honest acknowledgement of the gap between the statute and practice. An IPHA position paper, as summarised by one Irish law firm, found that 86% of medicines reimbursed between 2022 and 2024 exceeded the 180-day timeline.[7] The FASPM commits the State to an end-to-end, outcomes-based review in 2026 and to expanding the Drugs Group to 23 to 27 members in the first half of 2026 and 33 to 37 members by the end of 2026, with 31 meetings beginning in 2027.[2] The agreement runs from 1 January 2026 to 31 December 2029 and is expressly not legally binding.[8]
The HIQA reference case: what Irish models must do
NCPE applies the Health Information and Quality Authority (HIQA) national guidelines. Version 2.0 of the economic evaluation guidelines, published in March 2025, made major updates to the costing of pensions, the use of hyperbolic discounting and the depreciation of capital costs.[9] The reference case is summarised below alongside the NICE reference case, because many Irish submissions begin as adaptations of a model built for England.
| Element | HIQA v2.0 (Ireland) | NICE (England) |
|---|---|---|
| Evaluation type | Cost-utility analysis; CEA or CMA only in exceptional, justified cases | Cost-utility analysis |
| Cost perspective | Publicly funded health and social care system (the HSE) | NHS and personal social services |
| Comparator | Routine care in Ireland: the technologies most widely used in Irish practice | Defined in the NICE scope |
| Discount rate | 4.0% a year on costs and outcomes after the first year | 3.5% a year; 1.5% in specific circumstances |
| Equity | Equal weighting of QALYs; no quantitative modifiers currently accepted | Equal weighting except in specific circumstances, including a severity modifier |
| Drug price in base case | Public list price; HSE-wide reductions only where consistently available and guaranteed | Prices paid in the NHS; list or generally available price where no NHS-wide reduction exists |
Sources: HIQA economic evaluation guidelines v2.0;[9] NICE health technology evaluations manual.[10]
Two points deserve emphasis. First, HIQA states that no quantitative modifiers are currently accepted in Irish economic evaluations, although severity and rarity can be addressed narratively.[9] A model adapted from England must therefore remove any QALY weighting from the base case. Second, the comparator is routine care in Ireland, which may differ from established NHS practice in treatment sequences, reimbursed options and dosing.
Worked example: the effect of a 4% discount rate
HIQA computes the discount factor as 1 / (1 + r)^t, with t = 0 for the first year.[9] Consider a medicine with an incremental cost of 50,000 incurred in the first year and an incremental benefit of 0.10 QALYs a year for 20 years.
- At 4%, the sum of discount factors over years 0 to 19 is 14.134, giving 1.413 discounted QALYs and an ICER of about 35,400 per QALY.
- At 3.5%, the same sum is 14.710, giving 1.471 discounted QALYs and an ICER of about 34,000 per QALY.
The higher Irish rate reduces discounted QALYs by about 4% in this example, and by more where benefits accrue later. A single QALY gained in year 10 is worth 0.676 at 4% and 0.709 at 3.5%. For one-off or front-loaded therapies with long-term benefit, such as gene and cell therapies, the difference is material and should be shown transparently rather than discovered by the assessor.
Drug costs and budget impact: where Irish models often diverge
NCPE's Guidelines for Inclusion of Drug Costs (version 3.4, April 2026) define the total drug cost to the HSE as the sum of five components: price to wholesaler, wholesale mark-up, pharmacy fees, the rebate on sales, and VAT. VAT is excluded from cost-effectiveness analysis but included in budget impact analysis.[11] The guidelines state that, under the FASPM, the rebate applicable in 2026, 2027, 2028 and 2029 will be 9%, 7%, 6% and 5% respectively, and that confidential patient access schemes may be considered in scenario analysis but not in the base case.[11]
NCPE's own worked example for a patented hospital medicine with a price to wholesaler of 1,000 euro illustrates the difference between the two analyses:[11]
| Component | Cost-effectiveness model | Budget impact model (non-oral) |
|---|---|---|
| Price to wholesaler | €1,000.00 | €1,000.00 |
| Wholesale mark-up (0% where hospital order conditions met) | €0.00 | €0.00 |
| Framework Agreement rebate (9% of price to wholesaler) | −€90.00 | −€90.00 |
| VAT (23% of hospital price) | Excluded | €230.00 |
| Total cost to the HSE | €910.00 | €1,140.00 |
Oral medicines attract a zero VAT rate, whereas non-oral medicines are charged at the standard 23% rate.[11] The route of administration therefore changes the budget impact even when the ICER is unaffected.
HIQA's budget impact guidelines, also updated in March 2025, require the core analysis to estimate the annual financial impact over a minimum of five years, with costs presented in the year incurred and no discounting.[12] They distinguish incremental (net) cost, which is most relevant to funding decisions, from total (gross) cost, which matters for budget and resource planning, and they ask that the realisability of cost offsets be explored through scenario analysis.[12] The cost-effectiveness model and budget impact analysis are expected to rest on the same core assumptions.[12]
The €20,000 and €45,000 per QALY figures: what they are, and what they are not
Few numbers in Irish HTA are quoted as often, or as loosely, as €20,000 and €45,000 per QALY. Their status needs care.
- Origin: Ireland's drug threshold has been defined through pricing and supply agreements between the State and the industry body rather than by statute or empirical estimation. The 2012 and 2016 agreements both stated a threshold; the 2016 agreement introduced a decision authority level table with two thresholds of €20,000 and €45,000 per QALY and three net budget impact categories, which determined the level of HSE authority required for a decision.[13]
- Current agreements: The 2021 agreement did not mention thresholds.[14] The published IPHA text of the FASPM 2026 to 2029 refers to the cost-effectiveness criterion of the 2013 Act but, on our reading, contains no numerical threshold or decision authority table.[2]
- HIQA's position: HIQA states that there has historically been no stated willingness-to-pay threshold in Ireland below which funding is guaranteed; that €20,000 and €45,000 per QALY were used previously alongside budget impact thresholds to set decision authority levels; that it is pragmatic to report the probability of cost-effectiveness at both values; and that these thresholds have not been derived empirically.[9]
The practical reading is that submissions should report results against both values, as HIQA advises, while recognising that neither is a formal decision rule. Academic commentators have argued that a threshold set within a pricing agreement may not reflect the opportunity cost of HSE spending.[13] Others note that reimbursement within these levels has not been guaranteed and that technologies above them have been adopted.[14]
Precision mattersWe would avoid describing €45,000 per QALY as "the Irish threshold" in a submission. It is more accurate to present the ICER, the probability of cost-effectiveness at €20,000 and €45,000, and the price at which those probabilities change.
After the assessment: from recommendation to reimbursement
A full HTA ends in one of four recommendations: that the medicine be considered for reimbursement; considered if cost-effectiveness can be improved; not considered unless cost-effectiveness can be improved; or not considered.[6] Two of the four point explicitly to price.
The FASPM describes what follows. The HSE considers the report within 14 days. Where a final decision cannot yet be reached, commercial engagement between the HSE and the company may be required, which the agreement expects to be brief, with final offers submitted promptly. A medicine may then be submitted to the Drugs Group, and its recommendation, which is commercially confidential between the HSE and the company, goes to the Leadership Team. The outcome may be a decision to reimburse at the applied terms, a decision not to reimburse at those terms, or a requirement to meet the company to resolve issues.[2] The Act requires the HSE to give written notice of a decision, with reasons, within 14 days of making it.[15]
For oncology, the NCCP Technology Review Committee adds a clinical perspective on unmet need, effectiveness, alternatives, toxicity and cost-effectiveness before recommendations reach the Drugs Group.[4] Ireland has no distinct approval procedure for rare disease medicines.[16]
New medicines are priced with regard to the average currency-adjusted prices in 13 nominated EU member states, and the FASPM includes a declining rebate on newly listed medicines.[8] These are fixed parameters of any pricing agreement, so the commercial discussion in practice centres on the confidential terms that bring the HSE's effective cost into line with the value demonstrated.
What this means for evidence planning
Where the EU joint clinical assessment fits
The FASPM acknowledges that the Irish process will evolve to accommodate Regulation (EU) 2021/2282 on health technology assessment, and that rapid review and HTA dossiers can be submitted once marketing authorisation is granted, pursuant to that Regulation.[2] In our view, a joint clinical assessment report will increasingly anchor the clinical effectiveness section of NCPE assessments, but it will not answer the Irish questions: routine care in Ireland, Irish costs, a 4% discount rate, and the HSE budget. Companies should plan the national model in parallel with the JCA dossier rather than sequentially.
Practical priorities
- Assume a full HTA for any high-cost or uncertain medicine: Have the Irish cost-effectiveness model and budget impact model substantially complete before the rapid review submission. The four-week rapid review and the three-month notification window leave no time to build them afterwards.
- Use the notification windows deliberately: The 12 to 18 month horizon-scan notification and the three-month confirmation before submission are opportunities to ask NCPE about the likely assessment route and data requirements.
- Define routine care in Ireland with Irish clinicians: Comparator choice is one of the most common sources of disagreement in any HTA, and HIQA's definition is explicitly about Irish practice.
- Re-base the model, not just the inputs: Apply 4% discounting from year two, the HSE perspective, NCPE drug-cost components and no QALY weighting. Re-run validation after adaptation.
- Build the budget impact model to HIQA and NCPE specification: Five annual years, undiscounted, with VAT where applicable, net and gross costs reported, and cost offsets tested in scenarios.
- Report against €20,000 and €45,000 without over-claiming: Provide probabilities of cost-effectiveness at both values and threshold price analyses, so that the commercial discussion can begin from a shared understanding of value.
- Keep the team available for clock-stops: Under the FASPM, the HSE online application tracker is being updated to capture clock-stops. Fast, complete responses shorten the overall timeline.
- Plan for managed access where evidence is immature: Where a Managed Access Protocol is likely, design data collection so that it can resolve the uncertainties NCPE identifies.
How Evidaxia can help
Evidaxia prepares NCPE rapid review and full HTA submissions, responds to clarification questions, and builds the analyses that support pricing agreements, including threshold price and budget impact scenarios. We also adapt global and NICE models to the HIQA reference case and NCPE costing rules. See NCPE submissions in Ireland and model adaptation.
References
- Health (Pricing and Supply of Medical Goods) Act 2013, s. 18 (revised) [Internet]. Dublin: Law Reform Commission, Revised Acts; [cited 2026 Oct 30]. Available from: https://revisedacts.lawreform.ie/eli/2013/act/14/section/18/revised/en/html
- Department of Health, Health Service Executive and Irish Pharmaceutical Healthcare Association. The Framework Agreement on the Supply and Pricing of Medicines (FASPM) 2026-2029 [Internet]. Dublin: Government of Ireland; 2026 [cited 2026 Oct 30]. Available from: https://assets.gov.ie/static/documents/84296242/IPHA_FASPM_Agreement.pdf
- National Centre for Pharmacoeconomics. Overview of the drug reimbursement process [Internet]. Dublin: National Centre for Pharmacoeconomics; [date unknown] [cited 2026 Oct]. Available from: https://www.ncpe.ie/submission-process/overview-of-the-drug-reimbursement-process/
- National Cancer Control Programme. Technology Review Committee: terms of reference, version 6 [Internet]. Dublin: Health Service Executive; 2022 [cited 2026 Oct 30]. Available from: https://www.hse.ie/eng/services/list/5/cancer/profinfo/medonc/trc/trc-tor.pdf
- National Centre for Pharmacoeconomics. Interpreting NCPE recommendations [Internet]. Dublin: National Centre for Pharmacoeconomics; [date unknown] [cited 2026 Oct]. Available from: https://www.ncpe.ie/interpreting-ncpe-recommendations/
- National Centre for Pharmacoeconomics. NCPE recommendations [Internet]. Dublin: National Centre for Pharmacoeconomics; [date unknown] [cited 2026 Oct]. Available from: https://www.ncpe.ie/ncpe-recommendations/
- Mason Hayes and Curran. New Framework Agreement on the Supply and Pricing of Medicines announced [Internet]. Dublin: Mason Hayes and Curran; 2026 Feb 5 [cited 2026 Oct 30]. Available from: https://www.mhc.ie/latest/insights/new-framework-agreement-on-the-supply-and-pricing-of-medicines-announced
- Arthur Cox. Pricing and reimbursement of medicines in Ireland: new Framework Agreement 2026-2029 published [Internet]. London: Mondaq; 2026 Mar 26 [cited 2026 Oct 30]. Available from: https://www.mondaq.com/ireland/healthcare/1764044/pricing-and-reimbursement-of-medicines-in-ireland-new-framework-agreement-2026-2029-published
- Health Information and Quality Authority. National Guidelines for the Economic Evaluation of Health Technologies in Ireland, version 2.0 [Internet]. Dublin: Health Information and Quality Authority; 2025 Mar [cited 2026 Oct 30]. Available from: https://www.hiqa.ie/sites/default/files/2025-03/Economic-Evaluation-Guidelines.pdf
- National Institute for Health and Care Excellence. NICE health technology evaluations: the manual (PMG36), section 4: economic evaluation [Internet]. London: National Institute for Health and Care Excellence; [date unknown] [cited 2026 Oct]. Available from: https://www.nice.org.uk/process/pmg36/chapter/economic-evaluation
- National Centre for Pharmacoeconomics. Guidelines for Inclusion of Drug Costs in Pharmacoeconomic Evaluations, version 3.4 [Internet]. Dublin: National Centre for Pharmacoeconomics; 2026 Apr [cited 2026 Oct 30]. Available from: https://www.ncpe.ie/wp-content/uploads/2026/04/Guidelines-for-Inclusion-of-Drug-Costs-in-Pharmacoeconomic-Evaluations-v3.4.pdf
- Health Information and Quality Authority. National Guidelines for the Budget Impact Analysis of Health Technologies in Ireland [Internet]. Dublin: Health Information and Quality Authority; 2025 Mar 26 [cited 2026 Oct 30]. Available from: https://hiqa.ie/sites/default/files/2025-03/BIA-Guidelines.pdf
- O'Mahony JF. Revision of Ireland's cost-effectiveness threshold: new State-industry drug pricing deal should adequately reflect opportunity costs. PharmacoEconomics Open. 2021;5(3):339-48. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC8315504
- Kinchin I, Walshe V, Normand C, Coast J, Elliott R, Kroll T, et al. Expanding health technology assessment towards broader value: Ireland as a case study. Int J Technol Assess Health Care. 2023;39(1):e26. Available from: https://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/expanding-health-technology-assessment-towards-broader-value-ireland-as-a-case-study/67E5BFC09262C72091AE11BED3BB02FB
- Health (Pricing and Supply of Medical Goods) Act 2013, s. 19 [Internet]. Dublin: Irish Statute Book; 2013 [cited 2026 Oct 30]. Available from: https://www.irishstatutebook.ie/2013/en/act/pub/0014/sec0019.html
- Mason Hayes and Curran. Pricing and reimbursement in Ireland [Internet]. Dublin: Mason Hayes and Curran; 2025 Sep 23 [cited 2026 Oct 30]. Available from: https://www.mhc.ie/latest/insights/pricing-reimbursement-in-ireland
Sources accessed October 2026. This article is analysis for information and is not legal, regulatory or tax advice.
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What is the difference between an NCPE rapid review and a full HTA?
Every new medicine has a rapid review, which NCPE aims to complete in about four weeks and which decides whether a full health technology assessment is needed. A full HTA is a detailed review of the company dossier and economic model, with a clock-stop for clarification questions.
What triggers a full HTA in Ireland?
NCPE generally requires a full HTA for medicines that are high cost relative to comparators, have a net impact on the drugs budget, or raise questions about comparative clinical efficacy or value for money. NCPE does not publish numerical cut-offs.
Does Ireland have a cost-effectiveness threshold of €45,000 per QALY?
Not as a formal rule. The €20,000 and €45,000 figures came from earlier State and industry pricing agreements, where they set HSE decision authority levels. HIQA advises reporting the probability of cost-effectiveness at both values and notes they were not derived empirically.
What discount rate does the HIQA reference case use?
HIQA guidelines version 2.0 specify 4.0% a year on costs and outcomes occurring after the first year, with sensitivity analyses at 0% and 10%. Hyperbolic discounting may be used as a secondary analysis for time horizons over 30 years.
How long does Irish reimbursement take?
The 2013 Act requires a decision within 180 days, with the clock suspended while information is awaited. The FASPM 2026 to 2029 sets targets of 270 days by Q4 2027 and 180 days by Q1 2029.
Who makes the final reimbursement decision in Ireland?
The HSE makes the statutory decision. NCPE advises on clinical and cost-effectiveness and budget impact, the Drugs Group makes recommendations, and the HSE Leadership Team decides.
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