The Irish reimbursement journey in 2026: from HSE application to listing

One statutory decision, many contributors

Most discussion of Irish market access starts with the National Centre for Pharmacoeconomics (NCPE). That is understandable, because the NCPE assessment is where the evidence is examined in most detail. But the NCPE does not make the reimbursement decision. The Health Service Executive (HSE) does, under the Health (Pricing and Supply of Medical Goods) Act 2013, and the NCPE assessment is one of several inputs into that decision.

The Act creates the Reimbursement List: a list of drugs, medicines and medical and surgical appliances that the HSE must establish, publish on its website and maintain.^[1] Items on the list are supplied under the "relevant schemes", which the Act defines as the General Medical Services Scheme, the Drug Payment Scheme, the Long Term Illness Scheme and any other scheme administered by the HSE for the same purpose.^[2] The HSE has noted that medicines are funded across several systems, including hospitals, community services, the national community drug schemes and centrally funded arrangements.^[3] The scheme a medicine will sit in is therefore a planning variable from the start, not an administrative detail at the end.

Three features of the statute shape everything that follows:

• A 180-day decision period: The HSE must decide on an application within 180 days of receiving it. Where it needs further information, it must say in writing what it requires, and the 180-day period is suspended until the applicant provides it.^[4]
• Listing at an agreed price: An item is added to the list at a price agreed with the applicant, and subject to any conditions attached to the listing.^[4] A pricing agreement is built into the statutory route.
• Nine criteria: Before deciding, the HSE considers nine criteria, from the health needs of the public and clinical need to cost-effectiveness, budget impact and the resources available to the HSE.^[3]

The NCPE advises on three of those nine criteria: efficacy, effectiveness and added therapeutic benefit; cost-effectiveness; and budget impact.^[5] The other six are weighed elsewhere in the process. In our experience, the companies that move most smoothly through the Irish system are those that prepare for all nine from the outset, rather than treating the NCPE report as the finish line.

The journey, stage by stage

The Framework Agreement on the Supply and Pricing of Medicines (FASPM) between the State, the HSE and the Irish Pharmaceutical Healthcare Association (IPHA) runs from 1 January 2026 to 31 December 2029.^[6] Its Schedule 3 sets a target time for each step of the journey.

1. 12 to 18 months aheadPipeline notificationProducts expected to be submitted, where practicable
2. At least 3 months aheadConfirm intentNotice of the pricing and reimbursement application before NCPE submission
3. 4 weeksRapid reviewReport issued after commissioning and validation
4. 90 daysNCPE assessmentTarget from validation, excluding clock-stops
5. 14 daysHSE considerationAssessment report reviewed against the 2013 Act criteria
6. 45 daysDecisionLeadership Team decision after the Drugs Group recommendation
7. 45 daysImplementationReimbursement in place after approval

Source: FASPM 2026 to 2029, Schedule 3.^[6] Target times; clock-stops apply while information is awaited.

Before the application

The journey now starts well before the dossier. Under the FASPM, companies notify the HSE of products expected to be submitted in the following 12 to 18 months, where practicable, and confirm their intention to seek pricing and reimbursement no later than three months before submission to the NCPE.^[6] In our experience, these windows are among the most valuable early opportunities in Irish access planning. They are the natural point to align on the likely assessment route, the comparator in Irish practice and the scheme the medicine will sit in.

Application and the NCPE

The HSE's Corporate Pharmaceutical Unit (CPU) is the interface with industry on pricing and reimbursement applications. On receipt of an application it commissions the NCPE.^[5] Applicants can submit a rapid review once the EMA's Committee for Medicinal Products for Human Use has given a positive opinion.^[5] The FASPM also anticipates submission of rapid review and HTA dossiers once marketing authorisation is granted, under Regulation (EU) 2021/2282 on health technology assessment.^[6]

The rapid review report is due within four weeks of commissioning and validation, and the NCPE aims to complete a full assessment within 90 days of validation, excluding clock-stops.^[6] The NCPE website describes a full HTA as taking about 18 weeks, plus a clock-stop of about five weeks.^[5] For the detail of what triggers a full HTA and how each route works, see our companion piece on NCPE rapid review versus full HTA.

From assessment to decision

The HSE considers the assessment report within 14 days. The Drugs Group's recommendation is communicated to the company within 14 days, the Leadership Team decides within 45 days of the recommendation, and reimbursement is implemented within 45 days of approval. Where a Managed Access Protocol is needed, the target is to complete it within 90 days of the decision.^[6]

The NCPE stage in context

The rapid review is the default first step, and its effect on workload is well documented. In a peer-reviewed analysis, Varley and colleagues reported that annual submissions rose from 19 in 2010 to 57 in 2019, with a peak of 63 in 2017. Of 446 rapid reviews over that decade, 49.6% concluded that a full HTA was required.^[7] The authors estimated that the rapid review process saved about 15,631 appraisal days, a 26.3% reduction in NCPE appraisal time compared with a system without it.^[7]

That roughly even split is a useful planning prior. For a high-cost medicine, or one whose comparative case rests on indirect evidence, the full HTA is the more likely route, and the Irish model is best built before the rapid review rather than after it.

1. Application to CPUCPU commissions the NCPE
2. Rapid reviewCost, budget impact, comparative efficacy and international HTA findings
3. Full HTA, where neededCompany dossier, cost-effectiveness model and budget impact analysis
4. Report to CPUAlso to the NCCP for oncology medicines

• Considered for reimbursementProceeds to HSE consideration
• Considered if cost-effectiveness can be improvedValue and price aligned through commercial discussions
• Further data or price reviewAdditional evidence, or a revised price, before reconsideration

Sources: NCPE process overview and recommendation categories.^{[5, 8]} Outcomes grouped for clarity.

The NCPE publishes four categories of full HTA recommendation: considered for reimbursement; considered if cost-effectiveness can be improved; not considered unless cost-effectiveness can be improved; and not considered.^[8] Two of the four point directly to price. In our experience, those two outcomes are best read as the opening of the commercial phase, with the NCPE analysis providing a shared reference for what an aligned price looks like.

Value: the HIQA reference case and the €20,000 and €45,000 reference points

The NCPE applies the national guidelines of the Health Information and Quality Authority (HIQA). Version 2.0 of the economic evaluation guidelines, published on 26 March 2025, specifies the perspective of the publicly funded health and social care system in Ireland for costs, all health benefits accruing to individuals for outcomes, and an annual discount rate of 4.0% on costs and outcomes occurring after the first year.^[9] For the reference case, additional QALYs gained are assumed to be of equal value.^[9] The practical consequences of these choices for an adapted model are covered in our article on adapting global models for NICE and NCPE.

The two numbers most often quoted in Irish HTA need careful handling. HIQA states that, historically, there has been no stated willingness-to-pay threshold in Ireland below which funding was guaranteed. For drugs, thresholds of €20,000 and €45,000 per QALY have been used previously, in conjunction with budget impact thresholds, to determine the level of authority required within the HSE to make funding decisions.^[9]

"For reporting purposes, it is pragmatic to report the probability of cost effectiveness at thresholds of €20,000 and €45,000 per QALY."

The history explains the structure. The 2016 Framework Agreement introduced a decision authority table with two thresholds, €20,000 and €45,000 per QALY, and three net budget impact categories; approvals with a higher cost per QALY or a larger budget impact required a higher level of HSE authority.^[10] HIQA notes that these thresholds have not been derived empirically, and that cost-effectiveness is necessary but not the sole basis for decision-making.^[9] The FASPM 2026 to 2029 names cost-effectiveness, affordability and budget impact among its criteria but sets no numerical threshold.^[6]

Up to €20,000 per QALY€20,000 to €45,000 per QALY

€0€20k€45k€60k

Reporting reference points, not decision rules. Source: HIQA 2025;^[9] origin in the 2016 Framework Agreement decision authority table.^[10]

Worked example: threshold prices at both reference points

Because neither figure is a formal rule, the most useful output for the commercial phase is a pair of threshold prices. For a simple model in which drug cost scales linearly with price, the price at which the ICER equals a reference value λ is:

Threshold price = (λ × ΔQALY − Δnon-drug costs) / drug units per patient

Illustrative: a medicine yields 1.2 incremental discounted QALYs and €10,000 in incremental non-drug costs over the time horizon, and a patient uses 10 packs.

• At €45,000 per QALY: (45,000 × 1.2 − 10,000) / 10 = €4,400 per pack.
• At €20,000 per QALY: (20,000 × 1.2 − 10,000) / 10 = €1,400 per pack.

Presenting both prices, together with the probability of cost-effectiveness at each value as HIQA advises, gives the HSE and the company a transparent, shared map of value. In practice, models are rarely this linear: treatment duration, wastage and stopping rules all interact with price, so the calculation should be run in the model itself.

Budget impact: the second axis of value

Budget impact appears twice among the nine statutory criteria, once directly and once through the resources available to the HSE.^[3] HIQA's budget impact guidelines, version 2.0, issued on 26 March 2025, take the perspective of the publicly funded health and social care system and require the core analysis to estimate annual financial impact over a minimum of five years. Because costs are presented in the year incurred, no discounting is applied.^[11] The guidelines distinguish the gross cost of a technology from the net (incremental) cost after displaced costs, ask that uptake and market growth be evidence-based, and expect inputs to be consistent with the economic evaluation.^[11]

Irish price mechanics add detail that a global budget impact model will not contain. The NCPE's drug cost guidelines (version 3.4, April 2026) build the total cost to the HSE from five components: price to wholesaler, wholesale mark-up, pharmacy fees, the rebate on sales, and VAT. VAT is excluded from cost-effectiveness analysis and included in budget impact analysis; oral medicines carry a 0% rate and non-oral medicines, including injections, the standard 23% rate.^[12]

• 20269%
• 20277%
• 20286%
• 20295%

Bar length relative to a 10% scale. Source: FASPM 2026 to 2029, clause 10;^[6] NCPE drug cost guidelines v3.4.^[12]

The rebate steps down each year, which means that the effective cost of a newly listed medicine changes over the five-year budget impact horizon, depending on the year of listing.^{[6, 12]} Confidential patient access scheme discounts may be considered in scenario analysis but not in the base case.^[12] For a budget impact model that the HSE can use directly, see our budget impact model service.

Pricing, the Drugs Group and the HSE decision

The pricing reference

Under the FASPM, the HSE considers currency-adjusted prices in 13 Nominated States where the medicine is available at the date of application: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden.^[6] On-patent medicines already reimbursed realign, downwards only, to the average of Nominated State prices on set dates, and medicines added during the term have their first realignment on 1 March 2029, provided they have been listed for at least 36 months.^[6] International reference prices therefore set the frame for the list price, while the value case informs the confidential terms. Our international reference pricing work covers launch sequencing across the basket.

The Drugs Group

The HSE Drugs Group is the national committee that makes recommendations on the pricing and reimbursement of medicines. Its membership includes public interest members, and its minutes, including the recommendation for each medicine reviewed, are published.^[3] The FASPM expands its capacity in two phases: 23 to 27 members and 16 to 17 meetings a year in the first half of 2026, then 33 to 37 members by the end of 2026, with 31 meetings a year beginning in 2027.^[6]

The decision

The decision-making authority is the HSE Senior Leadership Team, which decides, in light of all the demands it faces across services, whether it can fund a new medicine or new use from the resources provided to it.^[3] For oncology medicines, the NCPE's full HTA report is also sent to the National Cancer Control Programme (NCCP).^[5]

NCPE assessment (3 criteria)

• Efficacy, effectiveness and added therapeutic benefit
• Cost-effectiveness, using the HIQA reference case
• Budget impact, to HIQA and NCPE specifications

HSE decision (all 9 criteria)

• The three NCPE criteria, informed by the assessment
• Health needs of the public and clinical need
• Availability and suitability of items for supply
• Costs, benefits and risks relative to similar items, and certainty of evidence
• Level of clinical supervision required
• Resources available to the HSE

Sources: NCPE;^[5] HSE, criteria under the 2013 Act.^[3]

In our experience, the six criteria outside the NCPE's remit are where a company can add most at this stage: a clear account of clinical need in Irish practice, a realistic view of the clinical supervision and service set-up a medicine requires, and a budget profile the HSE can plan around.

Listing, schemes and managed access

A positive decision leads to listing at the agreed price, subject to any conditions attached.^[4] For community-dispensed medicines, the relevant schemes determine how patients access them.^[2] Hospital-administered medicines follow hospital and centrally funded arrangements.^[3] Under the FASPM, implementation is targeted within 45 days of approval.^[6]

Where reimbursement is best delivered with defined eligibility and conditions, the HSE can reimburse under a Managed Access Protocol, with a FASPM target of 90 days from the decision to complete it.^[6] We would expect protocols of this kind to become a more deliberate part of planning as the FASPM timelines shorten: eligibility criteria, data collection and service requirements can be drafted in parallel with the assessment rather than after the decision. Our managed access work supports that design.

Timelines and funding: what the published data show

The FASPM timelines build on a programme of process improvement. A review of the governance arrangements supporting the HSE drug reimbursement process, published by the Minister for Health in February 2023, led the Minister to ask the HSE to launch a public application tracker and introduce indicative timelines for each stage.^[13] The FASPM takes this further: commentary on the agreement notes that its measures, including expanded Drugs Group capacity, are designed to support the State's objective of reimbursement decisions within 180 days.^[14]

180days: statutory decision period, with clock-stops

270 → 180days: FASPM end-to-end targets for Q4 2027 and Q1 2029

13Nominated States in the Irish pricing reference

€30mfor new medicines in the 2026 health budget

Sources: 2013 Act;^[4] FASPM 2026 to 2029;^[6] Department of Health, Budget 2026.^[15]

The FASPM's key performance indicators target 270 days by Q4 2027 and 180 days by Q1 2029, with monitoring from 1 May 2026, an end-to-end, outcomes-based review in 2026, and an update to the online tracker to show clock-stops.^[6]

Funding for new medicines is set in each annual budget. The Department of Health reported in 2023 that €100 million across the previous three budgets had enabled more than 130 new medicines to be added to the reimbursement list.^[13] The allocation for new medicines was €20 million in 2024 and €30 million in 2026.^{[16, 15]} When the FASPM was agreed in January 2026, IPHA expected its members to apply for around 32 new medicines that year.^[17]

In our experience, the annual allocation is the context in which the ninth criterion, the resources available to the HSE, is applied. A clear, well-evidenced budget profile is therefore part of the value case, not an appendix to it.

Where the EU joint clinical assessment fits

Since 12 January 2025, joint clinical assessments under Regulation (EU) 2021/2282 have applied to new active substances with a cancer indication and to advanced therapy medicinal products, with orphan medicines added in 2028 and all new medicines in 2030.^[18] The FASPM states that the Irish processes will evolve to accommodate the Regulation.^[6]

We would expect the joint clinical assessment report to anchor the relative effectiveness evidence in Irish assessments for products in scope. The Irish questions remain national: routine care in Ireland, HSE costs and rebates, 4% discounting, scheme placement and five-year budget impact. Planning the Irish model alongside the joint clinical assessment dossier, rather than after it, keeps the two consistent.

What this means for evidence planning

Seen end to end, Irish reimbursement rewards early, joined-up preparation. The checklist below summarises what we see making the most difference.

• Use the 12 to 18 month notificationAlign early on the assessment route, Irish comparator and scheme placement
• Build the Irish model before the rapid reviewAbout half of rapid reviews lead to a full HTA, so readiness shortens the path
• Apply the HIQA reference case in fullPublic health and social care perspective, 4% discounting and equal QALY weighting
• Report at €20,000 and €45,000 per QALYProbabilities and threshold prices give a shared view of value
• Model budget impact to Irish specificationFive years, undiscounted, with VAT, rebates by year, and net and gross costs
• Prepare for all nine criteriaClinical need, supervision and service set-up inform the HSE decision
• Map the Nominated State pricesThe 13-country reference frames the list price
• Keep clock-stop responses fastComplete answers keep the end-to-end timeline on target
• Draft managed access options earlyEligibility and data collection ready for the 90-day target

We would expect the FASPM to make Irish reimbursement more predictable. With target times for every stage and a published route from application to listing, the opportunity is to plan the evidence, the price and the budget case as one programme from the notification window onwards.

How Evidaxia can help

Evidaxia supports companies across the Irish journey, from early planning and NCPE submissions to the economic and budget impact analyses that inform pricing agreements and managed access. See NCPE submissions in Ireland, or contact us to discuss a forthcoming Irish launch. For how the Irish process compares with England, see our overview of NICE technology appraisal in 2026.

References

1. Health (Pricing and Supply of Medical Goods) Act 2013, s. 17 [Internet]. Dublin: Irish Statute Book; 2013 [cited 2026 Nov 1]. Available from: https://www.irishstatutebook.ie/2013/en/act/pub/0014/sec0017.html
2. Health (Pricing and Supply of Medical Goods) Act 2013, s. 2 (interpretation) [Internet]. Dublin: Irish Statute Book; 2013 [cited 2026 Nov 1]. Available from: https://www.irishstatutebook.ie/2013/en/act/pub/0014/sec0002.html
3. Health Service Executive, Primary Care Reimbursement Service. Response to parliamentary question PQ 60301/25 (Deputy Colm Burke) [Internet]. Dublin: Health Service Executive; 2025 Nov 20 [cited 2026 Nov 1]. Available from: https://about.hse.ie/publications/question-from-deputy-colm-burke-pq-60301-25/
4. Health (Pricing and Supply of Medical Goods) Act 2013, s. 18 (revised) [Internet]. Dublin: Law Reform Commission, Revised Acts; [cited 2026 Nov 1]. Available from: https://revisedacts.lawreform.ie/eli/2013/act/14/section/18/revised/en/html
5. National Centre for Pharmacoeconomics. Overview of the drug reimbursement process [Internet]. Dublin: National Centre for Pharmacoeconomics; [date unknown] [cited 2026 Nov]. Available from: https://www.ncpe.ie/submission-process/overview-of-the-drug-reimbursement-process/
6. 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 Nov 1]. Available from: https://assets.gov.ie/static/documents/84296242/IPHA_FASPM_Agreement.pdf
7. Varley A, Tilson L, Fogarty E, McCullagh L, Barry M. The utility of a rapid review evaluation process to a national HTA agency. PharmacoEconomics. 2022;40(2):203-14. Available from: https://link.springer.com/10.1007/s40273-021-01093-8
8. National Centre for Pharmacoeconomics. NCPE recommendations [Internet]. Dublin: National Centre for Pharmacoeconomics; [date unknown] [cited 2026 Nov]. Available from: https://www.ncpe.ie/ncpe-recommendations/
9. Health Information and Quality Authority. National Guidelines for the Economic Evaluation of Health Technologies in Ireland 2.0 [Internet]. Dublin: Health Information and Quality Authority; 2025 Mar 26 [cited 2026 Nov 1]. Available from: https://www.hiqa.ie/sites/default/files/2025-03/Economic-Evaluation-Guidelines.pdf
10. 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
11. Health Information and Quality Authority. National Guidelines for the Budget Impact Analysis of Health Technologies in Ireland 2.0 [Internet]. Dublin: Health Information and Quality Authority; 2025 Mar 26 [cited 2026 Nov 1]. Available from: https://hiqa.ie/sites/default/files/2025-03/BIA-Guidelines.pdf
12. 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 Nov 1]. Available from: https://www.ncpe.ie/wp-content/uploads/2026/04/Guidelines-for-Inclusion-of-Drug-Costs-in-Pharmacoeconomic-Evaluations-v3.4.pdf
13. Department of Health. Minister for Health publishes review of governance arrangements to support HSE drug reimbursement process [Internet]. Dublin: Government of Ireland; 2023 Feb 24 [cited 2026 Nov 1]. Available from: https://www.gov.ie/en/press-release/a6f4c-minister-for-health-publishes-review-of-governance-arrangements-to-support-hse-drug-reimbursement-process
14. 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 Nov 1]. Available from: https://www.mhc.ie/latest/insights/new-framework-agreement-on-the-supply-and-pricing-of-medicines-announced
15. Department of Health. Ministers for Health announce €27.4bn health budget for 2026 [Internet]. Dublin: Government of Ireland; 2025 Oct [cited 2026 Nov 1]. Available from: https://www.gov.ie/en/department-of-health/press-releases/ministers-for-health-announce-274bn-health-budget-for-2026/
16. Department of Health. Minister for Health announces €20 million in funding for new medicines in 2024 [Internet]. Dublin: Government of Ireland; 2023 [cited 2026 Nov 1]. Available from: https://www.gov.ie/en/department-of-health/press-releases/minister-for-health-announces-20-million-in-funding-for-new-medicines-in-2024
17. RTÉ News. Four-year medicines deal approved by Government [Internet]. Dublin: RTÉ News; 2026 Jan 20 [cited 2026 Nov 1]. Available from: https://www.rte.ie/news/2026/0120/1553992-medicines-deal
18. Arthur Cox. Health Technology Assessment Regulation applies as of 12 January 2025 [Internet]. Dublin: Arthur Cox; 2025 Jan 9 [cited 2026 Nov 1]. Available from: https://www.arthurcox.com/insights/health-technology-assessment-regulation-applies-as-of-12-january-2025

Sources accessed October 2026. This article is analysis for information and is not legal, regulatory or tax advice.