Dáil Éireann Debate, Thursday - 19 February 2026
642. Deputy Ken O'Flynn asked the Minister for Health whether her Department requires that lifetime modelling of avoided downstream healthcare costs, including reduced hospital admissions, surgical interventions, dialysis, and long-term disability supports, be incorporated as standard practice in value-for-money assessments conducted under the Health (Pricing and Supply of Medical Goods) Act 2013; and if she will make a statement on the matter. [13786/26]
Amharc ar fhreagra643. Deputy Ken O'Flynn asked the Minister for Health whether her Department has undertaken any review of the balance between short-term budget impact considerations and long-term prevention-based savings in medicines reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013; and whether any policy changes are under consideration in this regard. [13787/26]
Amharc ar fhreagra645. Deputy Ken O'Flynn asked the Minister for Health whether any internal Departmental policy documents, circulars, or guidance notes exist concerning the incorporation of long-term prevention outcomes in medicines reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013; and whether she will arrange for any such documents to be published. [13789/26]
Amharc ar fhreagraI propose to take Questions Nos. 642, 643 and 645 together.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices, therefore, I have asked the HSE for an update in this matter.
The HSE has advised that it is committed to providing timely access to as many medicines as possible within the resources available to it. To ensure public funds deliver maximum value, all applications for pricing and reimbursement are assessed through a robust, evidence-based process grounded in objective scientific and economic principles.
The HSE considers the following criteria prior to making any decision on pricing / reimbursement in line with the Health (Pricing and Supply of Medical Goods) Act 2013:
(1) The health needs of the public,
(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,
(3) The availability and suitability of items for supply or reimbursement,
(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,
(5) The potential or actual budget impact of the item or listed item,
(6) The clinical need for the item or listed item,
(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,
(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and
(9) The resources available to the HSE
The National Centre for Pharmacoeconomics (NCPE), an independent HTA agency, supports the HSE in this process by evaluating the clinical and cost-effectiveness of new medicines, new indications, and high-cost or uncertain treatments. All medicines undergo a Rapid Review with those requiring further assessment progressing to a full Health Technology Assessment (HTA). Full HTAs provide detailed analyses of clinical evidence, safety, cost-effectiveness, and budget impact. These evaluations inform the HSE as it assesses reimbursement applications using the statutory criteria above.
Once the assessment is complete the NCPE then provide a recommendation to the Corporate Pharmaceutical Unit in the HSE.
The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team.
The decision making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
