Obesity medications should only be promoted and provided to those who would receive health benefits from using them as identified by a healthcare professional. They should not be used by anybody for cosmetic purposes, particularly under 18’s and should only ever be sourced from licensed medical professionals. The HSE has responsibility for the distribution and reimbursement of a number of obesity medicines, such as GLP-1’s and has guidance for the process in applying to avail of these resources.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has sole statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes. HSE decisions on which medicines, including GLP-1 medicines, are reimbursed by the taxpayer are made on objective, scientific and economic grounds, outlined in the Health (Pricing and Supply of Medical Goods) Act 2013.
Reimbursement is for licenced indications which have been granted market authorisation either by the European Medicines Agency (EMA) or by the Health Products Regulatory Authority (HPRA).
Controls are in place within the HSE on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place for the Glucagon-like peptide-1 (GLP-1) receptor agonists to restrict reimbursement support to the HSE approved indication of Diabetes. This includes Ozempic® (semaglutide) and Trulicity® (Dulaglutide). Therefore, these products are not reimbursed under the Drugs Payment Scheme (DPS) and are confined to those persons with full General Medical Services (GMS/Medical Card) and Long-Term Illness (Diabetes Mellitus) eligibility.
Ozempic® does not have a licence in the EU for weight loss.
Mounjaro:
The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
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 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. Pharmacoeconomic reports are reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. 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.
In terms of the specific details of the applications for pricing and reimbursement of tirzepatide (Mounjaro®):
Type 2 diabetes mellitus
The HSE received an application for pricing and reimbursement of tirzepatide (Mounjaro®) on the 24th January 2024 from Eli Lilly (the applicant) for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes.
• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 24th January 2024.
• The NCPE Rapid Review assessment report was received by the HSE on the 6th February 2024. A full health technology assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of tirzepatide (Mounjaro®) compared with the current standard of care.
• The HSE commissioned a full HTA on the 1st March 2024 as per agreed processes.
• The HTA was completed by the NCPE on the 9th February 2026. The NCPE recommends that tirzepatide for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise (i) as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; (ii) in addition to other medicinal products for the treatment of diabetes; be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments: []www.ncpe.ie/tirzepatide-mounjaro-hta-id-24003/.
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. A meeting invitation has been issued by the CPU to the applicant to discuss this application.
• Weight management
• The HSE received an application for pricing and reimbursement of tirzepatide (Mounjaro®) on the 24th June 2024 from Eli Lilly (the applicant) indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of 30 kg/m2 (obesity) or 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).
• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the NCPE for assessment. The HSE commissioned the Rapid Review process on the 24th June 2024.
• The NCPE Rapid Review assessment report was received by the HSE on the 30th July 2024. A full HTA was recommended to assess the clinical effectiveness and cost effectiveness of tirzepatide (Mounjaro®) compared with the current standard of care.
• The HSE commissioned a full HTA on the 27th August 2024 as per agreed processes.
• The HTA was completed by the NCPE on the 3rd December 2025. The NCPE recommends that tirzepatide, as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial BMI of: 30kg/m2, or 27kg/m2 to < 30kg/m2 in the presence of at least one WRC be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments: []
www.ncpe.ie/tirzepatide-mounjaro-hta-id-24024/.
• The HSE CPU is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. The HSE CPU has met with the applicant to discuss this application.
Both applications remain under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
Saxenda:
The HSE follows statutory processes around the addition of medicines to the reimbursement list/schemes. Under those statutory processes, the HSE is legally required to consider a range of criteria which include unmet need, clinical evidence, economic evidence, budget impact and the resources available when making reimbursement decisions (i.e. add a medicine to the reimbursement list). The reimbursement decisions have to be in line with the relevant legislation, namely the Health (Pricing and Supply of Medical Goods) Act 2013 (the legislation the HSE operates under for pricing and reimbursement of medicines).
In accordance with the legislation, a medicine must have a marketing authorisation (licence) to be included in the formal list of reimbursable items. A pharmaceutical company can apply to the HSE for reimbursement for a specific indication (use) of a specific licensed medicine. Medicines can have more than one licensed (market authorised) indication and each indication represents a separate application.
Semaglutide (Ozempic®) currently has an EU marketing authorisation for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Following EU marketing authorisation for this indication (use), the HSE approved the addition of Semaglutide (Ozempic®) to the list of reimbursable items in September 2018.
Ozempic® currently does not have an EU marketing authorisation for the treatment of weight loss or any condition other than type 2 diabetes mellitus.
Controls are in place within PCRS on claiming processes to ensure that only HSE approved indications are reimbursed across a range of medicines. Controls are currently in place for the Glucagon-like peptide-1 (GLP-1) receptor agonists to restrict reimbursement support to the HSE approved indication of Diabetes. This includes Victoza® (liraglutide), Ozempic® (semaglutide) and Trulicity® (Dulaglutide).
Diabetes is one of the Long Term Illness (LTI) conditions for which eligible LTI persons can access their medicines to treat their Diabetes free of charge. Patients diagnosed with Diabetes Mellitus are entitled to be registered under the LTI Scheme.
Liraglutide (Saxenda®) 6 mg/ml solution for injection in pre-filled pen is the only product currently approved under Community Drug Schemes (GMS/DPS) for weight management with a managed access system in place as outlined in Circular 002/23 (attached).