Dáil Éireann Debate, Tuesday - 16 June 2026
978. Deputy Thomas Gould asked the Minister for Health the plans to approve the weight loss medications ozempic and mounjaro for inclusion in the drugs payment scheme; and if she will make a statement on the matter. [45657/26]
View answerUnder 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, the HSE have been asked to provide an update.
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 criteria set out in the Health (Pricing and Supply of Medical Goods) Act 2013 prior to making any decision on pricing / reimbursement.
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 Management Team.
The decision making authority in the HSE is the HSE Senior Management Team. The HSE Senior Management 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 application for pricing and reimbursement of tirzepatide (Mounjaro®):
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 and commercial negotiations are ongoing.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
In terms of the specific details of the reimbursement of semaglutide (Ozempic®):
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 GLP-1 agonists to restrict reimbursement support to the HSE approved indications.
Reimbursement approval is in place for semaglutide (Ozempic®) 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 and in addition to other medicinal products for the treatment of diabetes under the General Medical Services and Long Term Illness Scheme from the 1st September 2018.
Ozempic® does not currently have an EU marketing authorisation for the treatment of weight loss alone. Off-label prescribing of GLP-1 agonists are not supported for reimbursement under Community Drug Schemes.
It is incumbent on the company to apply to the appropriate regulatory body for a marketing authorisation to extend the licence for Ozempic® for the treatment of weight loss.
Once this is granted the HSE will process and assess any pricing and reimbursement application ,if received from the company, as efficiently as possible.
