413. Deputy Pádraig Mac Lochlainn asked the Minister for Health the plans to make mounjaro more financially accessible to patients who cannot afford to access it privately; whether consideration has been given to including mounjaro under the drugs payment scheme; and if she will make a statement on the matter. [52345/26]

The Government is committed to investing in new medicines. Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 270 new medicines, to date. 74 of these new medicines were for rare diseases. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.

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.

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.

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.