588. Deputy David Maxwell asked the Minister for Health the reason tirzepatide (Mounjaro), despite being authorised for the treatment of type 2 diabetes, is not currently covered under the medical card, long-term illness scheme or drugs payment scheme; and if she will outline the current position regarding access to this medication through the State schemes. [66674/26]

The Government is committed to investing in new medicines. Budgets 2021-2025 allocated €158 million for new drugs. This has facilitated the introduction of 250 new medicines/ new uses for existing medicines, including 101 for oncology and 70 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 provided this for the medicines budget. This has enabled the funding of 40 new medicines/ new uses for existing medicines, including 17 for oncology and 9 for rare diseases, for the period from January 2026-3rd September 2026.

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.

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 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 Eli Lilly (the applicant) to discuss the applications for tirzepatide (Mounjaro®) for the following indications:

- 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.

- 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).

A proposal has been received from the applicant and is under review. The HSE cannot make any comment on possible outcomes from the ongoing process.