3798. Deputy Louise O'Reilly asked the Minister for Health if the HSE is examining the reimbursement of saxenda (liraglutide); if this is being considered for patients who have been prescribed this by their consultant; the timeline for this consideration; and if she will make a statement on the matter. [57779/26]

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines. To commence this process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine, which has been granted European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation, to the HSE’s Corporate Pharmaceutical Unit.

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).

In line with the HSE reimbursement approval above, the HSE Medicines Management Programme (MMP) developed a Managed Access Protocol (MAP for liraglutide (Saxenda®) as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients, with an initial BMI of 35 kg/m2 with prediabetes and high-risk for cardiovascular disease.

This MAP outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of liraglutide (Saxenda®); further information is available on the MMP website www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/liraglutide-saxenda-/liraglutide-saxenda.html

Clinicians are required to submit an application for reimbursement support of liraglutide (Saxenda®) for their patients through an online application system.

Where there is a negative reimbursement decision, the outcome of the application can be appealed by the prescriber. Appeals can be sent directly to the HSE Medicines Management Programme at mmp@hse.ie. Appeals must be made by the patient’s clinician and should include any additional information to support the unmet clinical need for liraglutide (Saxenda®) based on failure of other treatment options.

Appeals are reviewed on a case-by-case basis reviewing the information provided in the initial online application and the information in the appeal submission to the MMP. A letter outlining the final reimbursement recommendation is communicated back to the clinician.

There has been a significant focus on improving access to and the affordability of healthcare services over the last few years. This includes reductions in the DPS threshold, expansion of access to free GP care, and the abolition of all public in-patient hospital charges for children and adults. These measures continue to create a health and social care service that offers affordable access to quality healthcare.

Individuals may also be entitled to claim tax relief on the cost of their medical expenses, including medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.