Written answers

Thursday, 24 November 2022

Photo of David CullinaneDavid Cullinane (Waterford, Sinn Fein)
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316. To ask the Minister for Health when saxenda will be approved for medical card holders; and if he will make a statement on the matter. [58612/22]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). 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 Drugs Group considers the NCPE assessment, the outputs from commercial engagements, patient interest group submissions, and any other pertinent information in advance of providing its recommendation to the HSE Executive Management Team (EMT).

The application for reimbursement was for the following indication: as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of ≥30 kg/m² (obesity), or ≥27 kg/m² to <30 kg

The Drugs Group has recommended Liraglutide (Saxenda) be reimbursed, subject to the development of a Managed Access Programme (MAP) by the HSE’s Medicines Management Programme (MMP).

MAPs are used to identify patients or subgroups of patients who would most benefit from the specific treatment approved for reimbursement and for whom the clinical evidence of therapeutic benefit is strongest. The MAP for Liraglutide (Saxenda) is currently under development. The Primary Care Reimbursement Service and the MMP are working with internal stakeholders with the view to having the finalised managed access programme (and supporting IT systems for same) in place by the end of Q4 2022.

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