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Medicinal Products

Dáil Éireann Debate, Tuesday - 29 March 2022

Tuesday, 29 March 2022

Questions (639)

Peadar Tóibín


639. Deputy Peadar Tóibín asked the Minister for Health if he plans to make wegovy available to medical card users in the future if medically indicated by a doctor in the treatment of weight loss and obesity; and if he will make a statement on the matter. [15877/22]

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Written answers (Question to Health)

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.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority. In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact

Wegovy (semaglutide) has been authorised by the European Medicines Agency 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:

- more than or equal to 30 kg/m² (obesity), or

- more than 27 kg/m² to less than 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

I am advised by the HSE that it has received no pricing/reimbursement application for this product to date, as of 28 March 2022.

If the marketing company decides to submit a pricing/reimbursement application for Wegovy, it will be assessed by the HSE in line with the 2013 Act.