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Medicinal Products Reimbursement

Dáil Éireann Debate, Tuesday - 15 January 2019

Tuesday, 15 January 2019

Questions (792)

John Curran

Question:

792. Deputy John Curran asked the Minister for Health if an access programme will be established to the drug Spinraza for children with spinal muscular atrophy; and if he will make a statement on the matter. [1612/19]

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Written answers (Question to Health)

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

Nusinersen (Spinraza) is indicated for the treatment of 5q spinal muscular atrophy (SMA), a disorder characterised by progressive muscle atrophy and weakness.

An application for Nusinersen is currently undergoing assessment by the HSE.

The statutory assessment process involves a Health Technology Assessment followed by detailed consideration by the HSE expert groups on new Drug therapies, including the Technology Review Group for Rare Diseases and the HSE Drugs Committee.

The assessment focus is twofold and particularly centred on reviewing the evidence of the clinical effectiveness of this new drug therapy i.e. the benefits for patients undergoing clinical trials; and on the cost effectiveness of the product in view of the prices being charged for the drug.

The application is currently going through the final stages of assessment, and the various reports are due to be considered shortly by the HSE Leadership Team, following which the final decision will be notified

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