Tom Neville (Limerick County, Fine Gael)
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509. To ask the Minister for Health when it is expected a drug (details supplied) will be available here; if the HSE has to date received a pricing and reimbursement application.; and if he will make a statement on the matter. [7235/17]

Simon Harris (Wicklow, Fine Gael)
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For a medicine to be considered for reimbursement by the HSE it must first have a marketing authorisation from the European Medicines Agency or the Health Products Regulatory Authority, before being assessed under the Health (Pricing and Supply of Medical Goods) Act 2013.

I understand that in Autumn 2016 Biogen applied to the European Medicines Agency for marketing authorisation in the EU for the drug Nusinersen. Along with other member states, Ireland's Health Products Regulatory Authority will actively participate in the assessment of this application. The European Medicines Agency assessment process generally takes around one year.

Should Nusinersen receive European marketing authorisation, the manufacturer would then be open to make an application to the HSE to have the product reimbursed under the community drug schemes.

While the authorisation process is on-going early access to this medicine has been granted to two Irish families. I understand that following an application from a consultant paediatric neurologist at Temple Street hospital, the company has extended their early access programme to two of his patients with SMA Type 1.