Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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39. To ask the Minister for Health if he or his Department has had consultation with the European Medicines Agency on the application for market authorisation in the EU for the drug nusinersen; the timeframe, following a decision from the EMA, in which the NCPE can commence its own process for assessment; the timeframe for this drug to be available; and if he will make a statement on the matter. [4554/17]

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.

The HSE assessment process is undertaken within the 180 day timeline as set out in the Health (Pricing and Supply of Medical Goods) Act 2013. This Act allows for a temporary suspension of the timeline where companies are required to provide additional data. The assessment process requires the National Centre for Pharmacoeconomics to conduct a health technology assessment of the applicant’s economic dossier on the cost effectiveness of the treatment. Once this assessment is completed, a summary report will be published on the National Centre for Pharmacoeconomics website.

The HSE then examines all the evidence which may be relevant in its view for the decision to reimburse the drug, including the assessment by the National Centre for Pharmacoeconomics.

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. The patients' families have been informed.