Written answers

Thursday, 19 January 2017

Department of Health

Medicinal Products Availability

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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195. To ask the Minister for Health the status of the drug Nusinersen for the treatment of spinal muscular atrophy, including timeframes; if there is any possibility of the drug being allowed on compassionate grounds (details supplied); and if he will make a statement on the matter. [2241/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE.

Prior to a medicine being marketed, made available to patients and/or submitted for assessment under the 2013 Act, it must have a market authorisation from the European Medicine Agency (EMA).

The European Medicines Agency provides independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.

The EMA’s evaluations of marketing-authorisation applications provide the basis for the in Europe. This is separate to the Statutory Assessment process conducted by the HSE.

I understand from the HSE that Biogen have applied to the European Medicines Agency (EMA) for market authorisation in the EU for the drug Nusinersen (Spinraza). The application to the EMA was submitted in Autumn 2016. The EMA 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 operation of patient access schemes is at the discretion of manufacturers. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need. I have previously asked manufacturers to show compassion and to provide access to patients, separate to the statutory assessment process. I understand that following an application from Dr Declan O'Rourke, 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. I further understand that the patients' families were informed.

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