Written answers

Wednesday, 5 October 2016

Department of Health

Medicinal Products Reimbursement

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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177. To ask the Minister for Health if CellCept is currently being considered as an acceptable drug in the treatment of multiple sclerosis, MS; if so, when will there be a decision, alternatively if it is currently not under consideration whether he will request an evaluation for its addition to the approved list for MS; and if he will make a statement on the matter. [28818/16]

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 on the advice of the National Centre for Pharmacoeconomics (NCPE).

Cellcept has not been authorised by the European Medicines Agency for the treatment of MS in the European Union. If the drug should receive marketing authorisation in the EU and Ireland, it would then be open to the marketing authorisation holder to make the drug available for prescribing, and to apply to the HSE to have the product reimbursed under the State drug schemes.

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