Written answers

Wednesday, 5 November 2014

Department of Health

Medicinal Products Licensing

Photo of Pat BreenPat Breen (Clare, Fine Gael)
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128. To ask the Minister for Health further to Parliamentary Question No. 759 of 8 July 2014, if she will provide an update on the application lodged with the Health Service Executive for the inclusion of the drug Fampyra for multiple sclerosis under the community drugs scheme; when she expects a decision to issue; and if she will make a statement on the matter. [42310/14]

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour)
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The decisions on which medicines are reimbursed by the taxpayer, are not political or ministerial decisions. These are made on objective, scientific and economic grounds by the Health Service Executive (HSE) on the advice of the National Centre for Pharmacoeconomics (NCPE).

The 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 HSE received an application for the inclusion of Fampridine in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines. In accordance with these procedures, the NCPE conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for Fampridine in the Irish healthcare setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE's website ().

On foot of this, the HSE decided that it was not in a position to add the drug to the List of Reimbursable Items supplied under the GMS and other community drug schemes.

As was outlined in the reply to your question of the 8th of July, it is open to the supplier, at any time, to submit a new application to the HSE for the inclusion of Fampridine on the community drugs schemes incorporating new evidence which demonstrates the cost-effectiveness of the drug, by offering a reduced price or both. A revised application was subsequently received by the HSE on 25th July 2014 and is currently being considered in line with the agreed procedures and timescales. No further comment is possible at this time as the HSE decision making process is ongoing.

I would like to assure the Deputy that the Department, and the HSE, fully understand the concerns of patients regarding the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever the price the drug company demands, I hope the Deputy will appreciate that the better interests of the health service require that we reimburse only the most effective medicines and only at a fair price.

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