Clare Daly
Question:417. Deputy Clare Daly asked the Minister for Health the progress in ensuring that MS sufferers who require the Fampyra drug are able to avail of it under the drug treatment scheme. [46188/14]
View answerTuesday, 2 December 2014
Questions (417, 433)
Pat Deering
Question:433. Deputy Pat Deering asked the Minister for Health if he will confirm that the manufacturer of the drug Fampyra has submitted a revised application to the Health Service Executive for its inclusion in the GMS and community drugs scheme; if so, the date on which it was received; and when a decision will be made by the Health Service Executive [46292/14]
View answerWritten answers
I propose to take Questions Nos. 417 and 433 together.
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 (www.ncpe.ie ).
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.
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 received by the HSE on 25th July 2014. The HSE's Corporate Pharmaceutical Unit has since been engaging with the company seeking improved commercial offering. These engagements have been completed and the HSE is now considering the outcome of those commercial engagements. Fampridine will be assessed along with a range of other applications for reimbursement of medicines for multiple sclerosis and other diseases.
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.