Tuesday, 10 June 2014

Questions (467, 470, 502, 504, 572)

Ciara Conway

Question:

467. Deputy Ciara Conway asked the Minister for Health when Fampyra will be included on the drug payment scheme or other schemes such as the general medical services scheme or the long-term illness scheme; and if he will make a statement on the matter. [24173/14]

View answer

Brendan Griffin

Question:

470. Deputy Brendan Griffin asked the Minister for Health if the MS drug Fampyra has been taken off the long-term illness scheme; if so, the reason for same; the person who made this decision; if it will be reinstated; if he is aware of the benefits that the drug brings to MS sufferers; if his Department will apologise to the persons affected for the distress caused at this time of already great difficulties in their lives; the way he plans to hold the person or persons responsible for this decision to account; and if he will make a statement on the matter. [24214/14]

View answer

Tom Fleming

Question:

502. Deputy Tom Fleming asked the Minister for Health if he will make available the MS drug Fampyra at an early date as it is the only drug that assists MS patients in their walking; and if he will make a statement on the matter. [24356/14]

View answer

Jonathan O'Brien

Question:

504. Deputy Jonathan O'Brien asked the Minister for Health if he will ensure that Fampyra will be made available on the medical card; and his plans to ensure that those who have benefited from Fampyra may continue to take this drug regardless of financial circumstances. [24364/14]

View answer

Dara Calleary

Question:

572. Deputy Dara Calleary asked the Minister for Health if a drug (details supplied) can be re-registered on the long-term illness scheme. [24796/14]

View answer

Written answers (Question to Health)

I propose to take Questions Nos. 467, 470, 502, 504 and 572 together.

Fampridine (Fampyra®) was never available to MS patients through the community drugs schemes, including the Long Term Illness (LTI) Scheme. I understand the manufacturer of Fampyra supplied the drug free of charge to some patients prescribed the drug by their clinician. However, the manufacturer has recently decided to stop supplying the drug free of charge and, as a consequence, these patients are now faced with financing the drug themselves if they wish to continue with this drug treatment.

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 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 (IPHA) for the assessment of new medicines. In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) conducted a pharmacoeconomic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate the cost effectiveness of Fampridine in the Irish health care setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE's website (www.ncpe.ie). The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. Due to the very difficult and challenging economic environment in which the Government targeted additional savings in health expenditure of €619 million in 2014, which must be achieved while protecting front line services to the most vulnerable to the greatest extent possible, the HSE decided 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 incorporating new evidence which demonstrates the cost effectiveness of Fampridine. The HSE will then re-consider the application to add this product to the List of Reimbursable Items, in line with the agreed procedures and timescales for the assessment of new medicines.