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.