Dáil Éireann Debate, Wednesday - 17 September 2014
914. Deputy Brendan Ryan asked the Minister for Health his plans to introduce the drug Fampyra in the near future under any Health Service Executive drug payment or reimbursement scheme for people suffering from multiple sclerosis; if not, if he will outline the reason; and if he will make a statement on the matter. [33465/14]
Amharc ar fhreagra937. Deputy Finian McGrath asked the Minister for Health the position regarding the life-changing treatment drug Fampyra for multiple sclerosis patients here; if he will make this a priority (details supplied); and if he will make a statement on the matter. [33556/14]
Amharc ar fhreagra965. Deputy Denis Naughten asked the Minister for Health if he will include the multiple sclerosis drug, Fampyra, in the drugs payment scheme; and if he will make a statement on the matter. [33749/14]
Amharc ar fhreagra966. Deputy Denis Naughten asked the Minister for Health his views on the exclusion of the multiple sclerosis drug, fampyra, from the long-term illness scheme; and if he will make a statement on the matter. [33750/14]
Amharc ar fhreagra979. Deputy Ciarán Lynch asked the Minister for Health if he will make Fampyra available to MS patients under the medical card or long-term illness schemes; and if he will make a statement on the matter. [33787/14]
Amharc ar fhreagra982. Deputy Robert Troy asked the Minister for Health if he will ensure a trial drug called Fampyra for treatment of MS continues to be covered by the Health Service Executive after November 2014. [33792/14]
Amharc ar fhreagra1032. Deputy Sandra McLellan asked the Minister for Health his plans to licence the drug Fampyra, Fampridine; and if he will make a statement on the matter. [34014/14]
Amharc ar fhreagraI propose to take Questions Nos. 914, 937, 965, 966, 979, 982 and 1032 together.
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 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 healthcare 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. Biogen Idec's Irish management indicated to the HSE in November 2013 that it intended to re-submit an application in April 2014. The HSE has advised it received a revised application from Biogen Idec on Friday 25th July. This application is currently being assessed in line with the agreed procedures and timescales. No further comment is possible at this time as the HSE decision making process is ongoing.
