Dáil Éireann Debate, Thursday - 17 July 2014
643. Deputy Thomas Pringle asked the Minister for Health the number of persons who suffer from multiple sclerosis who were prescribed the drug, Fampyra, in the Biogen Idec Fampyra NPS programme here; and if he will make a statement on the matter. [32085/14]
View answer645. Deputy Billy Kelleher 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. [32112/14]
View answer646. Deputy Billy Kelleher 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. [32113/14]
View answerI propose to take Questions Nos. 643, 645 and 646 together.
The Biogen Idec Fampridine (Fampyra®) NPS programme was not instituted by the Health Service Executive (HSE). The HSE has no access to data held by Biogen Idec in relation to this programme.
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.
Fampridine was never available to multiple sclerosis patients under the Long Term Illness (LTI) Scheme, however, 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 NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the manufacturer of the drug. 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. In these circumstances, the HSE has not approved the reimbursement of Fampridine under the GMS or other community drug schemes.
However, I am aware that studies are ongoing to assess the wider impact of Fampridine on both walking and quality of life for persons diagnosed with MS. The results of these studies will contribute to the evidence base demonstrating the clinical effectiveness of the product which can be used to support future applications for its inclusion on the lists of reimbursable items supplied under the GMS and other community drugs scheme.
The HSE met with Biogen Idec recently to discuss a potential revised application. The HSE expects that Biogen Idec will submit a revised application. The HSE will then re-consider the application in as timely a fashion as possible in line with the agreed procedures and timescales for the assessment of new medicines.
