Wednesday, 2 July 2014

Questions (177)

Robert Troy


177. Deputy Robert Troy asked the Minister for Health if the drug fampyra will be approved by his Department; and if it is to be listed for medical card patients. [28672/14]

View answer

Written answers (Question to Health)

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 (Fampyra®) 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 ( ). 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 Multiple Sclerosis. 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.