Tuesday, 1 July 2014
Department of Health
Medicinal Products Availability
566. To ask the Minister for Health his plans to make a drug (details supplied) available to patients under the general medical card scheme and the drugs payment scheme; and if he will make a statement on the matter. [28424/14]
572. To ask the Minister for Health the reason the medication Fampyra for multiple sclerosis, MS, sufferers has been removed from the long-term illness scheme; his plans to reinstate this drug on the long-term illness scheme, in view of its effectiveness in treating MS; and if he will make a statement on the matter. [28454/14]
I propose to take Questions Nos. 566 and 572 together.
Fampridine (Fampyra®) was never available under the Long Term Illness Scheme. However, I understand that the manufacturer of Fampyra supplied the drug free of charge to some patients who were prescribed the drug by their clinician. 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) is responsible for the administration of the primary care schemes. 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 (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 healthcare setting, it was unable to recommend the reimbursement of the product. The report is available on the NCPE's website ().
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 has 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.