Alex White (Dublin South, Labour) | Oireachtas source

I thank the Deputy for raising this issue. I wish to clarify that Fampridine, Fampyra, was never available to multiple sclerosis patients 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 it 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 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 my Department 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 its cost-effectiveness 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.

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 community drug schemes, including the long-term illness scheme.

I understand 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 account the Deputy read out demonstrates a very real human situation. The description of the very real circumstances faced by the individual concerned was very eloquent. The studies to assess the wider impact of the medicine in question are ongoing. The results of these studies will contribute to the evidence base demonstrating the clinical effectiveness of Fampridine that can be used to support future applications for its inclusion on the lists of reimbursable items supplied under the community drugs scheme. In this context, it is open to the manufacturer, at any time, to submit a new application to the HSE for the inclusion of Fampridine on the community drug schemes.

I understand the manufacturer has indicated to the HSE that it intends to submit a revised application for Fampridine. The HSE will then re-consider the application in line with the agreed procedures and timescales for the assessment of new medicines.

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