Speeches

Fampridine – Topical Issue

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Speech by Minister for Health Dr James Reilly TD

I wish to thank the Deputy for raising this issue.   I understand that the manufacturer of Fampridine (Fampyra®) has indicated to the HSE that it intends to submit a revised application to include Fampridine under the community drug schemes. The HSE will consider the application on receipt in line with the agreed procedures and timescales for the assessment of new medicines.

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.

As the Deputy will be aware, the HSE has already considered an application for the inclusion of Fampridine (Fampyra®) in the GMS and community drugs schemes. This 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 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 community drug schemes.

I understand 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 Fampridine which 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 want to assure the Deputy that I, and the HSE, fully understand that patients are very anxious that this product be made available under the community drug schemes. Therefore, as I mentioned earlier, on receipt of a revised application from the manufacturer of Fampridine, the HSE will consider the application in line with the agreed procedures and timescales for the assessment of new medicines so that the matter will be addressed and dealt with as quickly as possible.