James Reilly (Dublin North, Fine Gael) | Oireachtas source

I thank the Deputy for raising this important issue which relates not only to the specific drug to which she referred but to a range of medicines. I understand the manufacturer of Fampyra - a brand name for fampridine - has indicated to the HSE that it intends to submit a revised application to include the drug under the community drugs schemes. The HSE will consider the application on receipt, in line with the agreed procedures and timescales for the assessment of new medicines. The Deputy has indicated that the company submitted a revised application today.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE has already considered an application for the inclusion of 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 Fampyra 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 Fampyra under the community drugs schemes. I understand studies are ongoing to assess the wider impact of the drug on both walking ability and quality of life for persons diagnosed with MS. I acknowledge the Deputy's clear testament in this regard. The results of these studies will contribute to the evidence base demonstrating the clinical effectiveness of Fampyra, which can be used to support future applications for its inclusion on the lists of reimbursable items supplied under the community drugs schemes. In this context, it is open to the manufacturer at any time to submit a new application to the HSE for its product's inclusion. As we have heard, it did so this morning.

I assure the Deputy that I, and the HSE, fully understand that patients are very anxious that this product be made available under the community drugs schemes. The HSE will consider its manufacturer's revised application in line with the agreed procedures and timescales for the assessment of new medicines so that the matter is addressed and dealt with as quickly as possible.

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