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

That is fine. I actually dealt with this issue earlier today but thank Senator Colm Burke for raising it in this House.

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 executive received an application for the inclusion of Fampridine or Fampyra 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 pharmaco-economic 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 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 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 Fampridine which can be used to support future applications for its inclusion in the lists of reimbursable items supplied under the community drug schemes. 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 in the community drug schemes. The manufacturer has indicated to the HSE that it intends to submit a revised application for Fampridine and it is my understanding the company may actually have done so this morning.

The HSE and I fully understand patients are very anxious that this product be made available under the community drug schemes. Therefore, the HSE will reconsider the application on receipt, in line with the agreed procedures and timescales for the assessment of new medicines, in order that the matter will be addressed and dealt with as quickly as possible.