Billy Kelleher (Cork North Central, Fianna Fail)
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692. To ask the Minister for Health if the new hepatitis C treatment, Sovaldi, will be made available to patients, in view of the fact that it has been approved for the National Health Service in the UK; when he will sanction this treatment; and if he will make a statement on the matter. [41514/14]

Kathleen Lynch (Cork North Central, Labour)
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The Health Service Executive (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 in February 2014 for the inclusion of Sofosbuvir, the first of a new generation of drugs for the treatment of Hepatitis C, in the GMS and community drugs schemes. The application is being considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines.

In accordance with these procedures, the HSE asked the National Centre for Pharmacoeconomics (NCPE) to conduct a pharmacoeconomic evaluation of the new product in June 2014. The Report by the NCPE is expected shortly. This evaluation will provide detailed information on the potential budget impact of the medicine. It will also assess whether the product is cost effective at the price quoted by the manufacturer.

The NCPE report is an important input to assist the HSE in its decision making process. 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.

The Department has established an advisory group to advise on an evidence-based multi-annual pharmaceutical treatment plan for patients with Hepatitis C. This group will furnish a report to the Minister for Health on this issue in the coming weeks.

In advance of the completion of the multi-annual framework the Department and the HSE intend to engage with the pharmaceutical companies shortly regarding an early access programme for the highest priority patients that require immediate treatment in 2014.