Kathleen Lynch (Cork North Central, Labour) | Oireachtas source

I thank Deputy Tory for raising the issue of hepatitis C which is not just topical, but also a significant public health problem with its associated burden on individuals, families, health services, communities and society. We all know the origins of the difficulties for many hepatitis C patients in Ireland, although the people to whom Deputy Troy refers are not the only sufferers in the country. We are talking about a specific cohort of people in this instance but there are other hepatitis C sufferers in Ireland.

The development of new and innovative medicines for the treatment of hepatitis C is an opportunity to alleviate the burden for patients, their families and society as a whole. There are a number of new direct acting antiviral, DAA, therapies licensed in Europe for the treatment of hepatitis C. It is expected that several other therapies will be licensed in the coming months. However, these products have a significant cost. One of these new treatment regimens includes Sofosbuvir or Sovaldi which has been the subject of recent attention. The HSE received an application in February 2014 for the inclusion of Sofosbuvir in the GMS and community drugs schemes. The application is being considered in line with procedures and time scales agreed by the Department and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines. I am sure that Deputy Troy would agree that we must ensure the safety of patients in Ireland.

In accordance with these procedures, the National Centre for Pharmacoeconomics initiated a pharmacoeconomic evaluation of this new product in June 2014. The health technology assessment report on Sofosbuvir is expected in mid-October. This evaluation will provide detailed information on the potential budget impact of the medicine. It will also assess whether the products are cost effective at the price quoted by the manufacturer, and I am sure the Deputy will accept the importance of that point. This evaluation provides valuable information to enable the HSE to take a decision on the funding of this new medicine and ensuring that it is clinically appropriate, fair, consistent and sustainable.

With the advent of these new treatment regimens which are better tolerated by patients, it is necessary to consider how to optimise access to these treatments in a managed way over the coming years. In that regard, my Department is chairing an expert advisory group to advise the Minister for Health on the optimal management and treatment strategy for patients with hepatitis C. This group will advise on the development of a public health plan that will focus on the treatment and management of people with hepatitis C which will lead to reduction in prevalence in the population and a reduction in infection and spread of hepatitis C. Decisions around the feasibility of a HSE early access programme to these drugs will be considered in this context.

I hope this information is of some help to the Deputy. We are all very conscious of the urgent need as outlined by him.

See this speech in context