Hepatitis C – Topical Issues Debate

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Speech by Minister of State Kathleen Lynch, T.D.   I would like to thank the Deputy for raising this important issue.  Hepatitis C is recognised as a significant public health problem with its associated burden on individuals, families, health services, communities and society.

The development of new and innovative medicines for the treatment of Hepatitis C is an opportunity to alleviate this burden.

There are a number of new Direct Acting Antiviral (DAA) therapies licenced in Europe for the treatment of Hepatitis C.  It is expected that several other therapies will be licenced in the coming months.  However, these products have a significant cost.

One of these new treatment regimens includes Sofosbuvir (Solvaldi®) 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 timescales agreed by the Department and the HSE with the Irish Pharmaceutical Healthcare Association for the assessment of new medicines.

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.

This evaluation provides valuable information to enable the HSE to take a decision on the funding of this new medicine 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 the 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.