Home > Public health plan for the pharmaceutical treatment of Hepatitis C.

Ireland. Department of Health. (2015) Public health plan for the pharmaceutical treatment of Hepatitis C. Dublin: Department of Health.

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In Ireland and in other countries hepatitis C infection is recognised as a significant public health problem with its associated burden of managing and treating the disease on individuals, their families, health services, communities and society.

 

Hepatitis C became a notifiable disease in Ireland in 2004 and between then and 2013, 12,333 cases were notified with a peak in 2007 (n=1539). In recent years there has been a significant decrease in notifications with 847 cases notified in 2013. Studies to estimate the prevalence of chronic hepatitis C in the population have been carried out over the last few years. A study in 2009 estimated the national prevalence of chronic hepatitis C as 0.5-1.2% (20,000-50,000) while more recent information indicates prevalence is likely to be 0.5-0.7% (20,000-30,000). However although there has been a recent decrease in notifications there is still a significant burden associated with advanced stage hepatitis C infection including liver disease, liver failure, liver cancer requiring for some transplant and death.

 

In Ireland the main route of transmission is through sharing of needles and drug paraphernalia by people who inject drugs. In notified cases when data was available 75% of the cases of hepatitis C were in people who inject drugs. In the past transmission occurred primarily through infected blood products.

 

Viral eradication prevents disease progression. Until 2011 the standard treatment for people with hepatitis C infection was dual therapy interferon and ribavirin. This treatment led to a variable response but was associated with significant side effects, particularly from interferon. Recently new pharmacological treatment regimens have been developed which have demonstrated high rates of viral clearance in clinical trials. These new drug regimens are at various stages of development and regulatory approval. Some have been licensed and others are expected to be in the near future. Those licensed in the EU include sofosbuvir, daclatasvir and simeprevir. These drugs are commonly used in combination with other drugs for example Sofosbuvir +/- daclatasvir +/- ribavirin. Currently in Ireland a number of these new drug regimens are going through the assessment process for reimbursement in the HSE.

 

Internationally there is an increasing focus on these new drug treatments. They are recognised as clinically effective treatments with significantly improved treatment outcomes and fewer side effects, however the cost of these drugs is resulting in a significant burden on health care systems worldwide. A number of diverse strategies have been implemented by different countries to address these issues of affordability; with many adopting the approach of prioritisation based on clinical need of infected patients. Following these important developments in the area of new and emerging treatment regimens for hepatitis C, the Chief Medical Officer, in the Department of Health established a group to advise the Minister for Health through the office of the Chief Medical Officer.

 

The role of this advisory group was to advise on the feasibility of a multiannual public health treatment plan for patients with hepatitis C infection based on clinical prioritisation criteria for identification of patients for each treatment phase. The Advisory group included patient advocates, clinicians, the National Centre for Pharmaco-economics (NCPE), HIQA, the HSE and officials from the Department of Health and is chaired by the CMO’s office (Appendix 1).

 

After reviewing the evidence on clinical and cost effectiveness and the budget impact of the new drug regimens, the Group advised on the development of a treatment strategy. This treatment strategy’s implementation will over the next few years aim to increase the number of people with hepatitis C infection being treated effectively with complete clearance of the virus and reduce the numbers of people in the community with hepatitis C. The implementation of the treatment strategy is an important component in ultimately working towards eradication of hepatitis C in the Irish population.

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