Hepatitis C is a blood-borne virus that infects the liver. Children and young people get the disease primarily from their mothers at birth. If the virus is not cleared from the body, either naturally or through drugs to treat it, an acute infection (defined as the first six months following initial infection) can progress to chronic hepatitis C (long term infection, lasting more than six months). Chronic hepatitis C infection increases the risk of scarring of the liver (fibrosis and cirrhosis), liver failure and liver cancer. Peginterferon alfa-2a (Pegasys, Roche Products) and peginterferon alfa-2b (ViraferonPeg, Merck Sharp and Dohme (MSD)), in combination with ribavirin are the only treatments currently licensed in the UK for the treatment of chronic hepatitis C in children and adolescents.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Hepatitis C is a potentially debilitating condition, and although it rarely causes serious liver damage in children, if left untreated there is a high risk that it will cause liver cirrhosis and eventual liver failure many years down the line. The independent Appraisal Committee concluded that treatment with peginterferon alfa and ribavirin can decrease the hepatitis C virus to undetectable levels, effectively providing the equivalent of a cure for the disease. By widening access to these drugs this guidance will give clinicians and people living with hepatitis C more treatment options. Early successful treatment is also likely to lessen the social stigma that can be associated with hepatitis C infection later in life.”
Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
Notes to Editors
About the draft guidance
- The draft guidance will be available from 00:01hrs on Thursday 18 June
- Estimates from the Health Protection Agency in 2011 indicate that 26 people aged 1 year or less and 21 people between the ages of 1 and 14 years were newly diagnosed with HCV in England in 2010. Estimates for chronic infection in children and young people are not available.
- The Assessment Group calculated that, based on an average age of 11 years, a body weight of 35.5 kg and a body surface area of 1.19 m2, a 24-week course of peginterferon alfa-2a and ribavirin costs approximately £3700 while a 48-week course of treatment costs approximately £7400.
- A 24-week course of peginterferon alfa-2b and ribavirin oral solution costs approximately £4000, while a 48-week course of treatment costs approximately £8100.
- Ribavirin is manufactured by Roche Products (Copegus) and MSD (Rebetol). Each product is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa or interferon alfa. The marketing authorisation for Copegus does not include specific recommendations for use in children. Copegus should be administered only in combination with the interferon products made by Roche Products (peginterferon alfa-2a or interferon alfa-2a). Rebetol (MSD) is available as an oral solution and 200 mg hard capsules and has a UK marketing authorisation for children and adolescents aged 3 years and older in combination only with MSD products peginterferon alfa-2b or interferon alfa-2b.
- The cost effectiveness results suggested that peginterferon alfa-2a and peginterferon alfa-2b (each in combination with ribavirin were more effective and less costly than best supportive care.
- The comparison between peginterferon alfa-2a and peginterferon alfa-2b was not robust enough for the Committee to recommend one treatment over the other.
- NICE technology appraisals apply across the NHS in England and Wales.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health. Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012). Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provideare value for money, in order to reduce inequalities and variation. Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services. Follow us on Twitter: @NICEcomms
This page was last updated: 17 July 2013