(Ref: NICE)
October 11th, 2013
In final draft guidance published today NICE has confirmed its earlier draft guidance recommending peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.
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 after an acute infection (defined as the first 6 months following initial infection) the condition can progress to chronic hepatitis C (long term infection, lasting more than 6 months). Although hepatitis C rarely causes serous liver damage in children, if left untreated chronic hepatitis C infection increases the risk of scarring of the liver(fibrosis and cirrhosis), liver failure and liver cancer in the future. 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. They are also licensed for the treatment of chronic hepatitis C in adults.
Professor Carole Longson, NICEHealth Technology Evaluation Centre Director, said: "The independent Appraisal Committee concluded that treatment with peginterferon alfa and ribavirin can decrease the hepatitis C virus to undetectable levels, effectively providing a cure for the disease. Early successful treatment is also likely to lessen the social stigma that can be associated with hepatitis C infection later in life. By widening access to these drugs this guidance will give clinicians and people living with hepatitis C more treatment options."
NICE has not yet issued final guidance to the NHS. Consultees now have the opportunity to appeal the draft guidance. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
Final guidance is likely to be published in November 2013.
Ends
1. The draft guidance will be available from 00:01hrs on Friday 11 October from the NICE website
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. The comparison between peginterferon alfa-2a and peginterferon alfa-2b was not robust enough for the Committee to recommend one treatment over the other.
8. NICE technology appraisals apply across the NHS in England and Wales.
9. 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.
To find out more about what we do, visit our website: www.nice.org.uk and follow us on Twitter: @NICEcomms
To read more Press Release articles, click here.
No comments:
Post a Comment