UK NICE final draft guidance on treatment for chronic hepatitis C

The UK drugs watchdog the National Institute of Health and Care Excellence (NICE) this morning (October 11) confirmed its earlier draft guidance recommending peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.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 six months). Although hepatitis C rarely causes serious 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.

Pegasys and Viraferon plus ribavirin only currently licensed drugs for this patient population

Peginterferon alfa-2a (Pegasys, from Swiss drug major Roche [ROG: SIX)) and peginterferon alfa-2b (ViraferonPeg, from Merck Sharp and Dohme, the domestic unit of US pharma giant Merck & Co [NYSE: MRK]), 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.

Carole Longson, NICE Health 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 National Health Service. Consultees now have the opportunity to appeal the draft guidance.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.