pegylated interferon alfa-2a (Pegasys)

Following an abbreviated submission:

pegylated interferon alpha-2a (Pegasys®) is accepted for restricted use within NHS Scotland.

Indication under review: in combination with ribavirin, is indicated for the treatment of chronic hepatitis C (CHC) in treatment-naïve children and adolescents five years of age and older, who are positive for serum hepatitis-C-virus ribonucleic acid (HCV-RNA).

When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis.

SMC restriction: prescribing by specialist in paediatric infectious disease or paediatric gastroenterology.

Results from phase lll studies in paediatric patients suggest that efficacy and safety in this patient group is broadly similar to that in adults, with the exception of the reported effects on growth in children.

The Scottish Medicines Consortium has previously accepted this product for restricted use in adults. Pegylated interferon alpha-2a is listed in the British National Formulary for Children 2012-2013 for the treatment of chronic hepatitis C.