peginterferon alfa-2a (Pegasys)

In the absence of a submission from the holder of the marketing authorisation

peginterferon alfa-2a (Pegasys ®) is not recommended for use within NHS Scotland.

Indication under review: Treatment of hepatitis B envelope antigen (HBeAg)-positive chronic hepatitis B in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting.  As a result we cannot recommend its use within NHSScotland.

______________________________________________________________________________________

From January 2020, ADTCs may make formulary decisions on paediatric licence extensions for medicines previously accepted for use (or restricted use) for the corresponding indication in adults, taking account of relevant restrictions. This approach may also be applied retrospectively to medicines accepted for use in adults but not recommended in the corresponding indication in children due to absence of submission. PASAG liaises with companies to extend any PAS to include the younger age group and confirms arrangements with Boards.