bulevirtide (Hepcludex)

following a full submission assessed under the orphan medicine process:

bulevirtide (Hepcludex®) is accepted for restricted use within NHSScotland.

Indication Under Review: for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.

SMC restriction: to use in patients with evidence of significant fibrosis (METAVIR stage greater than or equal to F2), whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contra-indication.

In an open-label, phase III study, combined virological and biochemical response at week 48 was significantly improved with bulevirtide compared with observation in patients with HDV infection.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.