nintedanib (Ofev)

following a resubmission assessed under the orphan equivalent medicine process:

nintedanib (Ofev®) is accepted for restricted use within NHSScotland.

Indication under review: in adults for the treatment of idiopathic pulmonary fibrosis (IPF).

SMC restriction: For use in patients with a predicted forced vital capacity (FVC) >80%.
Nintedanib, compared with placebo, reduces the decline in pulmonary function assessed by FVC in patients with IPF.

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

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

Nintedanib (Ofev®) has previously been accepted for restricted use in adults with IPF with a predicted FVC ≤80% (SMC1076/15); this advice remains valid.