nintedanib (Ofev)

following a full submission assessed under the orphan process:

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

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) less than or equal to 80%.

Nintedanib, compared to placebo, reduces the decline in pulmonary function assessed by forced vital capacity in patients with IPF.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nintedanib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

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