Advice

following a full submission assessed under the orphan equivalent medicine process:

nivolumab (Opdivo®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

In a double-blind, randomised, phase III study, disease-free survival was significantly improved with adjuvant nivolumab compared with placebo in patients with MIUC at high risk of recurrence after surgery.

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.

Download detailed advice793KB (PDF)

Download

Medicine details

Medicine name:
nivolumab (Opdivo)
SMC ID:
SMC2503
Indication:

For the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

Pharmaceutical company
Bristol-Myers Squibb Pharmaceuticals Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published
13 February 2023