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)
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