following a full submission considered under the end of life and orphan equivalent process:
nivolumab (Opdivo®) is not recommended for use within NHS Scotland.
Indication under review: Nivolumab as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
In a single arm, phase II study of patients with metastatic, or surgically unresectable, urothelial carcinoma with progressive disease on or after platinum based chemotherapy, treatment with nivolumab resulted in an objective response in 20% of patients.
The submitting company did not present a sufficiently robust economic and clinical analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice392KB (PDF)
Medicine details
- Medicine name:
- nivolumab (Opdivo)
- SMC ID:
- 1285/18
- Indication:
As monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
- Pharmaceutical company
- Bristol-Myers Squibb Pharmaceuticals Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 15 January 2018