nivolumab (Opdivo)

following a resubmission assessed under the end of life and orphan medicine process:

nivolumab (Opdivo®) is accepted for use within NHS Scotland.

Indication under review: As monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults.

Nivolumab, compared with a mammalian target of rapamycin (mTOR) inhibitor, significantly increased overall survival in patients with advanced or metastatic renal cell carcinoma who had received one or two previous regimens of anti-angiogenic therapy.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nivolumab. 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 views from a Patient and Clinician Engagement (PACE) meeting.