obinutuzumab (Gazyvaro)

following a full submission considered under the ultra-orphan-medicine process.

obinutuzumab (Gazyvaro®) is accepted for use within NHS Scotland.

Indication under review: obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance is indicated for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen.

Obinutuzumab plus bendamustine induction therapy followed by obinutuzumab maintenance significantly increased progression free survival compared with bendamustine monotherapy induction without any maintenance treatment, in patients with rituximab-refractory follicular lymphoma.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of obinutuzumab. 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.