Advice

following a full submission considered under the orphan process

obinutuzumab (Gazyvaro®) is not recommended for use within NHS Scotland.

Indication under review: obinutuzumab in combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.

In a phase III study, obinutuzumab decreased the risk of disease progression compared with another monoclonal antibody in a subgroup of patients with previously untreated advanced follicular lymphoma. 

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

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Medicine details

Medicine name:
obinutuzumab (Gazyvaro)
SMC ID:
1286/18
Indication:
obinutuzumab in combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.
Pharmaceutical company
Roche
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Not recommended
Date advice published:
15 January 2018