rituximab subcutaneous (Mabthera)

following a full submission

rituximab subcutaneous injection (Mabthera®) is accepted for restricted use within NHS Scotland.

Indication under review: for non-Hodgkin’s lymphoma (NHL) in adults: 
- previously untreated  patients with stage III-IV follicular lymphoma in combination with chemotherapy;
- maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy;
-  treatment of patients with CD20 positive diffuse large B cell - non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

SMC restriction: Subcutaneous rituximab is accepted for use in line with previous SMC advice for intravenous rituximab i.e. accepted within licensed indication as above except in the maintenance setting, where use is restricted to patients who have responded to induction therapy with rituximab plus chemotherapy.

In two pharmacokinetic-based clinical bridging studies, rituximab subcutaneous injection was shown to be non inferior to rituximab intravenous infusion for trough concentration and area under the concentration time curve.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of rituximab subcutaneous injection.  This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.