1.1 Obinutuzumab is recommended as an option for untreated advanced follicular lymphoma in adults (that is, first as induction treatment with chemotherapy, then alone as maintenance therapy), only if:
the person has a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 or more
the company provides obinutuzumab according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with obinutuzumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Current first-line treatment for symptomatic advanced follicular lymphoma is induction therapy with rituximab plus chemotherapy, followed by maintenance treatment with rituximab when there has been a response to induction therapy.
The main evidence on the effectiveness and safety of obinutuzumab is from an ongoing clinical trial. It shows that obinutuzumab plus chemotherapy followed by obinutuzumab maintenance treatment delays disease progression more than current treatment. However, it also shows that undesirable side effects are more common with obinutuzumab than with rituximab. There are not enough data to know with certainty whether obinutuzumab increases life expectancy.
The company's revised economic analyses focuses on higher-risk subgroups. Obinutuzumab costs more than branded rituximab and even more than the biosimilar versions of rituximab. However, using the preferred assumptions and the discounted prices for obinutuzumab and rituximab, the cost-effectiveness estimate for obinutuzumab plus chemotherapy followed by obinutuzumab maintenance treatment, compared with rituximab plus chemotherapy followed by rituximab maintenance treatment, is lower than £30,000 per quality-adjusted life year gained. Therefore, obinutuzumab is recommended as an option for untreated advanced follicular lymphoma in patients at higher risk.