2 Information about obinutuzumab

2 Information about obinutuzumab

Marketing authorisation

Obinutuzumab (Gazyvaro, Roche) 'in combination with chemotherapy, followed by [obinutuzumab] maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma'.

Dosage in the marketing authorisation

Obinutuzumab is given by intravenous infusion. Induction with chemotherapy dosage:

  • With cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) or cyclophosphamide, vincristine and prednisolone (CVP):

    • cycle 1: 1,000 mg on days 1, 8 and 15 of the first 21‑day treatment cycle

    • cycles 2 to 8: 1,000 mg on day 1 of each 21‑day treatment cycle (with the CHOP regimen, obinutuzumab is given alone for the last 2 cycles).

  • With bendamustine:

    • cycle 1: 1,000 mg on days 1, 8 and 15 of the first 28‑day treatment cycle

    • cycles 2 to 6: 1,000 mg on day 1 of each 28‑day treatment cycle.

Maintenance dosage:

  • 1,000 mg every 2 months for 2 years or until disease progression (whichever occurs first).

Price

£3,312 per 1,000‑mg vial (excluding VAT; British national formulary [BNF] online, August 2017).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of obinutuzumab with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)