2 The technology
2.1 Obinutuzumab (Gazyvaro, Roche Products) is a type 2 glyco‑engineered antibody that binds to the CD20 protein present on B cells (except stem or plasma cells) and causes cell death. Obinutuzumab plus chlorambucil has a UK marketing authorisation for 'the treatment of adult patients with previously untreated chronic lymphocytic leukaemia and with comorbidities making them unsuitable for full‑dose fludarabine based therapy'. Obinutuzumab is administered as an intravenous infusion.
2.2 The summary of product characteristics lists the following common adverse reactions for obinutuzumab: urinary tract infection, nasopharyngitis, oral herpes, rhinitis, pharyngitis, squamous cell carcinoma of the skin, neutropenia, thrombocytopenia, anaemia, leukopenia, tumour lysis syndrome, hyperuricaemia, atrial fibrillation, hypertension, cough, diarrhoea, constipation, alopecia, arthralgia, back pain, musculoskeletal chest pain, pyrexia, decreased white blood cell count, decreased neutrophil count, increased weight and infusion‑related reactions. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 The price of obinutuzumab is £3312 per 1000‑mg vial (excluding VAT; 'British national formulary' [BNF] February 2015). The company stated that a course of treatment costs £26,496 (£9936 for cycle 1 and £3312 for cycles 2–6, excluding VAT). The recommended dosage is 1000 mg administered over days 1 and 2, 1000 mg on day 8 and 1000 mg on day 15 of treatment cycle 1, followed by 1000 mg on day 1 of treatment cycles 2–6. The company has agreed a patient access scheme with the Department of Health that makes obinutuzumab available with a discount. The size of the discount is commercial in confidence (see section 5.4). The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.