2 The technology

Guidance

Description of the technology	Pertuzumab (Perjeta, Roche) is a recombinant monoclonal antibody which targets human epidermal growth factor receptor 2 (HER2)-positive breast tumours. It interrupts the activation of the HER2 intracellular signalling pathway, leading to cell growth arrest and apoptosis. It is administered by intravenous infusion.
Marketing authorisation	Pertuzumab has a marketing authorisation in the UK 'in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence'.
Adverse reactions	The summary of product characteristics includes the following adverse reactions for pertuzumab: decreased appetite, headache, cough, diarrhoea, vomiting, nausea, constipation, rash, pain, oedema, fatigue, asthaenia and left ventricular dysfunction. For full details of adverse reactions and contraindications, see the summary of product characteristics.
Recommended dose and schedule	The recommended dosage of pertuzumab is an initial loading dose of 840 mg, followed by a maintenance dose of 420 mg every 3 weeks for 3 to 6 cycles.
Price	Pertuzumab costs £2,395 per 420‑mg vial (excluding VAT). The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of pertuzumab, 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.