2 The technology
2.1 Pembrolizumab (Keytruda, Merck Sharp & Dohme) is a humanised monoclonal antibody. It acts on the programmed cell death protein‑1 immune checkpoint receptor pathway, blocking its interaction with ligand on the tumour cells. This allows reactivation of anti‑tumour immunity. It has a marketing authorisation in the UK as monotherapy 'for the treatment of advanced (unresectable or metastatic) melanoma in adults'. Previously, pembrolizumab was available in the NHS through the early access to medicines schemes from the UK Medicines and Healthcare products Regulatory Agency. Pembrolizumab is administered intravenously for 30 minutes at a dose of 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
2.2 The most common (occurring in 1 in 10 people or more) adverse reactions with pembrolizumab in clinical trials were diarrhoea, nausea, itching, rash, joint pain and fatigue. The most serious adverse reactions were immune‑related adverse reactions and severe infusion‑related reactions. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 The acquisition cost of pembrolizumab is £1,315 per 50‑mg vial (excluding VAT; company's submission). The pricing arrangement considered during guidance development was that Merck Sharp & Dohme had agreed a patient access scheme with the Department of Health. This scheme provided a simple discount to the list price of pembrolizumab with the discount applied at the point of purchase or invoice. After guidance publication in October 2015, the company agreed a commercial access agreement with NHS England that replaces the patient access scheme on equivalent terms. The financial terms of the agreement are commercial in confidence.