2 The technology

2 The technology

Description of the technology

Pembrolizumab (Keytruda, Merck Sharp & Dohme) is a humanised monoclonal antibody that acts on the 'programmed death 1' protein (PD‑1). The PD‑1 protein is part of the immune checkpoint pathway, and blocking its activity may promote an anti-tumour immune response.

Marketing authorisation

Pembrolizumab has a marketing authorisation for treating locally advanced or metastatic non‑small‑cell lung cancer (NSCLC) in adults whose tumours express PD‑L1 (that is, with a tumour proportion score [TPS] ≥1%) and who have had at least 1 chemotherapy regimen. Patients with epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)‑positive tumour mutations should also have had approved therapy for these mutations before having pembrolizumab.

Adverse reactions

The most common treatment-related adverse events associated with pembrolizumab include fatigue, decreased appetite, nausea, rash and pruritus. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

2 mg/kg every 3 weeks by intravenous (IV) infusion. The summary of product characteristics recommends treatment with pembrolizumab until disease progression or unacceptable toxicity.

Price

Pembrolizumab is available at a cost of £1,315.00 per 50‑mg vial (excluding VAT; 'British national formulary' [BNF] online, accessed November 2016).

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 January 2017, 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.

  • National Institute for Health and Care Excellence (NICE)