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Description of the technology
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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.
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Marketing authorisation
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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.
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Adverse reactions
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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.
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Recommended dose and schedule
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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.
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Price
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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.
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