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Pembrolizumab for untreated metastatic or unresectable recurrent squamous cell head and neck cancer

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2 Information about pembrolizumab (monotherapy or in combination)

Marketing authorisation indication

2.1 Pembrolizumab (Keytruda, Merck Sharp & Dohme) has a UK marketing authorisation as monotherapy or with platinum and 5-fluorouracil (5-FU) chemotherapy '…for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS [combined positive score] ≥ 1'.

Dosage in the marketing authorisation

2.2 Pembrolizumab monotherapy consists of 200 mg taken by intravenous infusion every 3 weeks, or 400 mg every 6 weeks, until disease progression or unacceptable toxicity.

2.3 Pembrolizumab in combination with platinum chemotherapy and 5-FU consists of 200 mg taken by intravenous infusion every 3 weeks until disease progression or unacceptable toxicity.

2.4 PD-L1 mutation status should be determined using a validated test.

Price

2.5 Pembrolizumab costs £2,630 for a 100 mg vial, excluding VAT (BNF online, accessed December 2019).

2.6 The company has a commercial arrangement (managed access agreement including a commercial access agreement). This makes pembrolizumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.