Pembrolizumab [PEMB12]

For previously untreated metastatic or unresectable recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC) where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with pembrolizumab monotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti- cancer therapy.
2. The patient has a documented histological diagnosis of squamous cell carcinoma of the head and neck.
3. The patient has either metastatic head and neck cancer or locally advanced/unresectable recurrent head and neck cancer that is not amenable to curative intent with local therapy (surgery and/or radiation therapy with or without chemotherapy).
4. PD-L1 testing with an approved and validated test to determine the Combined Positive Score (CPS) has been done prior to this application and the CPS is ≥1% and the result is set out below. Please document the actual CPS below

Note

Note: pembrolizumab is not funded in this indication for patients with tumours without a documented ≥1% positive PD-L1 CPS score.

5. The patient has an ECOG performance status of 0 or 1 and would otherwise be potentially fit for 1st line combination chemotherapy.
6. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody for this metastatic or unresectable recurrent head and neck squamous cell carcinoma indication.
7. Pembrolizumab will be administered as monotherapy following the licensed dose schedules shown below • 395mg every 3 weeks, or 790mg every 6 weeks if given via subcutaneous injection • 200mg every 3 weeks, or 400mg every 6 weeks if given via intravenous infusion 8. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
8. The patient will receive a maximum treatment duration of 2 years of uninterrupted treatment (or 35 x 3-weekly cycles of pembrolizumab or its equivalent if 6-weekly pembrolizumab monotherapy dosing is used) or on disease progression or unacceptable toxicity, whichever occurs first.
9. Where a treatment break of more than 12 weeks beyond the expected 3 or 6-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment with pembrolizumab is recommenced.
10. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC)

NHS funded From: 23 February 2021

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA661 (25 November 2020)

Current Form Version

Note

The data on this page was produced using version 1.387 of the CDF list, downloaded from NHS England’s website on 24 February 2026 at 11:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• PEMB12_prior_to_cdf_1.361
• PEMB12_prior_to_cdf_1.387