Pembrolizumab [PEMB34]

Pembrolizumab for resectable, locally advanced, head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a combined positive score of 1 or more where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant, or internally accredited oncology specialty trainee, specifically trained and assessed in the use of systemic anti- cancer therapy.
2. The patient has a documented, histologically confirmed, diagnosis of non-metastatic, resectable, squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or oropharynx.
3. The patient has disease which is staged as below Stage III or IVA according to the AJCC 8th Edition: o HPV-positive oropharyngeal: Must be Stage III (T4, N0-2, M0). OR o HPV-negative oropharyngeal, larynx, hypopharynx, or oral cavity: Stage III or IVA.
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 CPS: ______

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.
6. The patient is treatment naïve, in terms of systemic anti-cancer therapy (SACT) for this diagnosis of head and neck cancer.
7. The patient will receive neoadjuvant pembrolizumab as shown below

• If using the subcutaneous formulation – TWO doses of 395mg given every 3 weeks OR ONE dose of 790mg
• If using the intravenous formulation – TWO doses of 200mg given every 3 weeks OR ONE dose of 400mg

8. Post surgery, the patient will receive adjuvant pembrolizumab, alongside adjuvant radiotherapy +/- concomitant cisplatin chemotherapy, as shown below

• If using the subcutaneous formulation –395mg given every 3 weeks OR 790mg given every 6 weeks
• If using the intravenous formulation – 200mg given every 3 weeks OR 400mg given every 6 weeks

9. Adjuvant pembrolizumab will continue until unacceptable toxicity, withdrawal of patient consent, progression of disease, or the completion of 15 x 3 weekly (or the equivalent number of 6 weekly) doses in the adjuvant phase, whichever of these events occurs first.
10. Where a treatment break of more than 12 weeks beyond the expected 3 or 6-weekly cycle length is needed, a treatment break approval form will be completeed to restart treatment, which MUST be approved before treatment with pembrolizumab is recommenced.
11. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 20 July 2026

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA1145 (21 April 2026)

Current Form Version

Note

The data on this page was produced using version 1.406 of the CDF list, downloaded from NHS England’s website on 09 September 2026 at 21:36.

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.

• PEMB34_prior_to_cdf_1.391
• PEMB34_prior_to_cdf_1.406