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 prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies and hepatitis.
3. The patient has a documented histological diagnosis of squamous cell carcinoma of the head and neck.
4. 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).
5. 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: pembrolizumab is not funded in this indication for patients with tumours without a documented ≥1% positive PD-L1 CPS score.
6. The patient has an ECOG performance status of 0 or 1 and would otherwise be potentially fit for 1st line combination chemotherapy.
7. 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 unless the patient has received pembrolizumab monotherapy for this indication via Interim COVID19 funding. Please tick one of the following options which applies as to any previous systemic therapy:

• the patient has not received any previous systemic therapy for this metastatic/locally advanced/unresectable recurrent indication or
• the patient has received pembrolizumab monotherapy as 1st line therapy for this metastatic/locally advanced/unresectable recurrent indication as part of Interim COVID19 funding

8. Pembrolizumab will only be administered as monotherapy at a dose of 200mg every 3 weeks or at a dose of 400mg every 6 weeks. Note: NICE has not recommended the use of pembrolizumab in combination with chemotherapy in this indication.
9. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
10. 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.
11. 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, including indication as appropriate if the patient had an extended break because of COVID19.
12. 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

Important

This is an older version of the form. To view the most up to date form follow this link

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