Nivolumab [NIV6]

The treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum-based chemotherapy where all the following crtieria are met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with nivolumab 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, hepatitis and skin toxicity.
3. The patient has a histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck.
4. The patient has recurrent or metastatic head and neck cancer that is not amenable to local therapy with curative intent (surgery and/or radiation therapy with or without chemotherapy).
5. The patient’s disease has progressed or recurred during or within 6 months of the last dose of previously received platinum-based chemotherapy. Please indicate below in which disease setting this previous platinum-based chemotherapy was given:

• in the adjuvant setting or
• in the neoadjuvant setting or
• concurrently with radiotherapy or
• in the palliative setting for recurrent or metastatic disease (Note: Patients progressing more than 6 months after completing platinum-based chemotherapy are not eligible for nivolumab).

6. The patient has an ECOG performance status of 0 or 1 and would otherwise be potentially fit for docetaxel-based 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.
8. Every effort has been made for the patient to have PD-L1 testing with an approved and validated test to determine the Tumour Proportion Score (TPS). Please document the TPS results below:

• TPS result on tissue (if negative enter zero): OR
• The TPS cannot be quantified OR
• PD-L1 testing was not possible as the pathologist has documented that there was insufficient tissue

9. Nivolumab will be administered as monotherapy at a dose of 240mg every 2 weeks or a dose of 480mg every 4 weeks. Note: nivolumab 480mg every 4 weeks is unlicensed, therefore Trust policy regarding the use of unlicensed treatments must be followed if using this dosing schedule.
10. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
11. The patient is to be treated with nivolumab until loss of clinical benefit or excessive toxicity or patient choice to discontinue therapy, whichever is the sooner.
12. When a treatment break of more than 3 months beyond the expected 2- or 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of Covid-19.
13. Nivolumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 18 January 2022

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA736 (20 October 2021)

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• NIV6_prior_to_cdf_1.361