Published

May 16, 2025

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 patient has a histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck.
  3. 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).
  4. 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).
  1. The patient has an ECOG performance status of 0 or 1 and would otherwise be potentially fit for docetaxel-based chemotherapy.
  2. 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.
  3. 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):_________
  • The TPS has been documented above
  • The TPS cannot be quantified
  • PD-L1 testing was not possible as the pathologist has documented that these was insufficient tissue Please explain why TPS could not be provided:_______
  1. The patient will receive the licensed* dose, frequency, and route of nivolumab for this indication, as shown below • Subcutaneously – at a dose of 600mg every 2 weeks, or 1200mg every 4 weeks • Intravenously – at a dose of 240mg every 2 weeks, or 480mg every 4 weeks (*4 weekly IV dosing is unlicensed)
  2. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  3. 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.
  4. When a treatment break of more than 12 weeks beyond the expected 2- or 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form requesting a restart of treatment. This must be approved before nivolumab is re-commenced.
  5. Nivolumab will otherwise be used as set out in its Summary of Product Characteristics (SPC) with the exception of criterion 8 and 11.

NHS funded From: 18 January 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA736 (20 October 2021)

Current Form Version

Note

The data on this page was produced using version 1.363 of the CDF list, downloaded from an archive of NHS England’s website on 16 May 2025 at 14:00.

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.

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