Published

May 11, 2025

Nivolumab [NIV3]

The treatment of relapsed or refractory classical Hodgkin Lymphoma in PAEDIATRIC patients where all the following criteria are met:

  1. An application has been made by and the first cycle of systemic anti-cancer therapy is to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
  2. The prescribing clinician is 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 histologically confirmed diagnosis of classical Hodgkin’s Lymphoma
  4. The patient has relapsed or refractory disease
  5. The patient has received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as part of previous therapy for classical Hodgkin’s Lymphoma
  6. The patient has had prior treatment with brentuximab vedotin
  7. The patient has an ECOG performance status (PS) 0-1
  8. The patient is a child* and either post pubescent or is pre pubescent and will receive nivolumab dosage as described in the publication Blood 2016; 128: 5414 *note there is a separate Bluteq form to be used for nivolumab in this indication in adults.
  9. Nivolumab will be given as monotherapy.
  10. The patient has no known central nervous system lymphoma.
  11. Nivolumab will only be requested by and administered in principal treatment centres.
  12. The use of the nivolumab has been discussed at a multi disciplinary team (MDT) meeting which must include at least two consultants in the subspecialty with active and credible expertise in the relevant field of whom at least one must be a consultant paediatrician. The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area.
  13. I confirm that Trust policy regarding unlicensed treatments has been followed as nivolumab is not licensed in this indication in children.
  14. The patient has not received prior treatment with an anti-PD-1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
  15. The patient will receive a maximum treatment duration of 2 years of uninterrupted treatment or 52 administrations (where administered every 2 weeks) or 26 administrations (where administered every 4 weeks) with nivolumab, whichever is the later.
  16. When a treatment break of more than 12 weeks beyond the expected cycle length is needed, a treatment break approval form will be completed to restart treatment.
  17. Nivolumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 26 August 2017

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: - (26 August 2017)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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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