Published

May 11, 2025

Pembrolizumab [PEMB17]

Pembrolizumab monotherapy for relapsed/refractory classical Hodgkin lymphoma in patients aged 3 years and older who have NOT been previously treated with stem cell transplantation brentuximab vedotin

  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. Tthe 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-1 or anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
  3. The patient has a histologically confirmed diagnosis of classical Hodgkin lymphoma.
  4. The patient is aged 3 years and older. Please mark below whether the patient is aged 3-17 years or 18 years and older:
  • the patient is aged between 3 and 17 years or
  • the patient is aged 18 years and older
  1. The patient has relapsed or refractory Hodgkin lymphoma following 2 prior lines of cytotoxic chemotherapy.
  2. The patient has never previously been treated with brentuximab vedotin.
  3. The patient has not been previously treated with stem cell transplantation of any kind.
  4. The patient is currently ineligible for stem cell transplantation.
  5. The patient is EITHER a candidate for future stem cell transplantation if there is sufficient benefit of treatment with pembrolizumab OR is not a candidate for stem cell transplantation however good the response to pembrolizumab may be. Please mark below the patient status as regards future autologous/allogeneic stem cell transplantation:
  • the patient is a candidate for future stem cell transplantation if there is sufficient benefit of treatment with pembrolizumab or
  • the patient is not a candidate for stem cell transplantation however good the response to treatment with pembrolizumab may be
  1. The patient has not received prior treatment with any antibody which targets PD-1 or PD-L1 or PD-L2 or CD137 or OX40 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).
  2. The patient has an ECOG performance status (PS) of 0 or 1 and is fit for treatment with pembrolizumab.
  3. Pembrolizumab will be administered as monotherapy: • For adult patients (aged 18 years and older), at a dose of either 200mg 3-weekly or 400mg 6-weekly. • For paediatric patients (aged between 3 and 17 years), pembrolizumab will commence at a dose of 2mg/kg bodyweight up to a maximum of 200mg 3-weekly.
  4. Pembrolizumab will be stopped at whichever of the following events occurs first: stem cell transplantation or disease progression or unacceptable toxicity or withdrawal of patient consent or after 2 years of treatment (or after 35 3-weekly cycles or its equivalent if 6-weekly dosing is used). Note: the 2 year stopping rule for pembrolizumab in this indication was a key part of the company submission to NICE of the clinical and cost effectiveness of pembrolizumab in this indication. Note: once pembrolizumab is stopped for any of the above reasons, it cannot be re-started.
  5. A formal medical review as to how pembrolizumab monotherapy is being tolerated and whether pembrolizumab should continue or not will be scheduled to occur at least by the end of the second 3-weekly cycle of treatment.
  6. When 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.
  7. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC) with the exception of criterion 13.

NHS funded From: 24 May 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA772 (23 February 2022)

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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