Pembrolizumab [PEMB5]

The treatment of relapsed or refractory classical Hodgkin lymphoma in ADULTS who are stem cell transplant-ineligible and have failed brentuximab vedotin 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 will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The prescribing clinician I am 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 toxicities.
3. The patient is an ADULT and has histologically documented classical Hodgkin lymphoma Note: there is a separate Blueteq form to be used for pembrolizumab in this indication in children.
4. The patient has failed at least 2 lines of chemotherapy and also failed treatment with brentuximab vedotin.
5. The patient has not received stem cell transplantation of any kind.
6. The patient is currently ineligible for stem cell transplantation.
7. The patient is EITHER potentially a candidate for future stem cell transplantation or not. Please mark appropriately in one of the boxes below:

• 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 pembrolizumab may be

8. The patient has an ECOG performance status (PS) of 0 or 1.
9. 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.
10. Pembrolizumab is being given as monotherapy and will commence at a fixed dose of either 3-weekly cycles of pembrolizumab monotherapy 200mg or 6-weekly cycles of pembrolizumab monotherapy 400mg.
11. A formal medical review as to whether treatment with pembrolizumab should continue or not will be scheduled to occur at least by the end of the third cycle of treatment if 3-weekly administration of pembrolizumab or by the end of the second cycle if 6-weekly administration is used.
12. The patient will be treated until stem cell transplantation occurs or loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment or completion of 2 years of treatment with pembrolizumab, whichever is the sooner.
13. The patient will receive a maximum treatment duration with pembrolizumab of 2 years (or 35 x 3-weekly cycles of pembrolizumab or its equivalent if 6-weekly pembrolizumab dosing is used).
14. When a treatment break of more than 12 weeks beyond the expected 3- or 6-weekly cycle length is needed, a treatment break approval form to re-start treatment will be completed.
15. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 30 July 2024

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA967 (01 May 2024)

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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• PEMB5_prior_to_cdf_1.361