Pembrolizumab [PEMB16]

For relapsed/refractory classical Hodgkin lymphoma in patients aged 3 years and older who have been treated with stem cell transplantation but never previously received 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 will be prescribed by a consultant, or internally accredited haematology specialty trainee, specifically trained and assessed in the use of systemic anti-cancer therapy.
2. The patient has a histologically confirmed diagnosis of classical Hodgkin lymphoma.
3. 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

4. The patient has relapsed or refractory Hodgkin lymphoma following stem cell transplantation. Please mark below whether the patient had autologous and/or allogeneic stem cell transplantation:

• autologous transplantation only
• allogeneic transplantation only
• both autologous and allogeneic transplantation

5. The patient has never previously been treated with brentuximab vedotin.

Note

Note: in patients previously treated with both SCT and brentuximab vedotin, nivolumab is available in routine commissioning using form NIV2.

6. 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).
7. The patient has an ECOG performance status (PS) of 0 or 1 and is fit for treatment with pembrolizumab.
8. Pembrolizumab will be administered as monotherapy: • For adult patients (aged 18 years and older) • 395mg every 3 weeks, or 790mg every 6 weeks if given via subcutaneous injection • 200mg every 3 weeks, or 400mg every 6 weeks if given via intravenous infusion
9. Pembrolizumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or after 2 years of treatment (or after 35 x 3-weekly cycles or its equivalent if 6-weekly dosing is used).

Note

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 after 2 years of treatment, it cannot be re-started.

10. 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, which MUST be approved before treatment with pembrolizumab is recommenced.
11. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC) with the exception of criterion 9.

NHS funded From: 24 May 2022

Additional information

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 1.406 of the CDF list, downloaded from NHS England’s website on 09 September 2026 at 21:36.

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.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• PEMB16_prior_to_cdf_1.361
• PEMB16_prior_to_cdf_1.406