Published

May 11, 2025

Pembrolizumab [PEMB2]

Pembrolizumab monotherapy for the first line treatment of locally advanced or metastatic non-small cell lung cancer which expresses PD-L1 with a tumour proportion score of at least 50% where the following criteria are met:

  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. The 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-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicities.
  3. The patient has a histologically- or cytologically-confirmed diagnosis of non-small cell lung cancer (squamous or non-squamous). Please mark below which histology applies to this patient:
  • squamous NSCLC
  • non-squamous NSCLC
  1. The patient has stage IIIB or IIIC or IV NSCLC or has disease that has recurred after previous potentially curative local management of NSCLC with surgery/chemoradiotherapy/radiotherapy.
  2. An approved and validated test has demonstrated that there is PD-L1 expression of at least 50% of tumour cells (the PD-L1 tumour proportion score). Please document the actual PD-L1 expression below: PD-L1 tumour proportion score_______
  3. Either the patient has been documented as NOT having a NSCLC which harbours an EGFR 19 or 21 mutation or an ALK gene fusion or the patient has a squamous cell carcinoma and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with pembrolizumab has been discussed with the patient during the consenting process, i.e. the patient has consented to be treated with an unknown EGFR/ ALK status. Please mark below which option applies to this patient:
  • Documented as NOT having a NSCLC which harbours an EGFR 19 or 21 mutation or an ALK gene fusion
  • Patient has squamous NSCLC and a decision to not test for an EGFR 19 or 21 mutation or an ALK gene fusion and proceed with pembrolizumab has been discussed with the patient during the consenting process.
  1. Either the patient has not received any previous systemic therapy for NSCLC or the patient completed the last treatment with chemotherapy or chemoradiotherapy or checkpoint inhibitor immunotherapy as part of adjuvant/neoadjuvant/maintenance therapy at least 6 months prior to the first diagnosis of locally recurrent or metastatic disease. Please indicate below whether the patient has received any previous adjuvant or neoadjuvant or maintenance systemic therapy for NSCLC:
  • the patient has not been previously treated with any adjuvant or neoadjuvant or maintenance systemic therapy for NSCLC or
  • the patient has been previously treated with adjuvant systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease or
  • the patient has been previously treated with neoadjuvant systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic or
  • the patient has been previously treated with maintenance systemic therapy for NSCLC and this was completed more than 6 months before first diagnosis of recurrent or metastatic disease
  1. 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 (CTL-4) antibody unless the patient discontinued/completed treatment with checkpoint inhibitor immunotherapy as part of adjuvant/neoadjuvant/maintenance therapy without disease progression and at least 6 months elapsed between the date of last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease. Note: NHS England does not commission any re-treatment with checkpoint inhibitor therapy for patients who have discontinued or completed previous checkpoint inhibitor therapy for the locally advanced/metastatic indication. all Please mark below if the patient has received previous checkpoint inhibitor therapy and in which setting:
  • the patient has never received any immunotherapy for NSCLC. If so, please type ‘n/a’ in the ‘Time Gap’ box below or
  • the patient has previously been treated with adjuvant immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of relapse. Please document in the box below the time gap in months between completion of previous adjuvant immunotherapy and first diagnosis of disease relapse or
  • the patient has previously been treated with neoadjuvant treatment containing immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous neoadjuvant immunotherapy and first diagnosis of disease relapse or
  • the patient has previously been treated with maintenance treatment containing immunotherapy for NSCLC and discontinued immunotherapy without disease progression and at least 6 months prior to the first diagnosis of disease relapse. Please document in the box below the time gap in months between completion of previous maintenance immunotherapy and first diagnosis of disease relapse Time gap in months after completion of previous adjuvant or neoadjuvant or maintenance checkpoint inhibitor immunotherapy and first diagnosis of disease relapse:_____ Note: the mandatory interval between the last date of administration of any prior adjuvant/neoadjuvant/maintenance immunotherapy and first relapse is at least 6 months. For patients suffering a first relapse within 6-12 months of previous immunotherapy, clinicians should bear in mind the long elimination half-lives of immunotherapies and make individual assessments of the overall benefit/risk ratio of re-treatment with immunotherapy.
  1. Pembrolizumab will be administered as monotherapy as 3-weekly or 6-weekly cycles or pembrolizumab will be administered according to the extended dosing schedule to which the patient has been randomised as per the protocol in the NIHR-approved REFINE-Lung trial (Reference NIHR133011).
  2. In the absence of disease progression pembrolizumab will continue for a total treatment duration of 2 years* of treatment or until disease progression or unacceptable toxicity or withdrawal of patient consent or unacceptable toxicity, whichever occurs first. *2 years treatment is defined as a maximum of 35 x 3-weekly cycles or the equivalent numbers of cycles if 6-weekly dosing is used or is defined by the extended dosing schedule to which the patient has been randomised as per the protocol in the NIHR-approved REFINE-Lung trial (Reference NIHR133011).
  3. The patient has an ECOG performance status of 0 or 1.
  4. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  5. A formal medical review as to how pembrolizumab 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 or first 6-weekly cycle of treatment.
  6. When a treatment break of more than 3 months beyond the expected cycle length is needed, a treatment break approval form will be completed to restart treatment, including indicating as appropriate if the patient had an extended break because of Covid-19.
  7. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics.

NHS funded From: 16 October 2018

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA531 (18 July 2018)

Current Form Version

Important

This is an older version of the form. To view the most up to date form follow this link

Older Form Versions

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