Download PEMB1_Pembrolizumab_prevtreated_NSCLC_Dec16_v1.1

PEMB1_ver1.1 National Cancer Drugs Fund Application Form – Pembrolizumab for treating PD-L1-positive nonsmall-cell lung cancer after chemotherapy.
Patient NHS No:
Trust:
Patient Hospital No:
Practice Code:
Patient's Initials and DoB:
GP Postcode:
Choose Consultant:
Consultant Name:
*
Notification Email Address:
Other Contact Details:
*
(@NHS.net account ONLY)
Treatment Start Date:
BY TICKING THESE BOXES AND SUBMITTING THE APPLICATION THE CLINICIAN IS CONFIRMING THE PATIENT
MEETS ALL THE CRITERIA BELOW. IT SHOULD BE NOTED THAT THE SACT DATASET WILL BE USED TO
MONITOR THAT THESE CRITERIA ARE BEING MET:
Please indicate whether patient meets the following criteria:
Please tick
1. I confirm that an application has been made and the first cycle of systemic anti -cancer therapy will be
prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer
therapy.
Yes
No
2. I confirm that as 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 and hepatitis.
Yes
No
3. I confirm that the patient has a histologically- or cytologically-confirmed diagnosis of stage IIIB or IV nonsmall cell lung cancer (squamous or non-squamous).
Yes
No
4. I confirm that the patient’s tumour expresses PD-L1 (that is, with a tumour proportion score [TPS] ≥1%)
by an approved and validated test.
Yes
No
5. I confirm that the patient has progressed after treatment with at least two cycles of platinum-containing
doublet chemotherapy for stage IIIB/IV disease AND a targeted treatment if they have an EGFR or ALKpositive tumour.
Yes
No
6. I confirm that the patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
1.
Yes
No
Yes
No
Yes
No
Yes
No
7. I confirm that the patient has no active brain metastases or leptomeningeal metastases.
8. I confirm that 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.
9. I confirm that pembrolizumab will be stopped at 2 years of treatment or on disease progression* or
unacceptable toxicity, whichever occurs first.
*Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few
months followed by tumour shrinkage) have been observed. It is recommended to continue treatment for
clinically stable patients with initial evidence of disease progression until further disease progression is
confirmed.
10. I confirm the licensed dose and frequency of pembrolizumab will be used with the exception of criteria 9.
11. What is the acquisition cost of the drug including VAT (if applicable)?
£ per month:
Commissioners will complete if cost not known as this will allow us to ensure budgets are allocated
appropriately.
Yes
No