Download IPINIV1_v1.1_IpilimumabNivolumab_Melanoma

National Cancer Drugs Fund Application Form –
Ipilimumab and Nivolumab
For the treatment of advanced (unresectable or metastatic)
melanoma in adults
Author(s)
David Thomson
Owner
Chemotherapy Clinical Reference Group
Version Control
Version Control
Date
Revision summary
Ver1.0
29 Jul 2016
New form following NICE FAD and interim funding
Ver1.1
18 Aug 2016
Updates to criteria 5 and 6 and addition of new note
Change to current version
Criteria
Changes
5
Detail added regarding adjuvant treatment in trials
6
Detail added
NOTE
Addition of new note regarding treatment breaks
National Cancer Drugs Fund – Application Form 18 Aug 2016
Ipilimumab and Nivolumab for melanoma
Page 1
National Cancer Drugs Fund Application Form –
Ipilimumab and Nivolumab
For the treatment of advanced (unresectable or metastatic) melanoma
in adults
Instructions to Consultants: Please fill in each section of the form electronically and save the
document with your own file name. [If you continue typing the boxes will enlarge to contain the text].
Please send electronically to ______________________. Please also send copies to your Trust’s link
accountant / corporate contracting team.
Security of Patient Identifiable Information: The patient will be identified by their NHS number only.
Please do not include any other patient identifiers for confidentiality reasons. All communication must be
sent to the Cancer Drugs Fund Office via secure e mail accounts: that is from an nhs.net account to the
____________ account.
Receipt of Application: The sender of the application will receive an acknowledgement, together with
details of the unique Cancer Drugs Fund reference.
Cancer Drugs Fund Policy: To check the status of a particular therapy please check the Cancer Drugs
Fund Policy at _________________
Applications will be subject to Clinical Audit arrangements.
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.
Approved Treatment Required for the treatment of advanced (unresectable or
metastatic) melanoma
TICK
All 6 conditions must be met
1. Application made by and first cycle of systemic anti-cancer therapy to be
prescribed by a consultant specialist specifically trained and accredited in the
use of systemic anti-cancer therapy
2. Histologically confirmed stage III (unresectable) or stage IV melanoma
3. PS 0 or 1
4. No previous treatment with any of anti-Programmed Death receptor-1 (PD-1),
anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T
lymphocyte associated antigen-4 (anti-CTLA-4) antibody.
5. Only prior systemic therapy allowed is either adjuvant treatment given in a
clinical trial (but no treatment types as listed above in criterion 4) or tyrosine
kinase inhibitors targeting BRAF and MEK or monotherapy targeting BRAF
6. No active brain metastases or leptomeningeal metastases ie brain secondaries
previously treated with surgery or stereotactic radiotherapy and considered to
be stable
NOTE: Treatment breaks are allowed as long as these are solely for toxicity and each cycle
commences within 12 weeks of the start date of the previous cycle of treatment
NOTE: In the interim funding period both ipilimumab and nivolumab will be funded from the
CDF
National Cancer Drugs Fund – Application Form 18 Aug 2016
Ipilimumab and Nivolumab for melanoma
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Consultant Approval (email authority)
Patient Consent Obtained (date of letter – copy to be retained on patient file)
National Cancer Drugs Fund – Application Form 18 Aug 2016
Ipilimumab and Nivolumab for melanoma
Page 3
Proposed Start Date for Therapy (add clinic date)*:
Consultant details*
(including signature or
email confirmation)
Name:
Hospital:
Address:
Post Code:
Telephone:
Nhs.net
Trust Pharmacist details of the Trust where
the patient will be
treated*
Mandatory - NHS No*:
Mandatory – Patients
date of birth*
Optional – Hospital No.
Clinical Commissioning
Group*
Patient’s GP*
(name, address,
telephone)
Name:
Hospital:
Address:
Post Code:
Telephone:
Nhs.net
NHS No:
DOB:
Hospital No:
CCG Name:
Name:
Address:
Post Code:
ICD-10 Code*
C43 – Malignant melanoma of skin
HRG Code
Completion of items marked with * is mandatory. Failure to complete these items may
mean that payment is not made.
National Cancer Drugs Fund – Application Form 18 Aug 2016
Ipilimumab and Nivolumab for melanoma
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