Download National Cancer Drugs Fund Application Form

National Cancer Drugs Fund Application Form – TAL1_v1.0
Talimogene Laherparepvec
For the treatment of unresectable regionally or distantly
metastatic melanoma in adults
Author(s)
David Thomson, Peter Clark
Owner
Chemotherapy Clinical Reference Group
Version Control
Version Control
Date
Revision summary
Ver1.0
09-Aug-2016
New form following NICE FAD and interim funding
Change to current version
Criteria
Changes
National Cancer Drugs Fund – Application Form Page 1
TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma
National Cancer Drugs Fund Application Form – TAL1_v1.0
Talimogene Laherparepvec
For the treatment of unresectable and regionally or distantly
metastatic melanoma in adults
Instructions to Consultants: Log in to https://www.blueteq-secure.co.uk/trust/Default.aspx to select this
form for CDF access to this drug, Complete each section of the form electronically (the boxes will
enlarge to contain more text). Please submit electronically.
Security of Patient Identifiable Information: The patient will be identified by their NHS number only.
Do not include any other patient identifiers. All communication must be sent to the Cancer Drugs Fund
Office via secure e mail accounts: that is from an nhs.net account to [email protected]
Receipt of Application: You will receive an acknowledgement and a unique Cancer Drugs Fund
reference. Please forward to your Trust’s link accountant / corporate contracting team.
Cancer Drugs Fund Policy: To check the status of a particular therapy please check the Cancer Drugs
Fund Policy at www.england.nhs.uk/ourwork/cancer/cdf
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 metastatic melanoma
All 8 conditions must be met
1. Application made by and first cycle of treatment to be prescribed and
administered by a consultant specialist experienced in the treatment of
melanoma
2. Treatment can only be given by specialists trained to give intra-lesional
injections of talimogene
3. Patients must have cutaneous, subcutaneous or nodal deposit(s) of melanoma
which is/are suitable for direct injection but which is/are not surgically
resectable
4. Stage IIIB, IIIC or IVM1a disease according to the AJCC stage criteria of 2009
7th edition and those with stage IVM1a disease (ie metastases to skin,
subcutaneous tissue or distant lymph nodes) must have a normal serum LDH
5. Patients should not have bone, brain, lung or any other visceral secondaries
and if stage IVM1a disease, the serum LDH should not be elevated
6. Treatment with talimogene must be sanctioned by a specialist multi-disciplinary
team meeting which includes an oncologist and a surgeon with expertise in the
management of metastatic and locally advanced melanoma, respectively
7. Treatment with talimogene should only be given to patients in whom
systemically administered immunotherapies or approved targeted therapies are
not considered the best option for the patient by a specialist multi-disciplinary
team meeting which includes an oncologist and a surgeon with expertise in the
management of metastatic and locally advanced melanoma, respectively
8. Talimogene is only to be administered as a single agent and not in combination
with systemic therapies eg chemotherapy, targeted agents or immunotherapy
unless in the context of a Health Research Authority clinical trial
Consultant Approval (email authority)
National Cancer Drugs Fund – Application Form Page 2
TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma
TICK
Patient Consent Obtained (date of letter – copy to be retained on patient file)
National Cancer Drugs Fund – Application Form Page 3
TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma
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 Page 4
TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma