LEN1_v2.1_Lenalidomide_MDS5qDel

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National Cancer Drugs Fund Application Form –
Lenalidomide
For the treatment of myelodysplastic syndromes (MDS)
associated with a deletion 5q plus one additional
cytogenetic abnormality.
Author(s)
David Thomson
Owner
Chemotherapy Clinical Reference Group
Version Control
Version Control
Date
Revision summary
Ver2.0
14 Jul 2014
Introduction of version control and addition of section re-SACT
and monitoring
Ver2.1
19 Jan 2015
Altered to include plus ones only. 5q deletion only NICE approved
Change to current version
Criteria
Changes
3.
Removal of “+/- one additional” and replacement with “plus one additional”
National Cancer Drugs Fund – Application Form 19 Jan 2015
Lenalidomide for MDS with 5q Deletion plus one
Page 1
National Cancer Drugs Fund Application Form –
Lenalidomide
For the treatment of myelodysplastic syndromes (MDS) associated with a
deletion 5q plus one additional cytogenetic abnormality.
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 Lenalidomide for the treatment of MDS associated
with a deletion 5q cytogenetic abnormality plus one additional cytogenetic
abnormality
TICK
All 5 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. Low or intermediate risk MDS
3. Associated with an isolated deletion 5q cytogenetic abnormality PLUS one
additional cytogenetic abnormality
4. Transfusion dependent anaemia (< 8 consecutive weeks without RBC
transfusions within 16 weeks prior to commencing treatment)
5. Other therapeutic options insufficient OR inadequate
6. To be used within the treating Trust’s governance framework, as Lenalidomide
is not licensed for this indication
Note: Lenalidomide is in baseline commissioning for low and intermediate risk MDS when
associated with an isolated deletion 5q cytogenetic abnormality
Consultant Approval (email authority)
Patient Consent Obtained (date of letter – copy to be retained on patient file)
National Cancer Drugs Fund – Application Form 19 Jan 2015
Lenalidomide for MDS with 5q Deletion plus one
Page 2
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*
D46.6 - Myelodysplastic syndrome with isolated del(5q)
chromosomal abnormality
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 19 Jan 2015
Lenalidomide for MDS with 5q Deletion plus one
Page 3
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