Download National Cancer Drugs Fund Application Form – Ibrutinib for Relapsed

National Cancer Drugs Fund Application Form –
Ibrutinib
For Relapsed/ Refractory Chronic Lymphocytic Leukaemia
Author(s)
David Thomson
Owner
Chemotherapy Clinical Reference Group
Version Control
Version Control
Date
Revision summary
Ver1.1
12 Jan 2015
New indication
Ver1.1
19 Jan 2015
Addition of new note
Ver1.2
04 Nov 2015
Update to criteria 3 and 9
Change to current version
Criteria
Changes
3
Addition of “anti-CD20-containing chemoimmunotherapy regimen”
9
Addition of scenario where prior idelalisib allowed
National Cancer Drugs Fund – Application Form 04 November 2015
Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia
Page 1
National Cancer Drugs Fund Application Form –
Ibrutinib
for Relapsed/ Refractory Chronic Lymphocytic Leukaemia
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 Ibrutinib for relapsed/ refractory Chronic
Lymphocytic Leukaemia
TICK
All 9 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. Confirmed CLL
3. Must have received at least one prior anti-CD20-containing
chemoimmunotherapy regimen for CLL
4. Considered not appropriate for treatment or retreatment with purine analogue
based therapy due to:
a. Failure to respond to chemoimmunotherapy OR
b. A progression-free interval of less than 3 years OR
c. Age of 70yrs or more OR
d. Age of 65yrs or more plus the presence of comorbidities OR
e. A 17p or TP53 deletion
5. Performance status of ECOG 0-2
6. A neutrophil count of ≥0.75 x 10⁹/l
7. A platelet count of ≥30 x 10⁹/l
8. Patient not on warfarin or CYP3A4/5 inhibitors
National Cancer Drugs Fund – Application Form 04 November 2015
Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia
Page 2
9. No prior treatment with idelalisib unless idelalisib has had to be stopped within
6 months of its start solely as a consequence of dose-limiting toxicity and in the
clear absence of disease progression
Note: Patients receiving Ibrutinib via the compassionate use programme should not be
switched to CDF funding. Free of charge supplies from the manufacturer should continue to
be used in these patients until NICE approval and as per the terms of the compassionate
use programme
Consultant Approval (email authority)
Patient Consent Obtained (date of letter – copy to be retained on patient file)
National Cancer Drugs Fund – Application Form 04 November 2015
Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia
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*
C91.1 – Chronic lymphocytic leukaemia of B-cell type
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 04 November 2015
Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia
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