National Cancer Drugs Fund Application Form –
Idelalisib
In combination with rituximab for patients with chronic
lymphocytic leukaemia (CLL)
Author(s)
David Thomson
Owner
Chemotherapy Clinical Reference Group
Version Control
Version Control
Date
Revision summary
Ver0.1
14 Jul 2014
Draft for discussion
Ver1.0
21 Oct 2014
Final version
Ver1.1
12 Jan 2015
Removal of reference to interim access scheme
Ver1.2
04 Nov 2015
Addition of criteria 7
Change to current version
Criteria
Changes
7
Addition of criteria regarding prior ibrutinib use
National Cancer Drugs Fund – Application Form 04 November 2015
Idelalisib for relapsed CLL
Page 1
National Cancer Drugs Fund Application Form –
Idelalisib
In combination with rituximab for patients with chronic lymphocytic
leukaemia (CLL)
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 relapsed refractory CLL
TICK
All 7 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. Disease progression within 24 months of last systemic therapy
4. At least one previous anti-CD 20 antibody-based treatment or 2 previous
chemotherapy regimens
5. Contraindications to cytotoxic chemotherapy (severe neutropenia or
thrombocytopenia as a consequence of previous treatments) or an estimated
creatinine clearance <60 mls/min or comorbidities as measured by a score of
>6 on the Cumulative Illness Rating Scale
6. Given in combination with Rituximab at a dose of 375 mg/m2, followed by 500
mg per square meter every 2 weeks for 4 doses and then every 4 weeks for 3
doses, for a total of 8 infusions. Idelalisib should be continued to progression.
7. No prior treatment with ibrutinib unless ibrutinib 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: Rituximab in this indication is funded via baseline commissioning
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
Idelalisib for relapsed CLL
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*
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
Idelalisib for relapsed CLL
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