Download OSI1_v1.0_Osimertinib_NSCLC

National Cancer Drugs Fund Application Form –
Osimertinib
For the treatment of locally advanced or metastatic
epidermal growth factor receptor T790M mutation-positive
non-small-cell lung cancer in adults
Author(s)
David Thomson
Owner
Chemotherapy Clinical Reference Group
Version Control
Version Control
Date
Revision summary
Ver1.0
30 Sep 2016
New form following NICE FAD and CDF funding
Change to current version
Criteria
Changes
National Cancer Drugs Fund – Application Form Page 1
Osimertinib for the treatment of locally advanced or metastatic epidermal growth factor receptor T790M
mutation-positive non-small-cell lung cancer in adults
National Cancer Drugs Fund Application Form –
Osimertinib
For the treatment of locally advanced or metastatic epidermal growth
factor receptor and T790M mutation-positive non-small-cell lung
cancer 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 Osimertinib for the treatment of locally advanced or
metastatic epidermal growth factor receptor and T790M mutation-positive non-smallcell lung cancer (NSCLC) in adults
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. Histologically or cytologically documented NSCLC that carries an EGFR and a
T790M mutation
3. Locally advanced or metastatic NSCLC
4. a. Radiological documentation of disease progression following 1st line EGFR
TKI treatment with only one TKI and without any further systemic anti-cancer
treatment.
.
b. Indicate below which 1st line EGFR TKI was used previously:
i. Gefitinib
ii. Erlotinib
iii. Afatinib
5. Treatment with no more than one prior line of treatment for advanced NSCLC
6. No prior chemotherapy unless any prior neoadjuvant or adjuvant chemotherapy
had been completed at least 6 months prior to starting 1st line EGFR treatment
7. a. PS 0 or 1
National Cancer Drugs Fund – Application Form Page 2
Osimertinib for the treatment of locally advanced or metastatic epidermal growth factor receptor T790M
mutation-positive non-small-cell lung cancer in adults
b. Indicate below the PS of the patient at the time of completing this form:
i. 0
ii. 1
8. At time of starting osimertinib, the patient must be fit enough to have potentially
started platinum-based doublet chemotherapy
9. Please document the date of expected start of treatment with osimertinib
_____
Consultant Approval (email authority)
Patient Consent Obtained (date of letter – copy to be retained on patient file)
National Cancer Drugs Fund – Application Form Page 3
Osimertinib for the treatment of locally advanced or metastatic epidermal growth factor receptor T790M
mutation-positive non-small-cell lung cancer in adults
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*
C34 – Malignant neoplasm of bronchus & lung
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
Osimertinib for the treatment of locally advanced or metastatic epidermal growth factor receptor T790M
mutation-positive non-small-cell lung cancer in adults