National Cancer Drugs Fund Application Form – Bevacizumab for low grade gliomas of childhood and young adults (3rd Line in Combination with Irinotecan) Author(s) David Thomson Owner Chemotherapy Clinical Reference Group Version Control Version Control Date Revision summary Ver0.1 11 Mar 2014 Draft for discussion Ver1.0 18 Mar 2014 Final draft for publication Ver1.1 14 Jul 2014 Addition of section re-SACT and monitoring Ver1.2 12 Jan 2015 Removal of age criteria; addition of SACT compliance Change to current version Criteria Changes 3 Age limit removed 9 New criteria re- SACT compliance National Cancer Drugs Fund – Application Form 12 January 2015 Bevacizumab for low grade gliomas of childhood and young adults 3rd Line in Combination with Irinotecan Page 1 National Cancer Drugs Fund Application Form – Bevacizumab for low grade gliomas of childhood and young adults (3rd Line in Combination with Irinotecan) 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 Bevacizumab for low grade gliomas of childhood and young adults – 3rd Line in Combination with Irinotecan 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 paediatric specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Progressive low grade glioma 3. No previous treatment with either irinotecan or bevacizumab 4. Irinotecan and bevacizumab to be the 3rd or further line of therapy 5. A maximum of 12 months duration of treatment to be used with a re-application required at 6 months 6. Consent with the parent/guardian to specifically document the unknown long term toxicity of this combination, particularly on growth and ovarian function 7. To be used within the treating Trust’s governance framework, as Bevacizumab and Irinotecan are not licensed in this indication in children 8. The treating Trust has to formally agree to comply with full SACT dataset collection 9. In the period immediately prior to the application for irinotecan and bevacizumab, the appropriate specialist MDT has considered the use of proton beam radiotherapy. NOTE: Bevacizumab is ONLY approved for use in combination with combination chemotherapy and is not approved for use as a single agent maintenance therapy National Cancer Drugs Fund – Application Form 12 January 2015 Bevacizumab for low grade gliomas of childhood and young adults 3rd Line in Combination with Irinotecan Page 2 NOTE: Additional data on long term toxicity must be collected by the paediatric oncology community Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 12 January 2015 Bevacizumab for low grade gliomas of childhood and young adults 3rd Line in Combination with Irinotecan 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 (please tick the relevant box)* 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 12 January 2015 Bevacizumab for low grade gliomas of childhood and young adults 3rd Line in Combination with Irinotecan Page 4