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National National Cancer Drugs Fund Application Form – Bevacizumab for Advanced Ovarian Cancer (1st line treatment) 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 05 Jun 2015 Update of criteria to allow inclusion of ICON 8b trial patients Change to current version Criteria Changes N/A Introduction of version control and addition of section re-SACT and monitoring National Cancer Drugs Fund – Application Form 05 June 2015 Bevacizumab for Advanced Ovarian Cancer – 1st line Page 1 National Cancer Drugs Fund Application Form – Bevacizumab for Advanced Ovarian Cancer (1st line treatment) 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 Advanced Ovarian Cancer – 1st line 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. Chemotherapy naïve advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (not licensed at this dosage) 3. 1st line indication 4. Patients must satisfy one of the following criteria: i) FIGO stage III debulked but residual disease more than 1cm OR ii) Stage IV disease OR iii) Stage III at presentation and requiring neo-adjuvant chemotherapy due to low likelihood of optimal primary surgical cytoreduction 5. Given with Carboplatin and Paclitaxel combination chemotherapy 6. Bevacizumab to start with: i) 1st or 2nd cycle of chemotherapy following primary debulking surgery, OR ii) 1st or 2nd cycle of chemotherapy following interval debulking surgery performed after 3 – 4 cycles of neo-adjuvant chemotherapy, OR iii) 1st or 2nd cycles of chemotherapy for those patients with stage IV disease or inoperable disease, OR National Cancer Drugs Fund – Application Form 05 June 2015 Bevacizumab for Advanced Ovarian Cancer – 1st line Page 2 iv) 1st cycle of neo-adjuvant chemotherapy 7. Bevacizumab dose to be 7.5mg/kg every 3 weeks 8. Maximum of 18 cycles of Bevacizumab 9. As neither this dosage of Bevacizumab nor its use in the neoadjuvant setting is licensed in ovarian cancer it must be used within the treating Trust's governance framework Note: This policy is NOT for patients with stage I-III disease who have had optimal debulking Note: These criteria also apply to patients entered into the ICON 8b trial. Clinicians should be aware that for patients randomised to the non-bevacizumab arm of ICON 8b, the use of bevacizumab in subsequent lines of treatment is not approved under current CDF criteria. Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 05 June 2015 Bevacizumab for Advanced Ovarian Cancer – 1st line 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* C56 – Malignant neoplasm of ovary 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 05 June 2015 Bevacizumab for Advanced Ovarian Cancer – 1st line Page 4