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National Cancer Drugs Fund Application Form – Cetuximab for Metastatic Colorectal Cancer (3rd or Subsequent Line as a Single Agent Treatment in Patients Not Treated to Progression Under NICE TA176) 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 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 14 July 2014 Page 1 Cetuximab for Metastatic Colorectal Cancer 3rd and Subsequent Line as a Single Agent Treatment in Patients Not Treated to Progression Under NICE TA176 National Cancer Drugs Fund Application Form – Cetuximab for Metastatic Colorectal Cancer (3rd or Subsequent Line as a Single Agent Treatment in Patients Not Treated to Progression Under NICE TA176) 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 Cetuximab for Metastatic Colorectal Cancer – 3rd and Subsequent Line as a Single Agent Treatment in Patients Not Treated to Progression Under NICE TA176 TICK All 6 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. Metastatic colorectal cancer 3. a) 3rd line indication b) 4th line indication 4. Patients with wild-type RAS 5. Performance status of 0 or 1 6. Response to previous Cetuximab in the context of NICE TA176 and discontinuation at 16 weeks for consideration of surgery (and therefore not treated to disease progression) Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent comorbidities) Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 14 July 2014 Page 2 Cetuximab for Metastatic Colorectal Cancer 3rd and Subsequent Line as a Single Agent Treatment in Patients Not Treated to Progression Under NICE TA176 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 relevant box)* C18 - Malignant neoplasm of colon C19 - Malignant neoplasm of rectosigmoid junction C20 - Malignant neoplasm of rectum 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 14 July 2014 Page 3 Cetuximab for Metastatic Colorectal Cancer 3rd and Subsequent Line as a Single Agent Treatment in Patients Not Treated to Progression Under NICE TA176