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National Cancer Drugs Fund Application Form – Ipilimumab and Nivolumab For the treatment of advanced (unresectable or metastatic) melanoma in adults Author(s) David Thomson Owner Chemotherapy Clinical Reference Group Version Control Version Control Date Revision summary Ver1.0 29 Jul 2016 New form following NICE FAD and interim funding Ver1.1 18 Aug 2016 Updates to criteria 5 and 6 and addition of new note Change to current version Criteria Changes 5 Detail added regarding adjuvant treatment in trials 6 Detail added NOTE Addition of new note regarding treatment breaks National Cancer Drugs Fund – Application Form 18 Aug 2016 Ipilimumab and Nivolumab for melanoma Page 1 National Cancer Drugs Fund Application Form – Ipilimumab and Nivolumab For the treatment of advanced (unresectable or metastatic) melanoma 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 the treatment of advanced (unresectable or metastatic) melanoma 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. Histologically confirmed stage III (unresectable) or stage IV melanoma 3. PS 0 or 1 4. No previous treatment with any of anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody. 5. Only prior systemic therapy allowed is either adjuvant treatment given in a clinical trial (but no treatment types as listed above in criterion 4) or tyrosine kinase inhibitors targeting BRAF and MEK or monotherapy targeting BRAF 6. No active brain metastases or leptomeningeal metastases ie brain secondaries previously treated with surgery or stereotactic radiotherapy and considered to be stable NOTE: Treatment breaks are allowed as long as these are solely for toxicity and each cycle commences within 12 weeks of the start date of the previous cycle of treatment NOTE: In the interim funding period both ipilimumab and nivolumab will be funded from the CDF National Cancer Drugs Fund – Application Form 18 Aug 2016 Ipilimumab and Nivolumab for melanoma Page 2 Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 18 Aug 2016 Ipilimumab and Nivolumab for melanoma 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* C43 – Malignant melanoma of skin 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 18 Aug 2016 Ipilimumab and Nivolumab for melanoma Page 4