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National Cancer Drugs Fund Application Form – TAL1_v1.0 Talimogene Laherparepvec For the treatment of unresectable regionally or distantly metastatic melanoma in adults Author(s) David Thomson, Peter Clark Owner Chemotherapy Clinical Reference Group Version Control Version Control Date Revision summary Ver1.0 09-Aug-2016 New form following NICE FAD and interim funding Change to current version Criteria Changes National Cancer Drugs Fund – Application Form Page 1 TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma National Cancer Drugs Fund Application Form – TAL1_v1.0 Talimogene Laherparepvec For the treatment of unresectable and regionally or distantly metastatic melanoma in adults Instructions to Consultants: Log in to https://www.blueteq-secure.co.uk/trust/Default.aspx to select this form for CDF access to this drug, Complete each section of the form electronically (the boxes will enlarge to contain more text). Please submit electronically. Security of Patient Identifiable Information: The patient will be identified by their NHS number only. Do not include any other patient identifiers. All communication must be sent to the Cancer Drugs Fund Office via secure e mail accounts: that is from an nhs.net account to [email protected] Receipt of Application: You will receive an acknowledgement and a unique Cancer Drugs Fund reference. Please forward to your Trust’s link accountant / corporate contracting team. Cancer Drugs Fund Policy: To check the status of a particular therapy please check the Cancer Drugs Fund Policy at www.england.nhs.uk/ourwork/cancer/cdf 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 metastatic melanoma All 8 conditions must be met 1. Application made by and first cycle of treatment to be prescribed and administered by a consultant specialist experienced in the treatment of melanoma 2. Treatment can only be given by specialists trained to give intra-lesional injections of talimogene 3. Patients must have cutaneous, subcutaneous or nodal deposit(s) of melanoma which is/are suitable for direct injection but which is/are not surgically resectable 4. Stage IIIB, IIIC or IVM1a disease according to the AJCC stage criteria of 2009 7th edition and those with stage IVM1a disease (ie metastases to skin, subcutaneous tissue or distant lymph nodes) must have a normal serum LDH 5. Patients should not have bone, brain, lung or any other visceral secondaries and if stage IVM1a disease, the serum LDH should not be elevated 6. Treatment with talimogene must be sanctioned by a specialist multi-disciplinary team meeting which includes an oncologist and a surgeon with expertise in the management of metastatic and locally advanced melanoma, respectively 7. Treatment with talimogene should only be given to patients in whom systemically administered immunotherapies or approved targeted therapies are not considered the best option for the patient by a specialist multi-disciplinary team meeting which includes an oncologist and a surgeon with expertise in the management of metastatic and locally advanced melanoma, respectively 8. Talimogene is only to be administered as a single agent and not in combination with systemic therapies eg chemotherapy, targeted agents or immunotherapy unless in the context of a Health Research Authority clinical trial Consultant Approval (email authority) National Cancer Drugs Fund – Application Form Page 2 TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma TICK Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form Page 3 TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma 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 Page 4 TAL1_v1.0 Talimogene Laherparepvec for metastatic melanoma