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National Cancer Drugs Fund Application Form – Trastuzumab Emtansine (Kadcyla) For the treatment of HER2-positive locally advanced/unresectable or metastatic (Stage IV) breast cancer who previously received trastuzumab and a taxane, separately or in combination 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 15 Jan 2015 Addition of new note Change to current version Criteria Changes N/A Note added regarding use beyond CNS only progression National Cancer Drugs Fund – Application Form 12 January 2015 Trastuzumab Emtansine for metastatic breast cancer Page 1 National Cancer Drugs Fund Application Form – Trastuzumab Emtansine (Kadcyla) For the treatment of HER2-positive locally advanced/unresectable or metastatic (Stage IV) breast cancer who previously received trastuzumab and a taxane, separately or in combination 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 HER2-positive locally advanced/ unresectable or metastatic (Stage IV) breast cancer TICK All 7 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. Progression of her-2 positive locally advanced or metastatic breast cancer 3. Progression during or after the most recent treatment for advanced stage disease or within 6 months of completing treatment for early stage disease 4. Previous treatment with a taxane 5. Previous treatment with trastuzumab 6. PS 0 or 1 7. Left ventricular ejection fraction of 50% or more To minimise the risk of errors due to the similarity of the product name Trastuzumab Emtansine (Kadcyla) with that of Trastuzumab (Herceptin) the recommendations in the Risk Minimisation Plan educational material from the manufacturer should be followed when prescribing, dispensing and administering the product NOTE: not to be used beyond first disease progression outside the CNS. Do not discontinue if disease progression is within the CNS alone Consultant Approval (email authority) National Cancer Drugs Fund – Application Form 12 January 2015 Trastuzumab Emtansine for metastatic breast cancer Page 2 Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 12 January 2015 Trastuzumab Emtansine for metastatic breast cancer 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* C50 – Malignant neoplasm of breast 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 Trastuzumab Emtansine for metastatic breast cancer Page 4