National Cancer Drugs Fund Application Form – Enzalutamide for Castrate-resistant Metastatic Prostate Cancer (chemotherapy naïve for metastatic disease) Author(s) David Thomson Owner Chemotherapy Clinical Reference Group Version Control Version Control Date Revision summary Ver0.1 14 Jul 2014 Draft for discussion Ver1.0 21 Jul 2014 Final version Ver1.1 24 Oct 2014 ICD-10 code corrected; criteria 2 updated Change to current version Criteria Changes 2 Criteria split into a. and b. to allow for non-histological confirmation National Cancer Drugs Fund – Application Form 24 Oct 2014 Enzalutamide for Castrate-resistant Metastatic Prostate Cancer Chemotherapy naïve for metastatic disease Page 1 National Cancer Drugs Fund Application Form – Enzalutamide for Castrate-resistant Metastatic Prostate Cancer (chemotherapy naïve for metastatic disease) 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 chemotherapy naïve Castrate-resistant Metastatic Prostate Cancer TICK All 8 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. a. Histologically/ cytologically confirmed adenocarcimoma of the prostate OR b. Clinical suspicion of prostate cancer is high due to high PSA value (>100ng/ml) and evidence of bone metastases (identified by a positive isotope bone scan or sclerotic metastases on plain radiographs) 3. Documented metastatic disease 4. Progressive disease despite the continued use of LHRH analogues or a previous bilateral orchidectomy 5. No previous chemotherapy for metastatic disease 6. Performance status 0 or 1 7. Asymptomatic (0 or 1) or mildly symptomatic (2-3) as scored on the Brief Pain Inventory Short Form question 3 8. No previous treatment with abiraterone unless abiraterone has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 24 Oct 2014 Enzalutamide for Castrate-resistant Metastatic Prostate Cancer Chemotherapy naïve for metastatic disease Page 2 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* C61 – Malignant neoplasm of prostate 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 24 Oct 2014 Enzalutamide for Castrate-resistant Metastatic Prostate Cancer Chemotherapy naïve for metastatic disease Page 3