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National Cancer Drugs Fund Application Form – Ibrutinib For Relapsed/ Refractory Chronic Lymphocytic Leukaemia Author(s) David Thomson Owner Chemotherapy Clinical Reference Group Version Control Version Control Date Revision summary Ver1.1 12 Jan 2015 New indication Ver1.1 19 Jan 2015 Addition of new note Ver1.2 04 Nov 2015 Update to criteria 3 and 9 Change to current version Criteria Changes 3 Addition of “anti-CD20-containing chemoimmunotherapy regimen” 9 Addition of scenario where prior idelalisib allowed National Cancer Drugs Fund – Application Form 04 November 2015 Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia Page 1 National Cancer Drugs Fund Application Form – Ibrutinib for Relapsed/ Refractory Chronic Lymphocytic Leukaemia 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 Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia TICK All 9 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. Confirmed CLL 3. Must have received at least one prior anti-CD20-containing chemoimmunotherapy regimen for CLL 4. Considered not appropriate for treatment or retreatment with purine analogue based therapy due to: a. Failure to respond to chemoimmunotherapy OR b. A progression-free interval of less than 3 years OR c. Age of 70yrs or more OR d. Age of 65yrs or more plus the presence of comorbidities OR e. A 17p or TP53 deletion 5. Performance status of ECOG 0-2 6. A neutrophil count of ≥0.75 x 10⁹/l 7. A platelet count of ≥30 x 10⁹/l 8. Patient not on warfarin or CYP3A4/5 inhibitors National Cancer Drugs Fund – Application Form 04 November 2015 Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia Page 2 9. No prior treatment with idelalisib unless idelalisib has had to be stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression Note: Patients receiving Ibrutinib via the compassionate use programme should not be switched to CDF funding. Free of charge supplies from the manufacturer should continue to be used in these patients until NICE approval and as per the terms of the compassionate use programme Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 04 November 2015 Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia 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* C91.1 – Chronic lymphocytic leukaemia of B-cell type 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 04 November 2015 Ibrutinib for relapsed/ refractory Chronic Lymphocytic Leukaemia Page 4