National Cancer Drugs Fund Application Form – Lenalidomide For the treatment of myelodysplastic syndromes (MDS) associated with a deletion 5q plus one additional cytogenetic abnormality. 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 19 Jan 2015 Altered to include plus ones only. 5q deletion only NICE approved Change to current version Criteria Changes 3. Removal of “+/- one additional” and replacement with “plus one additional” National Cancer Drugs Fund – Application Form 19 Jan 2015 Lenalidomide for MDS with 5q Deletion plus one Page 1 National Cancer Drugs Fund Application Form – Lenalidomide For the treatment of myelodysplastic syndromes (MDS) associated with a deletion 5q plus one additional cytogenetic abnormality. 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 Lenalidomide for the treatment of MDS associated with a deletion 5q cytogenetic abnormality plus one additional cytogenetic abnormality TICK All 5 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. Low or intermediate risk MDS 3. Associated with an isolated deletion 5q cytogenetic abnormality PLUS one additional cytogenetic abnormality 4. Transfusion dependent anaemia (< 8 consecutive weeks without RBC transfusions within 16 weeks prior to commencing treatment) 5. Other therapeutic options insufficient OR inadequate 6. To be used within the treating Trust’s governance framework, as Lenalidomide is not licensed for this indication Note: Lenalidomide is in baseline commissioning for low and intermediate risk MDS when associated with an isolated deletion 5q cytogenetic abnormality Consultant Approval (email authority) Patient Consent Obtained (date of letter – copy to be retained on patient file) National Cancer Drugs Fund – Application Form 19 Jan 2015 Lenalidomide for MDS with 5q Deletion plus one 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* D46.6 - Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality 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 19 Jan 2015 Lenalidomide for MDS with 5q Deletion plus one Page 3