Early Access to Medicines Scheme Pembrolizumab for the ...



Early Access to Medicines Scheme Application Form – PembrolizumabFor the treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 Author(s)David ThomsonOwnerChemotherapy Clinical Reference GroupVersion ControlVersion ControlDateRevision summaryVer0.115 March 2016Draft version for discussion and approvalChange to current versionCriteriaChangesNANAPEMO2-v0.1 Early Access to Medicines Scheme (EAMS)Application FormPembrolizumabFor the treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1Instructions to Consultants: Notifications can be submitted via england.eams@ 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 NHS England Office dealing with EAMS notifications via secure e mail accounts: that is from an account to england.eams@Receipt of Application: The sender of the application will receive an acknowledgement, together with details of the unique EAMS reference.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.EAMS Treatment Required for the treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1TICKAll 5 conditions must be metApplication 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 FORMTEXT ?????Patient is an adult with metastatic non-small cell lung cancer (NSCLC) who has not received prior systemic therapy ORPatient is an adult with metastatic NSCLC whose disease has progressed on or after platinum-containing chemotherapy. Patients with an EGFR sensitising mutation or ALK translocation should also have disease progression on approved therapies for these aberrations prior to receiving pembrolizumabThe patient has been tested for and shown to express PDL-1 on at least 50% of tumour cellsA specific patient access form for pembrolizumab EAMS has been completed and submitted to MSD * FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????The treating Trust has to formally agree to comply with full SACT dataset completionNOTE: SACT returns will be monitored on a regular basis and Trusts failing to comply with point 3 may have their access to the EAMS for new patients restricted FORMTEXT ?????Consultant Approval (email authority) FORMTEXT ?????Patient Consent Obtained (date of letter – copy to be retained on patient file) FORMTEXT ???????To register a patient for the EAMS program for NSCLC please contact MSD on 01992452740 or by email at pembrolizumabEAMS@. Proposed Start Date for Therapy (add clinic date)*: FORMTEXT ?????Consultant details* (including signature or email confirmation) Name: FORMTEXT ?????Hospital: FORMTEXT ?????Address: FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Post Code: FORMTEXT ?????Telephone: FORMTEXT ????? FORMTEXT ?????Trust Pharmacist - details of the Trust where the patient will be treated*Name: FORMTEXT ?????Hospital: FORMTEXT ?????Address: FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Post Code: FORMTEXT ?????Telephone: FORMTEXT ????? FORMTEXT ?????Mandatory - NHS No*:Mandatory – Patients date of birth*Optional – Hospital No.NHS No: FORMTEXT ?????DOB: FORMTEXT ?????Hospital No: FORMTEXT ?????Clinical Commissioning Group*CCG Name: FORMTEXT ?????Patient’s GP*(name, address, telephone)Name: FORMTEXT ?????Address: FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Post Code: FORMTEXT ?????ICD-10 Code*C34.9 tumour of the lungHRG Code FORMTEXT ?????Completion of items marked with * is mandatory. Failure to complete these items may mean that future access to this drug for new patients will not be available ................
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