CETUXIMAB FOR THE FIRST LINE TREATMENT OF METASTATIC COLORECTAL CANCER (MCRC)

Transcription

1 CETUXIMAB FOR THE FIRST LINE TREATMENT OF METASTATIC COLORECTAL CANCER (MCRC) 1. BACKGROUND submitted evidence to NICE on the 2 nd cetuximab in the treatment of mcrc. May 2008 for the appraisal of The addition of cetuximab to chemotherapy in a selected group of patients with metastatic colorectal cancer (mcrc) identified by genotype (hence providing tailored therapy) is expected to result in increased surgical cure rates for a proportion of patients with liver only metastases. This indication is currently being appraised by NICE. The results of new data (CELIM study) significantly change the material evidence base for consideration in this appraisal and potentially may improve cost effectiveness results. This new evidence may make cetuximab the first biological treatment in mcrc to be close to the NICE threshold. In agreement with NICE this new data will be submitted at the ACD stage of the appraisal. is proposing a patient access scheme for cetuximab in combination with oxaliplatin (FOLFOX, or other equivalent oxaliplatin regimens) for the first line treatment of patients with mcrc. 2. RATIONALE FOR PATIENT ACCESS SCHEME A patient access scheme may be considered based upon the CELIM study results and updated economic analyses to confirm cost effectiveness results and meet NICE willingness to pay thresholds. Such a patient access scheme would be a joint collaboration between and the NHS in a commitment to provide the most appropriate treatment to patients and aim at increasing rates of curative surgery. 3. METHODS have undertaken significant research to be able to target patients suitable for treatment based upon genotype. Hence, it is important that patient selection for the patient access scheme is specific to as stated in NICE guidance. This scheme may consist of the following features: To enter into the scheme NICE criteria for the use of cetuximab in this setting must be adhered and confirmation provided to. Throughout the scheme details of patient registration must be provided to ensure scheme integrity and NICE criteria for use of the medication is followed. Such data will only consist of that routinely registered as per pharmacy practice for high cost drug monitoring. At a minimum this information needs to confirm if the patient is still receiving treatment. (Subject to review of pharmacy practice. ) Within the proposed scheme the usage of cetuximab in combination with FOLFOX will be rebated in the form of free stock as standard (where the Trust concludes that rebate by way of free stock is inappropriate, an alternative method of reimbursement including, but not limited to, credit notes or cash, will be provided) based upon quantity utilised at a rate of 16% for all patients within the scheme on a per patient basis. If the 16% rebate equates to a partial vial being claimed, the rebate will be rounded to the nearest vial. 4. IMPLEMENTATION The patient access scheme proposed by fits into the implementation schematic presented below. We would suggest that the acquisition of cetuximab would occur as currently observed within the NHS and then and the individual hospital pharmacist would work together to identify the rebate required.

2 Cetuximab Cetuximab Wholesaler Payment Payment Hospital Cetuximab Rebate Claim from Hospital Scheme Administration steps: 1. The Trust pharmacy will carry out a monthly/ quarterly review of usage and make a claim to within the patient access scheme for the difference. 2. authorise the claim. 3. The Trust pharmacy raises an order for agreed free stock. 4. Free stock delivered direct. Any burden of the scheme to the NHS in terms of administration is as follows: Patient registration with to ensure that patient selection criteria are maintained. A quarterly review of cetuximab usage in combination with oxaliplatin and raising an invoice for the agreed free stock. will provide claim forms to facilitate the data collection and claims procedure.

3 ERBITUX (cetuximab) Patient Access Scheme For patients requiring first line treatment of metastatic colorectal cancer (MCRC) within the NHS in England, Wales and Northern Ireland You have expressed an interest in taking part in the above scheme. This letter lays out the terms under which the scheme operates. If you agree to the terms of the agreement, please sign both copies, returning the duplicate to Ltd. 1. This agreement is effective from XXXX until the next review of Erbitux for the treatment of first line mcrc by NICE, unless terminated earlier under clause Ltd will only make payments for stock supplied by (via AAH Hospital Service) that is used within its shelf life and that has been stored as per the SmPC recommendations and used correctly. 3. The Scheme and implementation is described graphically on the attached page. 4. All claims must be made on the appropriate form (copy attached) and will be subject to approval by Ltd (i.e. have the terms of the agreement been met and is the claim form fully completed). An authorised person (on behalf of the Hospital/Trust) must sign each form and the name of that person is to be printed alongside to facilitate the timely processing of your claim. All claims must be made within 60 days of the agreed review date. Claims should not make reference to a patient by name to maintain patient confidentiality. 5. Approved claims will be rebated in the form of free replacement stock as standard. Replacement stock can all normally be processed within 5 working days of the claim being approved. If the Hospital/Trust requires an alternative method of reimbursement, including credit notes or cash refunds, these will be provided. 6. Ltd reserves the right to terminate this Agreement by giving you 1 month s notice in writing. You may also terminate this Agreement by giving 1 month s notice in writing at any time. The company will undertake to replace stock/credit for any patient(s) who has commenced Erbitux treatment at the time of Agreement termination. 7. Claims that are in breach of any clause will be treated as being in breach of the Agreement and will render the Agreement void and will mean that no rebate (replacement stock/credit/cash refund will be made to that hospital/pharmacy). 8. Terminating this Agreement for whatever reason will not affect your right to purchase Erbitux from Ltd in the future, provided always that previous invoices have been paid according to our standard terms and conditions, which will continue to apply regardless of whether you agree to take part in the Scheme. In the event of conflict between this Agreement and our standard terms and conditions, this Agreement takes precedence. Please note also that we are unable to give credit for any returned stock that has been away from AAH for more than 5 days, unless it is covered by this Scheme. 9. By signing this Agreement you acknowledge that taking part in the Erbitux Patient Access Scheme is not dependent on the purchase of certain levels of stock and that no inducement has been supplied or suggested to persuade you to take part in this scheme. 10. In the interests of patient safety, Ltd Medical Affairs Team reserves the right to review/audit Trusts for any unusual pattern of claims where it may be deemed that cetuximab may not be being used appropriately to the Scheme. This review would be of anonymised patient level data, including, patient treatment history.

4 IMPLEMENTATION Cetuximab Cetuximab Wholesaler Payment Payment Hospital Cetuximab Rebate Claim from Hospital Scheme Administration steps: 1. The Trust pharmacy will carry out a monthly/ quarterly review of usage and make a claim to Merck Serono within the patient access scheme for the difference. 2. authorise the claim. 3. The Trust pharmacy raises an order for agreed free stock. 4. Free stock delivered direct. Any burden of the scheme to the NHS in terms of administration is as follows: Patient registration with to ensure that patient selection criteria are maintained and routine clinical data are provided. A quarterly review of cetuximab usage in combination with oxaliplatin for the treatment of first line mcrc and raising an invoice for the agreed free stock. will provide claim forms to facilitate the data collection and claims procedure.

5 ERBITUX (cetuximab) Patient Access Scheme For patients requiring first line treatment of metastatic colorectal cancer (MCRC) within the NHS in England, Wales and Northern Ireland We hereby agree to the terms of the Erbitux Patient Access Scheme. I confirm that under Trust standing financial instructions I am an authorised person. For and on behalf of.nhs Hospital Trust Address Signed.. Print Name Job title. Contact Details Please list the names and job title of the individuals authorised to complete and sign the Erbitux Patient Access Scheme claim form Please return by post to: Erbitux Patient Access Scheme Commercial Department, Ltd, Bedfont Cross, Stanwell Road, Feltham. Middlesex. TW14 8NX or fax to Erbitux SmPC

6 PHARMACY DEPARTMENT CLAIM FORM - ERBITUX (cetuximab) Patient Access Scheme For patients requiring first line treatment of metastatic colorectal cancer (MCRC) within the NHS in England, Wales and Northern Ireland Hospital Name: PCO name (if applicable):. Patient Hospital Identifier:. Treating Consultant:...GP name (optional):.. Erbitux treatment start date Final Erbitux treatment date... Replacement product details:... Complete ALL the following information: The following text will be modified in line with published NICE guidance and reflect the minimum amount of appropriate data to be collected. - Please confirm the patient is/was undergoing first line treatment of metastatic colorectal cancer (MCRC): YES / NO - Vials used only for single patient and not within an Erbitux clinical trial: YES / NO - Is the patient currently treated with cetuximab in combination with oxaliplatin. YES / NO - Is the patient still responding to treatment? YES / NO - Has the patient received a surgical resection? YES / NO - Is the patient still alive (where available)? YES / NO - Number of Erbitux 20ml 5mg/ml vials claimed.. - Comments I confirm that I am an authorised person within the hospital/trust and this claim is in accordance with the terms and conditions of the ERBITUX (cetuximab) Patient Access Scheme Agreement. Name Contact number... Signed Position. address Date By post, please send to: Erbitux Patient Access Scheme Commercial Department, Ltd, Bedfont Cross, Stanwell Road, Feltham. Middlesex. TW14 8NX Should you need any further information regarding the EPAS, please call our Customer Services Team on XXXXXXXXX Further information on the EPAS is also available on (website address to be added) For Ltd Use: Approved/Non-Approved If Non-approved, add reason: Date Received: Date Passed to Drug Safety Stamp to acknowledge receipt

7 PHARMACY DEPARTMENT REGISTRATION FORM - ERBITUX (cetuximab) Patient Access Scheme For patients requiring first line treatment of metastatic colorectal cancer (MCRC) within the NHS in England, Wales and Northern Ireland Hospital Name: PCO name (if applicable):. Patient Hospital Identifier:. Treating Consultant:...GP name (optional):.. Erbitux treatment start date Please confirm the patient is acceptable for first line treatment of metastatic colorectal cancer (MCRC) with cetuximab in combination with oxaliplatin YES / NO Complete ALL the following information: The following text will be modified in line with published NICE guidance and reflect the minimum amount of appropriate data to be collected. - Vials used only for single patient and not within an Erbitux clinical trial: YES / NO - The patient is EGFR expressing and KRAS wild type tumours. YES / NO - The patient has metastatic disease confined to the liver (currently unresectable). YES / NO - Based upon clinical opinion, the patient is fit enough for potential curative surgery (including contraindications). YES / NO - There is access to hepato-billiary surgeon as part of MDT or through referral. YES / NO - The patient is appropriate for treatment with cetuximab in combination with oxaliplatin. YES / NO I confirm that I am an authorised person within the hospital/trust and this registration is in accordance with the terms and conditions of the ERBITUX (cetuximab) Patient Access Scheme Agreement. Name Contact number... Signed Position. address Date By post, please send to: Erbitux Patient Access Scheme Commercial Department, Ltd, Bedfont Cross, Stanwell Road, Feltham. Middlesex. TW14 8NX Should you need any further information regarding the EPAS, please call our Customer Services Team on XXXXXXXXX Further information on the EPAS is also available on (website address to be added) For Ltd Use: Approved/Non-Approved If Non-approved, add reason: Date Received: Date Passed to Drug Safety Stamp to acknowledge receipt

8 ERBITUX (cetuximab) Patient Access Scheme (EPAS) for patients requiring first line treatment of mcrc within the NHS England, Wales and N.Ireland- Process Flow Customer EPAS Administrator Signs EPAS agreement with and completes patient registration EPAS registration form is sent to Customer upon receipt of signed EPAS agreement Notes: 1 The EPAS consists of a simple rebate as per quantity of vials utilised Orders Erbitux and payment made Quarterly/ Monthly review of overall cetuximab in combination with oxaliplatin (e.g. FOLFOX) usage for mcrc Hospital completes EPAS claim form for replacement stock dependant on overall use in the previous Quarter/month and raise order. raise with customer No EPAS form assessed by Claim validated 3 Y/N 2 The EPAS has no connection with patient response to Erbitux treatment 3 Claim Validation to check: Claim equates to registered patient EPAS claim form completed in full and signed Yes Replacement Product/ credit note delivered to customer Instruction to despatch replacement stock as per hospital order or credit note EPAS claim logged by