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Cetuximab and Panitumumab for Previously Untreated Metastatic Colorectal Cancer

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Cetuximab and Panitumumab for Previously Untreated Metastatic Colorectal Cancer Cetuximab and panitumumab for previously untreated metastatic colorectal cancer Technology appraisal guidance Published: 29 March 2017 www.nice.org.uk/guidance/ta439 © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights). Last updated 25 September 2017 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer (TA439) Your responsibility The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance are at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 2 conditions#notice-of-rights). Last updated 25 September 2017 of 25 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer (TA439) Contents 1 Recommendations ...................................................................................................................................................... 4 2 The technologies .......................................................................................................................................................... 5 3 Evidence .......................................................................................................................................................................... 7 4 Committee discussion ............................................................................................................................................... 8 Review objectives ........................................................................................................................................................................ 8 Clinical practice ............................................................................................................................................................................ 8 Clinical effectiveness .................................................................................................................................................................. 10 Cost effectiveness ....................................................................................................................................................................... 13 Cost-effectiveness results and conclusions ...................................................................................................................... 15 End-of-life considerations ........................................................................................................................................................ 16 Innovation ....................................................................................................................................................................................... 17 Pharmaceutical Price Regulation Scheme (PPRS) 2014 .............................................................................................. 17 Summary of appraisal committee's key conclusions ...................................................................................................... 17 5 Implementation ............................................................................................................................................................ 23 6 Appraisal committee members and NICE project team ............................................................................... 24 Appraisal committee members ............................................................................................................................................... 24 NICE project team ....................................................................................................................................................................... 24 Update information ........................................................................................................................................................ 25 © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 3 conditions#notice-of-rights). Last updated 25 September 2017 of 25 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer (TA439) This guidance replaces TA176. This guidance partially replaces TA240. 1 Recommendations 1.1 Cetuximab is recommended, within its marketing authorisation, as an option for previously untreated epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in adults in combination with: • 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) or • 5-fluorouracil, folinic acid and irinotecan (FOLFIRI). 1.2 Panitumumab is recommended, within its marketing authorisation, as an option for previously untreated RAS wild-type metastatic colorectal cancer in adults in combination with: • FOLFOX or • FOLFIRI. 1.3 The drugs are recommended only when the companies provide them with the discount agreed in the patient access scheme (for panitumumab) or commercial access agreement (for cetuximab). © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 4 conditions#notice-of-rights). Last updated 25 September 2017 of 25 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer (TA439) 2 The technologies Cetuximab Panitumumab Description of Cetuximab (Erbitux, Merck Serono) is a Panitumumab (Vectibix, Amgen) the chimeric monoclonal IgG1 antibody that is is a recombinant, fully human technologies specifically directed against epidermal IgG2 monoclonal antibody that growth factor receptor (EGFR). binds with high affinity and specificity to human EGFR. Marketing Cetuximab has a marketing authorisation in Panitumumab has a marketing authorisations the UK for treating 'patients with epidermal authorisation in the UK for growth factor receptor (EGFR)-expressing, treating 'adult patients with RAS wild-type metastatic colorectal cancer: wild-type RAS metastatic colorectal cancer (mCRC): • in combination with irinotecan-based chemotherapy, • in first-line in combination with FOLFOX or FOLFIRI • in first-line in combination with FOLFOX, [folinic acid, fluorouracil and • as a single agent in patients who have irinotecan]. failed oxaliplatin- and irinotecan-based • in second-line in combination therapy and who are intolerant to with FOLFIRI for patients irinotecan'. who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens'. Please note this appraisal considered the previously untreated population only. Monotherapy for previously treated mCRC was not within the scope of the appraisal. © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 5 conditions#notice-of-rights). Last updated 25 September 2017 of 25 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer (TA439) Adverse The most frequently reported adverse The most frequently reported reactions reactions are skin reactions, adverse reactions are skin hypomagnesaemia and infusion-related reactions and gastrointestinal reactions. For full details of adverse disorders. For full details of reactions and contraindications, see the adverse reactions and summary of product characteristics. contraindications, see the summary of product characteristics. Recommended Cetuximab is given by intravenous infusion Panitumumab is given by doses and once a week. The first dose of cetuximab is intravenous infusion once every schedules 400 mg/m2 body surface area. All further 2 weeks at a dose of 6 mg/kg of doses are 250 mg/m2 of cetuximab given body weight. weekly. Prices Cetuximab costs £178.10 per 20-ml vial and Panitumumab costs £379.29 per £890.50 per 100-ml vial (excluding VAT, 5-ml vial and £1,517.16 per 'British national formulary' [BNF] online, 20-ml vial (excluding VAT, BNF October 2015). online, October 2015). The pricing arrangement considered during The company has agreed a guidance development was that Merck had patient access scheme with the agreed a patient access scheme with the Department of Health, providing Department of Health. This scheme a simple discount to the list price provided a simple discount to the list price of panitumumab with the of cetuximab with
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