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Be Bevacizumab vacizumab in combination with paclitax paclitaxel el and carboplatin for first-line treatment of advanced o ovarian varian cancer Technology appraisal guidance Published: 22 May 2013 nice.org.uk/guidance/ta284 © NICE 2018 All rights reserved Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights) Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer (TA284) 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 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 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 2018 All rights reserved Subject to Notice of rights (https://www.nice.org.uk/terms-andconditions#notice-of-rights) Page of 42 Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer (TA284) Contents Guidance The technology The manufacturer's submission Consideration of the evidence 14 Clinical effectiveness 15 Cost effectiveness 20 Summary of Appraisal Committee's key conclusions 23 Implementation 30 Related NICE guidance 31 Published 31 Under development 31 Review of guidance 32 Appraisal Committee members and NICE project team 33 8.1 Appraisal Committee members 33 8.2 NICE project team 36 Sources of evidence considered by the Committee 37 Changes after publication 40 About this guidance 41 © NICE 2018 All rights reserved Subject to Notice of rights (https://www.nice.org.uk/terms-andconditions#notice-of-rights) Page of 42 Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer (TA284) Guidance Please note that NICE can only issue guidance on any drug within the terms of its marketing authorisation Consequently, bevacizumab for first-line treatment of advanced ovarian cancer has only been appraised at its licensed dose of 15 mg/kg body weight 1.1 Bevacizumab in combination with paclitaxel and carboplatin is not recommended for first-line treatment of advanced ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] stages IIIB, IIIC and IV epithelial ovarian, fallopian tube or primary peritoneal cancer) 1.2 People currently receiving bevacizumab for first-line treatment of advanced ovarian cancer should be able to continue treatment until they and their clinicians consider it appropriate to stop © NICE 2018 All rights reserved Subject to Notice of rights (https://www.nice.org.uk/terms-andconditions#notice-of-rights) Page of 42 Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer (TA284) The technology 2.1 Bevacizumab (Avastin, Roche) is a humanised monoclonal antibody that inhibits both vascular endothelial growth factor (VEGF)-induced signalling and VEGFdriven angiogenesis This reduces vascularisation of tumours, thereby inhibiting tumour growth Bevacizumab is administered by intravenous infusion Bevacizumab in combination with carboplatin and paclitaxel has a UK marketing authorisation for 'the front-line treatment of advanced (International Federation of Gynaecology and Obstetrics [FIGO] stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer' The licensed dose is 15 mg/kg body weight given once every weeks in addition to carboplatin and paclitaxel for up to cycles of treatment, followed by continued use of bevacizumab as single agent until disease progression, or for a maximum of 15 months, or until unacceptable toxicity is reached, whichever occurs earlier 2.2 The summary of product characteristics lists the following adverse reactions that may be associated with bevacizumab treatment: gastrointestinal perforations, fistulae, wound healing complications, hypertension, proteinuria, arterial and venous thromboembolism, haemorrhage, pulmonary haemorrhage or haemoptysis, congestive heart failure, posterior reversible encephalopathy syndrome, hypersensitivity or infusion reactions, osteonecrosis of the jaw, ovarian failure and neutropenia For full details of adverse reactions and contraindications, see the summary of product characteristics 2.3 Bevacizumab is available in 100 mg and 400 mg vials at prices of £242.66 and £924.40 respectively (excluding VAT; 'British national formulary' [BNF] edition 64) The manufacturer estimated the cost of bevacizumab (excluding VAT and assuming wastage) to be £36,078 for a patient weighing 65 kg at a dosage of 15 mg/kg every weeks, amounting to an average monthly cost of £2577 Costs may vary in different settings because of negotiated procurement discounts © NICE 2018 All rights reserved Subject to Notice of rights (https://www.nice.org.uk/terms-andconditions#notice-of-rights) Page of 42 Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer (TA284) The manufacturer's submission The Appraisal Committee (section 8) considered evidence submitted by the manufacturer of bevacizumab and a review of this submission by the Evidence Review Group (ERG; section 9) 3.1 The key evidence for the clinical effectiveness of bevacizumab plus paclitaxel and carboplatin came from randomised controlled trial (GOG-0218) The trial assessed the efficacy and safety of bevacizumab (at its licensed dose of 15 mg/ kg body weight) plus paclitaxel and carboplatin in people with previously untreated stage III (incompletely resected) or stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer who had undergone debulking surgery This evidence was supported by results from a randomised open-label trial (ICON7) that assessed the efficacy and safety of bevacizumab at an unlicensed dose (7.5 mg/kg body weight) plus paclitaxel and carboplatin in people with high-risk early stage or advanced epithelial ovarian, fallopian tube or primary peritoneal cancer 3.2 GOG-0218 was a double-blind randomised placebo-controlled multicentre trial conducted in North America and Asia, and included 1873 patients with previously untreated stage III or stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer who had undergone debulking surgery The trial was for up to 15 months and patients were randomised to of treatment arms: The CPP (carboplatin, paclitaxel and placebo) control group (n=625) received standard chemotherapy (carboplatin at a target area under the curve of mg/ml•min and paclitaxel 175 mg/m2 every weeks for cycles), plus placebo for cycles to 22 The CPB15 (carboplatin, paclitaxel and bevacizumab [15 mg/kg]) group (n=625) received the same standard chemotherapy as the CPP group, plus bevacizumab (15 mg/kg) for cycles to and placebo as monotherapy for cycles to 22 The CPB15+ group (n=623) received the same standard chemotherapy as the CPP group, plus bevacizumab (15 mg/kg) for cycles to 22 3.3 Cycles lasted weeks and treatment was discontinued at the onset of disease progression, unacceptable toxic effects, completion of all 22 cycles or withdrawal Patients in the control arm were allowed to cross over to receive bevacizumab after disease progression Randomisation was stratified for Gynaecologic Oncology Group (GOG) performance status (0, or 2), and cancer © NICE 2018 All rights reserved Subject to Notice of rights (https://www.nice.org.uk/terms-andconditions#notice-of-rights) Page of 42 Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer (TA284) stage and debulking status (optimally debulked stage III [with maximum residual lesion diameter of cm or less], suboptimally debulked stage III [with maximum residual diameter of more than cm] or stage IV) The primary outcome was progression-free survival (PFS), defined as the period from randomisation to disease progression or death Progression was assessed by the investigator based on any of the following measures: global clinical deterioration, Response Evaluation Criteria in Solid Tumours (RECIST) or rising serum cancer antigen-125 (CA-125) CA-125 progression was defined as at least twice the nadir or upper limit of normal Secondary outcomes included overall survival, objective response rate and health-related quality of life measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire, the Ovarian Cancer Subscale measure and abdominal discomfort score 3.4 The primary efficacy analysis of PFS used censored data from September 2009 in which patients with disease progression based on rising serum CA-125 alone and patients who received non-protocol therapies before progression were censored at the time of their previous scan and excluded from the analysis Based on an investigator assessment, the censored data showed a statistically significant improvement of months in the difference between the median PFS of the CPB15+ arm and the CPP arm (CPP 12 months, CPB15+ 18 months; hazard ratio [HR] 0.645, 95% confidence interval [CI] 0.551 to 0.756, p
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