Authors' recommendations: Despite some methodological limitations, the E2100 trial provides direct evidence to suggest that the addition of bevacizumab to q.w. paclitaxel increases PFS and objective response in the first-line treatment of mBC. This trial fails to show a significant benefit in terms of OS. The ERG noted that the manufacturer inappropriately excluded the large relevant AVADO trial in which the docetaxel dosing regime was generally reflective of UK current practice. The ERG extracted the limited available published data from this trial, which reported a markedly smaller benefit in terms of PFS and response rate of adding bevacizumab to docetaxel than was reported for adding bevacizumab to q.w. paclitaxel in E2100 (see Table 1). The AVADO trial also reported a non-significant benefit in combination therapy versus docetaxel monotherapy in terms of OS. Given the considerable limitations in the evidence selected and methods used for the indirect comparison, the manufacturer's reporting of a statistically significant benefit of bevacizumab plus q.w. paclitaxel over the currently recommended first-line treatment of docetaxel monotherapy cannot be considered reliable. The cost-effectiveness analysis presented by the manufacturer included judgements and assumptions that are subject to uncertainty. The manufacturer's most optimistic analyses suggested an ICER for BEV + PAC versus PAC q.w. of £77,000 per QALY gained using PASA prices for PAC and a 10-g cap on BEV, and £118,000 using NHS list prices. Further analysis by the ERG suggested that more pessimistic assumptions about the relative impact of bevacizumab on OS can increase the ICERs yet further, and, based on current prices, no plausible changes to the model assumptions will bring the ICER for BEV + PAC versus PAC q.w. within the threshold currently considered cost-effective by NICE.

Project Status: Completed

Year Published: 2011

URL for published report: http://www.hta.ac.uk/erg/supplements/supplement1501.pdf#nameddest=article01

URL for additional information: http://www.hta.ac.uk/2241

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

Copyright: 2011 Queen's Printer and Controller of HMSO