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No NICE Approval for Encorafenib Plus Cetuximab for Metastatic Colorectal Cancer

In draft guidance, NICE will not be approving encorafenib plus cetuximab for treating BRAF V600E mutation-positive metastatic colorectal cancer (mCRC) in adults who have had previous systemic treatment.

The draft guidance acknowledges that the treatment has demonstrated encouraging results in clinical trials. The multinational, open-label, randomised, phase 3 BEACON CRC trial compared encorafenib plus cetuximab with FOLFIRI or irinotecan plus cetuximab. It included people with BRAF V600E mutation-positive metastatic colorectal cancer whose disease had progressed after one or two previous lines of treatment.

Results from the final August 2019 data cut-off showed that encorafenib plus cetuximab increased overall survival (9.3 months; 95% CI 8.1-11.3 months) more than the investigator's choice of FOLFIRI plus cetuximab or irinotecan plus cetuximab (5.9 months; 95% CI 5.1-7.1 months). The associated hazard ratio was 0.61 (95% CI 0.48-0.77).

The NICE appraisal committee acknowledged that encorafenib plus cetuximab prolonged survival, but noted that the control arm of BEACON CRC does not reflect clinical practice in the NHS where epidermal growth factor receptor (EGFR) inhibitors, such as cetuximab, are not recommended beyond first-line treatment for mCRC. Similarly, subsequent treatments in BEACON CRC did not reflect NHS clinical practice but may extend life, NICE acknowledged.

Encorafenib plus cetuximab meets NICE's criteria for being a life-extending treatment at the end of life but the cost-effectiveness estimates were higher than NICE thresholds and so it cannot be recommended for routine use in the NHS.

NICE said collecting further data was unlikely to address the clinical uncertainty. This combined with economic modelling showed that encorafenib plus cetuximab did not have the potential to be cost-effective compared with current treatment so it cannot be recommended for use through the Cancer Drugs Fund.

The draft guidance is now open for comment. The closing date for receipt of comments is 5 pm, Friday September 25, 2020. The expected publication date is December 23, 2020.

This article originally appeared on Univadis, part of the Medscape Professional Network.

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