The National Institute for Health and Care Excellence (NICE) has back Pierre Fabre’s Braftovi plus cetuximab for the treatment of BRAF-positive metastatic colorectal cancer.

In September, NICE initially turned down Braftovi (encorafenib) after finding that the cost-effectiveness estimates were higher than what is normally considered value for money for the NHS.

However, NICE has now decided to recommend the drug in combination with cetuximab for BRAF V600E mutation-positive metastatic colorectal cancer (mCRC) in adults who have had previous systemic treatment.

The NICE decision is based on results from the phase III BEACON CRC trial, which showed that Braftovi plus cetuximab significantly improved median overall survival in patients with BRAF V600E-mutated mCRC and reduced the risk of death by 39%.

The combination treatment also produced an improved objective response rate compared to the control arm.

“We are delighted that NICE has recognised the value of Braftovi plus cetuximab for this high medical-need population,” said Laura McMullin, general manager UK & Ireland, Pierre Fabre.

“Securing NHS reimbursement is the culmination of collaborative discussions that we have been having with NICE and NHS England since the end of last year.

“In particular, we would like to recognise the efforts of NHS England who have consistently supported appropriate access for this treatment. The result underscores our commitment to the colorectal cancer community and we hope that as many people as possible will benefit from this innovative treatment,” she added.