NICE turns down Takeda colorectal cancer drug
Takeda's recently approved advanced colorectal cancer therapy Fruzaqla has been rejected by NICE for use by the NHS on the grounds that it is not cost-effective.
In draft guidance (PDF), the health technology assessment (HTA) agency concluded that, while the data submitted for appraisal shows that Fruzaqla (fruquintinib) increases how long patients have before their cancer gets worse and how long they live compared with placebo, there is no evidence to suggest it is better than alternative treatments at extending survival.
The ongoing review covers the use of Fruzaqla to treat metastatic colorectal cancer in patients who previously received chemotherapy, with or without anti-VEGF drugs, and anti-EGFR treatment if appropriate. Fruzaqla was approved for that indication by the UK medicine regulator, the MHRA, in September.
In its guidance, NICE also said that the cost of the medicine – which remains confidential until the final guidance is published – means that cost-effectiveness estimates "are unlikely to be within the range NICE normally considers a cost-effective use of NHS resources."
Takeda's UK subsidiary said it was disappointed by the verdict, but is "committed to working closely with NICE, NHS England, and the clinical and patient communities to overcome any uncertainties in order to make fruquintinib available to eligible patients on the NHS as quickly as possible."
It added that Fruzaqla is the first new targeted treatment in almost a decade to be licensed in the UK for metastatic disease, regardless of biomarker status, and represents a step forward in the treatment of advanced colorectal cancer.
The oral drug, which inhibits all three VEGF receptor kinases, was licensed by Takeda from China's Hutchmed for $400 million upfront last year and has also been approved in the US and EU, as well as other world markets.
It has been registered on the back of data from the FRESCO and FRESCO-2 trials, which showed that it reduced the risk of death by around a third compared to placebo in this heavily pre-treated population of metastatic colorectal cancer patients when given on top of supportive care. The result was billed as "practice-changing" when it was reported at the 2022 ESMO congress.
Commenting on the NICE decision, oncologist Professor Richard Adams of Cardiff University and the Velindre Cancer Centre called for Takeda, NICE, and the clinical community to work together to reach an access agreement.
"The licensing of fruquintinib brings another option to both eligible patients and healthcare professionals and, being an oral therapy, patients can receive their treatment at home," he pointed out.
"This will mean potentially fewer hospital visits and no additional capacity required at the hospital to deliver the treatment."
A spokesperson for Takeda told pharmaphorum that a submission to the Scottish Medicines Consortium (SMC) is currently in progress with a decision expected in the second quarter of 2025.
