The UK's National Institute for Health and Care Excellence (NICE) has declined to recommend Takeda's recently approved colorectal cancer therapy Fruzaqla (fruquintinib) for NHS use, determining that the treatment fails to meet cost-effectiveness thresholds.
The draft guidance acknowledges Fruzaqla's clinical benefits in extending progression-free survival and overall survival compared to placebo. However, NICE concluded there was insufficient evidence demonstrating superior survival benefits over existing treatment options for metastatic colorectal cancer patients who had previously received chemotherapy.
Clinical Evidence and Drug Profile
Fruzaqla, an oral inhibitor targeting all three VEGF receptor kinases, represents the first new targeted therapy approved in the UK in nearly a decade for metastatic disease, regardless of biomarker status. The drug's approval was supported by compelling data from the FRESCO and FRESCO-2 clinical trials, which demonstrated approximately a one-third reduction in mortality risk compared to placebo in heavily pre-treated patients when administered alongside supportive care.
Cost Considerations and Access Challenges
While specific pricing details remain confidential pending final guidance, NICE indicated that the drug's cost-effectiveness estimates fall outside the agency's acceptable range for NHS resource allocation. This decision comes despite Fruzaqla's potential advantages, including its oral administration route that enables home-based treatment and reduced hospital visits.
Professor Richard Adams of Cardiff University and the Velindre Cancer Centre emphasized the practical benefits of the medication, stating: "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. This will mean potentially fewer hospital visits and no additional capacity required at the hospital to deliver the treatment."
Next Steps and Regional Developments
Takeda's UK subsidiary has expressed disappointment with the decision but maintains its commitment to collaborating with NICE, NHS England, and clinical and patient communities to address outstanding concerns. The company aims to secure NHS access for eligible patients as quickly as possible.
Meanwhile, a separate evaluation is underway with the Scottish Medicines Consortium (SMC), with a decision anticipated in the second quarter of 2025. The drug has already secured regulatory approvals in multiple major markets, including the United States and European Union, following Takeda's $400 million licensing agreement with China's Hutchmed.
