1 Recommendations
1.1 Regorafenib is recommended as an option for treating unresectable or metastatic gastrointestinal stromal tumours in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib, only if:
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their Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1 and
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the company provides regorafenib with the discount agreed in the patient access scheme.
1.2 When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.
1.3 These recommendations are not intended to affect treatment with regorafenib that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Current treatment for unresectable or metastatic gastrointestinal stromal tumours after disease progression on, or intolerance to, prior treatment with imatinib and sunitinib is best supportive care.
The evidence shows that people having regorafenib have longer before their disease progresses compared with those having best supportive care. However there is some uncertainty around how long regorafenib increases the overall length of time people live compared with those on best supportive care.
Regorafenib meets NICE's criteria to be considered a life-extending end-of-life treatment, and the most plausible cost-effectiveness estimate is around £44,000 per quality-adjusted life year gained. Therefore it can be recommended for use in the NHS.
Regorafenib is only recommended for people who have an ECOG performance status of 0 to 1 because in clinical practice, regorafenib is only expected to be used in people who have an ECOG performance status of 0 to 1; there is limited evidence for its use in people with a performance status of 2 or more.