Resource impact statement
Cancer Drugs Fund
NICE has recommended sotorasib for use within the Cancer Drugs Fund as an option for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults whose disease has progressed on, or who cannot tolerate, platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy. It is recommended only if the conditions in the managed access agreement for sotorasib are followed.
This recommendation is not intended to affect treatment with sotorasib that was started in the NHS before the guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before the guidance was published, until they and their NHS clinician consider it appropriate to stop.
Sotorasib will be available to the NHS in line with the managed access agreement with NHS England. As part of this, NHS England and Amgen have a commercial access agreement that makes sotorasib available to the NHS at a reduced cost. The financial terms of the agreement are commercial in confidence.
It is estimated that around 850 people per year with KRAS G12C mutation-positive locally advanced or metastatic NSCLC are eligible for treatment with sotorasib.
When NICE recommends a treatment as an option for use within the Cancer Drugs Fund, NHS England will make it available according to the conditions in the managed access agreement. This means that, if a patient has previously treated KRAS G12C mutation-positive advanced NSCLC and the doctor responsible for their care thinks that sotorasib is the right treatment, it should be available for use, in line with NICE's recommendations and the Cancer Drugs Fund criteria in the managed access agreement.
The resource impact of sotorasib will be covered by the Cancer Drugs Fund budget. More evidence on sotorasib is being collected until further follow-up data from CodeBreaK100 trial and direct comparative data with docetaxel from CodeBreaK200 trial are available. After this, NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then. Further information can be found in NHS England’s Appraisal and Funding of Cancer Drugs from July 2016 (including the new Cancer Drugs Fund) - A new deal for patients, taxpayers and industry.
This technology is commissioned by NHS England. Providers are NHS hospital trusts.
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