Resource impact statement
Cancer Drugs Fund technology
NICE has recommended entrectinib for use within the Cancer Drugs Fund as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children 12 years and older if:
- the disease is locally advanced or metastatic or surgery could cause severe health problems and
- they have not had an NTRK-inhibitor before and
- they have no satisfactory treatment options.
Entrectinib will be available to the NHS in line with the managed access agreement with NHS England. As part of this, NHS England and Roche have a commercial arrangement (simple discount patient access scheme and a managed access agreement including a commercial access agreement). This makes entrectinib available to the NHS with a discount. The size of the discount is commercial in confidence.
Entrectinib’s European Public Assessment Report (EPAR) has not been made available ahead of guidance publication. Once the EPAR is available, updates may be made to the managed access agreement.
The resource impact of entrectinib will be covered by the Cancer Drugs Fund budget. The cost of genetic testing is met from genomics funding that is held separately within the Cancer Drugs Fund. As part of the managed access agreement, the technology will continue to be available through the Cancer Drugs Fund after the data collection period has ended and while the guidance is being reviewed. This assumes that the data collection period ends as planned and the review of guidance follows the standard timelines described in NICE’s Cancer Drugs Fund methods guide (addendum).
The data collection period is expected to end when sufficient data have been collected to address the committee’s uncertainties. The process for exiting the Cancer Drugs Fund will begin at this point and the review of the NICE guidance will start.
The aim of the review is to decide whether or not the drug can be recommended for routine use. 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.
There may be issues related to accessing entrectinib because the genomic testing needed to identify NTRK fusion-positive solid tumours is still being established as a national service (see section 4.1 of guidance for further details). It is understood that any variation in access to genomic testing will be resolved in the next 1 to 2 years.
It is estimated that 80 to 190 people per year with NTRK fusion-positive solid tumours, and who have had all other licensed treatments, would be eligible for treatment with entrectinib.
This technology is commissioned by NHS England. Providers are NHS hospital trusts.
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