Advice
NICE is unable to make a recommendation about the use in the NHS of entrectinib for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in people 12 years and over. Roche has confirmed that it does not intend to make a complete evidence submission to NICE for the appraisal. Roche considers that challenges in integrating the identification of eligible people within the existing NHS care pathway resulted in a low number of people accessing treatment with entrectinib. Subsequently, the evidence collected while entrectinib was in the Cancer Drugs Fund (NICE technology appraisal guidance 644) is insufficient to evaluate whether entrectinib is a cost-effective use of NHS resources.
NICE and Roche have considered all the options for producing guidance on entrectinib for this indication. The decision to terminate this appraisal has not been taken lightly.
For data collected when this technology was in the Cancer Drugs Fund, see the National Disease Registration Service's data report on entrectinib. Data from the Roche STARTRK-2 clinical trial will be published on the NICE website when available.
Information
If NHS organisations wish to consider entrectinib for this indication, they should follow the advice on rational local decision making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when there is no NICE guidance.
This treatment was made available through the Cancer Drugs Fund while further data was collected. People already having entrectinib for NTRK fusion-positive solid tumours can continue until they and their NHS healthcare professional consider it appropriate to stop. Please note that this decision does not impact NHS access to entrectinib for treating ROS1-positive advanced non-small-cell lung cancer (NICE technology appraisal guidance 643).
NICE will review the position if the company decides that it wants to make an evidence submission.
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