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Click here for Xalkori® (crizotinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

How to access Xalkori (crizotinib) for ROS1+ NSCLC

Access to XALKORI in England

On 31 May 2018, the National Institute for Health and Care Excellence (NICE) issued their Final Appraisal Determination (FAD) on the use of XALKORI for the treatment of ROS1-positive advanced non-small cell lung cancer (NSCLC).​​​​​​​1

RECOMMENDATIONS SET OUT IN THE NICE FAD:1
XALKORI is recommended for use within the Cancer Drugs Fund as an option for treating ROS1-positive advanced NSCLC in adults, only if the conditions in the managed access agreement are followed.

What does this mean for patients?

  • XALKORI is now available for all eligible patients in England, providing the conditions in the managed access agreement are followed​​​​​​​.​​​​​​​1
  • This guidance will be reviewed once the results of the data collection arrangement are available, as in the managed access agreement (MAA).4​​​​​​​

For further information on patient eligibility please refer to the Xalkori CDF MAA.​​​​​​​4

Access to funding via the CDF

  • Trusts can submit CDF requests online via Blueteq.*

*Blueteq is an online approval system for the management and approval of high-cost drugs, as per the agreed criteria from NHSE. The Blueteq CDF request system provides a specific form for each CDF therapy (www.blueteq.com/CDF) and an instant approval will be given, provided the form is completed correctly.

Access to XALKORI in Scotland

On 11 June 2018, the Scottish Medicines Consortium (SMC) issued their advice on the use of XALKORI for the treatment of adults with ROS1-positive advanced NSCLC.

RECOMMENDATIONS SET OUT IN THE SMC ADVICE:2
Following a full submission assessed under the ultra-orphan medicine process, XALKORI is accepted for use within NHS Scotland for the treatment of adults with ROS1-positive advanced NSCLC.

What does this mean for patients?

​​​​​​​XALKORI is now available across Scotland on the NHS for adults with ROS1-positive advanced NSCLC.


References
  1. National Institute for Health and Care Excellence. Crizotinib for treating ROS1-positive advanced non-small cell lung cancer. Final Appraisal Determination. May 2018. Available at: https://www.nice.org.uk/guidance/ta529/documents/final-appraisal-determination-document. Last accessed: December 2020. 
  2. Scottish Medicines Consortium. Crizotinib for adults with ROS1-positive advanced non-small cell lung cancer. Available at: https://www.scottishmedicines.org.uk/medicines-advice/crizotinib-xalkori-fullsubmission-132918/ Last accessed: July 2018.
  3. XALKORI Summary of Product Characteristics.
  4. National Institute for Health and Care Excellence. Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer. Managed access agreement. July 2018.Avaliable at: https://www.nice.org.uk/guidance/ta529/resources/managed-access-agreement-july-2018-pdf-4902993469. Last accessed: December 2020.
PP-XLK-GBR-1174. March 2021

Indication

  • XALKORI as a monotherapy is indicated for:3

    • The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
    • The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
    • The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)

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