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DosingSafetyClinical TrialsClinical TrialsXALKORI Clinical TrialsROS1+ NSCLC: PROFILE 1001ALK+ NSCLC: PROFILE 1014

Real World Evidence

Real World EvidenceReal World EvidenceSequential XALKORI® and Ceritinib in ALK+ NSCLCXALKORI® and Post-Progression Treatment in ALK+ NSCLC


The information on this website is based on data from adult patients with ALK (anaplastic lymphoma kinase)-positive / ROS 1-positive advanced NSCLC (non small cell lung cancer) treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics. XALKORI® (crizotinib) Prescribing Information click here. Adverse event reporting information can be found at the bottom of the page.

What does this mean for patients?

  • This guidance will be reviewed once the results of the data collection arrangement are available, as in the MAA.2
  • XALKORI® is now available for all eligible patients in England, providing the conditions in the managed access agreement are followed.1
For further information on patient eligibility please refer to the XALKORI® CDF MAA.2

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 and an instant approval will be given, provided the form is completed correctly.Access to XALKORI® in Scotland

In May 2018, the Scottish Medicines Consortium (SMC) issued their advice on the use of XALKORI® for the treatment of adults with ROS1+ advanced NSCLC.3

Recommendations set out in the SMC advice: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+ advanced NSCLC.3

What does this mean for patients?

  • XALKORI® is now available across Scotland on the NHS for adults with ROS1+ advanced NSCLC.3

CDF: Cancer Drugs Fund, FAD: final appraisal determination, MAA: managed access agreement, NICE: National Institute of Health and Care Excellence, NSCLC: non-small cell lung cancer, ROS: reactive oxygen species, SMC: Scottish Medicines Consortium 

References

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: August 2023. 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: August 2023.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: August 2023.XALKORI® Summary of Product Characteristics for Great Britain click here. XALKORI® Summary of Product Characteristics for Northern Ireland click here.
PP-XLK-GBR-1296. August 2023
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