Suggested remit: To appraise the clinical and cost effectiveness of infigratinib within its marketing authorisation for treating cholangiocarcinoma.
For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
 
Status Suspended
Technology type Medicine
Decision Selected
Process TA
ID number 3992

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Timeline

Key events during the development of the guidance:

Date Update
13 February 2023 Suspended. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
15 August 2022 The National Institute for Health and Care Excellence (NICE) has been asked to consider an evaluation of infigratinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement ID3992. We have recently invited stakeholders to respond to a written consultation on the draft scope for this proposed evaluation. Following a recent update from the company that market infigratinib, NICE has agreed that continuing the scoping exercise at this time would not be appropriate. As a consequence of this, the draft scope consultation has been cancelled. We apologise for any inconvenience this may cause. The scoping exercise will be rearranged for later date. If you have any comments or concerns, please contact the Scoping Project Manager for this proposed evaluation Emily Richards on (44 (0)161 413 4070 or via email on emily.richards@nice.org.uk).
24 November 2021 In progress. DHSC referral received

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