To appraise the clinical and cost effectiveness of lifitegrast within its marketing authorisation for treating dry eye disease.
Suspended
 
Status Suspended
Decision Selected
Process STA 2018
ID number 1229

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
09 July 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of lifitegrast for treating dry eye disease. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the European Medicines Agency 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.
08 July 2019 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of lifitegrast for treating dry eye disease. Please note that following on from advice received from the company, the timelines for this appraisal remain to be confirmed. This follows the announcement in May 2019 that Takeda entered into agreements to divest its Xiidra® (lifitegrast ophthalmic solution) 5% product (“Xiidra®”) to Novartis. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
24 June 2019 Suspended. Suspended
20 July 2018 In progress. Following a regulatory update from the company (Shire Pharmaceuticals) this appraisal has been rescheduled. The timelines have been revised and the appraisal is now expected to start in June 2019, with the deadline for submissions August 2019. The appraisal will follow the new technology appraisal process (April 2018).
05 September 2017 (00:00) Scoping workshop
17 July 2017 - 14 August 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

For further information on our processes and methods, please see our CHTE processes and methods manual