Suggested remit - To appraise the clinical and cost effectiveness of L-glutamine within its marketing authorisation for preventing painful crises in sickle cell disease in people aged 5 years and over.
As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of L-glutamine for treating sickle cell disease. However, the company have advised that during June 2019 the Committee for Medicinal Products for Human Use (CHMP) have adopted a negative opinion, recommending the refusal of the marketing authorisation for L-glutamine intended for treating sickle cell disease and the company is requesting an appeal. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes
 
Status Suspended
Process STA 2018
ID number 1523

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
19 June 2019 Suspended, As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of L-glutamine for treating sickle cell disease. However, the company have advised that during June 2019 the Committee for Medicinal Products for Human Use (CHMP) have adopted a negative opinion, recommending the refusal of the marketing authorisation for L-glutamine intended for treating sickle cell disease and the company is requesting an appeal. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes
12 March 2019 (10:00) Scoping workshop (London)
23 January 2019 - 20 February 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance