Suggested remit: To appraise the clinical and cost effectiveness of eflornithine with sulindac within its marketing authorisation for treating familial adenomatous polyposis.
As you will be aware, the Department of Health and Social Care has asked NICE to conduct an appraisal of Eflornithine with sulindac for treating familial adenomatous polyposis. On 24 June 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for eflornithine. Therefore, the appraisal of Eflornithine with sulindac for treating familial adenomatous polyposis has been suspended on the technology appraisals work programme and timelines remain to be confirmed. Upon information received from the company we note that they have requested a re-examination of the European Medicines Agency (EMA) June 2021 opinion and therefore, we will continue to monitor the situation and will update interested parties as and when the situation changes.
 
Status Suspended
Process STA 2018
ID number 1543

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
21 October 2021 Suspended. As you will be aware, the Department of Health and Social Care has asked NICE to conduct an appraisal of Eflornithine with sulindac for treating familial adenomatous polyposis. On 24 June 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for eflornithine. Therefore, the appraisal of Eflornithine with sulindac for treating familial adenomatous polyposis has been suspended on the technology appraisals work programme and timelines remain to be confirmed. Upon information received from the company we note that they have requested a re-examination of the European Medicines Agency (EMA) June 2021 opinion and therefore, we will continue to monitor the situation and will update interested parties as and when the situation changes.
13 October 2020 (14:00) Scoping workshop
20 August 2020 - 18 September 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

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