Suggested remit: To appraise the clinical and cost effectiveness of relugolix–estradiol–norethisterone acetate within its marketing authorisation for treating pain associated with endometriosis.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 3982

Project Team

Project lead Kate Moore

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors Gedeon Richter (relugolix)
Others Department of Health and Social Care
  NHS England
Professional groups Royal College of Physicians
Comparator companies Bayer – CAU not returned, not participating
  Besins Healthcare (progesterone)
  Lupin Healthcare – CAU not returned, not participatin
  Morningside Healthcare – CAU not returned, not participating
  Mylan– CAU not returned, not participating
  Organon Pharma– CAU not returned, not participating
  Pfizer – CAU not returned, not participating
  Theramex (combined hormonal contraception)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
22 May 2024 Declaration of interests
28 March 2024 - 22 April 2024 Draft guidance
07 March 2024 Committee meeting
03 August 2023 Invitation to participate
28 March 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Relugolix–estradiol–norethisterone acetate for treating pain associated with endometriosis have been revised. It is anticipated that the appraisal will begin in early-August 2023 when we will write to you about how you can get involved.
23 January 2023 - 20 February 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
23 January 2023 In progress. Scoping commenced
22 November 2022 As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of Relugolix–estradiol–norethisterone acetate for treating pain from endometriosis. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late July 2023. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.

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