Remit: To appraise the clinical and cost effectiveness of Relugolix within its marketing authorisation for treating Uterine fibroids (moderate, severe).
 
Status In progress
Technology type Medicine
Decision Selected
Process STA 2018
ID number 3842

Provisional Schedule

Final draft guidance 13 May 2022 - 27 May 2022
Expected publication 22 June 2022

Project Team

Project lead Louise Jafferally

Email enquiries

External Assessment Group Health Economics Research Unit and Health Services Research Unit, University of Aberdeen

Stakeholders

Companies sponsors Gedeon Richter (relugolix)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups FEmISA
Professional groups Royal College of Physicians
  UK Clinical Pharmacy Association
Associated guideline groups National Guideline Alliance
Associated public health groups None
Comparator companies Bayer (combined hormonal contraception, levonorgestrel, norethisterone) (confidentiality agreement signed, participating)
  Gedeon Richter (levonorgestrel) (confidentiality agreement signed, participating)
  Ipsen (triptorelin) (confidentiality agreement signed, participating)
  Takeda UK (leuprorelin) (confidentiality agreement signed, participating)
  AstraZeneca (goserelin) (confidentiality agreement not signed, not participating)
  Besins Healthcare (progesterone) (confidentiality agreement not signed, not participating)
  Lupin Healthcare (combined hormonal contraceptive) (confidentiality agreement not signed, not participating)
  Morningside Healthcare (combined hormonal contraception) (confidentiality agreement not signed, not participating)
  Mylan (combined hormonal contraception) (confidentiality agreement not signed, not participating)
  Novo Nordisk (oestradiol and norethisterone acetate) (confidentiality agreement not signed, not participating)
  Organon Pharma (combined hormonal contraceptive) (confidentiality agreement not signed, not participating)
  Pfizer (combined hormonal contraception, medroxyprogesterone, norethisterone) (confidentiality agreement not signed, not participating)
  Wockhardt UK (norethisterone) (confidentiality agreement not signed, not participating)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups None

Timeline

Key events during the development of the guidance:

Date Update
06 April 2022 Committee meeting: 1
18 October 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of relugolix with oestradiol and norethisterone acetate for treating uterine fibroids. Please note that following on from a request received from the company, the timelines for this appraisal have been revised.
23 April 2021 Invitation to participate
12 February 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of Relugolix with oestradiol and norethindrone acetate for heavy menstrual bleeding associated with uterine fibroids. 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 during late-April 2021 when we will write to you about how you can get involved. These timelines are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive submission.
20 January 2021 (10:00) Scoping workshop (Manchester)
23 November 2020 - 18 December 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
15 October 2020 In progress. DHSC referral received

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