Status In progress
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process STA Standard
ID number 6357

Provisional Schedule

Final draft guidance 01 May 2025 - 16 May 2025
Expected publication 04 June 2025

Project Team

Project lead Jeremy Powell

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors Theramex (linzagolix)
Others Department of Health and Social Care
  NHS England
Patient carer groups Endometriosis UK
Professional groups Royal College of Physicians
  UK Clinical Pharmacy Association
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Adalvo (dienogest) (not participating)
  ADVANZ Pharma (pregabalin, tramadol) (not participating)
  Amarox (duloxetine, gabapentin, pregabalin, tramadol) (not participating)
  Astra Zeneca (goserelin acetate) (not participating)
  Aristo Pharma Limited (pregabalin) (not participating)
  Aspire Pharma Ltd (pregabalin, tramadol) (not participating)
  AS Kalceks (tramadol) (not participating)
  Aurobindo Pharma – Milpharm Ltd (duloxetine, gabapentin, pregabalin, tramadol) (not participating)
  A. Menarini Farmaceutica Internazionale SRL (tramadol) (not participating)
  Bayer (combined hormonal contraception, levonorgestrel, norethisterone, levonorgestrel within intrauterine delivery system)
  Besins Healthcare (progesterone, dienogest)
  Bristol Laboratories Ltd (tramadol) (not participating)
  Brown & Burk UK Ltd (amitriptyline, gabapentin, pregabalin, tramadol) (not participating)
  Colonis Pharm Ltd (gabapentin) (not participating)
  Crescent Pharma (dienogest) (not participating)
  Dr Reddy’s Laboratory (duloxetine, pregabalin, pregabalin) (not participating)
  Eli Lilly (duloxetine) (not participating)
  Esteve Pharmaceuticals (gonadorelin) (not participating)
  Ethypharm UK Ltd (tramadol) (not participating)
  Ferring Pharmaceuticals (triptorelin) (not participating)
  Flamingo (amitriptyline) (not participating)
  Gedeon Richter (relugolix CT, dienogest, levonorgestrel within intrauterine delivery system)
  Genus Pharmaceuticals (pregabalin) (not participating)
  Glenmark Pharmaceuticals Europe (gabapentin) (not participating)
  Grunenthal Ltd (tramadol)
  Hameln pharma Ltd (tramadol) (not participating)
  Ipsen Ltd (triptorelin)
  Krka UK (duloxetine, tramadol) (not participating)
  Lupin Healthcare (combined hormonal contraceptive) (not participating)
  Morningside Healthcare (combined hormonal contraception, tramadol) (not participating)
  MSN Laboratories (pregabalin) (not participating)
  Mylan (combined hormonal contraception, duloxetine, pregabalin, tramadol) (not participating)
  NAARI B.V. (dienogest) (not participating)
  Neon Healthcare (buserelin) (not participating)
  Neuraxpharm UK Ltd (duloxetine, pregabalin) (not participating)
  Northumbria Pharma Limited (pregabalin) (not participating)
  Organon Pharma (combined hormonal contraception)(not participating)
  Pfizer (combined hormonal contraception, nafarelin) (not participating)
  Ranbaxy (UK) Ltd (pregabalin) (not participating)
  Rivopharm UK (gabapentin) (not participating)
  Rosemont Pharmaceuticals (amitriptyline, pregabalin) (not participating)
  Sandoz Limited (gabapentin, pregabalin, tramadol) (not participating)
  Sigma Pharmaceuticals PLC (tramadol) (not participating)
  Stragen UK (dienogest) (not participating)
  Strides (amitriptyline, gabapentin) (not participating)
  Takeda (leuprorelin acetate) (not participating)
  Thame (amitriptyline, gabapentin) (not participating)
  Tillomed Laboratories (duloxetine, pregabalin, tramadol) (not participating)
  Upjohn UK (gabapentin, pregabalin) (not participating)
  Wockhardt UK (amitriptyline) (not participating)
  Zentiva (duloxetine, pregabalin) (not participating)
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
Relevant research groups Cochrane Gynaecology and Fertility Group

Timeline

Key events during the development of the guidance:

Date Update
28 August 2024 Invitation to participate
31 July 2024 Please note that following on from conversations between NICE and the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late August 2024.
23 April 2024 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 early February 2025. 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.
14 March 2024 - 15 April 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6357
14 March 2024 In progress. Scoping commenced.
14 July 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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