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

Committee meeting: 1 01 April 2025
Expected publication 25 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 Action on Pain
  British Fibroid Trust
  Endometriosis Foundation
  Endometriosis UK
  Fertility Network UK
  Fibroid Network
  Go Girls
  Pain Concern
  Pain UK
  Pelvic Pain Support Network
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Wellbeing of Women
  Women’s Health Concern
Professional groups British and Irish Association of Robotic Gynaecological Surgeons
  British Fertility Society
  British Pain Society
  British Society for Gynaecological Endoscopy
  Primary Care Women's Health Forum
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Obstetricians and Gynaecologists
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  UK Clinical Pharmacy Association
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Adalvo (dienogest)
  ADVANZ Pharma (pregabalin, tramadol)
  Amarox (duloxetine, gabapentin, pregabalin, tramadol)
  Astra Zeneca (goserelin acetate)
  Aristo Pharma Limited (pregabalin)
  Aspire Pharma Ltd (pregabalin, tramadol)
  AS Kalceks (tramadol)
  Aurobindo Pharma – Milpharm Ltd (duloxetine, gabapentin, pregabalin, tramadol)
  A. Menarini Farmaceutica Internazionale SRL (tramadol)
  Bayer (combined hormonal contraception, levonorgestrel, norethisterone, levonorgestrel within intrauterine delivery system)
  Besins Healthcare (progesterone, dienogest)
  Bristol Laboratories Ltd (tramadol)
  Brown & Burk UK Ltd (amitriptyline, gabapentin, pregabalin, tramadol)
  Colonis Pharm Ltd (gabapentin)
  Crescent Pharma (dienogest)
  Dr Reddy’s Laboratory (duloxetine, pregabalin, pregabalin)
  Eli Lilly (duloxetine)
  Esteve Pharmaceuticals (gonadorelin)
  Ethypharm UK Ltd (tramadol)
  Ferring Pharmaceuticals (triptorelin)
  Flamingo (amitriptyline)
  Gedeon Richter (relugolix CT, dienogest, levonorgestrel within intrauterine delivery system)
  Genus Pharmaceuticals (pregabalin)
  Glenmark Pharmaceuticals Europe (gabapentin)
  Grunenthal Ltd (tramadol)
  Hameln pharma Ltd (tramadol)
  Ipsen Ltd (triptorelin)
  Krka UK (duloxetine, tramadol)
  Lupin Healthcare (combined hormonal contraceptive)
  Morningside Healthcare (combined hormonal contraception, tramadol)
  MSN Laboratories (pregabalin)
  Mylan (combined hormonal contraception, duloxetine, pregabalin, tramadol)
  NAARI B.V. (dienogest)
  Neon Healthcare (buserelin)
  Neuraxpharm UK Ltd (duloxetine, pregabalin)
  Northumbria Pharma Limited (pregabalin)
  Organon Pharma (combined hormonal contraception)
  Pfizer (combined hormonal contraception, nafarelin)
  Ranbaxy (UK) Ltd (pregabalin)
  Rivopharm UK (gabapentin)
  Rosemont Pharmaceuticals (amitriptyline, pregabalin)
  Sandoz Limited (gabapentin, pregabalin, tramadol)
  Sigma Pharmaceuticals PLC (tramadol)
  Stragen UK (dienogest)
  Strides (amitriptyline, gabapentin)
  Takeda (leuprorelin acetate)
  Thame (amitriptyline, gabapentin)
  Tillomed Laboratories (duloxetine, pregabalin, tramadol)
  Upjohn UK (gabapentin, pregabalin)
  Wockhardt UK (amitriptyline)
  Zentiva (duloxetine, pregabalin)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Campbell Collaboration Social Welfare Group
  Cochrane Gynaecology and Fertility Group
  Genomics England
  MRC Clinical Trials Unit
  National Institute for Health Research
  Pain Relief Foundation

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