Suggested remit - To appraise the clinical and cost effectiveness of darolutamide within its marketing authorisation for treating non-metastatic hormone-relapsed prostate cancer.
Status In progress
Process STA 2018
ID number 1443

Provisional Schedule

Committee meeting: 1 09 September 2020
Expected publication 25 November 2020

Project Team

Project lead Jeremy Powell

Email enquiries

Evidence Review Group / Assessment Group Health Economics Research Unit and Health Services Research Unit, University of Aberdeen


Companies sponsors Bayer (darolutamide)
Others Department of Health and Social Care
  NHS England
  NHS South Reading CCG
  NHS Swindon CCG
  Welsh Government
Patient carer groups Black Health Agency
  Bob Champion Cancer Trust
  Cancer Black Care
  Cancer Equality
  HAWC – Help Adolescents with Cancer
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  Muslim Council of Britain
  Pelican Cancer Foundation
  PCaSO - Prostate Cancer Support Organisation
  Prostate Cancer UK
  Prostate Help Association
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tackle Prostate Cancer
  Tenovus Cancer Care
Professional groups Association of Anaesthetists
  Association of Cancer Physicians
  Association of Surgeons of Great Britain and Ireland
  British Association of Urological Nurses
  British Association of Urological Surgeons
  British Geriatrics Society
  British Institute of Radiology
  British Prostate Group
  British Psychosocial Oncology Society
  British Uro-Oncology Group
  Cancer Research UK
  Prostate Cancer Advisory group
  Royal College of Anaesthetists
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal College of Surgeons
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK Health Forum
  UK Oncology Nursing Society
  Urology Foundation


Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord (bicalutamide)
  AstraZeneca UK (bicalutamide, goserelin)
  Bayer (cyproterone acetate)
  Concordia International (leuprorelin)
  Ferring Pharmaceuticals (degarelix, triptorelin)
  Generics UK T/A Mylan (flutamide)
  Ipsen (triptorelin)
  Orion Pharma UK (histrelin)
  Sanofi (buserelin)
  Sunpharma (bicalutamide)
  Takeda UK (leuprorelin)
  Wockhardt UK (cyproterone acetate)
  Zentiva (bicalutamide)
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, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Cochrane Urology
  Genomics England
  Institute of Cancer Research
  MRC Clinical Trials Unit
  National Cancer Research Institute
  National Cancer Research Network
  National Institute for Health Research
  Ovarian & Prostate Cancer Research Trust
  Pro Cancer Research Fund
  Prostate Cancer Research Centre


Key events during the development of the guidance:

Date Update
16 January 2020 Invitation to participate
08 July 2019 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of darolutamide for treating non-metastatic hormone-relapsed prostate cancer . Please note that following on from advice received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-January 2020. 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 evidence submission.
24 April 2019 - 23 May 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
08 May 2019 In progress. Referred 24 April 2017

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance