Suggested remit: To appraise the clinical and cost effectiveness of apalutamide within its marketing authorisation for treating localised hormone-relapsed prostate cancer.
Suspended
 
Status Suspended
Process STA 2018
ID number 1174

Project Team

Project lead Jeremy Powell

Email enquiries

Consultees

Companies sponsors Janssen (apalutamide)
Others Department of Health and Social Care
  NHS England
  NHS North East Hampshire and Farnham CCG
  NHS Swale CCG
  Welsh Government
Patient carer groups Black Health Agency
  Bob Champion Cancer Trust
  Cancer Black Care
  Cancer Equality
  HAWC
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  Muslim Council of Britain
  Orchid
  Pelican Cancer Foundation
  PCaSO - Prostate Cancer
  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

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord (bicalutamide)
  Astellas Pharma (enzalutamide)
  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 Commercial Medicines Unit
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Cochrane Urology
  Everyman
  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

Timeline

Key events during the development of the guidance:

Date Update
25 June 2019 The company that markets apalutamide has requested a meeting with OMA to determine the feasibility of conducting a molecule rather than indication specific appraisal. NICE will suspend the appraisal until the OMA engagement is complete and the most appropriate route and format to progress with the evidence submission is agreed.
15 February 2019 Following notification from the company, this appraisal has been delayed. The new timelines will be confirmed subsequently. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties as and when the situation changes.
15 February 2019 Suspended, Suspended
29 November 2018 Invitation to participate
08 August 2018 - 06 September 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
13 February 2018 In progress, DHSC referral date received

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