Suggested remit - To appraise the clinical and cost effectiveness of apalutamide within its marketing authorisation for treating non-metastatic, hormone-relapsed prostate cancer and metastatic hormone-sensitive prostate cancer.
Status In progress
Process STA 2018
ID number 1534

Project Team

Project lead Shonagh D'Sylva

Email enquiries

Evidence Review Group / Assessment Group Southampton Health Technology Assessment Centre (SHTAC), University of Southampton


Companies sponsors Janssen (apalutamide)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Prostate Cancer UK
  Tackle Prostate Cancer
Professional groups Association of Cancer Physicians
  Association of Surgeons of Great
  British Uro-Oncology Group
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists


Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord (docetaxel, bicalutamide) (not participating)
  Advanz Pharma (leuprorelin) (not participating)
  Astellas Pharma (enzalutamide)
  AstraZeneca UK (bicalutamide, goserelin)
  Bayer (cyproterone acetate)
  Concordia International (leuprorelin) (not participating)
  Ferring Pharmaceuticals (degarelix, triptorelin) (not participating)
  Generics UK T/A Mylan (flutamide) (not participating)
  Hospira (docetaxel) (not participating)
  Ipsen (triptorelin) (not participating)
  Janssen (abiraterone)
  Orion Pharma UK (histrelin)
  Sanofi (buserelin) (not participating)
  Seacross (docetaxel) (not participating)
  Sunpharma (bicalutamide) (not participating)
  Takeda UK (leuprorelin) (not participating)
  Wockhardt UK (cyproterone acetate) (not participating)
  Zentiva (bicalutamide) (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 Institute of Cancer Research


Key events during the development of the guidance:

Date Update
20 May 2021 - 11 June 2021 Appraisal consultation: 1
08 April 2021 Committee meeting: 2
04 March 2021 Committee meeting: 1
07 May 2020 The appraisals of apalutamide for treating metastatic hormone-sensitive prostate cancer [ID1534] and apalutamide for treating non-metastatic hormone-relapsed prostate cancer [ID1174] have been combined into a single appraisal with the title apalutamide for treating prostate cancer [ID1534]. All information relating to the development of this combined appraisal can be found on this webpage.
07 May 2020 In progress. Topic is in progress
07 May 2020 Invitation to participate
25 June 2019 Suspended. 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.
21 March 2019 - 18 April 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
20 July 2018 In progress. Topic referred

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