Suggested remit: To appraise the clinical and cost effectiveness of apalutamide within its marketing authorisation for treating localised hormone-relapsed prostate cancer.
Following on from information provided to NICE by the company in June 2019, the appraisal of Apalutamide for treating non-metastatic, hormone-relapsed prostate cancer [ID1174] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
- Status:
- Discontinued
- Technology type:
- Medicine
- Decision:
- Prioritised
- Process:
- TA
- ID number:
- 1174
Email enquiries
If you have any queries please email scheduling@nice.org.uk
Stakeholders
- 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
- 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 |
|---|---|
| 31 October 2022 | Discontinued. Following on from information provided to NICE by the company in June 2019, the appraisal of Apalutamide for treating non-metastatic, hormone-relapsed prostate cancer [ID1174] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued. |
| 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]. Please refer to https://www.nice.org.uk/guidance/indevelopment/gid-ta10423 for further information on this combined appraisal. |
| 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 our processes and methods, please see our CHTE processes and methods manual