Suggested remit: To appraise the clinical and cost effectiveness of talazoparib with enzalutamide within its marketing authorisation for treating hormone-relapsed metastatic prostate cancer in people who have not had prior systemic treatment.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 4004

Project Team

Project lead Vonda Murray

Email enquiries

Stakeholders

Companies sponsors Pfizer
Others Department of Health and Social Care
  NHS England
  Heath Technology Wales
Patient carer groups Black Health Agency for Equality
  Bob Champion Cancer Trust
  Cancer Black Care
  Cancer Equality
  Caribbean and African Health Network
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Macmillan Cancer Support
  Maggie's Centres
  Marie Curie
  Orchid
  PCaSO - Prostate Cancer Support Organisation
  Pelican Cancer Foundation
  Prost8 UK
  Prostate Cancer Research
  Prostate Cancer UK
  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 Oncology Pharmacy Association
  British Psychosocial Oncology Society
  British Society of Urogenital Radiology
  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 of England
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK Oncology Nursing Society
  Urology Foundation
Associated guideline groups NICE - National Guideline Alliance
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Accord (abiraterone)
  Aristo Pharma (abiraterone)
  Astellas Pharma (enzalutamide)
  AstraZeneca (olaparib)
  Axunio Pharma (abiraterone, olaparib)
  Celix Pharma (abiraterone)
  Cipla (abiraterone)
  Dr. Reddy's Laboratories (abiraterone)
  Genus Pharmaceuticals (abiraterone)
  Janssen (abiraterone)
  Krka (abiraterone)
  Ranbaxy (abiraterone)
  Sandoz (abiraterone)
  Teva (abiraterone)
  Tillomed Laboratories (abiraterone)
  Torrent Pharma (abiraterone)
  Viatris UK Healthcare (abiraterone)
  Wockhardt UK (abiraterone)
Evidence review group Peninsula Technology Assessment Group (PenTAG)
  National Institute for Health Research Health Technology Assessment Programme (NETSCC)
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
  National Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Cochrane UK
  Cochrane Urology
  Genomics England
  Institute of Cancer Research
  MRC Clinical Trials Unit
  National Cancer Research Institute
  National Institute for Health Research
  Pro Cancer Research Fund
  Prostate Cancer Research Centre

Timeline

Key events during the development of the guidance:

Date Update
15 July 2024 Invitation to participate
17 June 2024 - 01 July 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
17 June 2024 In progress. In progress
23 August 2023 Suspended. Please note the company has informed NICE that it will not provide an evidence submission for this appraisal at this time. Therefore, we are suspending the appraisal while we consider the next steps.
31 July 2023 - 04 August 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 1234
10 July 2023 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 September 2023. 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.
04 November 2022 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer. Please note that following on from information received from the company, the timelines for this appraisal will be aligned with the latest regulatory and UK launch expectations and further information regarding the scheduling of this appraisal will be available in due course. NICE will continue to monitor any developments and will update interested parties as and when the situation changes.
02 September 2022 - 30 September 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
02 September 2022 In progress. Scoping commenced
05 August 2022 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of Talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during late November 2022.
12 April 2022 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer. Following on from advice received from the company the timelines for this appraisal are to be aligned with the latest regulatory expectations and further information regarding the scheduling of this appraisal will be available in due course.

For further information on our processes and methods, please see our CHTE processes and methods manual