Suggested remit: To appraise the clinical and cost effectiveness of olaparib within its marketing authorisation for treating hormone-relapsed metastatic prostate cancer after treatment with hormonal therapy such as abiraterone or enzalutamide.
 
Status In progress
Decision Selected
Process STA 2018
ID number 1640

Project Team

Project lead Shonagh D'Sylva

Email enquiries

External Assessment Group Warwick Evidence, Warwick Medical School, University of Warwick

Stakeholders

Companies sponsors AstraZeneca (olaparib)
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
  British Uro-Oncology Group
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
Comparator companies Accord (docetaxel) – not participating
  Bayer (radium-223 dichloride) – not participating
  Hospira (docetaxel) – not participating
  Sanofi (cabazitaxel) – not participating
  Seacross (docetaxel) – 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

Timeline

Key events during the development of the guidance:

Date Update
05 January 2022 - 31 January 2022 Draft guidance: 2
02 September 2021 Appraisal update: The appraisal was discussed by the technology appraisal committee on 4 August 2021. The details of the appraisal committee discussion and preliminary recommendation are not being released at this stage while discussions take place between NICE, NHS England and Improvement and the company.
04 August 2021 Committee meeting: 2
29 June 2021 Topic update: Following the end of the consultation on the appraisal consultation document, we would like to inform you that the next committee meeting for the above technology appraisal is scheduled to take place on Wednesday 4 August 2021.
05 March 2021 - 26 March 2021 Draft guidance
04 February 2021 Committee meeting: 1
19 October 2020 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recently issued a positive opinion for olaparib. The indication in this opinion is narrower than the patient population included in the company’s submission. To ensure that the Committee will have the appropriate evidence on which to base a decision the company are submitting additional analyses. The Evidence Review Group (ERG) will then critique these. It will not be possible to carry out this work before the currently scheduled Committee meeting in November and the Committee would therefore be unable to make a decision.
23 March 2020 Invitation to participate
10 January 2020 - 31 January 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
18 December 2019 In progress. Referred December 5 2017

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