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 |
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Draft guidance: 2 |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Draft guidance |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