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
|
| Process |
STA 2018
|
| ID number |
1640
|
Project Team
| Project lead |
Shonagh D'Sylva |
Email enquiries
Consultees
| 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 |
Commentators
| 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 March 2021 - 26 March 2021
|
Appraisal consultation |
|
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 how we develop guidance, please see our page about NICE technology appraisal guidance