SMC Consultation on Olaparib
The Scottish Medicines Consortium (SMC) are consulting on whether Olaparib should be made available on the NHS in Scotland for men with metastatic castrate resistant prostate cancer and who have the BRCA1/2 gene, and who have previously had treatment with a novel hormone agent and whose cancer had progressed. We have been asked to present a submission and we would like to hear your view.
Olaparib is a new medicine for prostate cancer, that has recently been licensed for use in the treatment of advanced prostate cancer in men with the BRCA1/2 gene, where treatment with novel hormonal agents abiraterone or enzalutamide and also chemotherapy have ceased to be effective. Currently there are limited treatment options available for men where abiraterone, enzalutamide or chemotherapy have ceased to be effective.
Background
Olaparib works by inhibiting a protein called PARP, which helps cells repair themselves following DNA damage. Stopping cells repair themselves in this way does not impact on healthy cells as they have another way of repairing themselves, but cancer cells don’t have such effective repair systems; so that by inhibiting PARP cancer cells can die.
The research suggests that olaparib can extend progression free survival by comparison with novel hormone therapy for men with BRCA1/2 gene mutation as well as potentially offering longer survival. A significant international research trial, the TOPARP-B trial, which included Scotland had shown the antitumour activity of olaparib against metastatic prostate cancer.[i] This research was followed by a randomised control trial – the PROfound Trial – which showed that for patients with prostate cancer with a gene alteration such as BRCA1/2 and who had received a novel hormonal agent and whose cancer had progressed, those receiving Olaparib had longer progression free survival (7.4 months vs. 3.6 months) than for patients who had received a novel hormonal agent (enzalutamide or abiraterone). The trial also showed that the median overall survival for those receiving Olaparib was 18.5 months and 15.1 months in the control group. see Olaparib for Metastatic Castration resistant Prostate Cancer. [ii]
Can you help us?
Currently, we are developing our submission following an invitation from SMC for our perspective. We’d like to hear the perspectives of men with prostate cancer and family members on whether they believe this medicine should be made available in Scotland.
Please could you respond by email by 28th May to info@prostatescotland.org.uk
It would be very helpful to us if you could you answer the following five questions within your response.
1) I have had Olaparib as a treatment for advanced prostate cancer
Yes / No
2. If Yes was this part of a trial/treatment for prostate cancer? (Delete as appropriate)
Yes / No / Unsure
3. I think Olaparib should be made available on the NHS in Scotland for men with metastatic castrate resistant prostate cancer, and who have the BRCA1/2 gene and who have had treatment previously with a novel hormone agent
Yes / No
4. If you have received Olaparib as a treatment for prostate cancer – do you have any comments you would like to make about it?
5. Would you be happy for us to quote you? (please note no individual names will be used) (Delete as appropriate)
Yes /No – I would prefer my answers are only used for research purposes
Please reply to info@prostatescotland.org.uk
If you have any questions or would like any further information please contact us at info@prostatescotland.org.uk or 0131 603 8660.
Thank you for your help.
[i] See Mateo J., De Bono et al Lancet oncology 2019 Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations https://doi.org/10.1016/S1470-2045(19)30684-9
[ii] N Engl J Med 2020; 382:2091-2102 DOI: 10.1056/NEJMoa1911440. A further analysis of the survival benefits from the trial showed that for those with BRCa1/2 gene alterations the overall survival was 19.1 months with Olaparib compared with 14.7 with novel hormonal agents. Hussain m, Mateo J. et al N Engl J Med 2020; 383:2345-2357 DOI: 10.1056/NEJMoa2022485