6 minutes Adam Gaines

Prostate Scotland expresses disappointment over decision by Scottish Medicines Consortium not to approve darolutamide for advanced prostate cancer

Statement by Prostate Scotland Monday 10 March 2023  14.25 pm

Prostate Scotland, Scotland’s prostate disease charity, expressed its disappointment at the decision not to approve darolutamide to be available on the NHS in Scotland for the treatment of metastatic hormone sensitive prostate cancer.

‘We are very disappointed by this decision, given the research evidence showing darolutamide’s benefits for men with hormone sensitive advanced prostate cancer, as darolutamide has been shown to have longer progression free survival and improved life expectancy over standard care, as well as other benefits. Darolutamide, alongside chemotherapy and hormone therapy could have offered an additional treatment option for some men with advanced prostate cancer. We are disappointed that the medicine has not been accepted on cost grounds as darolutamide has been accepted for use in Scotland for non-metastatic hormone sensitive prostate cancer. We call on the makers to do more in relation to the cost benefits of this medicine, so that this treatment option can be available to men in Scotland with hormone sensitive metastatic prostate cancer.

‘Men with advanced prostate cancer can face an uncertain future – as to whether or when their cancer could progress. Being able to delay the progression of their cancer for as long as possible is very important. Research has shown that treatment with darolutamide alongside chemotherapy and hormone therapy for men with hormone sensitive-metastatic prostate cancer can lead to a delay in progression and potentially lead to an improvement in overall survival by comparison to standard hormone therapy and chemotherapy.  The availability of darolutamide could offer a further option for men with metastatic hormone sensitive prostate cancer, particularly for those fit enough for chemotherapy.

‘Research evidence, comments from clinicians and men with prostate cancer we consulted, suggest that there is a good case for making darolutamide available on the NHS in Scotland for men with hormone sensitive metastatic prostate cancer in combination with hormone therapy and chemotherapy, where their clinical circumstances suggest it could be useful. It could improve their quality of life and potentially increase the chances of metastatic progression free survival, and a potential reduction in risk of death/increase in overall survival.


Notes to Editors
For further information please contact Prostate Scotland at info@prostatescotland.org.uk or 0131 603 8660

In many cases where the prostate cancer has not spread, men will be offered surgery or radiotherapy treatments, with a curative intent.  Where the cancer has not yet spread and is locally advanced and still sensitive to hormone treatment it is called non-metastatic hormone sensitive prostate cancer and men will usually be offered hormone treatment/ Androgen Deprivation Treatment (ADT) and radiotherapy to halt the growth of the cancer cells and to try to slow/ halt the cancer from spreading.  Men, where the cancer has spread will usually also be offered hormone treatment/ Androgen Deprivation Treatment (ADT) to halt the growth of the cancer cells.  Where the prostate cancer is still sensitive to hormone treatment it is known metastatic hormone sensitive prostate cancer or mHSPC.  Often men at this stage will be offered abiraterone with prednisone (where they are at high risk of progression), or chemotherapy or Enzalutamide, in addition to ADT. The aim of treatment at this point is to continue to stop the cancer progressing to becoming hormone/castrate resistant. In some men after a period of time the cancer cells may adapt to or get used to lower levels of androgen, which fuels the cancer and start to grow again – this is known as castrate resistant prostate cancer.

The ARASENS trial results showed that use of darolutamide (in combination with ADT and docetaxel chemotherapy) by comparison with placebo lead to greater progression free survival – with 35% of men receiving darolutamide progressing during the trial period by comparison with 60% of the placebo group[i]. In addition, the trial has shown an 32.5 % reduction in risk of death from darolutamide with chemo and ADT by comparison with chemotherapy and ADT alone.

Prostate cancer is the most common cancer amongst men in Scotland, with a lifetime chance of one in ten men developing it[[ii]]. There were over 37,009 new registrations of men with prostate cancer between 2008 and 2018 and 9,782 deaths of men in Scotland from prostate cancer during that period.[iii]. The most recent figures for Scotland prior to the pandemic show that 4066 men in Scotland were diagnosed with prostate cancer in 2019 and in 2020 3394 were diagnosed. 1066 men died from prostate cancer in 2021 [[iv]]. Survival rates amongst men with prostate cancer have encouragingly doubled over the past two decades with 84% of men with prostate cancer now surviving it[[v]]. Projections by the NHS show that the diagnosis of men with prostate cancer is likely to rise by up to 35% over the decade to 2027[[vi]].

Prostate Scotland is a registered Scottish charity no SC037494. It was set up in 2006 as a Scottish charity to develop awareness of prostate disease, to support men and their families/ partners with the disease through providing advice and information and to advance treatment and research into prostate disease. Its aim is to reach out across Scotland to create greater awareness amongst men and their families/partners about prostate disease and to advance treatment. It has established an award winning website www.prostatescotland.org.uk providing a wide range of information about prostate disease and treatments, as well as providing information and advice about prostate disease to men and their families across Scotland. In 2010 the charity won a national award for its impact on community health and in 2013 and 2015 was commended in the British Medical Association Patient information Awards, and in 2017 was awarded Scottish health charity of the year.

[i] See Smith et al N Engl J Med 2022; 386:1132-1142 DOI: 10.1056/NEJMoa2119115 https://www.nejm.org/doi/full/10.1056/NEJMoa2119115
[ii] See Cancer Incidence in Scotland 2018 Public Health Scotland April 2020 pp21
[iii] See Cancer Incidence in Scotland 2018 Public Health Scotland April 2020, Cancer mortality in Scotland 2018 Public Health Scotland October 2019
[iv] See Cancer in Scotland Public Health Scotland April 2020 and Scottish cancer registry Cancer mortality in Scotland 2018 Public Health Scotland October 2019 p8 and ISD Cancer in Scotland April 2019 Information Services Division, NHS National Services Scotland and PHS Scotland April 2020 and 20221 and Cancer Mortality in Scotland 2021 -PHS Scotland 2022
[v] Cancer in Scotland: ISD, NHS National Services Scotland, October 2018 pp 16-2
[vi]  See Scottish Cancer Registry May 2016 and Cancer Incidence in Scotland (2014), and Information Services Division NHS National Services Scotland November 2015