Prostate Scotland expresses disappointment over SMC decision not to approve lutetium 177Lu but welcomes decision to approve darolutamide

Prostate Scotland expresses disappointment over Scottish Medicines Consortium (SMC) decision not to approve lutetium (177 Lu) for metastatic castrate resistant prostate cancer but welcomes decision to approve darolutamide for metastatic hormone sensitive prostate cancer

9 October 2023 10.50

Prostate Scotland, Scotland’s prostate disease charity,  has today (9 October 2023) expressed its disappointment at the decision by the SMC not to approve Lutetium (177Lu) vipivotide tetraxetan to be available on the NHS in Scotland for men with metastatic castrate resistant prostate cancer. This is a significant disappointment given the research evidence[i] showing significant benefits of this medicine for men whose prostate cancer has progressed and where novel hormone therapies or taxane based chemotherapy are no longer effective, or where chemotherapy is not suitable. There is an unmet need for further treatment options for men in such situations.

‘Lutetium 177 gives the potential for a demonstrated further new treatment option, which could clearly meet this unmet need, as well as potentially increase the chances/length of progression free and overall survival[ii]. There is little by way of further treatments, if the man’s prostate cancer progresses, following treatment with one of the novel hormone therapies or chemotherapy[1] and therefore this decision not to approve lutetium 177 vipivotide tetraxetan is a real disappointment.

‘We very much welcome the decision to approve Darolutamide to be available on the NHS in Scotland for the treatment of metastatic hormone sensitive prostate cancer. Darolutamide, alongside chemotherapy and hormone therapy offers for some men with advanced prostate cancer which is still hormone sensitive an additional treatment option, where their clinical circumstances suggest it could be useful -particularly for those fit enough for chemotherapy- in that it could improve their quality of life and potentially increase the chances of metastatic progression free, and a potential reduction in risk of death/increase in overall survival.

‘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.  Whilst it is welcome that Darolutamide will now be available as a treatment option for men with hormone sensitive prostate cancer – it is a significant disappointment that for men with advanced prostate cancer which is castrate resistant and no longer responding to novel hormone therapies or chemotherapy and whose options are limited that they will not have the opportunity of lutetium 177Lu on the NHS in Scotland’.

‘Lutetium 177 offers a number of potential benefits over the current standard of care which the SMC has recognised. It is disheartening for men and their families in this situation not to be able to access such a medicine at a time when they have limited other options.  We urge the manufacturers, the SMC and NHS Scotland to work together to find a solution to the cost consideration, so that men in Scotland who have advanced prostate cancer and who have limited future treatment options can access this important medicine on the NHS. There is an unmet need for this medicine.  This medicine is a step forward for men living with advanced prostate cancer, where novel hormone therapies and chemotherapy are no longer options- and who now have only limited options. The research results show strong improvements in progression free and overall survival.

Ends

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.  In this situation men may be offered novel hormone therapies or chemotherapy, and sometimes Radium 223 if the prostate cancer has spread to the bones.

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[iii]. 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[[iv]]. 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.[v]. The most recent figures for Scotland show that in 2021 4265 were diagnosed. 1066 men died from prostate cancer in 2021 [[vi]]. 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[[vii]]. 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[[viii]].

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.

[1] Some men may receive Cabazitaxel as a third line therapy, or Radium 223 if they have bone metastases.

[i] The results from the VISION  trial (N Engl J Med 2021; 385:1091-1103) show that use of Lutetium 177 plus standard care significantly prolonged, compared with standard care, both progression-free survival (median 8.7 vs. 3.4 months) and overall survival (median, 15.3 vs. 11.3 months).

[ii] The TheraP Trial in Australia (Hofman MS et al. Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer). Lancet 2021;397:797-804 showed Lutetium-PSMA-617 compared with cabazitaxel in men with metastatic castration-resistant prostate cancer led to a higher PSA response and fewer grade 3 or 4 adverse events.

[iii] 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

[iv] See Cancer Incidence in Scotland 2018 Public Health Scotland April 2020 pp21

[v] See Cancer Incidence in Scotland 2018 Public Health Scotland April 2020, Cancer mortality in Scotland 2018 Public Health Scotland October 2019

[vi] 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 2021. Cancer Incidence and Prevalence in Scotland to December 2021- Public Health Scotland 13 June  2023and Cancer Mortality in Scotland 2021 -PHS Scotland 2022

[vii] Cancer in Scotland: ISD, NHS National Services Scotland, October 2018 pp 16-2

[viii]  See Scottish Cancer Registry May 2016 and Cancer Incidence in Scotland (2014), and Information Services Division NHS National Services Scotland November 2015