For us, the days we get to report on a successful clinical trial of a new treatment for prostate cancer are among the best. But what happens after the fanfare? Once a treatment has been proven, it still has a long way to go before doctors can prescribe it to the men who need it. But we don’t bow out at that point. Behind the scenes, we work to try and make sure the best treatments get to the men who need them. This month, Policy Manager, Tim Windle, is in the thick of it in a bid to get a combination therapy for advanced disease approved.
TIM: Over the next few weeks, I’m going to be working on our submission to the appraisal of abiraterone in combination with androgen deprivation therapy (ADT or hormone therapy) for men newly diagnosed with advanced prostate cancer. This appraisal was recently announced by the National Institute for Health and Care Excellence (NICE).
I will be gathering the views of men with prostate cancer, collecting evidence and talking with the people who can make and influence the decision, including NICE and the company that developed the medicine, Janssen. I will also be finding and supporting patient experts (men with prostate cancer) to share their views and experiences with the treatment. You can find out further down how you might be able to get involved and help.
NICE will be looking at how clinically effective (how well it works) and how cost-effective this new treatment is compared to treatments that are already available. They will make a recommendation on whether the treatment should be available on the NHS. We will be making the case for men to have access to this treatment at every opportunity we get, but ultimately the decision will come down to a confidential discussion on cost between the pharmaceutical company and NICE.
Abiraterone was previously a last-line treatment for men with advanced prostate cancer which has metastasised and spread to other parts of the body. It is taken in tablet form and works by blocking the testosterone that prostate cancer needs to grow. This process can slow the growth of the cancer or shrink it. Recently, the STAMPEDE trial has shown that taking abiraterone in combination with hormone therapy can give men diagnosed with advanced prostate cancer an additional 18 months of life. If NICE were to approve the treatment, it could benefit around 2,200 men per year.
Whilst it is fantastic that this treatment can have such strong effects, the problem that abiraterone faces during its cost-effectiveness appraisal is that the STAMPEDE trial has also shown that the chemotherapy treatment docetaxel provides similar benefit to abiraterone for men at this stage. Docetaxel is the current standard of care for men newly diagnosed with advanced disease, and is also significantly cheaper due to being off-patent (no longer restricted to being produced only by the company who created it). As a result we are working to ensure that this treatment is available to men who are unable to have chemotherapy.
There is also a risk that the treatment will hit the threshold set by the budget impact test which says that access to any effective new treatment likely to cost the system more than £20 million per year can be indefinitely delayed.
To give this treatment combination the best chance of reaching men, Janssen are likely to make the case that this treatment should be available specifically for those men who are unable to have chemotherapy treatments such as docetaxel. Men may be unable to have chemotherapy for a number of reasons, some temporary and some permanent. These men have the greatest need to access the treatment as they are not able to benefit from the extra months of life that earlier docetaxel provides.
Despite being able to receive chemotherapy, men may also opt not to receive it for several reasons including the men deciding that they do not want to experience the potential side-effects associated with chemotherapy, or being too weak to manage those side-effects.
We will be doing everything we can to ensure that the manufacturer, NICE and NHS England all work together to make sure men who need this treatment can get it.
You might be able to help us build our response to NICE’s appraisal. If you have any experience of taking abiraterone in combination with hormone therapy, or if you or a loved one opted not to receive chemotherapy when it was offered, then we would be grateful to hear from you.
Please email me email@example.com with a few sentences about your experience with the treatment or the reason that you chose not to receive chemotherapy. Your contribution can help our work on this appraisal, could help to ensure men get access to this treatment and ultimately save men’s lives.
Whatever happens, this isn’t the end of how treatments like abiraterone and docetaxel are used. Research is coming down the pipeline comparing hormone therapy, docetaxel and abiraterone taken simultaneously. Trials have also proven the clinical effectiveness of using docetaxel for men with locally advanced prostate cancer, before it has spread elsewhere in the body.
And we have launched a major new research programme looking at how to identify which treatment combinations work best for which men, whilst also supporting development of new drugs to help extend more lives. As new developments surface, we will continue to campaign for men to get access to the right treatment for them at the right time.