Getting men the treatments they need

Over the last few years breakthroughs in advanced prostate cancer treatments that can prolong and improve quality of life have been coming thick and fast. A key part of our work is to review the latest evidence from clinical trials, and to ensure that all men can access effective treatments that are right for them, no matter where they live in the UK.

We talk with people affected by prostate cancer so that we can use real life experiences to influence the UK health bodies who decide whether these drugs should be made routinely available via the NHS or Health and Social Care. We also do all we can to understand the barriers that need to be overcome to make a treatment available, working with NICE, the SMC, NHS, drugs manufacturers, clinicians and patients to answer questions and develop evidence that will help to ensure men have access to the treatments they need. 

Thankfully, this collective effort has achieved a great deal – we are now in a position where all of the drugs we have campaigned on are routinely available on the NHS throughout the UK.

However, we know we have a very exciting next generation of treatments in the research pipeline for prostate cancer, so despite this great progress, we are still working hard to make sure men will continue to be able to access the best treatments in the future. For more detailed updates keep an eye on our campaigns pages for the latest updates, or sign up for our newsletter.

• More information on access to medication post-Brexit

For a long time, the only treatment option for men with advanced prostate cancer was hormone therapy. In 2016, this all changed. The STAMPEDE study had been looking at docetaxel, this is a chemotherapy treatment that was available to men with advanced prostate cancer once hormone therapy had stopped working. The STAMPEDE study found that Docetaxel is effective earlier for men with advanced prostate cancer that is still responding to hormone treatment, giving them an extra 15 months of life. This was a fantastic discovery and is now routinely available to men across the UK.  

In 2017 it was discovered that Abiraterone, another treatment that was previously only available when hormone therapy stopped working, was also effective for men at this earlier stage of prostate cancer when hormone therapy is still effective. Abiraterone offers a similar benefit to men as Docetaxel.

However, Abiraterone is on-patent, while Docetaxel is off-patent. This means that the manufacturer of Abiraterone has exclusive rights to manufacture and sell the medicine, while anybody has the right to manufacture Docetaxel. The competition between manufacturers producing Docetaxel means the price of Docetaxel is lower. This difference in price makes it harder to prove that Abiraterone is cost-effective compared to Docetaxel, especially given they offer a similar benefit to men. The role of NICE and the SMC is to determine whether a new medicine is cost-effective, if it is cost-effective then the treatment will be available to patients on the NHS.

While Docetaxel is a fantastic treatment option, the uptake of upfront docetaxel is low, with one report finding that only 40% of newly diagnosed men receive it. This means that around 60% of men could be missing out on the benefit of Docetaxel. These men may instead be able to benefit from Abiraterone. The key question is ‘why’ 60% of men who could benefit from Docetaxel don’t receive it. Some men may be reluctant to receive chemotherapy, some men may be too frail to tolerate the side-effects of chemotherapy, others may have other conditions that would make it inappropriate or even dangerous to receive chemotherapy.

At Prostate Cancer UK, we are working with clinicians to try and develop specific definitions of those men that are unable to have chemotherapy. They are called ‘contraindications’ to chemotherapy. This is no easy task, since a contraindication like frailty is subjective, while a contraindication like an allergic reaction to Docetaxel is unequivocal. Our hope is that in defining this population, it will be easier for NICE and the SMC to determine cost-effectiveness and ensure that those patients unable to have Docetaxel do not miss out on the benefit that both Docetaxel and Abiraterone can provide.

There are other new treatments coming for men with advanced hormone-sensitive prostate cancer. These medicines will face the same problem as Abiraterone. The TITAN trial is looking at a drug called Apalutamide in this setting. The ARCHES trial is looking at the earlier use of Enzalutamide, which like Abiraterone is already available to patients once hormone therapy stops being effective, for men in this setting. Our hope is that our work to identify those men that are unable to have Docetaxel will make it easier for each of these treatments to be available on the NHS for the men who need them.

New cancer drugs take years of investment to develop and are, as a result, often very expensive. The Cancer Drugs Fund (CDF) was set up in England in 2010 to address the disparity in UK patient access to cancer drugs compared to comparable countries around the world. It worked by covering the cost of expensive new cancer drugs, including those that NICE rejected due to their high price. Because of rising demand for drugs and prices remaining high, the CDF became unaffordable for the NHS.

Under the old system, NICE could determine that a drug was not cost-effective, but the pharmaceutical companies could still charge full-price for the treatment and have it made available in England through the CDF. It's no secret that this system was flawed, and no wonder that it was unsustainable.

In November 2015, NHS England and NICE opened a consultation on how they proposed to reform access to cancer drugs in England, which included major changes to the way that the CDF is used. This would allow NICE to give conditional approval to treatments while new data is collected; previously NICE had only been able to give positive or negative recommendations.

We joined forces with Tackle Prostate Cancer to submit a joint response to NHS England and NICE to try and address these issues. A key part of this involved asking you for your views and we used these to inform our submission, which you can read here.

In response to this consultation, NICE and NHS England published guidance on how the new system will operate. This guidance shows that our influencing alongside other cancer charities made an impact. In 2016, the new Cancer Drugs Fund was launched. Now, all eligible patients are now able to access treatments while they're being evaluated to get more information on the benefit they provide. We're also more reassured that all treatments that NICE decides need funding from the new Cancer Drugs Fund will be able to access it.

There was concern that the new Cancer Drugs Fund would result in reduced patient access to some of the latest treatments. But, by the end of 2018, NICE had reviewed all 33 treatments in the old fund and had approved all of them for routine use through the NHS, with only two rejected. This suggests that new evidence was presented, or new prices negotiated to make sure these treatments were cost-effective. This alleviates concerns about patient access and is a fantastic sign of success.

This new fund has implications for Wales and Northern Ireland too. Wales is already making these medicines available through its New Treatments Fund. In September 2018, the Northern Ireland Department of Health announced that it would pay for drugs in the CDF. In Scotland, the Scottish Medicines Consortium (SMC) makes decisions on which medicines should be available on the NHS and these drugs go through this process instead.

The Accelerated Access Review was set up by the previous Minister for Life Sciences, George Freeman MP, to explore the challenges involved in making innovative treatments and technologies available via healthcare systems in the UK as quickly as possible, and to come up with solutions to overcome these barriers.

The review published its final report in October 2016, setting out an ambitious approach for achieving the accelerated access of promising new innovations into the NHS. Its recommendations included:

• Give patients a greater voice at each stage of the innovation pathway, so that the outcomes that new scientific developments achieve are the ones that patients want the most;
• Anticipate the potentially transformative technologies that are on the horizon, ensuring they are affordable, beneficial to patients and can be adopted onto the NHS in a sustainable way;
• Energise the NHS so that it is more receptive to innovation as the means to deliver improved care with greater efficiency.

And underpinning this, it recommended developing stronger and more transparent mechanisms to identify and prioritise products that will be introduced into the health system.

The Government has indicated that most of its response to the recommendations of the review have be taken forward as part of the Life Sciences Industrial Strategy. One recommendation was to set up an Accelerated Access Collaborative to identify promising and underused treatments for which access should be improved. One of the treatments that the collaborative has identified is UroLift for treating enlarged prostate and we are working with the collaborative on how this might affect men. 

Towards the end of 2017 we started receiving reports from men that they were struggling to get prescriptions filled for bicalutamide, a hormone therapy medication. Men were being told by pharmacists that the off-patent medicine was low in supply and so unavailable.

Off-patent or generic medicines like bicalutamide are no longer restricted to being produced by a single company. This means that any company can make the drug and competition between these companies normally keeps prices down.

Pharmacists source and buy the medicine they require to fill patients’ prescriptions. Occasionally a pharmacist may not have supplies of a medicine and be unable to fill a prescription, but it should only take them a few days to find and receive more. At the time, men told us that pharmacists have been completely unable to source any bicalutamide.

Supply shortages like these aren’t unusual. Generic drugs are a worldwide commodities market, if demand increases or supply decreases then prices go up to match. Changes in supply or demand can be influenced by a huge number of factors including manufacturing issues or currency fluctuations.

The UK has a system to stop price fluctuations from impacting UK patient access to these treatments, called the concessionary prices scheme. This system is designed as a short-term measure until prices return to normal. However, the problems with bicalutamide and other generic medicines were going on for months.

In the summer of 2017, regulators forced four generic medicine manufacturers to suspend their production with fears over safety. This has the knock-on effect of reducing supply and so increasing prices. It appears that things are going back to normal now, but we learned some important lessons from this situation that will help us if future problems arise, particularly following the prospective departure of the UK from the European Union.

If you are unable to get a medicine or other treatment that you need, then you should immediately consult your GP or prescribing clinician. We would also appreciate you contacting Prostate Cancer UK to let us know about the potential shortage.