Peter Ford, Dale Rominger, Rob Banner and Hugh Gunn with the NICE enzalutamide petition

Important note: the first part of this page is about what we’re doing to make sure men continue to be able to access existing treatments and will be able to benefit from new treatments coming down the research pipeline. Information about existing available treatment options is available at the bottom of this page.

If you believe you are eligible for a treatment that has been approved for use, but you’re struggling to get access, then please contact us.

What we're doing

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. Several hundred men from across the UK have taken part in our various drug treatment surveys so far, which we use to inform our patient group submissions to the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC), urging them to make these treatments available - a huge thank you to everyone who has taken part.

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.

Opposing potential delays to patient access to treatments

The NHS is struggling with a limited budget and insufficient resources to meet increasing demand for its services. In this climate it is right that NHS England should ensure that pharmaceutical companies are making their treatments affordable. However, ahead of the implementation of changes to the drug appraisal and funding system by NICE and NHS England in April 2017, Prostate Cancer UK led efforts to highlight the potential impact on men. We were concerned that these proposals could significantly delay patient access to new NICE-approved treatments in the future.

The new ‘budget impact test’ means that where a new treatment is predicted to cost more than the arbitrary figure of £20m per year (and negotiations with the pharmaceutical company are unsuccessful), NHS England will be able to request a delay to making it available. As things stand, this delay also applies to “end of life” treatments, potentially leaving some patients to die before being able to access a treatment that would have extended their lives. While this won’t affect any current treatments which are already being prescribed, estimates suggest that one in five new treatments will breach this £20m per year figure.

We have called for these proposals to be dropped. But we must also make sure patients are protected. We have called for treatments that comply with NICE’s end of life criteria to be excluded from the proposals so they always get to patients without delay once approved. We also set out several other safeguards and exemptions that would make the proposals less dangerous if they are taken forward.

In addition to submitting a consultation response, we led work within the charity sector to highlight the dangers of the proposals more widely.

We created an online petition urging the Government to re-think the reforms that reached 29,000 signatures and handed this in to NHS England, as well as coordinating an open letter to The Times and a joint press release, both of which were signed by around 20 leading health charities. We also provided joint briefings to MPs and Peers for several debates on the Health Service Medical Supplies (Costs) Bill around an amendment that would have helped block the reforms, contributing to the Government losing two votes on the issue. 

Unfortunately in spite of all our efforts the “Budget Impact Test” as it is now known has come into force, but as our Chief Executive Angela Culhane recently said,

"While the power to delay now exists, there is always hope until it is actually used. We’re calling on NHS England and NICE to work together with patient groups and the pharmaceutical industry to find a resolution, which doesn’t leave patients stuck in limbo, waiting to access a treatment that has already been deemed to be cost-effective."

We have recently met with senior officials at both NHS England and NICE to set out our concerns and explore alternatives, so the fight goes on. 

NICE and the Cancer Drugs Fund in England

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. 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.

But, we're still concerned that patients may lose out in the battle between NHS England and pharmaceutical companies on the price charged for new treatments. That's why we are continuing to push for reforms, while making sure we're at the heart of this new appraisal and funding process when prostate cancer treatments go through it.

The Accelerated Access Review

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. We will continue to work with Government to ensure that the recommendations are taken forward in the way that maximises the chances of getting promising new treatments to men as quickly as possible. 

Bicalutamide

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. Men have been telling 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 have been going on for months.

In the summer of 2017, regulators forced four generic medicine manufacturers to suspend their production. This has the knock-on effect of reducing supply and so increasing prices. We are uncertain whether these manufacturers have resumed production or if this is the root cause of the problem, but the British Generic Manufacturers Association has suggested that this problem will last for “a small number of months”.

We are hopeful that things will return to normal soon. We understand that the Department of Health and NHS England are considering this issue, but may be focusing on the increased expense to the health service rather than the impact on patients. We have written to the Department of Health, NHS England and to the Pharmaceutical Services Negotiating Committee to urge them to ensure that patients can access these treatments and more information is made available to people on the changing situation.

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. 

Abiraterone

Abiraterone (Zytiga®) is a type of hormone therapy for men with prostate cancer that has spread to other parts of the body (advanced prostate cancer). This treatment may help some men to live longer, and can also help control symptoms.

Abiraterone was originally proven to be effective for use when other hormone treatments had stopped responding and after chemotherapy and is now also routinely available without the need for chemotherapy.

Recently, research has found that abiraterone has clinical benefit in combination with other hormone treatments like Androgen Deprivation Therapy (ADT) as soon as advanced prostate cancer is diagnosed. However, these benefits are similar to the benefits seen when these hormone treatments are combined with the chemotherapy treatment docetaxel. Abiraterone in combination with ADT is being appraised and we hope that it will become available on the NHS to those men with advanced prostate cancer who are unable to have chemotherapy.

  • Abiraterone after chemotherapy  

    • In England: approved by NICE in June 2012 and is now routinely available on the NHS. However, you won’t be able to have abiraterone if you’ve already had enzalutamide – unless you had to stop taking enzalutamide within three months because of severe side effects or because your cancer continued to grow.
    • In Scotland: approved by the Scottish Medicines Consortium (SMC) in August 2012 (without restriction with regards to previous use of enzalutamide.)
    • In Wales: approved by the All Wales Medicines Strategy Group (AWMSG) in February 2012 (without restriction with regards to previous use of enzalutamide). The AWMSG guidance was superseded by the NICE guidance in June 2012.
    • In Northern Ireland: approved by the Department of Health following the NICE recommendation in June 2012.
  • Earlier abiraterone (without chemotherapy)  

    • In Englandapproved by NICE in March 2016and should be routinely available to eligible men by June 2016.
    • In Scotlandapproved by SMC in October 2015 and is now routinely available on the NHS.
    • In Wales: originally denied by AWMSG, but will follow the NICE ruling of March 2016, and should be routinely available to eligible men by June 2016.
    • In Northern Ireland: decision yet to be announced by the Department of Health, but we would expect this would follow the NICE ruling of March 2016, and be available to men by July 2016.
  • Even earlier abiraterone (in combination with ADT hormone therapy)  

    • In England: Currently being assessed.
    • In Scotland: Not yet assessed or available.
    • In Wales: Not yet assessed or available.
    • In Northern Ireland: Not yet assessed or available.

Enzalutamide

Enzalutamide is a type of hormone therapy for men whose prostate cancer has spread to other parts of the body (advanced prostate cancer) and has stopped responding to other hormone therapy treatments. It may help some men to live longer. It can also help control symptoms.

Enzalutamide was originally proven to be effective for use after chemotherapy. It is also effective for men who have not, or will not, have chemotherapy. It is available UK-wide both before and after chemotherapy.

  • Enzalutamide after chemotherapy  

    • In Englandapproved by NICE in May 2014. However, you won’t be able to have enzalutamide if you’ve already had abiraterone – unless you had to stop taking abiraterone within three months because of severe side effects or because your cancer continued to grow.
    • In Scotlandapproved by SMC in November 2013.
    • In Wales: approved by AWMSG, with Wales following NICE guidance. Men may not be able to access enzalutamide if they have already had abiraterone.
    • In Northern Ireland: approved with the NI Department of Health following NICE guidance. Men may not be able to access enzalutamide if they have already had abiraterone.
  • Earlier enzalutamide (without chemotherapy)  

Radium-223

Radium-223 (Xofigo®) is a drug for men with prostate cancer that has spread to the bones and has stopped responding to hormone therapy.

Radium-223 delays bone symptoms of advanced cancer, such as bone fractures, and can reduce bone pain. It may also help men live longer. In a clinical trial, men who received radium-223 at the same time as their usual treatments lived about four months longer than men who took a placebo. 

Cabazitaxel

Cabazitaxel (Jevtana®) is a new type of chemotherapy. It can’t cure prostate cancer, but it may help men to live longer. It can also help control or delay symptoms.

Cabazitaxel is suitable for men whose prostate cancer has spread to other parts of the body (advanced prostate cancer) and has stopped responding to hormone therapy and the chemotherapy drug docetaxel (Taxotere®).

Read our information about getting new treatments for more on how to get treatments that are licensed but aren’t available on the NHS. For more information on cabazitaxel, speak to your doctor or nurse, or call our Specialist Nurses.

Earlier docetaxel chemotherapy

In 2015 the STAMPEDE trial reported that men with metastatic prostate cancer (cancer that has spread to other parts of the body) who were taking docetaxel chemotherapy at the same time as hormone therapy lived for an average of 15 months longer than those taking hormone therapy alone. This is a real game changer in the battle against prostate cancer, and Prostate Cancer UK has been working to speed up the process of ensuring that men who need this treatment can get it.

The patent for docetaxel has expired, which means that any pharmaceutical company is free to make and sell the drug. This means that, unlike when a new drug is licensed, there is no commercial incentive for any company to push upfront docetaxel through the usual approval processes (such as NICE and the SMC) to make hospitals provide it. In the absence of a clear-cut pathway to access, we worked closely with researchers, health professionals and commissioners to get things moving.

This issue of accessing off-patent medicines, or repurposing existing medicines for new uses, is one that we’re looking at longer term. We supported the Off-patent Drugs Bill, which was intended to overcome these challenges, as well the Accelerated Access Review, and current review of access to new medicines in Scotland. We’ll update you on this work as it progresses.

If you are eligible for this treatment, but you’re struggling to get access, then please contact us.

  • By nation  

    • In England: Following pressure from ourselves and evidence provided by researchers on the STAMPEDE trial, NHS England put earlier docetaxel through a rapid evidence review. In January 2016, NHS England informed their Specialised Commissioning Hubs that this treatment can now be prescribed for men who may benefit.
      However, this sort of approval is not legally binding, unlike decisions made by NICE, and so it’s key that men know that they are eligible for this treatment, and that all relevant healthcare professionals know about the potential benefits and that it can now be prescribed. We contacted 1,202 oncologists and 1,563 Specialist Nurses in England to make sure that they knew that this was the case, as well as trying to spread the word via the media and online.
    • In Scotland: First Minister Nicola Sturgeon took a personal interest in 2015 when it was reported to her on Twitter that men in the west of Scotland were getting earlier access to docetaxel, but not those elsewhere in the country. We wrote to the FM in August 2015 urging her to ensure the access was replicated across Scotland, as well as discussing the situation with the government’s Head of Medicines. Earlier docetaxel should now be available for all eligible men in Scotland, but please do get in touch with us if you are eligible for this treatment and struggling to get access, so that we can offer support.
    • In Wales: After talking to men and clinicians in Wales we knew that access to earlier docetaxel was patchy. We launched a successful campaign in order to make sure that all eligible men were able to access this treatment if it may benefit them. Earlier docetaxel should now be available for all men in Wales who meet the criteria. Please get in touch with us if you are eligible for this treatment but struggling to get access, so that we can offer support.
    • In Northern Ireland: Earlier docetaxel should now be available for all men in Northern Ireland  who meet the criteria. Please get in touch with us if you are eligible for this treatment but struggling to get access, so that we can offer support.
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