NICE has recently published updated clinical guidelines that recommend bisphosphonates are offered to some postmenopausal women to prevent their breast cancer spreading to other parts of their body. But what are bisphosphonates? Why are they so important? And what have we been doing to make sure that patients can access them?
Bisphospho – what?
Bisphosphonates are a group of drugs that strengthen the bone and have long been used to treat osteoporosis and reduce bone damage in people with cancer in their bones.
In 2015, research was published which showed that, in postmenopausal women, bisphosphonates could also reduce the risk of breast cancer spreading to the bone - where it becomes incurable – by 2.2%, and reduce the risk of dying from the disease by 3.3%, within 10 years.
Whilst a 3.3% reduction in risk might sound small, it is the equivalent of 1000 breast cancer deaths for every group of patients that starts taking bisphosphonates each year - or 10% of all deaths from breast cancer.
So, what’s the problem?
Drugs normally find their way to patients by getting a licence for use in the condition they have been developed to treat, and a recommendation for routine use on the NHS from the National Institute of Health and Care Excellence (NICE) - or, in Scotland, the Scottish Medicines Consortium (SMC).
However, when drugs have been around some time, like bisphosphonates, their patent expires. This means manufacturers other than the company that developed the drug can make and sell it. Competition between manufacturers usually means the drug is available much more cheaply.
This is a good thing for the NHS and taxpayers. But, unfortunately, it also means there is little incentive for any manufacturer to invest in licensing an off-patent drug for a new use. And NICE and the SMC do not usually look at drugs unless they have a licence – or a licence pending - for a specific use.
Drugs can be prescribed for uses they are not licensed for – this is known as ‘off-label’ prescribing. But because clinicians take these decisions on a case-by-case basis, access for patients can be inconsistent.
Will I be able to access bisphosphonates?
Since the research was published in 2015, we have been lobbying for clarity on which NHS body is responsible for funding bisphosphonates to prevent the spread of breast cancer, and for them to be made aware of this responsibility. Thousands of you wrote to your MP in support of this.
It was announced in March that bisphosphonates were available across Scotland for women at high risk of recurrence of their breast cancer, and Wales followed suit in April.
However, the picture in England remains patchy. The Department of Health and Social Care says it is the responsibility of Clinical Commissioning Groups (CCGs) to fund bisphosphonates to prevent the spread of breast cancer. But when we asked CCGs last year whether they were routinely funding this, only 42 (20%) said they were, and another 13 (6%) said they had agreed to, and were implementing that decision.
Since then NHS England’s Breast Clinical Expert Group has clinical advice recommending the use of bisphosphonates. And NICE has now published updated clinical guidelines on early and locally advanced breast cancer that recommend bisphosphonates for women at high risk of recurrence.
We hope that this will help to improve access to this potentially life-saving treatment for women across England.
We have gone back to CCGs to ask them again if they are funding bisphosphonates to prevent the spread of breast cancer and will let you know how the picture across England has changed later this year.
We’ll keep working to ensure that all women that could benefit from bisphosphonates – not just those at high risk of recurrence - can access them across the UK.
We have also been collaborating with the Department of Health and Social Care, the Association of Medical Research Charities, the Medicines and Healthcare products Regulatory Agency (which licences off-patent drugs for new uses in the UK), NICE and others to look at how access can be improved to off-patent drugs for which new uses are discovered.
Together, we submitted a report to Ministers at the end of last year. It makes recommendations to ensure that, in future, it will be quicker and easier for off-patent drugs which research shows to be effective in new uses to reach the patients that will benefit from them. We will be working with these organisations over the coming months to implement the recommendations of the report.
Find out more about bisphosphonates.
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