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Behind the headlines: anastrozole licensed as a risk-reducing treatment

Following the news that anastrozole is now licensed as a risk-reducing treatment, we look at why using repurposed drugs isn’t always easy, and how a programme launched by NHS England is helping.

What’s drug repurposing?

Existing drugs can often be used to treat conditions other than those they were originally developed for. For example, anastrozole is well known as a treatment for breast cancer. But research has shown it's also effective at reducing women’s chances of developing the disease in the first place, if they’re at increased risk. This is known as drug repurposing.

What’s the problem?

It can take huge amounts of time and effort to make sure repurposed drugs reach people, particularly when they’re ‘off-patent’.

Drugs normally reach people by getting a licence for a specific use. They’re then recommended for use on the NHS by the National Institute for Health and Care Excellence (NICE) - or, in Scotland, the Scottish Medicines Consortium (SMC).

After a period, the patent on drugs expires and they become ‘off-patent’. Manufacturers other than the company that developed the drug can then make and sell it. This leads to competition between manufacturers which drives the price down.

So, if researchers discover a new use for a drug, but the drug is already off-patent, there’s no financial incentive for the manufacturer to extend the license. In many cases, there’s also no clear way for the NHS to approve the new use for funding. Although doctors can prescribe drugs for uses they aren’t licensed for, (known as ‘off label’ prescribing) these decisions are taken on a case-by-case basis, so access can be patchy.

What we’ve been doing?

This is a problem we’re all too familiar with. Research published in 2015 showed that a group of drugs called bisphosphonates, originally licensed for osteoporosis could also reduce the risk of breast cancer spreading in post-menopausal women. But it took 5 years of campaigning by Breast Cancer Now, our supporters, our researchers and clinicians for the vast majority of hospital trusts in England to make bisphosphonates routinely available to patients.

We’ve also been working to make sure it's quicker and easier in the future for all off-patent repurposed drugs to reach people. We were a key member of a stakeholder group chaired by the Association of Medical Research Charities (AMRC) that published a 2017 report setting out the issues and solutions.

What’s happening now?

Following all this work, we were delighted when NHS England set up a Medicines Repurposing Programme in 2021. It has a Steering Group with representatives from the Department of Health and Social Care, NICE, the Medicines and Healthcare products Regulatory Agency, the National Institute for Health and Care Research, the Association of Medical Research Charities and 2 Patient and Public Voice partners.

The NHS programme identifies repurposed drugs and gives support to help ensure they reach patients. This could include support in establishing the evidence base and extending the license to cover the new use, as well as support with implementing the new use into practice. Drugs can be suggested for the programme by voluntary sector organisations, clinicians and pharmaceutical companies.

Improving access to anastrozole for risk-reduction

Anastrozole was the first drug to be supported by the Medicines Repurposing Programme. It was originally licensed for treating breast cancer,  but researchers found that taking it for 5 years also reduced the incidence of the disease by nearly 50% in postmenopausal women at increased risk.

In a first-of-its-kind initiative, the NHS programme worked with a pharmaceutical company, to extend the license for anastrozole to include this new use.

Of course, not everyone who is eligible will choose to take anastrozole, and women must be given the information and support they need to make the right decision for them. But we hope that the license being extended will help improve uptake of this option for women at increased risk because of their family history. A working group set up by NHS England and chaired by Breast Cancer Now has been monitoring the licensing process. It’s also looking at what else can be done to improve access to anastrozole as a risk-reducing treatment.

You can find more information about the Medicines Repurposing Programme on the NHS England website.

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If you have any questions about anastrozole, you can contact our nurses.

 

 

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