Published: 20 October 2022

By Melanie Sturtevant, Associate Director, Breast Cancer Now

Improving access to repurposed medicines is an issue close to the AMRC’s heart. This blog explains why and provides an update on NHS England’s work to help make this a reality.

A quick recap

Medicines repurposing - where existing medicines are found to be safe and effective in new uses – can help to improve patient outcomes and experience. Many AMRC members fund research into medicines repurposing, and many more will want to see positive results from research implemented quickly for the benefit of the patients they represent.

But there are obstacles to repurposed medicines being adopted into clinical practice, particularly when they are off-patent. Competition between manufacturers drives down the price, meaning there is little commercial incentive to extend the licence for the medicine to cover its new use. There is often no clear mechanism for the new use to be recommended for funding on the NHS. Although clinicians can prescribe medicines for uses they are not licensed for (known as ‘off label’ prescribing) as these decisions are taken on a case-by-case basis, patient access can be inconsistent.

At the government’s request, the AMRC chaired a stakeholder group which looked at the issues in repurposing off-patent medicines. The group published a report in December 2017 which recommended solutions, including providing incentives for generic manufacturers to get involved in repurposing, and producing commissioning policies to ensure patient access to repurposed medicines.

Where are we now?

NHS England has set up a Medicines Repurposing Programme, overseen by a Steering Group with representatives from the Department of Health and Social Care (DHSC), Medicines and Healthcare products Reglatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and National Institute for Health and Care Research (NIHR) MHRA, NICE and NIHR. The programme identifies and provides tailored support for repurposed medicines, including support for establishing the evidence base, facilitating a licence variation, and implementing into practice. The AMRC has a decision-making role on the programme Steering Group, alongside the national agencies and two Patient and Public Voice partners.

In order to be eligible for the programme, repurposed medicines need to have some evidence of safety and efficacy – being as good as, or better than, current standard care - not already be widely used, have a UK licence, and be supported by patients or clinicians.

Piloting the approach

Anastrozole is the first, pilot, medicine being supported by the programme. Anastrozole was originally licensed for treating breast cancer in post-menopausal women, but a phase 3 trial has also shown it can reduce the incidence of breast cancer in post-menopausal women at increased risk of the disease by nearly half over 10 years. Although it is recommended in NICE clinical guidelines, take up of anastrozole for this use is low.

In a first-of-its-kind initiative, NHS England has contracted with a pharmaceutical company to apply to the MHRA to extend the licence for anastrozole to cover this new use. If the MHRA grants a licence variation, this will provide reassurance to patients and prescribers that using anastrozole to help prevent breast cancer is safe and effective. A working group has been set up to monitor progress on the licensing work and consider other ways in which access to anastrozole as a preventative therapy can be improved – for example by providing information and support for prescribers.

How to get involved

Proposals for medicines for the programme can be submitted by voluntary-sector organisations, clinicians and pharmaceutical companies. So, if your organisation is involved in work on a repurposed medicine which may meet the criteria for the programme please get in touch with the team at NHS England on [email protected]. You can also subscribe to the mailing list using the same email address.

More information on NHS England’s work on anastrozole is included in their blog.