By Nisha Tailor, Head of Policy and Public Affairs, AMRC

Published: 5 December 2017

Today, AMRC publishes a new report - Facilitating adoption of off-patent, repurposed medicines into NHS clinical practice.

The report was prepared in response to a request from the office of the Minister for Life Sciences in 2015 to take a closer look at the potential for using off-patent, repurposed medicines. It was produced in collaboration with a wide range of stakeholders including medical research charities, the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA), Royal Colleges, representatives from industry and others.

Medical research and the benefit afforded to patients

Medical research is increasingly focusing on how existing medicines, licensed for use in treating particular conditions, can also be investigated for use in treating other conditions. Two examples in the report, bisphosphonates for preventing secondary breast cancer and docetaxel (in addition to standard hormone therapy) in metastatic prostate cancer, demonstrate the cost-effective and life-extending benefits to patients.

In the case of bisphosphonates, a study showed that giving a bisphosphonate to post-menopausal women with primary breast cancer could reduce the risk of breast cancer spreading to the bone within 10 years by nearly a third; reduce the risk of breast cancer spreading to any site, including the bone, within 10 years by around a fifth; and reduce the risk of death from breast cancer within 10 years by a sixth.

Research is promising and indicates that there could be many other disease areas and that patients could benefit from the use of off-patent medicines. Promising areas include those affected by multiple sclerosis and Parkinson’s disease.   

It is also helpful to note that repurposed medicines are included in the potential technologies to be considered for the Accelerated Access Pathway (AAP), as set out in the recent Government response to the Accelerated Access Review.

Facilitating access to off-patent medicines

Prescribers, patients and NHS services may want to use off-patent medicines that have been identified through new research and evidence to have potential therapeutic use for patients. However, without access to information and support prescribers may not pursue these treatment options for patients. The report provides information about the existing frameworks which support this within current legal and safety systems.

The report provides insights about the repurposing of off-patent medicines, including how the drug regulation system and national bodies can support it and how to navigate the different routes that support access to repurposed drugs for NHS patients.  It is currently the case that outside the licensed use of a medicine, existing frameworks for off-patent use are available to prescribers and their patient. Yet, greater support is needed to help prescribers and the respective commissioning bodies in their decision-making on the use of off-patent medicines, where this is clinically appropriate.

Highlighting the support that is already available to prescribers and commissioners, this report also outlines a framework to improve access to repurposed medicines for patients.

Recommendations to take forward

The recommendations in the report are those of the Drug Repurposing Group (see Annex A of the  report for membership) and reflect the range of stakeholders involved in off-patent medicines use and drug regulation, including for the MHRA, Regional Medicines Optimisation Committees and the British National Formulary. My hope is stakeholders will make progress of the recommendations and work together to create an environment that results in the rapid uptake of repurposed medicines when new evidence shows a clear benefit to patients.

A financial incentive to make the UK a world leader

One recommendation is for potential financial incentives for generic medicines manufacturers to participate in medicines repurposing, for instance, by extending the scope of HMRC Research & Development Tax Credits to include repurposing of generic medicines and exploring a UK Catalyst Fund to establish the UK as a leader in medicines repurposing.

This would address a key challenge in improving access to off-patent medicines for patients, and could position the UK as a world leader in off-patent, repurposed medicines in a post-Brexit world.

Ultimately, the goal is that the benefits of medical research into repurposed medicines are translated into practice to improve outcomes for patients.