January/February 2024 • PharmaTimes Magazine • 24-25
// MEDICINE //
Purpose puzzle
Repurposing with purpose is the modern mantra for healthcare delivery
Film producer and MTV visionary Tom Freston once said: “Innovation is taking two things that already exist and putting them together in a new way.”
Healthcare innovation is often portrayed exclusively as groundbreaking new medicines or technologies, breakthrough treatments that are capable of revolutionising patient care.
But in reality, there’s another side to innovation that can be just as impactful for patients and health systems – the far less heralded concept of medicine repurposing.
Jonathan Wilson, Senior Vice President and Susan Lau, Regulatory Clinical Manager, at Accord Healthcare discuss the company’s participation in the first MHRA and NHS England Medicine Repurposing Programme, sharing the lessons they learned along the way.
What is the Medicine Repurposing Programme?
The Medicines Repurposing Programme is a multi-agency effort aimed at identifying and capitalising on new applications for existing medicines, enhancing patient outcomes, experience and cost-effectiveness.
Endorsed by prominent health agencies in the UK – including the Department of Health and Social Care (DHSC), the Medicines and Healthcare products Regulatory Agency (MHRA), NICE, the National Institute for Health and Care Research (NIHR) and NHS England, and supported by various medical charities – the initiative promotes innovative research and advocates for the licensing of repurposed medicines.
This is with a view to ensuring equitable access and informed clinical decision-making. Meanwhile, eligible entities like healthcare professionals and pharmaceutical companies can propose medicines for programme consideration, which are then assessed and prioritised by a steering group for inclusion.
The programme supports researchers through partnerships and offers advice for NIHR funding applications, working towards systematic medicine repurposing within the NHS.
Visionary alignment
Our involvement in the Medicine Repurposing Programme aligns perfectly with our extensive therapeutic portfolio. We have a vested interest across various therapy areas, which positions us well to engage in repurposing discussions.
This initiative is a natural progression of our existing work, showcasing our agility in adapting to healthcare’s evolving needs.
Enhancing accessibility
Our engagement with the Medicine Repurposing Programme was less about profit and more about doing the right thing. Why wouldn’t we help use our licence and our people to do the submission?
This initiative is a direct reflection of our ethos – ‘We make it better’ – prioritising patient needs and working diligently to ensure that essential medicines are accessible to those in need.
After all, the true value of a medicine is only realised when it is within reach of every individual who can benefit from it.
In the realm of medicine repurposing, innovation extends beyond new indications for existing drugs. It can also encompass reformulations to expand the patient population.
The scope of repurposing can include modifying a medicine’s form to suit different populations, like creating liquid formulations for easier paediatric administration.
The challenges are multifaceted: ensuring the new formulation maintains the drug’s efficacy; navigating the intricacies of regulatory approvals, and ultimately, delivering a product that clinicians and patients can trust.
‘This initiative is a direct reflection of our ethos – prioritising patient needs and working to ensure that essential medicines are accessible to those in need’
Strengthening partnerships
Our journey through the Medicine Repurposing Programme was one of learning and adaptation. Some of the challenges we overcame included:
- Regulatory Navigation – Regulatory pathways aren’t always straightforward, especially with older medicines where data may not meet current standards.
We learned the importance of early engagement with regulatory bodies, which is critical to clarify the data requirements for repurposing and to streamline the submission process
- Commercial Considerations – Commercial considerations naturally often guide our industry’s direction and strategic choices need to be made. On this particular programme, we were fortunate to have available existing clinical trial data to support the new licensing application.
Although we had some challenges, the data was invaluable, as it allowed us to focus our efforts and resources on the regulatory process rather than on generating new clinical evidence. If we also had to conduct clinical trials, we would have considered this differently.
Looking ahead, for repurposing efforts where clinical data isn’t readily available, we believe it is worth considering partnerships with charities or other organisations that may have the means to support such research.
These collaborations could be essential for companies looking to repurpose medicines, ensuring that the investment required to bring a repurposed drug to market remains manageable and aligns with the goal of expanding patient access to important therapies.
Navigating challenges
Collaboration has been a cornerstone of our success. Fantastic support from the industry body and NHS England was crucial, Jonathan recalls.
Establishing effective communication between various partners required concerted effort and often meant navigating differing agendas and priorities. Our success came from fostering a collaborative spirit and shared goal orientation with all parties involved.
A vision for tomorrow
As we reflect on our journey through the Medicine Repurposing Programme, we have not only forged a path for our future endeavours but also illuminated the way for the broader industry.
In partnership with organisations like the British Generic Manufacturers Association (BGMA), we are showcasing the power of resilience, the necessity of collaboration and the imperative to keep patient welfare at the heart of our efforts.
This collaborative ethos underpins the following key insights, which are fundamental to the success and future direction of medicine repurposing:
- Expanding Patient Access and Care: A pivotal benefit of medicine repurposing is enhancing patient access to a wider range of treatments.
Streamlining the process to legitimise the use of repurposed medicines can have a profound impact on patient care and treatment options
- The Power of Communication: Success in medicine repurposing hinges on the cooperative efforts of diverse stakeholders. This includes pharmaceutical companies, healthcare systems, regulatory authorities and non-profit organisations. Early and proactive engagement with regulatory bodies, along with clear communication among stakeholders, are key to optimal outcomes
- Overcoming Data Challenges: A significant obstacle in repurposing is the often-limited data available for older medications. Innovating ways to generate and utilise new clinical data is crucial, acknowledging that this can be resource-intensive and may not always align with strategic business decisions
- Embracing Future Collaborations: Looking ahead, the role of strategic partnerships with various organisations is highlighted as a pathway to success. These collaborations can fill gaps in funding and resources, particularly in areas where commercial viability is challenging.
The lessons we’ve learned and the successes we’ve achieved as part of this programme are stepping stones for the industry, promising a future where innovation is not limited to the newest discoveries but also found in the renewed potential of existing therapies.