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Q & A on HERCULES

What is Project HERCULES?

Project HERCULES is the name given to a collaboration between Duchenne UK, and pharmaceutical companies who are developing medicines to treat Duchenne Muscular Dystrophy, DMD, to increase the chances of patients with DMD of accessing innovative treatments.

With a wave of treatments in, or about to enter clinical trials, and with some already gaining approval, the aim of HERCULES is to address the next challenge after medicines are approved: how we get governments to pay for these medicines. This is called reimbursement.

In order to persuade government bodies to pay for new medicines, companies often have to provide complex data analysis and burden of care studies which are costly and time-consuming. The aim of HERCULES is for companies to collaborate together on building such models, to save time, money and ensure that the collaboration speeds up access for patients.

What does HERCULES stand for?

HERCULES stands for HEalth Research Collaboration United in Leading Evidence Synthesis.

Why do we need HERCULES?

We all share the hope that new medicines coming through will improve the lives of those living with DMD and their families. However, we have concerns about how difficult it has been to get countries to make decisions about whether or not to pay for these new medicines.

And we’re concerned that changes to these procedures in the UK could further prevent or delay those with DMD with access to effective new treatments. Organisations like NICE, the National Institute of Clinical Excellence (NICE) in England, run what’s called Health Technology Assessments (HTA) to determine whether new medicines offer value for money and should be paid for, known as reimbursement, on the NHS.

In order to get NICE to pay for their medicines, companies are required to develop a vast amount of highly specialized and detailed work which includes data collection, economic modelling and quality of life measurements, all of which can be difficult, time consuming and expensive. The processes are well established and need to be followed. However, we hope that through the collaboration in Hercules, we can help industry better engage with this process and actually speed up the time it takes for industry to engage with bodies like NICE to make decisions.

What we propose with HERCULES, is to bring companies together to develop a SHARED model that will focus on developing common tools and practices, including:

*Data analysis, including mapping clinical trial endpoints to clinical outcomes

* An HTA relevant Quality of Life metric

* Cross-sectional study looking at the true Burden of Illness

* Economic model for individual companies to adapt to their products

* Training, expert input and mock appraisal committees

How does HERCULES fit in with other campaigns?

We recognise that many patient organisations are active in this area and will be having conversations with HTA agencies and other agencies over the coming months. HERCULES is intended to complement and build on the work already underway within the DMD community. Project HERCULES aim is to provide both practical and tactical support to companies, and to also to all patient groups, so that interactions with HTA bodies are cohesive, persuasive and supported with a strong and relevant evidence base.

Who is running project HERCULES?

Duchenne UK is delighted that, Josie Godfrey, a former Associate Director at NICE, who set up the Highly Specialised Technologies Appraisals System, is running HERCULES. The Steering Group will be chaired by Fleur Chandler who works in Health Value Outcomes at GSK and who also sits on the Patient Advisory Board of Duchenne UK. Together they bring much valuable experience of HTA methods and processes.

How to contact Project HERCULES?

If you would like to know more, please contact the project team at [email protected]

Further reading: We’re also pleased to share with you an article in Pharmaco-economics, by Anthony Hatswell and Fleur Chandler: Sharing is Caring: The Case for Company- Level Collaboration in Pharmacoeconomic Modelling

Duchenne UK is extremely grateful to Anthony Hatswell, Professor Ron Akehurst and the Bresmed Foundation for their early support for the project.

We would also like to thank the legal team at CMS for their advice and support.

Published on 13 November 2017

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