13 November 2017
Please note: Project HERCULES is an ongoing project. Please visit the Project HERCULES website for the latest information.
Duchenne UK is delighted to announce that seven leading pharmaceutical companies developing treatments for Duchenne Muscular Dystrophy, will collaborate with the charity on Project HERCULES, to develop a robust and relevant evidence base for payers to accelerate the time it takes for payers to make decisions about which medicines to fund. Duchenne UK is investing £200,000 in the initial stages of the project.
Project HERCULES aims to provide a core central evidence base to provide high quality material to enable an informed HTA process and enable smoother and speedier payer reviews for innovative treatments in Duchenne muscular dystrophy (DMD). The project will allow pharmaceutical companies to work together to build the evidence base for new therapies required by pricing watchdogs, such as the National Institute of Health and Care Excellence (NICE).
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 reach regulatory approval; how we get governments and health services to pay for these medicines.
It is widely recognised that the pace of innovation in treatments and medicines is outstripping the time it takes to approve them for use in the NHS. These delays are worsened for diseases as there is often limited evidence available to meet the requirements for access and pricing decisions.
In order to get NICE to recommend that the NHS can fund 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 of bodies like NICE to assess the cost effectiveness of a medicine 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, present relevant evidence as required and therefore enable the decision making process, and potentially speed up the time it takes for industry to engage with bodies like NICE to make decisions
HERCULES comes from a desire to help develop industry to develop this disease level evidence in collaboration, providing benefits which vary from improved modelling (reducing uncertainty), a broader evidence base, reduction of generating evidence which is duplicative or inconsistent, improved engagement with patients, lower costs and management time, additionally being ethically superior by making better use of patient input.
Duchenne UK is investing £200,000 in the initial stages of the project,
which will help companies to work 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
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.