Project HERCULES Aims to Help Britain’s Duchenne MD Patients Get New-therapy Coverage

Duchenne UK has teamed up with five pharmaceutical companies to start Project HERCULES, a  collaboration aimed at persuading the national health insurance system to cover new Duchenne muscular dystrophy therapies.

Ensuring that patients obtain access to innovative therapies is a two-part challenge. The first is obtaining regulatory approval of the drugs. The second is getting governments and health services to pay for the medicines, some of which are expensive.

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

Duchenne UK is investing £200,000 in the project initially — about $1.32 million.

One aim of the investment is creating a process that leads to speedier insurance-agency reviews of innovative treatments. Another is to persuade regulators to allow pharmaceuticals to gather evidence of a new therapy’s effectiveness for the National Institute of Health and Care Excellence, which recommends whether a new drug should receive government insurance coverage.

The pace of treatment innovation is overtaking the time required for regulators to approve them and for insurers to authorize their coverage, causing critical delays in the delivery of life-saving treatments.

To obtain a NICE recommendation for a new therapy, pharmaceutical companies must provide detailed information about it, including economic models and quality of life measurements.

The process ensures that patients can trust a new product. But the Project HERCULES partners believe it can be expedited.

HERCULES will help companies develop common tools and practices aimed at accelerating the process that leads to insurance coverage. The new approach will include a broader evidence base, a reduction in duplicated or inconsistent evidence, more patient engagement, a lower cost, and a shorter time frame.

“We are delighted to be able to launch HERCULES with the support of five industry partners, all of whom are developing treatments for DMD,” Emily Crossley of Duchenne UK said in a press release. “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.”

“I’m thrilled that this initiative for collaboration across companies to support successful reimbursement is launching with Duchenne UK,” said Fleur Chandler, a member of Duchenne UK’s parent advisory board. “It is a testament to the commitment of the companies to the Duchenne community to come together in this way and generate world-class disease-level evidence for payers.”

The start of the project coincides with the approval of the government’s Accelerated Access Pathway initiative, which will fast-track breakthrough treatments. The goal is to get them to patients up to four years earlier.

Phase 1 of the project has already begun. It involves researchers working with specialists to understand the latest in evidence bases, the cost of DMD, and clinical trial measurements. Phase 1 will also look at how DMD affects boys’ quality of life, including developing a gold standard measurement of this parameter. DMD strikes boys far more than girls.

Phase 2 will look at DMD’s impact on patients, families and caretakers as a way of developing an economic model of the disease that can help support drug pricing and insurance reimbursement decisions.

More about Project HERCULES can be found here, including information on how to donate. Those with personal questions can contact [email protected].