Markel Insurance has launched a reimbursement scheme to help boost enrolment for international trials evaluating rare disease therapies.
The enhancement is purchased by trial sponsors and reimburses eligible travel-related expenses for approved participant travel to and from clinical trial sites.
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Markel’s new travel cover enhancement has been developed in response to feedback from life science companies and brokers seeking a way to help trial sponsors support eligible participants who need to travel internationally to take part in rare-disease clinical trials. Rare disease trials often struggle with patient recruitment, with the small and dispersed populations being a contributing factor.
Research published by Suvoda found that 57% of prospective clinical-trial participants considered financial barriers “very important” when deciding whether to enrol. This leads to low enrolment, which continues to be the main reason for trial terminations globally.
Due to the nature of rare-disease patient populations, trial participants may need to travel internationally to access specialist research sites, meaning the costs are often incredibly high. Not only is this a consideration, but many patients may struggle to obtain travel insurance due to their rare disease.
The scheme by Markel also allows patients registered under the policy who have been medically assessed as fit to travel by their doctor to access 24-hour assistance from global healthcare services provider Healix, which includes necessary medical care while travelling. Markel’s scheme allows sponsors to be reimbursed without directly paying participants.
Robert Hannaford, senior life science underwriter at Markel International, commented: “People living with a rare disease may need to travel considerable distances to access specialist clinical trials. In rare-disease research, eligible participants and specialist trial sites are not always in the same country.
“When patient populations are geographically dispersed, participation can depend on a person’s ability to travel, not simply their willingness to take part. This enhancement is designed to help trial sponsors support eligible participants who need to make those journeys by reimbursing eligible travel-related expenses and providing access to assistance services while travelling, subject to policy terms and conditions.”
Rare disease recruitment a constant challenge
Companies are turning to real-world data (RWD) and natural history data, as well as digital twins, to try and bolster recruitment in rare disease trials. While these tactics do improve recruitment challenges by creating virtual control arms, this is still a challenge.
As a result, the US administration has introduced a variety of pathways for research, including the Rare Disease Evidence Pathway (RDEP), the Plausible Mechanism Pathway and the Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations, to assist sponsors in designing alternative trials powered for lower recruitment.
The US administration has shown significant support for the development of rare diseases, as well as chronic diseases, spearheaded by US Health Secretary Robert F. Kennedy Jr. (RFK Jr), who himself suffers from the chronic disease spasmodic dysphonia.
