Addressing the Cost Barrier to Inclusive Clinical Trials

When faced with a life-threatening condition, the decision to participate in a clinical trial is rarely taken lightly. For some Medicaid beneficiaries, the decision has been unnecessarily overwhelming, given financial barriers. The Clinical Treatment Act, which quietly went into effect in January, federally mandates Medicaid plans in all states cover routine costs for beneficiaries that participate in clinical trials. For context, Medicaid currently covers about one in four Americans, delivering healthcare benefits to individuals and families with low incomes. It’s also a key source of health coverage for many communities currently underrepresented in clinical research: nearly twice the proportion of Americans who identify as Black, Native American or Hispanic are enrolled in Medicaid.

Until this year, Medicaid was the only major US payer not required by federal mandate to cover routine costs associated with clinical trial participation. Medicare and most private insurance plans have been required to cover routine costs for years.

The Clinical Treatment Act enables more patients to potentially access investigational treatments through clinical trials. In clinical research, participant medical costs are typically split. Sponsors cover drugs or labs needed for research. Insurance covers routine costs a participant may incur during the trial, including doctor’s visits and emergency hospital stays, which can be costly.

The Clinical Treatment Act also supports a rising and overdue industry scientific and ethical imperative for more diverse trial participation; an imperative underscored repeatedly by the differences in disease causality, presentation, and progression in diverse patient populations, as well as divergence in drug safety and efficacy.

Today, many biopharmaceutical companies are leaning into areas they can largely control by exploring decentralized approaches, scrutinizing longstanding inclusion criteria that may inadvertently exclude certain demographics, and finding ways to compliantly cover non-medical participant expenses. They are helping to counter the often-earned mistrust of research within some communities, addressing physician bias and supporting programs designed to increase diversity among research teams. Depending on a patient’s income, geography, prior health system, and/or disease experience, among other factors, some combination of each will make all the difference for one person but not another.

Achieving diversity, equity, and inclusion goals in clinical research will require nothing less than a full-court press. Removing barriers for people who may be in economically precarious circumstances makes good sense, which is why part of a broader industry effort must continue to focus on medical costs and the role of insurance coverage. Even though the Clinical Treatment Act passed, there’s more to be done to ensure its intent is achieved.

Industry can play a big role here. Our government affairs colleagues can help ensure the mandate is fully implemented at the state level. Our clinical and commercial colleagues can inform healthcare providers, sites, and patient advocates of the coverage change and help ensure patient-facing educational materials are updated accordingly.

More so, we can do a better job communicating with all potential trial participants when it comes to cost—irrespective of insurance type. Trials demand patients take on many heavy-duty unknowns. They don’t know how well a study drug might work or what side effects may emerge. In this context, we can do more to remove ambiguity related to medical and non-medical costs. One area we can look to is the informed consent process, which requires the provision of clear information on what’s known to date about the investigational drug, the randomization approach, and other pertinent medical details.

In an era of rising health costs and opposition to surprise medical bills, and as we seek to engage more diverse communities—some of whom may be less familiar with and/or potentially more skeptical of research—reassurance about costs (both medical and nonmedical, such as travel expenses and time away from work) and clearer communications would go a long way in building and maintaining trust, and arm patients with as much information as possible, hopefully making the decision about whether to participate in a clinical trial easier.

Keri McDonough, Head, Patient Voice Consortium, Syneos Health