Navigating the Hidden Costs of Clinical Trials on Patient Power

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Navigating the Hidden Costs of Clinical Trials

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Nearly two years ago, Brad Adams’ doctor presented him with a few options to treat his chronic lymphocytic leukemia after it returned. Adams could continue taking an oral treatment for the rest of his life, his doctor said, or he could try a different approach as a participant in a clinical trial.

Adams, 69, of Friendswood, Texas, opted for the clinical trial. After enrollment, he was given a three-drug combination treatment of obinutuzumab (Gazyva), venetoclax (Venclexta), and acalabrutinib (Calquence). Following the roughly two-year-long trial, he said, the minimal residual disease test he took came back negative, meaning doctors could not find any more leukemia cells in his body. “The results have just been outstanding for me,” he said.

Participating in clinical trials can be a way for people with cancer to aid future patients by helping determine which new treatments work better than the current standard of care. And enrolling in a trial may, in some cases, give a patient access to a promising treatment that would otherwise not be available.

However, studies suggest that the out-of-pocket costs patients have to absorb during a trial may play a role in determining who chooses to participate. If you or a loved one are considering a clinical trial, there are ways to find financial support. Knowing what costs you are responsible for ahead of time can help.

Understanding Out-Of-Pocket Costs From Clinical Trials

Selin Kurnaz, PhD, is the co-founder and CEO of Massive Bio, an organization that matches patients with cancer to clinical trials and offers support along their journey. She explained that there are typically two types of potential out-of-pocket expenses: logistical and standard-of-care costs.

Logistical costs include expenses related to transportation, such as airfare, gas, taxi rides, and parking. Other travel-related logistical costs may include meals and hotel stays. “For some patients, that’s an additional impact on their cost of living,” she said.

Standard-of-care costs include routine tests and treatments related to your cancer that you would have received outside of the trial. Typically, private insurance plans have covered standard-of-care costs the same way they would cover other costs of cancer care. Medicare has also covered routine costs of qualifying clinical trials.

For patients on Medicaid plans, the passage of the Clinical Treatment Act, which went into effect on Jan. 1, 2022, now also requires these programs to cover routine costs of clinical trials in all states and U.S. territories. Medicaid is also required to cover routine patient costs even if a doctor or healthcare center is outside of your state or network.

Although every trial is different, most clinical study sponsors will cover the cost of any special treatment related to the trial’s research. Often sponsors will have financial navigators to help answer questions about any of these costs.

Questions to Ask When Considering a Clinical Trial

Before joining a clinical trial, patients receive what’s called an informed consent document. It lays out what the trial will cover and what it will not, among other key details. Because every trial is different, this is an important time to ask questions about the trial itself and what costs will be covered if you participate.

An engineer by trade, Adams said he kept meticulous track of any costs and what was being covered by his private health insurance providers and by the study center. While reflecting on his experience, Adams said the study center laid out the costs of the trial and what would be covered by the center and his insurance plans. Though he said he was fortunate to be in a financial position to cover standard-of-care costs and the costs of driving about 25 miles to the center, he recommended patients pay close attention during these meetings.

“I would certainly encourage everyone to read the trial documents and make sure they understand what that involves and the financial ramifications of the trial,” Adams said.

Another important question to ask while discussing the clinical trial is the visit frequency and procedures that may require you to stay at or near the clinical trial center. Knowing how often you’ll need to be at your clinical trial center can help you gauge travel costs and could also add to expenses in other ways, such as by necessitating childcare or time off from work.

Health Insurance Plans and Clinical Trials

While most private health insurers are required to cover costs of routine care associated with clinical trials, they may not be required to cover the costs of out-of-network doctors or hospitals unless that is part of the patient’s insurance plan. This can be challenging for patients who need to travel to another state for a clinical trial.

Navigating insurance plans can be confusing, but it’s important to understand your policy to avoid any surprises before enrolling in a trial. Certain institutions have finance offices where patients can get support and answer questions about what private insurance plans might cover. Kurnaz recommended patients have a serious conversation with their insurance providers about what their specific policy may or may not cover.

Tips for Navigating Hidden Clinical Trial Costs

Though nonmedical costs can add up, especially if a clinical study is far from home, pharmaceutical companies involved in the trial may be able to help shoulder certain out-of-pocket costs, Kurnaz said. She recommended calling the pharmaceutical company’s patient support line and asking if they will help cover certain costs related to non-medical expenses.

Kurnaz said that when she has asked companies sponsoring trials if they could cover a cost such as travel or parking, they have agreed in every instance.

Advocacy groups and foundations are another potential resource for financial support for patients enrolled in a clinical study. Foundations such as the Leukemia and Lymphoma Society, the International Myeloma Foundation, and the Patient Advocate Foundation can help pay for out-of-pocket costs for clinical trials and guide you through the process. Some groups will even help patients cover their home mortgage, rent, and utilities while enrolled in a clinical study, Kurnaz said.

by Youssef Rddad Staff Writer

Youssef Rddad is a medical journalist based in Florida. Before joining *Patient Power* in 2022, he covered news with a focus on health and science for several publications, including the *Minneapolis Star Tribune*, *The Associated Press*, and *The Advocate* in Baton Rouge, Louisiana. Youssef earned his bachelor’s degree in journalism from the University of Minnesota. He is also a staff writer for *OBR Oncology*.

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Len

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Thank you - good timing for me-

Virginia