For many ovarian cancer patients, clinical trials offer a promising avenue for expanding treatment options and extending survival. Unfortunately, participation comes at a steep financial cost that is often prohibitive – even for patients with health insurance. Over 20 percent of cancer patients report out-of-pocket costs as a major barrier to joining a trial.
The costs of clinical trials
There are three main types of expenses associated with clinical trial participation. First, there are indirect, non-medical expenses, like those associated with travel, lodging, taking time off work, or any childcare that may be necessary for participation in a clinical trial. These indirect costs – also referred to as “ancillary expenses” – can total $600/month, if not more.
Then, there are two types of direct – or medical – costs, which are categorized as either routine or investigational.
Routine medical costs are the expenses a patient would incur if they weren’t participating in a clinical trial, such as the cost of doctors’ visits, laboratory tests, and radiology exams. Investigational costs are unique to each trial and include the cost of the experimental therapy and any investigational laboratory tests required by the study protocol.
All coverage is not equal
Investigational costs are covered by the trial sponsor (whatever pharmaceutical company is manufacturing the trial drug being tested) – but coverage of routine care costs depends on your type of health plan. Some health plans discontinue coverage of routine care costs when enrollees are participating in clinical trials, leaving the patient to shoulder these costs, which can quickly add up.
Fortunately – over the past two decades – policies have been put in place to protect patient access to clinical trials and ensure this essential coverage is included in health plans.
Under the Affordable Care Act (ACA), private small individual and group health plans must cover routine costs in connection with participation in approved clinical trials for patients with ovarian cancer and other life-threatening conditions. Separately, 38 states and D.C. have passed laws at the state-level putting in place various coverage protections when it comes to participating in clinical trials. Some of these state-level laws go further than the ACA providing more favorable coverage protections to patients.
Medicare – the public health insurance program primarily serving seniors and a major financer of health care nationwide – has included coverage of all routine medical costs for enrollees participating in clinical trials since 2000. Unfortunately, Medicaid – the other major public health insurance program and financer of health care in the U.S. – has been slow to follow suit.
Medicaid is a joint federal and state program that insures more than 72 million low-income adults, pregnant women, elderly adults, and children nationwide. States operate their own Medicaid programs and determine the type, amount, duration and scope of services to cover within broad federal guidelines. As a result, benefits under Medicaid vary significantly state-by-state.
Currently, Medicaid programs in 12 states and the District of Columbia cover routine care costs for patients participating in clinical trials: Alaska, California, Florida, Indiana, Maryland, Michigan, Montana, New Mexico, North Carolina, Texas, West Virginia, and Vermont.
This leaves as many as 42.2 million Medicaid enrollees across 38 states without this essential coverage, meaning if these individuals wish to participate in a clinical trial, they’re on the hook for every routine doctor’s visit and procedure. These are expenses Medicaid would normally cover, but not when a patient is participating in a trial. Since a single trip to the oncologist can easily run hundreds – or even thousands – of dollars without insurance, this is simply a non-starter for most Medicaid patients.
A racial justice issue
Lack of Medicaid coverage for routine costs associated with a clinical trial represents not only a missed opportunity for these patients, an opportunity that may be the difference between life or death, but also a missed opportunity to bring much-needed diversity to clinical trial study populations and medical research more generally. According to data from 2018, 50% of Medicaid participants are Black or Hispanic. People of color have long been underrepresented in clinical trials, significantly limiting the value and application of clinical trial findings to real-world patients.
In ovarian cancer – where racial disparities in treatment and survival outcomes are especially pronounced – the importance of ensuring women of color are represented in clinical trials cannot be overstated. While ovarian cancer is diagnosed at far greater numbers in white women compared with women of other races, research has shown that Black women have worse survival rates than white women. According to a 2016 review of several peer-reviewed studies, Black women are more likely to be diagnosed in later stages, and less likely to receive recommended surgery and chemotherapy.
Since women of color are disproportionately insured through Medicaid, lifting barriers to clinical trial participation in Medicaid is key to understanding and addressing persistent disparities in ovarian cancer and other diseases. Research presented at the Society of Gynecologic Oncology’s (SGO’s) 2018 Annual Meeting on Women’s Cancer shows that participation in clinical trials may help overcome racial and geographic disparities in the treatment of advanced or recurrent ovarian cancer.
Fortunately, Representatives Ben Ray Lujan [D-NM] and Gus Bilirakis [R-FL] have stepped up to the plate with their bipartisan legislation, The CLINICAL TREATMENT Act (H.R. 913). This bill guarantees Medicaid coverage of routine care costs associated with clinical trial participation for patients with ovarian cancer and other qualifying conditions – regardless of their state of residence.
Ovarian Cancer Research Alliance (OCRA) – along with more than 100 organizations representing patients, providers, and medical researchers including the American Society of Clinical Oncology (ASCO), American Cancer Society, and the American Medical Association (AMA) – has proudly endorsed H.R. 913 and is calling on Congress for its swift passage and enactment.