Throughout most of her life, Katie Neu, a 31-year-old Massachusetts resident with Crohn’s disease, has struggled with insurance barriers.

Diagnosed at age 10, Neu was initially required by Medicaid to fail 5-aminosalicylate therapy before advancing to other treatments. Even after starting biologics, her disease remained uncontrolled, eventually requiring surgical removal of 13 inches of small intestine and a bladder reconstruction as a teenager. 

Later, access to infusions of vedolizumab required another battle with Medicaid. As a young adult managing her own health insurance, Neu once received a $26,000 bill for a vedolizumab infusion, which was only lowered after a switch to the insurer’s preferred infusion center.

More recently, after moving to her husband’s insurance plan, Neu faced a new barrier to covering her then-therapy, risankizumab. A pharmacy benefit manager informed her that her next dose would not be approved in time, and she would need to try a lower dose first. 

“I was bawling my eyes out,” Neu told Medscape Medical News.

The higher dose was eventually approved. However, the stress led to a flare, just the latest toll of her decades’ long battle against insurance barriers.

Young Adults Caught in Insurance Net

Like Neu, many young adults with inflammatory bowel disease (IBD) struggle to cope with insurance barriers.

The analysis, based on a 2023 Crohn’s & Colitis Foundation survey, found that young adults aged 18-25 were more likely than older adults or pediatric patients’ caregivers to face step therapy requirements, experience delays in medication access, and struggle navigating insurance barriers. 

Although the analysis included a relatively small number of respondents — 229 young adults among 1781 total respondents — clinicians say the results mirror what they routinely see in practice. 

The study findings were published in January in the journal Crohn’s & Colitis 360.

Young Adults Hit Hardest

Among young adult respondents, 35% reported being subject to step therapy mandates, compared with 27% of adults and 20% of pediatric caregivers. The same percentage (35%) of young adults said they were “not confident at all” in knowing what questions to ask their insurer when coverage issues arose.

More than two-thirds (69%) of young adults reported difficulty accessing medications due to insurance barriers, compared with 61% of adults and 59% of pediatric caregivers. Approximately 1 in 5 experience delays in receiving a medication of a month or longer, and a similar proportion reported an adverse health event because they had not taken a medication.

Lead author Ross M. Maltz, MD, associate professor of clinical pediatrics at The Ohio State University College of Medicine, Columbus, said it is unclear why young adults are more frequently subject to step therapy. A possible explanation may be insurance transitions, such as aging off a parent’s plan. In such cases, a young patient may have been stable on a particular medication for years, only to find the new plan insists on step therapy, Maltz told Medscape Medical News.

With step therapy, insurers usually require that a patient fail one or more less expensive drug therapies, said Laura Wingate, chief education, support, and advocacy officer for the Crohn’s & Colitis Foundation. As a consequence, patients are often “receiving suboptimal treatment for an aggressive disease,” Wingate told Medscape Medical News.

The financial toll can be severe for young adults, who may still be in school, not working, or already carrying student loan debt. 

“Trying to dig themselves out of that hole can be extremely challenging,” said Maltz. 

“The survey highlights that this is a particularly vulnerable group of people,” said Frank Scott, MD, associate professor of medicine at the Crohn’s and Colitis Center at the University of Colorado, Anschutz School of Medicine, Aurora. “They may have greater issues with regards to financial security,” and less experience with “navigating the process.” 

Clinical Consequences of Delayed Care

Delays in access to advanced therapies often lead to increased reliance on steroids to control symptoms in the interim, Scott told Medscape Medical News. Even short-term steroid exposure is associated with weight gain, mood swings, insomnia, fracture risk, infections, and blood clots. 

Scott has also seen patients hospitalized because of worsening symptoms during delays, with some ultimately requiring surgery because they could not access recommended therapy in time.

Scott served as lead author of the latest American Gastroenterological Association (AGA) clinical guidelines on the pharmacological management of moderate-to-severe Crohn’s disease, which he noted call for payors to align formularies with the “wealth of evidence” supporting the early use of advanced therapies, primarily biologics.

“We didn’t write this guideline to follow insurance rules,” said AGA guideline co-author Siddharth Singh, MD, Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, in a statement that accompanied their release. “Insurance coverage should follow the evidence.” 

Although the growing availability of IL-23 inhibitors and lower-cost biosimilars has expanded treatment options in IBD, insurers continue to erect barriers to their use.

“Step therapy hasn’t gone away,” said Wingate. “If anything, it’s really become a more entrenched policy,” with a greater focus on the same advanced therapies that “are very effective at getting people into remission and controlling disease.”

Ongoing State Protection Initiatives 

Thirty-nine states have enacted some form of protection against step therapy. However, these laws tend to only apply to certain health plans and only in those states. Approximately 60% of non-elderly Americans are covered by the federal Employee Retirement Income Security Act (ERISA) law and not subject to these protections.

Wingate noted that the Crohn’s & Colitis Foundation supports federal legislation such as the Safe Step Act, which would codify exceptions to step therapy for ERISA-regulated health plans. The bill has been introduced multiple times over the last decade but has yet to advance in Congress. 

The foundation also advocates for an expedited appeals process for those already stable on a medication. Such a model would ensure that an approval or denial is issued within 24 hours for urgent cases and within 72 hours for non-emergent cases. 

Self-Advocacy for All

Both Maltz and Scott said their institutions employ resources to help patients challenge step therapy and prior authorization decisions, but that they were likely the exception, not the rule.

At Nationwide Children’s Hospital in Columbus, Ohio, where Maltz serves as director of research at the Inflammatory Bowel Disease Center, transition programs help adolescents develop the skills necessary to manage their medical care independently. 

“They know how to navigate, who to contact, and how to be an advocate for themselves,” Maltz said. 

Scott serves on the leadership team for Qorus, the Crohn’s & Colitis Foundation’s national quality improvement initiative, which provides patient education tools and standardized prior authorization letters to help streamline the process. 

For her part, Neu now advises fellow patients through social media and blogging, encouraging self-advocacy. Yet she emphasized that clinician advocacy is just as critical.

“That is the game changer,” said Neu.

The survey of young adults was funded by the Crohn’s & Colitis Foundation. Neu disclosed that she provides consulting services on the patient experience for pharmaceutical companies. Maltz and Scott reported no conflicts. 

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.