Improving Treatment Delays in IBD Care to Improve Outcomes

By the early 2000s, the Food and Drug Administration (FDA) had only approved two biologic medications for inflammatory bowel disease (IBD) in children. For patients and their families, that meant a lot of waiting — and limited options. Decades later, there have been no new types of approved medications for children. Although children can use medication approved for adults after pediatric medications have failed, they often don’t reach them soon enough, prolonging the symptoms of IBD. Pediatric gastroenterologist Brad Constant, MD, is on a mission to change that.

IBD research explores the impact of prior authorizations

Dr. Constant, along with a team of researchers from the University of Colorado School of Medicine and the Children’s Hospital of Philadelphia, conducted studies to identify the factors behind these treatment delays. They found that insurance-mandated barriers — including prior authorizations, step therapy and denials — play a significant role.

The group conducted a retrospective study of pediatric patients with IBD who started biologic therapies. This included 190 patients from 2010 to 2020. Approximately 75% of the patients needed a prior authorization, a lengthy insurance process that requires a doctor to get approval from a health plan before prescribing medication. Overall, the median time to start biologic therapy was 21 days. For patients who needed prior authorization, the median time was 25 days, compared to 13 days for those who did not.

Researchers also analyzed how the complexity of prior authorization affected delays in therapy initiation. For patients who had a complicated prior authorization process, influenced by step therapy policies, peer-to-peer review or a letter of appeal after a denial, they waited on average 24.6 days longer than those not requiring prior authorization. Even an uncomplicated prior authorization process was associated with a 10.2 day increase in time to initiate a biologic. Any delay in starting treatment, Dr. Constant says, can increase the risk of complications.

“Time is bowel,” Dr. Constant says. “The longer we wait for medication is potentially more bowel we’ll have to resect. And with every delay, the longer children will suffer through symptoms of IBD (pain, diarrhea fatigue), miss school and experience the effects of corticosteroids.”

For Dr. Constant, the waiting, the wondering, the back and forth — it's all personal. He was 8 years old when he was diagnosed with Crohn’s disease.

“Every day that you wait for medication, it’s a terrible struggle,” Dr. Constant says.

As a child, his mother was his biggest advocate, pushing for new treatments and therapies. Now, as a pediatric gastroenterologist, he sees it as his purpose to ensure others receive timely care. That commitment drove him to dig deeper into the data.

Provider survey on accessing IBD treatments

In a separate study, Dr. Constant surveyed 373 providers about these requirements to access treatment. Nearly all respondents, 97%, reported that prior authorizations worsened care for their patients. And 83% reported that a delay due to prior authorization contributed to a disease-related hospitalization among their patients.

“The data is clear — these delays hurt patients,” Dr. Constant says.

The survey also revealed that these policies not only diminished quality of care but fueled provider burnout. Ninty-five percent say this clinical burden has increased over the past five years. Additionally, 161 providers reported spending 2 to 10 hours on this paperwork each week. Beyond delaying care, they also noted that prior authorizations influence medical decision-making and impede treatment recommendations.

The three drugs approved for pediatric use — infliximab, adalimumab and recently, golimumab — are all anti-TNF medications that work by blocking an inflammatory molecule. While about 60% of patients respond to these drugs, a significant number of children lose response each year. For patients who don’t respond to anti-TNF medications, doctors will usually recommend one of the other drugs only approved for adults. That’s where the back-and-forth begins.

“Our biggest problem isn’t that we need new drugs,” Dr. Constant shares. “We already have the drugs. We often just can’t use them. It’s frustrating for everyone. It’s demoralizing for the patients. It’s hard for a parent to grapple with the fact that they can’t use the medication their doctor wants to.”

Advocacy and further research aim to solve nationwide problem

Because of research and advocacy across the country, there has been progress in adjusting prior authorization requirements. Colorado passed a law that allows providers to adjust the dosage or frequency of certain previously approved medications without seeking new prior authorization. The law also extends the duration of approval to a calendar year, up from the previous 180 days.

Through his work with the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN), Dr. Constant has developed a comprehensive letter of medical necessity for IBD-related drug therapies. This sample letter explains why a provider is asking for this specific treatment, the dosage and other supporting evidence, to try and minimize denials and expedite approvals.

“We need to be upfront and direct with insurance companies. That changes denial rates and how fast these treatments are approved,” Dr. Constant says.

While Dr. Constant wants doctors to be able to easily prescribe the medications their patients need, he’s currently pushing for at least one improvement: a clear deadline for approval or denial.

“It’s this not knowing, waiting, watching as things get dragged through the mud,” Dr. Constant says. “We need to know if the drug’s approved, and if not, what drug we can use.”

In the meantime, Dr. Constant will continue to fight for patients to get access to the treatments they deserve.