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Managing Access and Making Advocacy Part of Your Pediatric Gastroenterology Practice

Sandra Kim, MD, unpacks the problem and shares ways to help your patients


The cost of and access to therapies for inflammatory bowel diseases (IBD) place a significant burden on children living with IBD, their families and the healthcare system. It’s a problem that Sandra Kim, MD, Chair of Cleveland Clinic Children’s Department of Gastroenterology, Hepatology & Nutrition, has been working to address for decades.


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Dr. Kim is a pediatric IBD specialist, but she says the issue of access is a common theme in many chronic illnesses. Patients with IBD, even those with health insurance, have reported significant concerns related to access and denials from insurance companies for lifesaving therapies, resulting in delayed care and poor outcomes.

The cost of IBD care is ‘staggering’

The exorbitant cost of lifesaving healthcare is a problem systemwide, and it is particularly troublesome within the context of caring for patients with GI diseases. “The cost is staggering,” says Dr. Kim, citing reports that estimated expenditures are $135.9 billion and more than $7 billion for Crohn’s disease and ulcerative colitis.

The Crohn’s & Colitis Foundation cites several factors associated with the disease’s disproportionate burden. Compared to other diseases, IBD patients tend to see more out-of-pocket expenses related to biologic therapies along with disease comorbidities such as anemia, mental illness and hospitalization. In addition, patients with IBD tend to have more work-related wage loss than non-IBD patients.

In children, specifically, it is common for symptoms to be more clinically severe. This is also reflected in the increased financial burden for these children and in studies that show pediatric patients with IBD have significant annual and lifetime cumulative costs related to their IBD. Prolonged time-to-diagnosis can lead to delayed access to therapy and hospitalization, further exacerbating clinical outcomes and quality of life for these children and their families. Given the severity of disease and the lifetime burden if their inflammation is not effectively treated, it is essential for these children to have access to appropriate therapies.

Biologic agents offer known benefits, but…

Children with moderate-to-severe IBD are often candidates for a biologic agent, monoclonal antibodies like infliximab, ustekinumab and adalimumab, for which there are good clinical data and known benefits, but access has become increasingly difficult for many families because there are fewer therapies with FDA approval for children, even with known data and clinical experience. This is further exacerbated by the current insurance, pharmacy benefits manager, approval processes and out-of-pocket expenses associated with these medications.

Dr. Kim says the issue of access is about more than just discussing therapies with families.


“It’s also about making sure families have the best comprehensive care that addresses all facets of life. It’s about getting education to these families and ensuring their primary care providers are reinforcing the same education. We need to ensure all patients have access to state-of-the-art research and clinical trials. For children who have more severe disease and those from underserved communities, this is where identifying and managing issues of access becomes particularly important,” she notes.

Navigating the prior authorization process

A sobering reality within the field is managing what can be a complex prior authorization process. Here is what it can look like: “A shared decision about a treatment plan is made between the patient and physician; the physician writes a prescription, but then the insurance company must authorize it to initiate therapies,” explains Dr. Kim.

“In some cases, it’s a simple authorization process, but other times it’s more complicated, involving a lengthy “fail first” approach,” she says.

“The bottom line is when kids are diagnosed with severe IBD and need to go on a biologic therapy, we have days, not weeks or months to wait, and an extended prior authorization process can increase the likelihood of IBD-related healthcare utilization, such as hospitalization or steroids, that could have been prevented otherwise. More importantly, a child’s life hangs in the balance during this delay, increasing the risk for complications that could have been avoided,” she says. Dr. Kim offers the following strategies to help expedite the process when possible:

  1. Understand the companies and be able to identify the top payers. “Typically, you’re going to know what insurance companies want, but get to know the formularies to the best of your abilities and develop a process for working with them.”
  2. Do the eligibility checks. “Before you write the order, submit for something, and then go through a rejection, find out what is in the formulary. Look at the complete data and give all the information as if you were presenting a patient.”
  3. Emphasize the medical and financial impact. “Use detailed clinical and diagnostic synopses with references.”
  4. Develop a good tracking system. “I used to use a secure spreadsheet, especially when I had 350 patients just with IBD and 60% were on biologics.”
  5. Set expectations with patients about this reality. “Know how to talk about the realities of this process with patients and their families. The Crohn’s & Colitis Foundation offers resources for this.”
  6. Be prepared to quickly appeal a denial. “The unfortunate reality is that this will happen. Start the peer-to-peer process immediately and utilize templates available from subspecialty societies.”

Who is failing whom?

Beginning an effective treatment regimen for IBD often means first demonstrating “failure” of a less expensive and often less effective drug. The problem? “Patients don’t fail medications,” says Dr. Kim. “Medications fail patients. Systems fail patients.”

Step therapy, or “fail first” policies are instituted by insurers and require patients and healthcare providers to utilize medications (often the least expensive) even when they do not follow established clinical practice guidelines. The prior authorization process for therapies prescribed by healthcare providers after discussion with patients, denials and appeal/grievance processes can add significant time to treatment access and, thus, delays in care.


Several IBD studies have found that while tighter control might have some initial cost savings, conventional management of the disease results in improved outcomes, less hospitalization and better quality of life. These data are leading to growing support in medical and legislative communities. Furthermore, recent studies, including a survey of U.S. pediatric gastroenterologists, show that healthcare teams are investing significant time in this process, contributing to increased provider burnout.

Making advocacy part of your personal and professional practice

Step therapy and medical nutrition reform have been introduced at federal and state levels and have received broad bipartisan support. “Safe Step” legislation would require group health plans to implement a clear exception to step therapy protocols in specified cases, offer exemptions for “fail-first protocols,” and have an expedited response time. Nutrition reform, a bill included in the Equity Act, would require insurers to cover medical nutrition (formulas and medical foods).

Dr. Kim, who works with the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and the Crohn’s and Colitis Foundation, advocates for these policies through meetings with health policy staffers and congressional visits on Capitol Hill. She says supporting legislative efforts is just one way to make advocacy a part of your practice and offers the following as well:

  • Get familiar with subspecialty societies and how they are aligning their legislative priorities. This is a great way to educated and find a space to get involved if you are new the advocacy space.
  • Focus research and funding efforts that improve pathways for regulatory approval, labeling of therapies for children, and advancing pediatric IBD therapeutic development. This is applicable to many chronic illnesses affecting children.
  • Encourage academic children’s hospitals to adopt a culture of advocacy through mission-driven collaboration with other centers, dedicated training and resources and promotional pathways for students, trainees and staff.
  • Find mentors and colleagues whose advocacy practices you admire or wish to emulate.
  • Utilize social media effectively to build awareness and connect with others.

Dr. Kim concludes, “We have developed therapies that can significantly change the lives of our patients as our research gives us a better understanding of the mechanisms leading to their disease. These advancements are and will continue to be crucial. However, if our patients cannot access the care they need, the impact of this critical work is neutralized. As pediatric GI specialists, we must find ways to make advocacy a part of our practice and give our pediatric patients a voice.”


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