Specialty Pharmacy's Expanding Role in IBD Care and Biosimilar Education

In an interview with Pharmacy Times, Shubha Bhat, PharmD, MS, clinical pharmacist of gastroenterology at Cleveland Clinic, discussed how specialty pharmacy services are improving outcomes for patients with inflammatory bowel disease (IBD). She highlighted findings from her ASHP Midyear–supported research evaluating educational strategies to help patients feel more confident about biosimilars. Bhat explained the barriers posed by payer requirements, insurance variability, and nonmedical switching, all of which disrupt continuity of care and create confusion for patients. She emphasized that as biosimilar use expands, specialty pharmacists will play an increasingly essential role in education, access support, and personalized medication management for individuals with IBD.

Pharmacy Times: How is specialty pharmacy improving outcomes for patients with IBD?

Shubha Bhat, PharmD, MS: The specialty pharmacy brings tremendous benefit to IBD care. This includes improving medication access, adherence, and continuity of care, and all of these are critical components for managing a chronic condition like IBD. One major development in this space has been the introduction of biosimilars. These are biologic medications that are highly similar to the original FDA-approved product and have been proven to be safe and effective for IBD.

However, most biosimilar use today is being driven by insurance-mandated switches, and in IBD we tend to avoid unnecessary medication changes. Naturally, patients feel concerned about switching, even though the active ingredient is the same. This can lead to a nocebo effect, where patients believe the new medication is not working despite objective evidence not validating that belief. Research has shown that education can improve confidence and acceptance of biosimilars, but the best way to deliver this education is still unclear.

In our ASHP-funded study supported by Amgen, we are evaluating different approaches, including shared medical appointments, one-on-one appointments with the pharmacist, and the standard FDA biosimilar pamphlet, to see which method best improves patient confidence. This is an ongoing study, but I anticipate that interactive formats like shared medical appointments or individual sessions will be more effective than the pamphlet alone. Identifying the best educational strategy will allow pharmacists to implement similar models in their own settings, helping patients feel comfortable with biosimilars while improving access, generating cost savings, reducing the risk of the nocebo effect, and preventing unnecessary treatment interruptions or changes.

Pharmacy Times: What are the biggest barriers to implementing specialty pharmacy services for IBD?

Bhat: One of the interesting aspects of the project was the collaboration it allowed. Because of how our specialty pharmacy model is structured at the Cleveland Clinic, I, as an embedded clinical pharmacist in the GI clinic, was able to partner closely with my counterpart in the specialty pharmacy. We encountered some barriers when setting up a biosimilar education service.

Scheduling shared medical appointments was challenging because we had to find a time that worked for both of us, and coordinating that time with the patient was not always easy. Another hurdle was getting patients to opt into the education session, especially because they were not yet facing an insurance-mandated switch. Insurance variability was another issue; preferred biosimilars—if offered at all—can differ by formulary, so we were not able to provide product-specific education.

Lastly, financial justification and resource allocation can be a challenge, especially when pharmacists cannot bill for their time or expertise or capture the biosimilar prescription. These are important considerations for institutions looking to implement similar services.

Pharmacy Times: How do payer requirements impact access and continuity of care for IBD patients?

Bhat: In the biosimilar space, one major challenge has been nonmedical switching. This is a situation where insurance requires patients to change medication for cost reasons rather than clinical need. Biosimilars were introduced to improve access and reduce the cost of biologic therapy, but adoption has not always been seamless.

There are multiple biosimilar options for medications like adalimumab and ustekinumab, and formulary preferences vary widely because unbranded and branded formulations exist. Mandated switches are often poorly communicated, and sometimes patients only learn about the change when they cannot refill their original prescription. Moreover, prior authorization approval for the original medication does not always transfer to the biosimilar, even when the switch is mandated, creating additional administrative burden.

Another trend we are seeing is that payers may require biosimilars as the preferred first-line option. While this reduces costs, it limits access to other medication classes that may be equally appropriate as first-line therapy. Additionally, patient support programs vary widely among manufacturers, so patients may not experience the cost savings that biosimilars are intended to deliver. Collectively, these factors create confusion and frustration, which is why education and proactive communication are so important.

Pharmacy Times: How do you see the specialty pharmacist’s role evolving in IBD management?

Bhat: This is a topic I am really passionate about. One of the great things about pharmacists in IBD care is the flexibility to practice in a variety of settings, whether in a specialty pharmacy, an infusion center, or directly in the GI clinic. Across these settings, pharmacists can provide critical clinical services such as medication education, therapeutic drug monitoring, and health maintenance reviews to ensure patients stay up to date on recommended vaccines and screenings.

As we have seen in our research, pharmacists are also leading initiatives around biosimilar adoption to improve access and affordability while supporting adherence through targeted interventions. As more biosimilars and new therapies enter the market, pharmacists will continue to play an essential role in guiding patients and providers through the complexity of the specialty medication landscape, with the goal of optimizing treatment and improving outcomes.