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Biosimilars in Immunological Conditions: Online CME Case Challenges Improved Knowledge and Competence among Rheumatologists and Gastroenterologists

Nimish Mehta, PhD, MBA1, Lindsey Gardner, MPP1, Laura Pincock, PharmD, MPH, CAPT/USPHS2 and Sarah Ikenberry, MA2, (1)Medscape LLC, New York, NY, (2)Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD

Theoretical Background and research questions/hypothesis:

Despite the availability of biosimilar agents for the treatment of immunologic conditions, adoption of biosimilars in the creation of customized patient care plans is limited by gaps in knowledge and competence of clinicians. We hypothesized that participation in case-based continuing medical education (CME) activity “Test Your Skill: Incorporating Biosimilars Into the Management of Patients With Immunological Conditions” would lead to improved knowledge and competence of rheumatologists and gastroenterologists regarding the use of biosimilars, and increased implementation in clinical practice.

Methods:

The online, self-paced CME activity consisted of 2 patient case scenarios delivered as an interactive, text-based format. Using a “test and teach” methodology to elicit cognitive dissonance, clinicians completed multiple-choice questions to test their application of evidence-based recommendations. Each response was followed by detailed, referenced, feedback. The educational effect was assessed using a repeated-pairs design with pre-/post-assessment, where 3 multiple choice questions assessed knowledge/competence. Significance was assessed using paired samples t-test for overall average number of correct responses and for confidence rating, and the McNemar’s test for individual questions (5% significance level, P <0.05). Cohen’s d estimated the effect size impact on number of correct responses (<.20 modest, .20-.49 small, .59-.79 moderate, ≥.80 large). Data were collected between 6/15/2022 and 12/12/2022.

In addition, a survey was sent to participants 30 to 60 days after activity participation to gauge performance-level changes implemented in practice as a result of this education as well as barriers that prevented them from making desired changes in practice.

Results:

The analysis set consisted of responses from rheumatologists (n=30) and gastroenterologists (n=33) who answered all pre/post-assessment questions during the study period. Analysis of pre- vs post-intervention responses demonstrated a significant improvement in overall knowledge; average correct responses increased from 80% pre to 94% post education for rheumatologists (P<.01, Cohen's d = 0.56), and 51% pre to 84% post education for gastroenterologists (P<.01, Cohen's d = 1.03). Specific areas of improvement in knowledge/competence include initiation of treatment with biosimilars, switching from reference biologic to a biosimilar, and interchangeability of biosimilars.

At the performance level, top 3 practice changes implemented as a result of participating in this education include: Identifying candidates for biosimilars, Including biosimilars as part of a customized care plan for patients, and Prescribing biosimilars in place of reference biologic therapies. Top barriers that prevented practice changes, include: Patient-related challenges (eg, difficulty identifying appropriate patients and patient reluctance to accept biosimilars), Uncertainty about the safety/ efficacy/ immunogenicity of biosimilar products, and Lack of time to discuss biosimilars with patients.

Conclusions:

This online, interactive, case-based CME activity significantly improved the ability of rheumatologists and gastroenterologists to communicate with patients to manage immunological conditions using biosimilars.

Implications for research and/or practice:

The increase in knowledge and competence of rheumatologists and gastroenterologists regarding the use of biosimilars in patients with immunological conditions is expected to result in better communication with patients regarding adoption of biosimilars in clinical practice, thus expanding treatment options for patients while recognizing cost savings for the healthcare system due to lower cost of biosimilars compared with reference biologic therapies.