Background

Inflammatory Bowel Disease (IBD) is a chronic condition that encompasses Crohn’s disease (CD) and ulcerative colitis (UC), both of which cause significant gastrointestinal inflammation. Patients experience symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition, with periods of relapse and remission. Despite advances in biologic therapies, treatment response varies, and there is a growing need for therapies that provide sustained efficacy, particularly in patients who have failed previous biologic or small molecule treatments.
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Challenge

The client aimed to position a novel biologic therapy for CD and UC within an increasingly competitive landscape, ensuring its differentiation from existing treatments. A key challenge was demonstrating the clinical value in a market influenced by established biologics and biosimilars. Additionally, regulatory agencies and health technology assessment (HTA) bodies required robust indirect treatment comparisons and cost-effectiveness models to assess the therapy’s value, particularly in treatment-experienced patients.

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Approach

A global advisory board was convened, consisting of 8 leading health economists, HTA experts, and clinical specialists in IBD. The process included:​​

• A pre-advisory board webinar providing an overview of the therapy’s Phase 3 clinical trial results

• Two half-day discussions focused on market access strategy, clinical differentiation, and economic modeling approaches

• Analysis of patient-relevant endpoints and their incorporation into cost-effectiveness models

• Expert review of indirect treatment comparison methodologies to assess positioning relative to existing therapies

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Outcomes

The advisory board discussions provided valuable insights into the challenges and opportunities for positioning the therapy within the competitive IBD treatment landscape. Experts highlighted key considerations related to clinical differentiation, economic modelling, and HTA agencies' expectations in light of evolving market dynamics.

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The client gained a deeper understanding of the factors that would be most relevant to patients, prescribers, and HTA agencies in different markets, enabling them to refine their approach to evidence generation, economic modelling, and payer engagement, and to strengthen their global market access strategy.