From Diagnosis to Coverage: Aligning Policy for Celiac Disease Therapeutics

On June 12th, 2026, the Celiac Disease Foundation and the Society for the Study of Celiac Disease hosted the first national policy symposium focused on preparing the healthcare system for the emerging era of celiac disease therapeutics.

For decades, the gluten-free diet has been the only treatment for celiac disease. Today, multiple therapies are advancing through clinical trials, bringing the field closer than ever to the possibility of new treatment options. However, scientific progress alone will not ensure that therapies reach patients. Diagnostic standards, treatment eligibility definitions, payer coverage frameworks, and federal research priorities must all evolve to support the transition from diet-only management to a therapeutic era.

This one-day virtual summit convened leading clinicians, researchers, policymakers, health economists, industry leaders, and patient advocates to examine the policy infrastructure required to bring future treatments to patients efficiently and equitably.

The symposium is now available for on-demand viewing. This program is endorsed by the AGA Institute.

Opening Session: Preparing the Field for the Therapeutic Era

Celiac disease therapies are closer to reality than ever before. This opening session sets the stage for the day by examining how the field must prepare for the transition from diet-only management to a therapeutic era. Leaders in clinical research and patient advocacy outline the opportunities ahead and the critical gaps that must be addressed in diagnosis, eligibility definitions, and coverage policy to ensure that new treatments can reach patients efficiently and equitably.

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Panel 1: Diagnostic Alignment in a Therapeutic Era

As treatments for celiac disease move closer to market, diagnostic clarity becomes more important than ever. Today, clinical guidelines vary across societies in areas such as biopsy versus non-biopsy pathways, serologic thresholds, and histologic interpretation. This panel examines where those differences matter most and how diagnostic variability could influence treatment eligibility and payer coverage decisions. Panelists explore opportunities to harmonize diagnostic approaches and strengthen documentation standards before therapies arrive.

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Panel 2: Trial Design, Genotype & Regulatory Signals

Genetic testing is a cornerstone of celiac disease diagnosis, but its role in therapeutic development is still evolving. This panel explores how HLA genotyping is being used in current clinical trials, how genetic testing is interpreted across clinical and consumer settings, and what signals regulators and payers may draw from these practices. Speakers also discuss guardrails needed to prevent genotype requirements in research from being misapplied in clinical eligibility or coverage policies.

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Panel 3: Defining Treatment-Eligible Celiac Disease

When therapies become available, who should receive them? This panel tackles one of the most important unanswered questions in the field: defining “treatment-eligible” celiac disease. Experts explore potential eligibility frameworks based on symptoms, serologic activity, histologic findings, and genetic considerations. The discussion also addresses pediatric versus adult care differences and the documentation standards needed to ensure fair and consistent access to treatment.

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Panel 4: Payer Coverage Strategy: Evidence, Data & Guidelines Required

Even the most effective therapies cannot reach patients without payer coverage. This panel brings together policy experts, health economists, and industry leaders to examine what evidence payers require when evaluating new treatments. Panelists discuss how clinical guidelines, real-world outcomes data, economic analyses, and drug pricing dynamics influence coverage decisions—and what the celiac field must prepare now to support sustainable access to future therapies.

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Panel 5: Advocacy Roadmaps to Coverage: Lessons from Other Conditions

Many disease communities have successfully navigated the complex path from therapeutic innovation to widespread coverage. In this session, leaders from other patient advocacy organizations share how they worked with clinicians, regulators, and payers to secure access to new treatments. Their experiences—from defining eligibility criteria to building evidence and engaging employers and insurers—offer valuable lessons for the celiac disease community as it prepares for the therapeutic era.

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Closing Plenary: The Research Agenda for Coverage-Ready Therapeutics

The symposium concludes with a forward-looking discussion on the research investments needed to bring celiac disease therapies from clinical promise to real-world access. Federal research leaders will highlight how agencies like NIH and CDMRP support therapeutic development, biomarker validation, and clinical trial infrastructure. The session will outline a strategic research agenda to ensure that scientific advances translate into treatments that are not only effective—but accessible to the patients who need them.

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