Key Takeaways from the 2026 National Celiac Disease Policy Symposium
On Friday, June 12, 2026, the Celiac Disease Foundation and the Society for the Study of Celiac Disease hosted the 2026 National Celiac Disease Policy Symposium, “From Diagnosis to Coverage: Aligning Policy for Celiac Disease Therapeutics.” This virtual symposium was the first step in getting doctors, diagnostic experts, regulators, and health insurance companies (a.k.a. payers) on the same page so that once new celiac disease treatments are approved, there’s a clear and fair process for deciding who qualifies and how those treatments get covered. It was a jam-packed day full of incredible information from the field’s leading experts on celiac disease, drug development, and health policy.
Below we lay out the key takeaways from each presentation and important action items for patients with celiac disease. You can watch the full recording of the day here: https://celiac.org/national-policy-symposium-2026/
Keynote with Dr. Dan Leffler
- The gluten-free diet is lifesaving but not enough for many patients. About 85% of patients surveyed reported gluten symptoms in the past three months, even with careful adherence.
- About 90% of celiac disease patients surveyed said they want a therapy to either replace or supplement the gluten-free diet, and roughly 75% of those with episodic gluten reactions missed work or school for at least a few days per episode.
- Excess annual medical costs for people with celiac disease are estimated at $6,000-$8,000 per person beyond those without the disease, and diagnosis delays of 6-10 years remain common for adults.
- Celiac disease screening programs are beginning to roll out in the U.S. and Europe which could dramatically increase diagnoses.
- The therapeutic pipeline is more active than ever, but FDA approval won’t automatically mean patients can get or afford the drugs. Payer coverage policies are the next major hurdle.
Panel 1 – Diagnostic Alignment in a Therapeutic Era with Dr. Christopher Cao, Dr. Marie Robert, Dr. Vahe Badalyan, Dr. Jack Doyle, and Dr. Jennifer Sealy-Voyksner
- Dr. Cao highlighted that North America and Europe currently use different diagnostic standards: North American guidelines generally still require a biopsy, while European guidelines allow a “non-biopsy” diagnosis when TTG is more than 10x the upper limit of normal plus a positive confirmatory test (anti-endomysial antibody). He presented a five-tier diagnostic certainty framework, ranging from high certainty (biopsy + serology confirmed) to low certainty (patient-reported sensitivity without testing), and shared that at Mount Sinai’s Celiac Disease Program, more than 50% of patients with a celiac diagnosis in their chart no longer had records to prove it which may prove a problem once a drug is available.
- Dr. Robert explained that biopsy interpretation has real variability between pathologists, especially when grading severity, but work is underway to standardize this.
- Dr. Badalyan noted that emerging biomarkers like IL-2 testing may eventually help confirm diagnosis without a gluten challenge, but these remain investigational and aren’t yet validated for routine use.
Panelists agreed that HLA genetic testing can rule celiac disease out (a negative result makes celiac extremely unlikely) but cannot confirm a diagnosis on its own.
Action items for patients: Track down your original diagnostic records (biopsy reports, blood test results) and store them somewhere accessible. If you were diagnosed years ago and don’t have records, ask your doctor about options to clarify your diagnosis going forward.
Panel 2 – Trial Design, Genotype & Regulatory Signals with Dr. Edwin Liu, Dr. Amelie Therrien, Elena Evans, Dr. Haley Zylberberg, Dr. Shelly Gunn, and Dr. Iris Jonkers
- Dr. Liu explained that about 90-95% of people with celiac disease carry HLA-DQ2.5 and 5-10% carry HLA-DQ8. A small percentage carry rarer variants (DQ2.2, DQ7.5) that can also confer risk but are sometimes missed by tests. Having either gene is necessary, but not sufficient for celiac disease: about 40% of the general population carries these genes, while only ~3% develop celiac disease.
- Dr. Therrien noted that some drugs in the pipeline are being designed specifically for DQ2.5 patients, meaning HLA type could eventually determine which treatment a patient is eligible for, and that IL-2 testing appears to work less reliably in people with DQ8 alone.
- Elena Evans and Dr. Gunn raised concerns about test quality: consumer genetic tests (like 23andMe) and clinical lab tests vary in what they report, and some don’t include rarer-but-relevant variants like DQ7.5 or DQ2.2, which could lead patients to be wrongly told they don’t have a “celiac gene.” Full genotyping from a clinical lab is preferred.
Action items for patients: If you’ve had HLA testing done, make sure you have the full results (not just “positive/negative”), including which specific alleles were found. If you’re interested in clinical trials, knowing your HLA type in advance could help you determine eligibility.
Panel 3 – Defining Treatment-Eligible Celiac Disease with Dr. Ben Lebwohl, Dr. Anne Lee, Julie Tierney, Dr. Dan Leffler, Dr. Hilary Jericho, and Danielle Green
- Dr. Lebwohl argued against requiring patients to “fail” the gluten-free diet through a specific documented process before accessing therapy, warning this could delay care unnecessarily. He also emphasized that symptoms and histology do not always align, so eligibility should not rely on one factor alone. He pointed to Crohn’s disease as a model, where drug labels are intentionally broad (e.g., “moderate to severely active Crohn’s disease”) rather than highly protocolized.
- Dr. Lee shared that the gluten-free diet has real nutritional downsides — lower fiber, vitamins, and minerals, with higher fat and simple sugar content — that are often missed in standard clinical care. She also presented striking quality of life data: gluten-related hypervigilance drives significant anxiety and social isolation, especially in young adults ages 23-35, over 75% of whom reported a major negative impact on their social life. Food insecurity compounds this, since gluten-free food costs 183–250%+ more than regular food and is harder to find in lower-income areas.
- Julie Tierney, offering an FDA perspective, said diagnosis by biopsy, a sufficiently symptomatic baseline, and evidence that symptoms stem from active celiac disease (not another condition) are likely requirements for clinical trials and, eventually, coverage decisions.
Action items for patients: Document not just your diagnosis but ongoing symptoms, quality of life impacts, dietary burden, and any nutritional deficiencies — this record could matter for future treatment access. Dietitian evaluations, ideally at least twice a year, are recommended to track lived experience and nutritional status.
Panel 4 – Payer Coverage Strategy – Evidence, Data & Guidelines Required with Jonathan Blum, Dr. Alexander Oshmyansky, Dr. Laura F. Garabedian, and Ryan Haumschild
- Jonathan Blum noted that Medicare, Medicaid, and private insurers all set their own coverage rules, and FDA approval doesn’t require any of them to cover a drug. Payers decide coverage based on whether something is “reasonable and necessary,” meaning better than current treatment (the gluten-free diet) and cost-effective.
- Dr. Garabedian noted a critical challenge: much of the cost of celiac disease (food, lost wages) is borne by patients rather than insurers, which can make it harder for payers to see a clear financial case for covering a new drug. She also highlighted a Massachusetts Medicaid program providing medically tailored meals, where reduced ER visits and hospitalizations almost fully offset the program’s cost within 7 months. Some states offer Medicaid 1115 waivers that support food-as-medicine programs for conditions including celiac disease.
- Ryan Haumschild explained that prior authorization will almost certainly be required for any future celiac drug, likely including confirmed diagnosis, specialist involvement, and evidence of dietary compliance.
Action items for patients: If you’re employed by a self-insured employer, know that your employer has more power than you might think to influence what drugs are covered.
Panel 5 – Advocacy Roadmaps to Coverage – Lessons from Other Conditions with Aaron Turner-Phifer, Michelle Rice, Dr. Sundeep Singh, and Vanessa Weisbrod
- Vanessa Weisbrod emphasized that FDA approval is not the finish line. For patients to actually benefit from a new therapy, there also needs to be insurance coverage, affordability, clinician education, and payer understanding, which all things other disease communities have already had to fight for.
- Aaron Turner-Phifer (Breakthrough T1D) shared that continuous glucose monitors (CGMs) took more than 10 years to go from FDA approval to widespread insurance coverage, and suggesting to start advocacy early. He noted that Medicare specifically required separate data on senior populations before covering CGMs, since payers often want disease-specific evidence in their own patient population, not just clinical trial data. His takeaway: be “persistent but not annoying.”
- Michelle Rice (hemophilia community) described how advocates began proactively educating payers in 2010, well before problems arose, and built a multi-stakeholder collaborative with payers, clinicians, and patients that’s still active today, now with 15–20 participating payers. Her key insight: payers often don’t know what they don’t know, and uniform cost-management policies like step therapy or “fail-first” requirements can backfire when they don’t account for disease complexity.
- Dr. Sundeep Singh emphasized that clear, concise clinical documentation is critical for prior authorization success, and that an economic argument (“here’s how this saves you money”) often persuades private payers more than a clinical argument alone.
- Panelists discussed that significant advocacy work remains even after FDA approval. Registries, outcome data, economic analyses, and consensus definitions need to be built before drugs reach the market.
- The celiac disease community’s biggest current gaps: limited health economic data on what celiac disease costs the system, public misunderstanding of its severity, limited long-term follow-up data, and inconsistent diagnostic documentation.
Closing Plenary with Dr. Kathryn Argue and Dr. Dawn Adams
- The Congressionally Directed Medical Research Program (CDMRP) has active funding opportunities for celiac disease research in 2026, spanning early discovery through clinical trials.
- Patient advocates hold voting seats in the grant review process, meaning the patient voice directly shapes what gets funded.
- If you know a researcher working in celiac disease, point them to CDMRP funding at cdmrp.army.mil.
Looking Forward
The Policy Symposium reinforced that, with several therapeutics already in clinical trials, now is the time to prepare for what happens if a drug shows efficacy: how FDA approval will translate into eligibility criteria and real-world coverage. The Celiac Disease Foundation is committed to being a trusted convenor of and liaison to health insurance companies, pharmaceutical companies, and the federal government, ensuring as many people as possible will have access to celiac disease drugs that they could benefit from.
Thank you to our sponsors Takeda Pharmaceuticals, the Michael Weiss Family, Forte Biosciences, Chugai Pharmaceuticals, and First Tracks Biotherapeutics for enabling this important event to happen.