Caly-003 cendakimab EoE pipeline

Indicated For

Eosinophilic Esophagitis (EoE)

About This Medication

# Cendakimab Patient Guide: How to Get Cendakimab at Low or No Cost **Important Notice:** As of March 2026, cendakimab (also known as CC-93538) is an investigational biologic drug primarily in phase 3 clinical trials for eosinophilic esophagitis (EoE) and atopic dermatitis, developed by Bristol Myers Squibb (BMS)[1][3]. It is not yet FDA-approved, and no commercial patient assistance program exists. This guide provides general information on accessing investigational drugs and potential future support. Always consult your doctor for personalized advice. ## About Cendakimab Cendakimab is a human monoclonal antibody that targets interleukin-13 (IL-13), a protein driving type 2 inflammation[1][4]. **It shows promise for treating EoE**, a chronic condition causing esophagus inflammation, swallowing difficulties, and food impaction in adults and adolescents. Phase 3 trials demonstrated symptom reduction, less esophageal inflammation, and improved endoscopic features, even in those unresponsive to steroids[1][3][4]. It's also studied for moderate-to-severe **atopic dermatitis (AD)**, improving skin clearance, itch, and disease severity after 16 weeks[2][5]. Administered subcutaneously (e.g., 360 mg weekly or every other week)[2][3], it appears safe and well-tolerated in trials up to 48 weeks[1]. Since it's investigational, access is limited to clinical trials or expanded access programs[3]. ## Who Qualifies for Assistance? No standard prescription assistance program (PAP) exists yet, as cendakimab lacks approval. Patients may qualify for: - **Clinical trials**: If you have active EoE or AD, meet criteria like severe symptoms or endoscopic abnormalities, and no recent esophageal dilation or immunosuppression[3]. - **Expanded access**: For serious conditions if trials aren't feasible[3]. - **Future BMS PAPs**: Once approved, BMS (developer[1]) typically offers programs for uninsured/underinsured patients below income thresholds. **Income Eligibility (Estimated for Future BMS PAP)**: BMS programs often use 400-500% Federal Poverty Level (FPL). Here's a hypothetical breakdown based on common pharma PAPs (2026 FPL estimates; actuals vary): | Household Size | Annual Income Limit (400% FPL) | Annual Income Limit (500% FPL) | |----------------|-------------------------------|-------------------------------| | Individual | $60,320 | $75,400 | | Couple | $81,760 | $102,200 | | Family of 3 | $103,200 | $129,000 | | Family of 4 | $124,640 | $155,800 | *Notes: Limits adjust yearly; includes all income sources. U.S. residents only; excludes most government insurance.*[General knowledge; no specific program data.] ## Insurance Requirements Investigational drugs like cendakimab are typically **not covered by insurance**, including Medicare Part D, as they're experimental[3]. - **Medicare/Medicaid**: Unlikely to cover; appeals rare for unapproved drugs. - **Private insurance**: May deny; prior authorizations fail without approval. - **Uninsured/low-income**: Prime candidates for trials or compassionate use. Once approved, PAPs often require no/limited insurance but exclude federal programs. ## Step-by-Step Application Process 1. **Consult your doctor**: Discuss if cendakimab fits your EoE/AD. Get diagnosis confirmation (e.g., biopsy for EoE). 2. **Check clinical trials**: Search clinicaltrials.gov for CC-93538 or cendakimab (e.g., NCT04753697[3]). Your doctor submits screening. 3. **Expanded access**: If ineligible for trials, doctor requests via BMS (contact medical info line). 4. **Future PAP (post-approval)**: - Visit BMS patient assistance site (hypothetical: bmsaccesssupport.com). - Download application or call 1-800-XXX-XXXX. - Submit proof of income, diagnosis, insurance denial. 5. **Doctor completes forms**: Prescriber verifies medical need. 6. **Mail/fax/upload**: Track submission. **Required Documents (Typical for PAPs)**: - Proof of income (tax returns, pay stubs). - Prescription. - Insurance denial letter. - ID/proof of residency. - Doctor's income/eligibility form. ## Timeline and Delivery - **Trial enrollment**: 2-8 weeks (screening, randomization[3]). - **Expanded access**: 4-12 weeks (review by BMS/FDA). - **PAP processing (future)**: 2-4 weeks; expedited for urgent cases. Drug ships free to doctor's office or home via specialty pharmacy. **Refills**: Auto-ship monthly; doctor reauthorizes yearly. ## Alternatives if Denied or Ineligible - **Other EoE treatments**: Proton pump inhibitors, swallowed steroids, diet elimination. - **Approved biologics**: Dupixent (dupilumab) for EoE/AD via manufacturer PAPs. - **AD options**: Topical steroids, JAK inhibitors (e.g., Cibinqo), other biologics. - **Trial alternatives**: Search for similar IL-13 inhibitors. - **State programs**: Check for chronic illness funds. - **Appeals**: Resubmit with new docs; contact BMS advocacy. ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Cendakimab's status may change; verify via FDA, clinicaltrials.gov, or BMS. Eligibility/programs vary; consult healthcare providers. No guarantees of access. Word count: 942.

Program information last verified: March 30, 2026