Ocaliva

Indicated For

Primary biliary cholangitis (PBC)

About This Medication

# Ocaliva Patient Guide: Important Update on Availability **Ocaliva (obeticholic acid) is no longer available in the US market.** Intercept Pharmaceuticals voluntarily withdrew it from commercial distribution on November 14, 2025. There is no active prescription assistance program for Ocaliva at this time.[1] ## About Ocaliva and Its Withdrawal Ocaliva (obeticholic acid) was a prescription medication used to treat **primary biliary cholangitis (PBC)**, a rare chronic liver disease. It was approved for use in adults with PBC who had an inadequate response to ursodeoxycholic acid (UDCA) or could not tolerate UDCA. The drug worked by acting as a farnesoid X receptor (FXR) agonist to reduce bile acid production in the liver and improve liver function markers.[5][8] However, on September 11, 2025, Intercept Pharmaceuticals announced the voluntary withdrawal of Ocaliva from the US commercial market. This was not a recall due to safety issues but a business decision by the manufacturer, now a subsidiary of Alfasigma S.p.A. The withdrawal took effect after a transition period, ending availability on November 14, 2025. Patients were advised to consult their healthcare providers for alternative treatments.[1][7] Prior to withdrawal, Ocaliva carried **important safety warnings**. The FDA restricted its use in PBC patients with advanced cirrhosis (Child-Pugh Class C) due to risks of serious liver injury, decompensation, failure, or death. It was also not recommended for those with decompensated cirrhosis, portal hypertension, or complete biliary obstruction. Common side effects included intense itching (pruritus), which sometimes required dose reduction or interruption.[8][9] ## Who Qualifies for Assistance? Current Status Since Ocaliva has been withdrawn, **no patient assistance program (PAP) exists** for obtaining the medication at low or no cost. Previously, Intercept offered the **Ocaliva Interconnect® support program**, which provided free samples or pharmacy-redeemable cards for eligible patients. This helped establish therapy but is no longer operational.[4] RxAssist, a database for pharmaceutical assistance programs, lists details for Ocaliva under program ID 1074, but with the market withdrawal, it is inactive.[3] Specialty pharmacies like Accredo handled prior authorizations and enrollments, requiring forms with patient, prescriber, and clinical details (e.g., ICD-10 codes, Child-Pugh class), but these services have ceased for new prescriptions.[9] ## Income Eligibility and Insurance Requirements **No income thresholds apply** because the program is discontinued. Historically, PAPs like Intercept's considered household income (often up to 400-500% of the federal poverty level), household size, and insurance status. Uninsured or underinsured patients were prioritized. For insurance: | Aspect | Details | |--------|---------| | **Commercial Insurance** | Prior authorizations often required proof of failure on UDCA (ursodiol). Step therapy was common (e.g., try UDCA first). Approvals lasted 3-12 months.[4][5][6] | | **Medicare Part D** | Coverage available pre-withdrawal; 2025 changes included a $2,000 out-of-pocket cap and Prescription Payment Plan to spread costs. Extra Help (Low-Income Subsidy) offered no deductibles/low copays for qualifying low-income enrollees.[2] | | **Medicaid/State Programs** | Varied; some states had assistance like Pennsylvania's PACE/PACENET.[2] | Ocaliva was a specialty drug, often requiring mail-order or 90-day supplies for cost savings.[2] ## Step-by-Step: What to Do Now 1. **Contact Your Doctor Immediately**: Discuss the withdrawal and transition to alternatives like UDCA (if tolerated), fibrates (e.g., bezafibrate, fenofibrate off-label), or emerging PBC therapies. Do not stop treatment without guidance.[1] 2. **Check Insurance/Pharmacy Options**: Call 1-844-622-4278 for legacy coordination or Medicare at 1-800-MEDICARE. Explore Extra Help eligibility (income/assets below limits: e.g., ~$22,590 individual income in 2025, adjusted annually).[2] 3. **Visit RxAssist or PAN Foundation**: Search for PBC alternatives. No Ocaliva-specific aid exists.[3] 4. **Join Patient Support Groups**: PBC Foundation (pbcfoundation.org) offers resources on obeticholic acid withdrawal and next steps.[7] 5. **Monitor for Refills/Denials**: Existing supplies may last briefly; insurers won't cover post-withdrawal.[1] ## Timeline and Delivery (Historical) Pre-withdrawal: - **Processing**: 1-2 weeks for PAP enrollment via fax (e.g., Accredo: 888.302.1028).[9] - **Delivery**: To prescriber's office or home via specialty pharmacy.[9] - **Reauthorization**: Annual, based on labs/response; initial 3 months.[5] Today: No new shipments possible. ## Alternatives if Denied or Unavailable - **UDCA (Ursodiol)**: First-line PBC treatment; cheaper, widely available.[4] - **Fibrates**: Off-label (e.g., fenofibrate); some insurers cover post-UDCA failure. - **Newer Agents**: Investigate elafibranor (Iqirvo, approved 2024 for PBC) or clinical trials via ClinicalTrials.gov. - **Financial Aid**: GoodRx coupons (pre-withdrawal), NeedyMeds, or state programs.[2] - **90-Day Supplies**: Reduces copays if insured.[2] ## Disclaimer This guide is for informational purposes only and not medical advice. Ocaliva's withdrawal means no PAP is available as of November 14, 2025. Consult your healthcare provider for personalized treatment. Eligibility, coverage, and programs change; verify with manufacturers/insurers. Not affiliated with Intercept Pharmaceuticals.[1][2]

Program information last verified: March 25, 2026