Clinical Policy: Obeticholic Acid (Ocaliva)
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Defines medical necessity, prior authorization, and continuation criteria for obeticholic acid (Ocaliva) for treatment of primary biliary cholangitis (PBC) for Ambetter Georgia lines of business. Applies to providers requesting initiation or continuation of therapy under Centene-affiliated health plans.
Manufacturer voluntarily withdrew Ocaliva from the US market and initiation of therapy is not permitted; existing users may be considered for continuation under specific conditions.
Continued therapy requires provider attestation acknowledging the voluntary withdrawal and evidence of response by reduction or maintenance of alkaline phosphatase (ALP).
Dosage limits defined: titrate 5 mg PO QD to 10 mg PO QD after 3 months based on efficacy and tolerability; maximum dose 10 mg/day and no more than 1 tablet/day.
Disclaimer about manufacturer withdrawal with removal of initial approval criteria and added requirement for provider attestation.
Intercept announced voluntary withdrawal of Ocaliva for primary biliary cholangitis (PBC) from the US market and clinical trials placed on hold.
Coverage Criteria for Obeticholic Acid (Ocaliva)
Continuation Therapy — Primary Biliary Cholangitis
Covered when ALL of the following are met for continued therapy in PBC patients currently receiving Ocaliva:
Approval duration: 12 months
Initial Therapy — Primary Biliary Cholangitis
Initial Approval — Primary Biliary Cholangitis (must meet all):
Approval duration: Not applicable
Other Indications/Off-label pathway
Other diagnoses/indications (must meet 1 or 2):
See related policies: CP.CPA.190, HIM.PA.33/HIM.PA.103, CP.PMN.255/CP.PMN.16, CP.CPA.09/HIM.PA.154/CP.PMN.53
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of safety and efficacy in accordance with the applicable off‑label use policies: CP.CPA.09 for commercial lines, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid.
The policy has been updated to reflect the manufacturer's voluntary withdrawal of Ocaliva for primary biliary cholangitis (PBC). As part of that operational change, the policy text that previously described initial approval criteria for new starts has been removed and replaced with guidance prohibiting initiation of therapy. Providers should follow the updated process requirements in this document, including any attestation obligations added after the withdrawal announcement.
Initiation of Ocaliva for PBC is not authorized. The policy explicitly states that authorization is not permitted for new starts because the manufacturer voluntarily withdrew Ocaliva from the U.S. market. If a member is currently receiving Ocaliva, refer to the continued therapy criteria in Section II.A. Providers must submit supporting clinical documentation for continuation requests and note that new initiation requests will be denied.
Historical policy edits: earlier versions included preemptive criteria for NASH that were subsequently removed. Following Intercept’s market withdrawal announcement, the policy removed the initial approval criteria for Ocaliva and implemented operational requirements such as a provider attestation for continuation requests rather than permitting new starts.
Initial Therapy Criteria
Initial Therapy — Initial therapy for PBC
Initial therapy for PBC
Approval duration: Not applicable
INITIAL THERAPY CRITERIA — Initial approval criteria removed
Initial approval criteria were removed after manufacturer withdrawal; provider attestation now required.
Approval duration: Not applicable
Continuation Therapy Criteria
Continuation Therapy — Continuation permitted for current users
Continuation permitted only for current users under conditions:
Approval duration: 12 months
Provider Actions and Requirements
Prior authorization required; no new starts allowed
Prior authorization is required for Ocaliva; initiation (new starts) is not permitted because the manufacturer voluntarily withdrew Ocaliva from the market. If the member currently uses Ocaliva, follow the continued-therapy criteria in the policy.
Initial approval criteria removed; attestation required
Initial approval criteria were removed following the manufacturer's voluntary withdrawal; providers must supply the attestation required by this policy update when requesting continuation for current users.
Preferred alternative: ursodiol with dosing guidance
Therapeutic alternative listed is ursodiol (Urso, Urso Forte, Actigall) with dosing guidance of 13–15 mg/kg/day PO in 2–4 divided doses and a maximum dose of 15 mg/kg/day.
- Consider UDCA (ursodiol) per AASLD guidance prior to Ocaliva use in PBC.
Step therapy bypass for Illinois (IL HIM)
A step therapy bypass was added for Illinois Health Insurance Marketplace (IL HIM) in accordance with IL HB 5395; follow that provision when applicable for IL HIM members.
Submit supporting clinical documentation
Provider must submit documentation such as office chart notes, lab results, or other clinical information to support that the member meets all approval criteria for continuation of therapy.
- Include baseline and follow-up ALP values when available to demonstrate response.
- Attach relevant clinic notes showing ongoing therapy and clinical rationale for continuation.
Provider attestation required after manufacturer withdrawal
Provider attestation acknowledging the manufacturer's voluntary withdrawal of Ocaliva is required per the policy update when requesting continuation for current users.
- Attestation should confirm the provider has informed the member of the withdrawal and that continuation is clinically warranted.
Denial for initiation requests due to market withdrawal
Requests to initiate Ocaliva will be denied because authorization for new starts is not permitted due to the manufacturer's voluntary withdrawal of the product from the market.
- Denial will apply to initial therapy requests for PBC.
- Non‑FDA indications may also be denied unless sufficient documentation is provided per off‑label policies.
Manufacturer withdrawal removed initial criteria; continuation requires attestation
Following manufacturer withdrawal, the policy removed initial approval criteria; continuation coverage now depends on meeting the updated continuation conditions and providing required provider attestation.
- Verify member was an existing user via Centene benefit or previously met initial criteria, or is in a state/product with continuity of care protections.
Coding and Laboratory Thresholds
Step Therapy and Therapeutic Alternatives
| Therapeutic alternative | Dosing / notes |
|---|---|
| {"text":"ursodiol (Urso®, Urso Forte®, Actigall®)","status":""}|{"text":"13-15 mg/kg/day PO in 2-4 divided doses; maximum 15 mg/kg/day. Per Appendix B, prescribers should consider UDCA (ursodiol) prior to obeticholic acid for PBC.","status":""} |
| Jurisdiction | Step therapy bypass |
|---|---|
| {"text":"Illinois (HIM)","status":""}|{"text":"Step therapy bypass added per IL HB 5395 (policy update adds explicit bypass for IL HIM).","status":""} |
Definitions and Clinical Response Criteria
Quantity Limits and Dosing
Background
Obeticholic acid (Ocaliva) is a farnesoid X receptor agonist that was indicated for adult patients with primary biliary cholangitis (PBC) as an add‑on to ursodeoxycholic acid (UDCA, i.e., ursodiol) for inadequate responders, or as monotherapy when UDCA is not tolerated. Its accelerated approval was based on reduction in alkaline phosphatase (ALP); a clinical benefit on survival or symptoms was not established in confirmatory studies. The manufacturer announced voluntary withdrawal of Ocaliva for PBC on September 11, 2025, following regulatory review and safety concerns identified by the FDA.
Revision History
3Q 2021 annual review: no significant clinical changes; references updated (HIM.PHAR.21 revised to HIM.PA.154).
3Q 2022 annual review: indication language clarified to specify 'without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension' and contraindicated Child‑Pugh B/C dosing removed per product labeling.
Template changes applied to other diagnoses/indications and continued therapy section.
3Q 2023 annual review: no significant clinical changes; added examples of evidence of portal hypertension and updated references.
Removal of NASH preemptive criteria from the policy.
3Q 2024 annual review: no significant clinical changes; references reviewed and updated.
3Q 2025 annual review: added step therapy bypass for Illinois HIM per IL HB 5395 and clarified that UDCA refers to ursodiol.
Added disclaimer noting the manufacturer voluntarily withdrew Ocaliva for PBC, removed initial approval criteria, and added requirement for provider attestation (operationalizes prohibition of new starts while allowing continuation under conditions).
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