Obeticholic acid (Ocaliva) coverage
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Defines medical necessity, prior authorization, and coverage criteria for obeticholic acid (Ocaliva) for Ambetter Georgia members across commercial, HIM, and Medicaid lines of business. Applies to providers requesting coverage for PBC and (pending) NASH indications.
No material clinical or coverage changes in this revision.
Coverage Criteria for Obeticholic Acid (Ocaliva)
inv-01: Initial Therapy — PBC
Covered when ALL of the following are met:
Approval duration: 6 months.
inv-02: Initial Therapy — NASH (pending)
Covered when ALL of the following are met (criteria to mirror prescribing information once FDA-approved):
Approval duration: 6 months (pending FDA indication).
inv-03: Continuation Therapy — PBC
Continued coverage when ALL of the following are met:
Approval duration: 12 months.
inv-04: Continuation Therapy — NASH (pending)
Continued coverage when ALL of the following are met (criteria to mirror prescribing information once FDA-approved):
Approval duration: 6 months (pending FDA indication).
inv-05: Other Indications
Approval duration typically 6 months or duration of request (whichever is less) if member is currently receiving and documentation supports positive response.
Coverage for diagnoses that are not FDA-approved is not authorized by this policy unless the request includes sufficient clinical documentation demonstrating efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PHAR.21 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).
Requests for obeticholic acid for non‑FDA approved indications will be denied unless adequate supporting documentation is provided showing efficacy and safety per the referenced off‑label use policies (CP.CPA.09, HIM.PHAR.21, CP.PMN.53). Such documentation should follow the evidentiary standards in those policies.
Initial Therapy Requirements
inv-25: Initial therapy — Initial therapy criteria by indication:
Initial therapy criteria by indication:
Approval duration: 6 months.
Approval duration: 6 months (pending FDA indication).
inv-26: Initial therapy (PBC) — Initial therapy requirements historically included prescriber and UDCA trial requirements.
Initial therapy requirements historically included prescriber and UDCA trial requirements.
See prior authorization section for required documentation.
Continuation Therapy and Monitoring
inv-27: Continuation therapy — Continuation criteria vary by indication:
Continuation criteria vary by indication:
Approval duration: 12 months (PBC).
Approval duration: 6 months (NASH, pending).
inv-28: Continuation/Monitoring — Policy updates and annual reviews referenced continuation criteria and monitoring changes.
Policy updates and annual reviews referenced continuation criteria and monitoring changes.
Follow Ocaliva prescribing information and hepatology guidelines for monitoring.
Provider Actions and Authorization Requirements
Prior authorization required with supporting documentation
Prior authorization is required for obeticholic acid. The request must include documentation that the member meets all approval criteria including diagnosis, documentation of prior therapies and trial durations (e.g., UDCA), specialist prescribing or consultation, relevant lab values (e.g., ALP), and dosing within policy limits.
- Include diagnosis (PBC or pending NASH indication) and age (≥18).
- Show prescriber is or consulted with a hepatologist or gastroenterologist.
- Provide evidence of prior therapy trials and durations (UDCA trial for PBC).
- Provide relevant labs such as ALP and other criteria-specific tests.
- Document requested dose does not exceed policy limits (10 mg/day for PBC; 25 mg/day for NASH pending approval).
Prescriber qualification and UDCA trial documented for authorization
Prior authorization requests must document prescriber qualification (prescribed by or in consultation with a hepatologist or gastroenterologist) and evidence of prior UDCA monotherapy trial of 12 months for PBC when applicable.
- Prescriber: documented hepatologist or gastroenterologist involvement per policy.
- UDCA trial: evidence of ≥12 months of UDCA (≥13 mg/kg/day) with sustained ALP ≥1.67×ULN when required.
Step therapy for NASH: prior trial of pioglitazone or vitamin E required
For the preemptive NASH criteria (pending FDA approval), prior authorization requires documentation of failure of a 6-month trial of pioglitazone or vitamin E at up to maximally indicated doses unless contraindicated before authorizing obeticholic acid.
- Document duration and dose of pioglitazone or vitamin E trial (6 months).
- If adverse effects or contraindications prevent trial, include supporting documentation.
UDCA monotherapy trial duration updated to 12 months (policy history)
Policy history documents that the prior trial requirement for UDCA monotherapy before Ocaliva for PBC was revised to a 12-month duration; prior authorization should reflect this 12-month UDCA requirement.
- UDCA monotherapy trial duration in policy history changed from 6 months to 12 months.
- Authorization requests should include documentation evidencing the 12-month UDCA trial when applicable.
Clinical documentation must be provided with the request
Submit clinical documentation such as office chart notes, lab results, and other clinical information that demonstrate the member meets all approval criteria (diagnosis, prior therapy trials, lab thresholds like ALP, specialist consults, dosing).
- Office notes documenting diagnosis, symptom history, and specialist involvement.
- Lab results showing ALP values and other required labs (e.g., HbA1c, LDL for NASH).
- Documentation of prior therapy trials, durations, and responses (UDCA, pioglitazone, vitamin E).
Providers must follow professional judgment and submit medical necessity documentation
Providers must exercise professional medical judgment and submit documentation supporting medical necessity consistent with this clinical policy and applicable coverage documents; state Medicaid provisions take precedence when they conflict with the policy.
- Follow professional judgment in treatment decisions and supply supporting clinical rationale in requests.
- For Medicaid members, ensure documentation aligns with state Medicaid requirements where they differ from this policy.
Incomplete documentation risks denial
Requests that do not include documentation showing the member meets all approval criteria (for example, diagnosis, required prior trials and their durations, relevant lab results, and evidence of specialist consultation) may be denied.
- Missing UDCA trial evidence (for PBC) or missing 6-month pioglitazone/vitamin E trial (for NASH pending) risks denial.
- Absence of required lab values (e.g., ALP) or lack of specialist prescriber documentation may trigger denial.
Combined Commercial/Medicaid policy — omissions may trigger denial
Policies have been combined for Commercial and Medicaid lines of business and prescriber requirements and UDCA trial-duration criteria were added or modified; omission of required prescriber information or failure to meet the UDCA trial-duration requirement may lead to denial.
- Confirm the prescriber meets the policy requirement (hepatologist/gastroenterologist) in the submission.
- Provide clear evidence that the UDCA trial met the policy’s 12‑month duration when applicable.
Clinical Thresholds and Coding-Related Definitions
Step Therapy Requirements
NASH step therapy: document failed 6-month trial of pioglitazone or vitamin E
For NASH (pending FDA approval), prior authorization will require evidence of a failed 6-month trial of pioglitazone or vitamin E at maximally indicated doses unless contraindicated; document duration, dosing, and reasons if therapy was not tolerated.
- Appendix B lists therapeutic alternatives and dosing (pioglitazone 30–45 mg/day; vitamin E 800 IU/day where applicable).
- If contraindicated or adverse effects occurred, include clinical justification and relevant records.
| Step | Required prior therapy | Duration / Notes |
|---|---|---|
| 1 | Failure of a 6-month trial of pioglitazone or vitamin E at up to maximally indicated doses, unless clinically significant adverse effects occur or both are contraindicated | 6 months; per policy the trial is required for NASH prior to obeticholic acid (criteria to mirror prescribing information once FDA-approved). See Appendix B for dosing alternatives and Appendix D for lifestyle recommendations. |
| Step | Required prior therapy | Duration / Notes |
|---|---|---|
| 1 | Trial of ursodeoxycholic acid (UDCA) monotherapy at recommended dose (13–15 mg/kg/day) with inadequate response as evidenced by sustained ALP ≥ 1.67 × ULN | UDCA trial duration: 12 months (policy history and prior authorization requirement); insufficient response after ≥12 months supports initiation of obeticholic acid for PBC. |
Formulations and Quantity Limits
Definitions and Clinical Context
Background
Obeticholic acid (Ocaliva) is a farnesoid X receptor agonist approved for primary biliary cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid or as monotherapy when UDCA is not tolerated. Coverage for other, non‑FDA indications is not authorized under this policy unless sufficient documentation supports efficacy and safety according to the off‑label use policies referenced above.
Revision History
UDCA monotherapy trial duration for PBC was modified from 6 months to 12 months (policy combined for Commercial and Medicaid and prescriber requirement added).
3Q 2018 annual review documenting combination of Commercial and Medicaid policies, addition of prescriber requirement, and modification of UDCA trial duration to 12 months.
Policies were combined for Commercial and Medicaid lines of business and a prescriber requirement was added; other criteria including UDCA trial duration were modified.
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