Clinical Policy: Seladelpar (Livdelzi)
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Policy governs medical necessity and prior authorization criteria for Seladelpar (Livdelzi) for treatment of primary biliary cholangitis (PBC) for Health Net (Centene-affiliated) lines of business including Commercial, HIM, and Medicaid.
No material clinical or coverage changes in this revision.
Coverage and Eligibility Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met:
Follow policy ordering and definitions
inv-02: Continuation Therapy
Covered for continuation when ONE of the following is met and patient is responsive:
If request is for dose increase, new dose must not exceed 10 mg/day; approval duration: 12 months.
If request is for dose increase, new dose must not exceed 10 mg/day; approval duration: 12 months.
Requests for use of Seladelpar (Livdelzi) for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or relevant evidence of coverage documents.
When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for any state‑specific coverage rules or exceptions that supersede this policy.
Use of Seladelpar (Livdelzi) is not recommended in patients who have or develop decompensated cirrhosis. Examples of decompensating events include, but are not limited to, ascites, variceal bleeding, and hepatic encephalopathy.
Key Clinical Thresholds and Coding-related Definitions
Prior Authorization, Documentation, and Provider Responsibilities
Prior Authorization Required
Prior authorization is required. Requests must meet initial or continued therapy criteria for Primary Biliary Cholangitis (PBC), including diagnosis of PBC, age ≥ 18 years, prescribed by or in consultation with a hepatologist or gastroenterologist, prescribed in combination with UDCA (ursodiol) unless contraindicated, evidence of prior UDCA failure (sustained ALP ≥ 1.67 × ULN after ≥ 12 months at ≥ 13 mg/kg/day) unless contraindicated, and dose not to exceed 10 mg (1 capsule) per day. Approval duration for initial therapy: 6 months; for continued therapy: 12 months.
- Initial approval: member ≥ 18 years; diagnosis of Primary Biliary Cholangitis; prescribed by or in consultation with a hepatologist or gastroenterologist; prescribed in combination with UDCA unless contraindicated; documented failure of a ≥ 12-month trial of UDCA (ursodiol) at ≥ 13 mg/kg/day with sustained ALP ≥ 1.67 × ULN unless contraindicated; max dose 10 mg/day. Approval duration: 6 months.
- Continued therapy: member currently receiving medication via Centene benefit or previously met initial criteria; member responding positively (initial reauthorization: reduction in ALP from pretreatment; subsequent reauthorization: continued reduction or maintenance); dose increases must not exceed 10 mg/day. Approval duration: 12 months.
Prior Authorization (operational)
The document does not list specific billing or PA code numbers in this section; providers should follow payer prior authorization submission processes and include all supporting clinical information per the plan's PA operational requirements.
Denial Risk for Non‑Covered Indications
Requests for indications that are not FDA‑approved and not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies (commercial: CP.CPA.09; marketplace: HIM.PA.154; Medicaid: CP.PMN.53) or other evidence of coverage documents.
Therapeutic Alternatives / Step Therapy
Therapeutic alternative: ursodiol (ursodeoxycholic acid, UDCA) is the preferred/required alternative and should be used at recommended dosing (example: up to 15 mg/kg/day per Appendix B), unless contraindicated or not tolerated. Documentation of a sufficient trial and failure of UDCA (see PA criteria) is required when applicable.
- Preferred alternative: ursodiol (UDCA).
- UDCA dosing guidance referenced in Appendix B (example dosing up to 15 mg/kg/day).
- A ≥ 12‑month trial of UDCA at ≥ 13 mg/kg/day with documentation of sustained ALP elevation (≥ 1.67 × ULN) is required to demonstrate treatment failure unless contraindicated.
Documentation and Contractual Notice
Provider must submit documentation (office chart notes, lab results, and other clinical information) supporting that the member has met all applicable criteria. Providers, members, and their representatives are bound by the payer's contractual terms; unauthorized copying or distribution of this policy is prohibited.
Therapeutic Background and Agent Summary
Seladelpar (brand name Livdelzi) is a peroxisome proliferator‑activated receptor‑delta (PPAR‑delta) agonist approved under accelerated approval for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to ursodeoxycholic acid (UDCA), or as monotherapy for patients unable to tolerate UDCA. Approval was based on reductions in alkaline phosphatase (ALP); improvement in survival or prevention of liver decompensation has not been demonstrated.
Definitions and Trial Response Criteria
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