CurrentHealth NetPolicy CP PHAR.698

Clinical Policy: Seladelpar (Livdelzi)

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.

Policy Summary

PayerHealth Net

PolicySeladelpar (Livdelzi) for primary biliary cholangitis

Policy CodePolicy CP PHAR.698

Change TypeNo material changes

Effective DateDec 1, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation showing PBC diagnosis, specialist involvement, UDCA trial/failure or contraindication, dose ≤10 mg/day, and supporting labs demonstrating biochemical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10 mgmaximum daily dose

6 moinitial approval duration

12 mocontinued therapy duration

ALP ≥1.67×ULNUDCA failure threshold

state lawMedicaid precedence note

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Coverage and Eligibility Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval for PBC: 1) Diagnosis of primary biliary cholangitis (PBC).

Initial Approval for PBC: 2) Prescribed by or in consultation with a hepatologist or gastroenterologist.

Initial Approval for PBC: 3) Patient age ≥ 18 years.

Initial Approval for PBC: 4) Inadequate response to ursodiol (UDCA) defined as sustained elevation in alkaline phosphatase (ALP) ≥ 1.67 × ULN after a ≥ 12‑month trial of UDCA (ursodiol) at a dose ≥ 13 mg/kg/day, unless UDCA is contraindicated or not tolerated.ALP ≥ 1.67 × ULN after ≥12 months of UDCA (≥13 mg/kg/day)

Follow policy ordering and definitions

Initial Approval for PBC: 5) Seladelpar prescribed in combination with UDCA unless UDCA is contraindicated or not tolerated.

Initial Approval for PBC: 6) Requested dose does not exceed 10 mg (1 capsule) per day; approval duration: 6 months.≤ 10 mg/day

inv-02: Continuation Therapy

Covered for continuation when ONE of the following is met and patient is responsive:

Continued Therapy Conditions: a) Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria; AND member is responding positively to therapy as evidenced by a reduction in ALP from pretreatment level (initial reauthorization).

If request is for dose increase, new dose must not exceed 10 mg/day; approval duration: 12 months.

Continued Therapy Conditions: b) Member is currently receiving medication and is enrolled in a state/product with continuity-of-care regulations (see state addendums); AND for subsequent reauthorization, there is continued reduction or maintenance of the initial reduction in ALP level.

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.

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

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.

Note

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

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.

Step Therapy

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 Required

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.

Definitions and Trial Response Criteria

Biochemical response (trial definition) — inv-16

Biochemical response (trial definition)ALP < 1.67 × ULN; ALP decrease ≥15% from baseline; and total bilirubin ≤ ULN (ULN ALP = 116 U/L; ULN TB = 1.1 mg/dL)

ALP upper limit referenceULN for ALP defined as 116 U/L in the Livdelzi trial

Total bilirubin upper limitULN for total bilirubin defined as 1.1 mg/dL in the Livdelzi trial

PBC diagnosis criteria — inv-17

Diagnostic rule for PBCDiagnosis established when two of the following are met: elevated ALP; positive anti-mitochondrial antibody (AMA) or other PBC-specific autoantibodies; histologic evidence on liver biopsy

ALP criterionALP elevated above the laboratory upper limit of normal (per local reference)

Serology criterionPositive AMA or other PBC-specific autoantibodies (e.g., sp100, gp210) if AMA is negative

Histology criterionLiver biopsy demonstrating histologic evidence consistent with PBC

OpenPayer

Clinical Policy: Seladelpar (Livdelzi)

Coverage and Eligibility Criteria

Key Clinical Thresholds and Coding-related Definitions

Prior Authorization, Documentation, and Provider Responsibilities

Therapeutic Background and Agent Summary

Definitions and Trial Response Criteria