CurrentUnitedHealthcarePolicy N/A

Iqirvo (elafibranor) prior authorization

Sets UnitedHealthcare pharmacy prior authorization and medical necessity criteria for Iqirvo (elafibranor) for treatment of primary biliary cholangitis (PBC) in adults, including initial and reauthorization requirements and prescriber restrictions.

Policy Summary

PayerUnitedHealthcare

PolicyIqirvo (elafibranor) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis of primary biliary cholangitis, documentation of UDCA trial or intolerance, and evidence of no decompensated cirrhosis; prescriber must be a hepatologist or gastroenterologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PBCindication covered

12 monthsreauthorization duration

Specialist onlyprescriber restriction

No seladelpar/obeticholic acidcombination restriction

ALP reduction requiredrenewal requirement

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Coverage Criteria for Iqirvo (elafibranor)

inv-01: Initial Therapy

Approved when ALL of the following are met:

Initial Authorization: Diagnosis of primary biliary cholangitis

No decompensated cirrhosis: Patient does not have decompensated cirrhosis

e.g., no ascites, variceal bleeding, hepatic encephalopathy

UDCA response or intolerance: Either (1) both: used in combination with ursodeoxycholic acid AND patient failed to achieve an alkaline phosphatase (ALP) <1.67×ULN after ≥12 consecutive months of UDCA, OR (2) history of contraindication or intolerance to ursodeoxycholic acidALP ≥1.67×ULN after ≥12 months

Tried/failed alternatives are supported by FDA labeling

Drug combination restriction: Patient is not receiving Iqirvo in combination with Livdelzi (seladelpar) or Ocaliva (obeticholic acid)

Prescriber restriction: Prescribed by a hepatologist or gastroenterologist

inv-02: Reauthorization / Continuation Therapy

Reauthorization approved when ALL of the following are met:

Demonstrated biochemical response: Submission of medical records (e.g., laboratory values) documenting a reduction in ALP level from pre-treatment baseline

Laboratory values required

No decompensated cirrhosis: Patient does not have decompensated cirrhosis

Drug combination restriction: Patient is not receiving Iqirvo in combination with Livdelzi (seladelpar) or Ocaliva (obeticholic acid)

Prescriber restriction: Prescribed by a hepatologist or gastroenterologist

Use of Iqirvo (elafibranor) is not recommended in patients who have or develop decompensated cirrhosis (for example, those with ascites, variceal bleeding, or hepatic encephalopathy). Requests for Iqirvo may be denied if decompensated cirrhosis is present or develops while on therapy.

Iqirvo must not be prescribed in combination with seladelpar (Livdelzi) or obeticholic acid (Ocaliva). Combination therapy with these agents is explicitly excluded from coverage and is a basis for denial of an authorization request.

Additionally, initial and reauthorization approvals require that the medication be prescribed by a specialist; the policy specifies a hepatologist or gastroenterologist as the authorized prescriber for Iqirvo.

Initial Therapy

inv-13: Initial Therapy

Initial authorization criteria:

Diagnosis: Primary biliary cholangitis

No decompensated cirrhosis: Patient must not have decompensated cirrhosis

e.g., no ascites, variceal bleeding, hepatic encephalopathy

UDCA requirement: Either: (1) Iqirvo used in combination with ursodeoxycholic acid AND patient failed to achieve ALP <1.67×ULN after at least 12 consecutive months of UDCA; OR (2) history of contraindication or intolerance to ursodeoxycholic acidALP ≥1.67×ULN after ≥12 months

(1) reflects failure to respond to UDCA; (2) documents intolerance/contraindication

Reauthorization / Continuation Criteria

inv-14: Reauthorization

Criteria required for reauthorization and continuation:

ALP reduction: Documentation of reduction in alkaline phosphatase (ALP) from pre-treatment baseline is required for reauthorization

Reauthorization will be issued for 12 months; submit laboratory records

Key Clinical Thresholds and Coding

Alkaline phosphatase (ALP) — threshold value

ALP thresholdLess than 1.67 times the upper limit of normal (ALP < 1.67×ULN)

ContextUsed to define inadequate biochemical response to UDCA for initial authorization when Iqirvo is given with UDCA.

MeasurementBased on standard laboratory reference range for alkaline phosphatase; compare to the laboratory’s ULN.

Duration of prior UDCA trial

Required durationAt least 12 consecutive months of ursodeoxycholic acid (UDCA) therapy

PurposeDefines the required trial period before considering UDCA nonresponse for Iqirvo initiation

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization requires documented diagnosis of primary biliary cholangitis (PBC), absence of decompensated cirrhosis, and other required evidence.

Diagnosis: primary biliary cholangitis (PBC) required
Patient must NOT have decompensated cirrhosis
Not to be prescribed in combination with Livdelzi (seladelpar) or Ocaliva (obeticholic acid)
Prescriber must be a Hepatologist or Gastroenterologist

Step Therapy

UDCA Trial Requirement

A trial of ursodeoxycholic acid (UDCA; e.g., Urso, ursodiol) is required unless there is a documented contraindication or intolerance. When tried, documentation must show inadequate response defined as alkaline phosphatase (ALP) ≥ 1.67 × upper limit of normal after at least 12 consecutive months of UDCA.

Required trial: UDCA (≥12 months)

Definitions

Inadequate response to UDCA — definition

DefinitionFailure to achieve an alkaline phosphatase (ALP) level of less than 1.67 times the upper limit of normal after at least 12 consecutive months of treatment with ursodeoxycholic acid (UDCA).

Role in authorizationMeets the criterion for inadequate response to UDCA when assessing eligibility for Iqirvo in combination with UDCA for initial approval.

Documentary requirementLaboratory values comparing ALP to the laboratory’s ULN should be submitted to demonstrate persistent ALP ≥1.67×ULN after ≥12 months of UDCA.

Decompensated cirrhosis — definition and policy note

DefinitionDecompensated cirrhosis includes clinical features such as ascites, variceal bleeding, or hepatic encephalopathy.

Policy position

Background

Iqirvo (elafibranor) is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to ursodeoxycholic acid (UDCA) when used in combination with UDCA, or as monotherapy in patients who cannot tolerate UDCA. The approval is under accelerated approval based on reduction in alkaline phosphatase (ALP); improvement in survival or prevention of liver decompensation has not been demonstrated, and use is not recommended in patients with decompensated cirrhosis.

Quantity Limits / Supply

Iqirvo (elafibranor) — supply / quantity limits

Quantity limitsIqirvo (elafibranor) may be subject to supply limits.

Plan variabilitySupply limits and dispense rules may vary by program or therapeutic class and are subject to plan-specific mandates.

Approval pathwaysUnitedHealthcare may approve based on previous claim/medication history or automated processes despite supply limits; check plan for specifics.

Policy Summary

PayerUnitedHealthcare

PolicyIqirvo (elafibranor) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2025

Next Review DateN/A

SourceLink

On This Page

Combination restriction: Not to be used with Livdelzi (seladelpar) or Ocaliva (obeticholic acid)

Prescriber: Must be prescribed by a hepatologist or gastroenterologist

Patients receiving Iqirvo in combination with UDCA when assessing inadequate response

Step	Requirement
1	Trial of ursodeoxycholic acid (UDCA) required unless contraindicated or intolerant; when used with UDCA, patient must have failed to achieve an alkaline phosphatase (ALP) level <1.67× upper limit of normal after at least 12 consecutive months of UDCA

Inadequate response threshold: ALP ≥ 1.67× ULN after ≥12 months

Exception: documented contraindication or intolerance to UDCA

Documentation Required

Reauthorization Documentation

For reauthorization, submit medical records (for example, laboratory values) documenting a reduction in ALP level from the pre-treatment baseline (i.e., prior to Iqirvo therapy). Reauthorization is contingent on continued absence of decompensated cirrhosis and not using Iqirvo with Livdelzi or Ocaliva; prescriber must remain a Hepatologist or Gastroenterologist.

Submit labs showing ALP reduction from pre-treatment baseline
Patient must not have decompensated cirrhosis at reauthorization
No concurrent use with Livdelzi (seladelpar) or Ocaliva (obeticholic acid)
Prescriber: Hepatologist or Gastroenterologist
Reauthorization period: 12 months

Denial Risk

Denial Risk / Prescriber Restriction

Requests may be denied if the diagnosis is not primary biliary cholangitis (PBC), if the patient has decompensated cirrhosis, if UDCA trial documentation is missing (or inadequate) and no contraindication is documented, or if the medication is prescribed by a non-specialist (not a Hepatologist or Gastroenterologist).

Denial risk if diagnosis is not PBC
Denial risk if decompensated cirrhosis is present
Denial risk if required UDCA trial (or documented contraindication) is not provided
Denial risk if prescribed by a non-specialist

Use of Iqirvo is not recommended in patients who have or develop decompensated cirrhosis.

Authorization impactPresence of decompensated cirrhosis excludes patients from initial authorization and reauthorization criteria.