CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Iqirvo_Livdelzi_20250201 1

Defines coverage criteria and authorization durations for Iqirvo and Livdelzi for treatment of primary biliary cholangitis (PBC) in adults, including initial approval and continuation requirements, limitations, and concomitant therapy exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Iqirvo_Livdelzi_20250201 1

Policy CodePolicy N/A

Change Typeclarified

Effective DateFeb 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation proving diagnosis (>=2 diagnostic criteria), baseline ALP, prior UDCA treatment or intolerance, and specialist prescribing or consultation to request 6 months authorization.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed 11/2024; effective date 02/01/2025 listed for Iqirvo and Livdelzi policy

1Covered Indication (PBC)

3Diagnostic options (need >=2)

6Initial authorization months

Coverage Summary

Iqirvo and Livdelzi are covered for the treatment of primary biliary cholangitis (PBC) in adults meeting the policy criteria. These approvals are under the FDA's accelerated approval pathway based on ALP reduction; clinical benefit on survival or prevention of liver decompensation has not been established. Use is not recommended in patients who have or develop decompensated cirrhosis (for example, ascites, variceal bleeding, hepatic encephalopathy).

Indications and Limitations

Covered when ALL of the following are met:

ALL of the following

Member is 18 years of age or older.
Diagnosis of primary biliary cholangitis (PBC) confirmed by at least two of the following: (1) Biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) for ≥6 months; (2) Presence of antimitochondrial antibodies (AMA) (titer >1:40) or PBC-specific ANA (eg, anti-gp210, anti-sp100); (3) Histologic evidence of PBC on liver biopsy.
Documentation of elevated serum ALP level prior to initiation of therapy.
Medication is prescribed by or in consultation with a hepatologist or gastroenterologist.
Member does not have decompensated cirrhosis (eg, ascites, variceal bleeding, hepatic encephalopathy).
Use of Iqirvo or Livdelzi is not recommended in patients with decompensated cirrhosis.
Prior UDCA requirement
- Inadequate response to ≥12 months of ursodeoxycholic acid (UDCA)/ursodiol at recommended dose (13–15 mg/kg/day) and member will continue concomitant UDCA/ursodiol.
- Intolerance to UDCA/ursodiol.
Member will not use Iqirvo, Livdelzi, and/or Ocaliva concomitantly.

Continuation of therapy

Documentation of clinical benefit from Iqirvo or Livdelzi with an ALP measurement within the last 6 months meeting ANY of the following: (1) ≥15% reduction in serum ALP; (2) Serum ALP <1.67 × ULN; (3) Normalization of ALP.
Authorization of 6 months may be granted for continuation when criteria are met.
Medication is prescribed by or in consultation with a hepatologist or gastroenterologist.
Member has not developed decompensated cirrhosis (eg, ascites, variceal bleeding, hepatic encephalopathy).
Member will not be using Iqirvo, Livdelzi, and/or Ocaliva concomitantly.

Initial Therapy Criteria (6-month authorization)

Initial authorization for Primary Biliary Cholangitis (PBC)

Authorization of 6 months may be granted when ALL of the following criteria are met:

ALL of the following

Age: Member is 18 years of age or older>= 18 years
Diagnostic criteria (need >=2)
- Diagnostic option 1: Biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months duration>= 6 months
- Diagnostic option 2: Presence of antimitochondrial antibodies (AMA) (titer >1:40 by immunofluorescence or immunoenzymatic reactivity) or PBC-specific antinuclear antibodies (ANA) (e.g., anti-gp210, anti-sp100)titer >1:40
- Diagnostic option 3: Histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and destruction of interlobular and septal bile ducts)
Baseline ALP: Documentation that member has an elevated serum ALP level prior to initiation of therapy with the requested drug
Specialist: This medication must be prescribed by or in consultation with a hepatologist or gastroenterologist
Exclusion - decompensated cirrhosis: Member does not have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
Prior UDCA or intolerance
- Prior UDCA: Member has had an inadequate response to at least 12 months of prior therapy with ursodeoxycholic acid (UDCA)/ursodiol at the recommended dose of 13-15 mg/kg/day and the member will continue concomitant therapy with UDCA/ursodiol>= 12 months at 13-15 mg/kg/day
- UDCA intolerance: Member has an intolerance to UDCA/ursodiol
Concomitant therapy exclusion: Member will not be using Iqirvo, Livdelzi and/or Ocaliva concomitantly

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Initial authorization numeric thresholds

Age>= 18 years

Prior UDCA therapy duration>= 12 months at 13-15 mg/kg/day

ALP elevation duration for diagnosis>= 6 months

Initial authorization duration6 months

Provider Actions

Prior Authorization

Prior authorization required

Authorization of 6 months may be granted when all initial criteria are met. Providers must submit documentation proving the diagnosis (at least two diagnostic criteria), a baseline serum alkaline phosphatase (ALP) level, evidence of prior UDCA/ursodiol treatment for ≥12 months or documentation of UDCA intolerance, and that the medication is prescribed by or in consultation with a hepatologist or gastroenterologist.

Diagnosis documented by ≥2 diagnostic criteria
Baseline serum ALP level prior to therapy initiation
Evidence of prior UDCA/ursodiol treatment for ≥12 months at 13–15 mg/kg/day or documentation of intolerance
Prescribed by or in consultation with a hepatologist or gastroenterologist

Documentation Required

Diagnostic documentation

Document at least two diagnostic criteria for PBC: (1) biochemical evidence of cholestasis with elevated ALP for at least 6 months, (2) presence of antimitochondrial antibodies (AMA) or PBC-specific ANAs (e.g., anti-gp210, anti-sp100), or (3) histologic evidence of PBC on liver biopsy. Also include the baseline elevated serum ALP level prior to initiation of therapy.

ALP elevation ≥6 months
AMA (titer >1:40) or PBC-specific ANA (e.g., anti-gp210, anti-sp100)
Liver biopsy showing histologic evidence of PBC
Baseline serum ALP prior to therapy

Documentation Required

Specialist involvement

This medication must be prescribed by, or initiated in consultation with, a hepatologist or gastroenterologist for both initiation and continuation of therapy. Documentation of specialist prescribing or consultation should be provided.

Specialist (hepatologist or gastroenterologist) prescription or consultation documented

Documentation Required

Monitoring for decompensated cirrhosis

Ensure the member does not have or develop decompensated cirrhosis. Presence of ascites, variceal bleeding, or hepatic encephalopathy excludes coverage and should be documented if present.

Document absence of ascites
Document absence of variceal bleeding
Document absence of hepatic encephalopathy

Denial Risk

Concomitant therapy exclusion

Claims may be denied if the member is using Iqirvo, Livdelzi and/or Ocaliva concomitantly. Verify medication list and do not authorize overlapping use of these agents.

Confirm patient is not taking Iqirvo, Livdelzi, or Ocaliva concomitantly

Documentation Required

Response documentation for continuation

For continuation authorization, submit a serum ALP measured within the last 6 months demonstrating one of the following: at least a 15% reduction from baseline, an ALP < 1.67 × ULN, or normalization of ALP. Include the lab report with date.

ALP within last 6 months showing ≥15% reduction
OR ALP < 1.67 × ULN
OR normalized ALP

OpenPayer

Medicaid_Iqirvo_Livdelzi_20250201 1

Coverage Summary

Initial Therapy Criteria (6-month authorization)

Continuation Therapy Criteria (6-month authorization)

Provider Actions

Applicable Codes

Clinical Evidence & Guidance

Background & Definitions

Revision History