CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Iqirvo (elafibranor) for Primary Biliary Cholangitis

Defines authorization criteria, documentation, prescribing specialty requirements, exclusions, and continuation criteria for coverage of Iqirvo (elafibranor) for treatment of primary biliary cholangitis (PBC) in adults.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIqirvo (elafibranor) for Primary Biliary Cholangitis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit pretreatment serum alkaline phosphatase (ALP) level with initial prior authorization request

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Covered Indication (PBC)

3Continuation response options

12Authorization duration (months)

Coverage Summary

Iqirvo (elafibranor) is indicated under accelerated approval for the treatment of primary biliary cholangitis (PBC) in adults: in combination with ursodeoxycholic acid (UDCA) for patients with an inadequate response to UDCA, or as monotherapy for patients who are intolerant to UDCA. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Improvement in survival or prevention of liver decompensation events has not been demonstrated.

Initial Therapy - Primary Biliary Cholangitis (PBC)

Initial Therapy

Authorization of 12 months may be granted for treatment of PBC in adult members when ALL of the following are met:

ALL of the following

Diagnosis of PBC (meet at least 2)
- Biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months duration>= 6 months
- Presence of antimitochondrial antibodies (AMA) or PBC-specific antinuclear antibodies (ANA)AMA titer >1:40
  AMA titer >1:40 by immunofluorescence or immunoenzymatic reactivity; examples of PBC-specific ANA include antigp210, anti-sp100.
- Histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and destruction of interlobular and septal bile ducts)
Member has an elevated serum ALP level prior to initiation of therapy with the requested drug
Submit pretreatment ALP as part of initial request documentation.
UDCA (ursodeoxycholic acid) response or intolerance
- Inadequate response to at least 12 months of prior therapy with UDCA/ursodiol; member will continue concomitant UDCA/ursodiol.
- Intolerance to UDCA/ursodiol.
Prescribed by or in consultation with a hepatologist or gastroenterologist
Prescriber specialty requirement applies to initiation of therapy.

Documentation Required

Initial request lab documentation

Submit pretreatment serum alkaline phosphatase (ALP) level with initial requests. Documentation should show ALP elevated prior to initiation (see criteria).

Prior Authorization

Prior Authorization Required

Prior authorization is required to initiate therapy. Authorization of up to 12 months may be granted when criteria are met.

Documentation Required

Prescriber Specialty Requirement

This medication must be prescribed by or in consultation with a hepatologist or gastroenterologist. Ensure documentation of the consulting specialist is included with the request.

Documentation Required

Continuation request lab documentation

For continuation requests, submit current serum alkaline phosphatase (ALP) and/or current total bilirubin level to demonstrate clinical benefit (e.g., ≥15% reduction in ALP, ALP <1.67× ULN, total bilirubin ≤ ULN).

Continuation of Therapy

Authorization of 12 months may be granted for adult members who have achieved or maintained a clinical benefit from therapy with the requested drug:

ALL of the following

Clinical benefit
- Relative ALP reduction: At least a 15% reduction in ALP level>= 15% reduction in ALP
- Absolute ALP threshold: ALP level less than 1.67 times upper limit of normal (ULN)ALP < 1.67 x ULN
- Total bilirubin less than or equal to ULNTotal bilirubin <= ULN
Prescriber specialty: Prescribed by or in consultation with a hepatologist or gastroenterologist
Document specialty or consultation in request

Prior Authorization

Prior authorization requirement

Prior authorization is required to continue therapy; authorization of 12 months may be granted for continuation when response criteria are met.

PA required to continue therapy
Authorization duration: 12 months

Exclusions / Not Covered

Exclusions

Decompensated cirrhosis exclusion: Use of Iqirvo is not recommended and coverage will not be provided for members who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
Examples of decompensated cirrhosis: ascites, variceal bleeding, hepatic encephalopathy
Other indications: All other indications beyond the specified PBC indication are considered experimental/investigational and not medically necessary

Denial Risk

Denial for decompensated cirrhosis

Include assessment of cirrhosis status in documentation. Claims will not be covered for members who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Include assessment of cirrhosis status in documentation
Coverage will not be provided for decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy)

Provider Actions & Documentation

Denial Risk

Denial for decompensated cirrhosis

Include assessment of cirrhosis status in documentation. Claims will not be covered for members who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Include assessment of cirrhosis status in documentation
Coverage will not be provided for decompensated cirrhosis

Thresholds

ALP elevation duration for diagnosis>= 6 months

Prior UDCA therapy to define inadequate response>= 12 months

Continuation response - relative ALP reduction>= 15% reduction in ALP

Continuation response - absolute ALP thresholdALP < 1.67 x ULN

Continuation response - total bilirubinTotal bilirubin <= ULN

AMA titer threshold> 1:40

Authorization duration12 months

Background & Definitions

Brief background: Iqirvo is approved under accelerated approval for PBC in adults who have an inadequate response to UDCA (as combination therapy) or who cannot tolerate UDCA (as monotherapy). Continued approval depends on results of confirmatory trials, and improvement in survival or prevention of liver decompensation events has not been demonstrated.

Term	Definition
Decompensated cirrhosis
Clinical features such as ascites, variceal bleeding, hepatic encephalopathy (presence excludes coverage)
UDCA
Ursodeoxycholic acid (ursodiol), standard initial therapy for PBC

OpenPayer

Iqirvo (elafibranor) for Primary Biliary Cholangitis

Coverage Summary

Initial Therapy - Primary Biliary Cholangitis (PBC)

Continuation of Therapy

Exclusions / Not Covered

Applicable Codes

Provider Actions & Documentation

Clinical Evidence & References

Background & Definitions