CurrentBlue Cross Blue Shield - IowaPolicy 05.02.02

Ocaliva (obeticholic acid) for primary biliary cholangitis — Coverage Criteria

Medical policy governing prior authorization, coverage criteria, and continuation criteria for Ocaliva (obeticholic acid) for treatment of primary biliary cholangitis (PBC) in adult members of Wellmark Blue Cross and Blue Shield - Iowa.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOcaliva (obeticholic acid) for primary biliary cholangitis — Coverage Criteria

Policy CodePolicy 05.02.02

Change TypeNo material change

Effective DateDec 4, 2024

Next Review DateOct 1, 2024

Key ActionObtain prior authorization; initial approval may be granted for 12 months when diagnostic and treatment criteria (age ≥18, confirmed PBC, elevated ALP, and UDCA trial or intolerance) are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

30/30dquantity limit

>=15%ALP reduction

<=1.67xULNALP threshold

Coverage Criteria for Ocaliva (obeticholic acid)

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inv-01: Initial Criteria for Approval

Covered when ALL of the following are met:

Initial Approval Criteria: Patient is >= 18 years old.age >=18

Confirmed diagnosis of primary biliary cholangitis (PBC): Diagnosis of PBC is confirmed by at least two of the following: (a) biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level for at least 6 months; (b) presence of antimitochondrial antibodies (AMA) or PBC-specific antinuclear antibodies (ANA); (c) histologic evidence of PBC on liver biopsy.

Baseline laboratory requirement: Patient has an elevated serum ALP level prior to initiation of therapy.elevated ALP prior to initiation

UDCA trial or intolerance: Patient has either: (a) inadequate response to at least 12 months of ursodeoxycholic acid (UDCA) and will continue UDCA, OR (b) intolerance to UDCA.UDCA trial >=12 months or documented intolerance

Authorization period: Authorization of 12 months may be granted when all above criteria are met.

inv-02: Continuation of Therapy

Covered when ANY of the following clinical benefit criteria are met for continuation:

Continuation Criteria: Patient has achieved or maintained clinical benefit from Ocaliva as evidenced by at least one of the following: (a) at least a 15% reduction in ALP from baseline, (b) serum ALP less than 1.67 times the upper limit of normal (ULN), or (c) total bilirubin less than or equal to ULN.>=15% ALP reduction OR ALP <1.67xULN OR total bilirubin <=ULN

Authorization of 12 months may be granted for patients meeting any of these criteria.

Coverage is excluded for patients with decompensated cirrhosis (for example, Child‑Pugh Class B or C) or a history of a prior decompensation event. Additionally, patients with compensated cirrhosis with evidence of portal hypertension—such as ascites, gastroesophageal varices, or persistent thrombocytopenia—are not eligible for coverage.

Coding and Laboratory Thresholds

Provider billing codes (placeholder)mixed

No codes listed

ALP requirements

Pretreatment ALP requirement (initiation)Patient must have an elevated serum alkaline phosphatase (ALP) level prior to initiation of therapy.

Continuation criterion — relative reduction>= 15% reduction in ALP from baseline demonstrated for continuation approval.

Continuation criterion — absolute thresholdALP less than 1.67 x upper limit of normal (ULN) qualifies for continuation.

Authorization durationAuthorization of 12 months may be granted when ALP-based criteria are met.

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy. Authorization of up to 12 months may be granted for treatment of primary biliary cholangitis (PBC) in patients 18 years of age or older when medical necessity criteria are met. Ensure required documentation is submitted with the request.

Initial approval period: up to 12 months
Age requirement: 18 years or older

Step Therapy

UDCA Trial or Documented Intolerance Required

A trial of ursodeoxycholic acid (UDCA; ursodiol) for at least 12 months is required prior to approval unless there is documented intolerance. If UDCA was ineffective, documentation of inadequate response after ≥12 months must be included. If the patient is intolerant to UDCA, documentation of intolerance must be provided.

Required: ≥12 months trial of UDCA (ursodiol) with continued concomitant therapy if applicable
Alternate: Documented intolerance to UDCA (if UDCA not tolerated)

Documentation Required

Required Laboratory Documentation

For initial requests, submit pretreatment serum alkaline phosphatase (ALP) level. For continuation of therapy, submit current serum ALP and/or current total bilirubin level to demonstrate response or ongoing need.

Initial: Pretreatment serum ALP
Continuation: Current serum ALP and/or current total bilirubin

Documentation Required

Prescriber Specialty Documentation

The requested medication must be prescribed by or in consultation with a hepatologist or a gastroenterologist. Include documentation of the prescriber's specialty or consultation notes with the prior authorization submission.

Prescriber must be a Hepatologist or Gastroenterologist, or include consultation with one

Denial Risk

Exclusions that Trigger Denial

Coverage will not be provided for patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event. Coverage is also excluded for patients with compensated cirrhosis with evidence of portal hypertension (for example: ascites, gastroesophageal varices, or persistent thrombocytopenia).

Exclude: Decompensated cirrhosis (Child-Pugh B or C) or prior decompensation event
Exclude: Compensated cirrhosis with evidence of portal hypertension (ascites, varices, persistent thrombocytopenia)

Key Definitions

Confirmed diagnosis of PBC

Diagnostic ruleDiagnosis of primary biliary cholangitis (PBC) must be confirmed by at least two of the following three criteria.

Criterion A — BiochemistryBiochemical evidence of cholestasis with elevation of ALP for at least 6 months.

Criterion B — SerologyPresence of antimitochondrial antibodies (AMA) (titer ≥1:40 by immunofluorescence or immunoenzymatic reactivity) or PBC-specific antinuclear antibodies (eg, anti-gp210, anti-sp100).

Criterion C — HistologyHistologic evidence of PBC on liver biopsy (eg, non-suppurative inflammation and destruction of interlobular and septal bile ducts).

Background

Ocaliva (obeticholic acid) is approved for treatment of adults with primary biliary cholangitis (PBC). Approval is directed at patients who either have an inadequate response to ursodeoxycholic acid (UDCA) and will continue UDCA, or who are intolerant to UDCA. Treatment authorization may be granted for 12 months when diagnostic and treatment criteria are met; approval is based on reduction in alkaline phosphatase (ALP) as a surrogate marker rather than demonstrated improvement in survival or symptoms.