CurrentAgency for Health Care AdministrationPolicy N/A

Bile Salts Agents

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This policy governs Medicaid fee-for-service prior authorization for preferred and non-preferred bile salts agents, including product-specific clinical criteria, documentation, laboratory monitoring, and authorization duration.

Policy Summary

PayerAgency for Health Care Administration

PolicyBile Salts Agents

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation that the patient meets the applicable product-specific criteria and has current laboratory results when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsMaximum authorization duration

1Preferred agents

7Non-preferred agents

30 daysCurrent lab timing

Product-Specific Coverage Criteria

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Actigall, Reltone, Urso, and Urso Forte

Covered when all of the following are met for the requested non-preferred ursodiol formulation:

Non-preferred ursodiol criteria

Diagnosis and preferred-therapy requirements
- The patient has an FDA-approved diagnosis for the medication requested.
- The patient has tried and failed preferred ursodiol formulations.
  Documentation of trial and failure is required.

Chenodal

Covered when all of the following are met:

Chenodal criteria

The patient is at least 18 years old.Age >=18
Qualifying cholelithiasis
- The patient has cholelithiasis with small radiolucent, non-calcified cholesterol gallstones.
- The patient has a normally functioning gallbladder.
The patient is not eligible for surgery due to disease or age.
ONE of
- The patient has had an inadequate response to ursodiol.
- The patient has a contraindication to ursodiol.
Current laboratory results have been submitted within 30 days of the request.Laboratory results within 30 days
Required labs: AST/ALT, ALP, bilirubin, INR, and lipids.

Cholbam

Covered when all of the following are met:

Cholbam criteria

ONE of the qualifying disorders
- The patient has a bile acid synthesis disorder due to a single enzyme defect, including Smith-Lemli-Opitz Syndrome.
- The patient has a peroxisomal disorder, including a Zellweger spectrum disorder.
ONE of the qualifying manifestations
- The patient exhibits manifestations of liver disease.
- The patient has steatorrhea.

Ctexli

Covered when all of the following are met:

Ctexli criteria

The patient is at least 18 years old.Age >=18
The patient has a diagnosis of cerebrotendinous xanthomatosis.
Current laboratory results have been submitted within 30 days of the request.Laboratory results within 30 days
Required labs: AST/ALT, bilirubin, lipids, plasma cholestanol, and urine 23S-pentol.

Iqirvo

Covered when all of the following are met:

Iqirvo criteria

The patient is at least 18 years old.Age >=18
The patient has a diagnosis of primary biliary cholangitis.
ONE of the ursodiol pathways
- Iqirvo is used in combination with ursodiol, with inadequate response to ursodiol.
- Iqirvo is used as monotherapy because the patient has a contraindication to ursodiol.

Livdelzi

Covered when all of the following are met:

Livdelzi criteria

The patient is at least 18 years old.Age >=18
The patient has a diagnosis of primary biliary cholangitis.
ONE of the ursodiol pathways
- Livdelzi is used in combination with ursodiol, with inadequate response to ursodiol.
- Livdelzi is used as monotherapy because the patient has a contraindication to ursodiol.

Ocaliva

Covered when all of the following are met:

Ocaliva criteria

The patient is at least 18 years old.Age >=18
Qualifying primary biliary cholangitis
- The patient has a diagnosis of primary biliary cholangitis.
- ONE of the cirrhosis-status pathways
  - The patient does not have cirrhosis.
  - The patient has compensated cirrhosis without evidence of portal hypertension.

Iqirvo and Livdelzi are not covered for patients with biliary obstruction or decompensated cirrhosis, including ascites, variceal bleeding, or hepatic encephalopathy. These exclusions apply in addition to the applicable age, diagnosis, treatment-history, and laboratory requirements.

Ocaliva is not covered for patients with biliary obstruction, decompensated cirrhosis such as Child-Pugh Class B or C, a prior decompensation event, compensated cirrhosis with evidence of portal hypertension such as ascites, gastroesophageal varices, or persistent thrombocytopenia, or complete biliary obstruction.

Initial Therapy Requirements

Actigall, Reltone, Urso, and Urso Forte

Initial therapy is covered when all of the following are met:

Non-preferred ursodiol initial therapy

The patient has an FDA-approved diagnosis for the requested medication.
The patient has tried and failed preferred ursodiol formulations.
Documentation of trial and failure is required.

Other non-preferred bile salts agents

For the requested agent, all applicable product-specific requirements must be met:

ONE requested-agent pathway

Chenodal
- The patient is at least 18 years old and meets the qualifying cholelithiasis, gallbladder, surgical-ineligibility, and inadequate-response-or-ursodiol-contraindication requirements.Age >=18
- Current AST/ALT, ALP, bilirubin, INR, and lipid results have been submitted within 30 days of the request.Laboratory results within 30 days
Cholbam
- The patient has a qualifying bile acid synthesis or peroxisomal disorder with liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption.
- Current AST/ALT, ALP, bilirubin, INR, and GGT results have been submitted within 30 days of the request.Laboratory results within 30 days
Ctexli
- The patient is at least 18 years old and has cerebrotendinous xanthomatosis.Age >=18
- Current AST/ALT, bilirubin, lipid, plasma cholestanol, and urine 23S-pentol results have been submitted within 30 days of the request.Laboratory results within 30 days
Iqirvo
- The patient is at least 18 years old, has primary biliary cholangitis, and meets the ursodiol combination or ursodiol-contraindication monotherapy pathway.Age >=18
- The patient does not have biliary obstruction or decompensated cirrhosis, and applicable women of childbearing potential have a negative pregnancy test before therapy initiation.
- Current ALT/AST, ALP, bilirubin, CPK, and INR results have been submitted within 30 days of the request.Laboratory results within 30 days
Livdelzi
- The patient is at least 18 years old, has primary biliary cholangitis, and meets the ursodiol combination or ursodiol-contraindication monotherapy pathway.Age >=18
- The patient does not have biliary obstruction or decompensated cirrhosis.
- Current ALT/AST, ALP, bilirubin, eGFR, and INR results have been submitted within 30 days of the request.Laboratory results within 30 days
Ocaliva
- The patient is at least 18 years old and has primary biliary cholangitis without cirrhosis or with compensated cirrhosis without evidence of portal hypertension.Age >=18
- The patient meets the ursodiol combination or ursodiol-contraindication monotherapy pathway and does not have biliary obstruction, decompensated cirrhosis, a prior decompensation event, compensated cirrhosis with portal hypertension, or complete biliary obstruction.
- Current AST/ALT, ALP, bilirubin, INR, and lipid results have been submitted within 30 days of the request.Laboratory results within 30 days

Preferred Product Requirement

Step	Preferred formulation	Non-preferred formulation requirement
1	Preferred ursodiol formulations	Before approval of Actigall, Reltone, Urso, or Urso Forte, the patient must have tried and failed preferred ursodiol formulations; documentation is required.

Authorization, Documentation, and Denial Conditions

Prior Authorization

Authorization Duration and Review

Prior authorization is required for bile salts agents. Authorization may be approved for up to 6 months, subject to review of the applicable initial criteria.

Maximum authorization duration: up to 6 months.

Step Therapy

Preferred Ursodiol Step Requirement

For Actigall, Reltone, Urso, and Urso Forte (ursodiol), verify that the patient has an FDA-approved diagnosis for the medication requested and has tried and failed a preferred ursodiol formulation.

Required step therapy: trial and failure of preferred ursodiol formulations.

Documentation Required

Non-Preferred Ursodiol Documentation

Submit documentation supporting the requested non-preferred ursodiol product, including the FDA-approved diagnosis and the required trial and failure of preferred ursodiol formulations.

Document the FDA-approved diagnosis for the medication requested.
Document trial and failure of preferred ursodiol formulations.

Documentation Required

Chenodal Documentation

For Chenodal, submit documentation confirming the patient is at least 18 years old and meets the cholelithiasis, gallstone, gallbladder, surgical-ineligibility, and ursodiol response or contraindication requirements.

Diagnosis of cholelithiasis with small radiolucent (non-calcified) cholesterol gallstones.
Normally functioning gallbladder.
Not eligible for surgery because of disease or age.
Inadequate response to or contraindication with ursodiol.
Current laboratory results collected within 30 days of the request: AST/ALT, ALP, bilirubin, INR, and lipids.

Unsupported block type: documentation

Documentation Required

Ctexli Documentation

For Ctexli, submit documentation confirming the patient is at least 18 years old, has cerebrotendinous xanthomatosis, and has the required current laboratory results.

Current laboratory results collected within 30 days of the request: AST/ALT, bilirubin, lipids, plasma cholestanol, and urine 23S-pentol.

Documentation Required

Iqirvo Documentation

For Iqirvo, document that the patient is at least 18 years old, has primary biliary cholangitis, and is receiving the medication with ursodiol after an inadequate response or as monotherapy because of a ursodiol contraindication.

No biliary obstruction or decompensated cirrhosis.
For women of childbearing potential, a negative pregnancy test collected before therapy initiation.
Current laboratory results collected within 30 days of the request: ALT/AST, ALP, bilirubin, CPK, and INR.

Documentation Required

Livdelzi Documentation

For Livdelzi, document that the patient is at least 18 years old, has primary biliary cholangitis, and is receiving the medication with ursodiol after an inadequate response or as monotherapy because of a ursodiol contraindication.

No biliary obstruction or decompensated cirrhosis.
Current laboratory results collected within 30 days of the request: ALT/AST, ALP, bilirubin, eGFR, and INR.

Documentation Required

Ocaliva Documentation

For Ocaliva, document that the patient is at least 18 years old, has qualifying primary biliary cholangitis, and is receiving the medication with ursodiol after an inadequate response or as monotherapy because of a ursodiol contraindication.

PBC without cirrhosis or with compensated cirrhosis without evidence of portal hypertension.
No biliary obstruction, decompensated cirrhosis, prior decompensation event, compensated cirrhosis with portal hypertension, or complete biliary obstruction.
Current laboratory results collected within 30 days of the request: AST/ALT, ALP, bilirubin, INR, and lipids.

Denial Risk

Non-Preferred Ursodiol Denial Conditions

Non-preferred ursodiol coverage should be denied when the requested medication does not have an FDA-approved diagnosis or when the required trial and failure of preferred ursodiol formulations is not documented.

Missing FDA-approved diagnosis for the medication requested.
Missing documentation of trial and failure of preferred ursodiol formulations.

Denial Risk

Chenodal Clinical Denial Conditions

Chenodal coverage should be denied when the patient does not meet the required age, cholelithiasis, gallstone, gallbladder, surgical-ineligibility, or ursodiol response or contraindication criteria, or when required current laboratory documentation is absent.

Patient is younger than 18 years of age.
Cholelithiasis with small radiolucent cholesterol gallstones is not documented.
Gallbladder is not normally functioning.
Patient is eligible for surgery.
No inadequate response to or contraindication with ursodiol.
Required laboratory results are not current or were not submitted within 30 days of the request.

Denial Risk

Cholbam Clinical Denial Conditions

Cholbam coverage should be denied when the patient lacks a qualifying single-enzyme-defect or peroxisomal bile acid synthesis disorder, does not exhibit a required clinical manifestation, or required current laboratory documentation is absent.

No qualifying bile acid synthesis disorder is documented.
No manifestation of liver disease, steatorrhea, or complication from decreased fat-soluble vitamin absorption is documented.
Required laboratory results are not current or were not submitted within 30 days of the request.

Denial Risk

Ctexli Clinical Denial Conditions

Ctexli coverage should be denied when the patient is younger than 18 years of age, does not have cerebrotendinous xanthomatosis, or required current laboratory documentation is absent.

Patient is younger than 18 years of age.
Cerebrotendinous xanthomatosis is not documented.
Required laboratory results are not current or were not submitted within 30 days of the request.

Denial Risk

Iqirvo and Livdelzi Clinical Denial Conditions

Iqirvo and Livdelzi coverage should be denied when the patient does not meet the age or primary biliary cholangitis requirements, lacks inadequate response to or a contraindication to ursodiol, has biliary obstruction or decompensated cirrhosis, or required documentation is absent.

Patient is younger than 18 years of age or PBC is not documented.
Combination use with ursodiol does not follow an inadequate response, and monotherapy is not supported by a ursodiol contraindication.
Biliary obstruction or decompensated cirrhosis is present.
Required current laboratory results were not submitted within 30 days of the request.
For Iqirvo, a required negative pregnancy test before therapy initiation is not documented for a woman of childbearing potential.

Denial Risk

Ocaliva Clinical Denial Conditions

Ocaliva coverage should be denied when the patient does not meet the age, PBC, cirrhosis-status, or ursodiol-response requirements, or has an excluded condition or lacks required current laboratory documentation.

Patient is younger than 18 years of age or PBC is not documented.
Cirrhosis is decompensated, or compensated cirrhosis has evidence of portal hypertension.
There is biliary obstruction, complete biliary obstruction, or a prior decompensation event.
Combination use with ursodiol does not follow an inadequate response, and monotherapy is not supported by a ursodiol contraindication.
Required laboratory results are not current or were not submitted within 30 days of the request.