Bile Salts and Related Therapies Prior Authorization (Georgia Medicaid Fee-for-Service)
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Prior authorization requirements and coverage criteria for bile salt therapies and related drugs (e.g., ursodiol, Cholbam, Chenodal, Bylvay, Livmarli, Iqirvo, Livdelzi, Reltone) for Georgia Medicaid fee-for-service members and prescribers.
No material clinical or coverage changes in this revision.
Coverage Criteria for Specific Agents
Bylvay initial criteria
Bylvay (odevixibat) — approvable when ALL of the following are met:
Livmarli initial criteria
Livmarli (maralixibat) — approvable when ALL of the following are met (separate branches for ALGS and PFIC):
Livmarli approval
- Branch 1: Alagille syndrome (ALGS): Member is >= 3 months of age with confirmed Alagille syndrome and is experiencing moderate to severe cholestatic pruritus AND has experienced inadequate response, allergy, contraindication, drug–drug interaction, or intolerable side effect with two of the following: ursodeoxycholic acid (UDCA)/ursodiol, rifampin, cholestyramine or colestipol, or naltrexone.
- Branch 2: Progressive familial intrahepatic cholestasis (PFIC): Member is >= 12 months of age with confirmed PFIC and is experiencing moderate to severe cholestatic pruritus AND has experienced inadequate response, allergy, contraindication, drug–drug interaction, or intolerable side effect with two of the following: ursodeoxycholic acid (UDCA)/ursodiol, rifampin, cholestyramine or colestipol, or naltrexone.
Chenodal criteria
Chenodal (chenodiol) — approvable when ALL of the following are met:
Cholbam criteria
Cholbam (cholic acid) — approvable when ALL of the following are met:
Iqirvo and Livdelzi criteria
Iqirvo (elafibranor) and Livdelzi (seladelpar) — approvable when ALL of the following are met:
For Reltone, the prescriber must submit a written letter of medical necessity that explains why the preferred products — generic ursodiol capsules and tablets — are not appropriate for the member.
Prior Authorization, Step Therapy, and Documentation Requirements
Prior authorization required for listed bile salts (Cholbam preferred but still requires PA)
Prior authorization (PA) is required for the bile salts and related products listed on the PA summary. Although Cholbam (cholic acid) is listed as preferred, it still requires prior authorization. To initiate PA, contact OptumRx at the number provided in the policy.
- Products listed: Cholbam, ursodiol generics (250 mg, 500 mg tablets; 300 mg capsules), Bylvay (odevixibat), Chenodal (chenodiol), Iqirvo (elafibranor), Livdelzi (seladelpar), Livmarli (maralixibat), Reltone (ursodiol 200 mg, 400 mg capsules).
- Cholbam is preferred but still requires prior authorization.
- Prior authorization requests can be initiated via OptumRx (1-866-525-5827).
Required prior trials / step therapy before approval
Certain agents require prior trials or documented inadequate response/intolerance to specified alternatives before approval. Bylvay and Livmarli require failure/intolerance to two listed therapies; Chenodal requires prior inadequate response or intolerance to ursodiol; Iqirvo and Livdelzi require failure to achieve adequate biochemical response or inability to take ursodiol and obeticholic acid.
- Bylvay: inadequate response/allergy/contraindication/DDI/intolerable side effects with two of: ursodeoxycholic acid (UDCA)/ursodiol, rifampin, cholestyramine or colestipol, naltrexone.
- Livmarli: inadequate response/allergy/contraindication/DDI/intolerable side effects with two of: UDCA/ursodiol, rifampin, cholestyramine/colestipol, naltrexone.
- Chenodal: inadequate response/allergy/contraindication/DDI/intolerable side effect with ursodiol (Actigall, Urso).
- Iqirvo/Livdelzi: tried and failed to achieve an adequate biochemical response or have allergies/contraindications/DDI/intolerable side effects with ursodiol and Ocaliva (obeticholic acid).
Reltone: written letter of medical necessity required
For Reltone, the prescriber must submit a written letter of medical necessity explaining why the preferred generic ursodiol capsules and tablets are not appropriate for the member.
- Letter must state the reasons the preferred products (generic ursodiol capsules and tablets) are not appropriate for the member.
Exceptions and denials: PA required for exception consideration
Exceptions to the conditions of coverage are handled through the prior authorization process; if a PA is not obtained, the request may be denied. The PA process can be initiated by calling OptumRx.
- Exceptions to coverage are considered through prior authorization.
- To initiate prior authorization, call OptumRx at 1-866-525-5827.
Policy Background
This prior authorization policy defines coverage requirements for bile salt and related therapies used to manage conditions such as progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), cholelithiasis from cholesterol stones, bile acid synthesis disorders, peroxisomal disorders, and primary biliary cholangitis (PBC). It outlines which agents require prior authorization, the age and diagnosis-specific indications for individual products, required prior trials or step-therapy failures (for example, trials of ursodiol/UDCA, rifampin, bile acid sequestrants, or naltrexone where specified), and the expectation that specialty medications be prescribed by or in consultation with a gastroenterologist, hepatologist, or other appropriate specialist. The document also notes that Cholbam (cholic acid) is a preferred product but still requires prior authorization, exceptions are handled via the PA process, and certain products (e.g., Reltone) require additional documentation such as a written letter of medical necessity.
Definitions and Disorder Lists
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