CurrentQualChoicePolicy CP.PHAR.784

Linerixibat (Lynavoy) Coverage Criteria

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Prior authorization and medical-necessity coverage for Lynavoy (linerixibat) to treat cholestatic pruritus associated with primary biliary cholangitis in adults across QualChoice commercial, marketplace/ICHRA, and Medicaid plans.

Policy Summary

PayerQualChoice

PolicyLinerixibat (Lynavoy) Coverage Criteria

Policy CodePolicy CP.PHAR.784

Change TypeNo material change

Effective DateSep 1, 2026

Last ReviewAug 1, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization documentation showing PBC-associated cholestatic pruritus, adult age, specialist involvement, and required cholestyramine failure or an applicable exception.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults with PBCFDA-approved covered population

80 mg/dayMaximum covered daily dose

12 monthsApproval duration

CholestyramineRequired prior therapy

40 mg tablet

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CurrentQualChoicePolicy CP.PHAR.784

Linerixibat (Lynavoy) Coverage Criteria

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Policy Summary

PayerQualChoice

PolicyLinerixibat (Lynavoy) Coverage Criteria

Policy CodePolicy CP.PHAR.784

Change TypeNo material change

Effective DateSep 1, 2026

Last ReviewAug 1, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization documentation showing PBC-associated cholestatic pruritus, adult age, specialist involvement, and required cholestyramine failure or an applicable exception.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults with PBCFDA-approved covered population

80 mg/dayMaximum covered daily dose

12 monthsApproval duration

CholestyramineRequired prior therapy

40 mg tablet

Decompensated cirrhosis excludedImportant limitation

Coverage Criteria

Initial therapy: cholestatic pruritus associated with PBC

Covered when all of the following are met:

Initial therapy criteria

The member has a diagnosis of cholestatic pruritus associated with primary biliary cholangitis (PBC).
The medication is prescribed by or in consultation with a hepatologist or gastroenterologist.
The member is at least 18 years old.Age ≥ 18 years
Cholestyramine has failed at up to maximally indicated doses, unless it is contraindicated or causes clinically significant adverse effects.
For Illinois HIM requests, this step-therapy requirement does not apply under IL HB 5395.
Lynavoy is not prescribed concurrently with another ileal bile acid transporter (IBAT) inhibitor, such as Livmarli or Bylvay.
The dose does not exceed 80 mg (2 tablets) per day.Maximum 80 mg (2 tablets) per day

Continuation therapy

Covered when all of the following are met:

Continuation therapy criteria

One of the following applies
- The member is currently receiving Lynavoy through the benefit or previously met the initial approval criteria.
- The member is currently receiving Lynavoy and is enrolled in a state and product subject to continuity-of-care regulations.
  Refer to state-specific continuity-of-care addenda CC.PHARM.03A and CC.PHARM.03B when applicable.
The member is responding positively to therapy.
Lynavoy is not prescribed concurrently with another IBAT inhibitor, such as Livmarli or Bylvay.

Other diagnoses or indications

Other diagnoses or indications must meet one of the following pathways:

One of the following pathways

Recent label-change pathway
- The drug has undergone a label change within the last 6 months, such as a newly approved indication, age expansion, or new dosing regimen, that is not yet reflected in this policy.Label change within the last 6 months
- Refer according to formulary or PDL status
  - For a drug on the commercial or health insurance marketplace/ICHRA formulary, or on the Medicaid PDL, refer to the applicable no-coverage criteria policy: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, or CP.PMN.255 for Medicaid.
  - For a drug not on the commercial or health insurance marketplace/ICHRA formulary, or not on the Medicaid PDL, refer to the applicable non-formulary policy: HIM.PA.103 for health insurance marketplace/ICHRA or CP.PMN.16 for Medicaid.

Avoid use in patients with decompensated cirrhosis or prior or active hepatic decompensation events, including variceal hemorrhage, ascites, or hepatic encephalopathy.

Lynavoy must not be prescribed concurrently with another ileal bile acid transporter (IBAT) inhibitor, such as Livmarli or Bylvay.

Non-FDA-approved indications not addressed in this policy are not authorized unless sufficient efficacy and safety documentation supports coverage under the applicable off-label use policy or evidence of coverage documents.

Dose and Age Parameters

Lynavoy Dose Limit

Maximum daily dose80 mg (2 tablets) per day

Tablet strength40 mg per tablet

Usual dosing regimen40 mg orally twice daily

Age Requirement

Minimum age18 years or older

Covered populationAdult patients with cholestatic pruritus associated with primary biliary cholangitis (PBC)

Initial approval duration12 months

Authorization and Documentation Requirements

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required. Initial approval requires the member to meet all applicable criteria for the requested indication, including the diagnosis, prescriber, age, prerequisite therapy, concurrent therapy, and dose requirements.

Submit the request under the initial approval criteria for cholestatic pruritus associated with primary biliary cholangitis (PBC).

Prior Authorization

Continuation Prior Authorization Required

Continuation authorization requires the member to meet all applicable continued-therapy criteria, including qualifying current or prior approval or continuity of care, positive response to therapy, and ongoing treatment requirements.

The member must be currently receiving Lynavoy through the Centene benefit or have previously met initial approval criteria, or be receiving the medication under applicable state and product continuity-of-care regulations.
For dose increases, the new dose must not exceed 80 mg (2 tablets) per day.

Clinical Background

Linerixibat (Lynavoy) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adults.

Definitions and Abbreviations

Definitions

AbbreviationIBAT

Full termIleal bile acid transporter

Drug classLinerixibat (Lynavoy) is an IBAT inhibitor

Definitions

AbbreviationPBC

Full termPrimary biliary cholangitis

Relevance to coverageLynavoy is indicated for cholestatic pruritus associated with PBC in adult patients

Initial Therapy

Initial therapy

Initial approval requires all of the following criteria to be met:

Initial approval for PBC-associated cholestatic pruritus

The member has a diagnosis of cholestatic pruritus associated with primary biliary cholangitis (PBC).
The prescriber is a hepatologist or gastroenterologist, or has consulted one.
The member is at least 18 years old.Age ≥ 18 years
Cholestyramine has failed at up to maximally indicated doses, unless it is contraindicated or causes clinically significant adverse effects.
The cholestyramine step requirement does not apply to Illinois HIM requests under IL HB 5395.

Continuation Therapy

Continuation therapy

Continuation therapy requires all of the following criteria to be met:

Continuation approval

One of the following applies
- The member is currently receiving Lynavoy through the benefit or previously met the initial approval criteria.
- The member is currently receiving Lynavoy under applicable continuity-of-care regulations.
  Review state-specific continuity-of-care addenda CC.PHARM.03A and CC.PHARM.03B when applicable.
The member is responding positively to therapy.
Lynavoy is not used concurrently with another IBAT inhibitor, such as Livmarli or Bylvay.

Required Prior Therapy

Step	Required prior therapy	Requirement before Lynavoy	Exception or dose details
1	Cholestyramine	Failure at up to maximally indicated doses	Not required when contraindicated or when clinically significant adverse effects occur. For Illinois HIM requests, this step-therapy requirement does not apply under IL HB 5395. Cholestyramine dosing: 4–8 g orally twice daily; maximum 24 g/day.

Quantity Limits

Maximum quantity80 mg (2 tablets) per day

Tablet strength40 mg per tablet

Dosing regimen40 mg orally twice daily

Policy Summary

PayerQualChoice

PolicyLinerixibat (Lynavoy) Coverage Criteria

Policy CodePolicy CP.PHAR.784

Change TypeNo material change

Effective DateSep 1, 2026

Last ReviewAug 1, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization documentation showing PBC-associated cholestatic pruritus, adult age, specialist involvement, and required cholestyramine failure or an applicable exception.

SourceLink

On This Page

For a requested dose increase, the new dose does not exceed 80 mg (2 tablets) per day.Maximum 80 mg (2 tablets) per day for dose increases

Off-label pathway

The requested use, such as a diagnosis, age, or dosing regimen, is not specifically listed under the policy's diagnoses or indications for which coverage is not authorized, and the recent label-change pathway does not apply.
Refer to the applicable off-label use policy: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, or CP.PMN.53 for Medicaid.

Cholestyramine Alternative

Maximum alternative dose24 g/day

Recommended regimen4 g to 8 g orally twice daily

Use before LynavoyCholestyramine must be tried at up to maximally indicated doses unless contraindicated or clinically significantly not tolerated

Lynavoy must not be used concurrently with other IBAT inhibitors, including Livmarli or Bylvay.

Step Therapy

Cholestyramine Prerequisite

The member must fail cholestyramine at up to maximally indicated doses before initial approval, unless cholestyramine is contraindicated or clinically significant adverse effects are experienced.

The listed therapeutic-alternative dose is cholestyramine 4 g to 8 g orally twice daily, with a dose limit of 24 g/day.
For Illinois HIM requests, the step-therapy requirement does not apply under IL HB 5395.

Documentation Required

Clinical Documentation Required

Submit clinical documentation supporting that the member meets all approval criteria. Acceptable documentation may include office chart notes, laboratory results, and other relevant clinical information.

Include supporting clinical information with the prior authorization request.

Documentation Required

Initial Approval Support

For initial approval, document cholestatic pruritus associated with PBC in an adult member and prescribing by, or consultation with, a hepatologist or gastroenterologist.

Diagnosis: cholestatic pruritus associated with PBC.
Age: 18 years or older.
Prescriber or consultant: hepatologist or gastroenterologist.
Maximum dose: 80 mg (2 tablets) per day.
Do not prescribe concurrently with other IBAT inhibitors, such as Livmarli or Bylvay.

Documentation Required

Continuation Documentation

For continuation approval, document positive response to therapy, the qualifying current or prior approval or applicable continuity-of-care basis, and the required ongoing treatment information.

Document current receipt through the Centene benefit or prior satisfaction of initial approval criteria, or applicable state and product continuity-of-care status.
Confirm positive response to Lynavoy.
Confirm no concurrent use of other IBAT inhibitors.
For a dose increase, document that the new dose does not exceed 80 mg (2 tablets) per day.

Denial Risk

Failure to Meet Approval Criteria

Coverage may be denied when required approval criteria are not met. The request must satisfy all applicable requirements for diagnosis, age, prescriber, prerequisite therapy, concurrent therapy, dose, and other criteria.

The approved indication is cholestatic pruritus associated with PBC in adults.
The medication must be prescribed by or in consultation with a hepatologist or gastroenterologist for initial approval.
Initial dosing must not exceed 80 mg (2 tablets) per day; a continuation dose increase must also remain within that limit.
Required cholestyramine failure, unless an exception applies, must be documented.
Concurrent use with other IBAT inhibitors is not authorized.

Unsupported block type: denial_risk นonsense?

Note

Other Indications Require Applicable Policy Review

Requests for other diagnoses or indications must be reviewed under the applicable policy rather than under the PBC-associated cholestatic-pruritus criteria.

For a recent label change not reflected in this policy, refer to the applicable no-coverage policy for formulary or PDL drugs: CP.CPA.190, HIM.PA.33, or CP.PMN.255.
For a recent label change involving a non-formulary or non-PDL drug, refer to the applicable non-formulary policy: CP.CPA.190, HIM.PA.103, or CP.PMN.16.
For other uses not specifically listed as non-authorized and not covered by the recent-label-change pathway, refer to the applicable off-label-use policy: CP.CPA.09, HIM.PA.154, or CP.PMN.53.

Definitions

AbbreviationALP

Full termAlkaline phosphatase

Relevance to PBC diagnosisAn ALP level elevated above the laboratory upper limit of normal is one of the three criteria used to establish a PBC diagnosis

Definitions

AbbreviationAMA

Full termAnti-mitochondrial antibodies

Relevance to PBC diagnosisPositive AMA is one of the criteria used to establish a PBC diagnosis; other PBC-specific auto-antibodies may be considered when AMA is negative

Lynavoy is not prescribed concurrently with another IBAT inhibitor, such as Livmarli or Bylvay.

The dose does not exceed 80 mg (2 tablets) per day.Maximum 80 mg (2 tablets) per day

For any requested dose increase, the new dose does not exceed 80 mg (2 tablets) per day.Maximum 80 mg (2 tablets) per day