CurrentColorado Rocky Mountain Health PlansPolicy N/A

Lybalvi (olanzapine/samidorphan) prior authorization

Defines prior authorization and medical necessity criteria for Lybalvi (olanzapine/samidorphan) for treatment of schizophrenia and bipolar I disorder for Colorado Rocky Mountain Health Plans members under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLybalvi (olanzapine/samidorphan) prior authorization

Policy CodePolicy N/A

Change TypeRevised

Effective DateNov 16, 2025

Next Review DateSep 1, 2025

Key ActionSubmit medical records documenting diagnosis and trials or contraindications/intolerances to at least three specified antipsychotics to request prior authorization.

SourceLink

POLICY UPDATE CHANGES

Updated to require a trial of three medications and removed weight gain requirement.

Lybalvi is typically excluded from coverage but may be approved with meeting prior authorization criteria.

3required failed/contraindicated/intolerant antipsychotics before approval

2FDA-approved indications listed

12 monthsauthorization duration

2025-11-16effective date

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Coverage Criteria for Lybalvi (olanzapine/samidorphan)

inv-01: Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Submission of medical records documenting diagnosis of schizophrenia OR bipolar I disorder; AND history of failure, contraindication, or intolerance to at least THREE of the following: aripiprazole; olanzapine; quetiapine IR or XR; risperidone; ziprasidone.at least 3 med trials

Trials may include documented contraindication or intolerance

inv-02: Reauthorization

Reauthorization covered when the following is met:

Reauthorization: Documentation of positive clinical response to therapy.positive clinical response

Authorization duration is 12 months upon approval; state mandates and member benefit plans may affect coverage.

Lybalvi is typically excluded from coverage unless the plan’s prior authorization criteria are met. Prior authorization requires submission of medical records documenting the diagnosis (schizophrenia or bipolar I disorder) and supporting documentation that the member has failed, has a contraindication to, or is intolerant of the required comparator antipsychotics; when these criteria are met authorization may be granted for 12 months.

Provider Actions, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit medical records documenting the diagnosis and required history/trials. Authorization (when approved) will be for up to 12 months. Note: state mandates, federal requirements, and member benefit plan details may affect coverage; other policies or utilization management programs may also apply.

Affected product: Lybalvi (typically excluded from coverage)
Authorization duration: 12 months

Step Therapy

Step Therapy Requirement

A trial of at least three of the listed antipsychotics is required unless there is documented contraindication or intolerance. The required trials include: aripiprazole; olanzapine; quetiapine (IR or XR); risperidone; ziprasidone.

Required trials: aripiprazole; olanzapine; quetiapine IR or XR; risperidone; ziprasidone
Exception: documented contraindication or intolerance to specific agents

Documentation Required

Submission of medical records is required to document both: (1) diagnosis — schizophrenia or bipolar I disorder; and (2) history of failure, contraindication, or intolerance to at least three of the specified antipsychotics. Failure to provide these records may result in denial.

Required documentation: clinical notes, medication trials, dates, and reasons for discontinuation (failure/contraindication/intolerance)
Diagnoses accepted: schizophrenia; bipolar I disorder

Denial Risk

Denial may be issued if required documentation is not submitted or if step therapy/diagnostic criteria are not met.

Denial triggers: missing medical records; fewer than three failed/tolerated antipsychotic trials without documented contraindication/intolerance; diagnosis not one of the listed conditions

Initial Therapy Requirements

inv-10: Initial Therapy

Initial approval requirements

Initial therapy: Diagnosis of schizophrenia or bipolar I disorder PLUS documented history of failure, contraindication, or intolerance to at least three of the following agents: aripiprazole; olanzapine; quetiapine IR or XR; risperidone; ziprasidone.3 failed/contraindicated/intolerant agents

Submission of medical records documenting diagnosis and prior trials (or documented contraindications/intolerances) is required.

Reauthorization / Continuation Criteria

inv-11: Reauthorization/Continuation

Continuation/Reauthorization

Reauthorization/Continuation: Documentation of positive clinical response to Lybalvi is required for ongoing coverage.12 months

When approved, authorization is issued for 12 months; state mandates and member-specific benefit plans may affect coverage.

Required step therapy before Lybalvi	Notes
Trial (or documented contraindication/intolerance) of at least three of the following antipsychotics
aripiprazole; olanzapine; quetiapine IR or XR; risperidone; ziprasidone — trials may be satisfied by documented contraindication or intolerance

Definitions and Background

Lybalvi (olanzapine/samidorphan) is a combination product that is FDA-approved for the treatment of schizophrenia and for Bipolar I disorder for acute manic or mixed episodes and maintenance. It pairs the antipsychotic olanzapine with samidorphan, an opioid receptor antagonist, and is intended to provide antipsychotic efficacy consistent with olanzapine while mitigating olanzapine-associated weight gain in some patients.

inv-09: Lybalvi — key value definition

Product nameLybalvi

Active componentsOlanzapine (antipsychotic) + Samidorphan (opioid receptor antagonist)

FDA‑approved indicationsSchizophrenia; Bipolar I disorder — acute manic or mixed episodes (monotherapy or adjunct to lithium/valproate) and maintenance

Quantity Limits

inv-13: Lybalvi (olanzapine/samidorphan) — quantity limit details and related limits

Authorization duration12 months upon approval

Supply limitsSupply limits may be in place per program-specific rules

Automated approvalsUnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD‑10) and/or claim logic

Program variationUse of automated approval and re-approval processes varies by program and/or therapeutic class

Site of Care and Program Constraints

Note

Site-of-care: supply limits and automated program approvals

Supply limits and program-specific automated approval/re-approval processes may apply; UnitedHealthcare may approve based on previous claim/medication history, diagnosis codes, and claim logic depending on the program.

Supply limits may be in place.
Automated approval and re-approval processes vary by program and therapeutic class and may be used in lieu of manual review.