VIVITROL (naltrexone) prior authorization for alcohol dependence
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Defines prior authorization requirements for VIVITROL (naltrexone) when used to treat alcohol dependence for Mississippi Division of Medicaid members.
No material clinical or coverage changes in this revision.
Coverage Criteria for VIVITROL (naltrexone)
inv-01: Initial Authorization
Covered when ALL of the following are met for initial authorization (6 months):
Initial authorization duration: 6 months.
inv-02: Re-Authorization
Re-authorization (12 months) covered when ALL of the following are met:
Re-authorization duration: 12 months.
Coverage for VIVITROL (naltrexone) is conditional on meeting the specified authorization criteria. Individuals are not eligible if they are not abstaining from alcohol at the time of therapy initiation or if they are currently using opioid analgesics, physiologically dependent on opioids, or in acute opioid withdrawal. These exclusions reflect the medication's indication and safety considerations and are required elements of the prior authorization review.
Prior authorization requests that do not document abstinence from alcohol at initiation or that indicate current opioid use/dependence or withdrawal are subject to denial per the stated criteria. Additionally, prescribed dosing must not exceed 380 mg monthly; requests exceeding this threshold may be denied.
Coding and Dose Limits
Provider Actions, Prior Authorization, and Documentation
Prior authorization required for VIVITROL (alcohol dependence)
Prior authorization is required for VIVITROL when used for alcohol dependence; approval will be considered only when all listed clinical criteria and supporting documentation are provided. Submit a Universal PA Form with the request.
- PA required for VIVITROL for alcohol dependence
- Approval considered only when listed criteria and documentation are provided
Action: Verify clinical eligibility before PA submission
Ensure the patient meets the clinical criteria before submitting a PA: diagnosis of alcohol dependence, abstinence at therapy initiation, not currently using or dependent on opioids, tolerability to naltrexone, and prescribed dose ≤ 380 mg monthly.
- Confirm diagnosis of alcohol dependence
- Confirm patient is abstaining from alcohol at initiation
- Confirm no current opioid use, opioid dependence, or acute opioid withdrawal
- Document tolerability to naltrexone
- Prescribed dose must not exceed 380 mg per month
Required documentation to support PA request
Submit the Universal PA Form plus supporting clinical documentation, including documentation or attestation of tolerability to naltrexone, evidence of diagnosis of alcohol dependence, and evidence the patient was abstaining from alcohol at initiation.
- Universal PA Form
- Documentation/attestation of tolerability to naltrexone
- Clinical evidence of alcohol dependence diagnosis
- Evidence of abstinence from alcohol at therapy initiation
Denial triggers and risks
Requests may be denied if the PA is not provided or if required documentation does not show the patient meets the listed criteria (for example: not abstaining at initiation, concurrent opioid use/dependence/withdrawal, or prescribed dose exceeding 380 mg monthly).
- Missing prior authorization will result in noncoverage
- Denial risk if patient not abstaining from alcohol at initiation
- Denial risk if patient is using opioids, physiologically opioid-dependent, or in acute opioid withdrawal
- Denial risk if prescribed dose > 380 mg per month
Clinical Background
VIVITROL (naltrexone) is an opioid antagonist used in the treatment of alcohol dependence. For the Medicaid prior authorization pathway, initial approvals are considered for a maximum duration of 6 months when all clinical criteria are met, including patient eligibility by age and weight per the package insert, documentation of alcohol dependence, and evidence of abstinence at therapy start.
Because naltrexone blocks opioid receptors, patients must not be taking opioids or be opioid-dependent or in acute opioid withdrawal at initiation. Documentation or attestation of prior tolerability to naltrexone is required, and dosing is limited to a maximum of 380 mg per month (administered once monthly).
Definitions
Medication and Treatment Modalities
inv-11: Medication (VIVITROL)
Formulation: one 380‑mg vial per dose; maximum monthly dose 380 mg.
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