CurrentBlue Cross Blue Shield - IowaPolicy 05.01.13

Vivitrol_Medical_Necessity_Criteria

Defines prior authorization, medical necessity criteria, required documentation, prescriber specialties, coverage criteria for alcohol use disorder and opioid use disorder, continuation criteria, dosing limits, and billing code for Vivitrol (naltrexone extended-release injectable). Applies to Wellmark Blue Cross and Blue Shield members per contract terms.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVivitrol_Medical_Necessity_Criteria

Policy CodePolicy 05.01.13

Change TypeReviewed

Effective DateSep 1, 2006

Next Review Date

Key ActionSubmit chart notes/lab results showing rehab program participation and a urine screen or naloxone challenge within 7 days when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Reviewed June 2025; last revision noted August 2021 but no material clinical policy change indicated in header.

2Indications covered

7Opioid-free duration (days)

380 mg/28dMax dose/frequency

Coverage Summary

Policy 05.01.13 (Wellmark Blue Cross and Blue Shield) covers Vivitrol (extended-release naltrexone, HCPCS J2315) with specific prior authorization medical necessity criteria for both Alcohol Use Disorder and Opioid Use Disorder — coverage stance: covered_with_criteria. Scope applies to Wellmark members per contract terms. Effective/last review dates: Original Effective Date September 2006; Reviewed June 2025 (last revision noted August 2021).

Quick facts and thresholds

Indications coveredAlcohol Use Disorder; Opioid Use Disorder

Opioid-free duration prior to initiationMinimum of 7 days (opioid and opiate-free prior to first dose)

Maximum dose / frequencyDo not exceed 380 mg intramuscularly every 28 days

Required urine/naloxone verification windowNegative urine screen or passed naloxone challenge within 7 days prior to initiation

Policy effective / last reviewOriginal effective date September 2006; Last reviewed June 2025

Initial Therapy Criteria

Alcohol Use Disorder - Initial Approval

Vivitrol may be considered medically necessary when ALL of the following criteria are met:

ALL of the following

Patient is 18 years of age or older
Patient is currently in treatment for alcohol dependence or alcohol use disorder
Patient is not receiving concurrent treatment with opioid analgesics for any indication
Patient has had an opiate and opioid-free duration of a minimum of seven days to treatment initiation including but not limited to buprenorphine, methadone, tramadol, and mitragyna speciosa korth (Kratom) prior7 days
Patient is not experiencing acute opioid withdrawal
Patient does not have acute hepatitis or liver failure (e.g., Child-Pugh C)
ONE of
- Patient has a recent (within 7 days) negative urine screen for opioidswithin 7 days
- Patient has recently (within 7 days) passed a naloxone challenge testwithin 7 days
Patient is not actively using alcohol at the time of Vivitrol administration
Documented participation in and adherence to a comprehensive rehabilitation program that includes psychosocial support
Patient has failed to adhere to oral naltrexone, disulfiram, or acamprosate therapy
Patient will not exceed a maximum dose of 380 mg intramuscularly every 28 days380 mg every 28 days

Opioid Use Disorder - Initial Approval

Vivitrol may be considered medically necessary when ALL of the following criteria are met:

ALL of the following

Patient is 18 years of age or older
Patient has successfully completed an opioid detoxification program and is not experiencing acute opioid withdrawal
Patient is currently being treated for opioid addiction, opioid dependence, or opioid use disorder
Patient has had an alcohol, opiate and opioid-free duration of a minimum of seven days to treatment initiation including but not limited to buprenorphine, methadone, tramadol, and mitragyna speciosa korth (Kratom) prior7 days

Continuation Therapy Criteria

Continuation of Therapy

Continuation is permitted when the following are met:

ALL of the following

Patient continues to meet the initial criteria listed in the Criteria for Initial Approval
Initial criteria must continue to be met
Patient has demonstrated clinical benefit
For Opioid Use Disorder: clinical benefit is defined by complete abstinence from opioids
There is no evidence of unacceptable toxicity from the requested medication

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization submission requirements

Submit chart notes or medical records documenting participation in and adherence to a comprehensive rehabilitation program with psychosocial support; provide chart notes, medical records, or laboratory values documenting urine screen results within 7 days and/or naltrexone oral challenge within 7 days; for alcohol use, include medical records or claims history documenting failed adherence to oral naltrexone, disulfiram, or acamprosate. Use HCPCS code J2315 for the injectable naltrexone depot when billing.

Chart notes/medical records documenting participation in and adherence to a comprehensive rehabilitation program with psychosocial support
Chart notes, medical records, or lab values documenting urine screen results within 7 days and/or naltrexone oral challenge within 7 days
For alcohol use: medical records or claims history documenting failed adherence to oral naltrexone, disulfiram, or acamprosate
Billing/HCPCS code: J2315 (injection, naltrexone, depot form)

Documentation Required

Urine/naloxone verification

Provide documentation of a recent negative urine screen for opioids within 7 days prior to initiation or documentation that the patient has passed a naloxone (naltrexone oral) challenge within 7 days. This verification must be included in the prior authorization submission to confirm the patient is opioid-free at the time of administration.

Negative urine screen for opioids within 7 days
Or passed naloxone/oral naltrexone challenge within 7 days

Documentation Required

Prescriber specialty requirement

The medication must be prescribed by or in consultation with an addiction medicine specialist or a psychiatrist. Documentation of the prescribing clinician's specialty or consultation should be submitted with the request.

Billing Rule

Dose and frequency limit

Do not exceed a maximum dose of 380 mg administered intramuscularly every 28 days. For initial treatment of alcohol use disorder, the approval duration is 6 months. Use HCPCS code J2315 when reporting the depot injection.

Maximum dose/frequency: 380 mg IM every 28 days (J2315)
Initial approval duration for alcohol use disorder: 6 months

Denial Risk

Contraindications and exclusion denial risk

Claims may be denied if the patient is actively using alcohol or opioids at the time of administration, is receiving concurrent opioid analgesics, is experiencing acute opioid withdrawal, or has acute hepatitis or liver failure (e.g., Child-Pugh C). These contraindications/exclusions should be evaluated and documented prior to treatment.

Clinical Evidence

Evidence and background note that randomized trials including the X:BOT (Lancet 2018) trial found buprenorphine-naloxone favored over extended-release naltrexone (XR-NTX) for relapse-free survival and successful induction in intention-to-treat analyses, with higher overdoses observed among XR-NTX-assigned participants (many occurring after failed induction). ICER (2018) concluded XR-NTX produced marginally fewer QALYs and similar life years to buprenorphine-naloxone and had inferior effectiveness at higher drug costs. Overall the evidence does not demonstrate superiority of Vivitrol to alternative treatments, and the induction requirement (opioid-free period) has resulted in poor induction rates and an associated increased risk of overdose when induction fails.

Background & Definitions

Vivitrol is an extended-release injectable formulation of naltrexone indicated for treatment of alcohol dependence (patients should be abstinent/not actively drinking at initial administration) and for prevention of relapse to opioid dependence following detoxification. Induction requires the patient be opioid-free (commonly a minimum of 7–10 days as noted) and pass urine or naloxone verification prior to administration; failure to complete induction is associated with increased overdose risk. The policy states current evidence does not demonstrate superiority of the injectable formulation over oral formulations or alternative treatments.

Term	Definition
XR-NTX	Extended-release naltrexone (Vivitrol) injectable formulation
Clinical benefit (OUD continuation)	Complete abstinence from opioids

Revision History

September 2006Original Effective Date

Policy originally became effective in September 2006.

August 2021Revised

Policy revision noted in August 2021 (no material clinical policy changes indicated in header).

June 2025ReviewedLatest

Policy review completed in June 2025; most recent review date on file.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVivitrol_Medical_Necessity_Criteria

Policy CodePolicy 05.01.13

Change TypeReviewed

Effective DateSep 1, 2006

Next Review Date

Key ActionSubmit chart notes/lab results showing rehab program participation and a urine screen or naloxone challenge within 7 days when requesting prior authorization.

SourceLink

On This Page

OpenPayer

Vivitrol_Medical_Necessity_Criteria

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Not Medically Necessary / Exclusions

Applicable Codes

Provider Actions & Prior Authorization

Clinical Evidence

Background & Definitions

Revision History