CurrentmhnPolicy CP.PHAR.96

Naltrexone (Vivitrol) Coverage

Defines medical necessity, authorization, and continuation criteria for injectable naltrexone (Vivitrol) for treatment of alcohol dependence and prevention of relapse to opioid dependence for members covered by the payer.

Policy Summary

Payermhn

PolicyNaltrexone (Vivitrol) Coverage

Policy CodePolicy CP.PHAR.96

Change TypeNo material change

Effective DateMar 1, 2012

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results such as naloxone challenge or urine drug screen, or clinical notes) showing the member meets initial approval criteria including diagnosis and opioid-free status as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

380 mgmaximum dose per administration

4 weeksdosing interval

6 monthstypical approval duration

7-10 daysrecommended opioid-free duration

J2315HCPCS code

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Approval - Alcohol and Opioid Dependence: 1) Diagnosis of one of the following: (a) Alcohol dependence; or (b) Opioid dependence; 2) Member meets one of the following: (a) Member is currently hospitalized or being treated in a residential addiction treatment facility and the request is for Vivitrol treatment post-hospital or facility discharge; OR (b) Member meets both of the following: (i) If diagnosis is alcohol dependence, member has abstained from drinking prior to Vivitrol therapy; and (ii) Member meets one of the following: (1) Recent naloxone challenge test or urine drug screen (within past 7 days) confirms the member is opioid-free; OR (2) Member is currently being treated at an addiction treatment center or outpatient facility and chart documentation is submitted demonstrating daily treatment with oral naltrexone; 3) Dose does not exceed 380 mg every 4 weeks or once a month.

inv-02: Continued Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation Therapy - Alcohol and Opioid Dependence: 1) Member meets one of the following: (a) Currently receiving medication via benefit or previously met initial approval criteria; OR (b) Member is currently receiving medication and is enrolled in a state and product with continuity-of-care regulations; 2) Member is responding positively to therapy; 3) Member does not have concurrent opioid claims per pharmacy record; 4) Evidence of adherence to Vivitrol per pharmacy claims record or provider's notes (if not adherent, member must meet initial criteria); 5) If request is for a dose increase, new dose does not exceed 380 mg every 4 weeks or once a month.

inv-03: Other Indications / Off-label — 1 top-level node

Other Indications: Requests for uses not listed should follow formulary/no-coverage or non‑formulary/off‑label policies for the applicable line of business. If the drug recently underwent a label change (within the last 6 months) that is not yet reflected in this policy, refer to the listed formulary or non‑formulary policies; otherwise refer to the off‑label use policy for the relevant line of business.

Refer to CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request is supported by sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (for example, CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents. Requests for off‑label use should include the clinical rationale and supporting literature per those referenced policies.

Uses that are non‑FDA approved and are not supported by adequate clinical evidence or the referenced off‑label use policies are not authorized. Providers should follow the plan’s off‑label review process and submit supporting clinical documentation when seeking coverage for such indications.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required when initiating Vivitrol. Providers must obtain prior authorization and ensure documentation demonstrates that the member meets all initial approval criteria (including applicable diagnosis and evidence of opioid/alcohol status) before therapy is started.

Prior authorization required for initiation of Vivitrol
Approval contingent on meeting all clinical criteria

Documentation Required

Required Clinical Documentation

Providers must submit documentation (e.g., office chart notes, laboratory results such as naloxone challenge or urine drug screen, pharmacy claims, or other clinical evidence) that supports the member has met all approval criteria. Coverage determinations and continued therapy approvals rely on this supporting clinical documentation.

Acceptable documentation: office chart notes, lab results, pharmacy/claims records
Documentation must support all elements of initial or continued approval criteria

Billing Rule

Coding Inclusion/Exclusion Disclaimer

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date professional coding guidance prior to claim submission.

HCPCS: J2315 — Injection, naltrexone, depot form, 1 mg (informational)
Verify current coding guidance before submission

Note

Policy Edit and Documentation Context

Policy edits and implementation notes: the policy history includes additions of bypasses for alcohol/opioid screening requirements for hospitalized or residentially treated members requesting Vivitrol post-discharge, expansion of bypasses to members treated at addiction treatment centers receiving daily oral naltrexone, and changes to approval durations and lines of business over time. Providers should follow the current policy language and submit documentation consistent with the latest requirements.

Policy updates have added screening test bypasses for specific treatment settings
Approval durations and line-of-business rules have been modified over time

Step Therapy

State Restrictions on Medical Management (Nevada)

State restriction: For members in Nevada, medical management techniques beyond step therapy — including quantity management — are not allowed per SB 439. Step therapy rules applicable to the benefit still apply; do not apply additional quantity-management constraints in Nevada.

Nevada exception (SB 439): no medical management beyond step therapy, including quantity management
Elsewhere, standard step therapy and quantity management policies apply as written

Background

Vivitrol is the intramuscular depot formulation of naltrexone, an opioid antagonist indicated for treatment of alcohol dependence in patients who are able to abstain from alcohol prior to initiation and for prevention of relapse to opioid dependence following detoxification. Therapy with Vivitrol should be part of a comprehensive treatment program that includes psychosocial support. Prior to initiation, patients must be documented as opioid‑free to avoid precipitated withdrawal; contraindications include current opioid analgesic use, physiologic opioid dependence, acute opioid withdrawal, failure of a naloxone challenge or positive urine opioid screen, and hypersensitivity to naltrexone or product components. The usual depot dosing regimen is 380 mg every 4 weeks per the product dosing guidance.

Definitions

inv-18: Vivitrol — injectable formulation of naltrexone used for alcohol dependence and prevention of relapse to opioid dependence

DefinitionAn injectable formulation of naltrexone (opioid antagonist) used for treatment of alcohol dependence and for prevention of relapse to opioid dependence.

Clinical contextShould be part of a comprehensive management program that includes psychosocial support.

Initiation requirement (alcohol dependence)Patients should be abstinent from alcohol prior to initial administration.

inv-19: Vivitrol (naltrexone depot) — Vivitrol prescribing information reference

Prescribing information referenceVivitrol Prescribing Information. Alkermes, Inc.; January 2024. Available at http://www.vivitrol.com.

AccessedAccessed November 1, 2024.

Additional referencesACM/ASAM and SAMHSA treatment guideline references included in policy reference list.

Initial Therapy Criteria

inv-20: Initial Therapy — Initial approval criteria for Vivitrol

Initial approval criteria for Vivitrol

Initial Therapy Criteria: Diagnosis of alcohol dependence OR opioid dependence; and either (a) member currently hospitalized or in residential treatment with request for post‑discharge Vivitrol, OR (b) documented opioid‑free status via naloxone challenge or urine drug screen within 7 days OR documentation of daily oral naltrexone treatment at an addiction treatment center/outpatient facility (chart note submitted); dose limit 380 mg every 4 weeks.

Policy edits have historically added bypasses for hospitalized or residential patients and for members treated daily with oral naltrexone; see editorial history for details.

inv-21: Initial Therapy (editorial history) — Policy edits historically adjusted initial approval durations and bypass criteria for certain settings

Policy edits historically adjusted initial approval durations and bypass criteria for certain settings

Initial approval and bypasses (editorial history): Template and policy updates added bypasses of alcohol/opioid screening requirements for currently hospitalized or residential addiction treatment patients, added bypass of naloxone challenge or urine drug screen for members receiving daily oral naltrexone in addiction treatment centers, and introduced separate initial approval durations for specific lines of business (e.g., 12 months for HIM and NH where noted).

See Coding Implications / policy history for dates of changes.

Continuation Criteria

inv-22: Continuation — Continuation criteria for ongoing Vivitrol therapy

Continuation criteria for ongoing Vivitrol therapy

See Continued Therapy: Member currently receiving medication via benefit or previously met initial criteria OR continuity of care; responding positively to therapy; no concurrent opioid claims; evidence of adherence per pharmacy claims or provider notes; dose increases must not exceed 380 mg every 4 weeks.

Template changes have been applied to continued therapy; standard approval language was added to Commercial line of business.

inv-23: Continued Therapy (editorial history) — Policy history notes changes to continued therapy language and approval durations across lines of business

Policy history notes changes to continued therapy language and approval durations across lines of business

Continued therapy editorial changes: Template changes applied to the continued therapy section; standard approval language added to Commercial line of business and prior updates modified approval durations and continuity‑of‑care considerations.

See Coding Implications / policy history for dates and specifics.

State	Restriction
Nevada (NV)	Medical management techniques, including quantity management beyond step therapy, are not allowed for members in Nevada.

State	Legislative / Policy Note
Nevada (NV)	Per SB 439: added disclaimer that medical management techniques, including quantity management beyond step therapy, are not allowed for members in Nevada.

Site of Care

Note

Outpatient initiation — alcohol abstinence required

Vivitrol is used in outpatient settings; when initiating for alcohol dependence, the patient must be abstinent from alcohol prior to the first administration.

Patients should not be actively drinking at the time of initial administration
Outpatient examples include addiction centers, outpatient clinics, or physician offices

Note

Outpatient facility initiation with chart documentation

The policy supports expanded outpatient settings: initiation may occur in an outpatient facility (e.g., physician office or outpatient clinic) when chart documentation demonstrates daily oral naltrexone treatment at an addiction treatment center or outpatient facility.

Chart note documentation must demonstrate daily oral naltrexone to qualify for the screening bypass in outpatient facilities

OpenPayer

Naltrexone (Vivitrol) Coverage

Coverage Criteria

Coding

Provider Actions and Requirements

Background

Definitions

Initial Therapy Criteria

Continuation Criteria

Step Therapy

Quantity Limits

Site of Care