CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Extended‑release buprenorphine injections (Sublocade, Brixadi) — Coverage Criteria

This policy governs authorization, dosing, and continuation criteria for Sublocade and Brixadi injectable extended‑release buprenorphine for treatment of moderate to severe opioid use disorder in eligible members, and applies to Medicare/Medicaid/Commercial as specified.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyExtended‑release buprenorphine injections (Sublocade, Brixadi) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2018

Next Review DateJan 1, 2026

Key ActionObtain prior authorization: initial approvals may be granted for 6 months when all coverage criteria and required documentation are provided.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization duration

12 monthscontinuation authorization duration

100/300 mgSublocade doses

8–32 wk; 64–128 moBrixadi dosing

Q9991,Q9992,J0577,J0578

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Coverage Criteria

Initial Therapy

Authorization of 6 months may be granted when ALL of the following are met:

Initial authorization for moderate to severe OUD: Member is 18 years of age or older AND member is part of a complete treatment program that includes counseling and psychosocial support AND member is not receiving other opioids during therapy with Sublocade OR Brixadi AND rationale is provided that the member cannot continue oral formulations of buprenorphine AND for Brixadi: member has initiated transmucosal buprenorphine at a dose of at least 4 mg or is transitioning from another buprenorphine-containing treatment and is stable with controlled withdrawal symptoms AND requested Brixadi dose does not exceed 32 mg weekly or 128 mg monthly AND for Sublocade: member has initiated treatment with a single dose of transmucosal buprenorphine (4 mg) or is already being treated with buprenorphine AND requested Sublocade maintenance dose does not exceed 300 mg monthlyage >=18; Brixadi <=32 mg/week or <=128 mg/month; Sublocade <=300 mg/month

All conditions must be satisfied for initial approval.

Continuation Therapy

Authorization of 12 months may be granted when ALL of the following are met:

Continuation criteria: Member continues to meet all initial criteria AND absence of unacceptable toxicity from the drug AND member has documentation of a decrease in signs of opioid dependence relapsenone specified

Examples of unacceptable toxicity include adrenal insufficiency, severe injection site reactions, life‑threatening respiratory/CNS depression, hepatitis, severe hypersensitivity reactions, QTc prolongation, severe orthostatic hypotension.

Requests that exceed the policy's specified maximum maintenance doses or that involve concurrent use of other opioids during therapy are not acceptable. Brixadi dosing must not exceed 32 mg weekly (one syringe per week) or 128 mg monthly (one syringe per month). Sublocade maintenance dosing must not exceed 300 mg per month. Additionally, members must not be receiving other opioids during therapy with Sublocade or Brixadi; such concurrent opioid use is a contraindication to coverage.

Continuation (renewal) authorizations will not be approved when there is evidence of unacceptable toxicity from the medication or when there is no documented clinical benefit. Examples of unacceptable toxicity include adrenal insufficiency, severe injection‑site reactions, life‑threatening respiratory or central nervous system depression, hepatitis, severe hypersensitivity reactions, QTc prolongation, and severe orthostatic hypotension. Continuation also requires documentation of a decrease in signs of opioid dependence relapse; absence of such documentation is a basis for a denial of continued therapy.

Coding and Dosing Details

HCPCS/CPT codesHCPCS

Q9991	Injection, buprenorphine extended-release (Sublocade), less than or equal to 100 mg.
Q9992	Injection, buprenorphine extended-release (Sublocade), greater than 100 mg.
J0577	Injection, buprenorphine extended-release (Brixadi), less than or equal to 7 days of therapy.
J0578	Injection, buprenorphine extended-release (Brixadi), greater than 7 days and up to 28 days of therapy.

Maximum maintenance dosing — Sublocade and Brixadi

Sublocade loading regimenTwo 300 mg subcutaneous loading doses (first two doses), second injection may be given 1 week to 1 month after the first; maintenance thereafter is 100 mg monthly.

Sublocade maintenance maximumMaintenance dose should not exceed 300 mg per month (documented maximum maintenance dose).

Brixadi weekly dosing optionsWeekly subcutaneous options: 8 mg, 16 mg, 24 mg, or 32 mg administered at 7-day intervals.

Brixadi monthly dosing optionsMonthly subcutaneous options: 64 mg, 96 mg, or 128 mg administered at 28-day intervals.

Brixadi maximumsMaximum Brixadi dosing limits: 32 mg per week or 128 mg per 28 days (monthly).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial authorization: up to 6 months for treatment of moderate to severe opioid use disorder in members ≥18 when all initial criteria are met (member enrolled in a complete treatment program including counseling/psychosocial support, not receiving other opioids during therapy, and rationale provided for injectable vs oral buprenorphine).

Initial authorization duration: 6 months
Continuation authorization: see continuation criteria (up to 12 months)

Step Therapy

Step Therapy Exception for Medicare

Medicare members who have previously received this medication within the past 365 days are exempt from Step Therapy requirements.

Applies to Medicare members with documented receipt of the same medication within the prior 365 days

Treatment Modalities: Injectable MAT

Extended‑release buprenorphine injections (Sublocade, Brixadi)

Sublocade modality: Monthly subcutaneous (subcutaneous) injection following initiation with a transmucosal buprenorphine product (single dose/initiation) or ongoing buprenorphine treatment; loading doses are 300 mg for the first two injections followed by maintenance (commonly 100 mg monthly) per dosing guidance; maintenance dose requested must not exceed 300 mg per month

Follow initiation and maintenance dosing as specified; documentation of transmucosal buprenorphine initiation required.

Brixadi modality: Weekly or monthly subcutaneous injection after initiation with transmucosal buprenorphine (at least 4 mg) or transition from another buprenorphine treatment; weekly options are 8, 16, 24, or 32 mg administered at 7‑day intervals; monthly options are 64, 96, or 128 mg administered at 28‑day intervals; requested Brixadi dose must not exceed 32 mg per week or 128 mg per 28 days

Documentation of transmucosal buprenorphine initiation (>=4 mg) or clinical rationale for transition is required.

Level of Care Criteria

Definitions

Responder / response — Trial outcome measures

Trial response measuresResponse in clinical trials was measured by urine drug screening and self‑report of illicit opioid use.

Outcome metric — weeks without useTrials assessed the number of weeks without positive urine tests or self‑report of opioid use (e.g., higher weeks without positive tests with Sublocade vs placebo).

Responder definition (trial context)Responders were identified based on urine drug screen results combined with self‑reported illicit opioid use during the treatment period.

Background

Indication: Sublocade and Brixadi are extended‑release buprenorphine injections indicated for the treatment of moderate to severe opioid use disorder in patients who have been initiated on or are currently treated with transmucosal buprenorphine. General description: Both products provide subcutaneous, long‑acting buprenorphine formulations intended as part of a comprehensive treatment program that includes counseling and psychosocial support. Initiation requirements differ by product: Brixadi requires prior initiation with transmucosal buprenorphine at ≥4 mg or transition from another buprenorphine treatment, and is available in weekly (8, 16, 24, 32 mg) or monthly (64, 96, 128 mg) dosing schedules with maximums of 32 mg/week or 128 mg/month; Sublocade is administered monthly following initiation with transmucosal buprenorphine (single 4 mg dose or existing buprenorphine therapy) and uses a loading regimen (two 300 mg doses) then maintenance doses (commonly 100 mg monthly) with a maintenance maximum of 300 mg/month.