CurrentUnitedHealthcarePolicy CS2025D0057V

Buprenorphine (Brixadi & Sublocade) — Medical Benefit Drug Policy

Medical benefit drug policy governing coverage and authorization criteria for subcutaneous buprenorphine extended-release injections (Brixadi and Sublocade) for treatment of moderate to severe opioid use disorder; affects providers submitting medical benefit requests to UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyBuprenorphine (Brixadi & Sublocade) — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0057V

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document opioid use disorder diagnosis, test-dose tolerance or prior maintenance on buprenorphine, and REMS certification as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmax authorization

J0577, J0578, Q9991, Q9992billing codes

24 weeksevidence duration

RequiredREMS

Coverage Criteria

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Initial and Continuation Therapy Criteria

Covered when ALL of the following are met

Overall indication: Patient is being treated for moderate to severe opioid use disorder

Initiation pathway: Either: (A) patient is not currently receiving maintenance buprenorphine treatment AND has received a test dose of buprenorphine demonstrating tolerance without precipitated withdrawal; OR (B) patient is currently maintained on oral, sublingual, or transmucosal buprenorphine

Both pathways require that the patient will neither receive nor continue to receive supplemental oral, sublingual, or transmucosal buprenorphine when on Brixadi or Sublocade

Dosing and authorization: Brixadi or Sublocade dosing is in accordance with the U.S. Food and Drug Administration approved labeling; initial and continuation authorization limited to no more than 12 months12 months

Continuation Therapy

Continuation covered when ALL of the following are met

Response and restrictions: Documentation of positive clinical response to buprenorphine extended-release therapy; patient has neither received nor will receive supplemental oral, sublingual, or transmucosal buprenorphine; dosing per U.S. Food and Drug Administration approved labeling; continuation authorization for no more than 12 months

This medical benefit drug policy does not apply to certain states. Refer to the listed state-specific policy or guideline where noted. States excluded from this policy generally include Indiana, Kansas, Kentucky, Louisiana, New Jersey, New Mexico, North Carolina, Ohio, and Pennsylvania. Separately, the policy for the Sublocade product does not apply in Arizona; providers should consult the state Medicaid clinical policy or other state-specific guidance as indicated.

Initial Therapy

Initial authorization covered when all criteria are met

Initial therapy criteria: Patient treated for opioid use disorder; either not currently on maintenance buprenorphine with a tolerated test dose OR currently maintained on oral, sublingual, or transmucosal buprenorphine; patient has neither received nor will receive supplemental oral, sublingual, or transmucosal buprenorphine; Brixadi or Sublocade dosing per U.S. Food and Drug Administration approved labeling; initial authorization for no more than 12 months

Continuation Therapy

Continuation authorization requirements

Continuation criteria: Documentation of positive clinical response to buprenorphine extended-release therapy; patient has neither received nor will receive supplemental oral, sublingual, or transmucosal buprenorphine; dosing per U.S. Food and Drug Administration approved labeling; continuation approved up to 12 months

Coding

Applicable HCPCS CodesHCPCS

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.
Q9991	Injection, buprenorphine extended-release (Sublocade), less than or equal to 100 mg.
Q9992	Injection, buprenorphine extended-release (Sublocade), greater than 100 mg.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation requests for Brixadi (buprenorphine extended‑release) and Sublocade (buprenorphine extended‑release). Initial approvals and continuation approvals are each limited to a maximum duration of 12 months. Requests must document that the patient either (1) is not currently receiving maintenance buprenorphine and has received a test dose demonstrating tolerance without precipitated withdrawal, or (2) is currently maintained on an oral, sublingual, or transmucosal buprenorphine product and meets the other clinical criteria in the policy. For continuation, documentation must show a positive clinical response to extended‑release buprenorphine therapy and that the patient is not receiving supplemental oral/sublingual/transmucosal buprenorphine. Dosing must align with FDA‑approved labeling.

Initial and continuation authorizations: max 12 months
Required: documentation of test dose tolerance OR documentation of prior maintenance buprenorphine therapy
Required: dosing per FDA labeling

Step Therapy

No Step Therapy / Fail‑First

No step therapy (fail‑first) algorithms are specified for Brixadi or Sublocade beyond requirements related to test dosing or prior maintenance buprenorphine therapy described in the prior authorization criteria.

No additional step therapy requirements specified
Clinical prerequisites limited to test dose tolerance or documented prior maintenance therapy as noted in prior authorization criteria

Documentation Required

Documentation Requirements

Providers must include documentation supporting the diagnosis of opioid use disorder, evidence of test dose tolerance or prior maintenance buprenorphine treatment (as applicable), documentation of positive clinical response for continuation requests, and dosing consistent with FDA labeling. For Brixadi and Sublocade, REMS program requirements apply — providers and administering sites must be certified in the respective REMS programs when applicable.

Diagnosis of moderate to severe opioid use disorder
Test dose documentation if initiating (tolerated without precipitated withdrawal)
Documentation of prior maintenance buprenorphine if switching from transmucosal therapy
For continuation: evidence of positive clinical response to extended‑release therapy
Site/provider REMS certification when administering Brixadi or Sublocade

Denial Risk

Denial Triggers / Risks

Requests that do not meet the initial or continuation criteria, that propose dosing inconsistent with FDA‑approved labeling, or that lack required documentation (diagnosis, test dose or prior maintenance records, REMS certification where required) may be denied.

Denial triggers: missing or insufficient documentation
Denial triggers: unsupported dosing or duration beyond 12 months per authorization limits
Denial triggers: failure to meet initial or continuation clinical criteria

Definitions & Program Requirements

REMS — Risk Evaluation and Mitigation Strategy requirements and operational notes

DefinitionRisk Evaluation and Mitigation Strategy (REMS): a restricted program requiring certification of healthcare settings and pharmacies for ordering, dispensing, and administration to mitigate risks (notably serious harm or death from intravenous self-administration).

Products requiring REMSBoth Brixadi and Sublocade are available only through their respective REMS programs (Brixadi REMS; Sublocade REMS Program).

REMS goalTo mitigate serious harm or death from intravenous self-administration by ensuring only certified healthcare settings and pharmacies dispense these products and that administration is performed by a healthcare provider.

Certification requirementHealthcare settings and pharmacies that order and dispense Brixadi or Sublocade must be certified in the appropriate REMS program.

Dispensing and administration operational noteProducts are dispensed only to certified healthcare settings/pharmacies for direct administration by a healthcare provider (not for patient self-administration).

Background

Brixadi and Sublocade are subcutaneous buprenorphine extended‑release injections intended to provide ongoing delivery of buprenorphine for the treatment of moderate to severe opioid use disorder. Dosing and administration must follow the U.S. Food and Drug Administration approved labeling; initiation may follow either a tolerated test dose in patients not currently on maintenance buprenorphine or transition from current oral/sublingual/transmucosal buprenorphine for patients already maintained on those formulations. Authorization for both initial and continuation therapy is limited to a maximum of 12 months when criteria are met.

Site of Care Requirements

Billing Rule

Administer only in REMS‑certified settings; dispense only to certified sites

Administration and dispensing are restricted to settings and pharmacies certified under each product's REMS; products must be dispensed only to certified healthcare settings/pharmacies for direct administration by a healthcare provider.

Brixadi is available only through the Brixadi REMS; healthcare settings and pharmacies must be certified and dispense Brixadi directly to a healthcare provider for administration.
Sublocade is available only through the Sublocade REMS Program; ordering and dispensing settings must be certified and comply with REMS requirements.