CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0057Y

Buprenorphine extended‑release injections (Brixadi & Sublocade) — Coverage Criteria

Coverage and medical-necessity criteria for subcutaneous extended‑release buprenorphine formulations (Brixadi and Sublocade) for treatment of opioid use disorder; applies to members under the payer's commercial medical benefit where state policy permits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBuprenorphine extended‑release injections (Brixadi & Sublocade) — Coverage Criteria

Policy CodePolicy CS2026D0057Y

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization demonstrating opioid use disorder diagnosis and that dosing follows FDA labeling; ensure transmucosal buprenorphine exposure or test dose per policy before initiating depot injection.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmaximum initial authorization duration

Brixadi, Sublocadeproducts covered

J0577/J0578/Q9991/Q9992HCPCS codes

F11.xdiagnosis group

Coverage and Medical Necessity Criteria

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Initial Therapy

Covered when ALL of the following are met for initial therapy:

Initial Therapy: Patient is being treated for opioid use disorder; dosing (Brixadi or Sublocade) is in accordance with FDA-approved labeling; initial authorization will be for no more than 12 months; and the patient has either initiated treatment with a single dose of a transmucosal buprenorphine product or is already being treated with buprenorphine. If the patient is not currently receiving maintenance buprenorphine treatment, a transmucosal buprenorphine test dose must have been received to establish buprenorphine tolerance without precipitated withdrawal (per Brixadi labeling).

Sources: policy coverage rationale and FDA indications/labeling

Continuation Therapy

Covered when ALL of the following are met for continuation:

Continuation Therapy: Documentation of positive clinical response to buprenorphine extended-release therapy; dosing (Brixadi or Sublocade) is in accordance with FDA-approved labeling; continuation authorization will be for no more than 12 months.

From policy continuation section

Not Medically Necessary

Excluded Indication: Use of buprenorphine extended-release injection for pain management is unproven and not medically necessary.

Explicit exclusion in policy

Use for pain management is unproven and not medically necessary. The policy explicitly excludes the use of buprenorphine extended‑release injections (Brixadi and Sublocade) for pain management as not medically necessary.

Buprenorphine extended‑release injection is unproven and not medically necessary for pain management. Coverage is not provided when the requested use is for pain management; such use is considered unproven and does not meet medical necessity criteria.

Applicable Codes

Applicable HCPCS / J/Q 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.

Applicable ICD-10 CodesICD-10

F11.20	Opioid dependence, uncomplicated.
F11.21	Opioid dependence, in remission.
F11.220	Opioid dependence with intoxication, uncomplicated.
F11.221	Opioid dependence with intoxication delirium.
F11.222	Opioid dependence with intoxication with perceptual disturbance.
F11.229	Opioid dependence with intoxication, unspecified.
F11.23	Opioid dependence with withdrawal.
F11.24	Opioid dependence with opioid-induced mood disorder.
F11.250	Opioid dependence with opioid-induced psychotic disorder with delusions.
F11.251	Opioid dependence with opioid-induced psychotic disorder with hallucinations.

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Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Brixadi (buprenorphine extended‑release) and Sublocade (buprenorphine extended‑release) injections. The request must document a diagnosis of opioid use disorder, and dosing must be consistent with the U.S. Food and Drug Administration–approved labeling. Initial authorizations will be for no more than 12 months; continuation authorizations will be for no more than 12 months.

Applies to J0577, J0578, Q9991, Q9992

Documentation Required

Required Documentation

Documentation submitted with the prior authorization request must include: confirmation that the patient is being treated for opioid use disorder; documentation that dosing is in accordance with FDA‑approved labeling; for continuation requests, evidence of a positive clinical response to extended‑release buprenorphine therapy. For initial therapy, documentation must also show that the patient is not currently receiving maintenance buprenorphine and has received a buprenorphine test dose demonstrating tolerance without precipitated withdrawal.

Note

Requirement for Prior Transmucosal Buprenorphine; REMS Certification

Per FDA labeling for both Brixadi and Sublocade, patients must have initiated treatment with a single dose of a transmucosal buprenorphine product or be currently treated with buprenorphine prior to transition to an extended‑release subcutaneous formulation. Brixadi and Sublocade are available only through their respective REMS programs; ordering and administering sites must be certified as required by the REMS.

Denial Risk

Excluded Indication — Pain Management

Use of buprenorphine extended‑release injection for pain management is considered unproven and not medically necessary and will not be approved.

Background

Brixadi and Sublocade are subcutaneous, extended‑release formulations of buprenorphine intended for treatment of opioid use disorder. These products are dosed in accordance with the U.S. Food and Drug Administration approved labeling, and both initial and continuation authorizations are limited to no more than 12 months. Use of these agents for pain management is explicitly noted as unproven and not medically necessary.

Definitions and Safety Programs

REMS — Restricted distribution and administration

REMS requirementBoth Brixadi and Sublocade are available only through restricted REMS programs that require healthcare settings and pharmacies to be certified and to dispense and administer the product only by certified healthcare providers to mitigate risk of serious harm or death from intravenous self-administration.

PurposeMitigate serious harm or death that could result from intravenous self-administration by restricting distribution and administration to certified providers and settings.

Who must be certifiedHealthcare settings and pharmacies that order and dispense Brixadi or Sublocade must be certified in the respective REMS program.

Administration requirementProducts must be dispensed directly to and administered by a healthcare provider in certified settings (clinic/office/infusion center).

Products covered by REMSBrixadi (buprenorphine extended-release) and Sublocade (buprenorphine extended-release).

Initial Therapy Specifics

Initial Therapy

Initial coverage requirements

Initial: Patient has moderate to severe opioid use disorder and either has initiated treatment with a single dose of a transmucosal buprenorphine product or is already being treated with buprenorphine; if not currently on maintenance buprenorphine, a transmucosal buprenorphine test dose must have been received to demonstrate tolerance without precipitated withdrawal (per Brixadi labeling). Dosing must follow FDA-approved labeling; initial authorization limited to no more than 12 months.

Includes Brixadi test dose requirement per labeling

Continuation Therapy Specifics

Continuation Therapy

Continuation covered when documentation shows clinical benefit and dosing per FDA labeling.

Continuation: Documented positive clinical response to buprenorphine extended-release therapy; dosing is in accordance with FDA-approved labeling; continuation authorization limited to no more than 12 months.