CurrentColorado Rocky Mountain Health PlansPolicy IEXD0057.11

Buprenorphine (Brixadi & Sublocade) — Extended‑Release Injection Coverage Criteria

Medical benefit drug policy governing coverage criteria for buprenorphine extended-release subcutaneous injections (Brixadi and Sublocade) for treatment of moderate to severe opioid use disorder for Individual Exchange plans (with state exceptions). Affects prescribers, facilities dispensing/administering these products, and prior authorization reviewers.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBuprenorphine (Brixadi & Sublocade) — Extended‑Release Injection Coverage Criteria

Policy CodePolicy IEXD0057.11

Change TypeMaterial revisions to initial therapy eligibility and supplemental buprenorphine allowance

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization and document either a tolerated buprenorphine test dose or that the patient is already being treated with buprenorphine.

SourceLink

POLICY UPDATE CHANGES

Initial therapy criterion changed from requiring the patient be currently maintained on an oral/sublingual/transmucosal buprenorphine product to 'the patient is already being treated with buprenorphine'.

Removed criterion that the patient has neither received nor will receive supplemental, oral, sublingual, or transmucosal buprenorphine for both initial and continuation therapy.

Replaced wording that injections are 'proven and medically necessary' with 'proven' for treatment of moderate to severe opioid use disorder when criteria are met.

Added ICD-10 diagnosis code F11.23 to Applicable Codes.

2products covered

J0577,J0578,Q9991,Q9992HCPCS codes

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Coverage Criteria

Covered: Initial and Continuation Therapy

Covered when ALL of the following are met

Overall: Patient has moderate to severe opioid use disorder and meets specific initial or continuation criteria for buprenorphine extended-release injection

Policy applies to Brixadi and Sublocade

Initial Therapy: Patient is being treated for opioid use disorder AND meets one of the following initial therapy pathways

See nested initial therapy pathways

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

Continuation requires clinical benefit and FDA-concordant dosing

Buprenorphine extended‑release injection (e.g., Brixadi, Sublocade) is unproven and not medically necessary for pain management. The policy specifically states that these subcutaneous, extended‑release buprenorphine products are indicated and covered only for the treatment of moderate to severe opioid use disorder when all coverage criteria are met; use for pain management is not a covered indication.

Use of buprenorphine extended‑release injection for pain management is considered unproven and not medically necessary. Requests for these products with a primary intent of treating pain do not meet the policy’s coverage rationale and should be denied as not medically necessary.

Initial Therapy

Initial authorization is covered when ALL of the following are met

Initial Therapy: Patient is being treated for opioid use disorder; and one of the pathways below is met; and Brixadi or Sublocade dosing is in accordance with the U.S. Food and Drug Administration approved labeling; and initial authorization will be for no more than 12 months

Dosing and duration requirements apply to initial authorizations

Pathway A - Test dose (for patients not currently on maintenance buprenorphine): Both of the following: Patient is not currently receiving maintenance buprenorphine treatment; and Patient has received a test dose of buprenorphine to establish that buprenorphine is tolerated without precipitated withdrawal

Test dose requirement applies when patient is not already being treated with buprenorphine

Pathway B - Already being treated with buprenorphine: Patient is already being treated with buprenorphine

Continuation of Therapy

Continuation authorizations require documentation that ALL of the following are met

Continuation Criteria: Documentation of positive clinical response to buprenorphine extended-release therapy; and Brixadi or Sublocade dosing is in accordance with the U.S. Food and Drug Administration approved labeling; and continuation authorization will be for no more than 12 months

Reviewers should document clinical benefit and verify FDA-concordant dosing for continuation

Coding and Authorization Details

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.

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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Authorization duration — initial and continuation

Initial authorization periodInitial authorization limited to no more than 12 months

Continuation authorization periodContinuation authorization limited to no more than 12 months

Dosing requirementBrixadi or Sublocade dosing must be in accordance with FDA-approved labeling

Documentation for continuationDocumentation of positive clinical response required for continuation

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required per the member's plan for buprenorphine extended‑release injections (Brixadi or Sublocade). Initial authorization will be for no more than 12 months; continuation authorizations will also be for no more than 12 months.

Prior authorization required — use applicable HCPCS/NDC codes for Brixadi (J0577, J0578) and Sublocade (Q9991, Q9992).
Initial and continuation authorizations limited to a maximum duration of 12 months each.

Note

Stabilization / Test‑Dose Requirement

A prior transmucosal buprenorphine test dose to establish tolerance is required for patients not already maintained on buprenorphine. Alternatively, the patient may already be receiving buprenorphine maintenance therapy prior to initiation of extended‑release injection.

If the patient is not currently on maintenance buprenorphine, documentation must show a prior transmucosal buprenorphine test dose without precipitated withdrawal.
If the patient is already being treated with buprenorphine, the test‑dose requirement is not required.

Site of Care and Dispensing

Note

Dispense and administer only in REMS‑certified settings

Brixadi and Sublocade are available only through their respective REMS programs and must be dispensed and administered by certified healthcare settings and pharmacies; the injections are to be administered by a healthcare provider (site-of-care: office or infusion center per REMS requirements).

Healthcare settings and pharmacies that order and dispense Brixadi or Sublocade must be certified in the product REMS.
Injections must be dispensed directly to and administered by a healthcare provider (office or infusion center).

Definitions

Brixadi / Sublocade — buprenorphine extended-release injections

Products includedBrixadi (buprenorphine extended-release) and Sublocade (buprenorphine-extended release)

Formulation & routeSterile solution for subcutaneous injection only (extended-release)

Duration of releaseBrixadi: weekly or monthly controlled delivery; Sublocade: monthly controlled delivery

REMS requirementBoth products are available only through REMS programs; healthcare settings and pharmacies must be certified and dispense/administer directly to a healthcare provider for administration

Indication summaryIndicated for moderate to severe opioid use disorder in patients who have initiated treatment with a single transmucosal buprenorphine dose or who are already being treated with buprenorphine

Background

Brixadi and Sublocade are subcutaneous, extended‑release formulations of buprenorphine that deliver medication over weekly or monthly intervals. These products are described in the policy as the buprenorphine extended‑release injections used as part of comprehensive treatment for moderate to severe opioid use disorder, and dosing must follow U.S. Food and Drug Administration approved labeling.

Requirement	Details
Patient already being treated with buprenorphine
Covered when the patient is already being treated for opioid use disorder with buprenorphine prior to initiating buprenorphine extended‑release injection (Brixadi or Sublocade).
Transmucosal buprenorphine test dose demonstrating tolerance
If the patient is not currently receiving maintenance buprenorphine treatment, a single test dose of transmucosal buprenorphine must have been administered and tolerated without precipitated withdrawal before initiating extended‑release injection therapy.