CurrentColorado Rocky Mountain Health PlansPolicy 2025D0057S

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

Defines medical benefit coverage criteria, coding, and prior authorization expectations for Brixadi and Sublocade subcutaneous buprenorphine extended‑release injections for treatment of moderate to severe opioid use disorder; intended for providers and payers applying Colorado Rocky Mountain Health Plans benefits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy 2025D0057S

Change TypeRevisions to initiation languageremoval of supplemental buprenorphine prohibitioncoding addition

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization showing indication for moderate to severe opioid use disorder and documentation that dosing follows FDA labeling; authorizations limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

Replaced language that stated buprenorphine extended‑release injection 'is proven and medically necessary' with language stating it 'is proven' for treatment of moderate to severe opioid use disorder when criteria are met.

Initial therapy criterion changed from requiring the patient be 'currently maintained on an oral, sublingual, or 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.

Added ICD-10 diagnosis code F11.23 to the applicable codes list.

12 monthsmax auth duration

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Coverage Criteria

Initial Therapy

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

Indication: Patient is being treated for opioid use disorder (moderate to severe)

Required indication per policy

Initiation status: One of the following: (1) Patient is not currently receiving maintenance buprenorphine treatment AND patient has received a test dose of buprenorphine demonstrating tolerance without precipitated withdrawal; OR (2) Patient is already being treated with buprenorphine

Policy allows either prior transmucosal test dose or existing buprenorphine treatment (see FDA labeling and policy)

Dosing and REMS: Brixadi or Sublocade dosing is in accordance with the U.S. Food and Drug Administration approved labeling; facility and pharmacy must be REMS certified as required by product labeling

REMS and dosing requirements referenced in FDA product information

Authorization length: Initial authorization will be for no more than 12 months12 months

Authorization limit stated in policy

Continuation Therapy

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

Clinical response: Documentation of positive clinical response to buprenorphine extended‑release therapy

Required for continuation authorization

Dosing and REMS: Brixadi or Sublocade dosing is in accordance with the U.S. Food and Drug Administration approved labeling; facility and pharmacy must remain REMS certified as required by product labeling

Continuation requires adherence to FDA labeling and REMS

Authorization length: Continuation authorization will be for no more than 12 months12 months

Continuation authorization limit stated in policy

Not Medically Necessary Indication

Pain management: Buprenorphine extended‑release injection is unproven and not medically necessary for pain management

Explicit non‑coverage for pain indication stated in policy

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

The policy considers buprenorphine extended‑release injection for the indication of pain management to be unproven and not medically necessary and therefore not eligible for coverage under this criterion.

Coding

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 diagnosis 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 Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for buprenorphine extended-release injections (Brixadi, Sublocade). Provide clinical rationale and dosing information consistent with FDA labeling when requesting authorization. Initial approvals are limited to up to 12 months; continuation approvals also require documentation of prior response and are limited to up to 12 months.

Affected products: Brixadi (J0577, J0578) and Sublocade (Q9991, Q9992)
Initial authorization: up to 12 months
Continuation authorization: up to 12 months

Step Therapy

Step Therapy / Prior Stabilization

There is no mandatory step therapy sequence required before approval of buprenorphine extended‑release injections for opioid use disorder; however, clinical trial entry criteria inform expectations (e.g., patients not currently receiving maintenance buprenorphine who tolerate a test dose). Use clinical judgment and document prior stabilization as appropriate.

Background

Brixadi and Sublocade are subcutaneous buprenorphine extended‑release injections developed to deliver buprenorphine over weekly or monthly intervals for the treatment of moderate to severe opioid use disorder. Both products are supplied for administration by a healthcare professional and are distributed under REMS (Risk Evaluation and Mitigation Strategy) requirements because of the risk of serious harm from intravenous self‑administration; they are intended to be used alongside counseling and psychosocial support.

Definitions

REMS

DefinitionREMS = Risk Evaluation and Mitigation Strategy programs required by product labeling to mitigate the risk of serious harm or death from intravenous self-administration of buprenorphine extended‑release injections.

Certification requirement for healthcare settingsHealthcare settings that order and administer Brixadi or Sublocade must be certified in the product REMS program.

Certification requirement for pharmaciesPharmacies that order and dispense Brixadi or Sublocade must be certified in the respective REMS program and may only dispense directly to a healthcare provider for administration by a healthcare provider.

PurposeREMS programs aim to mitigate the risk of intravenous self‑administration by ensuring restricted distribution and administration in certified settings.

Administration restrictionProducts are dispensed only to healthcare providers for administration by a healthcare provider as required by REMS.

Initial Therapy Criteria

Initial Therapy

Initial therapy coverage conditions:

Indication: Patient is being treated for opioid use disorder (moderate to severe)

Required indication per policy

Prior buprenorphine exposure: Either: (a) patient is not currently receiving maintenance buprenorphine and has tolerated a buprenorphine test dose without precipitated withdrawal; OR (b) patient is already being treated with buprenorphine

Policy language allows either pathway; mirrors FDA initiation wording

Dosing and REMS: Dosing must follow FDA approved labeling for Brixadi or Sublocade; healthcare settings and pharmacies must be certified under the product REMS and administration must be by a healthcare provider

REMS requirements and administration setting from FDA information

Continuation Therapy Criteria

Continuation Therapy

Continuation is allowed when criteria are met:

Continuation requirements: Documentation of positive clinical response to buprenorphine extended‑release therapy; dosing per FDA approved labeling; healthcare settings and pharmacies must remain REMS certified as required by product labeling

Continuation authorization requires evidence of benefit and adherence to REMS and labeling

Authorization length: Continuation authorization limited to no more than 12 months12 months

Continuation authorization duration per policy

Step Therapy / Clinical Trial Context

Note	Coverage status
Some clinical trials of Brixadi required an initial transmucosal buprenorphine test dose and stabilization period before randomization (Brixadi study used an open‑label 4 mg sublingual buprenorphine test dose; patients who tolerated the test dose were randomized)	neutral
Sublocade trials randomized patients after cravings and withdrawal symptoms were clinically controlled and applied a 4‑week 'grace period' to allow stabilization; supplemental transmucosal buprenorphine/naloxone was not permitted after randomization in the Sublocade study	neutral
Policy does not mandate prior maintenance on transmucosal buprenorphine for coverage; coverage allows either patients already being treated with buprenorphine or those who receive and tolerate a transmucosal test dose	neutral

Site of Care / REMS Administration

Note

Administer only in REMS‑certified settings; dispensing restricted

Administration must occur in a healthcare setting certified under the product REMS, and Brixadi or Sublocade may only be dispensed by REMS‑certified pharmacies or directly to a healthcare provider for administration.

Brixadi and Sublocade are available only through REMS programs requiring certification of healthcare settings and pharmacies
Products must be dispensed to and administered by a healthcare provider in certified settings