CurrentUnitedHealthcarePolicy IEXD0057.11

Buprenorphine (Brixadi & Sublocade)

Defines medical benefit coverage criteria for buprenorphine extended-release subcutaneous injections (Brixadi, Sublocade) for treatment of moderate to severe opioid use disorder for UnitedHealthcare Individual Exchange plans (with state exceptions).

Policy Summary

PayerUnitedHealthcare

PolicyBuprenorphine (Brixadi & Sublocade)

Policy CodePolicy IEXD0057.11

Change TypeMaterial and administrative revisions

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization showing the patient meets initial or continuation criteria, including evidence of buprenorphine treatment or tolerated transmucosal test dose.

SourceLink

POLICY UPDATE CHANGES

Initial therapy criterion changed from requiring 'currently maintained on an oral, sublingual, or transmucosal buprenorphine product' to 'already being treated with buprenorphine'.

Removed continuation criterion forbidding receipt of supplemental, oral, sublingual, or transmucosal buprenorphine.

Replaced language that stated the products are 'proven and medically necessary' with 'proven' for treatment of moderate to severe opioid use disorder.

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

Clarified FDA REMS requirements for both Brixadi and Sublocade (site/pharmacy certification and direct administration).

300/100 mgSublocade dosing arms studied (monthly)

504Pivotal trial patients

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy: Patient is being treated for opioid use disorder; and one of the following: either (A) patient is already being treated with buprenorphine; or (B) patient is not currently receiving maintenance buprenorphine treatment and has received a transmucosal buprenorphine test dose establishing tolerance without precipitated withdrawal.

Test dose pathway mirrors trial induction procedures (see clinical evidence).

Continuation of Therapy

Covered when ALL of the following are met:

Continuation Therapy: 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.

Continuation may be granted up to 12 months per authorization.

Authorization Limits

Authorization Duration: Initial and continuation authorizations limited to no more than 12 months.12 months

Not Medically Necessary - Pain

Pain Management: Buprenorphine extended-release injection is unproven and not medically necessary for pain management.

Explicit exclusion for pain indication.

Use of buprenorphine extended-release injection (Brixadi or Sublocade) for pain management is explicitly not covered. The policy states that buprenorphine extended-release injection is unproven and not medically necessary for pain management, and therefore requests for these products when the primary indication is pain should be denied as not medically necessary.

Providers should note an explicit exclusion: buprenorphine extended-release injection is considered unproven and not medically necessary for pain management. This duplicate statement reinforces that the policy only supports use for opioid use disorder indications consistent with the coverage criteria and does not support off‑label pain indications.

Coding

Applicable HCPCS/J-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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inv-09: Study duration

Pivotal trial durationPivotal Phase 3 trials for both Sublocade and Brixadi were 24 weeks.

Sublocade trial design detailsSublocade Phase 3 trial was a 24-week randomized, double-blind, placebo-controlled multicenter study with n=504 and efficacy evaluated Weeks 5–24.

Brixadi trial design detailsBrixadi Phase 3 trial was a 24-week randomized, double-blind, double-dummy active-controlled multicenter study with initial weekly injections for 12 weeks then monthly for 12 weeks.

Study visit cadence (Brixadi)Brixadi patients had weekly visits for the first 12 weeks and monthly visits for the final 12 weeks (with additional randomly scheduled visits).

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for buprenorphine extended‑release injections (Brixadi, Sublocade). Requests must demonstrate that the patient and requested use meet the policy's coverage criteria for initial or continuation therapy. Initial and continuation authorizations are limited to no more than 12 months per approval.

Prior authorization required prior to administration
Initial authorization: up to 12 months
Continuation authorization: up to 12 months

Step Therapy

Step Considerations / Initiation & Stabilization

For initial therapy the expected initiation approach includes either: (1) patient already receiving maintenance buprenorphine; or (2) patient not currently receiving maintenance buprenorphine but who has received a test dose of transmucosal buprenorphine and tolerated it without precipitated withdrawal. Clinical trials used a supervised 4 mg sublingual test dose on Day 1 followed by weekly injections with dose titration (16–32 mg) and transition to monthly dosing.

Initial Therapy Criteria

Initial Therapy

Covered when ALL of the following are met:

Test dose pathway mirrors trial induction procedures (see clinical evidence).

Continuation Therapy Criteria

Continuation Therapy

Covered when ALL of the following are met:

Continuation may be granted up to 12 months per authorization.

Step Therapy / Induction

Step	Requirement	Trial reflection / induction details	Coverage implication
1
Prior stabilization on transmucosal buprenorphine OR documented tolerated transmucosal test dose
Brixadi trials used an open-label 4 mg sublingual test dose on Day 1; patients who tolerated the test dose proceeded to weekly subcutaneous injections with initial titration (16 mg then 16–32 mg during the first week) and transitioned to monthly dosing. Sublocade trials initiated treatment with sublingual buprenorphine/naloxone for 7–14 days to control cravings/withdrawal prior to randomization and first injection.
Policy requires either current buprenorphine treatment or a documented tolerated transmucosal test dose consistent with the trial induction approaches prior to extended‑release injection; absence of this documentation may result in denial.

Definitions & Background

Brixadi and Sublocade are subcutaneous, extended‑release formulations of buprenorphine designed to provide prolonged delivery of medication. The policy’s background notes these agents are intended for treatment of opioid use disorder and that dosing must follow FDA‑approved labeling; pivotal clinical trials supporting use were conducted over 24 weeks with psychosocial support provided as part of the studies.

inv-15: REMS

REMS requirement (both products)Both Brixadi and Sublocade are available only through restricted REMS programs requiring healthcare settings and pharmacies to be certified and to dispense and administer the product directly to a certified healthcare provider to mitigate risk of intravenous misuse.

Site/pharmacy certificationHealthcare settings and pharmacies that order and dispense Brixadi or Sublocade must be certified in the respective REMS program.

Administration by certified providerProducts must be dispensed to and administered by a healthcare provider (not delivered for patient self-administration) as required by the REMS.

Site of Care

Note

REMS‑certified site-of-care and dispensing/administration rules

Brixadi and Sublocade are available only through REMS‑certified healthcare settings and pharmacies and must be dispensed to and administered directly by a certified healthcare provider; sites include clinics, pharmacies (dispensed to provider), and infusion centers that are REMS‑certified.

Healthcare settings and pharmacies that order and dispense Brixadi or Sublocade must be certified in the respective REMS program.
Products must be dispensed directly to a healthcare provider for administration by a healthcare provider to mitigate risk of intravenous misuse.