ModifiedCentenePolicy CP.PHAR.289

Buprenorphine Injection (Sublocade, Brixadi)

Defines medical necessity, prior authorization and continuation criteria for Sublocade and Brixadi injections for treatment of opioid use disorder for Centene-affiliated health plans (Commercial, HIM, Medicaid). Affects providers requesting coverage for these products.

Policy Summary

PayerCentene

PolicyBuprenorphine Injection (Sublocade, Brixadi)

Policy CodePolicy CP.PHAR.289

Change TypeMaterial revisions (dosing, Brixadi inclusion, duration, coding)

Effective DateDec 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, age ≥18, prior transmucosal buprenorphine exposure or test dose, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

For Sublocade, criteria were updated to include the FDA‑approved rapid initiation protocol per the prescribing information (previously required 7 days of transmucosal buprenorphine).

In continued therapy, removed requirement for no opioid use since last approval and removed option for provider documentation for use of opioid if due to acute pain.

Brixadi (weekly and monthly formulations) is included and dosing/transition guidance incorporated into the policy.

HCPCS/HCPCS code updates: removed C9154 and J0576 and added J0577 and J0578 for Brixadi; later added and removed other codes in prior updates.

≥18minimum age for coverage

300 mgSublocade dosing

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Coverage Criteria

Initial and product‑specific coverage criteria

Coverage is provided when dosing and initiation requirements per product prescribing information and plan authorization criteria are met.

Sublocade initiation: Two monthly initial injections of 300 mg subcutaneously (second injection may be given as early as 1 week and up to 1 month after the first based on patient need), followed by monthly maintenance doses (typically 100 mg); maintenance may be increased to 300 mg monthly when benefits outweigh risks. Induction in patients not already receiving buprenorphine: give an initial transmucosal test dose (e.g., 4 mg) and observe for one hour to confirm tolerability unless using the FDA‑approved rapid initiation per PI.Sublocade initial 300 mg x2; maintenance 100 mg typical; max 300 mg/month

Second initiation injection may be between Day 8 and 1 month per PI.

Brixadi initiation: Brixadi weekly initiation recommended at 24 mg subcutaneously with titration over the first week; weekly doses must be administered in 7‑day intervals. Monthly formulations are available with specified strengths; an additional 8 mg weekly may be given during a dosing interval up to a maximum of 32 mg per week or 128 mg per 28 days. Administer Brixadi as a single injection and do not divide doses. Refer to PI for transition guidance between weekly and monthly dosing.Brixadi max 32 mg/week or 128 mg/28 days

Weekly doses cannot be combined to yield a monthly dose.

Pain management is listed in the policy as an exclusion under diagnoses/indications for which coverage is not authorized. Coverage for indications not FDA‑approved is not allowed under this policy unless documentation meets the referenced off‑label use policies; pain management specifically is not authorized here.

Policy history notes template and content changes across multiple reviews; an explicit history entry records updates to diagnoses/indications and continued therapy language. These history entries document that the policy language governing which indications are not authorized — including pain management — was moved into Section III as part of prior template updates.

Non‑FDA approved indications are not covered by this policy unless there is sufficient documentation of efficacy and safety according to the plan's off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for HIM, and CP.PMN.53 for Medicaid). Requests for uses not addressed by the FDA label must include supporting clinical documentation per those off‑label policies.

Use of injectable buprenorphine products for pain management is not authorized under this policy. The policy history indicates this exclusion was added in prior updates and appears in the Section III list of diagnoses/indications for which coverage is not permitted.

Initial Therapy Criteria

Initial therapy (product‑specific)

Induction and initiation rules per product prescribing information

Sublocade initial regimen: Two monthly injections of 300 mg subcutaneously, with the second injection allowed between 1 week and 1 month after the first based on patient need; consider maintenance at 100 mg monthly typically, with option to increase to 300 mg monthly when clinically appropriate; induction for patients not on buprenorphine requires a transmucosal test dose (e.g., 4 mg) and observation unless using FDA rapid initiation per PI.max 300 mg/month

Prefilled syringes available: 100 mg/0.5 mL and 300 mg/1.5 mL.

Continuation / Renewal Criteria

Coding and Billing

Referenced codes for injectable buprenorphineHCPCS

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

Sublocade maximum monthly dose — key value

Maximum monthly dose (Sublocade)300 mg per month

Brixadi weekly maximum — key value

Maximum weekly dose (Brixadi)32 mg per week

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sublocade and Brixadi. Providers must request authorization and document the indication for treatment and that the member meets the policy criteria before services are rendered.

Prior authorization required for all members except as otherwise noted by state-specific rules (see Nevada exception).
Provider must document diagnosis, age ≥18, and prior transmucosal buprenorphine exposure or tolerance when applicable.

Prior Authorization

Authorization and Duration Overview

Authorization duration and overview: approvals are issued for initiation and maintenance dosing consistent with the dosing regimens in this policy. For members transitioning from transmucosal buprenorphine, document prior regimen and any test dose when applicable.

Document intended dosing regimen (initial and maintenance) and planned authorization length.
For Medicaid members initial approval duration may be extended to 12 months for maintenance therapy per applicability; commercial durations follow standard injectable medication language.

Step Therapy Requirements

Step	Requirement
1	Member must have initiated treatment with a transmucosal buprenorphine product or be currently treated with a transmucosal buprenorphine-containing product before injectable buprenorphine (Sublocade or Brixadi) is authorized.
Medical justification	Documentation supporting inability to continue transmucosal buprenorphine (one of: non-compliance, treatment failure, history of diversion, or contraindication/clinically significant adverse effects to transmucosal excipients).
Dose limits	Requested dose must not exceed product-specific initiation and maintenance dosing (Sublocade: initiation 300 mg x2 with second dose between Day 8 and 1 month; maintenance up to 300 mg/month; Brixadi: up to 32 mg weekly or 128 mg every 28 days).

Step	Plan note
1	Policy history references step therapy template changes; specific step therapy requirements are managed via medical management programs and may require prior steps as determined by the plan.
Nevada exception	For members in Nevada, medical management techniques, including quantity management beyond step therapy, are not allowed.

Quantity Limits and Packaging

Sublocade — quantity limit key value (300 mg)

Quantity limit (Sublocade)300 mg per month (maximum)

Brixadi — quantity limit key value (32 mg)

Quantity limit (Brixadi weekly)32 mg per week (per injection)

Brixadi — quantity limit key value (128 mg)

Quantity limit (Brixadi monthly)128 mg per 28 days (per injection)

Sublocade — formulation info (prefilled syringes: 100 mg/0.5 mL and 300 mg/1.5 mL)

Site of Care

Billing Rule

Administration site — provider‑administered in a healthcare setting

Sublocade and Brixadi must be administered by healthcare providers in a healthcare setting; these injectable products are intended for administration in a clinic/office environment.

Billing Rule

Dosing and administration imply clinic/office setting — follow single‑injection and interval rules

Policy dosing intervals and single‑injection requirements imply clinic/office administration even though the policy does not explicitly restrict site of care; document dosing schedule and confirm administration setting per plan requirements.

Weekly Brixadi must be given in 7‑day intervals; monthly Brixadi in 28‑day intervals.
Brixadi must be administered as a single injection and doses should not be divided.

Definitions and Background

Buprenorphine is a partial opioid agonist used as part of comprehensive treatment for moderate to severe opioid use disorder, combining medication with counseling and psychosocial support. Injectable extended‑release formulations (Sublocade, Brixadi) are intended for patients who have initiated treatment with, or are currently treated with, transmucosal buprenorphine and are administered by a healthcare provider in a healthcare setting.

MAT — Medication-assisted treatment definition

Medication‑assisted treatment (MAT)Use of medications like buprenorphine as part of a complete treatment program that includes counseling and psychosocial support

REMS — Risk Evaluation and Mitigation Strategy; products available only through REMS

REMS requirementSublocade and Brixadi are available only through their REMS programs

Transmucosal buprenorphine — definition/key term

Policy Summary

PayerCentene

PolicyBuprenorphine Injection (Sublocade, Brixadi)

Policy CodePolicy CP.PHAR.289

Change TypeMaterial revisions (dosing, Brixadi inclusion, duration, coding)

Effective DateDec 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, age ≥18, prior transmucosal buprenorphine exposure or test dose, and dosing within policy limits.

SourceLink

On This Page

Documentation Required

Documentation Required to Support Approval

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office/clinic notes, medication history, laboratory results, and any documentation of noncompliance, diversion, contraindications, or adverse reactions to transmucosal formulations.

Office chart notes and medication history that confirm diagnosis of opioid dependence and age.
Evidence of prior transmucosal buprenorphine tolerance (e.g., single 4 mg dose) or current transmucosal dosing when required.
Documentation of medical justification for injectable formulation (non‑compliance, treatment failure, diversion, contraindication to transmucosal excipients).

Denial Risk

Denial Risk from Coding and Documentation

Coverage determinations are subject to correct coding and documentation. Inclusion of codes in this policy is informational only and does not guarantee payment. Failure to submit required clinical documentation or use appropriate codes may result in denial of the claim.

Providers should reference current professional coding guidance prior to claim submission.
Codes listed in the policy (e.g., Q9991, Q9992, J0577, J0578, J0576) are informational and do not ensure coverage.

Documentation Required

Required Dosing and Product Documentation

Document dosing regimen and specific product details when requesting authorization or reporting administration. Include information on test doses and transition plans as applicable.

Specify product and strength (Sublocade 100 mg or 300 mg prefilled syringes; Brixadi weekly/monthly strengths per product availability).
For Sublocade: document initial and maintenance dosing plan (e.g., two monthly initial doses of 300 mg then maintenance dosing; maximum 300 mg/month).
For Brixadi: document whether weekly or monthly regimen is requested, any transmucosal test dose administered, and maximum dosing limits (32 mg/week or 128 mg/28 days).