ModifiedmhnPolicy CP.PHAR.289

Buprenorphine Injection (Sublocade, Brixadi)

Defines medical necessity and prior authorization criteria for Sublocade and Brixadi (buprenorphine injection) for treatment of moderate to severe opioid use disorder for Centene-affiliated health plans; applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyBuprenorphine Injection (Sublocade, Brixadi)

Policy CodePolicy CP.PHAR.289

Change TypeMaterial coverage and coding updates

Effective Date12.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation of opioid use disorder diagnosis, age ≥18, evidence of transmucosal buprenorphine tolerance or a tolerated 4 mg test dose (or use FDA rapid initiation per PI), and dosing within product limits.

SourceLink

POLICY UPDATE CHANGES

Added pain management to section III as diagnoses/indication for which coverage is not authorized.

For Sublocade, updated criteria to include FDA approved rapid initiation protocol per PI (previously required 7 days of transmucosal buprenorphine).

Brixadi FDA approval incorporated and combined from previously approved pre-emptive policy; clarified at least one dose of oral buprenorphine means tolerance of single 4 mg dose or current treatment with transmucosal product.

Updated HCPCS/JCODES for Brixadi (removed C9154, J0576; added J0577, J0578); added Q9991/Q9992 and J0577/J0578 coding implications.

≥18Minimum age for coverage

300 mgSublocade monthly limit

32 mg / 128 mg

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Brixadi dosing (wk / 28d)

6 monthsApproval duration

Coverage Criteria

Initial Therapy

Initial Approval — Opioid Dependence (must meet ALL of the following):

Initial Opioid Dependence Criteria: 1. Diagnosis of opioid dependence; 2. Age ≥ 18 years; 3. Member meets one of the following: a) switching from another non-transmucosal buprenorphine-containing product (e.g., Sublocade, Brixadi); OR b) one of: i) tolerated a single 4 mg dose of a transmucosal buprenorphine-containing product; ii) for Brixadi requests, currently being treated with a transmucosal buprenorphine-containing product; iii) for Sublocade requests, currently being treated with 8 mg to 24 mg daily of transmucosal buprenorphine; 4. Medical justification supports inability to continue transmucosal formulations as evidenced by one of: a) documentation of non-compliance to transmucosal formulations; b) treatment failure with transmucosal formulations; c) history of diversion with buprenorphine MAT products; d) contraindication(s) or clinically significant adverse effects to excipients of transmucosal formulations; 5. Requested dose does not exceed product-specific initiation or maintenance dosing limits for Sublocade or Brixadi.

Continuation Therapy

Continued Therapy — Opioid Dependence (must meet ALL of the following):

Continued Therapy Criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, OR is receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. One of the following: a) member has NOT received an opioid analgesic since last approval; OR b) prescriber documents that any opioid use since last approval was for acute pain; 4. If a dose increase is requested, the new dose must not exceed maintenance limits for Sublocade or Brixadi (Sublocade ≤ 300 mg/month; Brixadi ≤ 32 mg/week or 128 mg/28 days).

Initial and maintenance coverage criteria

Covered when ALL of the following are met

Indication: Use is for opioid use disorder treatment (not for pain management).

Pain management explicitly excluded per 1Q2025 update.

Initiation requirements: Patient has tolerated at least one transmucosal buprenorphine dose (e.g., single 4 mg) or is currently on transmucosal buprenorphine; OR meets product-specific rapid initiation protocol per FDA-approved prescribing information for Sublocade (rapid initiation option replaces prior 7-day transmucosal requirement).

For patients on 8–24 mg daily transmucosal buprenorphine, direct transition to 300 mg Sublocade starting dose is described.

Dosing adherence: Treatment follows product dosing regimens: Sublocade initial two monthly 300 mg injections (second injection may be given between Day 8 and 1 month per PI) followed by monthly maintenance (typical 100 mg; may increase to 300 mg monthly when benefits outweigh risks; maximum 300 mg/month); Brixadi administered weekly or monthly per PI with maximums of 32 mg/week or 128 mg/28 days and dosing/titration per prescribing information.

Refer to PI for transition and titration details for weekly vs monthly Brixadi dosing.

Coverage is not authorized for non‑FDA approved indications unless the provider supplies sufficient documentation of safety and efficacy consistent with the applicable off‑label use policies (see CP.CPA.09 for Commercial and CP.PMN.53 for Medicaid). Additionally, pain management is explicitly excluded from coverage under this policy.

Requests for buprenorphine injection for pain management indications are not authorized for coverage. This exclusion was added in the 1Q2025 update and is reflected in the policy’s list of non‑covered diagnoses/indications.

Use of Sublocade or Brixadi for pain management is explicitly listed as not authorized/covered by this policy and will be denied unless off‑label criteria specified in the referenced off‑label use policies are met and documented.

Coding and Reimbursement

Coding ImplicationsHCPCS

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 — 300 mg

Maximum monthly dose300 mg per month

Typical maintenance option100 mg monthly (can increase to 300 mg when benefits outweigh risks)

Initial regimen noteTwo monthly 300 mg injections for initiation; second injection may be given between Day 8 and 1 month per PI

Brixadi maximum weekly/28-day dose — 32 mg per week or 128 mg per 28 days

Maximum weekly dose32 mg per week

Maximum 28‑day (monthly) dose128 mg per 28 days

Titration guidance

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria for treatment of opioid use disorder with buprenorphine injectables (Sublocade, Brixadi). Authorization requires documentation of diagnosis of opioid dependence, age ≥ 18 years, and meeting step-therapy / tolerance requirements (see below).

Submit office chart notes, lab results, or other clinical information to support all approval criteria are met.
Coverage is limited to FDA‑approved indications for opioid use disorder; non‑FDA uses require meeting off‑label criteria per applicable off‑label policies.

Prior Authorization

Prior Authorization Requirements for Buprenorphine Injectables

Prior authorization for buprenorphine injectables requires: confirmation of an indication consistent with treatment of opioid use disorder, evidence that the member cannot continue or is unsuitable for transmucosal buprenorphine (see examples below), and adherence to dosing limits per product labeling. Dose limits: Sublocade—initiation and maintenance per FDA labeling (e.g., initiation series of 300 mg injections and maintenance up to 300 mg monthly); Brixadi—maximum 32 mg per week or 128 mg per 28 days per labeling. Documentation must support medical justification for injectable therapy.

Background

Buprenorphine extended‑release injections (Sublocade, Brixadi) are partial opioid agonists approved for the treatment of moderate to severe opioid use disorder. These agents are intended to be used as part of a comprehensive medication‑assisted treatment program that includes counseling and psychosocial support, and they must be administered by a healthcare professional in an appropriate healthcare setting per product labeling and REMS requirements.

Definitions

Buprenorphine injection (Sublocade, Brixadi)

Drug classPartial opioid agonist formulations administered by healthcare providers for opioid use disorder

Administration settingAdministered only by healthcare providers in a healthcare setting

REMS requirementProducts require enrollment in the Sublocade or Brixadi REMS Program

Role in treatmentPart of medication-assisted treatment combined with counseling and psychosocial support

Transmucosal buprenorphine

DefinitionBuprenorphine-containing sublingual tablets and buccal/sublingual films (includes buprenorphine and buprenorphine/naloxone products)

Initial Therapy Criteria

Initial — Initial therapy criteria for Sublocade and Brixadi

Sublocade initial regimen: Administer two monthly initial subcutaneous injections of 300 mg (Day 1 and second injection between Day 8 and up to 1 month per PI), then continue monthly maintenance dosing (typical 100 mg monthly; may increase to 300 mg monthly when benefits outweigh risks).

Brixadi initial regimen: For patients not currently receiving buprenorphine: perform a 4 mg transmucosal test dose and observe for tolerability before first injection; initiate weekly Brixadi per PI to achieve recommended weekly dosing (e.g., 16 mg then 8 mg within 3 days to reach 24 mg/week), with option to titrate up to 32 mg/week as needed; patients on transmucosal products may be switched directly to weekly or monthly Brixadi per PI.

Initial therapy — Initial dosing and induction

Initial dosing and induction

Sublocade initial dosing and induction:

Continuation Criteria

Continuation — Continued therapy requirements for buprenorphine injection

Continued therapy requirements for buprenorphine injection

Continued Therapy: 1. Member meets continuation criteria: currently receiving medication via Centene benefit or previously met initial approval criteria, or is in a state/product with continuity of care provisions; 2. Member is responding positively to therapy; 3. Member has not received an opioid analgesic since last approval, or prescriber documents any opioid use was for acute pain; 4. Any requested dose increase must not exceed maintenance limits for Sublocade or Brixadi.

Continuation therapy rules

Continuation/maintenance therapy

Sublocade maintenance: After initial two monthly 300 mg injections, continue monthly maintenance (100 mg typical); maintenance may be increased to 300 mg monthly when benefits outweigh risks. Maximum 300 mg per month.

Step Therapy

Jurisdiction	Policy statement
Nevada	For members in Nevada, medical management techniques, including quantity management, beyond step therapy are not allowed.

Requirement	Details
Prior transmucosal buprenorphine exposure or tolerance	Member should have tolerated a single 4 mg dose of a transmucosal buprenorphine product or be currently treated with a transmucosal buprenorphine-containing product prior to initiation of injectable buprenorphine formulations (unless using an FDA‑approved rapid initiation protocol per product prescribing information).

Quantity Limits & Formulations

Sublocade — 300 mg

Dose300 mg

Formulation noteInitial regimen: two monthly 300 mg injections followed by monthly maintenance

SourcePrescribing information dosing and maximum

Brixadi — 32 mg

Dose strength (weekly)32 mg

Usage noteCan be administered weekly with titration during first week per PI

ContextMaximum weekly dose per prescribing information

Site of Care Requirements

Note

Site-of-care — healthcare setting only

Sublocade and Brixadi must be administered only by healthcare providers in a healthcare setting.

Note

Administration site and technique — professional administration required

Administer injections per REMS and product instructions in an appropriate setting (office, infusion center, or hospital outpatient) and do not administer intravenously; a healthcare professional must perform the administration.

Follow REMS program requirements and boxed warning regarding IV administration.
Avoid intravenous administration; use subcutaneous injection per PI.

Revision History

10.31.24annual_reviewLatest

1Q 2025 annual review: added pain management to section III as a diagnosis/indication for which coverage is not authorized; references reviewed and updated.

02.22.24coding_update

Removed HCPCS codes C9154 and J0576 and added J0577 and J0578 for Brixadi.

05.30.24policy_clarification

Policy Summary

Payermhn

PolicyBuprenorphine Injection (Sublocade, Brixadi)

Policy CodePolicy CP.PHAR.289

Change TypeMaterial coverage and coding updates

Effective Date12.01.16

Next Review Date

SourceLink

On This Page

Weekly dosing may be titrated during first week to reach 24 mg (16 mg then 8 mg) and up to 32 mg if needed

Medical justification may include: non‑compliance with transmucosal formulations, treatment failure with transmucosal formulations, history of diversion with transmucosal MAT products, or contraindication/adverse effects to transmucosal excipients.
Adhere to product-specific initiation and maintenance dosing schedules per Prescribing Information.

Step Therapy

Step Therapy / Initial Tolerance Requirement

At least one of the following step‑therapy / tolerance requirements must be met before approval: tolerance of a single 4 mg transmucosal buprenorphine test dose (observed for tolerability), or current treatment with a transmucosal buprenorphine‑containing product (for Brixadi requests), or current daily transmucosal buprenorphine 8–24 mg (for Sublocade requests), or switching from another non‑transmucosal buprenorphine injectable.

Tolerated single 4 mg transmucosal test dose: patient observed for one hour before first injection as per product guidance.
For members already on transmucosal therapy, document current dose and stability if transitioning to injectable.

Documentation Required

Submission / Documentation Requirements

Provider must submit supporting clinical documentation with the PA request. Documentation should demonstrate prior transmucosal buprenorphine use or tolerance of a single 4 mg transmucosal test dose when required, and justify inability to continue transmucosal therapy when applicable.

Acceptable documentation: office chart notes, lab results, treatment history, documentation of non‑compliance, diversion, treatment failure, or contraindication to transmucosal excipients.

Denial Risk

Not Authorized Indications / Exclusion — Pain Management

Requests for indications not FDA‑approved and not addressed by this policy are not authorized unless sufficient documentation supports safety and efficacy per off‑label policies. Coverage is specifically NOT authorized for pain management indications.

Non‑FDA approved indications require meeting off‑label coverage criteria (see CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable).
Pain management is excluded — requests for buprenorphine injectables for pain will be denied unless off‑label criteria apply and are met.

Transmucosal formulations are the reference products for induction/tolerability prior to injectable initiation

Equivalency noteAppendix lists transmucosal brands/generics equivalent to Subutex/Suboxone formulations

REMS — Sublocade or Brixadi restricted program and boxed warning

REMS ProgramSublocade and Brixadi are available only through the Sublocade or Brixadi REMS Program

Boxed warningRisk of serious harm or death with intravenous administration

Administration requirementMust be administered by healthcare professionals per REMS and product instructions

Patients should receive an initial tolerability check (e.g., 4 mg transmucosal buprenorphine observed for one hour) before first injection when indicated; initiation regimen is two monthly 300 mg injections with second dose timing per PI; patients on 8–24 mg daily transmucosal buprenorphine may transition directly to 300 mg starting dose.

Brixadi initial dosing and induction: For patients not currently on buprenorphine, administer a 4 mg transmucosal test dose and observe for one hour; if tolerated, initiate weekly Brixadi dosing (first week titration to 24 mg with option to reach 32 mg/week), then continue weekly or switch to monthly per PI guidance.

Brixadi maintenance:

Administer Brixadi weekly or monthly per prescribing information; weekly injections given in 7-day intervals and monthly in 28-day intervals; do not combine weekly doses to create a monthly dose; dose adjustments may include an additional 8 mg during an interval up to maximums of 32 mg/week or 128 mg/28 days.

Brixadi — 128 mg

Dose strength (28‑day)128 mg

IntervalOne injection every 28 days (monthly)

Maximum monthly equivalentCorresponds to maximum 28‑day dosing per PI

Sublocade — Prefilled syringes 100 mg/0.5 mL and 300 mg/1.5 mL

Available syringesPrefilled syringes: 100 mg/0.5 mL and 300 mg/1.5 mL

PresentationSublocade supplied as prefilled subcutaneous injection syringes

ReferenceProduct availability section of PI

Brixadi — Prefilled single-dose syringes weekly: 8,16,24,32 mg; monthly: 64,96,128 mg

Weekly syringe strengths8 mg, 16 mg, 24 mg, 32 mg (prefilled single‑dose syringes)

Monthly syringe strengths64 mg, 96 mg, 128 mg (prefilled single‑dose syringes)

Most actionable itemAvailable single‑dose syringe strengths allow selection of weekly or monthly regimens per PI

Added disclaimer that medical management techniques, including quantity management, beyond step therapy are not allowed for members in Nevada per SB 439.

08.23.23addition

RT4: Brixadi FDA approval incorporated and clarified that at least one dose of oral/transmucosal buprenorphine means tolerance of a single 4 mg dose or current transmucosal treatment; added HCPCS code J0576.