CurrentCareSource Georgia MedicaidPolicy GA-MED-P-366579

Buprenorphine extended-release (Sublocade, Brixadi)

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This policy governs CareSource Georgia Medicaid coverage and prior authorization for extended-release buprenorphine products Sublocade and Brixadi used to treat moderate to severe opioid use disorder. It applies to providers seeking pharmacy or medical benefit authorization for eligible members.

Policy Summary

PayerCareSource Georgia Medicaid

PolicyBuprenorphine extended-release (Sublocade, Brixadi)

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateMarch 1, 2026

Last ReviewAug 24, 2022

Next Review DateN/A

Key ActionObtain pharmacy or medical prior authorization for Sublocade or Brixadi before treatment.

SourceLink

POLICY UPDATE CHANGES

The policy originally established coverage criteria for Sublocade on July 23, 2018.

The August 24, 2022 annual review updated the initial approval duration to 6 months and clarified reauthorization criteria.

The July 20, 2023 revision added Brixadi, an age requirement, a trial and failure requirement for a preferred buprenorphine product, and a medical benefit option.

The March 7, 2025 revision added provider attestation regarding prior transmucosal buprenorphine use and added a Brixadi quantity limit.

2Covered extended-release buprenorphine products

18+Minimum member age for initial authorization

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CurrentCareSource Georgia MedicaidPolicy GA-MED-P-366579

Buprenorphine extended-release (Sublocade, Brixadi)

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Policy Summary

PayerCareSource Georgia Medicaid

PolicyBuprenorphine extended-release (Sublocade, Brixadi)

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateMarch 1, 2026

Last ReviewAug 24, 2022

Next Review DateN/A

Key ActionObtain pharmacy or medical prior authorization for Sublocade or Brixadi before treatment.

SourceLink

POLICY UPDATE CHANGES

The policy originally established coverage criteria for Sublocade on July 23, 2018.

The August 24, 2022 annual review updated the initial approval duration to 6 months and clarified reauthorization criteria.

The July 20, 2023 revision added Brixadi, an age requirement, a trial and failure requirement for a preferred buprenorphine product, and a medical benefit option.

The March 7, 2025 revision added provider attestation regarding prior transmucosal buprenorphine use and added a Brixadi quantity limit.

2Covered extended-release buprenorphine products

18+Minimum member age for initial authorization

6 monthsInitial authorization duration

12 monthsAdditional reauthorization duration

300 mg/monthSublocade quantity limit

128 mg/monthBrixadi quantity limit

Coverage Criteria

Initial Therapy

Covered for initial authorization when ALL of the following requirements are met:

ALL of the following

Member is 18 years of age or older.
Member must have a trial and failure of a preferred buprenorphine product.
Provider attests that the member will have a single dose of a transmucosal buprenorphine product prior to treatment, unless the member is already being treated with buprenorphine.
ONE of the following product-specific dosage and quantity-limit regimens
- Sublocade: administer two monthly initial doses of 300 mg followed by 100 mg monthly maintenance doses subcutaneously. Quantity limit: 300 mg per month.
- Brixadi: administer once weekly or once monthly subcutaneously per prescribing information. Maximum dose is 32 mg (1 injection) per week or 128 mg (1 injection) per month. Quantity limit: 128 mg per month.

Continuation Therapy

Covered for reauthorization when the following requirement is met:

ALL of the following

Chart notes document a positive response to therapy, such as urine samples negative for opioids and no signs of opioid dependence or relapse.

CareSource considers buprenorphine extended-release (Sublocade, Brixadi) not medically necessary for the treatment of conditions that are not listed in this document.

For any other indication, please refer to the Off-Label policy.

Dosing and Quantity Details

Minimum Member Age

Minimum member age18 years or older

Sublocade Dosing Schedule

Initial dosesTwo monthly initial doses of 300 mg administered subcutaneously

Maintenance dose100 mg monthly maintenance doses administered subcutaneously

Sublocade Quantity Limit

Quantity limit300 mg per month

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required under both the pharmacy and medical benefits before coverage of extended-release buprenorphine (Sublocade or Brixadi).

Applies to Sublocade and Brixadi.

Note

Initial Authorization Period

When all initial authorization requirements are met, coverage is approved for six months.

Initial approval period: 6 months.

Note

Reauthorization Period

When continuation requirements are met, coverage may be approved for an additional 12 months.

Clinical Background

Buprenorphine extended-release is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Sublocade and Brixadi are indicated for the treatment of moderate to severe opioid use disorder and should be used as part of a complete treatment program that includes counseling and psychosocial support.

Key Definition

Buprenorphine Extended-Release

Mu-opioid receptor activityPartial agonist

Kappa-opioid receptor activityAntagonist

IndicationTreatment of moderate to severe opioid use disorder

Initial Authorization

Initial authorization requires ALL of the following clinical and utilization criteria:

Initial authorization

Age: Member is 18 years of age or older.18 years or older
Preferred product trial and failure: Member must have a trial and failure of a preferred buprenorphine product.
Transmucosal buprenorphine dose: Provider attests that the member will have a single dose of a transmucosal buprenorphine product prior to treatment, unless the member is already being treated with buprenorphine.One dose before treatment unless already receiving buprenorphine

Reauthorization

Reauthorization is available when the following requirement is met:

Positive clinical response: Chart notes document a positive response to therapy, such as urine samples negative for opioids and no signs of opioid dependence relapse.Positive response to therapy

When this requirement is met, coverage is approved for an additional 12 months.

Preferred Product Requirement

Step	Requirement	Failure criteria
1	Use a preferred buprenorphine product before requesting extended-release buprenorphine.	Trial and failure of a preferred buprenorphine product

Product Quantity Limits

Sublocade Quantity Limit

Sublocade300 mg per month

Brixadi Quantity Limit

Brixadi128 mg per month

Administration Setting

Billing Rule

Use the required site of care

Administer Sublocade or Brixadi subcutaneously according to the product-specific dosing instructions.

Policy Summary

PayerCareSource Georgia Medicaid

PolicyBuprenorphine extended-release (Sublocade, Brixadi)

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateMarch 1, 2026

Last ReviewAug 24, 2022

Next Review DateN/A

Key ActionObtain pharmacy or medical prior authorization for Sublocade or Brixadi before treatment.

SourceLink

On This Page

Brixadi Maximum Weekly Dose

Maximum weekly dose32 mg, 1 injection, per week

Brixadi Maximum Monthly Dose

Maximum monthly dose128 mg, 1 injection, per month

Brixadi Quantity Limit

Quantity limit128 mg per month

Reauthorization approval period: an additional 12 months.

Step Therapy

Preferred Buprenorphine Trial and Failure

Before initial authorization, document that the member has tried and failed a preferred buprenorphine product.

Required for initial authorization.

Documentation Required

Transmucosal Buprenorphine Attestation

Before treatment, the provider must attest that the member will receive a single dose of a transmucosal buprenorphine product, unless the member is already being treated with buprenorphine.

Attestation is required before treatment.
Exception: the member is already being treated with buprenorphine.

Documentation Required

Continuation Response Documentation

For reauthorization, chart notes must document a positive response to therapy.

Examples include urine samples negative for opioids and no signs of opioid dependence or relapse.

Denial Risk

Initial Authorization Requirements

Initial authorization may be denied unless the member is at least 18 years old, has tried and failed a preferred buprenorphine product, and meets the other initial authorization requirements.

Member must be 18 years of age or older.
Sublocade: two monthly initial 300 mg doses followed by 100 mg monthly maintenance doses subcutaneously; quantity limit is 300 mg per month.
Brixadi: administer once weekly or once monthly subcutaneously per prescribing information; maximum dose is 32 mg (1 injection) per week or 128 mg (1 injection) per month; quantity limit is 128 mg per month.
Provider attestation regarding a single transmucosal buprenorphine dose is required unless the member is already being treated with buprenorphine.

Denial Risk

Unlisted Indications

Coverage is not medically necessary for the treatment of conditions or indications not listed in this policy. For any other indication, refer to the Off-Label policy.

Unlisted indications are not medically necessary under this policy.

Dosing and quantity limits: The requested product is administered within the applicable product-specific dosing and quantity limits.

Sublocade: two monthly initial doses of 300 mg followed by 100 mg monthly maintenance doses subcutaneously; quantity limit 300 mg per month. Brixadi: once weekly or once monthly subcutaneous administration per prescribing information, with a maximum of 32 mg (1 injection) per week or 128 mg (1 injection) per month and a quantity limit of 128 mg per month.