Buprenorphine Extended-Release Injectable Products (Brixadi™, Sublocade®)

• buprenorphine extended-release (Brixadi™) subcutaneous injection for administration by a healthcare professional
• buprenorphine extended-release (Sublocade®) subcutaneous injection for administration by a healthcare professional

• Buprenorphine extended-release (Brixadi™)
  • For treatment of moderate to severe opioid use disorder in adults who have initiated treatment with a single dose of transmucosal buprenorphine product or who are already being treated with buprenorphine. This product should be used as part of a complete treatment plan that includes counseling and psychosocial support.
• Buprenorphine extended-release (Sublocade®)
  • For treatment of moderate to severe opioid use disorder in adults who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. This product should be used as part of a complete treatment program that includes counseling and psychosocial support. 

The restricted product(s) may be considered medically necessary for covered when the following criteria are met: 

1. The patient has been diagnosed with moderate to severe opioid use disorder; AND

2. The patient is part of a complete treatment program that includes counseling and psychosocial support; AND

3. The request is for Brixadi:

a. The patient will not be concomitantly receiving opioid medications or Soma (carisoprodol) while on treatment with Brixadi per the “Sublocade and Brixadi Pharmacy Restriction Policy”; AND

b. To receive therapy with opioid medications or Soma (carisoprodol) will require attestation of Brixadi discontinuation and clinical appropriateness per the “Sublocade and Brixadi Pharmacy Restriction Policy”; AND

c. If the request is for the weekly formulation, BOTH of the following:

i. ONE of the following at treatment initiation:

1. For patients not currently receiving buprenorphine treatment, the patient has tolerated a single 4 mg test dose of a transmucosal buprenorphine-containing product; OR

2. The patient is currently being treated with a transmucosal buprenorphine-containing product; AND

ii. The patient will receive weekly treatment with Brixadi with injections at 7-day intervals (and no less than 5 days apart); OR 

d. If the request is for the monthly formulation, BOTH of the following:

i. At treatment initiation, the patient is currently being treated with a transmucosal buprenorphine-containing product; AND

ii. The patient will receive monthly treatment with Brixadi with injections at 28-day intervals (and no less than 21 days apart); OR

4. The request is for Sublocade:

a. The patient will not be concomitantly receiving opioid medications or Soma (carisoprodol) while on treatment with Sublocade per the “Sublocade and Brixadi Pharmacy Restriction Policy”; AND

b. To receive therapy with opioid medications or Soma (carisoprodol) will require attestation of Sublocade discontinuation and clinical appropriateness per the “Sublocade and Brixadi Pharmacy Restriction Policy”; AND

c. Prior to treatment initiation, the patient has initiated or maintained therapy with a transmucosal buprenorphine-containing product (delivering the equivalent of 8 to 24 mg of buprenorphine daily) over a minimum 7-day period and is stable with clinically controlled cravings and withdrawal symptoms; AND

d. The patient will receive monthly treatment with Sublocade with injections no less than 26 days apart; AND

5. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval: 365 days (1 year) 

quantity limitations apply to brand and associated generic products. 

*Maximum units allowed for duration of approval

**Non-specific assigned HCPCS codes, must submit requested product NDC 

all information referenced is from FDA package insert unless otherwise noted below.

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

April 2024: Coding change: Added HCPCS code J0577 and J0578 for Brixadi to dosing reference table effective 4/1/2024; deleted J0576 termed 3/31/2024.

January 2024: Coding change: Added HCPCS code J0576 for Brixadi to dosing reference table effective 1/1/2024; deleted C9154, J3490, J3590 termed 12/31/2023.

October 2023: Coding change: Added HCPCS code C9154 for Brixadi to dosing reference table effective 10/1/2023; deleted C9399 termed 9/30/2023.

August 2023: Criteria change: Added newly approved Brixadi to policy for treatment of moderate to severe opioid use disorder, added associated dosing and maximum units to FDA label reference table. Changed policy name to “Buprenorphine Extended-Release Injectable Products (Brixadi™, Sublocade®)” from “Buprenorphine Extended-Release (Sublocade®)”. Adjusted Sublocade initiation criteria for clarity with no change to intent.

June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.