Guidance for Providers on Extended-Release (XR) Buprenorphine

Extended-release (XR) buprenorphine is a long-acting injectable buprenorphine formulation prescribed by a healthcare provider and administered in a healthcare setting for the treatment of moderate to severe opioid use disorder (OUD).  

Sublocade, a once monthly subcutaneous injection, and Brixadi, a once weekly or once monthly subcutaneous injection, are the two injectable XR-buprenorphine products currently available.

Sublocade, Brixadi, and all other buprenorphine products are Schedule III controlled substances.

This guidance includes:

• General Information about Facility Licensing, Prescribing, Storage, and Insurance Coverage for XR-Buprenorphine
• Sublocade-Specific Information
• Brixadi-Specific Information

Facility Licensing, Prescribing, Storage, and Insurance Coverage for XR-Buprenorphine

Facility Licensing Requirements for XR-Buprenorphine

Healthcare settings that have a New York State (NYS) registered pharmacy in their facility are eligible for a Class 3 Institutional Dispenser License (PDF) from the New York State Department of Health (NYS DOH). This license allows the facility, such as a hospital with an on-site pharmacy, to purchase stock supplies of controlled substances including XR-buprenorphine from a licensed manufacturer or distributor for inpatient or outpatient use.

Healthcare facilities that do not qualify for a Class 3 license may be eligible for a Class 3A Institutional Dispenser Limited License (PDF) that allows a facility to obtain and administer controlled substances to patients only pursuant to a prescription issued by a healthcare provider and filled at a registered pharmacy. 

The following facilities are not eligible for a Class 3A License:

• Part 819 Residential Programs
• Part 820 Residential Reintegration Programs
• Part 822 Outpatient Programs, including Opioid Treatment Programs
  • Article 32, only or Article 28/32
• Part 822 Outpatient Rehabilitation Services
  • Article 32, only or Article 28/32

For facilities that do not have a Class 3 or 3A license, federal regulations permit pharmacies to deliver a controlled substance prescribed for maintenance or detoxification treatment to a practitioner’s registered location for the purpose of direct administration to the patient named on the prescription no later than 14 days after the date of receipt of the controlled substance by the practitioner. 

Risk Evaluation and Mitigation Strategy (REMS) Programs 

Both brand-name formulations of XR-buprenorphine, Sublocade and Brixadi, are subject to risk evaluation and mitigation strategy (REMS) programs because of the increased risk of serious physical harm or death if either medication is injected intravenously rather than subcutaneously. The Sublocade REMS program website and the Brixadi REMS program website provide for a restricted distribution of these medications. 

Prescribers are not required to be certified in the Sublocade REMS program or Brixadi REMS program and can obtain Sublocade or Brixadi for a specifically named patient’s scheduled appointment by writing a prescription and sending it to a REMS-certified pharmacy who will coordinate delivery with the prescriber or the practitioner administering the medication with the patient’s appointment date. Information about REMS-certified pharmacies can be found on the Sublocade REMS program website and Brixadi REMS program website.

Any pharmacy or healthcare setting that wants to store a supply of and order Sublocade or Brixadi directly from an authorized distributor must be certified in the Sublocade REMS program or Brixadi REMS program prior to buying or dispensing the medications.

Storing XR-Buprenorphine

NYS Regulations describe the security standards for storing controlled substances. 

The Prescribing Information for Sublocade (PDF) and the Prescribing Information for Brixadi (PDF) provide full information about how to store each medication.

XR-Buprenorphine Disposal

As a Schedule III controlled substance XR-buprenorphine should be handled with adequate security and accountability. The medications should be disposed of in accordance federal, state, and local regulations for Schedule III medications.

Guidance documents about the proper disposal of controlled substances in NYS can be found on the NYS DOH Bureau of Narcotic Enforcement (BNE) website.

Insurance Coverage and Billing for XR-Buprenorphine

NYRx and the Medicaid Pharmacy Program

NYRx, the NYS Medicaid Pharmacy Program for most Medicaid members, follows a single formulary where coverage parameters are consistent across the Medicaid program. All medications for the treatment of substance use disorders are available without prior authorization when they are prescribed according to generally accepted national professional guidelines. The NYS DOH NYRx website provides information about the program and medications covered under the plan.

OASAS’ reimbursement webpage provides information about Medicaid Managed Care and Fee for Service base rates and procedure codes, including those for Sublocade and Brixadi.

Commercial Insurance Plans

For commercial insurance plans subject to NYS regulations, NYS Insurance Law requires coverage for buprenorphine, among other medications for the treatment of OUD.  Because formularies can change and it can be difficult to determine if an insurance policy is covered by NYS law, it is best practice for a healthcare provider to confirm that the medication is covered by a patient’s insurance.

For questions about and/or assistance with insurance coverage, please contact the NYS Community Health Access to Addition & Mental Healthcare Project (CHAMP) by email at [email protected] or call 888-614-5400.

Sublocade Dosing and Adverse Reactions

The prescribing information for Sublocade linked below provides full information about Sublocade dosing as well as adverse reactions associated with the medication.

Sublocade Administration

Medical or nursing staff administering the injections should carefully read the Instructions for Use in the Prescribing Information for Sublocade (PDF) and watch the video that demonstrates how Sublocade is administered subcutaneously. 

Additionally, Indivior, the manufacturers of Sublocade may be able to make in-person injection administration trainings available to provider agencies. If interested, provider agencies should contact the manufacturers directly.

Discontinuing Sublocade

Because Sublocade is a long-acting medication, opioid withdrawal symptoms may not be present immediately after discontinuation. Patients should be monitored for several months for signs of symptoms of withdrawal and transmucosal buprenorphine can be considered if needed to treat withdrawal symptoms.

Brixadi Dosing and Adverse Events

The prescribing information for Brixadi linked below provides full information about Brixadi weekly and Brixadi monthly dosing as well as adverse reactions associated with the medication. 

Brixadi Administration Medical and nursing staff administering the injections should carefully read the Instructions for Use in the Prescribing Information for Brixadi (PDF) and watch the video on the Brixadi website demonstrating how Brixadi weekly and Brixadi monthly are administered subcutaneously. 

Additionally, Braeburn, the manufacturers of Brixadi, may be able to make in-person injection administration trainings available to provider agencies. If interested, provider agencies should contact Braeburn directly. 

Discontinuing Brixadi

Because Brixadi weekly and monthly are long-acting medications, opioid withdrawal symptoms may not be present immediately after discontinuation. Patients should be monitored for several months for signs of symptoms of withdrawal and transmucosal buprenorphine can be considered if needed to treat withdrawal symptoms.

• For clinical questions about XR-buprenorphine, email [email protected].
• For insurance and reimbursement questions about XR-buprenorphine, email [email protected].