Last Review Date: 06/01/2023

Date of Origin: 02/01/2018

Dates Reviewed: 02/2018, 06/2023

1. Length of Authorization

2 months initially; 6 months thereafter

2. Dosing Limits

A. Quantity Limit (max daily dose) [Pharmacy Benefit]:

• Sublocade 300 mg/1.5 mL single-dose PFS: 1 per 28 days for 2 doses only
• Sublocade 100 mg/0.5 mL single-dose PFS: 1 per 28 days thereafter

B. Max Units (per dose and over time) [Medical Benefit]:

• Loading dose (Q9992 only): 1 billable unit (300 mg) every 28 days x 2 doses
• Maintenance dose (Q9991 only): 1 billable unit (100 mg) every 28 days

3. Initial Approval Criteria

   Sublocade (buprenorphine ER injection) will be approved when ALL of the following are met:

1. The prescriber is requesting the agent to treat a diagnosis of opioid dependence

AND

2. The prescriber meets the qualification certification criteria in the Drug Addiction Treatment Act (DATA) of 2000 and has been issued a unique DEA identification number by the DEA, indicating that he or she is a qualified physician under the DATA to prescribe buprenorphine

AND

3. The prescriber has reviewed the patient’s records in the state’s prescription drug monitoring program (PDMP)

AND

4. The patient has a clinical reason (that the prescriber has documented and submitted) that does not allow the patient to utilize a transmucosal buprenorphine-containing product

AND

5. The patient is abstinent from illicit drug use (includes all addictive substances) confirmed by a urine drug screen

AND

6. The prescriber has submitted evidence of an initial patient assessment and treatment plan which includes BOTH of the following:
   1. Medication history review

AND

1. 2. Current informed consent or written agreement for treatment of substance abuse signed by the prescriber and the patient

AND

7. ONE of the following:
   1. The patient is not currently taking an opioid agent, including tramadol and tapentadol

OR

1. 2. If the patient is receiving any other opioid medication, including tramadol and tapentadol, the prescriber has submitted information supporting the medical necessity of the opioid, including the specific pain that the current opioid is being used to treat and the expected duration of therapy with the opioid (e.g., dental procedure with dates, surgery with dates, acute injury with dates)

AND

8. BOTH of the following:
   1. The patient is not currently taking other non-prescription drugs of abuse or alcohol

AND

1. 2. ONE of the following:
      1. The patient is not currently taking other addictive prescription medications (e.g. muscle relaxants, benzodiazepines, sedative/hypnotics, non-prescription drugs of abuse or alcohol) to be verified by absence of claims in patient claims history upon request submission

     OR

1. 1. 2. The prescriber has submitted documentation indicating benefits of treatment/use of the listed prescription agent(s) outweighs risk associated with concomitant buprenorphine use (to be reviewed and verified by a pharmacist or physician)

AND

9. The prescriber has documented that the patient has initiated treatment on a transmucosal buprenorphine‐containing product delivering the equivalent of 8 to 24 mg of buprenorphine daily and the patient has maintained this dosing for a minimum of 7 days

AND

10. The patient will not be on a buprenorphine-containing product (including transmucosal and implantable buprenorphine), methadone, or another agent utilized for opioid dependence in addition to the requested agent

AND

11. ONE of the following:
    1. The patient is currently enrolled in an ongoing outpatient drug addiction treatment program/counseling (appointment dates if available)

OR

1. 2. The patient has agreed to enroll in an ongoing outpatient drug addiction treatment program/counseling within the initial approval timeframe of 6 months

OR

1. 3. The patient has completed 6 months or more of outpatient drug addiction treatment/counseling and the prescriber provides rationale as to why the patient no longer needs to continue (to be reviewed and verified by a pharmacist or physician)

AND

12. The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent

AND                              

13. The dose is within the FDA labeled dose

4. Renewal Criteria

The requested agent will be approved when ALL of the following are met:

• The patient has been previously approved for therapy with the requested agent through the Medical Drug Review process

AND

• The prescriber is requesting the agent to treat a diagnosis of opioid dependence

AND

• The prescriber meets the qualification certification criteria in the Drug Addiction Treatment Act (DATA) of 2000 and has been issued a unique DEA identification number by the DEA, indicating that he or she is a qualified physician under the DATA to prescribe buprenorphine

AND

• The prescriber has reviewed the patient’s records in the state’s prescription drug monitoring program (PDMP)

AND

• The patient is abstinent from illicit drug use (includes all addictive substances) confirmed by a urine drug screen

AND

• The prescriber has submitted a current (within 30 days) patient assessment and treatment plan which includes BOTH of the following:
  • Medication history review

AND

• • Current informed consent or written agreement for treatment of substance abuse signed by the prescriber and the patient

AND

• ONE of the following:
  • The patient is not currently taking an opioid agent, including tramadol and tapentadol

OR

• • If the patient is receiving any other opioid medication, including tramadol and tapentadol, the prescriber has submitted information supporting the medical necessity of the opioid, including the specific pain that the current opioid is being used to treat and the expected duration of therapy with the opioid (e.g., dental procedure with dates, surgery with dates, acute injury with dates)

AND

• BOTH of the following:
  • The patient is not currently taking other non-prescription drugs of abuse or alcohol

AND

• • ONE of the following:
    • The patient is not currently taking other addictive prescription medications (e.g. muscle relaxants, benzodiazepines, sedative/hypnotics, non-prescription drugs of abuse or alcohol) to be verified by absence of claims in patient claims history upon request submission

     OR

• • • The prescriber has submitted documentation indicating benefits of treatment/use of the listed prescription agent(s) outweighs risk associated with concomitant buprenorphine use (to be reviewed and verified by a pharmacist or physician)

AND

• The patient will not be on a buprenorphine-containing product (including transmucosal and implantable buprenorphine), methadone, or another agent utilized for opioid dependence in addition to the requested agent

AND

• ONE of the following:
  • The patient is currently enrolled in an ongoing outpatient drug addiction treatment program/counseling (appointment dates if available)

OR

• • The patient has completed 6 months or more of outpatient drug addiction treatment/counseling and the prescriber provides rationale as to why the patient no longer needs to continue (to be reviewed and verified by a pharmacist or physician)

AND

• The patient does not have any FDA labeled contraindication(s) to therapy with the requested agent

AND

• The dose is within the FDA labeled dose

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS:

• Q9991 - Injection, buprenorphine extended-release (sublocade), less than or equal to 100 mg: 1 billable unit = 100 mg
• Q9992 - Injection, buprenorphine extended-release (sublocade), greater than 100 mg: 1 billable unit = 300 mg

NDC:

• Sublocade, 100 mg/0.5 mL single-dose prefilled syringe: 12496-0100-xx
• Sublocade, 300 mg/1.5 mL single-dose prefilled syringe: 12496-0300-xx

7. References

• Center for Substance Abuse Treatment. Clinical guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) series 40. DHHS Publication No. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004. Available at: http://www.naabt.org/documents/TIP40.pdf. Accessed June 2012.
• Bridge, TP, Fudala PJ, et al. Safety and health policy considerations related to the use of buprenorphine/naloxone as an office-based treatment for opiate dependence. Drug Alcohol Depend. 2003;70(2 Suppl):S79-85.
• ASAM Guideline http://www.asam.org/practice-support/guidelines-and-consensus-documents/npg/supplement. June 2015
• Sublocade prescribing information. Indivor, Inc. November 2017.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): N/A