Sublocade™

Drug - Sublocade™ (buprenorphine solution) [Indivior Inc.]

April 2019

Therapeutic Area - Opiate Dependence Treatments

Initial approval criteria

Provider must:

Be certified to treat addictions under the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver and provide an X-DEA number AND
Provide written attestation of a comprehensive treatment plan between provider and patient AND
Provide written attestation of a comprehensive review of patient’s medications and education provided to patient about risks of concomitant use of benzodiazepines, sedatives, opioid analgesics, alcohol or other CNS depressants, if applicable
Provide written attestation that concomitant psychosocial support has been recommended AND
Have complied with all aspects of the REMS program AND

Patient must:

Be 18 years old or older AND
Meet diagnosis of DSM-5 criteria for moderate or severe opioid use disorder AND
Have initiated treatment and had at least 7 days of therapy on a transmucosal buprenorphine-containing product delivering the equivalent of 8 mg to 24 mg of buprenorphine daily with control of cravings and withdrawal symptoms AND
Discontinue therapy with transmucosal buprenorphine upon initiation of Sublocade AND
NOT have pre‐existing moderate to severe hepatic impairment OR
NOT have a history of Long QT Syndrome OR
NOT have concurrent Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide), or other medications that prolong the QT interval AND
Have a urine drug screen, including buprenorphine, within the past 30 days of prior authorization submission is provided (if negative for buprenorphine or positive for other opioids, the provider must provide an explanation) AND
NOT be receiving methadone AND
NOT be receiving other long-acting products for the treatment of opioid abuse disorder (e.g. – buprenorphine [Probuphine®] implant, naltrexone [Vivitrol®], etc.)

Initial approval is for 3 months

Provider must:

Be certified to treat addictions under the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver and provide an X-DEA number AND
Provide written attestation of a comprehensive treatment plan between provider and patient AND
Provide written attestation of a comprehensive review of patient’s medications and education provided to patient about risks of concomitant use of benzodiazepines, sedatives, opioid analgesics, alcohol or other CNS depressants, if applicable
Provide written attestation that concomitant psychosocial support has been recommended AND
Have complied with all aspects of the REMS program AND

Patient must:

Have a urine drug screen, including buprenorphine, within the past 30 days of prior authorization submission is provided (if negative for buprenorphine or positive for other opioids, the provider must provide an explanation) AND
NOT be on concurrent long-acting naltrexone, buprenorphine-containing or methadone product AND
NOT have moderate or severe hepatic impairment AND
NOT have adrenal insufficiency AND
NOT have evidence of tampering or attempts to remove the depot at the injection site AND
NOT be receiving other long acting-products for the treatment of opioid abuse disorder (e.g. – buprenorphine [Probuphine] implant, naltrexone [Vivitrol])

Renewal approval is for 6 months

Sublocade is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.

MHCP Provider Call Center 651-431-2700 or 800-366-5411