Buprenorphine/Naloxone Agents (Suboxone Film, Zubsolv)

Buprenorphine/Naloxone Agents (SUBOXONE film, ZUBSOLV)

Self-Administration – oral sublingual (SL) tablets and film.

Diagnosis considered for coverage:

• Opioid dependence: Indicated for the treatment of opioid dependence.

Coverage Criteria:

For diagnosis of opioid dependence:

• Diagnosis of opioid dependence; AND
• Documentation of a trial and failure or intolerable side effects to generic buprenorphine/naloxone SL tablets.

Dosing:

• Prior to induction, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence.  To avoid precipitating withdrawal, induction with buprenorphine should be undertaken when objective and clear signs of withdrawal are evident.
• For maintenance treatment (16 years of age and older):
  • The target dosage of Suboxone SL film is usually 16 mg/4 mg as a single daily dose.
  • The target dosage of Zubsolv SL tablet is 11.4 mg/2.9 mg as a single daily dose.
• Maximum dose:
  • Suboxone SL film (or generic): 24 mg/6 mg per day.
  • Zubsolv SL tablets: 17.1 mg/4.2 mg per day.

Coverage Duration:

• 1 year

Authorization is not covered for the following:

The use of this drug for indications listed below and any others not listed in this policy do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

• Pain

Additional Information:

• Prior to December 2022, use of buprenorphine-containing products approved for the treatment of opioid use disorder (OUD) was limited to healthcare providers with a unique identification number (also known as an X-waiver) provided by the Department of Health and Human Services under the Drug Addiction Treatment Act (DATA). The passage of the 2023 Consolidated Appropriations Act lifted these restrictions in an effort to expand patient access to buprenorphine-containing products for the treatment of OUD. Healthcare providers who are eligible to prescribe U.S. DEA Schedule III medications are now eligible to prescribe buprenorphine-containing medications for OUD using their current DEA registration, and additional training for providers treating OUD is in development.
• Bunavail buccal film formulations have been discontinued.
• There is no maximum recommended duration of maintenance treatment.  Patients may require treatment indefinitely and should continue for as long as patients are benefiting and use contributes to the intended treatment goals.
• Reducing dosage and stopping treatment: The decision to discontinue therapy after a period of maintenance should be made as part of a comprehensive treatment plan.  Advise patients of the potential to relapse to illicit drug use following discontinuation of opioid agonist/partial agonist medication-assisted treatment.  Taper patients to avoid the occurrence of withdrawal signs and symptoms.

Policy Updates:

• 06/30/2020 – Annual review, no changes.
• 09/01/2023 – Remove PA on generic Suboxone SL tablets; remove requirement for provider with specialized training; remove references to discontinued Bunavail (P&T 08/15/2023).

References:

1. Suboxone [package insert]. North Chesterfield, VA: Indivior Inc.; 2002.
2. Zubsolv [package insert]. Morristown, NJ: Orexo US, Inc.; 2002.