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Drug Category: Central Nervous System Agents

Medication Class/Individual Agents: Alcohol/Drug Cessation Agents

I. Prior-Authorization Requirements

 Drug and Alcohol Cessation Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

acamprosate test  
buprenorphine / naloxone buccal film Bunavail PA  
buprenorphine / naloxone film Suboxone BP PD PA   - > 90 days (> 24 mg/day and ≤ 32 mg/day)
buprenorphine / naloxone film Suboxone BP PD PA   - > 32 mg/day
buprenorphine / naloxone film ≤ 24 mg/day Suboxone BP PD test  
buprenorphine / naloxone tablet PA  
buprenorphine / naloxone tablet-Zubsolv Zubsolv PA  
buprenorphine extended-release injection Sublocade PA  
buprenorphine implant Probuphine PA  
buprenorphine tablet PA  
disulfiram Antabuse # test  
lofexidine Lucemyra PA  
naloxone nasal spray Narcan test  
naloxone vial, syringe test  
naltrexone injection Vivitrol test  
naltrexone powder PA  
naltrexone tablet test  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

Prescribing:

  • The Drug Addiction and Treatment Act of 2000 (DATA 2000) allows specially trained physicians to use Schedules III, IV, and V medicines to treat opioid dependence. If a qualified physician (i.e., MD or DO only) fulfills specific training requirements and provides access to psychosocial therapy, he/she will be able to treat either 30 or 100 patients depending on the date when the physician submitted first notification of intent. For more information, call (866) 287-2728 or visit www.buprenorphine.samhsa.gov.

FDA Approved Uses:

  • Buprenorphine and buprenorphine/naloxone are Schedule III controlled substances approved for treatment of opioid dependence. These agents are not FDA-approved for pain management.
  • Naltrexone injection is FDA-approved for the treatment of opioid and alcohol dependence in patients who are abstinent at treatment initiation.

Contraindications:

  • acamprosate: those who have had a hypersensitivity reaction to acamprosate in the past and severe renal impairment (creatinine clearance ≤ 30 mL/min)
  • buprenorphine: hypersensitivity to buprenorphine
  • buprenorphine/naloxone: hypersensitivity to buprenorphine and/or to naloxone
  • disulfiram: recent use of metronidazole, paraldehyde, alcohol, or alcohol-containing products, myocardial disease or coronary occlusion, psychoses and hypersensitivity to disulfiram or other thiuram derivatives
  • naltrexone: current use of or dependence on opioids, acute withdrawal, those who have failed a naloxone challenge test or have a positive urine screen for opioids, acute hepatitis, or liver failure and sensitivity to naltrexone or any component of the product

Warnings/Precautions:

  • acamprosate: does not eliminate or diminish withdrawal symptoms
  • buprenorphine: acute alcoholism, adrenal cortical insufficiency, delirium tremens, CNS depression, respiratory depression, head injury, dependence, large doses of narcotics, hypotension
  • buprenorphine/naloxone: respiratory depression, CNS depression, CNS depressants, acute abdominal conditions, acute alcoholism, adrenal cortical insufficiency, concomitant CYP3A4 inhibitors, delirium tremens, elderly or debilitated patients, dependence, hepatitis, allergic reactions, head injury and increased intracranial pressure, prostatic hypertrophy or urethral stricture, and opioid withdrawal effects
  • disulfiram: diabetes mellitus, disulfiram-alcohol reaction, hepatic dysfunction; hypothyroidism, epilepsy, cerebral damage, renal impairment, rubber contact dermatitis and environmental or occupational exposure to ethylene dibromide or its vapors
  • naltrexone: hepatotoxicity, hepatic impairment, history of suicide attempts, with or without depression, symptoms of withdrawal

 

Please see the following link to find out more information regarding buprenorphine/naloxone tablets and buprenorphine/naloxone film: https://www.mass.gov/lists/masshealth-pharmacy-publications-and-notices-for-prescribers-and-other-providers-0.

 
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Management of opioid withdrawal symptoms
  • Opioid dependence

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

   

buprenorphine/naloxone tablet ≤ 24 mg/day, Bunavail ≤ 12.6 mg/2.1 mg/day, Zubsolv ≤ 17.2 mg/4.3 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an adverse reaction to buprenorphine/naloxone film that is allergic in nature, or cannot be expected or managed during the course of buprenorphine therapy.

buprenorphine/naloxone tablet > 24 mg/day to ≤ 32 mg/day, Bunavail > 12.6 mg/2.1 mg/day to ≤ 16.8 mg/2.8 mg/day, Zubsolv > 17.2 mg/4.3 mg/day to ≤ 22.8 mg/5.8 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an adverse reaction to buprenorphine/naloxone film that is allergic in nature, or cannot be expected or managed during the course of buprenorphine therapy; and
    • one of the following:
      • this is the lowest effective dose for the member; or
      • complete treatment plan.

buprenorphine/naloxone tablet > 32 mg/day, Bunavail > 16.8 mg/2.8 mg/day, Zubsolv > 22.8 mg/5.8 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an adverse reaction to buprenorphine/naloxone film that is allergic in nature, or cannot be expected or managed during the course of buprenorphine therapy; and
    • clinical rationale why member requires dosing greater than 32 mg/day for buprenorphine/naloxone tablet, 16.8 mg/2.8 mg/day for Bunavail, and 22.8/5.8 mg/day for Zubsolv.

buprenorphine tablet  24 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale for prescribing buprenorphine instead of buprenorphine/naloxone documented as one of the following:
      • medical records documenting naloxone allergy; or
      • current pregnancy (request must include anticipated date of delivery); or
      • member is breastfeeding; or
      • prescriber documents desire to avoid buprenorphine/naloxone due to moderate-to-severe hepatic impairment (i.e., Child-Pugh B to C).

buprenorphine tablet > 24 mg/day to 32 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale for prescribing buprenorphine instead of buprenorphine/naloxone documented as one of the following:
      • medical records documenting naloxone allergy; or
      • current pregnancy (request must include anticipated date of delivery); or
      • member is breastfeeding; or
      • prescriber documents desire to avoid buprenorphine/naloxone due to moderate-to-severe hepatic impairment (i.e., Child-Pugh B to C); and
    • one of the following:
      • this is the lowest effective dose for the member; or
      • complete treatment plan.

buprenorphine tablet > 32 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale for prescribing buprenorphine instead of buprenorphine/naloxone documented as one of the following:
      • medical records documenting naloxone allergy; or
      • current pregnancy (request must include anticipated date of delivery); or
      • member is breastfeeding; or
      • prescriber documents desire to avoid buprenorphine/naloxone due to moderate-to-severe hepatic impairment (i.e., Child-Pugh B to C); and
    • clinical rationale why member requires dosing greater than 32 mg/day.

buprenorphine/naloxone film > 24 mg/day to  32 mg/day for > 90 days

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • this is the lowest effective dose for the member; or
      • complete treatment plan.

buprenorphine/naloxone film > 32 mg/day

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why member requires dosing greater than 32 mg/day.

Lucemyra

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • inadequate response, adverse reaction, or contraindication to oral clonidine; and
    • requested dose is ≤ 0.72 mg four times daily; and
    • requested duration is ≤ 14 days.

naltrexone powder

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives of the requested drug cannot be used. 

Probuphine

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is currently stabilized on ≤ 8 mg buprenorphine or equivalent dosed formulation for at least six months; and
    • medical necessity for the use of the implanted formulation; and
    • medical records documenting an adverse reaction that is allergic in nature, or cannot be expected or managed during the course of buprenorphine therapy, contraindication, or inadequate response to all other appropriate therapeutic alternatives. 

Sublocade

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member has been stabilized on ≤ 24 mg buprenorphine per day for at least seven days; and
    • medical necessity for the use of the extended-release injection formulation.  

 

Please see the following link to find out more information regarding buprenorphine/naloxone tablets and buprenorphine/naloxone film: https://www.mass.gov/lists/masshealth-pharmacy-publications-and-notices-for-prescribers-and-other-providers-0.


Original Effective Date: 05/2007

Last Revised Date: 08/2019


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Last updated 11/25/19