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Drug Category: Central Nervous System

Medication Class/Individual Agents: Barbiturates, Benzodiazepines, and Miscellaneous Anti-Anxiety Agents

I. Prior-Authorization Requirements

 Anti-Anxiety Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

buspirone PA   - < 6 years

            

 
buspirone powder PA  
chlordiazepoxide / clidinium Librax PA  
meprobamate PA  

 Barbiturates

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

butabarbital Butisol test  

      

 
phenobarbital test  
secobarbital Seconal test  

 Benzodiazepines

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

alprazolam Xanax # PA   - < 6 years
  • Extended-release, orally disintegrating, and powder-based benzodiazepine formulations require prior authorization (PA) due to the availability of less costly dosage formulations.
 
alprazolam extended-release Xanax XR # PA   - < 6 years and PA > 60 units/month
alprazolam orally disintegrating tablet PA  
alprazolam powder PA  
chlordiazepoxide PA   - < 6 years
clonazepam 0.125 mg, 0.25 mg, 0.5 mg, 1 mg orally disintegrating tablet PA   - < 6 years and PA > 90 units/month
clonazepam 2 mg orally disintegrating tablet PA  
clonazepam powder PA  
clonazepam tablet Klonopin # PA   - < 6 years
clorazepate Tranxene # PA   - < 6 years
diazepam powder PA  
diazepam rectal gel Diastat PA   - > 5 kits (10 syringes) /month
diazepam solution, tablet PA   - < 6 years
estazolam PA   - < 6 years and PA > 30 units/month
flurazepam PA   - < 6 years and PA > 30 units/month
lorazepam powder PA  
lorazepam solution, tablet Ativan # PA   - < 6 years
midazolam injectable test  
midazolam powder PA  
midazolam syrup PA   - < 6 years
oxazepam PA   - < 6 years
temazepam 22.5 mg Restoril PA  
temazepam 7.5 mg, 15 mg, 30 mg Restoril # PA   - < 6 years and PA >30 units/month
triazolam Halcion # PA   - < 6 years and PA > 30 units/month
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.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Anxiety, panic disorder, skeletal muscle spasm, or seizure (benzodiazepines)
  • Anxiety (meprobamate)
  • Emotional and somatic factors in gastrointestinal disorders (Librax)
  • Adjunctive therapy in peptic ulcer, irritable bowel syndrome, and acute enterocolitis (Librax)

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.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

 

alprazolam extended-release > 60 units/month

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • dose requested cannot be consolidated within quantity limits; and
    • medical necessity for exceeding quantity limits.

      

alprazolam orally disintegrating tablet

  • Documentation of all of the following is required:       
    • appropriate diagnosis; and
    • dose requested cannot be consolidated; and
    • medical necessity for an orally disintegrating tablet (ODT) formulation.

 

alprazolam powder, buspirone powder, clonazepam powder, diazepam powder, lorazepam powder, and midazolam powder

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

 

clonazepam 0.125 mg, 0.25 mg, 0.5 mg, and 1 mg orally disintegrating tablet > 90 units/month

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • prescriber is a neurologist or psychiatrist, or provides consult notes from a neurologist or psychiatrist; and
    • dose requested cannot be consolidated within quantity limits; and
    • medical necessity for exceeding quantity limits.

 

clonazepam 2 mg orally disintegrating tablet

  • Documentation of all of the following is required:       
    • appropriate diagnosis; and
    • medical necessity for an orally disintegrating tablet (ODT) formulation; and
    • one of the following:
      • quantity requested is ≤ 90 units/30 days; or
      • medical necessity for exceeding quantity limits.

 

diazepam rectal gel > 5 kits (10 syringes) per month

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for greater than 5 kits (10 syringes) per month; and
    • prescriber is a neurologist or provides consult notes from a neurologist.

 

estazolam, flurazepam, temazepam 7.5 mg, 15 mg, and 30 mg, and triazolam > 30 units/month

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • dose requested cannot be consolidated within quantity limits; and
    • medical necessity for exceeding quantity limits.

   

Librax

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • quantity requested is ≤ 240 units/30 days; and
    • prescriber is a gastrointestinal specialist or provides consult notes from a gastrointestinal specialist; and
    • inadequate response or adverse reaction to two anticholinergic/antispasmodics or contraindication to all antispasmodics; and
    • inadequate response or adverse reaction to an SSRI, or contraindication to all SSRIs; and
    • inadequate response or adverse reaction to a non-benzodiazepine anxiolytic, or contraindication to all non-benzodiazepine anxiolytics; and
    • inadequate response or adverse reaction to one other benzodiazepine; and
    • requested medication will be used as an adjunctive therapy; and
    • for a diagnosis of peptic ulcer, all of the following:
      • inadequate response (defined as at least four weeks of therapy) or adverse reaction to two proton pump inhibitors, or contraindication to all proton pump inhibitors; and
      • requested treatment duration does not exceed 12 weeks; and
      • for H. pylori-positive peptic ulcer, an inadequate response to one four-week course of appropriate combination therapy; or
    • for a diagnosis of irritable bowel syndrome with constipation, both of the following:
      • inadequate response or adverse reaction to two of the following or contraindication to all of the following: Amitiza (lubiprostone), Linzess (linaclotide), Trulance (plecanatide); and
      • inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives, stimulant laxatives); or
    • for a diagnosis of irritable bowel syndrome with diarrhea, inadequate response or adverse reaction to five of the following or contraindication to all of the following: alosetron (females only), bile acid sequestrants, bismuth subsalicylate, bulk-forming laxatives, diphenoxylate/atropine, loperamide, Xifaxan (rifaximin); or
    • for a diagnosis of acute enterocolitis, all of the following:
      • inadequate response, adverse reaction, or contraindication to loperamide; and
      • inadequate response, adverse reaction, or contraindication to bismuth subsalicylate; and
      • requested treatment duration does not exceed three days.

   

meprobamate

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to the use of at least two benzodiazepines; or
      • contraindication to the use of all benzodiazepine agents.  

 

temazepam 22.5 mg

  • Documentation of all of the following is required:       
    • appropriate diagnosis; and
    • medical records documenting an adverse reaction or inadequate response to ALL of the following hypnotic benzodiazepines:       
      • estazolam; and
      • flurazepam; and
      • temazepam 7.5 mg, 15 mg, or 30 mg; and
      • triazolam; and
    • one of the following:
      • quantity requested is ≤ 30 units/30 days; or
      • medical necessity for exceeding quantity limits; and
    • dose requested cannot be consolidated within quantity limits.

 

Brand-name products (Ativan, Klonopin, Tranxene, Xanax)

  • Documentation of all of the following is required:       
    • appropriate diagnosis; and
    • medical records documenting an adverse reaction or inadequate response to a generic equivalent to the requested product; and
    • inadequate response (defined by 30 days of therapy) or adverse reaction to one other non-hypnotic benzodiazepine; and
    • dose requested cannot be consolidated.

  

Benzodiazepine Polypharmacy (overlapping pharmacy claims for two or more benzodiazepines [excludes clobazam, rectal diazepam, and injectable formulations] for at least 60 days within a 90-day period) for members ≥ 18 years old

  • Documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnosis; and
      • treatment plan including names of current benzodiazepine agents and corresponding diagnoses; and
      • one of the following:
        • cross-titration/taper of benzodiazepine therapy; or
        • clinical rationale for use of ≥ two benzodiazepines of different chemical entities.

  

In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions.

 

Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, hypnotic agents, and mood stabilizers] within a 45-day period) for members < 18 years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ two mood stabilizers (also includes regimens that do not include a mood stabilizer), documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.

 

  • For regimens including ≥ three mood stabilizers, documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
      • one of the following:
        • member has a seizure diagnosis only; or
        • member has an appropriate psychiatric diagnosis and one of the following:
          • Cross-titration/taper of mood stabilizer therapy; or
          • Inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate; or
        • member has a diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain)  and documentation that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed; or
        • member has  psychiatric and comorbid diagnosis in which mood stabilizers may be clinically appropriate  (e.g., migraine, neuropathic pain) and documentation that other clinically relevant  therapies have been tried and failed; therefore, multiple mood stabilizers are needed, and one of the following:
          • Cross-titration/taper of mood stabilizer therapy; or
          • Inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.

SmartPA: Claims will usually process at the pharmacy without a PA request if the member is < 18 years of age, has a history of MassHealth medical claims for seizure, and has a history of paid MassHealth pharmacy claims for four or less behavioral health medications within the past 60 days and one mood stabilizer agent is identified as being used for seizure only.

    

Benzodiazepine Polypharmacy (overlapping pharmacy claims for two or more benzodiazepines [hypnotic benzodiazepine agents, clobazam, rectal diazepam, and injectable formulations are not included] for at least 60 days within a 90-day period) for members < 18 years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
      • member has a seizure diagnosis only; or
    • all of the following:
      • appropriate diagnosis; and
      • treatment plan including names of current benzodiazepines and corresponding diagnoses; and
      • one of the following:
        • cross-titration/taper of benzodiazepine therapy; or
        • clinical rationale for use of ≥ two benzodiazepines of different chemical entities.

   

buspirone for members < six years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required:
    • one of the following:
      • member  had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnosis; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g. psychiatrist, neurologist) or consult is provided.

 

Benzodiazepine (hypnotic benzodiazepine agents are not included) for members < six years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
      • member has a seizure diagnosis only; or
    • all of the following:
      • appropriate diagnosis; and
      • treatment plan including names of current behavioral health medications and corresponding indications; and
      • prescriber is a specialist (e.g. psychiatrist, neurologist) or consult is provided.

SmartPA: Claims for mood stabilizers or benzodiazepines will usually process at the pharmacy without a PA request if the member is < six years of age, has a history of MassHealth medical claims for seizure, and does not have a history of MassHealth medical claims for psychiatric diagnoses and/or other diagnoses in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain).

    

estazolam, flurazepam, temazepam 7.5 mg, 15 mg, and 30 mg, and triazolam for members < six years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required for members with a diagnosis of insomnia with other behavioral health comorbidities, excluding ADHD:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.

 

  • Documentation of the following is required for members with a diagnosis of insomnia without behavioral health comorbidities:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
    • inadequate response (defined by ≥ 10 days of therapy), adverse reaction, or contraindication to melatonin.

 

  • Documentation of the following is required for members with a diagnosis of insomnia with comorbid ADHD:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
    • inadequate response (defined by ≥ 10 days of therapy), adverse reaction, or contraindication to melatonin; and
    • inadequate response (defined by ≥ 10 days of therapy), adverse reaction, or contraindication to clonidine.

 

temazepam 22.5 mg for members < six years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult was provided.

 

 

†Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 03/2013

Last Revised Date: 06/2019


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Last updated 07/15/19