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Table 50: Narcolepsy and Miscellaneous Sleep Disorder Therapy Agents


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Central Nervous System (CNS)

Medication Class/Individual Agents: Narcolepsy and Sleep Disorder

I. Prior-Authorization Requirements

 Narcolepsy and Miscellaneous Sleep Disorder Therapy Agents – Modafinil Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

armodafinil Nuvigil PA   - < 6 years and PA > 1 unit/day #
modafinil 100 mg Provigil PA   - < 6 years and PA > 1.5 units/day #
modafinil 200 mg Provigil PA   - < 6 years and PA > 2 units/day #

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.

  

Clinical trials for solriamfetol did not evaluate its use in combination with other medications that could affect excessive sleepiness, including cerebral stimulants, modafinil agents, or sodium oxybate.

 

 Narcolepsy and Miscellaneous Sleep Disorder Therapy Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate Xywav PA  
pitolisant Wakix PA  
sodium oxybate Xyrem PA  
solriamfetol Sunosi PA  
tasimelteon Hetlioz PA  
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:

  • cataplexy associated with narcolepsy
  • excessive daytime sleepiness (EDS) associated with narcolepsy
  • EDS associated with obstructive sleep apnea (OSA)
  • non-24-hour sleep-wake disorder
  • Smith-Magenis syndrome (SMS)

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).

     

armodafinil and modafinil exceeding quantity limits

  • Documentation of all of the following is required:
    • appropriate dose; and
    • medical records documenting titration to doses exceeding FDA-recommendations.

   

Hetlioz capsule

  • Documentation of all of the following is required for non-24 hour sleep wake disorder:
    • appropriate diagnosis; and
    • member is totally blind; and
    • member is ≥ 18 years of age; and
    • prescriber is a sleep specialist, or consult notes from a sleep specialist are provided; and
    • inadequate response (defined as at least four weeks of therapy), adverse reaction, or contraindication to melatonin; and
    • requested dose does not exceed the quantity limit of one unit/day.

 

  • Documentation of all of the following is required for SMS:
    • appropriate diagnosis; and
    • prescriber is a sleep specialist or consult notes from a sleep specialist are provided; and
    • member is ≥ three years of age; and
    • inadequate response (defined by at least four weeks of therapy), adverse reaction, or contraindication to melatonin; and
    • requested dose does not exceed the quantity limit of one unit/day.

 

Hetlioz suspension

  • Documentation of all of the following is required for SMS:
    • appropriate diagnosis; and
    • prescriber is a sleep specialist or consult notes from a sleep specialist are provided; and
    • member is ≥ three years of age; and
    • inadequate response (defined by at least four weeks of therapy), adverse reaction, or contraindication to melatonin; and
    • medical necessity for use over capsule formulation; and
    • requested dose does not exceed the quantity limit of five mL/day.

 

Sunosi

  • Documentation of all of the following is required for a diagnosis of EDS associated with narcolepsy:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
    • inadequate response, adverse reaction, or contraindication to one cerebral stimulant agent; and
    • inadequate response, adverse reaction, or contraindication to armodafinil or modafinil; and
    • one of the following:
      • the requested medication will be used as monotherapy; or
      • clinical rationale for use of the requested agent in combination with other medications for EDS associated with narcolepsy; and
    • requested dose does not exceed the quantity limit of one unit/day.

 

  • Documentation of all of the following is required for a diagnosis of EDS associated with obstructive sleep apnea (OSA):
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • medical records documenting the sleep study used to diagnose OSA [polysomnogram (PSG)]; and
    • one of the following:
      • medical records documenting the member is utilizing CPAP/BiPAP, an oral appliance, or has undergone successful surgical treatment for OSA; or
      • clinical rationale for not utilizing CPAP/BiPAP or an oral appliance or undergoing surgical treatment for OSA; and
    • inadequate response, adverse reaction, or contraindication to armodafinil or modafinil; and
    • requested dose does not exceed the quantity limit of one unit/day.

   

Wakix

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
    • requested dose does not exceed the quantity limit of two units/day; and
    • inadequate response or adverse reaction to three of the following, or contraindication to all of the following:
      • armodafinil or modafinil; or
      • cerebral stimulant agent; or
      • Sunosi; or
      • Xyrem.

  

Xyrem and Xywav

  • Documentation of all of the following is required for a diagnosis of narcolepsy with cataplexy:
    • appropriate diagnosis; and
    • medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
    • prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
    • inadequate response or adverse reaction to one, or contraindication to all of the following: tricyclic antidepressant, SSRI, venlafaxine; and
    • requested quantity does not exceed the quantity limit of nine grams (18 mL)/day; and
    • for Xywav, medical necessity for use instead of Xyrem.

 

  • Documentation of all of the following is required for a diagnosis of EDS due to narcolepsy (without cataplexy):
    • appropriate diagnosis; and
    • medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
    • prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
    • inadequate response, adverse reaction, or contraindication to one cerebral stimulant agent; and
    • inadequate response, adverse reaction, or contraindication to armodafinil or modafinil; and
    • requested quantity does not exceed the quantity limit of nine grams (18 mL)/day; and
    • for Xywav, medical necessity for use instead of Xyrem.

 

 

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, armodafinil, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, donepezil, hypnotic agents, memantine, modafinil, mood stabilizers, naltrexone, and viloxazine] 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 45 days and one mood stabilizer agent is identified as being used for seizure only.

  

armodafinil and modafinil 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 alpha agonist(s) and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is 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: 11/2010

Last Revised Date: 06/2021


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Last updated 10/25/21