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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

armodafinil Nuvigil PA  
modafinil Provigil PA  

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.

Armodafinil and modafinil are indicated as adjunct treatments of obstructive sleep apnea (OSA). The process of properly using CPAP/BiPAP may be very difficult to achieve. If using armodafinil or modafinil without treating the underlying disease properly, complications from OSA may still occur as the underlying disease state is not being treated.

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

sodium oxybate Xyrem PA  
solriamfetol Sunosi PA  
tasimelteon Hetlioz PA  
Table Footnotes

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)
  • EDS associated with shift work sleep disorder
  • non-24-hour sleep-wake disorder

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

  • Documentation of all of the following is required for a diagnosis of EDS associated with narcolepsy:
    • appropriate diagnosis; and
    • member is ≥ 17 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
    • one of the following:
      • for armodafinil and modafinil 100 mg, requested dose does not exceed the quantity limit of 30 tablets/month; or
      • for modafinil 200 mg, requested dose does not exceed the quantity limit of 60 tablets/month.

 

  • Documentation of all of the following is required for a diagnosis of EDS associated with obstructive sleep apnea (OSA):
    • appropriate diagnosis; and
    • member is ≥ 17 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
    • one of the following:
      • for armodafinil and modafinil 100 mg, requested dose does not exceed the quantity limit of 30 tablets/month; or
      • for modafinil 200 mg, requested dose does not exceed the quantity limit of 60 tablets/month.

 

  • Documentation of all of the following is required for a diagnosis of EDS associated with shift work sleep disorder:
    • appropriate diagnosis; and
    • member is ≥ 17 years of age; and
    • inadequate response, adverse reaction, or contraindication to one hypnotic agent; and
    • inadequate response, adverse reaction, or contraindication to melatonin; and
    • one of the following:
      • for armodafinil and modafinil 100 mg, requested dose does not exceed the quantity limit of 30 tablets/month; or
      • for modafinil 200 mg, requested dose does not exceed the quantity limit of 60 tablets/month.

 

SmartPA: Claims for armodafinil or modafanil 100 mg will usually process at the pharmacy without a PA request if the member is ≥ 17 years of age, has a history of paid claims for 90 out of the past 120 days for the requested agent, and the current claim plus history is 30 tablets per month.†

SmartPA: Claims for modafanil 200 mg will usually process at the pharmacy without a PA request if the member is ≥ 17 years of age, has a history of paid claims for 90 out of the past 120 days for modafanil, and the current claim plus history is 60 tablets per month.† 

   

Hetlioz

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is totally blind; and
    • prescriber is a sleep specialist, or a sleep specialist consult is provided; and
    • inadequate response (defined as at least four weeks of therapy), adverse reaction, or contraindication to melatonin; and
    • quantity requested is ≤ 30 units/30 days.

         

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 modafinil or armodafinil; 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 30 tablets/month.

 

  • 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 modafinil or armodafinil; and
    • requested dose does not exceed the quantity limit of 30 tablets/month.

   

Xyrem

  • 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.

  

  • 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.

 

† 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: 11/2019


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Last updated 11/25/19