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Drug Category: Central Nervous System (CNS)

Medication Class/Individual Agents: Modafinil Agents

I. Prior-Authorization Requirements

 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.

  • Obstructive sleep apnea (OSA) is confirmed through a PSG showing > 15 events per hour or > 5 events per hour in a patient who has any of the following: unintentional sleeping episodes during wakefulness, daytime sleepiness, unrefreshing sleep, fatigue, insomnia, waking up holding breath, gasping, choking, loud snoring, breathing interruptions. OSA severity is classified by the respiratory disturbance index (RDI).
    • mild = RDI ≥ 5 and < 15 per hour
    • moderate = RDI ≥ 15 and < 30 per hour
    • severe = RDI > 30 per hour
  • Armodafinil and modafinil are indicated as adjunct treatments of 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.
 
Table Footnotes

II. Therapeutic Uses

FDA-approved, for example:

  • excessive daytime sleepiness associated with narcolepsy
  • excessive daytime sleepiness associated with obstructive sleep apnea
  • excessive daytime sleepiness associated with shift work sleep 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

  • Documentation of the following is required for diagnosis excessive daytime sleepiness associated with narcolepsy:
    • appropriate diagnosis; and
    • member ≥ 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
    • inadequate response, adverse reaction, or contraindication to modafinil; and
    • inadequate response, adverse reaction, or contraindication to one cerebral stimulant agent from either class (methylphenidate or amphetamine); and
    • requested dose does not exceed the quantity limit of 30 tablets/month

 

  • Documentation of the following is required for diagnosis excessive daytime sleepiness associated with obstructive sleep apnea (OSA):
    • appropriate diagnosis; and
    • member ≥ 17 years of age; and
    • medical records documenting the sleep study used to diagnose OSA [polysomnogram (PSG)]; and
    • inadequate response, adverse reaction, or contraindication to modafinil; and
    • one of the following:
      • if the member is using CPAP/BiPAP, all of the following must be provided:
        • medical records of the sleep study documenting the appropriate pressure for the CPAP/BiPAP or member uses an automatically titrating CPAP/BiPAP machine; and
        • current medical records (within the past 3 months) documenting that member is compliant to treatment*; or
      • medical records documenting the member has undergone successful surgical treatment for OSA (with a post-surgical PSG to assess results) and still has residual daytime sleepiness; or
      • medical records documenting consistent use and compliance to an oral appliance after failure of CPAP/BiPAP, including a PSG using the appliance that confirms efficacy, but member still has residual daytime sleepiness.
    • requested dose does not exceed the quantity limit of 30 tablets/month

*Please note, if the member is compliant and therapy is ineffective, re-titration and adjustment of pressure is necessary. Modafinil products do not treat OSA and untreated OSA can have severe complications.

 

  • Documentation of the following is required for diagnosis excessive daytime sleepiness associated with shift work sleep disorder:
    • appropriate diagnosis; and
    • member ≥ 17 years of age; and
    • inadequate response, adverse reaction or contraindication to one cerebral stimulant agent from either class (methylphenidate or amphetamine); and
    • inadequate response, adverse reaction, or contraindication to modafinil; and
    • inadequate response, adverse reaction, or contraindication to one hypnotic agent; and
    • inadequate response, adverse reaction, or contraindication to melatonin; and
    • requested dose does not exceed the quantity limit of 30 tablets/month

 

SmartPA: Claims for armodafinil 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 armodafanil and the current claim plus history is 30 tablets per month.†

 

modafinil

  • Documentation of the following is required for diagnosis excessive daytime sleepiness associated with narcolepsy:
    • appropriate diagnosis; and
    • member ≥ 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
    • inadequate response, adverse reaction or contraindication to one cerebral stimulant agent from either class (methylphenidate or amphetamine); and
    • requested dose does not exceed the quantity limit of 30 tablets/month for modafanil 100mg and 60 tablets/month for modafanil 200mg

 

  • Documentation of the following is required for diagnosis excessive daytime sleepiness associated with obstructive sleep apnea (OSA):
    • appropriate diagnosis; and
    • member ≥ 17 years of age; and
    • medical records documenting the sleep study used to diagnose OSA [polysomnogram (PSG)]; and
    • one of the following:
      • if the member is using CPAP/BiPAP, all of the following must be provided:
        • medical records of the sleep study documenting the appropriate pressure for the CPAP/BiPAP or member uses an automatically titrating CPAP/BiPAP machine; and
        • current medical records (within the past 3 months) documenting that member is compliant to treatment*; or
      • medical records documenting the member has undergone successful surgical treatment for OSA (with a post-surgical PSG to assess results) and still has residual daytime sleepiness; or
      • medical records documenting consistent use and compliance to an oral appliance after failure of CPAP/BiPAP, including a PSG using the appliance that confirms efficacy, but member still has residual daytime sleepiness.
    • requested dose does not exceed the quantity limit of 30 tablets/month for modafanil 100mg and 60 tablets/month for modafanil 200mg

*Please note, if the member is compliant and therapy is ineffective, re-titration and adjustment of pressure is necessary. Modafinil products do not treat OSA and untreated OSA can have severe complications.

 

  • Documentation of the following is required for diagnosis excessive daytime sleepiness associated with shift work sleep disorder:
    • appropriate diagnosis; and
    • member ≥ 17 years of age; and
    • inadequate response, adverse reaction, or contraindication to one cerebral stimulant agent from either class (methylphenidate or amphetamine); and
    • inadequate response, adverse reaction, or contraindication to one hypnotic agent; and
    • inadequate response, adverse reaction, or contraindication to melatonin; and
    • requested dose does not exceed the quantity limit of 30 tablets/month for modafanil 100mg and 60 tablets/month for modafanil 200mg

SmartPA: Claims for modafanil 100mg 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 30 tablets per month.†

SmartPA: Claims for modafanil 200mg 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.† 

 

† 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: 08/2019


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Last updated 08/29/19