Agents for Sleep Disorders - Essential

Restriction applies to brand and generic products

• Provigil® (modafinil)
• Nuvigil® (armodafinil)
• Sunosi™ (solriamfetol)
• sodium oxybate (authorized generic Xyrem®)
• Wakix® (pitolisant)
• Lumryz™ (sodium oxybate)
• Xyrem® (sodium oxybate)
• Xywav™ (calcium, magnesium, potassium, and sodium oxybates)

• Provigil and Nuvigil are approved for the improvement of wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Provigil is not indicated to treat the underlying airway obstruction in OSA.
• Sunosi is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Sunosi is not indicated to treat the underlying airway obstruction in OSA.
• Wakix is approved for the treatment of excessive daytime sleepiness (EDS) in patients 6 years of age and older with narcolepsy or cataplexy in adult patients with narcolepsy.
• Lumryz is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
• Xyrem and Xywav are approved for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
• Xywav is approved for idiopathic hypersomnia (IH) in adults.

1. The request is for Provigil, generic modafinil (Provigil) or Nuvigil; AND
   1. The patient has tried and failed or has a clinical contraindication/intolerance to generic armodafinil (Nuvigil); OR
2. The request is for Sunosi; AND
   1. The patient is 18 years of age or older; AND 
   2. ONE of the following:
      1. The patient has narcolepsy with symptoms of excessive sleepiness; AND
         1. The patient has tried and failed or has a clinical contraindication/intolerance to generic armodafinil (Nuvigil) or generic modafinil (Provigil) (medical record documentation required); OR
      2. The patient has obstructive sleep apnea (OSA) with symptoms of excessive sleepiness; AND
         1. The patient is currently being treated with or will begin using continuous positive airway pressure (CPAP) therapy or is not a candidate for CPAP therapy; AND
         2. The patient must demonstrate compliance with regular CPAP use while concurrently taking Sunosi; AND
         3. The patient has tried and failed or has a clinical contraindication/intolerance to generic armodafinil (Nuvigil) or generic modafinil (Provigil) (medical record documentation required); AND 
            
   3. Sunosi will NOT be used concurrently with armodafinil (Nuvigil), or modafinil (Provigil); AND
   4. Sunosi will NOT be used concurrently with a monoamine oxidase inhibitor (MAOI) or within 14 days of starting the medication; OR
3. The request is for Lumryz; AND
   1. The patient is 18 years of age or older; AND
   2. ONE of the following:
      1. The patient has a diagnosis of narcolepsy with symptoms of excessive daytime sleepiness (EDS); AND 
         1. The patient has tried and failed or has a clinical contraindication/intolerance to Modafinil (Provigil) or Armodafinil (Nuvigil) (medical record documentation required); OR
         2. The patient has tried and failed or has a clinical contraindication/intolerance to amphetamine/methylphenidate-based therapy (medical record documentation required); OR
      2. The patient has a diagnosis of cataplexy in narcolepsy; AND
         1. The patient has tried and failed or has a clinical contraindication/intolerance to therapy with ONE of the following (medical record documentation required): 
            1. Tricyclic antidepressants
            2. Selective serotonin reuptake inhibitor 
            3. Venlafaxine; OR
         2. The patient has experienced severe cataplexy with bilateral weakness or paralysis which caused, or placed the patient at risk of collapse; AND
   3. The provider has submitted the following (medical record documentation required);
      1. Polysomnogram test (with at least 6 hours of sleep time) that showed the absence of other pathology which would cause excessive daytime sleepiness; AND
      2. Multiple sleep latency test that confirmed the patient’s diagnosis; AND
   4. Lumryz will NOT be used concurrently with Nuvigil, Provigil, Xyrem, Xywav or Wakix; AND
   5. The patient will not take sedative hypnotics and abstain from alcohol while taking Lumryz; OR 
4. The request is for Xyrem, authorized generic sodium oxybate (Xyrem) or Xywav; AND
   1. ONE of the following:
      1. The patient has a diagnosis of excessive daytime sleepiness in narcolepsy; AND
         1. The patient is 18 years of age or older; AND
            1. The patient has tried and failed or has a clinical contraindication/intolerance to modafinil (Provigil) or armodafinil (Nuvigil) (medical record documentation required); AND
            2. The patient has tried and failed or has a clinical contraindication/intolerance to amphetamine/methylphenidatebased therapy (medical record documentation required); AND 
            3. The patient has tried and failed or has a clinical contraindication/intolerance to Sunosi (medical record documentation required); OR
         2. The patient is between 7 years and 17 years of age; AND
            1. The patient has tried and failed or has a clinical contraindication/intolerance to amphetamine/methylphenidate based therapy (medical record documentation required); OR
      2. The patient has a diagnosis of cataplexy in narcolepsy; AND
         1. The patient is between 7 years and 17 years of age; OR
         2. The patient is 18 years of age or older; AND
            1. The patient has tried and failed or has a clinical contraindication/intolerance to therapy with ONE of the following (medical record documentation required):
               1. Tricyclic antidepressants
               2. Selective serotonin reuptake inhibitor 
               3. Venlafaxine; OR
         3. The patient has experienced severe cataplexy with bilateral weakness or paralysis which caused, or placed the patient at risk of collapse; OR
      3. The patient has a diagnosis of idiopathic hypersomnia; AND
         1. The request is for Xywav; AND
         2. The patient is 18 years of age or older; AND
            1. The patient has tried and failed or has a clinical contraindication/intolerance to modafinil (Provigil) or armodafinil (Nuvigil) (medical record documentation required); AND
            2. The patient has tried and failed or has a clinical contraindication/intolerance to amphetamine/methylphenidatebased therapy (medical record documentation required); AND
   2. The provider has submitted the following (medical record documentation required);
      1. Polysomnogram test (with at least 6 hours of sleep time) that showed the absence of other pathology which would cause excessive daytime sleepiness; AND
      2. Multiple sleep latency test that confirmed the patient’s diagnosis; AND
   3. For patients requesting brand Xyrem, the patient has tried and failed or has a clinical contraindication/intolerance to authorized generic sodium oxybate (Xyrem) (medical record documentation required); OR
5. The request is for Wakix; AND
   1. ONE of the following:
      1. The patient has narcolepsy with symptoms of excessive sleepiness; AND
         1. The patient is 18 years of age or older; AND 
            1. The patient has tried and failed or has a clinical contraindication/intolerance to generic modafinil (Provigil) or armodafinil (Nuvigil) (medical record documentation required); AND
            2. The patient has tried and failed or has a clinical contraindication/intolerance to amphetamine/methylphenidate based therapy (medical record documentation required); AND
            3. The patient has tried and failed or has a clinical contraindication/intolerance to Sunosi (medical record documentation required); OR
         2. The patient is between 6 years and 17 years of age; AND
            1. The patient has tried and failed or has a clinical contraindication/intolerance to amphetamine/methylphenidate based therapy (medical record documentation required); OR
      2. The patient has a diagnosis of cataplexy in narcolepsy; AND
         1. The patient is 18 years of age or older; AND
            1. The patient has tried and failed or has a clinical contraindication/intolerance to therapy with ONE of the following (medical record documentation required):
               1. Tricyclic antidepressants
               2. Selective serotonin reuptake inhibitor
               3. Venlafaxine; OR
            2. The patient has experienced severe cataplexy with bilateral weakness or paralysis which caused, or placed the patient at risk of, collapse; AND
   2. The provider has submitted the following (medical record documentation required);
      1. Polysomnogram test (with at least 6 hours of sleep time) that showed the absence of other pathology which would cause excessive daytime sleepiness; AND
      2. Multiple sleep latency test that confirmed the diagnosis of narcolepsy; AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity limitations apply to brand and associated generic products. 

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: 365 days (1 year)

All information referenced is from FDA package insert unless otherwise noted below.

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

February 2025: Criteria change (Lumryz, Wakix):  Updated trial and failure requirement for Wakix to include modafinil (Provigil). Updated trial and failure of Lumryz to only require one agent for approval.

October 2024v2: Criteria update (Lumryz): Added new to market Lumryz Starter Pack to the criteria. 

October 2024: Criteria change: (Xyrem, authorized generic sodium oxybate (Xyrem) and Xywav and Wakix): Added new age requirements for each indication for Xyrem and authorized generics and added new age requirement of 18 and older for of cataplexy in narcolepsy indication for Wakix.

July 2024: Criteria change (Wakix, Sunosi): Added new expanded indication for the treatment of excessive daytime sleepiness (EDS) in patients 6 years of age and older with narcolepsy. Clarified age of 18 years and older for use of Sunosi.

October 2023: Criteria change (Xyrem): Request for brand Xyrem required to step through authorized generic sodium oxybate (Xyrem).

May 2023: Criteria update: Added new to market Lumryz to the criteria.

January 2023: Criteria update: Added generic sodium oxybate (Xyrem) to the criteria.

December 2022: Criteria change: Addition of medical records to Sunosi, Xyrem, Xywav, and Wakix for tried and failed or has a clinical contraindication/intolerance language. Updated criteria name to Agents for Sleep Disorders.

October 2021: Criteria change: Request for Xywav or Xyrem for narcolepsy without cataplexy required to also step through Sunosi.

August 2021: Criteria change: New indication for Xywav for IH. Decreased duration of approval to 365 days. Created Essential only policy.

April 2021: Criteria change: Removed step through Xyrem for Xywav requests.

October 2020: Criteria change: Added criteria for expanded indication of Wakix for cataplexy in narcolepsy.

October 2020: Criteria update: Added Xywav to the policy.

August 2020: Criteria change: For Wakix requests, added requirement to t/f Sunosi.

July 2020: Criteria change: Removed quantity limit requirements from Nuvigil and Provigil.

January 2020: Criteria change: Removed diagnostic and amphetamine-based therapy requirements for Sunosi, added failure of armodafinil or modafinil to policy.

October 2019: Criteria update: Combined Nuvigil/Provigil/Sunosi/Xyrem criteria. Added new Wakix product to policy.

July 2019: Original utilization management criteria issued for Sunosi.

Oct 2018: Generic Armodafinil released from restriction. Criteria for approval changed to a trail or clinical contraindication/intolerance to generic armodafinil.

Jan 2017: Reviewed for ASO Net Results and Essential formularies; Non-formulary verbiage added.

Jul 2016: Revised quantity limit of Provigil (modafinil) from 2 tablets per day to 1 tablet per day; removed the following from the coverage criteria: Idiopathic hypersomnia. Sleep study (polysomnogram and/or multiple sleep latency test, as appropriate) confirming diagnosis by ruling out other sleep disorders must be submitted; Fatigue related to multiple sclerosis, in which fatigue causes significant distress or impairment.