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INDEX:
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

Effective Date: 09/01/2006 Title: Modafinil/Armodafinil
Revision Date: 07/01/2020 Document: BI170:00
CPT Code(s): None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

Modafinil and Armodafinil are medications used to treat various forms of sleepiness when other treatments are not successful.


Modafinil and Armodafinil require preauthorization for coverage under the pharmacy benefit.


Medical Statement

Modafinil and Armodafinil require pre-authorization to be eligible for payment under the prescription benefits. These products will be preauthorized for members meeting any of the following criteria:

  1. Narcolepsy or Idiopathic Hypersomnia
    1. The diagnosis should be documented by sleep study and Multiple Sleep Latency Test; AND
    2. Failed minimum of 2 weeks trial of at least two alternative stimulants1 or
    3. Allergy or intolerance to two other agents or
    4. Contraindication to other agents
  2. Fatigue due to Multiple Sclerosis
    1. Failed 2 week trail of at least two alternative treatments2 or
    2. Allergy or intolerance of  two other agents or
    3. Contraindication to two other agents
  3. Persistent Obstructive sleep apnea /Hypopnea syndrome
    1. Member has had at least a 12 week trial of continuous positive airway pressure (CPAP)  OR
    2. Member has had an uvulopalatopharyngoplasty (UPPP), with diagnosis of ongoing OSA documented by a repeat sleep study.

4.    Traumatic brain injury related fatigue

    1. To promote wakefulness during therapy

5.    Shift work sleep disorder

a.    To improve wakefulness in patients with excessive sleepiness.


Limits

Modafinil is limited to 30 units per month.

Armodafinil 150mg and 250mg is limited to 30 units per month.

Armodafinil 50mg is limited to 60 units per month.

Modafinil and Armodafinil are considered experimental for treatment of major depressive disorder because their use in this condition is not supported by the peer-reviewed medical literature.

 

1. Alternatives for Narcolepsy/Idiopathic Hypersomnia

·         methylphenidate (Ritalin)

·         methylphenidate SR (Ritalin SR )

·         methylphenidate SR (Methylin ER)

·         methylphenidate CR (Metadate ER, Metadate CD)

·         Dextroamphetamine (Dexedrine, Dextrostat)

·         amphetamine/Dextroamphetamine (Adderall)

·         amphetamine/Dextroamphetamine ER (Adderall XR)

 

2. Alternatives for MS-related Fatigue

·         ANY agent listed under Narcolepsy

·         amantadine (Symmetrel)

·         bupropion (Wellbutrin)

·         venlafaxine (Effexor)

·         fluoxetine (Prozac)

·         paroxetine (Paxil)

·         sertraline (Zoloft)


Reference
  1. Practice parameters for the treatment of narcolepsy: an update for 2000. Sleep 2001; 24(4):451-66.
  2. Beusterien KM, et al. Health-related quality of life effects of Modafinil for treatment of narcolepsy. Sleep 1999; 22(6):757-65.
  3. Silber MH. Neurologic treatment. Sleep disorders. Neurol Clin 2001; 19(1):173-86.
  4. US Modafinil in Narcolepsy Study Group. Randomized trial of Modafinil as a treatment for the excessive daytime somnolence of narcolepsy. Neurology. 2000; 54(5):1166-75.
  5. Rugino TA, Copey TC. Effects of Modafinil in children with attention-deficit/hyperactivity disorder: An open-label study. J Am Acad Child Adolesc Psychiatry. 2001; 40(2):230-5.
  6. Mitler MM. Evaluation of treatment with stimulants in narcolepsy. Sleep 1994; 17(8 Suppl):S103-6.
  7. Drug evaluation monographs (Modafinil). Micromedex Inc.; vol.99 Exp 2/28/99.
  8. Mitler MM, Hajdukovic. Relative efficacy of drugs for the treatment of sleepiness in narcolepsy. Sleep. 1991;14(3):218-20.
  9. Rammahan KW, et al. Modafinil - efficacy for the treatment of fatigue in patients with multiple sclerosis [abstract S11.004]. Neurology. 2000;54(suppl 3):A24.
  10. Terzoudi M, et.al. Fatigue in multiple sclerosis: evaluation and a new pharmacological approach [abstract P01.100]. Neurology. 2000;54(suppl 3):A61-A62.
  11. Branas P, Jordan R, Fry-Smith A, et al. Treatments for fatigue in multiple sclerosis: a rapid and systemic review. Health Technol Assess. 2000;4:1-61.
  12. Provigil Product Information. Cephalon, West Chester, PA, February 2004.
  13. Aetna Medical Clinical Policy Bulletin (CPB) #4: Obstructive Sleep Apnea; revised February 17, 2004. http://aetnet.aetna.com/mpnt/cpb/cpba0004.html
  14. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2005.
  15. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
  16. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
  17. Nuvigil Product Information. Cephalon, Westchester, PA, January 2007

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.