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Pharmacy Clinical Policy Bulletins

Subject: Stimulants - Narcolepsy

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
FE Provigil® (modafinil) X X     X
NOTE: Criteria for other oral stimulants are discussed in Pharmacy Clinical Policy Bulletin: Stimulants; AND criteria for oral antidepressants are discussed in Pharmacy Clinical Policy Bulletin: Antidepressants

*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy ‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to Step-Therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).

Important Note

This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Issues Manual can be found on the following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.

Policy

  1. Precertification Criteria - (A OR B OR C OR D) AND E

    Under some plans, including plans that use an open or closed formulary, Provigil is subject to precertification. If precertification requirements apply Aetna considers Provigil to be medically necessary for those members who meet the following precertification criteria:

    1. A documented diagnosis of narcolepsy or idiopathic hypersomnia
        AND
        One of the following:
        • Contraindication to two preferred alternatives indicated for the member's condition OR
        • Intolerance to two preferred alternatives indicated for the member's condition OR
        • Allergy to two preferred alternatives indicated for the member's condition OR
        • Failure of an adequate clinical trial of two weeks each of two preferred alternatives indicated for the member's condition

      OR

    2. A documented diagnosis of fatigue associated with multiple sclerosis
        AND
        One of the following:
        • Contraindication to one preferred alternative indicated for the member's condition OR
        • Intolerance to one preferred alternative indicated for the member's condition OR
        • Allergy to one preferred alternative indicated for the member's condition OR
        • Failure of an adequate clinical trial of two weeks of one preferred alternative indicated for the member's condition

      OR

    3. A documented diagnosis of obstructive sleep apnea/hypopnea syndrome
        AND
        One of the following:
        • Member has already had an adequate therapeutic trial of twelve weeks of continuous positive airway pressure (CPAP) treatment OR
        • Member has undergone an uvulopalatopharyngoplasty (UPPP).

      OR

    4. A documented diagnosis of traumatic brain injury-related fatigue, to promote wakefulness during rehabilitation.

      AND

      E. Quantity limits:

    According to the manufacturer, Provigil can be dosed once per day, up to a maximum daily dose of 400 mg. A quantity of Provigil as indicated below will be considered medically necessary, if member fulfills criteria A, B, C, or D above:

    Provigil 100 mg, 200 mg tablets - up to 60 tablets per 30 days

      For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of Provigil will be considered medically necessary for those members who meet ANY of the following criteria:

      • Member requires a dose including half tablets OR
      • Member's dose is being titrated by physician (3-month limit) OR
      • Member has had intolerance to the drug administered as a single daily dose OR
      • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.

  2. Medical Exception Criteria - A OR B OR C OR D

    Provigil is currently listed on the Aetna Formulary Exclusions List.* Therefore, Provigil is excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted. Aetna considers Provigil to be medically necessary for those members who meet ANY of the following criteria:

    1. A documented diagnosis of narcolepsy or idiopathic hypersomnia
        AND
        One of the following:
        • Contraindication to two preferred alternatives indicated for the member's condition OR
        • Intolerance to two preferred alternatives indicated for the member's condition OR
        • Allergy to two preferred alternatives indicated for the member's condition OR
        • Failure of an adequate clinical trial of two weeks each of two preferred alternatives indicated for the member's condition

      OR

    2. A documented diagnosis of fatigue associated with multiple sclerosis
        AND
        One of the following:
        • Contraindication to one preferred alternative indicated for the member's condition OR
        • Intolerance to one preferred alternative indicated for the member's condition OR
        • Allergy to one preferred alternative indicated for the member's condition OR
        • Failure of an adequate clinical trial of two weeks of one preferred alternative indicated for the member's condition

      OR

    3. A documented diagnosis of obstructive sleep apnea/hypopnea syndrome
        AND
        One of the following:
        • Member has already had an adequate therapeutic trial of twelve (12)weeks of continuous positive airway pressure (CPAP) treatment OR
        • Member has undergone an uvulopalatopharyngoplasty (UPPP).

      OR

    4. A documented diagnosis of traumatic brain injury-related fatigue, to promote wakefulness during rehabilitation.

NOTE: Aetna does NOT consider Provigil to be medically necessary for those members with a diagnosis of shift work sleep disorder.

NOTE: Provigil is considered experimental for treatment of major depressive disorder because its use in this condition is not supported by the peer-reviewed medical literature.

Alternatives on Formulary for Narcolepsy/Idiopathic Hypersomnia
    methylphenidate (Ritalin)
    methylphenidate SR (Ritalin SR )
    methylphenidate SR (Methylin ER)
    methylphenidate CR (Metadate ER, Metadate CD)
    dextroamphetamine (Dexedrine, Dextrostat)
    amphetamine/dextroamphetamne (Adderall)
    amphetamine/dextroamphetamine ER (Adderall XR)
Alternatives on formulary for MS-related Fatigue
    ANY agent listed under Narcolepsy
    amantadine (Symmetrel)
    bupropion (Wellbutrin)
    venlafaxine (Effexor)
    fluoxetine (Prozac)
    paroxetine (Paxil)
    sertraline (Zoloft)
    pemoline (NON-formulary, and not recommended due to toxicity, but may count as prerequisite)
*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.

The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.

For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

Place of Service:

    Outpatient

The above policy is based on the following references:

  1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington D.C., American Psychiatric Association, 1994.
  2. Schweitzer JB, Cummins TK, Kant CA. Advances in the pathophysiology and treatment of psychiatric disorders: implications for internal medicine. Med Clin North Am. 2001;85(3):757-77.
  3. Practice parameters for the treatment of narcolepsy: an update for 2000. Sleep 2001;24(4):451-66.
  4. Beusterien KM, et al. Health-related quality of life effects of modafinil for treatment of narcolepsy. Sleep 1999;22(6):757-65.
  5. Silber MH. Neurologic treatment. Sleep disorders. Neurol Clin 2001;19(1):173-86.
  6. 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.
  7. 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.
  8. Mitler MM. Evaluation of treatment with stimulants in narcolepsy. Sleep 1994;17(8 Suppl):S103-6.
  9. Modafinil Drug Monograph. The Formulary Monograph Service, Facts and Comparisons. St. Louis, MO. March 1999.
  10. McClellan KJ, et al. Modafinil. CNS Drugs 1998 9(4):311-324.
  11. Drug evaluation monographs (modafinil). Micromedex Inc.;vol.99 Exp 2/28/99.
  12. Mitler MM, Hajdukovic. Relative efficacy of drugs for the treatment of sleepiness in narcolepsy. Sleep. 1991;14(3):218-20.
  13. 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.
  14. Terzoudi M, et.al. Fatigue in multiple sclerosis: evaluation and a new pharmacological approach [abstract P01.100]. Neurology. 2000;54(suppl 3):A61-A62.
  15. 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.
  16. Provigil Product Information. Cephalon, West Chester, PA, February 2004.
  17. Aetna Medical Clinical Policy Bulletin (CPB) #4: Obstructive Sleep Apnea; revised February 17, 2004. http://aetnet.aetna.com/mpnt/cpb/cpba0004.html
  18. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2005.
  19. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
  20. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
  21. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.

Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 1, 2006