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Pharmacy Clinical Policy Bulletins

Subject: Stimulants

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
P amphetamine/ dextroamphetamine   X      
P dextroamphetamine   X      
P methylin® (methylphenidate)- tablets   X      
P methylin ER®(methylphenidate SR)   X      
P methylphenidate   X      
P methylphenidate SR   X      
P Adderall XR® (amphetamine/ dextroamphetamine ER)   X      
P Metadate CD® (methylphenidate once-daily)   X      
P Metadate ER® (methylphenidate SR)   X      
NP Adderall® (amphetamine/ dextroamphetamine)   X      
NP Dexedrine® (dextroamphetamine)   X      
NP Dextrostat® (dextroamphetamine)   X      
NP Ritalin® (methylphenidate)   X   X X
NP Ritalin SR® (methylphenidate SR)   X   X X
FE Concerta® (methylphenidate once-daily)   X   X X
FE Desoxyn® (methamphetamine)   X   X X
FE Focalin™ (dexmethylphenidate)   X   X X
FE Focalin XR™ (dexmethylphenidate SR)   X   X X
FE Methylin® (methylphenidate) - chew, solution   X   X X
FE Ritalin LA® (methylphenidate ER)   X   X X
FE Strattera® (atomoxetine)   X   X X

*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 Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.

Policy

  1. Precertification Criteria

    Under some plans, including plans that use an open or closed formulary, Adderall, Adderall XR, amphetamine/dextroamphetamine, Concerta, Desoxyn, Dexedrine, dextroamphetamine, Dextrostat, Focalin, Focalin XR , Metadate CD, Metadate ER, Methylin, Methylin ER, methylphenidate, methylphenidate SR,, Ritalin, Ritalin LA, Ritalin SR, and Strattera are subject to precertification. If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet the following precertification criteria:

      A. Quantity limits:

    According to the manufacturers, the stimulant agents can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Adderall, amphetamine/ dextroamphet. 60 mg/ Once or twice daily 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 30 mg Up to 60 tablets in 30 days
    Adderall, amphetamine/ dextroamphet. 60 mg/ Once or twice daily 20 mg Up to 90 tablets in 30 days
    Adderall XR 30 mg/ Once or twice daily 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg Up to 60 capsules in 30 days
    Concerta 72 mg/ Once or twice daily 18 mg Up to 90 tablets in 30 days
    Concerta 72 mg/ Once or twice daily 27 mg, 36 mg, 54 mg Up to 60 tablets in 30 days
    Desoxyn methamphetamine 60 mg/ Once or twice daily 5mg Up to 120 tablets in 30 days
    Desoxyn CR methamphetamine 60 mg/ Once or twice daily 5 mg, 10 mg, 15 mg Up to 120 tablets in 30 days
    Dexedrine dextroamphet. Dextrostat 60 mg/ Once or twice daily 5mg, 10mg, 15mg Up to 120 tablets in 30 days
    Dexedrine spansule CR dextroamphet.CR 60 mg/ Once or twice daily 5mg, 10mg, 15mg Up to 90 capsules in 30 days
    Focalin 20 mg/ Twice daily 2.5 mg, 5 mg, 10mg Up to 60 tablets in 30 days
    Focalin XR 20 mg/ Once daily 5 mg, 10 mg, 20 mg Up to 30 capsules in 30 days
    Metadate CD 60 mg/ Once daily 10 mg, 40 mg, 50 mg, 60 mg Up to 30 capsules in 30 days
    Metadate CD 60 mg/ Once daily 20 mg Up to 90 capsules in 30 days
    Metadate CD 60 mg/ Once daily 30 mg Up to 60 capsules in 30 days
    Metadate ER, Methylin, Methylin ER, methylphenidate, methylphen. SR, Ritalin, Ritalin SR 60 mg/ Two or three times daily 5mg, 10mg, 20mg Up to 90 tablets in 30 days
    Methylin chew tablets 60 mg/ Two or three times daily 2.5mg, 5mg, 10mg Up to 180 tablets in 30 days
    Methylin solution 60 mg/ Two or three times daily 5mg/ 5ml Up to 1800ml in 30 days (60ml/day)
    Methylin solution 60 mg/ Two or three times daily 10mg/ 5ml Up to 900ml in 30 days (30ml/day)
    Ritalin LA 60 mg/ Once daily 10 mg, 20 mg, 30 mg, 40 mg Up to 60 capsules in 30 days
    Strattera 100 mg/ Once or twice daily 10mg, 18mg, 25mg, 40mg, 60mg Up to 60 capsules in 30 days
    Strattera 100 mg/ Once or twice daily 80 mg,100 mg Up to 30 capsules in 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 drug class/brand names 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 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. Step-Therapy Criteria

    Under some plans, including plans that use an open or closed formulary, Concerta, Desoxyn, Focalin, Focalin XR, Metadate ER, Methylin (chew tabs, solution), Ritalin, Ritalin LA, Ritalin SR, and Strattera are subject to step-therapy. Aetna considers these medications to be medically necessary for those members who meet the following step-therapy criterion:

    A documented trial of one month of one of the following - methylphenidate, methylphenidate SR, Adderall XR, Metadate CD, Metadate ER - alternatives on the Preferred Drug List.

    If it is medically necessary for a member to be initially treated with a medication subject to Step-Therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (see criteria under section III below).

  3. Medical Exception Criteria

    Ritalin and Ritalin SR currently are listed on the Aetna Step-Therapy List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that require step-therapy criteria, unless a medical exception is granted. Aetna considers Ritalin or Ritalin SR to be medically necessary for those members who meet the criteria below.

    Concerta, Desoxyn, Focalin, Focalin XR, Methylin (chew tabs, solution), Ritalin LA and Strattera are currently listed on the Aetna Formulary Exclusions and Step-Therapy lists.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers these medications to be medically necessary for those members who meet the following criteria:

    • A documented:
      • 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 trial of one month of one preferred alternative indicated for the member's condition.

      OR

    • Member is documented to be currently stabilized on stimulant agent - FOR Concerta, Desoxyn, Focalin, Focalin XR or Strattera ONLY

*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. Cyr MB. Current drug therapy recommendations for the treatment of attention deficit hyperactivity disorder. Drugs 1998 Aug;56(2):215-223.
  2. Dulcan M. Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. American Academy of Child and Adolescent Psychiatry. Journal of American Academy of Child and Adolescent Psychiatry 1997 Oct;36(10 Suppl):85S-121S.
  3. Homer, CJ, et al., Clinical Practice Guideline: Diagnosis and Evaluation of the Child with Attention-deficit/hyperactivity Disorder, Pediatrics, 2000 May: 105(5): 1158-70.
  4. National Attention Deficit Disorder Association, http://www.add.org/.
  5. Zametkin, AJ, Ernst, M, Problems in the Management of Attention-Deficit-Hyperactivity Disorder. N Eng J Med. 1999 January 7; 340(1):40-46.
  6. Elia, J, et al, Treatment of Attention-Deficit-Hyperactivity Disorder. N Eng J Med. 1999; 34(10):780-788.
  7. Hallowell E. An introduction to A.D.D. through questions and answers. Hidden Disorders Conference. Atlanta, GA, 11/15/2001.
  8. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington D.C., American Psychiatric Association, 1994.
  9. Wender EH. Managing stimulant medication for attention-deficit/hyperactivity disorder. Pediatr Rev 2001;22(6):183-90.
  10. American Academy of Pediatrics. Clinical Practice Guideline: Treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics 2001;108:1033-44.
  11. National Institutes of Health Consensus Development Conference Statement: Diagnosis and treatment of attention-deficit/hyperactivity disorder (ADHD). J Am Acad Child Adolesc Psychiatry 2000;39(2);194-7
  12. Manisses Communications Group, Inc. Adult ADHD: Advances in understanding and treatment. Psychopharmacology Update 2002:13(1):4-5.
  13. Kehoe WA. Treatment of attention deficit hyperactivity disorder in children. Ann Pharmacother 2001;35:1130-4.
  14. Searight HR, Burke JM, Rottnek F. Adult ADHD: Evaluation and treatment in family medicine. Am Fam Physician 2000;62:2077-86; 2091-2.
  15. 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.
  16. Pliszka SR, Greenhill LL, Crismon ML, et al. The Texas Children's medication algorithm project: Report of the Texas Consensus Conference Panel on medication treatment of childhood attention-deficit/hyperactivity disorder. Part II: Tactics. J Am Acad Child Adolesc Psychiatry. 2000;39(7):920-7.
  17. Swanson, J et al, Initiating Concerta (OROS methylphenidate HCl) QD in Children with Attention-Deficit Hyperactivity Disorder, Journal of Clinical Research, 2000 ; 3:59-76.
  18. Schachter HM, Pham B, King J, et al. How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? A meta-analysis. CMAJ 2001;165(11):1475-88.
  19. Clinical Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital and Harvard Medical School , Timothy E Wilens on behalf of the Concerta Study Group, Prospective One-Year Study of OROS® MPH Dosed QD in Children with ADHD, poster presentation presented at the American Academy of Neurology Annual Meeting, San Diego, CA, April 29-May 6, 2000.
  20. James M Swanson, Sharon B Wigal, Marc A Lerner and the UCI Concerta Study Group, Comparison of the Efficacy and Safety of OROS Methylphenidate HCl with Methylphenidate TID and Placebo in Children with ADHD, Presented at the Pediatric Academic Societies and American Academy of Pediatrics Joint Meeting, Boston, MA, May 12-16, 2000.
  21. Clinical Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital and Harvard Medical School , Timothy E Wilens on behalf of the Concerta Study Group, Prospective One-Year Study of OROS MPH, Dosed QD in Children with ADHD, Presented at the American Academy of Neurology Annual Meeting, San Diego, CA, April 29-May 6, 2000.
  22. Laurence Greenhill, MD for the Concerta Study Group, Randomized Controlled Trial of OROS Methylphenidate HCl Doses QD in Children with Attention Deficit Hyperactivity Disorder, Presented at the American Psychiatric Association Annual Meeting, Chicago, IL, May 13-18, 2000.
  23. Gonzalez MA, Pentikis HS, Anderl N, et al. Methylphenidate bioavailability from two extended-release formulations. Int J Clin Pharmacol Ther.2002;40:175-84.
  24. Dirksen SJH, D'Imperio JM, Birdsall D, Hatch SJ. A postmarketing clinical experience study of Metadate CD. Curr Med Res Opin. 2002;18:371-80.
  25. Greenhill LL, Findling RL, Swanson JM, and MPH MR AD/HD Study Group. A double-blind, placebo-controlled study of modified-release methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2002;109(3):E39.
  26. Biederman J, Lopez FA, Boellner SW, Chandler MC. A randomized, double-blind, placebo-controlled, parallel-group study of SL1381 (Adderall XR) in children with attention-deficit/hyperactivity disorder. Pediatrics 2002;110 (2 Pt1):258-66.
  27. Michelson D, Adler L, Spencer T, et al. Atomoxetine in adults with AD/HD: Two randomized, placebo-controlled studies. Biol Psychiatry 2003;53:112-20.
  28. Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad Child Adolesc Psychiatry 2002;41(S2):26S-49S.
  29. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006.
  30. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006.
  31. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  32. DRUGDEX® System: Klasco RK (Ed): DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.

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.

March 1, 2006