Pharmacy Clinical Policy Bulletins Aetna Medicare Prescription Drug Plan
Subject: Stimulants
Status
Drug
PR-B/D
PR
PR-QL
PR-AL
ST
M EX‡
TOC§
C
amphetamine/ dextroamphetamine
X
X
C
dexmethylphenidate
X
C
dextroamphetamine
X
X
C
dextroamphetamine CR
X
X
C
Dextrostat™ (dextroamphetamine)
X
X
C
Metadate ER 20mg™ (methylphenidate SR)
X
C
methamphetamine
X
C
Methylin® (methylphenidate)-tablets
X
C
Methylin ER® (methylphenidateSR)
X
C
methylphenidate
X
C
methylphenidate SR
X
C
Desoxyn®(methamphetamine)
X
X
X
X
C
Strattera®(atomoxetine)
X
X
X
NC
Adderall®(amphetamine/ dextroamphetamine)
X
X
X
X
NC
Adderall XR®(amphetamine/ dextroamphetamine ER)
X
X
X
X
X
NC
Concerta®(methylphenidate once-daily)
X
X
X
X
NC
Daytrana®(methylphenidate transdermal)
X
X
X
NC
Dexedrine®(dextroamphetamine)
X
X
X
NC
Dexedrine® CR (dextramphetamine CR)
X
X
X
NC
Focalin®(dexmethylphenidate)
X
X
X
X
NC
Focalin XR ®(dexmethylphenidate SR)
X
X
X
X
NC
Metadate CD®(methylphenidate once-daily)
X
X
X
X
NC
Metadate ER 10mg®(methylphenidate SR)
X
X
X
NC
Methylin® chew, solution(methylphenidate)
X
X
X
NC
Ritalin®(methylphenidate)
X
X
X
NC
Ritalin LA®(methylphenidate ER)
X
X
X
X
NC
Ritalin SR®(methylphenidate SR)
X
X
X
NC
Vyvanse®(lisdexamfetamine dimesylate)
X
X
X
X
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, amphetamine/dextroamphetamine, dexmethylphenidate, dextroamphetamine, dextroamphetamine CR, methamphetamine, Methylin, Methylin ER, methylphenidate, methylphenidate SR, Strattera, Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Dexedrine CR, Dextrostat, Focalin, Focalin XR, Metadate CD, Metadate ER, Methylin, Ritalin, Ritalin LA, Ritalin SR and Vyvanse are subject to Precertification as specifically described below.
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, 12.5mg, 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
Daytrana
30mg/ Once daily (remove 9 hours after application)
10 mg, 15 mg, 20mg, 30 mg
Up to 30 patches in 30 days
Desoxyn
methamphetamine
60 mg/ Once or twice daily
5 mg
Up to 120 tablets in 30 days
Dexedrine
dextroamphet.
Dextrostat
60 mg/ Once or twice daily
5 mg, 10 mg, 15 mg
Up to 120 tablets in 30 days
Dexedrine spansule CR
dextroamphet.CR
60 mg/ Once or twice daily
5 mg, 10 mg, 15 mg
Up to 90 capsules in 30 days
Focalin
dexmethylphenidate
20 mg/ Twice daily
2.5 mg 5 mg, 10 mg
Up to 60 tablets in 30 days
Focalin XR
20 mg/ Once daily
5 mg, 10 mg, 15 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
5 mg, 10 mg, 20 mg
Up to 90 tablets in 30 days
Methylin chew tablets
60 mg/ Two or three times daily
2.5 mg, 5 mg, 10 mg
Up to 180 tablets in 30 days
Methylin solution
60 mg/ Two or three times daily
5 mg/5ml
Up to 1800ml in 30 days (60ml/day)
Methylin solution
60 mg/ Two or three times daily
10 mg/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
10 mg, 18 mg, 25 mg, 40 mg, 60 mg
Up to 60 capsules in 30 days
Vyvanse
70 mg/ Once daily
30 mg, 50 mg, 70 mg
Up to 30 capsules in 30 days
For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of stimulant medications 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.
B. Age limit for members greater than or equal to 65 years of age:
A. Member has tried and failed alternative drugs that are appropriate in the elderly
to treat the condition. OR
B. Member has been stabilized on the drug for an extended period and discontinuation or
change in the drug might result in physical and/or mental impairment. OR C. Member is in a critical or terminal state and disruption of therapy at this point would be
inappropriate. AND
Member is being monitored. AND
Member has no known history of emergency department visits and/or hospital admissions
from use of the drug in the member.
Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Focalin, Focalin XR, Metadate CD, Metadate ER 10mg, Methylin chew tabs/solution, Ritalin, Ritalin LA, Ritalin SR, Strattera and Vyvanse are subject to step-therapy. Aetna considers these medications to be medically necessary for those members who meet the following step-therapy criterion:
For Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Focalin, Focalin XR, Metadate CD, Metadate ER 10mg, Methylin chew tabs/solution, Ritalin, Ritalin LA, Ritalin SR and Strattera
A documented trial of one month of one of the following covered alternatives: amphetamine/
dextroamphetamine, dexmethylphenidate, dextroamphetamine, dextroamphetamine CR, Dextrostat, Metadate ER 20mg, methamphetamine, Methylin tablets, Methylin ER, methylphenidate or methylphenidate SR.
For Vyvanse
A documented trial of one month of the covered generic alternative dextroamphetamine CR.
If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, or if the member meets transition of coverage (TOC) criteria for a medication subject to TOC, 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).
Medical Exception Criteria
Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Focalin, Focalin XR, Metadate CD, Metadate ER 10mg, Methylin chew tabs/solution, Ritalin, Ritalin LA, Ritalin SR, Strattera and Vyvanse are currently Not Covered Part D drugs (Please Note: Desoxyn, Metadate ER and Strattera are covered drugs) under the Aetna Medicare Prescription Drug Plan*and are on the Aetna Step-Therapy List.* 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:
For Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Focalin, Focalin XR, Metadate CD, Metadate ER 10mg, Methylin chew tabs/solution, Ritalin, Ritalin LA, Ritalin SR and Strattera
A. A documented:
Contraindication to one of the following covered alternatives: amphetamine/dextroamphetamine, dexmethylphenidate, dextroamphetamine, dextroamphetamine CR, Dextrostat, Metadate ER 20mg, methamphetamine, Methylin tablets, Methylin ER, methylphenidate or methylphenidate SR OR,
Intolerance to one of the following covered alternatives: amphetamine/dextroamphetamine, dexmethylphenidate, dextroamphetamine, dextroamphetamine CR, Dextrostat, Metadate ER 20mg, methamphetamine, Methylin tablets, Methylin ER, methylphenidate or methylphenidate SR OR,
Allergy to one of the following covered alternatives: amphetamine/dextroamphetamine, dexmethylphenidate, dextroamphetamine, dextroamphetamine CR, Dextrostat, Metadate ER 20mg, methamphetamine, Methylin tablets, Methylin ER, methylphenidate or methylphenidate SR OR,
Failure of an adequate trial of one month of one of the following covered alternatives: amphetamine/dextroamphetamine, dexmethylphenidate, dextroamphetamine, dextroamphetamine CR, Dextrostat, Metadate ER 20mg, methamphetamine, Methylin tablets, Methylin ER, methylphenidate or methylphenidate SR OR,
Member has a medical condition or a valid clinical reason that prevents the member from using a preferred oral alternative (Daytrana ONLY) OR
Member has a documented diagnosis of anxiety, seizure disorder, Tourette's or a documented history or risk of drug abuse/rehabilitation (Strattera ONLY)
OR
B. Transition of Coverage: FOR Adderall XR, Concerta, Focalin, Focalin XR, Metadate CD or Ritalin LA - ONLY
Member is within 90 days of his or her effective date of enrollment
Member is stable on Adderall XR, Concerta, Focalin, Focalin XR, Metadate CD, or Ritalin LA for 30 days or longer
If applicable, quantity limits, age or gender edits will apply. Approval is valid one year from the date of request.
If the member has been a Medicare member for 91 days or longer standard precertification, step-therapy, or medical exception criteria will apply.
For Vyvanse
A. A documented:
Contraindication to the covered generic alternative dextroamphetamine CR OR,
Intolerance to the covered generic alternative dextroamphetamine CR OR,
Allergy to the covered generic alternative dextroamphetamine CR OR,
Failure of an adequate trial of one month of the covered generic alternative dextroamphetamine CR
Dexedrine and Dexedrine CR are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* 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. A documented:
Contraindication to one preferred alternative OR,
Intolerance to one preferred alternative OR,
Allergy to one preferred alternative OR,
Failure of an adequate trial of one month of one preferred alternative indicated for the member's condition.
Place of Service:
Outpatient
The above policy is based on the following references:
CyrMB. Current drug therapy recommendations for the treatment of attention deficit hyperactivity disorder. Drugs 1998 Aug;56(2):215-223.
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.
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.
Zametkin, AJ, Ernst, M, Problems in the Management of Attention-Deficit-Hyperactivity Disorder. N Eng J Med. 1999 January 7; 340(1):40-46.
Elia, J, et al, Treatment of Attention-Deficit-Hyperactivity Disorder. N Eng J Med. 1999; 34(10):780-788.
Hallowell E. An introduction to A.D.D. through questions and answers. Hidden Disorders Conference. Atlanta, GA, 11/15/2001.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington D.C., American Psychiatric Association, 1994.
AmericanAcademyof Pediatrics. Clinical Practice Guideline: Treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics 2001;108:1033-44.
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
Manisses Communications Group, Inc. Adult ADHD: Advances in understanding and treatment. Psychopharmacology Update 2002:13(1):4-5.
KehoeWA. Treatment of attention deficit hyperactivity disorder in children. AnnPharmacother 2001;35:1130-4.
Searight HR, Burke JM, Rottnek F. Adult ADHD: Evaluation and treatment in family medicine. Am Fam Physician 2000;62:2077-86; 2091-2.
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.
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.
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.
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.
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.
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.
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.
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.
Gonzalez MA, Pentikis HS, Anderl N, et al.Methylphenidate bioavailability from two extended-release formulations. Int J Clin Pharmacol Ther.2002;40:175-84.
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.
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.
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.
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.
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.
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults.Arch Intern Med. 2003;163:2716-24.
Zahn C, Sangl J, Bierman AS, et al.Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29.
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.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.