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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Antipsychotics/Bipolar Disorder

Status Drug PR PR-QL PR-AL ST M EX‡
P clozapine   X      
P chlorpromazine          
P haloperidol          
P fluphenazine          
P perphenazine          
P prochlorperazine          
P thioridazine          
P trifluoperazine          
P thiothixene          
P Risperdal®  (risperidone)   X      
P Risperdal M®  ((risperidone)disintegrating tab)   X      
P Seroquel®  (quetiapine)   X      
P Seroquel XR®  (quetiapine sr)   X      
P Zyprexa Zydis®  (olanzapine)   X      
P Zyprexa®  (olanzapine)   X      
NP Clozaril®  (clozapine)   X      
NP Compazine®  (prochlorperazine)          
NP Moban®  (molindone)          
NP Navane®  (thiothixene)          
NP Orap®  (pimozide)          
NP Prolixin®  (fluphenazine)          
NP Thorazine®  (chlorpromazine)          
FE Abilify®  (aripiprazole)   X     X
FE Fazaclo®  (clozapine)   X     X
FE Geodon®  (ziprasidone)   X     X
FE Invega™  ((paliperidone SR))   X   X X
Other Medications to Treat Bipolar Disorder
P lamotrigine chew          
P lithium carbonate          
P lithium carbonate SR/ER          
P lithium citrate          
P Depakote®  (divalproex)          
P Depakote ER®  (divalproex)          
P Depakote Sprinkles®  (divalproex)          
P Lamictal®  (lamotrigine)          
NP Eskalith®CR  (lithium carbonate SR)          
NP Lithobid®  (lithium carbonate ER)          
FE Symbyax®  (olanzapine/fluoxetine)   X     X
FE Equetro®  (carbamazepine)         X
Note:

Criteria for Antidepressants AND Anticonvulsants are discussed in the Pharmacy Clinical Policy Bulletins:

Antidepressants /products/rxnonmedicare/data/CNS/antidepressants_2007.html; Anticonvulsants  /products/rxnonmedicare/data/CNS/anticonvulsants_2007.html



Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Abilify, clozapine, Clozaril, Fazaclo, Geodon, Invega, Risperdal, Risperdal M, Serentil, Seroquel, Seroquel XR, Symbyax, Zyprex, and Zyprexa Zydis are subject to precertification.   If precertification requirements apply Aetna considers Abilify, clozapine, Clozaril, Fazaclo, Geodon, Invega, Risperdal, Risperdal M, Serentil, Seroquel, Seroquel XR, Symbyax, Zyprex, and Zyprexa Zydis to be medically necessary for those members who meet the following precertification criteria:

    According to the manufacturer, these antipsychotics 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
    aripiprazole Abilify 30 mg/ once daily 2mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg All strengths; Up to 30 tablets in 30 days
    aripiprazole Abilify 30 mg/ once daily 1 mg/ml solution Up to 900 ml in 30 days
    aripiprazole Abilify 30 mg/ once daily 10 mg, 15 mg disc (disintegrating tablets) Up to 30 in 30 days
    clozapine 900 mg/ up to three times daily 12.5 mg Up to 30 tablets in 30 days
    clozapine Clozaril 900 mg/ up to three times daily 25 mg Up to 90 tablets in 30 days
    clozapine Clozaril 900 mg/ up to three times daily 100 mg Up to 270 tablets in 30 days
    Fazaclo 900 mg/ up to three times daily 12.5 mg Up to 30 tablets in 30 days
    Fazaclo 900 mg/ up to three times daily 25 mg Up to 90 disintegrating tablets in 30 days
    Fazaclo 900 mg/ up to three times daily 100 mg Up to 270 disintegrating tablets in 30 days
    Geodon 160 mg/ up to twice daily 20 mg, 40 mg, 60 mg, 80 mg cap All strengths; Up to 60 capsules in 30 days
    Invega 12 mg/ up to twice daily 3 mg, 6 mg Up to 60 tablets in 30 days
    Invega 9 mg/ once daily 9 mg Up to 30 tablets in 30 days
    Risperdal 16 mg/once or twice daily 4 mg Up to 120 tablets in 30 days
    Risperdal 16 mg/ once or twice daily 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg Up to 60 tablets in 30 days
    Risperdal M 16 mg/ once or twice daily 0.5 mg , 1 mg, 2 mg, 3 mg disintegrating tablet Up to 60 tablets in 30 days
    Risperdal M 16 mg/ once or twice daily 4 mg Up to 120 tablets in 30
    Seroquel 800 mg/ two or three times daily 25 mg Up to 180 tablets in 30 days
    Seroquel 800 mg/ two or three times daily 50 mg Up to 90 tablets in 30 days
    Seroquel 800 mg/ two or three times daily 100 mg Up to 90 tablets in 30 days
    Seroquel 800 mg/ two or three times daily 200 mg Up to 120 tablets in 30 days
    Seroquel 800 mg/ two or three times daily 300 mg Up to 60 tablets in 30 days
    Seroquel 800 mg/ two or three times daily 400 mg Up to 60 tablets in 30 days
    Seroquel XR 800mg/ once daily 200 mg; Up to 30 tablets in 30 days
    Seroquel XR 800mg/ once daily 300 mg; 400 mg Up to 60 tablets in 30 days
    olanzapine/fluoxetine Symbyax 18 mg/75 mg / once or twice daily 12-25 mg; 12-50 mg; 6-25 mg; 6-50 mg; 3-25mg All strengths; Up to 30 capsules in 30 days
    Zyprexa 20 mg/ once daily 2.5 mg Up to 60 tablets in 30 days
    Zyprexa 20 mg/ once daily 5 mg, 7.5 mg, 10 mg, 15 mg, & 20 mg All strengths; Up to 30 tablets in 30 days
    Zyprexa Zydis 20 mg/ once daily 5 mg, 10 mg, 15 mg, 20 mg tab All strengths; Up to 30 tablets in 30 days


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of these antipsychotics 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); except Risperdal 4mg  OR 
    • Member has had intolerance to drug administered as a single daily dose (Abilify 10mg, 15mg, 20mg tablets; Zyprexa/Zyprexa Zydis 5mg, 7.5mg, 10mg) OR 
    • Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fazaclo 100mg; Geodon 60mg, 80mg capsules; Risperdal 3mg, 4mg tablets; Serentil 100mg; Seroquel 200mg, 300mg, 400mg; Zyprexa, Zyprexa Zydis 15mg, 20mg)
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose (Abilify 20mg, 30mg tablets; Clozaril 100mg; Fazaclo 100mg; Geodon 60mg, 80mg; Risperdal 3mg, 4mg; Serentil 100mg; Seroquel 200mg, 300mg, 400mg;  Zyprexa, Zyprexa Zydis 15mg, 20mg).


  3. Step Therapy Criteria
  4. Under some plans, including plans that use an open or closed formulary, Invega is subject to step-therapy.  Aetna considers Invega to be medically necessary for those members who meet the following step-therapy criteria:

    A documented trial of one month of the preferred alternative Risperal.


    If it is medically necessary for a member to be treated initially 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. (See criteria under section III below.)

     

  5. Medical Exception Criteria
  6. Abilify, Equetro, Fazaclo, Geodon and Symbyax are currently listed on the Aetna Formulary Exclusions List.* Therefore, Abilify, Fazaclo, Geodon, Serentil and Symbyax are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Abilify, Fazaclo, Geodon, Serentil and Symbyax to be medically necessary for those members who meet any of the following criteria:

    Invega is currently listed on the Aetna Formulary Exclusions and Aetna Step-Therapy Lists.* Therefore, it is 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 Invega  to be medically necessary for those members who meet the following criteria:

    For Fazaclo
     
    A documented:

    • Contraindication to the preferred alternative generic clozapine OR
    • Intolerance to preferred alternative generic clozapine OR
    • Allergy to preferred alternative generic clozapine OR
    • Failure of an adequate trial of one month of formulary alternative generic clozapine

    For Abilify and Geodon

    A.   A documented:

    • Intolerance to two preferred atypical antipsychotics OR
    • Contraindication to two preferred atypical antipsychotics OR
    • Allergy to two preferred alternative agent indicated for the member's  condition OR
    • Failure of an adequate trial of one month each of two preferred atypical antipsychotics

     OR

    B.  Member is documented to have been successfully treated with requested   antipsychotic in the past - aripiprazole (Abilify) or ziprasidone (Geodon)

    For Symbyax

    A.   A documented:

    • Contraindication to one preferred antipsychotic or other agent indicated  for mania AND one preferred antidepressant OR
    • Intolerance to one preferred antipsychotic or other agent indicated for mania AND one preferred antidepressant OR
    • Failure of an adequate trial of one month each of one preferred antipsychotic or other agent indicated for mania AND one preferred antidepressant

     OR

    B.  Member is documented to have been successfully treated with olanzapine/ fluoxetine (Symbyax) in the past.

    For Equetro

    A.   A documented:

    • Intolerance to two preferred atypical antipsychotics OR
    • Contraindication to two preferred atypical antipsychotics OR
    • Allergy to two preferred alternative agent indicated for the member's  condition OR
    • Failure of an adequate trial of one month each of two preferred atypical antipsychotics

    For Invega

    A.   A documented:

    • Intolerance to preferred alternative agent Risperdal OR
    • Contraindication to preferred alternative agent Risperdal OR
    • Allergy to preferred alternative agent Risperdal indicated for the member's  condition OR
    • Failure of an adequate trial of one month of the  preferred alternative agent Risperdal

Place of Service:

Outpatient

The above policy is based on the following references:
  1. St. Louis, MO. 2006.
  2. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006.
  3. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  4. DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
  5. PDR® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
  6. Risch, S. Craig, Pathophysiology of schizophrenia and the role of newer antipsychotics, Pharmacotherapy 1996; 16 (1 pt 2): 115-145.
  7. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Schizophrenia. J Am Acad Child Adolesc Psychiatry. 2001;40(7 Supl):4S-23S
  8. Seroquel Package Insert. AstraZeneca, Wilmington, DE. January 2004
  9. Risperdal Package Insert. Janssen Pharmaceutica Products, Titusville, NJ. December 2003
  10. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  11. Williamson JS and Wyandt CM. Treating schizophrenia: new strategies. Drug Topics November 6, 2000. P64-73.
  12. Geodon Package Insert. Pfizer, New York, NY.  December 2003
  13. Zyprexa Package Insert. Eli Lilly, Indianapolis, IN, March 2004.
  14. Ereshefsky L. Pharmacologic and pharmacokinetic considerations in choosing an antipsychotic. J Clin Psychiatry 1999;69(Suppl 10):20-30.
  15. Kane JM, Leucht S, Carpenter D, and Docherty JP. The Expert Consensus Guideline Series. Optimizing Pharmacologic Treatment of Psychotic Disorders. J Clin Psychiatry. 2003;64[suppl 12]:1-97.
  16. Abilify Package Insert. Bristol-Myers Squibb, Princeton, NJ. And Otsuka America Pharmaceutical, Inc. March 2004.
  17. Keck Jr PE, McElroy SL, Arnold LM. Advances in the pathophysiology and treatment of psychiatric disorders: Implications for internal medicine. Med Clin North Am 2001;85(3):645-61.
  18. Clozaril package Insert. Novartis, East Hanover, NJ. January 2003.
  19. Pappadopulos E, MacIntyre JC, Crismon ML, et al. Treatment recommendations for the use of antipsychotics for aggressive youth. Part II. J Am Acad Child Adolesc Psychiatry. 2003; 42(2):145-61.
  20. Wood AJJ. Schizophrenia. N Engl J Med. 2004;349:18:1738-49.
  21. Kane JM. Oral ziprasidone in the treatment of schizophrenia: A review of short-term trials. J Clin Psychiatry. 2003;64[suppl 19]:19-25.
  22. Practice Guideline for the Treatment of Patients with Schizophrenia, 2nd Ed. Am J Psychiatry. 2004;161(2) Suppl:1-56.
  23. Correll CU, Leucht S, Kane JM. Lower risk for tardive dyskinesia associated with second-generation antipsychotics: A systematic review of 1-year studies. Am J Psychiatry. 2004;161:414-25
  24. Invega product information. 2006.
  25. Product Information Fazaclo: http://www.fazaclo.com/PDF_Files/FAZACLO_PI.pdf accessed 8-28-07

 

Copyright 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.

October 19, 2007
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