Note: Criteria for Antipsychotic-Bipolar drugs are also discussed in the Pharmacy Clinical Policy Bulletin: Antipsychotic-Bipolar Agents
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, Abilify, Abilify Disc, clozapine, Clozaril, Fazaclo, Geodon, Invega, Mellaril, Risperdal, Risperdal M, Seroquel, Seroquel XR, Symbyax, thioridazine, Zyprexa and Zyprexa Zydis are subject to precertification. If precertification requirements apply Aetna considers Abilify, Abilify Disc, clozapine, Clozaril, Fazaclo, Geodon, Invega, Risperdal, Risperdal M, Seroquel, Seroquel XR, Symbyax, thioridazine, Zyprexa and Zyprexa Zydis to be medically necessary for those members who meet the following precertification criteria:
For Abilify, Abilify Disc, clozapine, Clozaril, Fazaclo, Geodon, Invega, Risperdal, Risperdal M, Seroquel, Seroquel XR, Symbyax, Zyprexa and Zyprexa Zydis
A. Quantity limits:
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
2 mg, 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 Disc
30 mg/ once daily
10 mg, 15 mg
Up to 60 tablets 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
900 mg/ up to three times daily
50 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
clozapine
900 mg/ up to three times daily
200 mg
Up to 120 tablets in 30 days
Fazaclo
900 mg/ up to three times daily
12.5 mg
Up to 60 disintegrating 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/day
3 mg, 6 mg
Up to 60 tablets in 30 days
Invega
12 mg/day
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
Up to 60 tablets in 30 days
Risperdal M
16 mg/once or twice daily
4 mg
Up to 120 tablets in 30 days
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
3-25mg; 6-25mg; 6-50 mg; 12-25 mg; 12-50mg
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 capsules in 30 days
Zyprexa Zydis
20 mg/ once daily
5 mg, 10 mg, 15 mg, 20 mg tab
All strengths; 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. 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) OR
Member has had intolerance to drug administered as a single daily dose OR
Member has failed the maximum labeled dose AND has a therapeutic response to a higher dose OR
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
For thioridazine and Mellaril
A. Age limit for members greater than or equal to 65 years of age:
Member has tried and failed alternative drugs that are appropriate in the elderly to the treat the condition OR
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
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, Abilify, Abilify Disc, Geodon and Invega are subject to step-therapy. Aetna considers Abilify, Abilify Disc, Geodon and Invega to be medically necessary for those members who are new starts on these medications not those who are currently stabilized on the medications and who meet the following step-therapy criterion:
For Abilify, Abilify Disc and Geodon
A documented trial of one month of one of the following alternatives on the Aetna Medicare Preferred Drug List: clozapine, Risperdal, Seroquel, Seroquel XR, Zyprexa Zydis or Zyprexa.
For Invega
A documented trial of one month of Risperdal- an alternative on the Aetna Medicare Preferred Drug List
If it is medically necessary for a member to be initially treated 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
Abilify, Abilify Disc, Geodon and Invega are currently listed on the Aetna Step-Therapy List.* If it is medically necessary for a member to be treated initially with one of these medications subject to step-therapy, Aetna considers these drugs to be medically necessary for those members who are new starts and who meet the criteria specified below:
For Abilify, Abilify Disc and Geodon
A. A documented:
Contraindication to one of the following preferred alternatives: clozapine, Risperdal, Seroquel, Seroquel XR, Zyprexa Zydis or Zyprexa OR
Intolerance to one of the following preferred alternatives: clozapine, Risperdal, Seroquel, Seroquel XR, Zyprexa Zydis or Zyprexa OR
Allergy to one of the following preferred alternatives: clozapine, Risperdal, Seroquel, Seroquel XR, Zyprexa Zydis or Zyprexa OR
Failure of an adequate trial of one month of one of the following preferred alternatives: clozapine, Risperdal, Seroquel, Seroquel XR, Zyprexa Zydis or Zyprexa
OR
B. Member is documented to be currently stabilized on one of these antipsychotics: Abilify, Abilify Disc or Geodon.
OR
C. Transition of Coverage:
Member is within 90 days of his or her effective date of enrollment
Member is stable on Abilify, Abilify Disc or Geodon 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 Invega
A. A documented:
Contraindication to the preferred alternative Risperdal OR
Intolerance to the preferred alternative Risperdal OR
Allergy to the preferred alternative Risperdal OR
Failure of an adequate trial of one month to the preferred alternative Risperdal
OR
B. Member is documented to be currently stabilized on Invega.
Clozaril, Haldol, Haldol inj, Loxitane, Mellaril, Navane,Symbyax and Thorazine tabs 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, unless a medical exception is granted. Aetna considers Clozaril, Haldol, Haldol inj, Loxitane, Mellaril, Navane, Symbyax and Thorazine tabs to be medically necessary for those members who are new starts and who meet the criteria below:
For Clozaril, Haldol, Haldol inj, Mellaril, Loxitane, Navane and Thorazine tabs
A documented:
Contraindication to the preferred generic equivalent OR
Intolerance to the preferred generic equivalent OR
Allergy to the preferred generic equivalent OR
Failure of an adequate trial of one month of the preferred generic equivalent
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 be currently stabilized on Symbyax.
OR
C. Transition of Coverage:
Member is within 90 days of his or her effective date of enrollment
Member is stable on Symbyax 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.
Place of Service:
Outpatient
The above policy is based on the following references:
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.
Risch, S. Craig, Pathophysiology of schizophrenia and the role of newer antipsychotics, Pharmacotherapy 1996; 16 (1 pt 2): 115-145.
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
Seroquel Package Insert. AstraZeneca,Wilmington,DE. January 2004
Risperdal Package Insert. Janssen Pharmaceutica Products,Titusville,NJ. December 2003
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics,Montvale,NJ; 2003.
Williamson JS and Wyandt CM. Treating schizophrenia: new strategies. Drug TopicsNovember 6, 2000. P64-73.
Geodon Package Insert.Pfizer,New York, NY. December 2003
Zyprexa Package Insert. Eli Lilly,Indianapolis,IN, March 2004.
Ereshefsky L. Pharmacologic and pharmacokinetic considerations in choosing an antipsychotic. J Clin Psychiatry 1999;69(Suppl 10):20-30.
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.
Abilify Package Insert. Bristol-Myers Squibb,Princeton,NJ. And Otsuka America Pharmaceutical, Inc. March 2004.
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.
Clozaril package Insert. Novartis,East Hanover,NJ. January 2003.
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.
Wood AJJ. Schizophrenia. N Engl J Med. 2004;349:18:1738-49.
Kane JM. Oral ziprasidone in the treatment of schizophrenia: A review of short-term trials. J Clin Psychiatry. 2003;64[suppl 19]:19-25.
Practice Guideline for the Treatment of Patients with Schizophrenia, 2nd Ed. Am J Psychiatry. 2004;161(2) Suppl:1-56.
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.
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.