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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Androgens - Topical, Oral, and Injectable Agents

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C danazol oral              
C methyltestosterone oral       X      
C oxandrolone   X          
C testosterone enanthate inj              
C testosterone cypionate inj              
C Androderm®  (testosterone patch)              
C Androgel®  (testosterone topical gel)              
C Methitest®  (methyltestosterone)       X      
NC Anadrol®  (oxymetholone)   X       X  
NC Android®  (methyltestosterone)       X   X  
NC Androxy®  (fluoxymesterone)           X  
NC Delatestryl® inj  (testosterone enanthate)           X  
NC Depo® Testosterone inj  (testosterone cypionate)           X  
NC Oxandrin®  (oxandrolone)   X       X  
NC Striant®  (testosterone buccal system)         X X  
NC Testim®  (testosterone topical gel)         X X  
NC Testred®  (methyltestosterone)       X   X  
NC Winstrol®  (stanozolol)   X       X  


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary  Android, Anadrol, Methitest, methyltesterone, Oxandrin, oxandrolone, Testred and Winstrol are subject to precertification.  If precertification requirements apply Aetna considers Androderm, Androgel, Android, Anadrol, Androxy, Delatestryl, Depo-Testosterone, First Testosterone, Methitest, methyltesterone, Oxandrin, oxandrolone, Striant, Testim, testosterone cypionate, testosterone enanthate, Testred, and Winstrol to be medically necessary for those members who meet the following precertification criteria:

    For Anadrol, Oxandrin, oxandrolone and Winstrol

    Documented diagnosis of wasting syndrome (weight loss/cachexia) due to HIV-AIDS, cancer or other major chronic progressive diseases.

      

    For Android, Methitest, methyltesterone and Testred (for members greater than or equal to 65 years of  age)

    Documentation that:

    • 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

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

    A documented trial of one month of Androderm or Androgel - alternatives on the Aetna Medicare Preferred Drug List

    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 at 1-800-414-2386. (See criteria under section III below.)



  5. Medical Exception Criteria
  6. Anadrol, Android, Androxy, Androgel, Delatestryl, Depo-Testosterone,  Oxandrin, Striant, Testim, Testred and Winstrol 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 Anadrol, Android, Androxy, Androgel, Delatestryl, Depo-Testosterone, Oxandrin, Striant, Testim, Testred and Winstrol to be medically necessary for those members who meet ANY of the following criteria:

    For Android, Androxy, Androgel, Delatestryl, Depo-Testosterone and Testred

    A.   A documented:

    • Contraindication to one covered testosterone alternative indicated for the member's condition OR
    • Intolerance to one covered  testosterone alternative indicated for the member's condition OR
    • Allergy to one covered testosterone alternative indicated for the member's condition OR
    • Failure of an adequate trial of one month of one covered testosterone alternative indicated for the member's condition.

    For Striant and Testim

    A.   A documented:

    • Contraindication to one of the following covered alternatives: Androderm or Androgel OR
    • Intolerance to one of the following covered alternatives: Androderm or Androgel OR
    • Allergy to one of the following covered alternatives: Androderm or Androgel OR
    • Failure of an adequate trial of one month of one of the following covered alternatives: Androderm or Androgel

    For Anadrol, Oxandrin and Winstrol

    A.   A documented:

    • diagnosis of wasting syndrome (weight loss/cachexia) due to HIV-AIDS, cancer or other major chronic progressive diseases.

    AND

    B.   A documented (For Oxandrin ONLY):

    • Contraindication to the covered generic equivalent indicated for the member's condition OR
    • Intolerance to the covered generic equivalent indicated for the member's condition OR
    • Allergy to the covered generic equivalent indicated for the member's condition OR
    • Failure of an adequate trial of one month of the covered generic equivalent indicated for the member's condition.

Place of Service:

Outpatient

The above policy is based on the following references:
  1. Thomson Micromedex USPDI (online thru statref). Montvale, NJ. 2003.
  2. McEvoy GK, editor. AmericanHospitalFormulary Service First Professional Edition (online thru statref). Bethesda, Maryland 2003.
  3. Thomson Physicians Desk Reference (CD-ROM electronic library updated quarterly). Montvale, NJ. 2003
  4. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2003.
  5. Product Information, Testim.  Auxilium Pharmaceuticals, Inc., Noirristown, PA October  2002.
  6. Product Information , Striant.  Columbia labs, Livingston, NJ  June 2003
  7. Product Information Insert. Testoderm/Testoderm with Adhesive/Testoderm TTS Alza Pharmaceuticals, Pal Alto, CA.  January 1998.
  8. Product Information, Androderm.  Watson Pharma, Inc., Corona, CA.  August 1999.
  9. Product Information, AndroGel.  Unimed Pharmaceuticals, Inc., Deerfield, IL Nov 2002
  10. Product Information, First-Testosterone 2% Testosterone propionate ointment compound kit, CutisPHarma Inc, Beverly Ma March 2002
  11. Rolf C.  Interpersonal testosterone transfer after topical application of a newly developed testosterone gel preparation. Clin Endocrinol(Oxf)2002; 56(5): 637-41.
  12. 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.
  13. 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.

October 8, 2007
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