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 cypionate inj
C
testosterone enanthate 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:
Precertification Criteria
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
A documented diagnosis of:
Wasting syndrome (weight loss/cachexia) due to HIV-AIDS, cancer or other major chronic progressive diseases OR
Acquired aplastic anemia OR
Anemia of chronic renal failure OR
Myelosuppression induced by cancer chemotherapy OR
Fanconi's anemia OR
Pure red cell aplasia
For Oxandrin and oxandrolone
A documented diagnosis of:
Wasting syndrome (weight loss/cachexia) due to HIV-AIDS, cancer or other major chronic progressive diseases OR
Alcoholic hepatitis OR
Adjunct for severe burns OR
Adjunctive therapy to promote weight gain in members who have lost weight as a result of chronic infection, extensive surgery, or severe trauma. Also for use to offset protein catabolism after prolonged corticosteroid use, and in members who fail to gain or maintain weight without definite pathophysiologic reasons OR
Bone pain associated with osteoporosis
For Winstrol
A documented diagnosis of:
Cryofibrinogenemia OR
Hereditary angioedema OR
Intractable case of liposclerosis OR
Thrombotic disorder involving congenital or acquired deficiencies in anticoagulant protein C levels OR
Urticaria in combination with corticosteroids
For Android, Methitest, Testred, and methyltesterone (for members greater than or equal to 65 years of age)
Documentation that:
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 of time OR
C. Discontinuation of the drug or change in drug therapy might result in physical and/or mental
impairment OR
D. Member is in a critical or terminal state and disruption of therapy would be inappropriate OR
E. It is medically necessary that the member receive the drug AND Member is being monitored AND Member has no known history of emergency department visits and/or hospital admissions
from use of the drug OR
F. Member received a prescription for the drug from an emergency room physician or from a
physician in an acute care setting and will only be using the drug for a short duration of time.
Step Therapy Criteria
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.)
Medical Exception Criteria
Anadrol, Android, Androxy, 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, 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, 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
A documented diagnosis of:
Wasting syndrome (weight loss/cachexia) due to HIV-AIDS, cancer or other major chronic progressive diseases OR
Acquired aplastic anemia OR
Anemia of chronic renal failure OR
Myelosuppression induced by cancer chemotherapy OR
Fanconi's anemia OR
Pure red cell aplasia
For Oxandrin
A. A documented diagnosis of:
Wasting syndrome (weight loss/cachexia) due to HIV-AIDS, cancer or other major chronic progressive diseases. OR
Alcoholic hepatitis OR
Adjunct for severe burns OR
Adjunctive therapy to promote weight gain in members who have lost weight as a result of chronic infection, extensive surgery, or severe trauma. Also for use to offset protein catabolism after prolonged corticosteroid use, and in members who fail to gain or maintain weight without definite pathophysiologic reasons OR
Bone pain associated with osteoporosis
AND
B. A documented:
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.
For Winstrol
A documented diagnosis of:
Cryofibrinogenemia OR
Hereditary angioedema OR
Intractable case of liposclerosis OR
Thrombotic disorder involving congenital or acquired deficiencies in anticoagulant protein C levels OR
Urticaria in combination with corticosteroids
Place of Service:
Outpatient
The above policy is based on the following references:
Product Information, First-Testosterone 2% Testosterone propionate ointment compound kit, CutisPHarma Inc, Beverly Ma March 2002
Rolf C. Interpersonal testosterone transfer after topical application of a newly developed testosterone gel preparation.Clin Endocrinol(Oxf)2002; 56(5): 637-41.
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,BiermanAS, et al. Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29.
ARCHIVE VERSION
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
CS = Covered under Specialty Tier
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.
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