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Prior Authorization Protocol
TESTIMR, AXIRONR, FORTESTAR, VOGELXOTM, NATESTO, TESTOSTERONE (testosterone)



NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
  2. Health Net Approved Indications and Usage Guidelines:
    • Deficiency or absence of endogenous testosterone
    AND
    • Failure or clinically significant adverse effects to Androgel
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    This section intentionally left blank.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    AndrogelR 1% (testosterone)

    1% starting dose: 50 mg of testosterone applied topically QD. Dose may be titrated to a maximum of 100 mg QD based on serum testosterone level.

    10 gm gel/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Axiron

    30 mg of testosterone (1 pump actuation) applied topically QD to each axilla. Dose may be titrated to a maximum of 120 mg QD based on serum testosterone level. Dose should be titrated to maintain serum testosterone in the range of 300-1050 ng/dL.

    Length of Benefit

    Fortesta

    40 mg of testosterone (4 pump actuations) applied topically QD to the thighs. Dose may be titrated to a maximum of 70 mg (4 pump actuations on one thigh and 3 pump actuations on the other thigh) QD based on serum testosterone level. Dose should be titrated to maintain serum testosterone in the range of ≥500 and <1250 ng/dL.

    Length of benefit

    Testim

    5 gm of gel (50 mg of testosterone applied topically QD to the shoulders and/or upper arms. Dose may be titrated to a maximum of 100 mg QD based on serum testosterone level. Dose should be titrated to maintain serum testosterone in the range of 300-1000 ng/dL.

    Length of benefit

    Vogelxo

    50 mg of testosterone (one
    tube or one packet or 4 pump actuations) applied topically QD at
    approximately the same time each day to the shoulders and/or upper arms. Dose may be titrated to a maximum of 100 mg QD based on serum testosterone level. Dose should be titrated to maintain serum testosterone in the range of 300-1000 ng/dL.
    Length of benefit

    Natesto

    11 mg of testosterone (2 pump actuations; 1 actuation per nostril) administered intranasally TID. Discontinue therapy when total testosterone concentration consistently exceeds 1050 ng/dL, Alternative treatment should be considered if total testosterone concentration is consistently below 300 ng/dL.

    Length of Benefit

    Testosterone

    50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet) applied topically QD in the morning to the shoulders and upper arms and/or abdomen area (preferably at the same time every day). Dose may be titrated to 100 mg as instructed by the physician. Dose should be titrated to maintain normal range of 298-1043 ng/dL.

    Length of Benefit

  7. Product Availability:
    • Testim: 1% (testosterone gel), 5 gm gel (50 mg testosterone) per tube
    • Fortesta: 60 gm canisters with a metered dose pump. The metered dose pump is capable of dispensing 120 metered pump actuations. Each complete pump actuation dispenses 0.5 gm of gel containing 10 mg testosterone.
    • Axiron: A metered dose pump containing 110 mL of solution. The pump is capable of dispensing 90 mL of solution in 60 metered pump actuations. One pump actuation delivers 30 mg of testosterone in 1.5 mL of solution. Each metered dose pump is supplied with an applicator.
    • Vogelxo: Unit-dose tubes, unit-dose packets, and multiple-dose metered pumps. Each tube or packet provides 50 mg testosterone in 5 gm of gel. One pump actuation delivers 12.5 mg testosterone in 1.25 gm of gel. Each 88-gm pump is capable of dispensing 60 metered pump actuations containing 1.25 gm of gel.
    • Natesto: Intranasal gel, 7.32 g per tube. One pump actuation delivers 5.5 mg of testosterone.
    • Testosterone: Metered-dose pump containing 88g capable of dispensing 60 metered pump actuations; each pump actuation delivers 12.5 mg testosterone in 1.25 gm of gel. Unit dose packet containing 25 mg testosterone in 2.5 gm of gel, 50 mg testosterone in 5 gm of gel.
  8. References:
    1. Testim [Prescribing Information]. Chesterbrook, PA: Auxilium Pharmaceuticals, Inc; June 2014.
    2. Axiron [Prescribing Information]. Indianapolis, IN: Lilly USA; May 2015.
    3. Fortesta [Prescribing Information]. Malvern, PA: Endo Pharmaceuticals Inc.; June 2014.
    4. Vogelxo [Prescribing Information]. Maple Grove, MN: Upsher-Smith Laboratories, Inc.; May 2015.
    5. Natesto [Prescribing Information]. Malvern, PA: Endo Pharmaceuticals Inc.; May 2015.
    6. Testosterone [Prescribing Information]. Allergan, MI: Perrigo Pharmaceuticals; May 2015.
    7. Androgel 1% [Prescribing Information] North Chicago, IL: AbbVie Inc.; May 2015.
    8. Testosterone, Testosterone Cypionate, Testosterone Enanthate, Testosterone Propionate. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 24, 2015.
    9. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colorado: Thomson Healthcare. Updated periodically. Accessed June 24, 2015.
    10. Clinical Pharmacology Web site, Available at http://clinicalpharmacology-ip.com/default.aspx. Accessed June 24, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.