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Prior Authorization Protocol
SEROSTIMR (somatropin)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • The treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.
  2. Health Net Approved Indications and Usage Guidelines:
    All of the following must be met:
    • Documented HIV infection with concomitant anti-viral therapy
    • Involuntary weight loss of >10% of body weight
    • Absence of concurrent illness or condition other than HIV infection that could explain the findings (e.g. cancer, tuberculosis, cryptosporidiosis or other specific enteritis)
    • Patient must have adequate appetite
    • If inadequate appetite, failure or clinically significant adverse effects to megestrol acetate or dronabinol to stimulate appetite; if inadequate intake due to nausea, failure or clinically significant adverse effects to the preferred agents for nausea
    • Failure or clinically significant adverse effects to a therapeutic trial of testosterone in combination with an anabolic steroid in males
  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:
    • Micromedex lists the use of Serostim for Fat Maldistribution with HIV Infection as Recommendation IIb.
    • For prior authorization guidelines on the use of Serostim in other indications, please refer to the Human Growth Hormone Guidelines.
    • Body cell mass (BCM): The total mass of all the cellular elements in the body which constitute all the metabolically active tissue of the body. The preferred method for assessing BCM depletion is bioelectrical impedance analysis (BIA) which can be performed with portable equipment in the office setting.
    • Preferred agents for nausea/vomiting include ondansetron, hydroxyzine, promethazine, prochlorperazine, meclizine, trimethobenzamide, or dimenhydranate.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Appetite Stimulants

    Megestrol (MegaceR)

    400 - 800 mg PO daily (10 - 20 ml/day)

    800 mg/day

    Appetite Stimulants

    Dronabinol (MarinolR)

    2.5 mg PO BID

    20 mg/day

    Testosterone Replacement Products

    Testosterone enanthate or cypionate (Various brands)

    100 - 600 mg IM Q1 - 4 wks

    600 mg Q wk

    Testosterone Replacement Products

    AndrodermR (testosterone transdermal)

    2.5 - 7.5 mg patch applied topically QD

    7.5 mg/day

    Testosterone Replacement Products

    AndrogelR (testosterone gel)

    5 - 10 gm gel (delivers 5 - 10 mg testosterone) applied topically QD

    10 gm/day gel (10 mg/day testosterone)

    Testosterone Replacement Products

    TestimR (testosterone gel)

    5 - 10 gm gel (delivers 5 - 10 mg testosterone) applied topically QD

    10 gm/day gel (10 mg/day testosterone)

    Anabolic Steroid

    Oxandrolone (OxandrinR)

    2.5 - 20 mg PO /day

    20 mg/day

    Anabolic Steroid

    Nandrolone decanoate

    100 mg IM Q 1-2 wks

    100 mg Q wk

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

    Serostim

    < 35 kg = 0.1 mg/kg SC daily
    35 to 45 kg = 4 mg SC daily
    45 kg to 55 kg = 5 mg SC daily
    > 55 kg = 6 mg SC daily
    Initial authorization: 12 wks
    Reauthorization: Up to 6 months based on positive response to therapy which is defined as 2% increase in body weight and/or BCM.

    Note: Once BCM is normalized, therapy may be stopped and the patient may be monitored for wasting to reoccur.
  7. Product Availability:
    Vial (powder for injection): 4 mg multi-use vial; 5, 6 mg single-use vial
  8. References:
    1. Serostim [Prescribing information] Rockland, MA: EMD Serono, Inc; April 2012.
    2. Clinical Pharmacology Web site. Available at http://clinicalpharmacology-ip.com/. Accessed July 18, 2013.
    3. Micromedex Healthcare Series [Internet Database]. Greenwood, Colo: Thomson Healthcare. Updated periodically. Accessed June 16, 2014.
    4. Management of tissue wasting in patients with HIV infection. UpToDateR available at: http://www.uptodate.com/home. Accessed June 16, 2014.
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.