Prior Auth Protocol

FDA Approved Indications:

The treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and to improve physical endurance. Concomitant antiretroviral therapy is necessary.

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
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
Weight at time of request is provided

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

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.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Appetite stimulants Megestrol(Megace^R)	400 - 800 mg PO daily (10 - 20 ml/day)	800 mg/day
Appetite stimulants Dronabinol (Marinol^R)	2.5 mg PO bid	20 mg/day
Testosterone replacement products Testosterone enanthate or cypionate (Various brands)	100 mg IM every 1 week to 400 mg IM every 2-4 weeks	400 mg IM every 2 weeks
Testosterone replacement products Androderm^R (testosterone transdermal)	2 - 4 mg/day patch applied topically QD	6.0 gm/day
Testosterone replacement products Androgel^R (testosterone gel)	5 - 10 gm gel (delivers 50 100 mg testosterone) applied topically QD	10 gm/day gel (100 mg/day testosterone)
Testosterone replacement products Testim^R (testosterone gel)	5 - 10 gm gel (delivers 50 100 mg testosterone) applied topically QD	10 gm/day gel (100 mg/day testosterone)
Anabolic steroids Oxandrolone (Oxandrin^R)	2.5 - 20 mg PO/day	20 mg/day
Anabolic steroids Nandrolone decanoate	100 mg IM Q 1-2wks	100 mg Q wk

* Requires Prior Authorization

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.

Product Availability:

Vial (powder for injection): 4 mg multi-use vial; 5, 6 mg single-use vial

References:

1. Serostim [Prescribing information] Rockland, MA: EMD Serono, Inc; June 2014..
2. Clinical Pharmacology Web site. Available at http://clinicalpharmacology-ip.com/. Accessed June 17, 2015.
3. Micromedex Healthcare Series [Internet Database]. Greenwood, Colo: Thomson Healthcare. Updated periodically. Accessed June 17, 2015.
4. Management of tissue wasting in patients with HIV infection. UpToDate. available at: http://www.uptodate.com/home. Accessed June 17, 2015.
5. Androderm [Prescribing Information] Parssipany, NJ: Actavis Pharma Inc.; May 2015.
6. Testosterone Cypionate Injection [Prescribing Information] New York, NY: Pharmacia and
Upjohn Company; April 2015.