Prior Authorization Protocol SEROSTIM (somatropin)
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. I. 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.
II. 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
III. 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
IV. 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. • Contraindicated in patients with active malignancy, diabetic retinopathy, and who are critically ill.
V. Therapeutic Alternatives: Drug* Dosing Regimen Dose Limit/Maximum Dose Appetite stimulants Megestrol (Megace ) 400 - 800 mg PO daily (10 – 800 mg/day 20 ml/day) Dronabinol (Marinol ) 2.5 mg PO bid 20 mg/day Testosterone replacement products
Confidential and Proprietary Page - 1 Draft Approved: 09.30.03 Approved by Health Net Pharmacy & Therapeutics Committee: 11.19.03, 04.11.06, 05.21.08, 11.19.08, 11.17.10, 11.09.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Updated: 04.13.04, 04.12.05 LR, 06.10.05. LR, 02.15.06 PT, 02.15.07 RJL, 12.04.07 MH, 06.18.08 MH, 01.27.09 MH,03.29.10 R. Gedey,06.30.10 M.Hashemian, 12.06.10 S. Spears, 07.15.11 M. Vien, 07.10.12 T. Wills, 07.17.13 S Ara, 06.16.14 T Kubo,9.10.14 DTeng, 06.17.15 A Giordano, 01.08.16 L Borichevskiy, 12.15.16 A Sahota
Prior Authorization Protocol SEROSTIM (somatropin)
NATL Drug* Dosing Regimen Dose Limit/Maximum Dose Testosterone enanthate or 50 - 400 mg IM Q2 – 4 wks 400 mg 2 wks cypionate (Various brands) Androderm (testosterone 2.5 – 7.5 mg patch applied 7.5 mg/day transdermal) topically QD Androgel (testosterone gel) 5 - 10 gm gel (delivers 50 – 10 gm/day gel (100 mg/day 100 mg testosterone) testosterone) applied topically QD Testim (testosterone gel) 5 - 10 gm gel (delivers 50 – 10 gm/day gel (100 mg/day 100 mg testosterone) testosterone) applied topically QD Anabolic steroid Oxandrolone (Oxandrin ) 2.5 – 20 mg PO /day 20 mg/day Nandrolone decanoate 100 mg IM Q week 100 mg Q wk *Requires Prior Authorization *Check Health Plan for RDL/PDL status
VI. Recommended Dosing Regimen and Authorization Limit: Drug Dosing Regimen Authorization Limit Serostim < 35 kg = 0.1 mg/kg SC daily 6 months or to member's renewal period, whichever is longer 35 to 45 kg = 4 mg SC daily
45 kg to 55 kg = 5 mg SC daily
> 55 kg = 6 mg SC daily
VII. Product Availability: Vial (powder for injection): 4 mg multi-use vial; 5, 6 mg single-use vial
VIII. References: 1. Serostim [Prescribing information] Rockland, MA: EMD Serono, Inc; June 2014... 2. Clinical Pharmacology Web site. Available at http://clinicalpharmacology-ip.com/ . Accessed January 8, 2016. 3. Micromedex Healthcare Series [Internet Database]. Greenwood, Colo: Thomson Healthcare. Updated periodically. Accessed January 8, 2016. .
The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual needs and the benefits covered under your contract.
Confidential and Proprietary Page - 2 Draft Approved: 09.30.03 Approved by Health Net Pharmacy & Therapeutics Committee: 11.19.03, 04.11.06, 05.21.08, 11.19.08, 11.17.10, 11.09.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Updated: 04.13.04, 04.12.05 LR, 06.10.05. LR, 02.15.06 PT, 02.15.07 RJL, 12.04.07 MH, 06.18.08 MH, 01.27.09 MH,03.29.10 R. Gedey,06.30.10 M.Hashemian, 12.06.10 S. Spears, 07.15.11 M. Vien, 07.10.12 T. Wills, 07.17.13 S Ara, 06.16.14 T Kubo,9.10.14 DTeng, 06.17.15 A Giordano, 01.08.16 L Borichevskiy, 12.15.16 A Sahota