Prior Auth Protocol

FDA Approved Indications:

Treatment of acromegaly in patients who have had an inadequate response to surgery, or radiation therapy, or for whom these therapies are not appropriate

Health Net Approved Indications and Usage Guidelines:

AND

Failure of surgery or radiation therapy unless surgery or radiation therapy is not appropriate for the patient

AND

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:

The therapeutic goal is normalization of age-adjusted serum insulin-like growth factor-I (IGF-I) levels. Pegvisomant interferes with commercially available growth hormone assays; therefore, growth hormone levels should not be used to adjust therapy.
Patients should be monitored for growth hormone deficiency.
Patients should have liver function tests at baseline and monthly for the first 6 months, quarterly for the next six months and every 6 months thereafter if normal. Package insert information contains recommendations if test results are abnormal.
Patients with diabetes should be monitored for hypoglycemia. Adjustments of hypoglycemic agents may be necessary.
According to the 2011 American Association of Clinical Endocrinologists (AACE) Acromegaly Guidelines, Endocr Pract. 2011;17(Suppl 4), combo therapy may be warranted if patients are partial responders to somatostatin analogs. However, combo therapy can lead to increased Liver Function Tests (LFTs) and should be monitored closely.
Temporary use while awaiting the results of surgery or radiation therapy is not recommended.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
octreotide (Sandostatin^R)*	100 to 500 mcg SC TID	1500 mcg/day
Somatuline depot^R(lanreotide)	60 to 120 mg SC q 4 weeks	120 mg q 4 weeks
Sandostatin^RLAR (octreotide)*	10 - 40 mg IM q 4 weeks	40 mg q 4 weeks

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Somavert	Initial dose: 40 mg loading dose SC followed by 10 mg SC QD adjusted to serum IGF-I levels. Maximum daily maintenance dose: 30 mg	6 months with re-approval upon demonstrated age-adjusted IGF-I levels in the normal range.

Product Availability:

Lyophilized powder for injection: 10 mg, 15 mg, 20 mg, 25 mg, 30 mg pegvisomant protein with diluent

References:

Somavert [Prescribing information] New York, NY; Pfizer Pharmacia & Upjohn Co; August 2014.
Clinical Pharmacology Web site. Available at http://www.clinicalpharmacology-ip.com. Accessed May 29 2015.
Micromedex Healthcare Series [Internet Database]. Greenwood, Colo: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed May 29 2015.
Pegvisomant. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 29 2015.
Melmed S, Colao A, Barkan A, et al. Guidelines for acromegaly management: An update. J Clin Endocrinol Metab; 2009;94:1509-1517.
Neggers SJ, van Aken MO, Janssen JA, et al. Long-term efficacy and safety of combined treatment of somatostatin analogs and pegvisomant in acromegaly. J Clin Endocrinol Metab 2007;92:4598-4601.
AACE Acromegaly Guidelines, Endocr Pract. 2011;17(Suppl 4).