Prior Auth Protocol

FDA Approved Indications:

Signifor: For the treatment of adult patients with Cushing`s Disease for whom pituitary surgery is not an option or has not been curative.
Signifor LAR: For the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Health Net Approved Indications and Usage Guidelines:

CUSHINGS DISEASE (Signifor)

Confirmed diagnosis of Cushing`s Disease (CD)

ACROMEGALY (Signifor LAR)

Confirmed diagnosis of acromegaly

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:

Expert consensus recommends transsphenoidal pituitary surgery as first line therapy for all patients with CD unless otherwise contraindicated.
Signifor is currently being investigated for use in treating other types of neuroendocrine tumors. Phase 3 trials have not been published.
The manufacturer recommends testing fasting plasma glucose, hemoglobin A1c, liver function tests, electrocardiogram (ECG), serum potassium, serum magnesium, and gallbladder ultrasound prior to initiation of therapy.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Signifor	0.6 mg or 0.9 mg SC BID	Length of Benefit
Signifor LAR	40 - 60 mg IM every 4 weeks	Length of Benefit

Product Availability:

Signifor: Single-dose ampules: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL
Signifor LAR Kit: 20mg, 40mg, 60mg vials for reconstitution

References:

1. Signifor [prescribing information] East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2015.
2. Colao A, Petersenn S, Newell-Price J, et al. A 12-Month Phase 3 Study of Pasireotide in Cushing`s Disease. N Engl J Med 2012;366:914-24.
3. Biller BM, Grossman AB, Stewart PM, et al. Treatment of Adrenocorticotropin-Dependent Cushing`s Syndrome: A Consensus Statement. J Clin Endocrinol Metab. July 2008, 93(7):2454-2462.
4. Micromedex Healthcare Series [Internet Database]. Greenwood, Colo: Thomson Reuters (Healthcare) Inc. Updated periodically. Accessed June 29, 2015.
5. Pasireotide. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 29, 2015.
6. Signifor LAR [prescribing information] Basel, Switzerland: Novartis Pharma AG; December 2014.
7. Giustina A, Chanson P, Melmed S, et al. Expert consensus document: A consensus on the medical treatment of acromegaly. Nat Rev Endocrinol 2014 Apr;10(4):243-8. Available at: www.nature.com/nrendo/journal/v10/n4/full/nrendo.2014.21.html