Prior Auth Protocol

FDA Approved Indications:

To improve glycemic control in adults and children with diabetes mellitus.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of Diabetes Mellitus Type 1 or 2

AND

Apidra must be used in regimens that include a longer-acting insulin or basal insulin analog (e.g., insulin NPH, insulin Lantus^R)

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:

There are no studies to support the use of Apidra for treatment of obesity.
Apidra may be infused by external insulin infusion pumps.
Apidra may be administered intravenously under proper medical supervision in a clinical setting for glycemic control.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Humulin R^R (regular insulin) Short Acting	0.5 to 1 U/kg/day SC (Individualize dosage)	This field intentionally left blank.
Humalog^R (insulin lispro) Rapid-Acting	0.5 to 1 U/kg/day SC (Individualize dosage)	This field intentionally left blank.

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Apidra	Doses are individualized. Give SC or IV within 15 minutes before a meal or within 20 minutes after starting a meal	Length of Benefit

Product Availability:

Vials: 100 units per mL (U-100), 10 mL vials
SoloStar^.: 100 units per mL (U-100), 3 mL prefilled pen (package of 5 pens)

References:

1. Apidra [Prescribing Information] Bridgewater, NJ: Sanofi-Aventis; February 2015.

2. Danne T, et al. Pharmacokinetics, prandial glucose control, and safety of insulin glulisine in children and adolescents with type 1 diabetes. Diabetes Care. 2005. 28:2100-2105. http://care.diabetesjournals.org/cgi/content/full/28/9/2100

3. Dailey G, et al. Insulin glulisine provides improved glycemic control in patients with Type 2 diabetes. Diabetes Care. 2004. 27:2363-2368. http://care.diabetesjournals.org/cgi/reprint/27/10/2363

4. Dreyer M, et al. Efficacy and safety of Insulin glulisine in patients with Type 1 diabetes. Hormone and Metabolic Research 2005. 37(11): 702-7.

5. American Diabetes Association Standards of Medical Care in Diabetes. Diabetes Care. 2008. Volume 31: Supplement :S12-S54.

6. American College of Endocrinology Consensus Statement on Guideline for Glycemic Control, Endocrine Practice. 2007;13(suppl 1):S3-S34.

7. Micromedex^R Healthcare Series [Internet Database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed June 5, 2015.

8. Apidra. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 5, 2015.

9. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/default.aspx. Accessed June 5, 2015.