Prior Auth Protocol

FDA Approved Indications:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Health Net Approved Indications and Usage Guidelines:

AND

Failure to achieve HgbA1C less than or equal to 6.5% on at least 1,500 mg per day of metformin, unless contraindicated

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:

Both the American Diabetes Association guideline and the American Association of Clinical Endocrinologists/American College of Endocrinology algorithm recommend metformin as an initial first line agent due to its safety and efficacy profile.
Warning of acute pancreatitis and hepatic failure (fatal) postmarking.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
metformin (Glucophage^R)	500 mg PO BID or 850 mg PO QD	2,550 mg/day
glyburide (Micronase^R Diabeta^R)	2.5-5 mg PO QD	20 mg/day
glyburide, micronized (Glynase^RPres Tab)	1.5 to 3 mg PO QD	12 mg/day
glimepiride (Amaryl^R)	1-2 mg PO QD	8 mg/day
glipizide (Glucotrol^R)	5-40 mg PO QD	40 mg/day
glipizide ER (Glucotrol XL^R)	5-20 mg PO QD	20 mg/day
pioglitazone (Actos^R)	15-45 mg PO QD	45 mg/day
Tradjenta^TM (linagliptin)	5 mg PO QD	5 mg/day
Onglyza^TM(saxagliptin)	2.5-5 mg PO QD	5 mg/day
acarbose (Precose^R)	25 - 100 mg PO TID	300 mg/day
Glyset^R(miglitol)	25 - 100 mg PO TID	300 mg/day
Invokana^TM (canagliflozin)	100 mg PO QD	300 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Nesina	25 mg PO QD CrCL 30-60: 12.5 mg PO QD CrCL <30: 6.25 mg PO QD	Length of Benefit

Product Availability:

Nesina Tablets: 25 mg, 12.5 mg, 6.25 mg

References:

Neisna [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; August 2013.
Rodbar HW, wt al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology Consensus Panel on Type 2 Diabetes Mellitus: An Algorithm for Glycemic Control. Endocrine Practice, volume 15, number 6, September/October 2009.
Inzucchi SE, et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Diabetes Care (online). care.diabetesjournals.org April 2012.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 28, 2015.