Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 Diabetes
Treatment: Januvia (sitagliptin)

The insurer denied coverage for Januvia (sitagliptin).
The denial is upheld.

The patient is a female with a history of type 2 diabetes, alcohol use, arthritis, diverticulosis, hypercholesterolemia, hypertension, and obstructive sleep apnea (OSA). She presented to the Endocrinologist's office for a follow up visit for diabetes. Glycated hemoglobin (HbA1c) level slightly improved to 7% (percent). The claimant has a history of Metformin intolerance due to side effects. The physician recommended starting 15 units of Lantus at night (QHS) and continuing 100 milligrams (mg) of Januvia once a day (QD). 

The topic of this review is the request for approval of Januvia (sitagliptin) to treat the patient's condition.  The formulary drug is unlikely to cause an adverse reaction. Januvia and Tradjenta are from the same class of drugs (dipeptidyl peptidase (DPP)-4 inhibitors) and they have similar efficacy and side effect profiles.      

The formulary alternative has not been shown to be ineffective based on the patient's clinical history. There is no provided documentation that the claimant has tried and failed the preferred formulary drug which is Tradjenta (Linagliptin). The formulary alternative of Tradjenta is from the same class of medication that the patient is currently taking.     

The requested drug would not be more effective than the formulary drug. Linagliptin (Tradjenta) alone or in combination with other antidiabetic agents has shown a significant reduction in HbA1c while remaining safe and tolerable. The efficacy profile of alogliptin is comparable to other DPP-4 inhibitors. There are no head-to-head studies, but review of individual studies show that Tradjenta produces the same lowering effect of Januvia.

Linagliptin is available for use as an adjunct to diet and exercise in adults with type 2 diabetes. The usual dose of linagliptin is 5 mg once daily, taken with or without food. It is primarily eliminated via the enterohepatic system. No dose adjustment is necessary in patients with renal or hepatic impairment. Inducers of P-glycoprotein (eg, rifampin) may decrease the efficacy of linagliptin. Therefore, patients requiring such drugs should receive an alternative to linagliptin.

The efficacy of linagliptin as monotherapy and in combination with metformin, glimepiride, combined metformin and sulfonylurea, sodium-glucose cotransporter-2 (SGLT2) inhibitor, or pioglitazone is illustrated by the following trials:

In one trial, 503 patients with diabetes were randomly assigned to linagliptin (5 mg daily) or placebo [67]. After 24 weeks, A1C (Glycated hemoglobin) decreased by 0.44 percentage points in the linagliptin group compared with an increase of 0.25 percentage points in the placebo group. (Del Prato et al.,).

Venkata, S. et al. "DPP-4 inhibitors, known as gliptins, are a class of oral diabetic medications approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus in adults. DPP-4 inhibitors that have FDA approval include sitagliptin, saxagliptin, linagliptin, and alogliptin."                                                       

The insurer's denial of Formulary Exception for Januvia (sitagliptin) is upheld.