Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Diabetes
Treatment: Januvia (sitagliptin)
The insurer denied coverage for Januvia (sitagliptin).
The denial is upheld.

According to the medical records, the patient is a male with diagnosis of type 2 diabetes mellitus without complications.  

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 (milligrams) 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 CYP3A4 [Cytochrome] or P-glycoprotein (for example, 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:

American Diabetic Association (ADA), "The choice of medication added to metformin is based on the clinical characteristics of the patient and their preferences. Important clinical characteristics include the presence of established ASCVD [atherosclerotic cardiovascular disease] or indicators of high ASCVD risk, other comorbidities, and risk for specific adverse drug effects, as well as safety, tolerability, and cost. Although there are numerous trials comparing dual therapy with metformin alone, there is little evidence to support one combination over another. A comparative effectiveness meta-analysis suggests that each new class of noninsulin agents added to initial therapy with metformin generally lowers A1C (glycated hemoglobin) approximately 0.71.0% (percent) (46,47). If the A1C target is not achieved after approximately months, metformin can be combined with any one of the preferred six treatment options: sulfonylurea, thiazolidinedione, DPP-4 (dipeptidyl-peptidase 4) inhibitor, SGLT2 inhibitor, GLP-1 RA [glucagon-like peptide-1 receptor agonists], or basal insulin; the choice of which agent to add is based on drug-specific effects and patient factors (Fig. 9.1 and Table 9.1)."
 
Venkata, S., et al (2021), "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 prescribing physician wrote that the patient has tried and had an inadequate treatment response or intolerance to Metformin.

The formulary drug is unlikely to cause an adverse reaction.      

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 (glycated hemoglobin) while remaining safe and tolerable. The efficacy profile of alogliptin is comparable to other DPP-4 inhibitors.     

The patient has not tried and failed the preferred formulary drug, which is Linagliptin.

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