Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 diabetes

Treatment: Janumet (sitagliptin-metformin)

The insurer is denied coverage for Janumet (sitagliptin-metformin).

The denial is upheld. 

This male patient has a history of Type 2 diabetes.

As per Up to Date "Sitagliptin, saxagliptin, linagliptin, and alogliptin are the dipeptidyl peptidase 4 (DPP-4) inhibitors available for the treatment of type 2 diabetes in the United States and many other countries. ..." With regard to "Glycemic efficacy - The DPP-4 inhibitors appear to have similar glycemic efficacy [7]. They result in modest improvement in glycated hemoglobin (A1C)".
Per the American Diabetic Association, (2020), "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 approximately 0.71.0% (46,47). If the A1C target is not achieved after approximately 3 months, metformin can be combined with any one of the preferred six treatment options: sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT2 [sodium-glucose co-transport 2] 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."        
Based on the medical facts from the available records, the formulary drugs are unlikely to cause an adverse reaction. Dipeptidyl peptidase 4 (DPP-4) inhibitors have the same mechanism of action and similar side effect profile for the treatment of type 2 diabetes.      
The requested drug would not be more effective than the formulary drugs. Dipeptidyl peptidase 4 (DPP-4) inhibitors have the same efficacy. Therefore, the formulary options would be medically appropriate. 
The formulary alternatives, Jentadueto, is a combo of linagliptin and metformin, similar to how Janumet is a combo of sitagliptin and metformin. There are no listed contraindications to, or past intolerances of the plan's formulary options.  A trial of the formulary alternatives to treat this patient's condition would be reasonable.

The health plan did act reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for the Janumet (sitagliptin-metformin) is upheld.  The medical necessity is not substantiated.