Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: type 2 diabetes mellitus

Treatment: Januvia (sitagliptin).

The insurer is denied coverage for Januvia (sitagliptin).

The denial is upheld. 

This male patient has a history of chronic lymphoid leukemia, type 2 diabetes mellitus, mixed hyperlipidemia, benign essential hypertension, benign prostatic hypertrophy with outflow obstruction, degeneration of lumbar intervertebral disc, and chronic renal insufficiency.

A systematic review was conducted to identify all clinical trials published by 2015 which compared the two drugs in patients with type 2 diabetes. Using keywords such as "linagliptin", "type 2 diabetes mellitus", "sitagliptin" and related combinations, we searched databases including Scopus, PubMed, and Web of Science. The quality of the selected studies was evaluated using the Jadad score. Considering primary and secondary outcomes extracted from the reviewed studies, a network meta-analysis was used to conduct a systematic comparison between the two studied drugs... The results showed no significant difference between linagliptin and sitagliptin in terms of key efficacy and safety outcomes such as HbA1c changes from baseline, body weight change from baseline, percentage of patients achieving HbA1c <7, and percentage of patients experiencing hypoglycemic events (p > 0.05). The results showed that the efficacy of the two drug regimens was the same.

"Sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4I), received Food and Drug Administration (FDA) approval in 2006 for treatment of type 2 DM (T2DM) and dose adjustments prior to and during treatment are recommended to reduce adverse renal events. Other currently available DPP-4I, saxagliptin, alogliptin and vildagliptin, require similar adjustments; however, linagliptin11 is exempt as it is mainly fecally eliminated. Patients receiving dialysis can receive sitagliptin,7 alogliptin8 or vildagliptin, regardless of timing of dialysis; however, with saxagliptin, it is recommended that it should be administered 4hours post-dialysis session as dialysis will remove ~23% of the dose.9" (Singh-Franco et al 2016).

This 24-week, randomized, placebo-controlled, double-blind, parallel-group study was carried out in 82 centres in 10 countries. Patients with HbA1c levels of 7.0-10.0% on metformin and a maximum of one additional antidiabetes medication, which was discontinued at screening, continued on metformin 1500 mg/day for 6 weeks, including a placebo run-in period of 2 weeks, before being randomized to linagliptin 5 mg once daily (n = 524) or placebo (n = 177) add-on. The primary outcome was the change from baseline in HbA1c after 24 weeks of treatment, evaluated with an analysis of covariance (ANCOVA).   Mean baseline HbA1c and fasting plasma glucose (FPG) were 8.1% and 9.4 mmol/l, respectively. Linagliptin [tradjenta]showed significant reductions vs. placebo in adjusted mean changes from baseline of HbA1c (-0.49 vs. 0.15%), FPG (-0.59 vs. 0.58 mmol/l) and 2hPPG (-2.7 vs. 1.0 mmol/l); all p < 0.0001. Hypoglycaemia was rare, occurring in three patients (0.6%) treated with linagliptin and five patients (2.8%) in the placebo group. Body weight did not change significantly from baseline in both groups (-0.5 kg placebo, -0.4 kg linagliptin).  

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 Januvia (sitagliptin).  is upheld.  The medical necessity is not substantiated.