Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Type 2 Diabetes Mellitus.
Treatment: Dexcom Sensor.
The insurer denied: Dexcom Sensor.
The denial is upheld.

This is an adult male diagnosed with type 2 diabetes mellitus. This request is for Dexcom Sensor. As per chart note he is on Dexcom G6 (sensor; receiver and transmitter), Levemir 30 units daily; metformin 1000 mg tablet (1 tablet twice daily). His A1C (glycated hemoglobin) was 6.8 %. 

The health plan should not cover the proposed treatment. 

Continuous glucose monitoring systems including real-time systems have FDA (Food Drug Administration) approval [1, 2]. They are not the subject of Phase I-III clinical trials. The peer 
reviewed literature supports the long-term use of CGMS (continuous glucose monitoring system) in adult patients. The ADA (American Diabetes Association) position statement on 
standards of medical care in diabetes published in January 2011[3], states, "Continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens can be a useful tool to lower A1C in selected adults with type 1 diabetes." The ADA (American Diabetes Association) considers this to have a level of evidence of "A" which is "Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered." This is based on a recent large-scale trial published in the New England Journal of Medicine in September 2008 that showed that CGMS (continuous glucose monitoring system) is effective in reducing HbA1c (glycated hemoglobin), in adults with type 1 diabetes over a 6-month period [4]. The latest ADA (American Diabetes Association) on the standards of medical care in diabetes 2011 states the following regarding the use of CGM (continuous glucose monitoring) in children and adolescents [3]: "Although the evidence for A1C lowering is less strong in children, teens, and younger adults, CGM may be helpful in these groups. Success correlates with adherence to ongoing use of the device." This is based on a recent trial published in the New England Journal of Medicine [5] showing benefit of CGMS (continuous glucose monitoring system) in children and adolescents with type 1 diabetes who are not well controlled. In addition, the peer reviewed literature supports the use of long-term CGMS (continuous glucose monitoring system) in patients with type 1 diabetes with hypoglycemia unawareness and episodes of hypoglycemia [6]. The ADA (American Diabetes Association) position statement on standards of medical care in diabetes published in January 2009[7] states, "CGM may be a supplemental tool to SMBG in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes." There is evidence that real-time CGMS (continuous glucose monitoring system) with an alarm function detects hypoglycemia [8], leads to an improvement in glycemic excursion, leads to a reduction in duration of hypoglycemia prevents hypoglycemic reactions in adult patients with type 1 diabetes [9-12]. Although not all episodes were detected [13], the majority were detected. This represents a 60% reduction in patients with complete hypoglycemia unawareness. 
The patient does not have documentation of type 1 rather than type 2 diabetes in the form of a low c-peptide with positive autoantibodies. Long term CGMS (continuous glucose monitoring system) use in type 2 diabetes has not been shown to improve outcomes except in patients on multiple daily injections of insulin [14-17]. The patient is not on multiple daily injections of 
insulin. The request does not meet the standard of care. The health plan requires the trial and failure of the formulary alternative Accu Chek. The formulary alternative would be as effective as the non-formulary Dexcom as Dexcom has not been shown to be effective in patients not on multiple daily injections of insulin such as this patient as described above.