Appeal type: Formulary Exception
Decision: Overturned

The health plan Determination is Overturned in whole.
The formulary Breeze 2 Test Strips and Kit; Contour Test Strips; Contour Kit, or Contour Link Kit will be or has been ineffective, would not be as effective as the non-formulary drug Dexcom G6 Sensor XX MISC, or would have adverse effects. 

This is a patient diagnosed with Type 1 Diabetes Mellitus (T1DM). This request is for Dexcom receiver G6. As reported patient has significant glycemic variability and is on insulin therapy. Patient has significant insulin sensitivity and hypoglycemia unawareness.  Glycemic control significantly improved while  on Omnipod insulin pump and Dexcom continuous glucose monitoring (CGM) (private pay). 
In the hospital the patient was diagnosed with diabetes Ketoacidosis and T1DM and was discharged on basal insulin therapy. Patient is on Humalog with Insulin to Carb ratio (ICR) was 1:10 and Insulin Sensitivity Factor (ISF) was 1:50. According to the records submitted for review patient was on Freestyle Libre sensor, receiver and reader and has a glucagon kit at home.
GAD was >250; C-peptide was low; A1C was 9.7 %
At a later date A1C  was 5.6 %; and then was 7.6 %
The formulary Breeze 2 Test Strips and Kit; Contour Test Strips; Contour Kit, or Contour Link Kit will be or has been ineffective, would not be as effective as the non-formulary drug Dexcom G6 Sensor XX MISC, or would have adverse effects.

Continuous glucose monitoring systems including real-time systems have Food and Drug Administration (FDA) approval(1, 2). They are not the subject of Phase I-III clinical trials. The peer reviewed literature supports the long-term use of continuous glucose moonitoring system (CGMS) in adult (>=25 year old) patients. The American Diabetes Association (ADA) 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 (age >=25 years) with type 1 diabetes." The ADA 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 is effective in reducing HbA1c in adults with type 1 diabetes over a 6 month period(4).

The latest ADA statement on the standards of medical care in diabetes- 2011 states the following regarding the use of CGM 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 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 in patients with type 1 diabetes with hypoglycemia unawareness and episodes of hypoglycemia(6). The ADA position statement on standards of medical care in diabetes published in January 2009(7) states, "CGM may be a supplemental tool to (self monitoring blood glucose )SMBG in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes." There is evidence that real-time CGMS 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 has type I diabetes and is on an intensive insulin regimen. The patient is reported to have hypoglycemia unawareness. The patient has benefited from continuous glucose monitoring. The formulary alternatives are all blood glucose monitoring devices and do not include an interstitial continuous glucose monitor and are not appropriate alternatives. As described in the studies above, continuous glucose monitoring is superior to blood glucose monitoring especially in patients with hypoglycemia and hypoglycemia unawareness. Blood glucose monitoring is not expected to be as effective as interstitial continuous glucose monitoring. The continuous glucose monitoring receiver is needed for the entire system to function properly. The request is consistent with generally accepted standards of medical practice. The request is therefore medically necessary.