Limited coverage drugs – FreeStyle Libre 2 Flash Glucose Monitor (FGM)
Last updated on September 27, 2024
Note: Special Authority approval is required for coverage, even if a patient is already using a FGM.
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Product name |
FreeStyle Libre 2 Flash Glucose Monitoring (FGM) System |
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Form |
Flash glucose monitor (FGM) |
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Special Authority criteria |
Approval period |
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INITIAL COVERAGE: The patient is 4 years of age or older with diabetes mellitus (DM) and requires multiple daily injections of insulini or insulin pump therapy as part of intensive insulin therapy AND The patient/family/caregiver agrees to comprehensive and age-appropriate diabetes education by an interdisciplinary diabetes healthcare team and commits to regular follow-up AND The patient has one of the following: Hypoglycemia unawarenessii OR Frequent and unpredictable hypoglycemic episodesiii OR Unpredictable swings in blood glucoseiv OR At least one functional restriction that inhibits the use of blood glucose test strips (BGTS) (e.g., dexterity, mobility, dermatological condition) OR An occupation where hypoglycemia presents a significant safety risk (e.g., pilots, air traffic controllers, commercial drivers) |
1 year |
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COVERAGE RENEWAL The patient with DM continues to require multiple daily injections of insulini or insulin pump therapy as part of intensive insulin therapy AND The patient will benefit from continued use of a flash glucose monitor |
5 years |
Practitioner exemptions
- None
Special notes
- i Multiple daily injections of insulin is defined as 1 or more injections of basal insulin and 3 or more injections of bolus insulin with a minimum of at least of 4 total insulin injections per day
- ii Hypoglycemia unawareness is defined as the inability of a patient to recognize or communicate early symptoms of hypoglycemia, resulting in the inability to take corrective action to prevent severe hypoglycemic episodes
- iii Frequent hypoglycemic episodes is defined as more than 3 episodes per week. Unpredictable hypoglycemic episodes is defined as those that are not associated with predictable causes (e.g., physical activity, reduced food intake, acute illness, medication dosing errors)
- iv Unpredictable swings in blood glucose is defined as variability in blood glucose levels of less than 4 mmol/L and/or greater than 10 mmol/L throughout the day that are not associated with a predictable cause (e.g., physical activity, food intake, acute illness, medication dosing errors)