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ph-91150

Continuous Glucose Monitor (CGM) Step Therapy with Quantity Limit Program Summary

Policy Number: PH-91150

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

For Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies, the preferred products are Freestyle Libre, Freestyle Libre 2, Freestyle Libre 3, Dexcom G6, and Dexcom G7.

For NetResults A series formulary, the preferred products are Dexcom G6 and Dexcom G7.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
07-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Dexcom G6®
Dexcom G7®
Freestyle Libre®
Freestyle Libre 2®, Freestyle Libre 2 Plus®
Freestyle Libre 3®, Freestyle Libre 3 Plus®

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Continuous Glucose Monitoring (CGM)

Glucose measurements are critical to effective diabetes management. While measurement of glycated hemoglobin (HbA1c) has been the traditional method for assessing glycemic control, it does not reflect intra- and interday glycemic excursions that may lead to acute events (such as hypoglycemia) or postprandial hyperglycemia. These events have been linked to both microvascular and macrovascular complications. While self-monitoring of blood glucose (SMBG) has been shown to improve glycemic control and quality of life in patients, it cannot predict impending hypoglycemia or alert for hypoglycemia. Real-time continuous glucose monitoring (rtCGM) and intermittently viewed CGM (iCGM) address many of the limitations inherent in HcA1c testing and SMBG. rtCGM uniformly tracks the glucose concentrations in the body’s interstitial fluid, providing near real-time glucose data; iCGM uses similar methodology to show continuous glucose measurements retrospectively at the time of checking. Both rtCGM and iCGM facilitate monitoring of time spent in the target glucose range (“time in range”). However, only rtCGM can warn users if glucose is trending toward hypoglycemia or hyperglycemia. With iCGM, these trends can only be viewed after physically scanning the sensor.(1)

CGM affords 2 major benefits over the current standard of SMBG coupled with A1c testing. First, a vast increase in the quantity of blood glucose information, which provides a more comprehensive view of glycemic control. Rather than snapshots in time, continuous information allows us to capture important metrics like time in range, time in hypoglycemia, glucose variability, and many other emerging “glycometrics.” These additional metrics cannot be captured with SMBG, even in the most diligent patients. A CGM recording blood glucose every 5 minutes will record 105,120 BG readings per year compared with between just 1000 to 2000 for a person doing frequent SMBG. Second, is the ability of CGM systems to provide real-time biofeedback. With real-time data now seamlessly available on a user’s mobile device and the internet, easily visible trends and trajectories can help a person understand their own glycemic response in a more meaningful way. Patients can observe which foods and exercises affect them the most. Iterative exposure to this immediate biofeedback allows patients to learn about their own bodies and physiologic responses.(2)

The American Diabetes Association (ADA) guidelines recommend that rtCGM should be offered for diabetes management in adults with diabetes on basal insulin who are capable of using devices safely. The use of CGM and blood glucose monitoring (BGM) devices should be considered from the outset of the diagnosis of diabetes that requires insulin management. The choice of CGM device should be made based on the individual’s circumstances, preferences, and needs. CGM use allows for close tracking of glucose levels with adjustments of insulin dosing and lifestyle modifications and removes the burden of frequent BGM. In addition, early CGM initiation after diagnosis of type 1 diabetes in youth has been shown to decrease A1C levels and is associated with high parental satisfaction and reliance on this technology for diabetes management. According to the ADA, the evidence is insufficient regarding when to prescribe BGM and how often monitoring is needed for insulin-treated people with diabetes who do not use intensive insulin therapy, such as those with type 2 diabetes taking basal insulin with or without oral agents and/or noninsulin injectables. However, for those taking basal insulin, assessing fasting glucose with BGM to inform dose adjustments to achieve blood glucose goals results in lower A1C levels.(3)

REFERENCES

Number	Reference
1	Danne T, Nimri R, Battelino T, et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017;40(12):1631-1640. doi:10.2337/dc17-1600
2	Kompala T, and Neinstein A. “A New Era: Increasing Continuous Glucose Monitoring Use in Type 2 Diabetes”. Evidence-based Diabetes Management. March 2019, Volume 25, Issue 4. Available at: https://www.ajmc.com/view/a-new-era-increasing-continuous-glucose-monitoring-use-in-type-2-diabetes.
3	ElSayed NA, McCoy RG, Aleppo G, et al. 7. Diabetes Technology: Standards of Care in Diabetes—2025. Diabetes Care. 2024;48(Supplement_1):S146-S166. doi:10.2337/dc25-s007

POLICY AGENT SUMMARY STEP THERAPY

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Dexcom g6 receiver ; Dexcom g7 receiver	continuous glucose system receiver**		M ; N ; O ; Y	N
Dexcom g6 sensor ; Dexcom g7 sensor	continuous glucose system sensor**		M ; N ; O ; Y	N
Dexcom g6 transmitter	continuous glucose system transmitter**		M ; N ; O ; Y	N
Freestyle libre 14 day/re ; Freestyle libre 2/reader/ ; Freestyle libre 3/reader/ ; Freestyle libre/reader/fl	continuous glucose system receiver**		M ; N ; O ; Y	N
Freestyle libre 14 day/se ; Freestyle libre 2 plus/se ; Freestyle libre 2/sensor/ ; Freestyle libre 3 plus/se ; Freestyle libre 3/sensor/	continuous blood glucose system sensor** ; continuous glucose system sensor**		M ; N ; O ; Y	N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Dexcom g6 receiver ; Dexcom g7 receiver	continuous glucose system receiver**		1	Receiver	365	DAYS			08627007801 ; 08627009111;
Dexcom g6 sensor ; Dexcom g7 sensor	continuous glucose system sensor**		3	Sensors	30	DAYS			08627005303 ; 08627007701;
Dexcom g6 transmitter	continuous glucose system transmitter**		1	Transmitter	90	DAYS			08627001601;
Freestyle libre 14 day/re ; Freestyle libre 2/reader/ ; Freestyle libre 3/reader/ ; Freestyle libre/reader/fl	continuous glucose system receiver**		1	Reader	365	DAYS			50090710000 ; 57599000021 ; 57599000200 ; 57599080300 ; 57599082000;
Freestyle libre 14 day/se ; Freestyle libre 2 plus/se ; Freestyle libre 2/sensor/ ; Freestyle libre 3 plus/se ; Freestyle libre 3/sensor/	continuous blood glucose system sensor** ; continuous glucose system sensor**		2	Sensors	28	DAYS			57599000101 ; 57599080000 ; 57599081800 ; 57599083500 ; 57599084400;

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Dexcom g6 receiver ; Dexcom g7 receiver	continuous glucose system receiver**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dexcom g6 sensor ; Dexcom g7 sensor	continuous glucose system sensor**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dexcom g6 transmitter	continuous glucose system transmitter**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Freestyle libre 14 day/re ; Freestyle libre 2/reader/ ; Freestyle libre 3/reader/ ; Freestyle libre/reader/fl	continuous glucose system receiver**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Freestyle libre 14 day/se ; Freestyle libre 2 plus/se ; Freestyle libre 2/sensor/ ; Freestyle libre 3 plus/se ; Freestyle libre 3/sensor/	continuous blood glucose system sensor** ; continuous glucose system sensor**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Dexcom g6 receiver ; Dexcom g7 receiver	continuous glucose system receiver**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dexcom g6 sensor ; Dexcom g7 sensor	continuous glucose system sensor**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dexcom g6 transmitter	continuous glucose system transmitter**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Freestyle libre 14 day/re ; Freestyle libre 2/reader/ ; Freestyle libre 3/reader/ ; Freestyle libre/reader/fl	continuous glucose system receiver**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Freestyle libre 14 day/se ; Freestyle libre 2 plus/se ; Freestyle libre 2/sensor/ ; Freestyle libre 3 plus/se ; Freestyle libre 3/sensor/	continuous blood glucose system sensor** ; continuous glucose system sensor**		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

TARGET AGENT(S)	TARGET AGENT(S)
Dexcom G6® Dexcom G7® Freestyle Libre® Freestyle Libre 2® Freestyle Libre 3®	insulin insulin/GLP1 combination (Xultophy, Soliqua)

Target Agent(s) will be approved when ONE of the following is met:

The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
The patient has a medication history of use of in the past 90 days to ONE prerequisite agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
QL	Quantity limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity does NOT exceed the program quantity limit OR The requested quantity exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled quantity for the requested indication AND There is support for therapy with a higher quantity for the requested indication OR BOTH of the following: The requested quantity does NOT exceed the maximum FDA labeled quantity for the requested indication AND There is support for why the requested quantity cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity exceeds the maximum FDA labeled quantity for the requested indication AND There is support for therapy with a higher quantity for the requested indication Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity does NOT exceed the program quantity limit OR
The requested quantity exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled quantity for the requested indication AND
  2. There is support for therapy with a higher quantity for the requested indication OR
2. BOTH of the following:
  1. The requested quantity does NOT exceed the maximum FDA labeled quantity for the requested indication AND
  2. There is support for why the requested quantity cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. BOTH of the following:
  1. The requested quantity exceeds the maximum FDA labeled quantity for the requested indication AND
  2. There is support for therapy with a higher quantity for the requested indication

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ CGM_STQL _ProgSum