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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
01-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Dexcom G6^® CGM System
Dexcom G7®
Freestyle Libre 2^®
Freestyle Libre^®
Freestyle Libre 3®

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)

Numerous studies have shown that use of rtCGM improves glycemic control and quality of life in both children and adults with type 1 diabetes treated with either continuous subcutaneous insulin infusion or multiple daily insulin injection therapy, improving HbA1c, shortening the time spent in hypoglycemia and hyperglycemia, and reducing moderate-to-severe hypoglycemia. Benefits of rtCGM use have also been reported in individuals with type 2 diabetes who are managed with or without intensive insulin treatment. There is limited data regarding the benefit of rtCGM as an outcome measure for individuals with gestational diabetes mellitus and type 2 diabetes, especially for those who do not use insulin. The benefit of rtCGM is directly correlated to persistence and frequency of use. A meta-analysis found that every 1-day increase of sensor usage per week increased the effect of CGM; the effect on HbA1c is more pronounced the higher the initial HbA1c.(1)

High costs and uncertainty over efficacy and necessity have kept CGM from widespread use in people with type 2 diabetes. However, the newest CGM models, the Abbott Freestyle Libre and Dexcom G6, have begun to overcome many of these technical barriers to use of CGM systems. The sensors are inserted painlessly, are small enough to fit easily under clothing, can remain in place for 10 to 14 days, and are FDA approved as sufficiently accurate to use in lieu of fingersticks to make insulin-dosing decisions. Overcoming another significant barrier to use, data can now be seamlessly and continuously uploaded wirelessly to the cloud via a user’s smartphone.(2)

Technology is rapidly changing, but there is no “one-size-fits-all” approach to technology use in people with diabetes. Patient interest in devices and willingness for adoption can vary. Use of technology should be individualized based on a person's specific needs, preferences, and skill level. In general, no device used in diabetes management works optimally without education, training, and ongoing support.(3)

In the 2023 Guidelines, the American Diabetes Association published a recommendation that rtCGM should be offered for diabetes management in adults with diabetes on basal insulin who are capable of using devices safely.(3)

REFERENCES

Number	Reference
1	Danne T, Nimri R, Barrelino T, et al. “International Consensus on Use of Continuous Glucose Monitoring”. Diabetes Care 2017 Dec;40(12): 1631-1640. Available at: https://care.diabetesjournals.org/content/40/12/1631.
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	American Diabetes Association Professional Practice Committee; 7. Diabetes Technology: Standards of Care in Diabetes-2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S126–S144. https://doi.org/10.2337/dc24-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 of an insulin containing 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 with ST	Quantity limit for the Target Agent(s) will be approved when the following is met: There is support for therapy with a higher quantity Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

QL with ST

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

There is support for therapy with a higher quantity

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_ 01-01-2025