#1 CGM in the U.S.*

Reducing diabetes-related costs through life-changing technology^†‡1-7

FreeStyle Libre 3 System sensor and smartphone app, the #1 CGM technology in the U.S.

Use of the FreeStyle Libre portfolio is associated with:

Improved clinical outcomes^{†‡5,6,8-13}

Reduced resource utilization^{†‡2-4,7,14,15}

Budget-neutrality for a health plan (Commercial/Medicaid)^†‡1,16

Diabetes management outcomes for members

Lower HbA1c^†‡8-13

Increased Time in Range^†‡5,13

Reduction in time in hypoglycemia^†‡5,6

Reduction in number of hypoglycemic events^†‡5,6

SEE CLINICAL OUTCOMES

Reduced resource utilization (after purchase)^{†‡2-4,7,14,15}

Studies have demonstrated that use of the FreeStyle Libre portfolio is associated with decreased rates of acute diabetes events and hospital admissions^{†‡2-4,7,14,15}.

66%

reduction in number of diabetes-related hospital admissions^†‡§3

[over 12 months (P<0.001)]

61%

reduction in acute diabetes events among patients with T2DM^†‡||4

(P<0.001)

Comparative effectiveness

Similar acute diabetes event rates compared to a competitor CGM device^†‡¶17

Budget-neutrality

Expanding access to FreeStyle Libre portfolio can be cost-neutral for Medicaid and Commercial plans and can offer cost-savings compared to blood glucose monitoring^†‡#1,16.

Utilization management
Operational efficiencies
Cost savings^**††

SEE PHARMACY COVERAGE

Female diabetes patient discusses FreeStyle Libre 3 system with female doctor

Every 10% change in Time in Range is associated with 0.8% change in HbA1c¹⁹
Time in Range complements HbA1c with more actionable information than using HbA1c alone for a wide range of people with diabetes¹⁸

smartphone screen showing FreeStyle Libre 3 time in range data

Highlights of clinical guidelines for the use of CGM

Several clinical organizations, including the ADA and AACE, have published guidelines for the use of CGM in the management of diabetes^20-22. Highlights from the published guidelines are included below.

American Diabetes Association (ADA)

The ADA published diabetes treatment guidelines as part of the 2023 Standards of Care in Diabetes²⁰, making the following clinical and access recommendations specific to FreeStyle Libre Personal CGMs:

[CGM] should be offered for diabetes management in adults with diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are capable of using devices safely (either by themselves or with a caregiver)
[CGM] should be offered for diabetes management in youth with type 1 [or type 2] diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are capable of using the device safely (either by themselves or with a caregiver)
[CGM] should be offered for diabetes management in adults with diabetes on basal insulin who are capable of using devices safely (either by themselves or with a caregiver)
The type(s) and selection of devices should be individualized based on a person’s specific needs, preferences, and skill level
People with diabetes should have uninterrupted access to their supplies to minimize gaps in continuous glucose monitoring

American Association of Clinical Endocrinologists (AACE)

The AACE published recommendations in 2022²¹, regarding the use of CGMs in the management of people with diabetes. The following recommendations were highlighted with respect to continuous glucose monitoring²¹:

Real-time continuous glucose monitoring (rtCGM) or intermittently scanned continuous glucose monitoring (isCGM) is recommended for all persons with T1D, regardless of insulin delivery system, to improve A1C levels and to reduce the risk for hypoglycemia and DKA
rtCGM or isCGM is recommended for persons with T2D who are treated with insulin therapy, or who have high risk for hypoglycemia and/or with hypoglycemia unawareness
Persons with T2D and their healthcare professionals should use patient-centered shared decision-making to agree on therapy targets and treatments as well as a regimen for glucose monitoring (ie, BGM, structured BGM, or CGM)
Glycemic targets for those using CGM should include achievement of CGM targets such as Time in Range (TIR), percentage in low and very low range, time above range, and glycemic variability

Recommendations from the ADA and AACE on CGM Metrics:

Two metrics, %TIR (Time in Range) and %TBR (Time Below Range), should be used as a starting point for the assessment of quality of glycemic control and as the basis for therapy adjustment, with emphasis on reducing %TBR when the percentages of CGM values failing below 54 mg/dL or 70 mg/dL are close to or exceed targets²¹
Time in range (TIR) is associated with the risk of microvascular complications and can be used for assessment of glycemic control. Additionally, time below range and time above range are useful parameters for the evaluation of the treatment regimen²²

The role of CGM in reducing costs and complications

NDC Codes²³

57599-0002-00: FreeStyle Libre 14 day reader

57599-0001-01: FreeStyle Libre 14 day sensor

57599-0803-00: FreeStyle Libre 2 reader

57599-0800-00: FreeStyle Libre 2 sensor

57599-0818-00: FreeStyle Libre 3 sensor

HCPCS Codes

For therapeutic CGM, the following codes are applicable²⁴:

A4239: Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

E2103: Non-adjunctive, non-implanted continuous glucose monitor or receiver

Class II DME (including FreeStyle Libre 2 system) does not utilize a modifier

KF modifier applies to Class III DME (including FreeStyle Libre 14 day system)

Phone and CGM FreeStyle Libre 3 sensor with app and store icons

At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state.

Medicare coverage is available for the FreeStyle Libre 2 system if the FreeStyle Libre 2 reader is used to review glucose data on some days every month. Medicare and other third party payor criteria apply.

Abbott provides this information as a courtesy, it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payors.

The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app. Use of the FreeStyle Libre 3 app requires registration with LibreView.

FreeStyle Libre 2 and FreeStyle Libre 3 systems are indicated for use in people with diabetes age 4 and older.

* Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
† Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 3 has the same features as FreeStyle Libre 14 day system with real-time glucose alarms. Therefore the study data is applicable to both products.
‡ Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional real-time glucose alarms. Therefore the study data is applicable to both products.
§ Represents percentage of people experiencing a diabetes-related hospital admission.
|| Represents inpatient events or emergency outpatient events for hypoglycemia, hyperglycemia, diabetic ketoacidosis, or hyperosmolarity.
¶ Compared to Dexcom.
# Given that the coverage criteria of CGM for Medicare, the Veterans Administration, Department of Defense, and Indian Health Services is governed at the federal level through policy decisions, a budget impact analysis was not completed for persons covered by these payers.
** Cost savings results from removal of manual prior authorization (PA) process. Under pharmacy benefit, PAs can either be eliminated or automated via smart PA.
†† Does not apply to Medicare and Medicaid.

References: 1. FreeStyle Libre 2 AMCP Dossier 2. Charleer S, et al. Diabetes Care (2020): https://doi.org/10.2337/dc19-1610 3. Fokkert, M. BMJ Open Diabetes Res Care (2019): https://doi.org/10.1136/bmjdrc-2019-000809 4. Bergenstal, R. J Endocr Soc (2021): https://doi.org/10.1210/jendso/bvab013 5. Bolinder, J. The Lancet (2016): https://doi.org/10.1016/s0140-6736(16)31535-5 6. Haak, T. Diabetes Ther (2017): https://doi.org/10.1007/s13300-016-0223-6 7. Miller E, et al. AJMC (2021): https://doi.org/10.37765/ajmc.2021.88780 8. Tyndall, V. Diabetologia (2019): https://doi.org/10.1007/s00125-019-4894-1 9. Evans M, et al. Diabetes Therapy (2022): https://doi.org/10.1007/s13300-022-01253-9 10. Wright, E. Diabetes Spectr (2021): https://doi.org/10.2337/ds20-0069 11. Kroger, J. Diabetes Ther (2020): https://doi.org/10.1007/s13300-019-00741-9 12. Carlson AL, et al. BMJ Open Diabetes Res Care (2022): https://doi.org/10.1136/bmjdrc-2021-002590 13. Campbell, F. Pediatr Diabetes (2018): https://doi.org/10.1111/pedi.12735 14. Kerr M, et al. Poster presented at the ATTD Conference, Madrid, Spain, February 19-22, 2020. https://doi.org/10.1089/dia.2020.2525.abstracts 15. Deshmukh, H. Diabetes Care (2020): https://doi.org/10.2337/dc20-0738 16. Frank, JR. Diabetes Technol Ther (2021): https://doi.org/10.1089/dia.2021.0263 17. Miller E, et al. Am J Med Open (2022): https://doi.org/10.1016/j.ajmo.2022.100008 18. Battelino, T. Diabetes Care (2019): https://doi.org/10.2337/dci19-0028 19. Vigersky, RA. Diabetes Technol Ther (2019): https://doi.org/10.1089/dia.2018.0310 20. ADA. Standards of Care in Diabetes—2023. Diabetes Care (2023) https://doi.org/10.2337/dc23-Srev 21. AACE Clinical Practice Guidelines, Volume 28, Issue 10, P923-1049, (2022): https://doi.org/10.1016/j.eprac.2022.08.002 22. ADA. Standards of Care in Diabetes—2023. Diabetes Care (2023) https://doi.org/10.2337/dc23-S006 23. First DataBank, June 2022. 24. Centers for Medicare & Medicaid Services. CMS Local Coverage Article A52464. Revision Effective January 01, 2023. Accessed January 24, 2023. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52464

ADC-52428 v3.0 02/23

#1 CGM in the U.S.*

Use of the FreeStyle Libre portfolio is associated with:

Improved clinical outcomes^{†‡5,6,8-13}

Reduced resource utilization^{†‡2-4,7,14,15}

Budget-neutrality for a health plan (Commercial/Medicaid)^†‡1,16

Diabetes management outcomes for members

Lower HbA1c^†‡8-13

Increased Time in Range^†‡5,13

Reduction in time in hypoglycemia^†‡5,6

Reduction in number of hypoglycemic events^†‡5,6

Reduced resource utilization (after purchase)^{†‡2-4,7,14,15}

Studies have demonstrated that use of the FreeStyle Libre portfolio is associated with decreased rates of acute diabetes events and hospital admissions^{†‡2-4,7,14,15}.

66%

reduction in number of diabetes-related hospital admissions^†‡§3

61%

reduction in acute diabetes events among patients with T2DM^†‡||4

Comparative effectiveness

Similar acute diabetes event rates compared to a competitor CGM device^†‡¶17

Budget-neutrality

Expanding access to FreeStyle Libre portfolio can be cost-neutral for Medicaid and Commercial plans and can offer cost-savings compared to blood glucose monitoring^†‡#1,16.

Advantages of pharmacy benefit

Time in Range is a new standard of care^18,19

Highlights of clinical guidelines for the use of CGM

View highlights from clinical guidelines

NDC & HCPCS Codes

SITE PAGES

Other Freestyle Libre Sites

Disclaimer

#1 CGM in the U.S.*

Use of the FreeStyle Libre portfolio is associated with:

Improved clinical outcomes†‡5,6,8-13

Reduced resource utilization†‡2-4,7,14,15

Budget-neutrality for a health plan (Commercial/Medicaid)†‡1,16

Diabetes management outcomes for members

Lower HbA1c†‡8-13

Increased Time in Range†‡5,13

Reduction in time in hypoglycemia†‡5,6

Reduction in number of hypoglycemic events†‡5,6

Reduced resource utilization (after purchase)†‡2-4,7,14,15

Studies have demonstrated that use of the FreeStyle Libre portfolio is associated with decreased rates of acute diabetes events and hospital admissions†‡2-4,7,14,15.

66%

reduction in number of diabetes-related hospital admissions†‡§3

61%

reduction in acute diabetes events among patients with T2DM†‡||4

Comparative effectiveness

Similar acute diabetes event rates compared to a competitor CGM device†‡¶17

Budget-neutrality

Expanding access to FreeStyle Libre portfolio can be cost-neutral for Medicaid and Commercial plans and can offer cost-savings compared to blood glucose monitoring†‡#1,16.

Advantages of pharmacy benefit

Time in Range is a new standard of care18,19

Highlights of clinical guidelines for the use of CGM

View highlights from clinical guidelines

NDC & HCPCS Codes

Please contact us for more information about the FreeStyle Libre 3 system and the rest of the FreeStyle Libre portfolio.

SITE PAGES

Other Freestyle Libre Sites

Stay connected

Disclaimer

Improved clinical outcomes^{†‡5,6,8-13}

Reduced resource utilization^{†‡2-4,7,14,15}

Budget-neutrality for a health plan (Commercial/Medicaid)^†‡1,16

Lower HbA1c^†‡8-13

Increased Time in Range^†‡5,13

Reduction in time in hypoglycemia^†‡5,6

Reduction in number of hypoglycemic events^†‡5,6

Reduced resource utilization (after purchase)^{†‡2-4,7,14,15}

Studies have demonstrated that use of the FreeStyle Libre portfolio is associated with decreased rates of acute diabetes events and hospital admissions^{†‡2-4,7,14,15}.

reduction in number of diabetes-related hospital admissions^†‡§3

reduction in acute diabetes events among patients with T2DM^†‡||4

Similar acute diabetes event rates compared to a competitor CGM device^†‡¶17

Expanding access to FreeStyle Libre portfolio can be cost-neutral for Medicaid and Commercial plans and can offer cost-savings compared to blood glucose monitoring^†‡#1,16.

Time in Range is a new standard of care^18,19