056 Form

1

Pharmacy Medical Policy Glucagon-like Peptide-1 (GLP-1) Receptor Agonists and Related Drugs for the Treatment of Type 2 Diabetes Table of Contents Related Policies
Policy
Policy History
Prior Authorization Information
Provider Documentation
Forms
Summary
Individual Consideration
References
Policy Number: 056 BCBSA Reference Number: N/A Related Policies • GLP-1 and GLP-1/GIP Agonist Drugs for Anti-Obesity Management and Other Non-Obesity Conditions #572 • Quality Care Dosing guidelines may apply and can be found in Medical Policy #621B

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 5/2026 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or

2

that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information. This policy applies to members utilizing the below GLP-1 or GIP/GLP-1 receptor agonist medications for the treatment of type 2 diabetes mellitus. Coverage of medications listed below that are FDA-approved for non-diabetic indications can be found in the related medical policy listed above.

Drug Formulary Status (BCBSMA Commercial Plan)

Step Requirement Preferred Liraglutide AG PA, QCD

See below for PA criteria. Mounjaro™ (tirzepatide) PA, QCD Ozempic ® (subcutaneous injection) PA, QCD Rybelsus ® (semaglutide oral) PA, QCD Trulicity ® (dulaglutide) PA, QCD Non-Preferred Adlyxin ™ (lixisenatide) NFNC, PA, QCD

See below for PA criteria. Bydureon ™ (exenatide) NFNC, PA, QCD Byetta ® (exenatide) NFNC, PA, QCD Exenatide NFNC, PA, QCD Soliqua ™ (insulin glargine / lixisenatide) NFNC, PA, QCD Victoza ® (liraglutide) NFNC, PA, QCD Xultophy ® (insulin degludec / liraglutide) NFNC, PA, QCD QCD - Quality Care Dosing (quantity limits policy #621B); NFNC – Non-formulary-Not Covered; PA – Prior Authorization Length of Approval 12 months

Clinical Coverage Criteria INITIAL APPROVAL
Coverage may be considered MEDICALLY NECESSARY when ALL the following criteria are met. Diagnosis Type 2 Diabetes Mellitus Applicable Medications Mounjaro, Ozempic, Rybelsus, Trulicity, Liraglutide

1. Member meets ONE of the following: a. Age 10 years or older for Mounjaro, Trulicity, and Liraglutide b. Age 18 years or older for Ozempic or Rybelsus
   AND
2. Requested drug is not being prescribed for concurrent use with another GLP-1 or GLP-1/GIP receptor agonist AND
3. Has an ICD 10 or documented diagnosis of Type 2 Diabetes Mellitus confirmed by any ONE of the following:
   a. HbA1C > 6.5% b. Fasting plasma glucose (FPG) ≥ 126 mg/dL post 8-hour fast c. 2-hour plasma glucose ≥200 mg/dL during a 75-g oral glucose tolerance test (OGTT)

3

d. Random plasma glucose ≥ 200 mg/dL with presence of classic symptoms of hyperglycemia (polyuria, polydipsia, polyphagia) e. Documented ICD-10 code for Type 2 Diabetes AND

4. Meets ONE of the following%% verified by claim or documented clinical history:
   a. History of antidiabetic medication use such as insulin, sulfonylureas, metformin, SGLT-2 inhibitor (flozins), DPP-IV inhibitor (gliptins) or other
   b. History of intolerance, contraindication, clinically significant adverse effects, or inadequate response to metformin c. For Trulicity Requests: ICD 10 diagnosis code or documentation of chronic kidney disease (CKD) OR established atherosclerotic cardiovascular disease†† (ASCVD) OR at least two risk factors for ASCVD
   d. For Liraglutide and Victoza Requests: ICD 10 diagnosis code or documentation of established atherosclerotic cardiovascular disease†† (ASCVD)
   e. For Ozempic Requests: ICD 10 diagnosis code or documentation of chronic kidney disease (CKD) OR established atherosclerotic cardiovascular disease†† (ASCVD)
   f. For Rybelsus Requests: History or documentation that the patient is at high risk for major cardiovascular (CV) events (e.g CV death, non-fatal myocardial infarction or non-fatal stroke)
   %% - per the American Diabetes Association (ADA) and American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) guidelines †† - ASCVD: Coronary Heart Disease (myocardial infarction, angina, coronary artery disease); Cerebrovascular Disease, (e.g., transient ischemic attack, ischemic stroke); Peripheral Artery Disease; Aortic Atherosclerotic Disease - ASCVD risk factors: Dyslipidemia, Hypertension, Current tobacco use, Obesity/Overweight INITIAL APPROVAL
   Coverage may be considered MEDICALLY NECESSARY when ALL the following criteria are met. Diagnosis Type 2 Diabetes Mellitus Applicable Medications Adlyxin, Bydureon, Byetta, Exenatide, Soliqua, Victoza, Xultophy

5. Member meets ONE of the following: a. Age 10 years or older for Bydureon, and Victoza b. Age 18 years or older for Adlyxin, Byetta, Soliqua, and Xultophy AND
6. Requested drug is not being prescribed for concurrent use with another GLP-1 or GLP-1/GIP receptor agonist AND
7. Has an ICD 10 or documented diagnosis of Type 2 Diabetes Mellitus confirmed by any ONE of the following: a. HbA1C > 6.5%
   b. Fasting plasma glucose (FPG) ≥ 126 mg/dL post 8-hour fast c. 2-hour plasma glucose ≥200 mg/dL during a 75-g oral glucose tolerance test (OGTT)
   d. Random plasma glucose ≥ 200 mg/dL with presence of classic symptoms of hyperglycemia (polyuria, polydipsia, polyphagia) e. Documented ICD-10 code for Type 2 Diabetes. AND
8. Meets ONE of the following%% verified by claim or clinical history:
   a. History of antidiabetic medication use such as Insulin, sulfonylureas, metformin, SGLT-2 inhibitor (flozins), DPP-IV inhibitor (gliptins) or other

4

b. History of intolerance, contraindication, clinically significant adverse effects, or inadequate response to metformin
c. ICD 10 diagnosis code or documentation of established atherosclerotic cardiovascular disease†† (ASCVD) if the request is for Victoza. AND

5. Documented trial or inadequate response, intolerance, or contraindication to at least TWO covered GLP- 1/GLP-1-related formulary alternatives (see formulary drug table above). %% - per the American Diabetes Association (ADA) and American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) guidelines †† - ASCVD: Coronary Heart Disease (myocardial infarction, angina, coronary artery disease); Cerebrovascular Disease, (e.g., transient ischemic attack, ischemic stroke); Peripheral Artery Disease; Aortic Atherosclerotic Disease. ** - ASCVD risk factors: Dyslipidemia, Hypertension, Current tobacco use, Obesity/Overweight

   Appendix We may also use prescription claims records to establish prior use of metformin. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of other.
   Formulary Status For non-covered medications, in addition to the prior authorization criteria, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient. Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug. Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that the member has met all approval criteria. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.

5

(for Atypical Patients) If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289 Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review. Policy History

Date Action 5/2026 Updated Mounjaro due to FDA labeled age expansion. Updated references. 3/15/2026 Updated Rybelsus criteria to include expanded FDA indications 9/15/2025 Added generic exenatide to the policy as a non-preferred agent. Updated formatting and references. 8/1/2025 Added Ozempic expanded indication for CKD 1/2025 Updated to move Victoza to Non-Formulary, Non-Covered (NFNC) and move liraglutide (Authorized Generic of Victoza) to Preferred brand. 10/2024 Updated to add the Authorized Generic Liraglutide to the policy as NFNC. 7/2024 New PA policy created for GLP-1 and GIP/GLP-1 receptor agonists

References

1. American Diabetes Association. Standards of medical care in diabetes – 2022. Diabetes Care. 2022;45(Suppl. 1): S1-S264.
2. Rybelsus® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.;10/2025.
3. Mounjaro™ [package insert]. Indianapolis, IN: Eli Lily and Company; January 2026.
4. Byetta® injection [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.; October 2009.
5. Victoza® injection [package insert]. Princeton, NJ: NovoNordisk; May 2025.

6

6. Garber A, Henry R, Ratner R, et al; for the LEAD-3 (Mono) study group. Liraglutide versus glimeperide monotherapy for type 2 diabetes (LEAD-3 mono): a randomized, 52-week, phase III, double-blind, parallel- treatment trial. Lancet. 2009;373:473-481.
7. Nauck M, Frid A, Hermansen K, et al; for the LEAD-2 study group. Efficacy and safety comparison of liraglutide, glimeperide, and placebo, all in combination with metformin, in type 2 diabetes. Diabetes Care. 2009; 32:84-90
8. Buse JB, Rosenstock J, Sesti G, et al; for the LEAD-6 study group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomized, parallel-group, multinational, open-label trial (LEAD- 6). Lancet. 2009;374:39-47.
9. Rodbard HW, Davidson JA, Garber AJ, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology Consensus Panel of Type 2 Diabetes Mellitus: an algorithm for glycemic control. Endocr Pract. 2009;15(6):540-559
10. Trulicity™ [package insert]. Indianapolis, IN: Eli Lily and Company; September 2020.
11. Xultophy® injection [package insert]. Princeton, NJ: NovoNordisk; May 2025.