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Pharmacy Medical Policy Diabetes Step Therapy Table of Contents Authorization Information Summary
Coverage Criteria Appendix Policy History
Coding Information References Endnotes
Policy Number: 041 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply and can be found in Medical Policy #621B • Heart Failure and Hypertrophic Cardiomyopathy Medical Policy #063 • GLP-1 and GLP-1/GIP Agonists for Anti-Obesity Management and Other Non-Obesity Conditions

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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 3/15/2026 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 that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.

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See Appendix for additional information.

Summary This is a comprehensive policy covering step therapy and quantity limit requirements for oral anti-diabetic medications.
This step therapy policy applies to members utilizing the below medications for the treatment of diabetes. Coverage of medications listed below that are FDA-approved for non-diabetic indications can be found in the related medical policies listed above. Policy Length of Approval 24 months Formulary Status All requests must meet the Step Therapy requirement and for non-covered medications, 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.

Traditional Anti-diabetic Medications Coverage for traditional anti-diabetic medications may be may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:

1. Documented diagnosis of Type 2 Diabetes Mellitus AND

2. Meet the step therapy requirements described below.
   Drug Formulary Status (BCBSMA Commercial Plan) Step Requirement Step 1 Generics in Alpha-Glucosidase Inhibitor class (e.g., acarbose) Covered

   Covered with no requirements Generics in Biguanide class (e.g., metformin); Excluding ER generics of Fortamet & Glumetza Covered Generics in Diabetic Combination (e.g., glyburide-metformin); Excluding Pioglitazone combinations) Medications class Covered Generics in D-Phenylalanine class (e.g., Nateglinide) Covered Generics in Meglitinide class (e.g., Repaglinide) Covered Generics in Sulfonylurea class (e.g., glyburide) Covered

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Formulary Injectable Insulin (e.g., Novolin/Novolog) Covered, QCD Step 2 Actos ® (pioglitazone) ST, QCD Requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication in this table within the previous 130 days.

See below for prior use criteria.

Afrezza ® (Insulin) ST Avandia ® (rosiglitazone) ST, QCD Kerendia ® (finerenone) ST, QCD pioglitazone ST, QCD pioglitazone & glimepiride ST pioglitazone & metformin ST, QCD Riomet ER ™ (metformin Solution) ST Step 3 Actoplus Met ® (pioglitazone / metformin) NFNC, QCD Requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication in this table within the previous 130 days.

See below for prior use criteria. Duetact ® (pioglitazone and glimepiride) NFNC Cycloset (Bromocriptine Mesylate) NFNC Fortamet ® (metformin) NFNC Glumetza ® (metformin) NFNC Glynase ® (glyburide) NFNC metformin hydrochloride ER (Generic of Glumetza ®) NFNC metformin hydrochloride 625mg NFNC Metformin hydrochloride 750 mg NFNC metformin hydrochloride Film-Coated ER (Generic of Fortamet ®) NFNC Precose ® (acarbose) NFNC Riomet ® (metformin solution) ST QCD - Quality Care Dosing (quantity limits policy #621B); ST – Step Therapy, NFNC – Non-Formulary Non-Covered

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Coverage of DPP-4 inhibitors may be may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:

1. Documented diagnosis of Type 2 Diabetes Mellitus AND
2. Meet the step therapy requirements described below.
   Drug Formulary Status (BCBSMA Commercial Plan) Step Requirement Step 1 Generics in Alpha-Glucosidase Inhibitor class (e.g., acarbose) Covered Covered with no requirements Generics in Biguanide class (e.g., metformin); Excluding ER generics of Fortamet & Glumetza Covered Generics in Diabetic Combination (e.g., glyburide- metformin); Excluding Covered

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Pioglitazone combinations) Medications class Generics in D-Phenylalanine class (e.g., Nateglinide) Covered Generics in Meglitinide class (e.g., Repaglinide) Covered Generics in Sulfonylurea class (e.g., glyburide) Covered Formulary Injectable Insulin (e.g. Novolin/Novolog) Covered, QCD Step 2 Glyxambi ® (empagliflozin / linagliptin) ST, QCD Requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication in this table within the previous 130 days.

See below for prior use criteria.

Janumet ™ (sitagliptin / metformin) ST Janumet ™ XR (sitagliptin / metformin) ST Januvia ™ (sitagliptin) ST saxagliptin ST saxagliptin/metformin ST Trijardy XR ™ (empagliflozin / linagliptin & metformin) ST, QCD Step 3 Alogliptin NFNC Requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication in this table within the previous 130 days.

See below for prior use criteria.

Alogliptin & Metformin NFNC Alogliptin & Pioglitazone NFNC Brynovin (sitagliptin) NFNC Jentadueto ™/ XR (linagliptin / metformin) NFNC Kazano ™ (alogliptin / metformin) NFNC Kombiglyze ™ XR (saxagliptin / metformin) NFNC linagliptin / metformin NFNC Nesina ™ (alogliptin) NFNC Onglyza ™ (saxagliptin) NFNC Oseni ™ (alogliptin / pioglitazone) NFNC Qtern ® (dapagliflozin / saxagliptin) NFNC, QCD sitagliptin NFNC sitagliptin / metformin NFNC Steglujan ™ (ertugliflozin and sitagliptin) NFNC, QCD Tradjenta ™ (Linagliptin) NFNC Zituvimet (sitagliptin/metformin) NFNC Zituvio ® (sitagliptin) NFNC QCD - Quality Care Dosing (quantity limits policy #621B); ST – Step Therapy, NFNC – Non-Formulary Non-Covered

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Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors Coverage of SGLT2 inhibitors may be may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:

1. Documented diagnosis of Type 2 Diabetes Mellitus AND

2. Meet the step therapy requirements described below.
   Drug Formulary Status (BCBSMA Commercial Plan) Step Requirement Step 1 Generics in Alpha-Glucosidase Inhibitor class (e.g., acarbose) Covered Covered with no requirements.

   Generics in Biguanide class (e.g., metformin); Excluding ER generics of Fortamet & Glumetza Covered Generics in Diabetic Combination (e.g., glyburide- metformin); Excluding Pioglitazone combinations) Medications class Covered Generics in D-Phenylalanine class (e.g., Nateglinide) Covered Generics in Meglitinide class (e.g., Repaglinide) Covered Generics in Sulfonylurea class (e.g., glyburide) Covered Formulary Injectable Insulin (e.g. Novolin/Novolog) Covered, QCD Step 2 Farxiga ® (dapagliflozin) ST, QCD Requires prior use of ONE step 1 medication OR history of prior use of any step 2 medication in this table within the previous 130 days.

   See below for prior use criteria. Glyxambi ® (empagliflozin / linagliptin) ST, QCD Jardiance ® (empagliflozin) ST, QCD Synjardy ® (empagliflozin / metformin) ST, QCD Synjardy ® XR (empagliflozin / metformin) ST, QCD Trijardy XR ™ (empagliflozin / linagliptin & metformin) ST, QCD Xigduo ™ XR (dapagliflozin / metformin) ST, QCD Step 3 Brenzavvy ™ (bexagliflozin) NFNC, QCD Requires prior use of TWO step 2 medications OR history of prior use of a step 3 medication in this table within the previous 130 days.

   See below for prior use criteria. bexagliflozin NFNC, QCD dapagliflozin NFNC, QCD dapagliflozin /metformin NFNC, QCD Invokamet ™/ XR (canagliflozin / metformin) NFNC, QCD

   Invokana ™ (canagliflozin) NFNC, QCD Qtern ® (dapagliflozin / saxagliptin) NFNC, QCD Steglatro ™ (ertugliflozin) NFNC, QCD

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Steglujan ™ (ertugliflozin and sitagliptin) NFNC, QCD Segluromet ™ (ertugliflozin and metformin) NFNC, QCD QCD - Quality Care Dosing (quantity limits policy #621B); ST – Step Therapy, NFNC – Non-Formulary Non-Covered

Appendix Prior Use of Criteria

The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information.
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 (for Atypical Patients) 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.
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:

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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 3/15/2026 Added linagliptin/metformin as Step 3. 1/15/2026 Added Brynovin as Step 3. Updated references. 1/2026 Added Cycloset as Step 3. Updated formatting and references. 6/2025 Clarified/updated the examples of preferred insulins (e.g. Novolin/Novolog) 2/2025 Updated to add Zituvimet to the DPP-4 table as NFNC also updated to add Metformin 750mg immediate release to Step 3 of the traditional table in the policy. 10/2024 Updated to add bexagliflozin to step 3 of SGLT2 table. 8/2024 Updated to add sitagliptin & sitagliptin/metformin to the policy. 7/2024 Update to remove GLP-1s from policy and place them in Policy 056. 4/2024 Clarified coding for Glynase ® and Duetact ®. 3/2024 Updated to add Zituvio ® (sitagliptin) to Step 3 in the DPP-4 table and added AG of Farxiga and Xigduo to Step 3 of the SGLT2 table. 1/2024 Updated to add saxagliptin/metformin to Step 2 in the DPP-4 table 10/2023 Updated to add saxagliptin to Step 2 in the DPP-4 table and Brenzavvy ™ to step 3 in the SGLT2 table. 9/2023 Reformatted policy. Updated IC section to align with 118E MGL § 51A. 7/2023 Reformatted Policy. 1/2023 Updated to add Ozempic ®, Rybelsus ® and Victoza ® to preferred and to move Onglyza Kombiglyze ®, Byetta ®, and Bydureon ™ to non-covered.
8/2022 Updated to add Mounjaro to Step 2 of the GLP table and Metformin 625mg to the Step 3 Traditional table in the policy. 4/2022 Updated to clarify Actoplus Met® coding as non-preferred. 1/2022 Updated to add Trijardy XR™ to Step two in SGLT2 & DPP4 tables 10/2021 Updated to include Kerendia ® as step 2 drug and also added an ASCVD automation to Jardiance ® and Farxiga ®. 4/2021 Updated to remove Avandamet as FDA discontinued marketing. 10/2020 Updated to make Farxiga® & Xigduo™ XR step 2 and to move Invokana™ & Invokamet™/XR to step 3. 6/2020 Updated to include Trijardy™ XR to the policy. 2/2020 Updated to add Rybelsus® to Step 3 1/2020 Updated Step 3 criteria to require two step 2 medications prior to an approval. 9/2019 Updated to revise Step Criteria. 1/2019 Updated to add Glyxambi® to Step 2 and to make Victoza® Not Covered. 5/2018 Updated to Include Ozempic, Steglatro, Steglujan, and Segluromet. 1/2018 Updated to include Class specific tables inside of the policy plus merged in policy

282 GLP1s.

4/2017 Added Alogliptin and Alogliptin/Metformin Authorized generics to Step 3. 1/2017 Added Synjardy to Step 2. 3/2016 Added metformin hydrochloride ER to step 3 & added Standard PA form. 12/2015 Updated to include Glyxambi®

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8/2015 Updated to add Afrezza® to step2. 1/2015 Updated to include Xigduo™XR on Step 3. 11/2014 Updated to include Jardiance® as step 2. 8/2014 Update Step 1 for Pioglitazone combinations exception. 6/2014 Updated to include Farxiga on Step 3. 3/2014 Updated policy to add Step 1 classes section and Step 3 drugs section and added standard step language. 1/2014 Pioglitazone/glimepiride, Nesina™, Oseni™, Kazano™, Invokana™ to step 2. Updated ExpressPAth language. 8/2012 Updated 8/12 to include coverage criteria for pioglitazone/metformin, pioglitazone, Janumet™ XR and Jentadueto™. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
7/2011 Updated to include coverage criteria for new FDA approved medication Tradjenta™. 5/2011 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 3/2011 Updated to include coverage criteria for new FDA approved medication Kombiglyze™ XR.
112010 Updated to include coverage criteria for new FDA approved product Actoplus Met® XR.
3/2010 Updated to include coverage criteria for new FDA approved product Onglyza™. 2/2010 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 1/2010 Policy updated to include coverage criteria for Thiazolidinediones to include: Actoplus Met, Actos. Avandamet, Avandaryl, Avandia, Duetact.
9/2009 Policy updated to change 180 day look back period to 130 days, add sample language and to remove Medicare Part D criteria from Medical Policy. 2/2009 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 3/2008 Updated to include Janumet™ as part of step therapy policy for all formularies.
1/1/2008 New policy, effective 1/1/2008, describing covered and non-covered indications.

References

1. Actoplus Met ® [package insert]. Deerfield, IL: Takeda Pharmaceuticals, Inc.: 2009.
2. Actos ® [package insert]. Deerfield, IL: Takeda Pharmaceuticals, Inc.: 2009.
3. Afrezza ® [package insert]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC.: 2015
4. American Diabetes Association Position Statement. Standards of Medical Care in Diabetes – 2007. Diabetes Care 2007; 30 (1): S4-S41.
5. Avandamet ® [package insert]. Research Triangle Park, NC: GlaxoSmithKline: 2008.
6. Avandaryl ® [package insert]. Research Triangle Park, NC: GlaxoSmithKline: 2008.
7. Avandia ® [package insert]. Research Triangle Park, NC: GlaxoSmithKline: 2008.
8. Brynovin [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc.. 1/2025.
9. 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.
10. Byetta ® injection [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.; October 2009.
11. Cycloset [package insert]. Tiverton, RI: VeroScience, LLC. 8/2020.
12. Duetact ® [package insert]. Deerfield, IL: Takeda Pharmaceuticals, Inc.: 2009.
13. Farxiga ™ [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP.: 2014
14. Fortamet ® [package insert]. Florham Park, NJ: Shionogi Inc.: April 2012.
15. 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.
16. Glucophage ®/XR [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.:Jan 2009.
17. Glyxambi ® [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.: Aug 2015

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18. Invokana ™ [package insert]. Titusville, NJ: Takeda Pharmaceuticals, Inc.: 2013.
19. Janumet ™ [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.: September 2013.
20. Janumet XR ™ [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.: February 2013.
21. Januvia ™ [package insert]. Whitehouse Station, NJ: Merck &Co., Inc. February 2013.
22. Jardiance ® [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.: 2014
23. Jentadueto ™ [package insert]. Inc.: Ridgefield, CT; 06877; Boehringer Ingelheim; August 2013.
24. Kazano ™ [package insert]. Deerfield, IL: Takeda Pharmaceuticals, Inc.: 2013.
25. Kerendia ® [package insert]. Leverkusen, Germany: Bayer AG.; July 2021.
26. Kombiglyze ™ XR [package insert]. Princeton, NJ: Bristol-Myers Squibb: 2010.
27. Mounjaro ™ [package insert]. Indianapolis, IN: Eli Lily and Company; 5/2022.
28. 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
29. Nesina ™ [package insert]. Deerfield, IL: Takeda Pharmaceuticals, Inc.: 2013.
30. Onglyza ™ [package insert]. Princeton, NJ: Bristol-Myers Squibb: 2009.
31. Oseni ™ [package insert]. Deerfield, IL: Takeda Pharmaceuticals, Inc.: 2013.
32. Ozempic ® injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; Dec 2017.
33. 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
34. Rybelsus ® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; Sept 2019.
35. Segluromet ™ [package insert]. Whitehouse Station, NJ: Merck &Co., Inc. Dec 2017.
36. Steglatro ™ [package insert]. Whitehouse Station, NJ: Merck &Co., Inc. Dec 2017.
37. Steglujan ™ [package insert]. Whitehouse Station, NJ: Merck &Co., Inc. Feb 2018.
38. Tanzeum ™ injection [package insert]. Wilmington, DE: GlaxoSmithKline LLC.; 2014
39. Tradjenta ™ [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2011.
40. Trulicity ™ [package insert]. Indianapolis, IN: Eli Lily and Company; 3/2015
41. Victoza ® injection [package insert]. Princeton, NJ: NovoNordisk; January 2010.
42. Xigduo ™XR [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP.: 2014
43. Xultophy ® injection [package insert]. Princeton, NJ: NovoNordisk; Nov 2016
44. Zituvimet ™ [package insert]. Ahmedabad, India: Zydus Lifesciences Ltd.; 5/2022.
45. Zituvio ® [package insert]. Ahmedabad, India: Zydus Lifesciences Ltd.; November 2023.