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Sodium-glucose Co-transporter 2 (SGLT-2) Inhibitors and Combinations Step Therapy with Quantity Limit Program Summary

Policy Number: PH-1135

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

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

4/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Farxiga®
(dapagliflozin)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors

To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II-IV)

To reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression

Limitations of use:

  • Not for treatment of type 1 diabetes mellitus. 
  • Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m^2.
  • Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease.

2

Glyxambi®
(empagliflozin/linagliptin)

Tablet

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease

Limitations of use:

  • Not recommended in patients with type 1 diabetes mellitus.
  • Has not been studied in patients with a history of pancreatitis.

DPP-4 Inhibitor Combinations

14

Invokamet®
(canagliflozin/metformin)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both canagliflozin and metformin HCl is appropriate

Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease

Canagliflozin is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria

Limitation of use: Not recommended in patients with type 1 diabetes mellitus

3

Invokamet XR®
(canagliflozin/metformin ER)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both canagliflozin and metformin HCl is appropriate

Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease

Canagliflozin is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria

 

Limitation of use: Not recommended in patients with type 1 diabetes mellitus or diabetic ketoacidosis

3

Invokana®
(canagliflozin)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

To reduce the risk of major cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria

Limitations of use:

  • Not recommended in patients with type 1 diabetes mellitus
  • Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m^2

1

Jardiance®
(empagliflozin)

Tablet

To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure

To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Limitations of use:

  • Not recommended in patients with type 1 diabetes mellitus.
  • Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m^2.

4

Qtern®
(dapagliflozin/saxagliptin)

Tablet

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 

Limitation of use: Not recommended for patients with type 1 diabetes mellitus.

DPP-4 Inhibitor Combinations

15

Segluromet®
(ertugliflozin/metformin)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 

Limitation of use: Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis

 

9

Steglatro®
(ertuglifozin)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

 

Limitation of use: Not recommended in patients with type 1 diabetes mellitus 

 

 

8

Steglujan®
(ertugliflozin/sitagliptin)

Tablet

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 

Limitations of use:

  • Not recommended for patients with type 1 diabetes mellitus 
  • Has not been studied in patients with a history of pancreatitis.

DPP-4 Inhibitor Combinations

16

Synjardy®
(empagliflozin/metformin)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 

To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. 

Limitation of use: Not recommended in patients with type 1 diabetes mellitus

 

6

Synjardy® XR
(empagliflozin/metformin ER)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 

To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. 

Limitation of use: Not recommended in patients with type 1 diabetes mellitus 

 

7

Trijardy XR®
(empagliflozin/linagliptin/metformin ER)

Tablet

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease

Limitations of use:

  • Not recommended in patients with type 1 diabetes.
  • Has not been studied in patients with a history of pancreatitis

DPP-4 Inhibitor Combinations

 

17

Xigduo® XR 
(dapagliflozin/metformin ER)

Tablet

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II through IV)

To reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression

Limitations of use:

  • Not recommended for the treatment of type 1 diabetes mellitus. 
  • Because of the metformin component, the use of Xigduo XR is limited to adults with type 2 diabetes mellitus for all indications. 
  • Not recommended for the treatment of chronic kidney disease with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease.

5

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

CLINICAL RATIONALE

DIABETES

The American Diabetes Association (ADA) recommends:

  • First line therapy depends on comorbidities, patient-centered treatment factors, and management needs and generally includes metformin and comprehensive lifestyle modification
  • Other medications (glucagon-like peptide 1 receptor agonists, sodium-glucose cotransporter 2 inhibitors) with or without metformin based on glycemic needs, are appropriate initial therapy for individuals with type 2 diabetes with or at high risk for atherosclerotic cardiovascular disease, heart failure, and/or chronic kidney disease
  • Among individuals with type 2 diabetes who have established atherosclerotic cardiovascular disease or indicators of high cardiovascular risk, established kidney disease, or heart failure, a sodium-glucose cotransporter 2 inhibitor and/or glucagon-like peptide 1 receptor agonist is recommended as part of the glucose-lowering regimen and comprehensive cardiovascular risk reduction, independent of A1C and in consideration of patient-specific factors.10

 

Dapagliflozin and empagliflozin have been shown to significantly reduce the risk of worsening heart failure or cardiovascular death independently of diabetes status.(2,4)  Angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitors (ARNIs), funny current channel inhibitors (e.g., Corlanor), aldosterone antagonists, beta blockers, isosorbide dinitrate and hydralazine are all medications commonly used for heart failure with reduced ejection fraction (HFrEF).(13)  

Safety

Farxiga, Invokana, Jardiance, Steglatro, and Glyxambi are contraindicated in patients on dialysis.(1,2,4,8,14)

 

Invokamet and Invokamet XR are contraindicated in patients with severe renal impairment, acute or chronic metabolic acidosis, including diabetic ketoacidosis.(3)

 

Segluromet, Synjardy, Synjardy XR, Xigduo XR, and Trijardy XR are contraindicated in patients with severe renal impairment, end stage renal disease (ESRD), patients on dialysis, and patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.(5-7,9,17)  

 

Steglujan and Qtern are contraindicated in patients with severe renal impairment, end stage renal disease (ESRD), or on dialysis.(15,16)

 

Invokamet, Invokamet XR, Segluromet, Synjardy, Synjardy XR, Trijardy XR, and Xigduo XR all have a black box warning for lactic acidosis due to their metformin component:(3,5-7,9,17)

  • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL. 
  • Risk factors include renal impairment, concomitant use of certain drugs, age greater than 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the Full Prescribing Information. 
  • If lactic acidosis is suspected, discontinue the medication and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

REFERENCES                                                                                                                                                                            

Number

Reference

1

Farxiga prescribing information. Astra Zeneca. July 2022.

2

Invokana prescribing information. Janssen Pharmaceuticals, Inc. November 2021.

3

Invokamet and Invokamet XR prescribing information. Janssen Pharmaceuticals, Inc. November 2021.

4

Jardiance prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. March 2022.

5

Xigduo XR prescribing information. AstraZeneca Pharmaceuticals LP. April 2022.

6

Synjardy prescribing information. Boehringer Ingelheim. March 2022.

7

Synjardy XR prescribing information. Boehringer Ingelheim. March 2022.

8

Steglatro prescribing information. Merck & Co, Inc. March 2022.

9

Segluromet prescribing information. Merck Sharp & Dohme Corp. May 2022.

10

American Diabetes Association. Standards of Medical Care in Diabetes-2022. Available at https://care.diabetesjournals.org/content/45/Supplement_1/ 

11

Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2020 Executive Summary. Available at https://pro.aace.com/pdfs/diabetes/algorithm-exec-summary.pdf  Reference no longer used.

12

Petrie MC, Verma S, Docherty KF, et. al. Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes. JAMA 2020 Mar 27.  Abstract available at: https://jamanetwork.com/journals/jama/article-abstract/2763950  Reference no longer used.

13

Yancy CW, Jessup M, Bozkurt B, et. al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017;136:e137-e161. Available at: https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000509

14

Glyxambi prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc and Eli Lilly and Company. March 2022.

15

Qtern prescribing information. Astra Zeneca. March 2022.

16

Steglujan prescribing information. Merck & Co., Inc. June 2022.

17

Trijardy XR prescribing information. Boehringer Ingelheim International GmbH. June 2021.

 

POLICY AGENT SUMMARY STEP THERAPY

Agent Names

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

Qtern, Steglujan, 2-Step Edit

QTERN*dapagliflozin-saxagliptin tab

5 MG

M ; N ; O

N

STEGLUJAN*ertugliflozin-sitagliptin tab

15 MG ; 5 MG

M ; N ; O

N

All other Target Agents 2-Step Edit

INVOKAMET*canagliflozin-metformin hcl tab  ; INVOKAMET*canagliflozin-metformin hcl tab er

150 MG ; 50 MG

M ; N ; O

N

INVOKANA*canagliflozin tab

100 MG ; 300 MG

M ; N ; O

N

SEGLUROMET*ertugliflozin-metformin hcl tab

2.5 MG ; 7.5 MG

M ; N ; O

N

STEGLATRO*ertugliflozin l-pyroglutamic acid tab

15 MG ; 5 MG

M ; N ; O

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Days Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Effective Date

Farxiga

dapagliflozin propanediol tab

10 MG ; 5 MG

30.0

TABS

30

Days

Glyxambi

empagliflozin-linagliptin tab

25 MG ; 5 MG

30.0

TABS

30

Days

Invokamet ; Invokamet xr

canagliflozin-metformin hcl tab  ; canagliflozin-metformin hcl tab er

150 MG ; 50 MG

60.0

TABS

30

Days

Invokana

canagliflozin tab

100 MG ; 300 MG

30.0

TABS

30

Days

Jardiance

empagliflozin tab

10 MG ; 25 MG

30.0

TABS

30

Days

Qtern

dapagliflozin-saxagliptin tab

5 MG

30.0

TABS

30

Days

Segluromet

ertugliflozin-metformin hcl tab

2.5 MG ; 7.5 MG

60.0

TABS

30

Days

Segluromet

Ertugliflozin-Metformin HCl Tab 2.5-500 MG

2.5 MG

120.0

TABS

30

Days

Steglatro

Ertugliflozin L-Pyroglutamic Acid Tab 15 MG (Base Equiv)

15 MG

30.0

TABS

30

Days

Steglatro

Ertugliflozin L-Pyroglutamic Acid Tab 5 MG (Base Equiv)

5 MG

60.0

TABS

30

Days

Steglujan

ertugliflozin-sitagliptin tab

15 MG ; 5 MG

30.0

TABS

30

Days

Synjardy

empagliflozin-metformin hcl tab

12.5 MG ; 5 MG

60.0

TABS

30

Days

Synjardy xr

empagliflozin-metformin hcl tab er

10 MG ; 12.5 MG ; 25 MG ; 5 MG

60.0

TABS

30

Days

Synjardy xr

Empagliflozin-Metformin HCl Tab ER 24HR 25-1000 MG

25 MG

30.0

TABS

30

Days

Trijardy xr

empagliflozin-linaglip-metformin tab er  ; empagliflozin-linagliptin-metformin tab er

10 MG ; 12.5 MG ; 25 MG ; 5 MG

30.0

TABS

30

Days

Trijardy xr

Empagliflozin-Linaglip-Metformin Tab ER 24HR 12.5-2.5-1000MG

12.5 MG

60.0

TABS

30

Days

Trijardy xr

Empagliflozin-Linagliptin-Metformin Tab ER 24HR 5-2.5-1000MG

5 MG

60.0

TABS

30

Days

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 10-1000 MG

10 MG

30.0

TABS

30

Days

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 10-500 MG

10 MG

30.0

TABS

30

Days

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 2.5-1000 MG

2.5 MG

60.0

TABS

30

Days

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 5-1000 MG

5 MG

60.0

TABS

30

Days

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 5-500 MG

5 MG

30.0

TABS

30

Days

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Invokamet ; Invokamet xr

canagliflozin-metformin hcl tab  ; canagliflozin-metformin hcl tab er

150 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Invokana

canagliflozin tab

100 MG ; 300 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Qtern

dapagliflozin-saxagliptin tab

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Segluromet

ertugliflozin-metformin hcl tab

2.5 MG ; 7.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Steglatro

ertugliflozin l-pyroglutamic acid tab

15 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Steglujan

ertugliflozin-sitagliptin tab

15 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Farxiga

dapagliflozin propanediol tab

10 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Glyxambi

empagliflozin-linagliptin tab

25 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Invokamet ; Invokamet xr

canagliflozin-metformin hcl tab  ; canagliflozin-metformin hcl tab er

150 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Invokana

canagliflozin tab

100 MG ; 300 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Jardiance

empagliflozin tab

10 MG ; 25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Qtern

dapagliflozin-saxagliptin tab

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Segluromet

ertugliflozin-metformin hcl tab

2.5 MG ; 7.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Segluromet

Ertugliflozin-Metformin HCl Tab 2.5-500 MG

2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Steglatro

Ertugliflozin L-Pyroglutamic Acid Tab 15 MG (Base Equiv)

15 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Steglatro

Ertugliflozin L-Pyroglutamic Acid Tab 5 MG (Base Equiv)

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Steglujan

ertugliflozin-sitagliptin tab

15 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Synjardy

empagliflozin-metformin hcl tab

12.5 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Synjardy xr

empagliflozin-metformin hcl tab er

10 MG ; 12.5 MG ; 25 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Synjardy xr

Empagliflozin-Metformin HCl Tab ER 24HR 25-1000 MG

25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Trijardy xr

empagliflozin-linaglip-metformin tab er  ; empagliflozin-linagliptin-metformin tab er

10 MG ; 12.5 MG ; 25 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Trijardy xr

Empagliflozin-Linaglip-Metformin Tab ER 24HR 12.5-2.5-1000MG

12.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Trijardy xr

Empagliflozin-Linagliptin-Metformin Tab ER 24HR 5-2.5-1000MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 10-1000 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 10-500 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 2.5-1000 MG

2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 5-1000 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xigduo xr

Dapagliflozin-Metformin HCl Tab ER 24HR 5-500 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

2-Step Edit: All other Target Agent(s)

Invokana® (canagliflozin)
Invokamet™ (canagliflozin/metformin)
Invokamet XR™ (canagliflozin/metformin ER) 
Segluromet™ (ertugliflozin/metformin)
Steglatro™ (ertugliflozin)

All other Target Agent(s) will be approved when BOTH of the following are met:

  1. ONE of the following:
    1. The patient’s medication history includes use of an agent containing dapagliflozin OR
    2. The patient has an intolerance or hypersensitivity to dapagliflozin OR
    3. The patient has an FDA labeled contraindication to dapagliflozin AND
  2. ONE of the following:
    1. The patient’s medication history includes use of an agent containing empagliflozin OR
    2. The patient has an intolerance or hypersensitivity to empagliflozin OR
    3. The patient has an FDA labeled contraindication to empagliflozin

Length of approval: 12 months

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

2-Step Edit: Qtern, Steglujan

Qtern® (dapagliflozin/saxagliptin)
Steglujan™ (ertugliflozin/sitagliptin)

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

  1. The patient’s medication history includes use of Glyxambi or Trijardy XR OR
  2. The patient has an intolerance or hypersensitivity to BOTH Glyxambi and Trijardy XR OR
  3. The patient has an FDA labeled contraindication to BOTH Glyxambi and Trijardy XR

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

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

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) is greater than 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 dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support why the requested quantity (dose) 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 (dose) is greater than the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose 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 _ OP _ Sodium-glucose Co-transporter 2 (SGLT-2) Inhibitors and Combinations Step Therapy with Quantity Limit _ProgSum_ 4/1/2023