|
Effective Date
|
Date of Origin
|
|
04-01-2024
|
|
FDA APPROVED INDICATIONS AND DOSAGE
|
Agent(s)
|
FDA Indication(s)
|
Notes
|
Ref#
|
|
Brenzavvy®, Bexagliflozin
Tablet
|
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Limitation of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus
|
|
19
|
|
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 factor
To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
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 use to improve glycemic control 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 45 mL/min/1.73 m^2. Farxiga is likely to be ineffective in this setting based upon its mechanism of action
- 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 the treatment of kidney disease. Farxiga is not expected to be effective in these populations.
|
|
2
|
|
Glyxambi®
(empagliflozin/linagliptin)
Tablet
|
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.
Limitations of Use:
- Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. Has not been studied in patients with a history of pancreatitis.
- 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.
|
DPP-4 Inhibitor Combinations
|
14
|
|
Inpefa™
(sotagliflozin)
Tablets
|
To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
- heart failure or
- type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors
|
|
18
|
|
Invokamet®
(canagliflozin/metformin)
Tablet
|
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus 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
Limitations of Use: Not recommended for use to improve glycemic control 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 sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Limitations of Use:
- Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
- Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 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 intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease.
|
|
4
|
|
Qtern®
(dapagliflozin/saxagliptin)
Tablet
|
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
|
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Limitations of Use:
Not recommended for use to improve glycemic control in 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 and pediatric patients aged 10 years and older with type 2 diabetes mellitus
Empagliflozin, when used as a component of Synjardy or Synjardy XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:
- Cardiovascular death in adults with established cardiovascular disease.
- Cardiovascular death and hospitalization for heart failure in adults with heart failure.
Limitations of Use:
- Not recommended for use in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
- Because of the metformin component, Synjardy and Synjardy XR are not recommended for use in patients with heart failure without type 2 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
Empagliflozin, when used as a component of Synjardy or Synjardy XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:
- Cardiovascular death in adults with established cardiovascular disease.
- Cardiovascular death and hospitalization for heart failure in adults with heart failure.
Limitations of Use:
- Not recommended for use in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
- Because of the metformin component, Synjardy and Synjardy XR are not recommended for use in patients with heart failure without type 2 diabetes mellitus.
|
|
7
|
|
Trijardy XR®
(empagliflozin/linagliptin/metformin ER)
Tablet
|
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
Dapafliflozin is indicated 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.
- The risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II through IV)
- 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 the following guidelines:(10,11)
- Healthy lifestyle behaviors, diabetes self-management education and support, avoidance of clinical inertia, and social determinants of health should be considered in the glucose-lowering management of type 2 diabetes. Pharmacologic therapy should be guided by person-centered treatment factors, including comorbidities and treatment goals.
- In adults with type 2 diabetes and established/high risk of atherosclerotic cardiovascular disease, heart failure, and/or chronic kidney disease, the treatment regimen should include agents that reduce cardiorenal risk.
- Pharmacologic approach that provide adequate efficacy to achieve and maintain treatment goals should be considered, such as metformin or other agents, including combination therapy.
- Weight management is an impactful component of glucose-lowering management in type 2 diabetes. The glucose-lowering treatment regimen should consider approaches that support weight management goals.
- Metformin should be continued upon initiation of insulin therapy (unless contraindicated or not tolerated) for ongoing glycemic and metabolic benefits. A Early combination therapy can be considered in some individuals at treatment initiation to extend the time to treatment failure.
- The early introduction of insulin should be considered if there is evidence of ongoing catabolism (weight loss), if symptoms of hyperglycemia are present, or when A1C levels (>10% [86 mmol/mol]) or blood glucose levels (greater or equal to 300 mg/dL) are very high.
- A person-centered approach should guide the choice of pharmacologic agents. Consider the effects on cardiovascular and renal comorbidities, efficacy, hypoglycemia risk, impact on weight, cost and access, risk for side effects, and individual preferences.
- 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 with demonstrated cardiovascular disease benefit is recommended as part of the glucose-lowering regimen and comprehensive cardiovascular risk reduction, independent of A1C and in consideration of person-specific factors.
- In adults with type 2 diabetes, a glucagon-like peptide 1 receptor agonist is preferred to insulin when possible.
Healthy lifestyle behaviors, diabetes self-management, education, and support, avoidance of clinical inertia, and social determinants of health should be considered in the glucose-lowering management of type 2 diabetes. Pharmacologic therapy should be guided by person-centered treatment factors, including comorbidities and treatment goals. Pharmacotherapy should be started at the time type 2 diabetes is diagnosed unless there are contraindications. Pharmacologic approaches that provide the efficacy to achieve treatment goals should be considered, such as metformin or other agents, including combination therapy, that provide adequate efficacy to achieve and maintain treatment goals. In adults with type 2 diabetes and established/high risk of atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and/or chronic kidney disease (CKD), the treatment regimen should include agents that reduce cardiorenal risk.(11)
Pharmacologic approaches that provide the efficacy to achieve treatment goals should be considered, specified as metformin or agent(s), including combination therapy, that provide adequate efficacy to achieve and maintain treatment goals. In general, higher-efficacy approaches have greater likelihood of achieving glycemic goals, with the following considered to have very high efficacy for glucose lowering: the GLP-1 RAs dulaglutide (high dose) and semaglutide, the gastric inhibitory peptide (GIP) and GLP-1 RA tirzepatide, insulin, combination oral therapy, and combination injectable therapy. Weight management is an impactful component of glucose-lowering management in type 2 diabetes. The glucose-lowering treatment regimen should consider approaches that support weight management goals, with very high efficacy for weight loss seen with semaglutide and tirzepatide.(11)
Metformin is effective and safe, is inexpensive, and may reduce risk of cardiovascular events and death. Metformin is available in an immediate-release form for twice-daily dosing or as an extended-release form that can be given once daily. Compared with sulfonylureas, metformin as first-line therapy has beneficial effects on A1C, weight, and cardiovascular mortality. For people with type 2 diabetes and established ASCVD or indicators of high ASCVD risk, HF, or CKD, an SGLT2 inhibitor and/or GLP-1 RA with demonstrated CVD benefit is recommended as part of the glucose-lowering regimen independent of A1C, independent of metformin use and in consideration of person-specific factors. For people without established ASCVD, indicators of high ASCVD risk, HF, or CKD, medication choice is guided by efficacy in support of individualized glycemic and weight management goals, avoidance of side effects (particularly hypoglycemia and weight gain), cost/access, and individual preferences.(11)
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).(12,13)
|
|
Safety
|
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 >5 mcg/mL.
- Risk factors include renal impairment, concomitant use of certain drugs, age more 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.
Brenzavvy, Farxiga, Invokana, Jardiance, Steglatro, and Glyxambi are contraindicated in patients on dialysis.(1,2,4,8,14,19)
Inpefa is contraindicated in history of serious hypersensitivity reaction to Inpefa.(18)
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.(5-7,9,17)
|
REFERENCES
|
Number
|
Reference
|
|
1
|
Invokana prescribing information. Janssen Pharmaceuticals, Inc. July 2023.
|
|
2
|
Farxiga prescribing information. Astra Zeneca. September 2023.
|
|
3
|
Invokamet and Invokamet XR prescribing information. Janssen Pharmaceuticals, Inc. July 2023.
|
|
4
|
Jardiance prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. September 2023.
|
|
5
|
Xigduo XR prescribing information. AstraZeneca Pharmaceuticals LP. September 2023.
|
|
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
|
Nuha A. ElSayed, et. al, American Diabetes Association, 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care 1 January 2023; 46 (Supplement_1): S140-S157. https://doi.org/10.2337/dc23-S009.
|
|
12
|
American Diabetes Association, 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2023. Diabetes Care 1 January 2023; 46 (Supplement_1): S158-S190. https://doi.org/10.2337/dc23-S010.
|
|
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. September 2023.
|
|
16
|
Steglujan prescribing information. Merck & Co., Inc. June 2022.
|
|
17
|
Trijardy XR prescribing information. Boehringer Ingelheim International GmbH. October 2022.
|
|
18
|
Inpefa Prescribing Information. Lexicon Pharmaceuticals, Inc. May 2023.
|
|
19
|
Brenzavvy prescribing information. TheracosBio, LLC. September 2023.
|
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
|
|
Qtern, Steglujan, 2-Step Edit
|
|
Qtern
|
dapagliflozin-saxagliptin tab
|
10-5 MG ; 5-5 MG
|
M ; N ; O
|
N
|
|
|
|
Steglujan
|
ertugliflozin-sitagliptin tab
|
15-100 MG ; 5-100 MG
|
M ; N ; O
|
N
|
|
|
|
All other Target Agents 2-Step Edit
|
|
Brenzavvy
|
bexagliflozin tab
|
20 MG
|
M ; N ; O
|
M
|
|
|
|
Inpefa
|
sotagliflozin tab
|
200 MG ; 400 MG
|
M ; N ; O
|
N
|
|
|
|
Invokamet ; Invokamet xr
|
canagliflozin-metformin hcl tab ; canagliflozin-metformin hcl tab er
|
150-1000 MG ; 150-500 MG ; 50-1000 MG ; 50-500 MG
|
M ; N ; O
|
N
|
|
|
|
Invokana
|
canagliflozin tab
|
100 MG ; 300 MG
|
M ; N ; O
|
N
|
|
|
|
Segluromet
|
ertugliflozin-metformin hcl tab
|
2.5-1000 MG ; 2.5-500 MG ; 7.5-1000 MG ; 7.5-500 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
|
Day Supply
|
Duration
|
Addtl QL Info
|
Allowed Exceptions
|
Targeted NDCs When Exclusions Exist
|
|
|
|
Brenzavvy
|
bexagliflozin tab
|
20 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Farxiga
|
dapagliflozin propanediol tab
|
10 MG ; 5 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Glyxambi
|
empagliflozin-linagliptin tab
|
10-5 MG ; 25-5 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Inpefa
|
sotagliflozin tab
|
200 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Inpefa
|
sotagliflozin tab
|
400 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Invokamet ; Invokamet xr
|
canagliflozin-metformin hcl tab ; canagliflozin-metformin hcl tab er
|
150-1000 MG ; 150-500 MG ; 50-1000 MG ; 50-500 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Invokana
|
canagliflozin tab
|
100 MG ; 300 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Jardiance
|
empagliflozin tab
|
10 MG ; 25 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Qtern
|
dapagliflozin-saxagliptin tab
|
10-5 MG ; 5-5 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Segluromet
|
ertugliflozin-metformin hcl tab
|
2.5-1000 MG ; 2.5-500 MG ; 7.5-1000 MG ; 7.5-500 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Segluromet
|
Ertugliflozin-Metformin HCl Tab 2.5-500 MG
|
2.5-500 MG
|
120
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Steglatro
|
Ertugliflozin L-Pyroglutamic Acid Tab 15 MG (Base Equiv)
|
15 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Steglatro
|
Ertugliflozin L-Pyroglutamic Acid Tab 5 MG (Base Equiv)
|
5 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Steglujan
|
ertugliflozin-sitagliptin tab
|
15-100 MG ; 5-100 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Synjardy
|
empagliflozin-metformin hcl tab
|
12.5-1000 MG ; 12.5-500 MG ; 5-1000 MG ; 5-500 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Synjardy xr
|
empagliflozin-metformin hcl tab er
|
10-1000 MG ; 12.5-1000 MG ; 25-1000 MG ; 5-1000 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Synjardy xr
|
Empagliflozin-Metformin HCl Tab ER 24HR 25-1000 MG
|
25-1000 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Trijardy xr
|
empagliflozin-linaglip-metformin tab er ; empagliflozin-linagliptin-metformin tab er
|
10-5-1000 MG ; 12.5-2.5-1000 MG ; 25-5-1000 MG ; 5-2.5-1000 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Trijardy xr
|
Empagliflozin-Linaglip-Metformin Tab ER 24HR 12.5-2.5-1000MG
|
12.5-2.5-1000 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Trijardy xr
|
Empagliflozin-Linagliptin-Metformin Tab ER 24HR 5-2.5-1000MG
|
5-2.5-1000 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 10-1000 MG
|
10-1000 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 10-500 MG
|
10-500 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 2.5-1000 MG
|
2.5-1000 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 5-1000 MG
|
5-1000 MG
|
60
|
Tablets
|
30
|
DAYS
|
|
|
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 5-500 MG
|
5-500 MG
|
30
|
Tablets
|
30
|
DAYS
|
|
|
|
CLIENT SUMMARY – STEP THERAPY
|
Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
Client Formulary
|
|
Brenzavvy
|
bexagliflozin tab
|
20 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Inpefa
|
sotagliflozin tab
|
200 MG ; 400 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Invokamet ; Invokamet xr
|
canagliflozin-metformin hcl tab ; canagliflozin-metformin hcl tab er
|
150-1000 MG ; 150-500 MG ; 50-1000 MG ; 50-500 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
|
10-5 MG ; 5-5 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Segluromet
|
ertugliflozin-metformin hcl tab
|
2.5-1000 MG ; 2.5-500 MG ; 7.5-1000 MG ; 7.5-500 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
|
15-100 MG ; 5-100 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
|
|
Brenzavvy
|
bexagliflozin tab
|
20 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Farxiga
|
dapagliflozin propanediol tab
|
10 MG ; 5 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Glyxambi
|
empagliflozin-linagliptin tab
|
10-5 MG ; 25-5 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Inpefa
|
sotagliflozin tab
|
400 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Inpefa
|
sotagliflozin tab
|
200 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Invokamet ; Invokamet xr
|
canagliflozin-metformin hcl tab ; canagliflozin-metformin hcl tab er
|
150-1000 MG ; 150-500 MG ; 50-1000 MG ; 50-500 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
|
10-5 MG ; 5-5 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Segluromet
|
ertugliflozin-metformin hcl tab
|
2.5-1000 MG ; 2.5-500 MG ; 7.5-1000 MG ; 7.5-500 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Segluromet
|
Ertugliflozin-Metformin HCl Tab 2.5-500 MG
|
2.5-500 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
|
15-100 MG ; 5-100 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Synjardy
|
empagliflozin-metformin hcl tab
|
12.5-1000 MG ; 12.5-500 MG ; 5-1000 MG ; 5-500 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Synjardy xr
|
empagliflozin-metformin hcl tab er
|
10-1000 MG ; 12.5-1000 MG ; 25-1000 MG ; 5-1000 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Synjardy xr
|
Empagliflozin-Metformin HCl Tab ER 24HR 25-1000 MG
|
25-1000 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Trijardy xr
|
empagliflozin-linaglip-metformin tab er ; empagliflozin-linagliptin-metformin tab er
|
10-5-1000 MG ; 12.5-2.5-1000 MG ; 25-5-1000 MG ; 5-2.5-1000 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
|
12.5-2.5-1000 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Trijardy xr
|
Empagliflozin-Linagliptin-Metformin Tab ER 24HR 5-2.5-1000MG
|
5-2.5-1000 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 10-1000 MG
|
10-1000 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 10-500 MG
|
10-500 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 2.5-1000 MG
|
2.5-1000 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 5-1000 MG
|
5-1000 MG
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Xigduo xr
|
Dapagliflozin-Metformin HCl Tab ER 24HR 5-500 MG
|
5-500 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 Agents
|
Target Agent(s)
Brenzavvy, bexagliflozin
Inpefa (sotagliflozin)
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:
- ONE of the following:
- The patient’s medication history includes use of an agent containing dapagliflozin OR
- The patient has an intolerance or hypersensitivity to dapagliflozin OR
- The patient has an FDA labeled contraindication to dapagliflozin AND
- ONE of the following:
- The patient’s medication history includes use of an agent containing empagliflozin OR
- The patient has an intolerance or hypersensitivity to empagliflozin OR
- 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.
*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
|
|
2-Step Edit: Qtern, Steglujan
|
Target Agent(s)
Qtern (dapagliflozin/saxagliptin)
Steglujan (ertugliflozin/sitagliptin)
Target Agent(s)-Qtern, Steglujan will be approved when ONE of the following is met:
- The patient’s medication history includes use of Glyxambi or Trijardy XR OR
- The patient has an intolerance or hypersensitivity to BOTH Glyxambi and Trijardy XR OR
- 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.
*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
|
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:
- The requested quantity (dose) does NOT exceed the program quantity limit OR
- The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
- BOTH of the following:
- The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
- Information has been provided to support therapy with a higher dose for the requested indication OR
- BOTH of the following:
- The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
- 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
- BOTH of the following:
- The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
- 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 _ OCReg _ Sodium-glucose_Co-transporter_(SGLT)_Inhibitors_and_Combinations_STQL _ProgSum_ 04-01-2024
|
