Aetna
Aetna Aetna
Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Antidiabetic Agents ST, Post PA Policy 676-D, BOG 6332-D UDR 05-2024

Drug
ANTIDIABETIC AGENTS
AMYLIN ANALOG:
SYMLINPEN  (pramlintide acetate)
GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST:
ADLYXIN  (lixisenatide)
BYDUREON BCISE  (exenatide extended-release)
BYETTA  (exenatide)
OZEMPIC  (semaglutide)
RYBELSUS  (semaglutide)
TRULICITY  (dulaglutide)
VICTOZA  (liraglutide)
GLUCOSE-DEPENDENT INSULINOTROPIC POLYPEPTIDE (GIP) RECEPTOR AND GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST:
MOUNJARO  (tirzepatide)
SODIUM-GLUCOSE COTRANSPORTER 2 (SGLT2) INHIBITOR:
BRENZAVVY  (bexagliflozin)
FARXIGA  (dapagliflozin)
INVOKANA  (canagliflozin)
JARDIANCE  (empagliflozin)
STEGLATRO®  (ertugliflozin)
SGLT2 INHIBITOR / METFORMIN:
INVOKAMET  (canagliflozin / metformin HCl)
INVOKAMET XR  (canagliflozin /metformin HCl extended-release)
SEGLUROMET  (ertugliflozin / metformin HCl)
SYNJARDY  (empagliflozin / metformin HCl)
SYNJARDY XR  (empagliflozin / metformin HCl extended-release)
XIGDUO XR  (dapagliflozin / metformin HCl extended-release)
SGLT2 INHIBITOR / DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITOR:
GLYXAMBI  (empagliflozin / linagliptin)
QTERN  (dapagliflozin / saxagliptin)
STEGLUJAN  (ertugliflozin / sitagliptin)
SGLT2 INHIBITOR / DPP4 INHIBITOR / METFORMIN:
TRIJARDY XR  (empagliflozin / linagliptin / metformin HCl extended-release)
LONG ACTING INSULIN/GLP-1 RECEPTOR AGONIST:
SOLIQUA  (insulin glargine / lixisenatide injection)
XULTOPHY  (insulin degludec / liraglutide injection)


Policy:

FDA APPROVED INDICATIONS
AMYLIN ANALOG:
SymlinPen
SymlinPen is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.

GLP-1 RECEPTOR AGONIST:
Adlyxin
Adlyxin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
  •  Adlyxin has not been studied in patients with chronic pancreatitis or a history of unexplained
     pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  •  Adlyxin should not be used in patients with type 1 diabetes mellitus.
  •  Adlyxin has not been studied in patients with gastroparesis and is not recommended in patients
     with gastroparesis.
Bydureon BCise
Bydureon BCise is indicated 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
  •  Bydureon BCise is not recommended as first-line therapy for patients who have inadequate
     glycemic control on diet and exercise because of the uncertain relevance of the rat thyroid C-cell
     tumor findings to humans.
  •  Bydureon BCise is not indicated for use in patients with type 1 diabetes mellitus.
  •  Bydureon BCise is an extended-release formulations of exenatide and should not be used with
     other products containing the active ingredient exenatide.
  •  Bydureon BCise has not been studied in patients with a history of pancreatitis. Consider other
     antidiabetic therapies in patients with a history of pancreatitis.
Byetta
Byetta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
  •  Byetta is not indicated for use in patients with type 1 diabetes.
  •  Byetta contains exenatide and should not be used with other products containing the active
     ingredient exenatide.
Byetta has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
Ozempic
Ozempic is indicated:
  •  as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
     mellitus.
  •  to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal
     myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established
     cardiovascular disease.
Limitations of Use
  •  Ozempic has not been studied in patients with a history of pancreatitis. Consider other antidiabetic
     therapies in patients with a history of pancreatitis.
  •  Ozempic is not indicated for use in patients with type 1 diabetes mellitus.
Compendial Uses
Advanced chronic kidney disease (CKD) in adults with type 2 diabetes mellitus30
Rybelsus
Rybelsus is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
  •  Rybelsus has not been studied in patients with a history of pancreatitis. Consider other
     antidiabetic therapies in patients with a history of pancreatitis.
  •  Rybelsus is not indicated for use in patients with type 1 diabetes mellitus.
Trulicity
Trulicity is indicated:
  •  As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10
     years of age and older with type 2 diabetes mellitus.
  •  To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal
     myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have
     established cardiovascular disease or multiple cardiovascular risk factors.
Limitations of Use
  •  Trulicity has not been studied in patients with a history of pancreatitis. Consider other antidiabetic
     therapies in patients with a history of pancreatitis.
  •  Trulicity should not be used in patients with type 1 diabetes mellitus.
  •  Trulicity has not been studied in patients with severe gastrointestinal disease, including severe
     gastroparesis and is therefore not recommended in these patients.
Compendial Uses
Advanced chronic kidney disease (CKD) in adults with type 2 diabetes mellitus30
Victoza
Victoza is indicated:
  •  as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with
     type 2 diabetes mellitus.
  •  to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
Limitations of Use
  •  Victoza should not be used in patients with type 1 diabetes mellitus.
  •  Victoza contains liraglutide and should not be coadministered with other liraglutide-containing
     products.
Compendial Uses
Advanced chronic kidney disease (CKD) in adults with type 2 diabetes mellitus30

GIP/GLP-1 RECEPTOR AGONIST:
Mounjaro
Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
  •  Mounjaro has not been studied in patients with a history of pancreatitis.
  •  Mounjaro is not indicated for use in patients with type 1 diabetes mellitus.

SGLT2 INHIBITOR:
Brenzavvy
Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
Brenzavvy is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
Farxiga
Farxiga (dapagliflozin) is indicated:
  •  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.
  •  To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure
     visits in adults with heart failure.
  •  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.
  •  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
  •  Farxiga is not recommended for use to improve glycemic control in patients with type 1 diabetes
     mellitus.
  •  Farxiga is 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 m2. Farxiga is likely to be ineffective in this
     setting based upon its mechanism of action.
  •  Farxiga is 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. Farxiga is not expected to be effective in these populations.
Invokana
Invokana (canagliflozin) is indicated:
  •  as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
     mellitus.
  •  to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal
     myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus and established
     cardiovascular disease (CVD).
  •  to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine,
     cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes
     mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.
Limitations of Use
Invokana is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
Invokana is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73m2. Invokana is likely to be ineffective in this setting based upon its mechanism of action.
Jardiance
Jardiance is indicated:
  •  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 adult patients 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,
Limitation of Use
Jardiance is 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.
Jardiance is 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 m2. Jardiance is likely to be ineffective in this setting based upon its mechanism of action.
Jardiance is 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. Jardiance is not expected to be effective in these populations.
Steglatro
Steglatro is 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 use to improve glycemic control in patients with type 1 diabetes mellitus.

SGLT2 INHIBITOR / METFORMIN:
Invokamet, Invokamet XR
Invokamet and Invokamet XR are a combination of canagliflozin and metformin hydrochloride (HCl) indicated 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 (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).
Canagliflozin is indicated to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.
Limitations of Use
Invokamet/Invokamet XR is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
Segluromet
Segluromet is 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 use to improve glycemic control  in patients with type 1 diabetes mellitus.
Synjardy, Synjardy XR
Synjardy is a combination of empagliflozin and metformin hydrochloride (HCl) indicated 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.
Synjardy XR is a combination of empagliflozin and metformin hydrochloride (HCl) indicated 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/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.
Limitation of Use
  •  Synjardy/Synjardy XR are not recommended for use to improve glycemic control in patients with
     type 1 diabetes It may increase the risk of diabetic ketoacidosis in these patients.
  •  Because of the metformin component, Synjardy/Synjardy XR is limited to patients with type 2
     diabetes mellitus for all indications.
Xigduo XR
Xigduo XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated 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.
Dapagliflozin 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
     (NYHA class II-IV) with reduced ejection fraction.
  •  the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease,
     cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at
     risk of progression.
Limitation of Use
  •  Xigduo XR is not recommended for use to improve glycemic control in patients with type 1
     diabetes mellitus.
  •  Because of the metformin component, the use of Xigduo XR is limited to adults with type 2
     diabetes for all indications.
  •  Xigduo XR is 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. Xigduo XR is not expected to be effective in these populations.

SGLT2 INHIBITOR / DPP-4 INHIBITOR:
Glyxambi
Glyxambi is a combination of empagliflozin and linagliptin 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
Glyxambi is 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.
Glyxambi has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using Glyxambi.
Glyxambi is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 ml/min/1.73m2. Glyxambi is likely to be ineffective in this setting based upon its mechanism of action.
Qtern
Qtern is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
Qtern is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
Steglujan
Steglujan is 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 use to improve glycemic control in patients with type 1 diabetes mellitus.
  •  Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with
     a history of pancreatitis are at increased risk for the development of pancreatitis while using
     Steglujan.

SGLT2 INHIBITOR / DPP-4 INHIBITOR / METFORMIN:
Trijardy XR
Trijardy XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) 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
Trijardy XR is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
Trijardy XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using Trijardy XR.

Long Acting Insulin / GLP-1 RECEPTOR Agonist:
Soliqua
Soliqua 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
  •  Soliqua 100/33 has not been studied in patients with a history of pancreatitis. Consider other
     antidiabetic therapies in patients with a history of pancreatitis.
  •  Soliqua 100/33 is not recommended for use in combination with any other product containing a
     GLP-1 receptor agonist.
  •  Soliqua 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment
     of diabetic ketoacidosis.
  •  Soliqua 100/33 has not been studied in patients with gastroparesis and is not recommended in
     patients with gastroparesis.
  •  Soliqua 100/33 has not been studied in combination with prandial insulin.

Xultophy
Xultophy 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
  •  Xultophy 100/3.6 is not recommended as first-line therapy for patients who have inadequate
     glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell
     tumor findings to humans.
  •  Xultophy 100/3.6 is not recommended for use in combination with any other product containing
     liraglutide or another GLP-1 receptor agonist.
  •  Xultophy 100/3.6 is not indicated for use in patients with type 1 diabetes mellitus or for the
     treatment of diabetic ketoacidosis.
  •  Xultophy 100/3.6 has not been studied in combination with prandial insulin.

INITIAL STEP THERAPY*
*Include Rx and OTC products unless otherwise stated.

INITIAL STEP THERAPY For AMYLIN ANALOGS (SymlinPen):
If the patient has filled a prescription for at least a 30-day supply of a rapid-acting insulin or short-acting insulin or pre-mixed insulin [e.g., insulin aspart (Novolog), insulin glulisine (Apidra), insulin lispro (Humalog), insulin regular R (Afrezza, Humulin R, Novolin R)] within the past 120 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit. If the patient does not meet the initial step therapy criteria, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

INITIAL STEP THERAPY For GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONISTS AND GLUCOSE-DEPENDENT INSULINOTROPIC POLYPEPTIDE (GIP)-GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONISTS:
If the patient has filled a prescription for at least a 30-day supply of metformin when the date of a metformin fill is AT LEAST 10 days prior to the claim for a GLP-1 receptor agonist or a GIP-GLP-1 receptor agonist within the past 180 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit. If the patient does not meet the initial step therapy criteria, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

INITIAL STEP THERAPY For ALL OTHER TARGET DRUGS:
If the patient has filled a prescription for at least a 30-day supply of metformin within the past 180 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit. If the patient does not meet the initial step therapy criteria, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.


COVERAGE CRITERIA

Chronic Kidney Disease
Authorization may be granted when the patient has a diagnosis of chronic kidney disease at risk of progression when the following criteria is met:
  •  The request is for Farxiga (dapagliflozin) or Jardiance (empagliflozin)

Heart Failure
Authorization may be granted for a diagnosis of heart failure when the following criteria is met:
  •  The request is for Farxiga (dapagliflozin) or Jardiance (empagliflozin)

Type 1 or 2 Diabetes Mellitus
Authorization may be granted for a diagnosis of type 1 or type 2 diabetes mellitus when ALL of the following criteria are met:
  •  The request is for SymlinPen (pramlintide acetate)
  •  The patient has NOT been receiving a stable maintenance dose of the requested drug for at least
     3 months and the following criteria is met:
     °  The patient has failed to achieve desired glucose control despite receiving optimal insulin
         therapy, including mealtime insulin

Type 2 Diabetes Mellitus
Authorization may be granted for a diagnosis of type 2 diabetes mellitus when the patient has NOT been receiving a stable maintenance dose of the requested drug for at least 3 months when ONE of the following criteria are met:
  •  The patient experienced an inadequate treatment response, intolerance, or has a contraindication
     to metformin
     °  The patient requires combination therapy AND has an A1C of 7.5 percent or greater
  •  The patient has established cardiovascular disease and the following criteria is met:
     °  The request is for Farxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin),
         Ozempic (semaglutide), Trulicity (dulaglutide), or Victoza (liraglutide)
  •  The patient has a diagnosis of diabetic nephropathy with albuminuria greater than 300 mg per day
     and the following criteria is met:
     °  The request is for Invokana (canagliflozin)
  •  The patient has multiple cardiovascular risk factors and the following criteria is met:
     °  The request is for Trulicity (dulaglutide) or Farxiga (dapagliflozin)
  •  The patient has a diagnosis of heart failure and the following criteria is met:
     °The request is for Farxiga (dapagliflozin) or Jardiance (empagliflozin)
  •  The patient has a diagnosis of chronic kidney disease at risk of progression and the following
     criteria is met:
     °  The request is for Farxiga (dapagliflozin) or Jardiance (empagliflozin)
  •  The patient has a diagnosis of advanced chronic kidney disease (CKD) (estimated glomerular
     filtration rate [eGFR] less than 30 mL/min/1.73m2) and the following criteria is met:
     °  The request is for Ozempic (semaglutide), Trulicity (dulaglutide) or Victoza (liraglutide)

CONTINUATION OF THERAPY

Chronic Kidney Disease
All patients (including new patients) requesting authorization for continuation of therapy must meet ALL initial authorization criteria.

Heart Failure
All patients (including new patients) requesting authorization for continuation of therapy must meet ALL initial authorization criteria.

Type 1 or 2 Diabetes Mellitus
Authorization may be granted for a diagnosis of type 1 or type 2 diabetes mellitus when ALL of the following criteria are met:
  •  The request is for SymlinPen (pramlintide acetate)
  •  The patient has been receiving a stable maintenance dose of the requested drug for at least 3
     months and the following criteria is met:
     °  The patient has demonstrated a reduction in A1C since starting this therapy

Type 2 Diabetes Mellitus
Authorization may be granted for a diagnosis of type 2 diabetes mellitus when the patient has been receiving a stable maintenance dose of the requested drug for at least 3 months when ONE of the following criteria are met:
  •  The patient has demonstrated a reduction in A1C since starting this therapy
  •  The patient has established cardiovascular disease and the following criteria is met:
     °  The request is for Farxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin),
        Ozempic (semaglutide), Trulicity (dulaglutide), or Victoza (liraglutide)
  •  The patient has a diagnosis of diabetic nephropathy with albuminuria greater than 300 mg per day
     and the following criteria is met:
     °The request is for Invokana (canagliflozin)
  •  The patient has multiple cardiovascular risk factors and the following criteria is met:
     °  The request is for Trulicity (dulaglutide) or Farxiga (dapagliflozin)
  •  The patient has a diagnosis of heart failure and the following criteria is met:
     °  The request is for Farxiga (dapagliflozin) or Jardiance (empagliflozin)
  •  The patient has a diagnosis of chronic kidney disease at risk of progression and the following
     criteria is met:
     °  The request is for Farxiga (dapagliflozin) or Jardiance (empagliflozin)
  •  The patient has a diagnosis of advanced chronic kidney disease (CKD) (estimated glomerular
     filtration rate [eGFR] less than 30 mL/min/1.73m2) and the following criteria is met:
     °  The request is for Ozempic (semaglutide), Trulicity (dulaglutide) or Victoza (liraglutide)

DURATION OF APPROVAL (DOA)

  •  676-D: DOA: 36 months
  •  BOG 6332-D: DOA: 36 months (If the request is for Farxiga approve Brand name Farxiga. If the
     request is for Xigduo XR approve Brand name Xigduo XR.)

 


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Adlyxin [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC; June 2022.
  2. Brenzavvy [package insert]. Marlborough, MA: TherascoBio, LLC.; September 2023.
  3. Bydureon BCise [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; May 2023.
  4. Byetta [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2022.
  5. Farxiga [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; June 2024.
  6. Glyxambi [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2023.
  7. Invokamet, Invokamet XR [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2024.
  8. Invokana [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; July 2023.
  9. Jardiance [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; September 2023.
  10. Mounjaro [package insert]. Indianapolis, IN: Lilly USA, LLC.; July 2023.
  11. Ozempic [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; September 2023.
  12. Qtern [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2023.
  13. Rybelsus [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; January 2024.
  14. Segluromet [package insert]. Rahway, NJ: Merck Sharpe & Dohme LLC.; September 2023.
  15. Soliqua [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC; September 2023.
  16. Steglatro [package insert]. Rahway, NJ: Merck Sharpe & Dohme LLC.; September 2023.
  17. Steglujan [package insert]. Rahway, NJ: Merck Sharpe & Dohme LLC.; October 2023.
  18. SymlinPen [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2019.
  19. Synjardy [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2023.
  20. Synjardy XR [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2023.
  21. Trijardy XR [package Insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2023.
  22. Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; December 2022.
  23. Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; July 2023.
  24. Xigduo XR [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; June 2024.
  25. Xultophy [package insert]. Plainsboro, NJ: Novo Nordisk U.S. LLC; July 2023.
  26. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://www.micromedexsolutions.com/ https://www.micromedexsolutions.com/Accessed March 4, 2024.
  27. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 03/04/2024).
  28. Blonde L, Umpierrez GE, Reddy SS et. al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan – 2022 Update. Endocrine Practice 28 (2022) 923-1049.
  29. Davies MJ, Aroda VR, Collins BS, et. al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753-2786.
  30. American Diabetes Association Professional Practice Committee. American Diabetes Association, Standards of Care in Diabetes – 2024. Diabetes Care. 2024:47(Suppl. 1):S1-S322.
  31. Heidenreich PA, Bozkurt B, Aguilar D et. al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022;79:e263-e421.
  32. Kittleson MM, Panjrath GS, Amancherla K et. al. 2023 ACC expert consensus decision pathway on management of heart failure with preserved ejection fraction: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023;81(18):1835-1878.
  33. Maddox TM, Januzzi JL Jr, Allen LA, et. al. 2024 ACC expert consensus decision pathway for treatment of heart failure with reduced ejection fraction: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol 2024;XX:XXX-XX.
  34. Samson SL, Vellanki P, Blonde L et. al. American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm – 2023 Update. Endocrine Practice 2023;29(5):P305-340.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 27, 2024
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