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GLP-1 (glucagon-like peptide-1) Agonists Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91007

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

POLICY REVIEW CYCLE

Effective Date

Date of Origin   

07-01-2024           

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Adlyxin®

(lixisenatide)

Subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

  • 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
  • Should not be used in patients with type 1 diabetes 
  • Has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis.

8

Bydureon®  

(exenatide)

Subcutaneous injection

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 as first-line therapy for patients inadequately controlled on diet and exercise
  • Is not indicated for use in patients with type 1 diabetes mellitus
  • Bydureon is an extended-release formulation of exenatide and should not be used with other products containing the active ingredient exenatide.
  • Has not been studied in patients with a history of pancreatitis.  Consider other antidiabetic therapies in patients with a history of pancreatitis.

3

Bydureon BCise®

(exenatide)

Subcutaneous injection

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 as first-line therapy for patients inadequately controlled on diet and exercise.
  • Is not indicated for use in patients with type 1 diabetes mellitus
  • Bydureon BCise is an extended-release formulation of exenatide. It should not be used with other products containing the active ingredient exenatide.
  • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

4

Byetta®

(exenatide)

Subcutaneous injection

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

  • Should not be used for the treatment of type 1 diabetes.
  • Has not been studied in patients with a history of pancreatitis.  Consider other antidiabetic therapies in patients with a history of pancreatitis.

1

Mounjaro®

(tirzepatide)

Subcutaneous injection

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

Limitations of Use

  • Has not been studied in patients with a history of pancreatitis
  • Is not indicated for use in patients with type 1 diabetes mellitus

11

Ozempic®

(semaglutide)

Subcutaneous injection

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 in adults with type 2 diabetes mellitus and established cardiovascular disease

Limitations of Use:

  • Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy
  • Not for treatment of type 1 diabetes mellitus

5

Rybelsus®

(semaglutide)

Tablet

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Limitations of Use:

  • Not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise
  • Has not been studied in patients with a history of pancreatitis
  • Not indicated for use in patients with type 1 diabetes mellitus

6

Trulicity®

(dulaglutide)

Subcutaneous injection

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 who have established cardiovascular disease or multiple cardiovascular risk factors

Limitations of Use:

  • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients
  • Not for treatment of type 1 diabetes 
  • Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis.

7

Victoza®

(liraglutide)

Subcutaneous injection

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:

  • Should not be used in patients with type 1 diabetes mellitus.
  • Contains liraglutide and should not be coadministered with other liraglutide containing products

2

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

CLINICAL RATIONALE

Diabetes Mellitus

The American Diabetes Association (ADA) recommends the following guidelines:(9,10)

  • 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 approaches 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.
  • An A1C level of greater than or equal to 6.5% is recommended for most nonpregnant adults, if it can be achieved safely. Glucose targets should be individualized with consideration for life expectancy, disease duration, presence or absence of micro- and macrovascular complications, cardiovascular disease (CVD) risk factors, comorbid conditions, and risk for hypoglycemia, as well as a person’s cognitive and psychological status.
  • Adopt less stringent glycemic goals (A1C 7% to 8%) in persons with a history of severe hypoglycemia, hypoglycemia unawareness, limited life expectancy, advanced renal disease, extensive comorbid conditions, or long-standing DM in which the A1C goal has been difficult to attain despite intensive efforts, so long as the person remains free of hyperglycemia-associated symptoms.

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. 

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.

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.(10)

The American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) recommend glucagon-like peptide 1 receptor agonists (GLP-1) as an add-on therapy to oral agents and in combination with insulin for the treatment of diabetes. Current guidelines by the ADA and AACE do not support combination therapy of GLP-1 and dipeptidyl peptidase 4 inhibitors (DPP-4) due to lack of added clinical benefit. The mechanism of action by which GLP-1 and DPP-4 medications control blood glucose is by targeting the body’s incretin system. GLP-1 agonists act as “incretin mimetics” and DPP-4 inhibitors prevent the breakdown of endogenous incretin. Unlike endogenous incretin, GLP-1 is not broken down by the DPP-4 enzyme. Therefore, using these medications at the same time yields no additional benefit due to the simliar mechanism of action. (10,12,13)

Safety

Bydureon, Bydureon BCise, Mounjaro, Ozempic, Rybelsus, Trulicity, and Victoza all share the same boxed warning and contraindications:(2-7,11)

  • Causes thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether these agents cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of induced rodent thyroid C-cell tumors has not been determined. 
  • Contraindicated in:
    • Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
    • Prior serious hypersensitivity reaction to the active ingredient or any of the product components

Adlyxin and Byetta are contraindicated in patients with severe hypersensitivity to the active product ingredient or any component. (1,8)

REFERENCES

Number

Reference

1

Byetta prescribing information. AstraZeneca Pharmaceuticals, Inc. December 2022.

2

Victoza prescribing information. Novo Nordisk A/S. July 2023.

3

Bydureon prescribing information. AstraZeneca Pharmaceuticals, Inc. December 2022.

4

Bydureon BCise prescribing information. AstraZeneca Pharmaceuticals, Inc. December 2022.

5

Ozempic prescribing information. Novo Nordisk. September 2023.

6

Rybelsus prescribing information. Novo Nordisk A/S. January 2022.

7

Trulicity prescribing information. Eli Lilly and Company. November 2022.

8

Adlyxin prescribing information. Sanofi-Aventis US. LLC. June 2022.

9

American Diabetes Association. 6. Glycemic Targets: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan;47(Suppl 1):S97-S1https://doi.org/10.2337/dc24-S00610. 

10

American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care 1 January 2023; 47 (Supplement_1): S158–S178. https://doi.org/10.2337/dc23-S009.

11

Mounjaro prescribing information. Lilly, USA. June 2023.

12

Nauck, Michael A. Addition of dipeptidyl peptidase-4 inhibitor, sitagliptin, to ongoing therapy with the glucagon-like peptide-1 receptor agonist liraglutide: A randomized controlled trial in patients with type 2 diabetes. Diabetes Obesity and Metabolism. (2):200-207. dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.12802.

13

Blonde, L., Umpierrez, G. et. al., 2022 Clinical Practice Guideline for Development of a Diabetes Mellitus Comprehensive Care Plan. October 2022. 28(10): 923-1049. https://doi.org/10.1016/j.eprac.2022.08.002.

14

American Diabetes Association. Understanding A1C. https://diabetes.org/about-diabetes/a1c.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Trulicity

dulaglutide soln pen-injector

0.75 MG/0.5ML ; 1.5 MG/0.5ML ; 3 MG/0.5ML ; 4.5 MG/0.5ML

M ; N ; O ; Y

N

1. Preferred

Bydureon bcise

exenatide extended release susp auto-injector

2 MG/0.85ML

M ; N ; O ; Y

N

1. Preferred

Ozempic

semaglutide soln pen-inj

2 MG/1.5ML ; 2 MG/3ML ; 4 MG/3ML ; 8 MG/3ML

M ; N ; O ; Y

N

1. Preferred

Rybelsus

semaglutide tab

14 MG ; 3 MG ; 7 MG

M ; N ; O ; Y

N

1. Preferred

Mounjaro

tirzepatide soln pen-injector

10 MG/0.5ML ; 12.5 MG/0.5ML ; 15 MG/0.5ML ; 2.5 MG/0.5ML ; 5 MG/0.5ML ; 7.5 MG/0.5ML

M ; N ; O ; Y

N

1. Preferred

Byetta

exenatide soln pen-injector

10 MCG/0.04ML ; 5 MCG/0.02ML

M ; N ; O ; Y

N

2. Non-Preferred

Victoza

liraglutide soln pen-injector

18 MG/3ML

M ; N ; O ; Y

N

2. Non-Preferred

Adlyxin starter pack

lixisenatide pen-inj starter kit

10 & 20 MCG/0.2ML

M ; N ; O ; Y

N

2. Non-Preferred

Adlyxin

lixisenatide soln pen-injector

20 MCG/0.2ML

M ; N ; O ; Y

N

2. Non-Preferred

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

Adlyxin

Lixisenatide Soln Pen-injector 20 MCG/0.2ML (100 MCG/ML)

20 MCG/0.2ML

2

Pens

28

DAYS

Adlyxin starter pack

Lixisenatide Pen-inj Starter Kit 10 MCG/0.2ML & 20 MCG/0.2ML

10 & 20 MCG/0.2ML

2

Pens

180

DAYS

Bydureon bcise

Exenatide Extended Release Susp Auto-Injector 2 MG/0.85ML

2 MG/0.85ML

4

Pens

28

DAYS

Byetta

Exenatide Soln Pen-injector 10 MCG/0.04ML

10 MCG/0.04ML

1

Pen

30

DAYS

Byetta

Exenatide Soln Pen-injector 5 MCG/0.02ML

5 MCG/0.02ML

1

Pen

30

DAYS

Mounjaro

Tirzepatide Soln Pen-injector

2.5 MG/0.5ML

4

Pens

180

DAYS

Mounjaro

Tirzepatide Soln Pen-injector

5 MG/0.5ML

4

Pens

28

DAYS

Mounjaro

Tirzepatide Soln Pen-injector

7.5 MG/0.5ML

4

Pens

28

DAYS

Mounjaro

Tirzepatide Soln Pen-injector

10 MG/0.5ML

4

Pens

28

DAYS

Mounjaro

Tirzepatide Soln Pen-injector

12.5 MG/0.5ML

4

Pens

28

DAYS

Mounjaro

Tirzepatide Soln Pen-injector

15 MG/0.5ML

4

Pens

28

DAYS

Ozempic

Semaglutide Soln Pen-inj

2 MG/3ML

1

Pen

28

DAYS

Ozempic

Semaglutide Soln Pen-inj

8 MG/3ML

1

Pen

28

DAYS

Ozempic

Semaglutide Soln Pen-inj

4 MG/3ML

1

Pen

28

DAYS

Ozempic

Semaglutide Soln Pen-inj 0.25 or 0.5 MG/DOSE (2 MG/1.5ML)

2 MG/1.5ML

1

Pen

28

DAYS

Rybelsus

semaglutide tab

14 MG ; 3 MG ; 7 MG

30

Tablets

30

DAYS

Rybelsus

Semaglutide Tab 3 MG

3 MG

30

Tablets

180

DAYS

Trulicity

dulaglutide soln pen-injector

0.75 MG/0.5ML ; 1.5 MG/0.5ML ; 3 MG/0.5ML ; 4.5 MG/0.5ML

4

Pens

28

DAYS

Victoza

liraglutide soln pen-injector

18 MG/3ML

3

Pens

30

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Bydureon bcise

exenatide extended release susp auto-injector

2 MG/0.85ML

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

Mounjaro

tirzepatide soln pen-injector

10 MG/0.5ML ; 12.5 MG/0.5ML ; 15 MG/0.5ML ; 2.5 MG/0.5ML ; 5 MG/0.5ML ; 7.5 MG/0.5ML

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

Ozempic

semaglutide soln pen-inj

2 MG/1.5ML ; 2 MG/3ML ; 4 MG/3ML ; 8 MG/3ML

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

Rybelsus

semaglutide tab

14 MG ; 3 MG ; 7 MG

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

Trulicity

dulaglutide soln pen-injector

0.75 MG/0.5ML ; 1.5 MG/0.5ML ; 3 MG/0.5ML ; 4.5 MG/0.5ML

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

Adlyxin

lixisenatide soln pen-injector

20 MCG/0.2ML

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

Adlyxin starter pack

lixisenatide pen-inj starter kit

10 & 20 MCG/0.2ML

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

Byetta

exenatide soln pen-injector

10 MCG/0.04ML ; 5 MCG/0.02ML

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

Victoza

liraglutide soln pen-injector

18 MG/3ML

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

Adlyxin

Lixisenatide Soln Pen-injector 20 MCG/0.2ML (100 MCG/ML)

20 MCG/0.2ML

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

Adlyxin starter pack

Lixisenatide Pen-inj Starter Kit 10 MCG/0.2ML & 20 MCG/0.2ML

10 & 20 MCG/0.2ML

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

Bydureon bcise

Exenatide Extended Release Susp Auto-Injector 2 MG/0.85ML

2 MG/0.85ML

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

Byetta

Exenatide Soln Pen-injector 10 MCG/0.04ML

10 MCG/0.04ML

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

Byetta

Exenatide Soln Pen-injector 5 MCG/0.02ML

5 MCG/0.02ML

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

Mounjaro

Tirzepatide Soln Pen-injector

15 MG/0.5ML

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

Mounjaro

Tirzepatide Soln Pen-injector

12.5 MG/0.5ML

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

Mounjaro

Tirzepatide Soln Pen-injector

10 MG/0.5ML

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

Mounjaro

Tirzepatide Soln Pen-injector

7.5 MG/0.5ML

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

Mounjaro

Tirzepatide Soln Pen-injector

5 MG/0.5ML

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

Mounjaro

Tirzepatide Soln Pen-injector

2.5 MG/0.5ML

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

Ozempic

Semaglutide Soln Pen-inj

2 MG/3ML

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

Ozempic

Semaglutide Soln Pen-inj

8 MG/3ML

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

Ozempic

Semaglutide Soln Pen-inj

4 MG/3ML

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

Ozempic

Semaglutide Soln Pen-inj 0.25 or 0.5 MG/DOSE (2 MG/1.5ML)

2 MG/1.5ML

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

Rybelsus

semaglutide tab

14 MG ; 3 MG ; 7 MG

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

Rybelsus

Semaglutide Tab 3 MG

3 MG

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

Trulicity

dulaglutide soln pen-injector

0.75 MG/0.5ML ; 1.5 MG/0.5ML ; 3 MG/0.5ML ; 4.5 MG/0.5ML

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

Victoza

liraglutide soln pen-injector

18 MG/3ML

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

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

CoT with Dx check

Preferred Target Agent(s)

Non-Preferred Target Agent(s)

Bydureon (exenatide)
Mounjaro (tirzepatide)
Ozempic (semaglutide)
Rybelsus (semaglutide)
Trulicity (dulaglutide)

Adlyxin (lixisenatide)
Byetta (exenatide)
Victoza (liraglutide)

 

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

  1. The patient has a diagnosis of type 2 diabetes AND
  2. The patient’s diagnosis has been confirmed by lab tests (e.g., A1C greater than or equal to 6.5%) (lab test results required) AND
  3. ONE of the following:
    1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

Ozempic, Rybelsus, Trulicity, Mounjaro, Bydureon

  

      1. The patient has been treated with a preferred agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with a preferred agent within the past 90 days (starting on samples is not approvable) AND is at risk if therapy with a preferred agent is discontinued OR
    1. BOTH of the following:
      1. ONE of the following:
        1. The patient has tried and had an inadequate response to an agent containing metformin or insulin OR
        2. The patient has an intolerance or hypersensitivity to metformin or insulin OR
        3. The patient has an FDA labeled contraindication to BOTH metformin AND insulin OR
        4. The patient has a diagnosis of type 2 diabetes with/or at high risk for atherosclerotic cardiovascular disease, heart failure, and/or chronic kidney disease AND
      2. ONE of the following:
        1. The requested agent is a preferred GLP-1 or GLP-1/GIP OR
        2. The agent is a non-preferred GLP-1 and TWO of the following:
          1. The patient has tried and had an inadequate response after at least a 90 day trial of therapy, has an intolerance, has a hypersensitivity, or has an FDA labeled contraindication to semaglutide (Ozempic OR Rybelsus) OR
          2. The patient has tried and had an inadequate response after at least a 90 day trial of therapy, has an intolerance, has a hypersensitivity, or has an FDA labeled contraindication to dulaglutide (Trulicity) OR
          3. The patient has tried and had an inadequate response after at least a 90 day trial of therapy, has an intolerance, has a hypersensitivity, or has an FDA labeled contraindication to tirzepatide (Mounjaro) AND
  1. The patient will NOT be using the requested agent in combination with a DPP-4 containing agent for the requested indication AND
  2. The patient will NOT be using the requested agent in combination with another GLP-1 receptor agonist agent

Length of Approval: 12 months

NOTE: If Quantity Limit program also 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

QL with PA

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. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. 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. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
    3. There is support for 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.

ALBP _  Commercial _ CSReg _ GLP-1_Agonists_PAQL _ProgSum_ 07-01-2024  _ © Copyright Prime Therapeutics LLC. May 2024 All Rights Reserved