Asset Publisher

ph-1007

print Print Back Back

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

Policy Number: PH-1007

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 

6/1/2023

FDA APPROVED 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 (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) 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 other antidiabetic therapies in patients with a history of pancreatitis
  • Not indicated for use in patients with 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.  Consider other antidiabetic therapies 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

Overview

Overview

The American Diabetes Association (ADA) recommends:

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

 

Bydureon, Bydureon BCise, Mounjaro, Ozempic, Rybelsus, Trulicity, and Victoza all share the same black box warning:

  • 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).(2-7, 11)

REFERENCES                                                                                                                                                                           

Number

Reference

1

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

2

Victoza prescribing information.  Novo Nordisk A/S.  June 2022.

3

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

4

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

5

Ozempic prescribing information. Novo Nordisk. March 2022.

6

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

7

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

8

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

9

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

10

Garber AJ, Handelsman Y, Grunberger G et, al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm-2020 Executive Summary.  Endocrine Practice, 26 (1) January 2020.  107-139.  Available at: https://www.aace.com/disease-state-resources/diabetes/clinical-practice-guidelines-treatment-algorithms/comprehensive Reference no longer used.

11

Mounjaro prescribing information.  Lilly, USA.  May 2022.

 

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

M ; N ; O ; Y

N

1. Preferred

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

Victoza

liraglutide soln pen-injector

18 MG/3ML

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

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

Exenatide Extended Release for Susp Pen-injector 2 MG

4

Pens

28

DAYS

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

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

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

Ozempic

Semaglutide Soln Pen-inj 1 MG/DOSE (2 MG/1.5ML)

2 MG/1.5ML

2

Pens

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

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

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

Victoza

liraglutide soln pen-injector

18 MG/3ML

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

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Exenatide Extended Release for Susp Pen-injector 2 MG

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

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

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/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

Ozempic

Semaglutide Soln Pen-inj 1 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

TARGET AGENT(S)

Preferred Agent(s)

Non-Preferred Agent(s)

Bydureon® (exenatide)
Mounjaro™ (tirzepatide)
Ozempic® (semaglutide)
Rybelsus® (semaglutide)
Trulicity® (dulaglutide)
Victoza® (liraglutide)

Adlyxin® (lixisenatide)
Byetta® (exenatide)

Evaluation

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

  1. The patient has a diagnosis of type 2 diabetes mellitus (documentation required) AND ONE of the following:
    1. If the requested agent is a preferred GLP-1, then ONE of the following:

Agent(s) Eligible for Continuation of Therapy

Ozempic, Rybelsus, Trulicity, Mounjaro, Victoza, Bydureon

      1. Information has been provided that indicates 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 is with a preferred agent is discontinued OR
    2. ALL 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 duration 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 duration 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 duration of therapy, has an intolerance, has a hypersensitivity, or has an FDA labeled contraindication to tirzepatide (Mounjaro) 

Length of approval: 12 months

NOTE: If Quantity Limit program also applies, please refer to Quantity Limit criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

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

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) is greater than 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) is greater than the program quantity limit AND
    2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
    3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

 

Length of Approval:  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 _ PS _ GLP-1 (glucagon-like peptide-1) Agonists Prior Authorization with Quantity Limit _ProgSum