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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 |
10-01-2024 |
|
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:
|
|
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:
|
|
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:
|
|
4 |
Byetta® (exenatide) Subcutaneous injection |
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:
|
|
1 |
Mounjaro® (tirzepatide) |
An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use
|
|
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:
|
|
5 |
Rybelsus® (semaglutide) Tablet |
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use:
|
|
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:
|
|
7 |
Victoza®, Liraglutide (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:
|
|
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. 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)
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 |
|
|
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 |
|
|
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 |
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 |
M |
|
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 10 MG/0.5ML |
10 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Mounjaro |
Tirzepatide Soln Pen-injector 12.5 MG/0.5ML |
12.5 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Mounjaro |
Tirzepatide Soln Pen-injector 15 MG/0.5ML |
15 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Mounjaro |
Tirzepatide Soln Pen-injector 2.5 MG/0.5ML |
2.5 MG/0.5ML |
4 |
Pens |
180 |
DAYS |
|
|
|
Mounjaro |
Tirzepatide Soln Pen-injector 5 MG/0.5ML |
5 MG/0.5ML |
4 |
Pens |
28 |
DAYS |
|
|
|
Mounjaro |
Tirzepatide Soln Pen-injector 7.5 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 |
|
|
|
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 |
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 |
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 |
Bydureon bcise |
exenatide extended release susp auto-injector |
2 MG/0.85ML |
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 |
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 10 MG/0.5ML |
10 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Mounjaro |
Tirzepatide Soln Pen-injector 12.5 MG/0.5ML |
12.5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Mounjaro |
Tirzepatide Soln Pen-injector 15 MG/0.5ML |
15 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Mounjaro |
Tirzepatide Soln Pen-injector 2.5 MG/0.5ML |
2.5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Mounjaro |
Tirzepatide Soln Pen-injector 5 MG/0.5ML |
5 MG/0.5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Mounjaro |
Tirzepatide Soln Pen-injector 7.5 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 |
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 |
Target Agent(s) will be approved when ALL of the following are met:
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:
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 _ CSReg _ GLP-1_Agonists_PAQL _ProgSum_ 10-01-2024 _ _v2_