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Insulin Combination Agents (Soliqua, Xultophy) Step Therapy and Quantity Limit Program Summary
Policy Number: PH-91050
This program applies to Blue Partner, Commercial, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
4/1/2024 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Soliqua® 100/33 (insulin glargine/lixisenatide) Injection |
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use:
|
|
1 |
Xultophy® 100/3.6 (insulin degludec/liraglutide) Injection |
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of use:
|
|
2 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Guidelines |
The American Diabetes Association (ADA) states that first-line therapy for type 2 diabetes depends on comorbidities, patient-centered treatment factors, and management needs but will generally include metformin and comprehensive lifestyle modification. When A1c is greater than or equal to 1.5% above the glycemic target, many patients will require dual combination therapy to achieve their target A1c level. Insulin has the advantage of being effective where other agents are not and should be considered as part of any combination regimen when hyperglycemia is severe, especially if catabolic features are present. If basal insulin has been titrated to an acceptable fasting blood glucose level (or if the dose is greater than 0.5 units/kg/day with indications of need for other therapy) and A1c remains above target, consider advancing to combination injectable therapy. This approach can use a GLP-1 added to basal insulin or multiple doses of insulin. The combination of basal insulin and GLP-1 has potent glucose-lowering actions and less weight gain and hypoglycemia compared with intensified insulin regimens. For patients with established atherosclerotic cardiovascular disease (ASCVD) or indicators of high ASCVD risk (such as patients greater than or equal to 55 years of age with coronary, carotid, or lower-extremity artery stenosis greater than 50% or left ventricular hypertrophy), heart failure, or chronic kidney disease, an SGLT2 inhibitor or GLP-1 with demonstrated CVD benefit is recommended as part of the glucose-lowering regimen independent of the A1C, independent of metformin use, and in consideration of other patient-specific factors.(3) Basal with or without prandial insulin treatment may be needed as initial therapy if the A1C is >10% and/or glucose values are >300 mg/dL, combined with catabolic symptoms, such as weight loss. If symptomatic hyperglycemia is present, a GLP-1 RA alone is not recommended as it requires titration and may delay glucose control. The goal of initial intensive insulin therapy for symptomatic hyperglycemia is to reduce glucose levels safely and promptly. After improved glycemic control is achieved with short-term insulin therapy, especially with a new diagnosis of DM, a role for noninsulin antihyperglycemic agents could be considered. For most persons who need intensification of glycemic control and who are already undergoing 3 to 4 oral therapies, a GLP-1 RA or GIP/GLP-1 RA should be the initial choice, if not already in use. If glycemic targets are not achieved with these therapies, basal insulin should be added alone or as a basal insulin/GLP-1 RA combination injection. Stepwise addition of prandial insulin at 1 to 3 meals is recommended if additional glycemic control is required. The dose of basal insulin can be based on A1C levels at the time of initiation. For an A1C <8%, basal insulin can be started at 0.1 to 0.2 U/kg/day and for an A1C >8%, 0.2 to 0.3 U/kg/day can be considered. Analog insulins, including detemir, glargine, or degludec are preferred over human insulins such as neutral protamine Hagedorn (NPH) to reduce hypoglycemia.(4) |
Safety (1,2) |
Xultophy carries a black box warning. Liraglutide, one of the components of Xultophy, causes thyroid C-cell tumors at clinically relevant expression in both genders of rats and mice. It is unknown whether Xultophy causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.(2) Xultophy has the following contraindications:(2)
Soliqua has the following contraindications:(1)
|
REFERENCES
Number |
Reference |
1 |
Soliqua prescribing information. Sanofi-Aventis US LLC. June 2022. |
2 |
Xultophy prescribing information. Novo Nordisk Inc. July 2023. |
3 |
American Diabetes Association. Standards of medical care in diabetes-2022. Available at: https://diabetesjournals.org/care/issue/45/Supplement_1. |
4 |
American Diabetes Association, 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2023. Diabetes Care 1 January 2023; 46 (Supplement_1): S140–S157. https://doi.org/10.2337/dc23-S009. |
POLICY AGENT SUMMARY STEP THERAPY
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Soliqua 100/33 |
insulin glargine-lixisenatide sol pen-inj |
100-33 UNT-MCG/ML |
M ; N ; O |
N |
|
|
Xultophy 100/3.6 |
insulin degludec-liraglutide sol pen-inj |
100-3.6 UNIT-MG/ML |
M ; N ; O |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Soliqua 100/33 |
insulin glargine-lixisenatide sol pen-inj |
100-33 UNT-MCG/ML |
6 |
Pens |
30 |
DAYS |
|
|
|
Xultophy 100/3.6 |
insulin degludec-liraglutide sol pen-inj |
100-3.6 UNIT-MG/ML |
5 |
Pens |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – STEP THERAPY
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Soliqua 100/33 |
insulin glargine-lixisenatide sol pen-inj |
100-33 UNT-MCG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Xultophy 100/3.6 |
insulin degludec-liraglutide sol pen-inj |
100-3.6 UNIT-MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Soliqua 100/33 |
insulin glargine-lixisenatide sol pen-inj |
100-33 UNT-MCG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Xultophy 100/3.6 |
insulin degludec-liraglutide sol pen-inj |
100-3.6 UNIT-MG/ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
STEP THERAPY CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||
|
Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: 12 months NOTE: If Quantity Limit 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:
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 _ PS _ Insulin_Combination_Agents_(Soliqua,_Xultophy)_STQL _ProgSum_ 04-01-2024