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Long Acting Insulin Prior Authorization Program Summary
Policy Number: PH-1159
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
7/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Basaglar® Injection |
To improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus |
|
1 |
Lantus® Injection |
To improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus |
|
2 |
Levemir® Injection |
To improve glycemic control in adults and pediatric patients with diabetes mellitus |
|
3 |
Rezvoglar™ |
To improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus |
|
9 |
Semglee®, Insulin glargine-yfgn Injection |
To improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus |
|
4 |
Toujeo®, Toujeo® Max Injection |
To improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus |
|
5 |
Tresiba®, Insulin degludec Injection |
To improve glycemic control in patients 1 year of age and older with diabetes mellitus |
|
6 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Overview |
The American Diabetes Association Standards of Medical Care in Diabetes recommend the following therapy for type 1 diabetes mellitus:
For type 2 diabetes mellitus, the American Diabetes Association recommends the following:
The American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) algorithm for type 2 diabetics recommends starting insulin therapy if the patient has an A1c > 9% and is having hyperglycemia symptoms. Patients with recent-onset type 2 diabetes or who have mild hyperglycemia (A1c less than 7.5%), lifestyle therapy plus antihyperglycemic monotherapy (preferably with metformin) is recommended. Patients who present with an A1c greater than 7.5% should be started initially on metformin plus another agent, one of which is insulin. Patients taking two oral antihyperglycemic agents who have an A1c greater than 8 and/or long-standing type 2 diabetes are less likely to reach their target with a third oral antihyperglycemic agent. Although adding a GLP-1 receptor agonist as the third agent may lower hyperglycemia, eventually many patients will still require insulin. When insulin becomes necessary, a single daily dose of basal insulin should be added to the regimen. Dosage should be adjusted at regular and at short intervals to achieve the glycemic goal. Patients whose glycemia remains uncontrolled while receiving basal insulin in combination with oral agents or GLP-1 receptor agonists may require mealtime insulin to cover postprandial hyperglycemia.(8)
|
REFERENCES
Number |
Reference |
1 |
Basaglar prescribing information. Eli Lilly and Company. July 2021. |
2 |
Lantus prescribing information. Sanofi-Aventis US, LLC. January 2021. |
3 |
Levemir prescribing information. Novo Nordisk, Inc. July 2022. |
4 |
Semglee prescribing information. Mylan Specialty L.P. July 2021. |
5 |
Toujeo, Toujeo Max prescribing information. Sanofi-Aventis U.S. LLC. December 2020. |
6 |
Tresiba prescribing information. Novo Nordisk Inc. July 2022. |
7 |
American Diabetes Association. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2022. Available at https://diabetesjournals.org/care/issue/45/Supplement_1 |
8 |
AACE/ACE Comprehensive Type 2 Diabetes Management Algorithm (2020) Executive Summary. Available at: https://pro.aace.com/pdfs/diabetes/AACE_2019_Diabetes_Algorithm_03.2021.pdf |
9 |
Rezvoglar precribing information. December 2021. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
|
insulin degludec inj ; insulin degludec soln pen-injector |
100 UNIT/ML ; 200 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Lantus ; Lantus solostar ; Rezvoglar kwikpen |
insulin glargine inj ; insulin glargine soln pen-injector ; insulin glargine-aglr soln pen-injector |
100 UNIT/ML ; 300 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
insulin degludec inj ; insulin degludec soln pen-injector |
100 UNIT/ML ; 200 UNIT/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Lantus ; Lantus solostar ; Rezvoglar kwikpen |
insulin glargine inj ; insulin glargine soln pen-injector ; insulin glargine-aglr soln pen-injector |
100 UNIT/ML ; 300 UNIT/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||||
|
EVALUATION Non-preferred Target Agent(s) will be approved when ONE of the following is met:
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 _ Long Acting Insulin Prior Authorization _ProgSum_ 7/1/2023