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ph-1159

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^® (insulin glargine) 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^® (insulin glargine) 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^® (insulin detemir) Injection	To improve glycemic control in adults and pediatric patients with diabetes mellitus		3
Rezvoglar™ (insulin glargine-aglr) Injection	To improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus Limitation of use: Not recommended for treating diabetic ketoacidosis		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 (insulin glargine) 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:

Most people with type 1 diabetes should be treated with multiple daily injections of prandial and basal insulin, or subcutaneous insulin infusion
Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk.
Patients with type 1 diabetes should receive education on how to match prandial insulin doses to carbohydrate intake, premeal blood glucose, and anticipated physical activity.(7)

For type 2 diabetes mellitus, the American Diabetes Association recommends the following:

Metformin is the preferred initial pharmacological agent for type 2 diabetes
The early introduction of insulin should be considered if there is evidence of ongoing catabolism, if symptoms of hyperglycemia are present, or when A1C levels or blood glucose levels are very high
A patient-centered approach should be used to guide the choice of pharmacological agents. Considerations include comorbidities, hypoglycemia risk, impact on weight, cost, risk of side effects, and patient preferences.(7)

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

Preferred Agents	Non-Preferred Target Agents
Semglee Insulin glargine-yfgn	Lantus Insulin glargine Rezvoglar
Tresiba	Insulin degludec

EVALUATION

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

The patient has an intolerance, or hypersensitivity to ALL preferred long acting insulin agents that is not expected to occur with the requested agent (medical records required) OR
The patient has an FDA labeled contraindication to ALL preferred long acting insulin agents that is not expected to occur with the requested agent (medical records required)

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