ModifiedCentenePolicy HIM.PA.09

Clinical Policy: Insulin Glargine (Basaglar, Lantus/unbranded Lantus, Rezvoglar, Toujeo/unbranded Toujeo)

Defines medical necessity and prior authorization criteria for insulin glargine products (Basaglar, Lantus/unbranded Lantus, Rezvoglar, Toujeo/unbranded Toujeo) for members under Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Insulin Glargine (Basaglar, Lantus/unbranded Lantus, Rezvoglar, Toujeo/unbranded Toujeo)

Policy CodePolicy HIM.PA.09

Change TypeMultiple edits — step therapy, redirection, product additions (2024–2025)

Effective Date03.01.19

Next Review DateN/A

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Updated redirection language to require use of insulin glargine-yfgn (unbranded Semglee) and failure of branded Tresiba.

Added Rezvoglar to policy and updated FDA indications.

Updated FDA approved indications section for Semglee to align with prescriber information and updated references.

Removed age restriction to align with class approach for other insulin products; references reviewed and updated.

Per SDC, removed Basaglar redirection and added redirection to branded Semglee; added Semglee as therapeutic alternative in Appendix B; added Basaglar to criteria; added Insulin Glargine-yfgn and clarified criteria apply to unbranded Semglee.

Removed unbranded Semglee from policy; added redirection to unbranded Semglee if branded Semglee is unavailable due to shortage.

Added step therapy bypass for IL HIM per IL HB 5395.

Updated redirection language: removed redirection to branded Semglee and unbranded Tresiba; added redirection to insulin glargine-yfgn (unbranded Semglee) and branded Tresiba.

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Coverage Criteria

Initial Therapy — Diabetes Mellitus

Covered when ALL of the following are met for Initial Approval (Diabetes Mellitus):

Initial Diabetes Criteria: 1. Diagnosis of type 1 or type 2 diabetes mellitus;

Initial Therapy Step Requirements

Step a: a. Member must use insulin glargine-yfgn (unbranded Semglee);
Step b: b. Failure of branded Tresiba (insulin degludec).
Approval duration: 12 months

Continuation Therapy — Diabetes Mellitus

Covered when ALL of the following are met for Continued Therapy (Diabetes Mellitus):

Continuation Eligibility: 1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations.

Continued Therapy Step Requirements

Step a: a. Member must use insulin glargine-yfgn (unbranded Semglee);
Step b: b. Failure of branded Tresiba (insulin degludec);

Response to Therapy: 3. Member is responding positively to therapy.

Approval duration: 12 months

Other Diagnoses/Indications

Other diagnoses/uses:

Other Indications: 1. If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to: a. HIM.PA.33 for drugs on the formulary (health insurance marketplace) or b. HIM.PA.103 for drugs NOT on the formulary (health insurance marketplace).

Other Indications: 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy HIM.PA.154 for health insurance marketplace.

Requests for uses of insulin glargine that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the provider supplies adequate documentation demonstrating efficacy and safety in accordance with the plan’s off‑label use requirements (see HIM.PA.154) or the member’s evidence of coverage documents.

Coverage and any authorization decisions are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance) and to applicable state and federal laws and Health Plan administrative policies and procedures. If legal or regulatory requirements differ from this clinical policy, the applicable law or regulation governs.

Insulin glargine products in this policy are not recommended for treatment of diabetic ketoacidosis. Additionally, requests for non‑FDA indications that lack sufficient evidence of efficacy and safety per the plan’s off‑label use policy (HIM.PA.154) are not authorized.

Coding and Product Availability

NDC / Product CodesNDC

Basaglar KwikPen (100 units/mL, 3 mL)	NDCs vary by packaging and manufacturer—refer to pharmacy system for exact NDC.
Basaglar Tempo Pen (100 units/mL, 3 mL)	NDCs vary by packaging and manufacturer—refer to pharmacy system for exact NDC.
Lantus vial (100 units/mL, 10 mL)	NDCs vary by packaging and manufacturer—refer to pharmacy system for exact NDC.
Lantus SoloStar pen (100 units/mL, 3 mL)	NDCs vary by packaging and manufacturer—refer to pharmacy system for exact NDC.
Toujeo SoloStar pen (300 units/mL, 1.5 mL)	NDCs vary by packaging and manufacturer—refer to pharmacy system for exact NDC.
Toujeo Max SoloStar pen (300 units/mL, 3 mL)	NDCs vary by packaging and manufacturer—refer to pharmacy system for exact NDC.
Rezvoglar (insulin glargine-aglr) KwikPen (100 units/mL, 3 mL)	NDCs vary by packaging and manufacturer—refer to pharmacy system for exact NDC.

Age restriction (product-specific) — Toujeo age and other product age notes

Toujeo age restrictionNo product-specific minimum age listed; follow prescriber guidance and FDA labeling for pediatric use

Basaglar and Lantus age notesRefer to individual product labeling for pediatric dosing and approvals; dosing varies by type 1 vs type 2 diabetes and prior insulin use

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for both initial and continued therapy. Providers must obtain prior authorization before initiating treatment and for renewals to ensure coverage under the member’s benefit plan.

Approval duration: 12 months

Prior Authorization

Prior Authorization and Redirection Requirements

Prior authorization requests must document adherence to redirection and biosimilar routing where applicable. Current policy requires use of insulin glargine-yfgn (unbranded Semglee) and documented failure of branded Tresiba (insulin degludec) per the step therapy/redirection controls unless state-specific exceptions apply. Recent updates include redirection preferences to insulin glargine-yfgn and branded Tresiba; availability-based redirection to unbranded Semglee may be used when branded product is unavailable.

Per policy updates, redirection preferences have been modified — verify current preferred product routing at time of request
For shortage scenarios, redirection to unbranded Semglee may apply

Background

Insulin glargine is a long‑acting human insulin analog formulated to provide basal insulin replacement and improve glycemic control in patients with diabetes mellitus. Branded and unbranded formulations (including Basaglar, Lantus/ unbranded Lantus, Rezvoglar, and Toujeo) are indicated for adults and pediatric patients as specified in each product’s prescribing information. Note that Basaglar, Lantus, Toujeo, and Rezvoglar are not recommended for diabetic ketoacidosis and product‑specific age indications apply (for example, Toujeo is indicated for patients 6 years and older).

Definitions and Limitations of Use

Insulin glargine — definition and products

DefinitionInsulin glargine is a long-acting human insulin analog used to improve glycemic control in patients with diabetes mellitus.

Listed product namesBasaglar; Lantus / unbranded Lantus; Rezvoglar; Toujeo / unbranded Toujeo.

Indications summaryProducts are indicated to improve glycemic control in adults and pediatric patients (Toujeo indicated for patients 6 years and older).

Limitation of use — not recommended for diabetic ketoacidosis

Limitation of use (DKA)Basaglar, Lantus/unbranded Lantus, Toujeo/unbranded Toujeo, and Rezvoglar are not recommended for treating diabetic ketoacidosis.

Non-FDA or off-label uses

Documentation Required

Documentation Supporting Medical Necessity

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including initial-therapy requirements, prior trials, treatment response, and any contraindications or adverse effects.

Acceptable documentation: chart notes, medication history, lab results, prior authorization history
Documentation should demonstrate member is responding positively to therapy for continuation requests

Step Therapy

Step Therapy and Illinois (IL) Bypass

Per Illinois HB 5395 (effective 01/01/2026) there is a step therapy bypass for Illinois HIM requests — step therapy requirements do not apply for Illinois HIM requests. Also note state-specific exceptions (e.g., New York) where step therapy does not apply. Always indicate if the member is in a state/product with continuity of care regulations or if statutory bypass applies.

IL HIM bypass effective 01/01/2026 — do not require step therapy for Illinois HIM requests
New York: step therapy requirements do not apply for NY requests
Indicate if member is enrolled in a state/product with continuity of care regulations