ModifiedCentenePolicy HIMPA.09

Insulin Glargine (Basaglar; Lantus/unbranded Lantus, Rezvoglar; Toujeo/unbranded Toujeo)

Clinical coverage criteria and prior authorization requirements for insulin glargine products (brand and unbranded) used to improve glycemic control in members with type 1 or type 2 diabetes mellitus under Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyInsulin Glargine (Basaglar; Lantus/unbranded Lantus, Rezvoglar; Toujeo/unbranded Toujeo)

Policy CodePolicy HIMPA.09

Change TypeProduct additions and redirection/step-therapy updates

Effective DateMar 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of type 1 or type 2 diabetes and evidence that member meets redirection/step requirements (use branded Semglee unless shortage).

SourceLink

POLICY UPDATE CHANGES

Added Rezvoglar to the policy.

Redirection language updated to require use of branded Semglee and failure of unbranded Tresiba for redirection logic.

Added Insulin glargine-yfgn (Semglee) to policy and clarified criteria apply to unbranded Semglee.

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

Removed Basaglar redirection and added redirection to branded Semglee; added Semglee as therapeutic alternative option in Appendix B; added Basaglar to criteria; for continued therapy requests, added redirection to preferred products; added Insulin Glargine-yfgn to policy and clarified that criteria apply to unbranded Semglee.

Added Lantus (branded and unbranded) and unbranded Toujeo to criteria; updated redirection language to require use of branded Semglee in some redirection paths and align failure language for unbranded Tresiba.

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

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Coverage Criteria for Insulin Glargine Products

Initial and Continued Therapy

Covered when ALL of the following are met:

Initial Approval: Member has a diagnosis of type 1 or type 2 diabetes mellitus

Diabetes Mellitus requirements

a) Branded Semglee availability: Member must use branded Semglee unless branded Semglee is unavailable due to shortage, in which case insulin glargine-yfgn (unbranded Semglee) may be used
Shortage contingency per policy updates
b) Failure requirement for redirection: Failure of unbranded Tresiba (insulin degludec; specific NDCs referenced in policy) may be required for some redirection paths
Policy references specific NDCs for unbranded Tresiba

Continued Therapy: Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria and is responding positively to therapy

Approval duration: 12 months

Product inclusion and redirection

Policy criteria updated to include and redirect among specified insulin glargine products.

Product inclusion and redirection updates: Policy includes Basaglar; Insulin Glargine-yfgn (Semglee) as unbranded Semglee when shortage of branded Semglee exists; branded and unbranded Lantus; Rezvoglar; and Toujeo/unbranded Toujeo in the criteria. Redirection language requires use of branded Semglee in applicable paths and aligns failure language for unbranded Tresiba. Policy also specifies redirection to unbranded Semglee only when branded Semglee is unavailable due to shortage.

Full initial/continuation logic and specific failure/NDC details are in the main criteria (see Initial and Continued Therapy).

Requests for non‑FDA approved indications that are not specifically addressed in this insulin glargine clinical policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the plan's Off‑Label Use Policy (HIM.PA.154) or other applicable evidence of coverage documents.

Coverage under this clinical policy is subject to all plan terms, conditions, exclusions, and limitations described in the member's evidence of coverage or contract. This policy provides medical necessity guidance to assist coverage decisions but does not guarantee payment; final determinations must follow the applicable coverage documents and Health Plan administrative policies.

Authorization for indications not approved by the FDA requires submission of clinical documentation demonstrating efficacy and safety consistent with the plan's off‑label use requirements. Providers should reference HIM.PA.154 (Off‑Label Use Policy) and include supporting records (e.g., peer‑reviewed literature, chart notes, and rationale) to justify coverage for non‑FDA uses.

Medical necessity determinations for insulin glargine requests will follow the criteria in this clinical policy together with the member's plan coverage rules. The Health Plan retains discretion to interpret plan terms and to apply exclusions or limitations; providers are expected to supply documentation needed for a medical necessity review.

Policy Identifier, Codes, and Age Limits

Policy identifier (document)mixed

Reference: HIMPA.09

Policy reference number

Covered / Affected Codes (generic)mixed

affected codes

Codes referenced generically in policy (specific CPT/HCPCS/NDC codes not present in this document excerpt)

Minimum age for Toujeo and Rezvoglar — pediatric age indications

Minimum age (Toujeo)6 years and older (Toujeo indicated for pediatric patients 6 years and older)

Minimum age (Rezvoglar)6 years and older (Rezvoglar indicated for pediatric patients 6 years and older)

Applies toPediatric patients for Toujeo and Rezvoglar indications

Prior Authorization, Documentation, and Redirection

Prior Authorization

Prior Authorization Required

Prior authorization is required for insulin glargine products. Providers must obtain PA before dispensing Basaglar, Lantus (branded or unbranded), Rezvoglar, Toujeo (branded or unbranded), Semglee (branded and unbranded when applicable), and other insulin glargine formulations covered by this policy.

PA required prior to initiation or continuation of therapy
Approval duration: up to 12 months

Documentation Required

Required Documentation

Provider must submit supporting documentation with the PA request. Acceptable documentation includes office chart notes, recent lab results (e.g., A1C, blood glucose logs), prior medication history, and any records demonstrating failure or intolerance of preferred products.

Include office notes and labs showing diagnosis and clinical need
Document prior trials, reasons for failure or adverse effects, and continuity-of-care information when applicable

Background on Insulin Glargine

Insulin glargine is a long‑acting human insulin analog used to improve glycemic control in patients with type 1 and type 2 diabetes. Multiple branded and unbranded formulations are governed by this policy — for example, Basaglar and Lantus are commonly available as 100 units/mL pens or vials, while Toujeo is formulated as 300 units/mL pens; product selection and dosing considerations may change when switching between concentrations or brands.

Definitions and Product Presentations

Insulin glargine definition — long-acting human insulin analog

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

Therapeutic useUsed for treatment of type 1 and type 2 diabetes mellitus to provide basal insulin coverage.

Formulation noteMultiple branded and unbranded formulations exist (e.g., Basaglar, Lantus, Rezvoglar, Toujeo, Semglee) with varying concentrations.

Product presentations — Basaglar, Lantus (100 units/mL) and Toujeo (300 units/mL) presentations

Basaglar presentationSingle-patient-use prefilled pen, 100 units/mL, 3 mL (Basaglar Tempo Pen)

Lantus presentation (branded/unbranded)Multiple-dose vial: 10 mL containing 100 units/mL; Single-patient-use prefilled pen (Lantus SoloStar) 3 mL containing 100 units/mL

Policy Summary

PayerCentene

PolicyInsulin Glargine (Basaglar; Lantus/unbranded Lantus, Rezvoglar; Toujeo/unbranded Toujeo)

Policy CodePolicy HIMPA.09

Change TypeProduct additions and redirection/step-therapy updates

Effective DateMar 1, 2019

Next Review Date

SourceLink

On This Page

Step Therapy

Redirection / Step Therapy

Step therapy and product redirection apply. When policy criteria specify preferred branded products (for example, branded Semglee), members must use the preferred product unless it is unavailable due to shortage, clinically significant adverse effects, or contraindication. Failure to try or document trial of preferred products may result in denial or redirection.

Member must use branded Semglee unless branded Semglee is unavailable due to shortage
If branded Semglee is unavailable due to shortage, unbranded insulin glargine-yfgn (unbranded Semglee) may be used
Failure of unbranded Tresiba (insulin degludec) may be required per criteria

Denial Risk

Insufficient Documentation / Redirection Denial Risk

Denial risk increases when documentation is insufficient or when requests are for non‑FDA approved indications without evidence per off‑label policies. Requests may be redirected to preferred branded products (e.g., branded Semglee) or denied if step-therapy requirements are not met.

Non‑FDA indications require sufficient supporting evidence per HIM.PA.154 or member EOC
Insufficient clinical documentation risks denial
Requests may be redirected to preferred products or denied if criteria (including step therapy) are unmet

Definition of redirection — policy mechanism for substituting requested product with preferred product

DefinitionRedirection is the policy mechanism requiring substitution of a requested product with a preferred branded or unbranded insulin glargine product when specified in the criteria.

Operational effectRequests may be redirected to preferred products (for example, branded Semglee) per policy edits; failure to meet redirection requirements may trigger denial or redirection.

Shortage contingencyUnbranded Semglee may be allowed only if branded Semglee is unavailable due to shortage, per contingency language in the policy.