ModifiedCentenePolicy HIM.PA.171

Clinical Policy: Insulin Detemir (Levemir)

Defines medical necessity, prior authorization, and continued-therapy criteria for Levemir (insulin detemir) for members under Centene-affiliated health plans; applies to providers requesting coverage for diabetes mellitus treatment.

Policy Summary

PayerCentene

PolicyClinical Policy: Insulin Detemir (Levemir)

Policy CodePolicy HIM.PA.171

Change TypeMaterial updates to authorization and step therapy

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with provider attestation acknowledging discontinuation of Levemir products and documentation of prior failure of Semglee and Tresiba when required.

SourceLink

POLICY UPDATE CHANGES

Requirement for provider attestation acknowledging the discontinuation of Levemir products was added.

Step therapy redirection to insulin glargine-yfgn (unbranded Semglee) and branded Tresiba (insulin degludec) is required prior to Levemir, with specified exceptions.

Appendix E documents the dates when Levemir products were discontinued by the manufacturer.

CentenePolicy owner

DiscontinuedProduct status

RequiredStep therapy

12 months

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Coverage Criteria for Levemir (Insulin detemir)

Initial Therapy (Diabetes Mellitus)

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

Initial Diabetes Mellitus: 1. Provider attestation acknowledging the discontinuation of Levemir products (e.g., FlexPen, FlexTouch, vials; see Appendix E).

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

Initial Diabetes Mellitus: 3. Failure of insulin glargine-yfgn (unbranded Semglee) and branded Tresiba (insulin degludec), unless clinically significant adverse effects are experienced or both are contraindicated (note: Illinois HIM requests are exempt from this step therapy requirement as of 1/1/2026).

Continued Therapy (Diabetes Mellitus)

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

Continued Therapy Diabetes Mellitus: 1. Provider attestation acknowledging the discontinuation of Levemir products (e.g., FlexPen, FlexTouch, vials; see Appendix E).

Continued Therapy Diabetes Mellitus: 2. Member meets ONE of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR b) currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Continued Therapy Diabetes Mellitus: 3. Failure of insulin glargine-yfgn (unbranded Semglee) and branded Tresiba (insulin degludec), unless clinically significant adverse effects are experienced or both are contraindicated (note: step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026 and do not apply for New York requests).

Continued Therapy Diabetes Mellitus: 4. Member is responding positively to therapy.

Other Indications

Other uses (non-specified in main criteria):

Other indications: 1. If the drug has had a recent label change (within the last 6 months) not yet reflected in this policy, follow the applicable formulary/no-coverage or nonformulary policy: HIM.PA.33 or HIM.PA.103 as applicable.

Other indications: 2. If the requested use is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy HIM.PA.154 for the relevant line of business.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the Health Plan's off‑label use policy (HIM.PA.154) or the member's applicable evidence of coverage documents. Requests for such uses should include clinical rationale and supporting literature or chart documentation per the off‑label policy to be considered for coverage.

Coverage determinations under this clinical policy are made in the context of the member's benefit plan. All coverage is 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). Providers must follow those documents and related Health Plan administrative policies when requesting coverage.

Levemir (insulin detemir) is not recommended for diabetic ketoacidosis and thus requests for use in diabetic ketoacidosis are considered not medically necessary. Additionally, non‑FDA approved indications that lack sufficient supporting evidence are not authorized unless documentation demonstrates efficacy and safety per the Health Plan's off‑label policy (HIM.PA.154) or applicable coverage documents.

Referenced Billing and Coding

Referenced billing codesmixed

J3590	Unclassified biologics.
C9399	Unclassified drugs or biologicals.
S5553	Insulin, long acting; 5 units.
S5571	Insulin delivery device, disposable pen (including insulin); 3 mL size

Coding implications / referenced productsmixed

Semglee	mentioned in coding implications
Tresiba	branded Tresiba mentioned

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must attest that Levemir products have been discontinued (e.g., FlexPen, FlexTouch, vials; see Appendix E) and document that the member has tried and failed required alternatives (insulin glargine-yfgn [Semglee] and branded Tresiba [insulin degludec]) unless clinically significant adverse effects or contraindications exist. For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395; for New York requests, step therapy requirements may be exempt per state-specific rules.

Required alternatives: insulin glargine-yfgn (Semglee) and branded Tresiba (insulin degludec)
State exceptions: IL (IL HB 5395) and NY as noted in policy appendices

Documentation Required

Documentation Required — Incomplete Requests May Be Denied

Providers must submit supporting documentation (office chart notes, lab results, or other clinical information) that verifies all approval criteria and any required attestation. Requests lacking the required documentation or the provider attestation acknowledging Levemir discontinuation will be denied or returned for additional information.

Background and Context

Insulin detemir (Levemir) is a long‑acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. The product is not recommended for treatment of diabetic ketoacidosis. Novo Nordisk has discontinued commercial Levemir presentations (see Appendix E), and the policy includes conversion guidance when switching from insulin glargine or NPH, which can generally be done on a unit‑to‑unit basis with clinical adjustments as needed.

Definitions and Conversion Guidance

Definition — Insulin detemir (Levemir)

DrugInsulin detemir (Levemir): long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Limitation of useNot recommended for the treatment of diabetic ketoacidosis (DKA).

Manufacturing statusNovo Nordisk has discontinued Levemir FlexPen, FlexTouch, and vials (see Appendix E).

Conversion guidance — unit-to-unit conversion to Levemir

General conversionWhen converting from insulin glargine to Levemir, change can generally be done on a unit-to-unit basis.

NPH conversionWhen converting from NPH insulin to Levemir, conversion can generally be done on a unit-to-unit basis, though some patients with type 2 diabetes may require higher Levemir doses.