Insulin icodec-abae (Awiqli) coverage criteria
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Defines medical necessity, prior authorization, and coverage criteria for Awiqli (insulin icodec-abae) for adults with type 2 diabetes mellitus under QualChoice HIM/ICHRA lines of business; applies to providers requesting coverage and prior authorization.
No material clinical or coverage changes in this revision.
Coverage Criteria for Awiqli (insulin icodec-abae)
Initial Therapy
Covered when ALL of the following are met
For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
Continuation Therapy
Covered when ALL of the following are met
For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
Not Authorized Indications
Not covered when the following apply
Non‑FDA approved indications are not covered by this policy unless there is sufficient documentation of efficacy and safety in accordance with the Health Plan’s off‑label use policy HIM.PA.154 (health insurance marketplace/ICHRA) or the member’s evidence of coverage documents.
Coverage and benefit administration for requests reviewed under this policy are governed by the member’s coverage documents and applicable law. Benefits are subject to all terms, conditions, exclusions, and limitations in the member’s evidence of coverage, certificate of coverage, policy or contract, as well as applicable state and federal requirements and Health Plan administrative policies and procedures.
Requests for Awiqli to treat non‑FDA approved indications without adequate supporting documentation of efficacy and safety will be considered not medically necessary unless the submission meets the documentation standards set forth in off‑label use policy HIM.PA.154 or the member’s evidence of coverage explicitly allows such use.
Coding and Dosing Guidance
Provider Actions and Prior Authorization Requirements
Prior authorization required
Prior authorization is required. Submit a prior authorization request with documentation demonstrating the member meets the policy’s initial or continued therapy criteria (diagnosis of type 2 diabetes mellitus, age ≥ 18 years, and required prior therapy failures/contraindications).
- Include evidence of prior therapy failures or contraindications to required agents when applicable.
- Approval duration when authorized: 12 months.
Authorization and coding guidance
This clinical policy is used to guide medical necessity determinations, but providers must follow the Health Plan’s authorization processes and contract terms for coverage decisions and claims submission.
- Codes shown in the policy are informational only; follow current professional coding guidance prior to claim submission.
- The Health Plan may change or withdraw the policy; effective dates and applicable legal/regulatory requirements govern.
Step therapy: document failure of Semglee and Tresiba
Step therapy must be documented: before approval for initial or continued therapy, the member must have failure of both insulin glargine-ygfn (unbranded Semglee) and branded Tresiba (insulin degludec), unless contraindicated or clinically significant adverse effects are documented. Illinois HIM requests are exempt from step therapy as of 1/1/2026 per IL HB 5395.
- Document trial durations, outcomes, and reasons for discontinuation or intolerability for each agent.
- If both agents are contraindicated, provide clinical justification in the request.
Include continuity and state-specific information when applicable
Provide any additional clinically relevant notes or justifications in the authorization request to support medical necessity decisions (e.g., continuity of care, enrollment in state/product continuity programs).
- If member is currently receiving medication via Centene benefit or has prior approval history, indicate this in the request.
- Refer to state-specific continuity of care addendums when applicable.
Required clinical documentation to support PA
Submit supporting clinical documentation with the prior authorization request—examples include office chart notes, lab results, and other clinical information demonstrating the member meets all approval criteria.
- Documentation should show diagnosis, age, response to therapy (for continuation), and trials or contraindications to required prior agents.
- Include blood glucose/HbA1c results or other objective measures when available.
Coverage subject to member contract terms
Coverage determinations and administration of benefits are governed by the member’s coverage documents and applicable Health Plan-level policies; verify contract terms and evidence of coverage when submitting requests.
- Coverage is subject to terms, conditions, exclusions, and limitations in evidence of coverage, certificate of coverage, policy, or contract.
- State and federal requirements and plan-level administrative policies may supersede or affect coverage.
Denial risk for incomplete documentation or non‑FDA indications
Requests missing required documentation that the member meets all approval criteria, or requests for non‑FDA approved indications without sufficient evidence per the off‑label use policy, may be denied.
- Non‑FDA indications require adequate documentation of efficacy and safety per HIM.PA.154 or evidence of coverage to be considered.
- Ensure all approval criteria are clearly documented to avoid administrative denials.
Coding may affect claims — verify codes before billing
The HCPCS codes listed in this policy are informational; inclusion or exclusion of codes does not guarantee coverage. Verify current coding guidance before submitting claims, as incorrect coding may affect reimbursement.
Initial Therapy Approval Criteria
Initial Therapy
Initial therapy covered when criteria are met
Approval duration: 12 months. For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
Continuation / Renewal Criteria
Continuation Therapy
Continued therapy covered when criteria are met
Approval duration: 12 months. For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.
Step Therapy Requirements
| Step | Required prior therapy (failure or contraindication) | Notes / Exceptions |
|---|---|---|
| 1 | Insulin glargine-ygfn (unbranded Semglee) — failure or contraindication | Must document failure of both agents or contraindications prior to approval; Illinois HIM requests are exempt from step therapy per IL HB 5395 (effective 1/1/2026). |
| 1 | Branded Tresiba (insulin degludec) — failure or contraindication | Must document failure of both agents or contraindications prior to approval; Illinois HIM requests are exempt from step therapy per IL HB 5395 (effective 1/1/2026). |
Quantity Limits and Dispensing Guidance
Background
Awiqli (insulin icodec‑abae) is a long‑acting human insulin analog indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is administered subcutaneously once weekly and is supplied as a high‑concentration formulation in prefilled pens (700 units/mL). Approval under this policy is for adults meeting the policy’s coverage criteria and prior authorization requirements.
Definitions
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