Clinical Policy: Depemokimab-ulaa (Exdensur)
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Defines medical necessity, prior authorization, and coverage criteria for Exdensur (depemokimab-ulaa) as add-on maintenance treatment of severe eosinophilic asthma for eligible members; applies to QualChoice HIM line of business.
Added HCPCS code J2361 and removed miscellaneous/unlisted codes (J3590 and others).
Added HCPCS code J2361.
Coverage Criteria for Depemokimab-ulaa (Exdensur)
Initial Therapy
Covered when ALL of the following are met:
Follow step therapy exceptions for Illinois as noted in policy.
Continuation Therapy
Continued coverage when ALL of the following are met:
Other/Label Changes
Other indications (non-standard or recently changed labeling):
Exdensur is not indicated for the treatment of acute bronchospasm or status asthmaticus. Requests for coverage to treat these acute conditions are not authorized under this policy.
When there is a conflict between this clinical policy and state Medicaid coverage provisions for Medicaid members, the state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual for any differing coverage rules.
Uses of Exdensur that are not FDA‑approved and are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the Health Plan’s off‑label use policy (HIM.PA.154) or applicable evidence‑of‑coverage documents.
Coding and Billing
| J2361 | Injection, depemokimab-ulaa, 1 mg |
| J2361 | Injection, depemokimab-ulaa, 1 mg |
| J3590 | Unclassified biologics (removed from policy) |
Provider Actions, Prior Authorization & Documentation
Prior authorization required; use HCPCS J2361
Prior authorization is required for Exdensur (depemokimab-ulaa); include supporting clinical documentation with the request and bill using HCPCS code J2361 (Injection, depemokimab-ulaa, 1 mg).
- Attach office chart notes, lab results (e.g., eosinophil count), and documentation of exacerbation history when submitting the PA request.
PA applies; bill with J2361
Prior authorization requirements for depemokimab-ulaa apply per the Health Plan; claims should be submitted using HCPCS code J2361 for depemokimab-ulaa, 1 mg.
- Verify current Health Plan prior authorization processes and include J2361 on claim submissions.
Step therapy: failure of Dupixent and Fasenra required
Step therapy requires documented failure of both Dupixent and Fasenra, each used for ≥ 4 consecutive months at up to maximally indicated doses, unless clinically significant adverse effects or contraindications are documented.
- Illinois HIM requests are exempt from this step therapy requirement per IL HB 5395 effective 1/1/2026.
Ensure complete documentation and coding on submission
Ensure the request includes all required supporting documentation and coding information; incomplete submissions may delay review.
- Provide office notes, recent absolute blood eosinophil count (within 3 months), exacerbation records, controller therapy adherence, and prior biologic trial details.
Submit clinical documentation supporting approval criteria
Provider must submit documentation (office notes, labs, or other clinical information) showing the member meets all approval criteria, including recent eosinophil count and exacerbation history.
- Include absolute blood eosinophil count within past 3 months and evidence of ≥2 exacerbations in prior 12 months when applicable.
Documentation and coding guidance
Providers should follow up-to-date professional coding guidance and supply supporting clinical documentation consistent with medical necessity and Health Plan coverage terms.
- Reference current coding manuals and Health Plan coding guidance when selecting HCPCS codes for claims.
Insufficient documentation may result in denial or delay
Requests that do not include documentation proving the member meets all approval criteria (diagnosis, eosinophil count, prior exacerbations, concomitant controller therapy, prior biologic trials or exemptions, prescriber specialty, age) may be denied or delayed.
- Missing recent eosinophil count, lack of exacerbation documentation, absent prior biologic trial records, or omission of prescriber specialty are common reasons for denial.
Coding mismatch (e.g., use of J3590) may trigger denial
Claims billed with codes removed from this policy (for example J3590) may be inconsistent with updated coding guidance and risk denial if not billed with the current HCPCS code J2361.
- Do not use unlisted/removed codes such as J3590 for depemokimab-ulaa; submit J2361 instead.
Definitions and Reference Metrics
Background
Depemokimab‑ulaa (Exdensur) is an interleukin‑5 antagonist monoclonal antibody approved as an add‑on maintenance treatment for severe eosinophilic asthma in appropriate patients. It is intended for use as part of controller therapy and is not for acute rescue treatment.
Revision History and Policy Changes
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