Exdensur (depemokimab-ulaa) prior authorization for severe eosinophilic asthma
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Requirements for medical prior authorization and step-edit requests for Exdensur (depemokimab-ulaa) for treatment of severe eosinophilic asthma for AvMed members; affects prescribers, office staff, and pharmacies processing medical benefit requests.
No material clinical or coverage changes in this revision.
Coverage Criteria for Exdensur (depemokimab-ulaa)
Initial Therapy
Covered when ALL of the following are met:
Continuation Therapy
Covered when ALL of the following are met:
Not allowed concomitant biologics
Concomitant use of Exdensur with other biologics is not permitted. The Health Plan considers combination therapy with Cinqair, Dupixent, Exdensur, Fasenra, Nucala, Tezspire, and Xolair to be experimental and investigational; safety and efficacy have not been established and such combinations will not be approved. If a member has an active authorization on file for any of these agents, subsequent requests for Exdensur will not be approved. Providers should ensure the request form is complete and include all required documentation (labs, diagnostics, chart notes) because incomplete submissions can delay or result in denial.
Use of manufacturer samples to start therapy does not satisfy the plan's step-edit or preauthorization requirements. Sample use to initiate therapy will not be accepted as meeting the prior authorization criteria; previous therapies must be documented and will be verified through pharmacy paid claims or submitted chart notes.
Coding and Clinical Thresholds
| J3590 | Unclassified biologics (listed for Exdensur in form) |
What Providers Must Do
Medical prior authorization required for Exdensur (J3590)
Prior authorization is required for Exdensur (depemokimab-ulaa) billed under J3590. Submit a completed, signed medical prior authorization/step-edit request form with supporting clinical documentation demonstrating that all coverage criteria are met.
- Use HCPCS code J3590 for Exdensur as listed on the form.
- Include verification of trials, labs, diagnostics, and chart notes as requested; incomplete requests may be delayed.
Step therapy: failed biologic trials and controller therapy requirement
Member must have trialed and failed two specified biologics and be on or have attempted high‑dose inhaled corticosteroid (ICS) plus an additional controller or one maximally dosed combination ICS/LABA unless there is a contraindication or intolerance.
- Required failed biologics (two): Nucala (mepolizumab), Fasenra (benralizumab), Dupixent (dupilumab), or Xolair (omalizumab).
- Compliance on prior controller therapy must be verified by pharmacy paid claims for at least 90 consecutive days within a year of request.
- Pharmacy claims will be used to verify trials and 90‑day adherence.
Required documentation and prescriber signature
Prescriber signature is required on the PA/step‑edit request form (preprinted stamps are not valid). Provide supporting documentation including baseline and post‑trial peripheral blood eosinophil counts, FEV1 values, chart notes documenting prior therapy trials and exacerbation history, and pharmacy paid claims to verify medication trials and adherence.
- Prescribing physician must sign and clearly print name on the form; preprinted stamps are not valid.
- Submit baseline (pre‑treatment) peripheral blood eosinophil count (≥150 cells/µL) and eosinophil after trial data as specified.
- Submit FEV1 % predicted (FEV1 < 80% predicted; <90% for ages 6–17) within the year of request.
- Attach chart notes and pharmacy paid claims to document prior biologic trials and 90‑day adherence.
Incomplete or missing documentation may delay or cause denial
Incomplete, incorrect, or illegible information on the request form or missing required documentation (labs, diagnostics, chart notes, pharmacy claims) can delay review or lead to denial; active authorizations for listed concomitant biologics will result in denial of Exdensur requests.
- Authorization may be delayed if the form is incomplete, incorrect, or illegible.
- Requests lacking required lab results, diagnostics, chart notes, or pharmacy paid claims may be denied.
- If a member has an active authorization for Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair, subsequent Exdensur requests will NOT be approved.
Background and Indication
Exdensur (depemokimab-ulaa) is indicated in this policy for members with severe eosinophilic asthma (SEA). Approval for initial therapy requires demonstration of the eosinophilic phenotype with a baseline (pre-treatment) peripheral blood eosinophil count of ≥150 cells/µL, treatment with either high‑dose inhaled corticosteroid plus an additional controller or a maximally dosed combination ICS/LABA, and a history of exacerbations (two or more requiring medical treatment in the past 12 months or any prior intubation). The prescriber must be an allergist, immunologist, or pulmonologist (or consult with one), and the member must be at least 12 years of age. Prior biologic therapy is required: the member must have tried and failed two of the specified biologics (Nucala, Fasenra, Dupixent, Xolair) with documented compliance for at least 90 consecutive days unless contraindicated or intolerant. Reauthorization requires a sustained positive clinical response such as improvement in % predicted FEV1, reduction in inhaled or oral corticosteroid use, or reduced asthma symptoms, with continued adherence to an appropriate controller regimen.
Definitions and Phenotype Thresholds
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