Exdensur (depemokimab-ulaa) coverage for severe eosinophilic asthma
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Defines medical necessity criteria, continuation requirements, and not-medically-necessary situations for coverage of Exdensur as add-on maintenance therapy in members age 12 and older with severe eosinophilic asthma.
New policy added to the prescription drug section allowing Exdensur (depemokimab-ulaa) to be considered medically necessary when specified criteria are met for severe eosinophilic asthma.
Coverage Criteria for Exdensur (depemokimab-ulaa)
Initial Therapy — Initial Treatment
Covered when ALL of the following are met:
Continuation Therapy — Continuation of Treatment
Continuation of Treatment — Covered when ALL of the following are met:
Not Medically Necessary
Not Medically Necessary — Covered stance: not medically necessary in these situations
See Appendices
Initial therapy - severe eosinophilic asthma
Policy states Exdensur may be considered medically necessary when specified criteria are met for individuals with severe eosinophilic asthma.
See full policy for complete criteria
Requests for Exdensur used concurrently with other biologic agents or immunomodulators are not permitted under this policy. Specifically, use in combination with Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair, or with any other biologic DMARD, targeted synthetic DMARD, or other immunomodulator is addressed as an excluded combination; see the Appendices for the full lists of agents referenced in the policy.
Refer to Appendix 2 (biologic disease-modifying antirheumatic agents), Appendix 1 (conventional disease‑modifying agents), and the targeted synthetic agents appendix for the detailed lists of medications that should not be prescribed concurrently with Exdensur when determining medical necessity.
Within the portion of the document addressed here there are no additional explicit exclusions beyond the combination therapy exclusions referenced elsewhere. The policy’s coding and coverage statements note that inclusion or exclusion of a code in the Codes table does not alone determine member coverage; benefit determinations remain subject to the member’s specific plan and the policy’s stated criteria.
Requests will be considered not medically necessary when Exdensur is prescribed concurrently with other listed biologic agents or immunomodulators (for example, Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair), or when the patient does not meet the policy’s stated initiation or continuation criteria. In these situations prior authorization should be denied per the policy language.
No additional, specific exclusions are specified in this extracted portion of the policy beyond the combination-therapy exclusions noted elsewhere. For any other potential exclusions, reviewers should consult the full policy Appendices and the complete document text.
Coding and Clinical Thresholds
| No codes listed |
| 0173-0927-42 | Exdensur (depemokimabg-ulaa) 100 mg/ml, single-dose, pre-filled syringe |
| J3490 | Unclassified drugs |
| J82.8 | Pulmonary eosinophilia, not elsewhere classified |
| J82.83 | Eosinophilic asthma |
Provider Requirements and Prior Authorization
Prior authorization required — initiation and continuation documentation
Prior authorization is required for both initiation and continuation of Exdensur to confirm that all initiation and continuation criteria are met, including documented baseline spirometry (pretreatment FEV1 < 80% predicted and FEV1 reversibility ≥12% and 200 mL after bronchodilator), blood eosinophil count, treatment history, and exacerbation history.
- Confirm pretreatment FEV1 <80% predicted and FEV1 reversibility ≥12% and 200 mL after albuterol (chunk 3).
- Include blood eosinophil count ≥150 cells/µL at initiation and note exclusion of other causes of eosinophilia (chunk 4).
- Document treatment history including a 3-month trial and inadequate response or intolerance to combination controller therapy and prior exacerbations (chunks 3–4).
Reference NDC/HCPCS on prior authorization requests
When submitting prior authorization requests for Exdensur, reference the listed NDC and/or HCPCS codes and include supporting documentation that criteria for severe eosinophilic asthma are met.
- Use NDC 0173-0927-42 (Exdensur 100 mg/ml pre-filled syringe) and HCPCS J3490 where applicable (chunk 20).
- Policy addition to the prescription drug section implies prior authorization for Exdensur; include clinical documentation when using these codes (chunk 21).
Document 3‑month trial and inadequate response/intolerance to controller therapy
Document that the member had an inadequate response or intolerance to a 3-month trial of high‑dose inhaled corticosteroid plus a long‑acting beta2‑agonist (or other listed controller therapies) before initiating Exdensur.
- Specify duration: 3-month trial of combination controller therapy (high-dose ICS + LABA, leukotriene modifiers, LAMA, or oral corticosteroids) (chunk 3).
- State the nature of failure: inadequate response or intolerance to the trial (chunks 3 and 5).
Appendices list conventional, biologic, and targeted agents (reference only)
Appendices list conventional, biologic, and targeted synthetic DMARDs and biologic agents for reference; the appendices do not impose additional explicit step‑therapy requirements for Exdensur in this section.
- Appendix 1 lists conventional DMARDs (e.g., methotrexate, azathioprine) (chunk 23).
- Appendix lists biological DMARDs (e.g., abatacept, adalimumab) and additional biologic agents (chunks 24 and 26).
- Targeted synthetic DMARDs (e.g., apremilast, baricitinib) are listed in Appendix (chunk 27).
Required documentation: age, diagnosis, spirometry, and eosinophil count
Include key documentation items in the medical record and prior authorization: member age, diagnosis of severe eosinophilic asthma, pretreatment spirometry results, and blood eosinophil count meeting the policy thresholds.
- Age: member is ≥12 years (chunk 3).
- Diagnosis: severe eosinophilic asthma (chunk 3).
- Spirometry: pretreatment FEV1 <80% predicted AND FEV1 reversibility ≥12% and 200 mL after albuterol (chunk 3).
- Eosinophil count: blood eosinophils ≥150 cells/µL at initiation (chunk 4).
Supply supporting documentation for diagnosis and medical necessity
Providers must supply documentation supporting the diagnosis of severe eosinophilic asthma and that all medical necessity criteria in the policy are met when requesting coverage for Exdensur.
- Provide records showing that initiation criteria were met or that continuation criteria and clinical benefit are documented (chunks 5 and 20).
- Include evidence referenced by the policy (spirometry, exacerbation history, treatment trials, eosinophil count) to substantiate medical necessity (chunks 3–5).
Denial risk: combination use with other biologics or immunomodulators
Requests will be denied as not medically necessary when Exdensur is used in combination with other biologic agents or immunomodulators listed in the policy appendices.
- Not medically necessary when used with Cinqair, Dupixent, Fasenra, Nucala, Tezspire, Xolair, or any other biologic DMARD, targeted synthetic DMARD, or other immunomodulator (chunk 6).
- See the policy appendices for the full lists of conventional, biologic, and targeted agents (chunks 23–27).
Billing note: code inclusion does not guarantee coverage
Inclusion of an NDC or HCPCS code in the policy does not guarantee coverage or payment; benefit determinations remain subject to the member‑specific benefit plan and the written coverage position in this medical policy.
- The policy states that the inclusion of a code does not guarantee coverage or provider reimbursement and that determinations are subject to member-specific plan documentation and other terms and conditions (chunk 20).
- Use codes for reference only and ensure clinical documentation aligns with the written coverage position (chunk 20).
Background on Exdensur
Exdensur (depemokimab-ulaa) is an interleukin‑5 (IL‑5) antagonist monoclonal antibody indicated as add‑on maintenance treatment for individuals aged 12 years and older with severe eosinophilic asthma. It is administered subcutaneously by a healthcare provider, with the product provided as a 100 mg prefilled syringe/pen and typical dosing given every 6 months. Clinical trials demonstrated reductions in annualized exacerbation rates in patients with blood eosinophil counts ≥150 cells/µL at initiation (or ≥300 cells/µL in the prior 12 months).
Definitions
Initial Therapy Criteria
Initial Therapy — formal initial therapy criteria for Exdensur
Initial Therapy — Covered when ALL of the following are met:
Initial therapy — covered when specified policy criteria for severe eosinophilic asthma are met
Covered when ALL of the following are met for individuals with severe eosinophilic asthma:
Continuation and Maintenance Criteria
Continuation of Exdensur — continuation criteria to maintain therapy
Continuation of Exdensur — Covered when ALL of the following are met:
Continuation therapy — continuation guidance
Continuation guidance — implied maintenance criteria (specific continuation thresholds not prespecified):
Full continuation thresholds not explicitly specified in this extract
See coding and prior authorization guidance (NDC/HCPCS)
Step Therapy and Prior Failures
| Requirement | Details |
|---|---|
| Prior controller trial | 3-month trial with inadequate response or intolerance to combination controller therapy (high‑dose inhaled corticosteroids plus long‑acting beta2‑agonist, leukotriene modifiers, long‑acting muscarinic antagonists, or oral corticosteroids) |
| Spirometry evidence | Pretreatment FEV1 < 80% predicted AND FEV1 reversibility ≥ 12% and 200 mL after albuterol |
| Exacerbation history | Two or more asthma exacerbations in the prior 12 months requiring systemic corticosteroids or increase in maintenance oral corticosteroids |
| Eosinophil threshold | Blood eosinophil count ≥ 150 cells/µL at initiation (after exclusion of other causes of eosinophilia) |
| Age | Member is 12 years of age or older |
| Drug class / List | Examples (not an explicit prior-failure requirement) |
|---|---|
| Conventional DMARDs | azathioprine (Azasan, Imuran); cyclophosphamide (Cytoxan); cyclosporine (Neoral, Gengraf, Sandimmune); hydroxychloroquine (Plaquenil); leflunomide (Arava); methotrexate (Rheumatrex, Trexall); mycophenolate (Cellcept); sulfasalazine (Azulfidine) |
| Biologic DMARDs | abatacept (Orencia); adalimumab (Humira); anakinra (Kineret); brodalumab (Siliq); certolizumab (Cimzia); etanercept (Enbrel); golimumab (Simponi); guselkumab (Tremfya); infliximab (Remicade/Avsola/Inflectra/Renflexis); ixekizumab (Taltz); risankizumab (Skyrizi); rituximab (Rituxan/Riabni/Ruxience/Truxima); sarilumab (Kevzara); secukinumab (Cosentyx); spesolimab (Spevigo); tildrakizumab (Ilumya); tocilizumab (Actemra); ustekinumab (Stelara); vedolizumab (Entyvio) |
| Targeted synthetic DMARDs | apremilast (Otezla); baricitinib (Olumiant); deucravacitinib (Sotyktu); tofacitinib (Xeljanz/XR); upadacitinib (Rinvoq) |
| Policy note | Appendices list conventional, biologic, and targeted synthetic DMARDs; the appendices do not explicitly mandate prior step‑therapy failures before initiating Exdensur |
Quantity Limits and Dosing
Site-of-Care Guidance
Administered by a healthcare provider (office administration)
Exdensur is administered by a healthcare provider and the policy specifies administration in the office setting.
Place of service: outpatient
Place of service is indicated as outpatient in the coding guidance; no additional outpatient site‑of‑care restrictions are specified in this section.
Revision History and Policy Changes
Blue Cross of Idaho adopted a new prescription drug policy adding Exdensur (depemokimab-ulaa); policy to be effective 2026-09-01 and states Exdensur may be considered medically necessary when specified criteria are met for severe eosinophilic asthma.
Policy became effective allowing coverage of Exdensur (depemokimab-ulaa) for individuals meeting the documented medical necessity criteria for severe eosinophilic asthma.
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