ModifiedBluecross IdahoPolicy MP 5.01.678

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.

Policy Summary

PayerBluecross Idaho

PolicyExdensur (depemokimab-ulaa) coverage for severe eosinophilic asthma

Policy CodePolicy MP 5.01.678

Change TypeNew policy added

Effective DateSep 1, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

Key ActionSubmit prior authorization with documentation of age, diagnosis of severe eosinophilic asthma, baseline spirometry, 3-month controller trial history, exacerbation history, and blood eosinophil count ≥150 cells/µL.

SourceLink

POLICY UPDATE CHANGES

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.

≥12Minimum age for coverage

≥150Eosinophil threshold

6 moDosing interval

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ModifiedBluecross IdahoPolicy MP 5.01.678

Exdensur (depemokimab-ulaa) coverage for severe eosinophilic asthma

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Policy Summary

PayerBluecross Idaho

PolicyExdensur (depemokimab-ulaa) coverage for severe eosinophilic asthma

Policy CodePolicy MP 5.01.678

Change TypeNew policy added

Effective DateSep 1, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

SourceLink

POLICY UPDATE CHANGES

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.

≥12Minimum age for coverage

≥150Eosinophil threshold

6 moDosing interval

Coverage Criteria for Exdensur (depemokimab-ulaa)

Initial Therapy — Initial Treatment

Covered when ALL of the following are met:

Age: Member is 12 years of age or older>=12 years

Diagnosis of severe eosinophilic asthma

Spirometry evidence: Pretreatment FEV1 < 80% predicted AND FEV1 reversibility >= 12% and 200 milliliters after albuterol administrationFEV1 <80% and >=12% & 200 mL reversibility

Controller therapy trial: Three-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)3 months

Exacerbation history: Two or more asthma exacerbations in the prior 12 months requiring systemic corticosteroid use or temporary increase in maintenance oral corticosteroids>=2 in prior 12 months

Eosinophil threshold: Blood eosinophil count >= 150 cells/microliter at initiation in the absence of other potential causes of eosinophilia (e.g., hypereosinophilic syndromes, neoplastic disease, parasitic infection)>=150 cells/µL

Continuation Therapy — Continuation of Treatment

Continuation of Treatment — Covered when ALL of the following are met:

Prior coverage: Coverage criteria for initiation of Exdensur therapy have previously been met

Clinical response: Treatment has resulted in clinical improvement in one or more of: decreased reliever medication use; decreased frequency of exacerbations; increase in percent predicted FEV1 from pretreatment baseline; or reduction in asthma‑related symptoms (awakening symptoms, coughing, fatigue, dyspnea, sleep disturbance, wheezing)

Concomitant therapy: Continued use in combination with inhaled corticosteroid‑based controller therapy

Not Medically Necessary

Not Medically Necessary — Covered stance: not medically necessary in these situations

Contraindicated combinations: Use in combination with other biologic agents (Cinqair, Dupixent, Fasenra, Nucala, Tezspire, Xolair) or any other biologic DMARD, targeted synthetic DMARD, or other immunomodulator

See Appendices

Criteria not met or other indications: When the above initiation or continuation criteria are not met, or for all other non‑specified indications

Initial therapy - severe eosinophilic asthma

Policy states Exdensur may be considered medically necessary when specified criteria are met for individuals with severe eosinophilic asthma.

Initial medical necessity: Member has severe eosinophilic asthma and meets the specified initiation criteria in this policy (age, spirometry, controller therapy trial, exacerbation history, and blood eosinophil threshold)

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

See Codes tablemixed

No codes listed

NDC - ExdensurNDC

0173-0927-42

Exdensur (depemokimabg-ulaa) 100 mg/ml, single-dose, pre-filled syringe

HCPCS - Unclassified drugsHCPCS

J3490

Unclassified drugs

ICD-10-CM - Related diagnosesICD-10

J82.8	Pulmonary eosinophilia, not elsewhere classified
J82.83	Eosinophilic asthma

inv-13: Blood eosinophil count — threshold for initiation

ThresholdBlood eosinophil count ≥150 cells/microliter (150 cells/mm3) at initiation — exclude other causes of eosinophilia (hypereosinophilic syndromes, neoplastic disease, parasitic infection)

ContextUsed as a biomarker to identify eosinophilic phenotype and predict response to anti–IL-5 therapy; trials required ≥150 cells/µL at initiation or ≥300 cells/µL in prior 12 months

Measurement timingCount must be at initiation of therapy (baseline) as documented in medical record

inv-14: FEV1 reversibility — criterion for diagnosis (post-bronchodilator change)

Reversibility criterionFEV1 reversibility ≥12% and ≥200 milliliters after albuterol administration

Provider Requirements and Prior Authorization

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).

Prior Authorization

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.

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

inv-26: Severe asthma — definition and treatment context

DefinitionSevere asthma: asthma requiring treatment with high‑dose inhaled corticosteroids plus a long‑acting beta‑agonist (or equivalent) for the previous year to prevent uncontrolled symptoms, or requiring systemic corticosteroid treatment for >50% of the previous year

Treatment contextExdensur is indicated as add‑on maintenance treatment for individuals ≥12 years with severe eosinophilic asthma; administered by HCP every 6 months subcutaneously

Clinical pathwayERS/ATS guidance recommends confirming diagnosis with spirometry and differentiating severe from milder asthma before initiating biologic therapy

inv-27: Uncontrolled asthma (ERS/ATS) — criteria (ACQ/ACT, exacerbations, steroid bursts)

ERS/ATS uncontrolled asthma criteriaPoor symptom control (ACQ >1.5 or ACT <20); OR frequent severe exacerbations (≥2 systemic corticosteroid bursts in prior year); OR history of serious exacerbation (hospitalization/ICU/mechanical ventilation); OR airflow limitation (post‑bronchodilator FEV1 <80% predicted)

Initial Therapy Criteria

Initial Therapy — formal initial therapy criteria for Exdensur

Initial Therapy — Covered when ALL of the following are met:

Age: Member is 12 years of age or older>=12 years

Diagnosis: Severe eosinophilic asthma

Spirometry: Pretreatment FEV1 less than 80% predicted AND FEV1 reversibility of at least 12% and 200 milliliters after albuterolFEV1 <80% and >=12% & 200 mL reversibility

Controller therapy failure:

Continuation and Maintenance Criteria

Continuation of Exdensur — continuation criteria to maintain therapy

Continuation of Exdensur — Covered when ALL of the following are met:

Prior approval: Initiation criteria previously met

Documented benefit: Documented clinical improvement in one or more of: decreased reliever use; decreased exacerbation frequency; increased percent predicted FEV1; or reduced asthma‑related symptoms

Concomitant controller therapy: Continued use with inhaled corticosteroid‑based controller therapy

Continuation therapy — continuation guidance

Continuation guidance — implied maintenance criteria (specific continuation thresholds not prespecified):

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

inv-35: Exdensur (depemokimab-ulaa) 100 mg — quantity limit: 1

ProductExdensur (depemokimab-ulaa) 100 mg (100 mg/mL prefilled pen/syringe)

Quantity limitLimit = 1 prefilled pen/syringe every 6 months (100 mg) per course as listed in policy quantity limits

AdministrationAdministered by a healthcare provider subcutaneously every 6 months

inv-36: Exdensur (depemokimab-ulaa) — quantity limits not fully specified / placeholder

ProductExdensur (depemokimab-ulaa)

Quantity limitsNot specified in policy extract for formulations or alternate dosing intervals; refer to full policy for additional limits

Site-of-Care Guidance

Note

Administered by a healthcare provider (office administration)

Exdensur is administered by a healthcare provider and the policy specifies administration in the office setting.

Note

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

2026-05-28New policy adopted

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.

2026-09-01Policy effectiveLatest

Policy became effective allowing coverage of Exdensur (depemokimab-ulaa) for individuals meeting the documented medical necessity criteria for severe eosinophilic asthma.

Policy Summary

PayerBluecross Idaho

PolicyExdensur (depemokimab-ulaa) coverage for severe eosinophilic asthma

Policy CodePolicy MP 5.01.678

Change TypeNew policy added

Effective DateSep 1, 2026

Last ReviewMay 28, 2026

Next Review DateMay 28, 2026

SourceLink

On This Page

PurposeDemonstrates reversible airflow obstruction supportive of asthma diagnosis

Testing conditionsPost-bronchodilator measurement after albuterol per spirometry protocol

inv-15: Pretreatment FEV1 — baseline spirometry requirement

Pretreatment FEV1 requirementPretreatment FEV1 <80% predicted

RoleBaseline spirometry required to document airflow limitation prior to initiating Exdensur

Relation to other criteriaCombined with FEV1 reversibility (≥12% and 200 mL) to confirm asthma evidence

inv-16: None specified — placeholder for unspecified coding elements

Coding elementsNo additional coding thresholds or numeric limits specified in this section

GuidanceInclusion of codes in the policy does not guarantee coverage; verify member plan and document medical necessity

Reference codesSee Codes table for NDC and HCPCS entries (policy lists NDC 0173-0927-42 and HCPCS J3490)

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).

Step Therapy

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).

Note

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).

Documentation Required

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).

Documentation Required

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

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 Rule

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).

Documented measuresUse ACQ/ACT scores, exacerbation history (systemic steroid bursts/hospitalization), and spirometry to support uncontrolled status

Relevance to therapyUncontrolled asthma despite high‑dose ICS+LABA supports consideration of add‑on biologic therapy such as Exdensur

inv-28: Eosinophilic asthma — definition placeholder

TermEosinophilic asthma — referenced as phenotype guiding anti‑IL‑5 therapy selection

BiomarkerBlood eosinophil count used as primary biomarker for eosinophilic phenotype in this policy

Further detailPolicy references eosinophilic asthma concept but provides no extended definition beyond phenotype labeling in extracted text

Three‑month trial with inadequate response or intolerance to high‑dose inhaled corticosteroid plus long‑acting beta2‑agonist or other controller therapies

Exacerbation history: Two or more exacerbations in the prior 12 months requiring systemic corticosteroids or temporary increase in maintenance oral corticosteroids>=2 in prior 12 months

Eosinophil count: Blood eosinophils >=150 cells/microliter at initiation (exclude other causes of eosinophilia)>=150 cells/µL

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:

Age and diagnosis: Member is >=12 years and has a diagnosis of severe eosinophilic asthma>=12 years

Baseline assessments: Pretreatment FEV1 <80% predicted and demonstrated reversibility (>=12% and 200 mL) after bronchodilatorFEV1 <80% and >=12% & 200 mL reversibility

Prior controller therapy: At least a 3‑month trial with inadequate response or intolerance to high‑dose ICS+LABA or other controller regimens3 months

Exacerbations: History of two or more exacerbations in prior 12 months requiring systemic corticosteroids or increased maintenance oral steroids>=2 in prior 12 months

Eosinophil requirement: Blood eosinophil count >=150 cells/microliter at initiation (absent other causes of eosinophilia)>=150 cells/µL

Ongoing suitability: Continuation may be approved when the member continues to meet initial medical necessity criteria and demonstrates ongoing clinical benefit as described in the policy

Full continuation thresholds not explicitly specified in this extract

Documentation: Provide documentation of ongoing benefit and continued use with inhaled corticosteroid‑based controller therapy; prior authorization is required

See coding and prior authorization guidance (NDC/HCPCS)

NDC 0173-0927-42 and HCPCS J3490 are listed; inclusion does not guarantee coverage—confirm plan requirements