CurrentViva Health PlanPolicy IC-P0831

Exdensur (depemokimab-ulaa) Coverage Criteria

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This policy governs prior authorization coverage for subcutaneous Exdensur (depemokimab-ulaa), including initial approval, renewal, dosing limits, continuation therapy, clinical eligibility, concomitant immunomodulator use, and contraindications. It applies to providers requesting Exdensur for plan members.

Policy Summary

PayerViva Health Plan

PolicyExdensur (depemokimab-ulaa) Coverage Criteria

Policy CodePolicy IC-P0831

Change TypeNo material change

Effective DateN/A

Last ReviewJul 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization request with the required clinical documentation for Exdensur coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization

12 monthsRenewal interval

100 units/6 monthsDosing limit

150 cells/microliterEosinophil threshold

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CurrentViva Health PlanPolicy IC-P0831

Exdensur (depemokimab-ulaa) Coverage Criteria

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Policy Summary

PayerViva Health Plan

PolicyExdensur (depemokimab-ulaa) Coverage Criteria

Policy CodePolicy IC-P0831

Change TypeNo material change

Effective DateN/A

Last ReviewJul 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization request with the required clinical documentation for Exdensur coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization

12 monthsRenewal interval

100 units/6 monthsDosing limit

150 cells/microliterEosinophil threshold

Covered diagnosis codes

Coverage Criteria

Renewal Therapy

Renewal approval requires all of the following.

Renewal criteria

The member was previously approved for Exdensur through the plan's prior authorization process.
Members not previously approved require initial evaluation review.
The member has had clinical benefit with Exdensur.
If treated for severe eosinophilic asthma, the member is currently treated within the past 90 days and is compliant with asthma-control therapy, such as ICS, ICS/LABA, LTRA, LAMA, or theophylline.
Provider-administered product support
- There is support for use of provider-administered Exdensur over Nucala 100 mg vial, Fasenra 30 mg/mL prefilled syringe, and Cinqair 100 mg/10 mL vial.
The prescriber is a specialist in the member's diagnosis, such as an allergist, immunologist, or pulmonologist, or has consulted with an appropriate specialist.
Concomitant therapy
- The member will not use Exdensur with another immunomodulatory agent.
- ALL of the following
  - The requested agent's prescribing information does not limit combination use with another immunomodulatory agent.
  - Supporting clinical trials, phase III studies, or guidelines for combination therapy are submitted.
The member does not have an FDA-labeled contraindication to Exdensur.

Exdensur must not be used concomitantly with another immunomodulatory agent unless the requested agent’s prescribing information does not limit the combination and the provider submits supporting clinical evidence, such as clinical trials, phase III studies, or guidelines. This requirement applies at both initial approval and renewal.

Members with an FDA-labeled contraindication to Exdensur are excluded from approval. The provider must document that no FDA-labeled contraindication applies to the requested therapy.

Exdensur must not be used concomitantly with agents identified in the policy’s Agents NOT to be used Concomitantly or Contraindicated as Concomitant Therapy listings. These listings include immunomodulatory, biologic, specialty, and asthma therapies; providers should verify the complete current list when evaluating a combination regimen.

Concomitant use of Exdensur with any agent listed as not to be used concomitantly or as contraindicated is excluded from coverage. Use of another immunomodulatory agent may be considered only when the prescribing information permits the combination and supporting clinical evidence or guidelines are submitted, subject to the policy’s listed-agent restrictions.

The listed contraindicated biologic, immunomodulatory, or specialty agents may not be used with Exdensur. The policy identifies agents including Spevigo, Starjemza, Stelara, Steqeyma, Taltz, Tezspire, tofacitinib, Tofidence, Tremfya, Truxima, Tyenne, Tyruko, Tysabri, ustekinumab, Velsipity, Wezlana, Xeljanz, Xeljanz XR, and Xolair; concomitant therapy with these agents may result in nonapproval.

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J2361	Injection, depemokimab-ulaa, 1 mg; 1 billable unit = 1 mg (Effective 07/01/2026)
J3590	Unclassified biologics (Discontinue use on 07/01/2026)
C9399	Unclassified drugs or biologicals (Hospital Outpatient Use Only) (Discontinue use on 07/01/2026)

NDCNDC

00173-0927-xx

Exdensur 100 mg/mL single-dose prefilled syringe

Covered Diagnosis CodesICD-10Covered

J45.50	Severe persistent asthma, uncomplicated
J82.81	Chronic eosinophilic pneumonia
J82.82	Acute eosinophilic pneumonia
J82.83	Eosinophilic asthma
J82.89	Other pulmonary eosinophilia, not elsewhere classified

Dosing Limit

MedicationExdensur (depemokimab-ulaa)

Maximum quantity100 billable HCPCS units

Time periodEvery 6 months

Baseline Blood Eosinophil Count

MeasurementBaseline blood eosinophil count before therapy with the requested agent

Minimum threshold150 cells/microliter or higher

Qualifying use

Provider Actions and Authorization Risks

Prior Authorization

Prior Authorization Duration

Prior authorization is required. Initial authorization is valid for 12 months (365 days), and renewal may be requested every 12 months (365 days) thereafter.

Initial authorization: 12 months (365 days)
Renewal interval: every 12 months (365 days)

Prior Authorization

Prior Authorization Required: Review Concomitant Therapy

Submit the prior authorization request only after reviewing the requested agent against the plan’s concomitant-use restrictions. Exdensur must not be used with another immunomodulatory agent unless the prescribing information permits the combination and supporting evidence is submitted.

The request must address the Agents NOT to be used Concomitantly table.
Combination therapy requires prescribing-information support and clinical trials, phase III studies, or guideline support.

Policy Background

Exdensur (depemokimab-ulaa) is a subcutaneous therapy reviewed primarily for severe eosinophilic asthma. Coverage is subject to prior authorization and requires documentation of a qualifying indication, appropriate disease severity or eosinophilic inflammation, relevant background therapy when applicable, and specialist involvement. The policy also addresses continuation and renewal requirements, dosing limits, and restrictions on concomitant use with specified immunomodulatory or specialty agents.

Definitions and Evidence Standards

Compendia Allowed

AHFSAllowed

DrugDexLevel 1 or 2a evidence

NCCNLevel 1 or 2a recommended use

Serious Asthma Exacerbation

HospitalizationRequired for a serious asthma exacerbation

Mechanical ventilationRequired for a serious asthma exacerbation

Emergency or urgent careAn emergency-room or urgent-care visit qualifies

Initial Therapy Criteria

Continuation Criteria

Continuation of Therapy

All target agents are eligible for continuation of therapy.

Continuation eligibility

The member has been treated with the requested agent, excluding samples, within the past 90 days.Within the past 90 days
The prescriber states that the member was treated with the requested agent, excluding samples, within the past 90 days and is at risk if therapy is changed.Within the past 90 days

Step Therapy Requirements

Step	Requirement	Required product(s)	Failure criteria
1	For severe eosinophilic asthma, complete both required biologic trial pathways.	Benralizumab (Fasenra) or mepolizumab (Nucala); and reslizumab (Cinqair).	Previous failure, intolerance, or contraindication to a trial of the applicable product(s).

Step	Renewal requirement	Provider-administered trial product	Coverage support required
2	Support use of provider-administered Exdensur over each listed product.	Nucala 100 mg vial	Support for provider-administered Exdensur over this product.
2	Support use of provider-administered Exdensur over each listed product.	Fasenra 30 mg/mL prefilled syringe	Support for provider-administered Exdensur over this product.
2	Support use of provider-administered Exdensur over each listed product.	Cinqair 100 mg/10 mL vial	Support for provider-administered Exdensur over this product.

Quantity and Frequency Limits

Quantity Limits

MedicationExdensur (depemokimab-ulaa)

Quantity limit100 billable units

FrequencyEvery 6 months

Recommended Dosage

MedicationExdensur (depemokimab-ulaa)

Dose100 mg

Frequency and routeOnce every 6 months by subcutaneous injection

Policy Summary

PayerViva Health Plan

PolicyExdensur (depemokimab-ulaa) Coverage Criteria

Policy CodePolicy IC-P0831

Change TypeNo material change

Effective DateN/A

Last ReviewJul 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization request with the required clinical documentation for Exdensur coverage.

SourceLink

On This Page

One option for confirming severe eosinophilic asthma

Fraction of Exhaled Nitric Oxide

MeasurementFraction of exhaled nitric oxide (FeNO)

Minimum threshold20 parts per billion or higher

Corticosteroid contextWhile on high-dose inhaled corticosteroids or daily oral corticosteroids

Sputum Eosinophils

MeasurementSputum eosinophils

Minimum threshold2% or higher

Corticosteroid contextWhile on high-dose inhaled corticosteroids or daily oral corticosteroids

Severe Asthma Exacerbations

Exacerbation typeSevere asthma exacerbation

Minimum frequency2 or more

Lookback periodWithin the past 12 months

Serious Asthma Exacerbations

Exacerbation typeSerious asthma exacerbation

Minimum frequency1 or more

Lookback periodWithin the past 12 months

Baseline FEV1

MeasurementBaseline Forced Expiratory Volume (FEV1) before therapy with the requested agent

ThresholdLess than 80% of predicted

Qualifying useOne option for demonstrating uncontrolled asthma

Inhaled Corticosteroid Treatment and Adherence

TherapyMaximally tolerated inhaled corticosteroid

Treatment durationAt least 3 months

Adherence windowAdherent for 90 days within the past 120 days

Additional Asthma-Control Therapy

Eligible therapyOne of the following: LABA, LAMA, LTRA, or theophylline

Treatment durationAt least 3 months

Adherence windowAdherent for 90 days within the past 120 days

Prior Authorization

Prior Authorization Required

Prior authorization is required because the request concerns an indication for a medical-benefit drug and the cost of the drug. The submission should identify the requested indication and provide the clinical and utilization information needed for review.

Indication: consider for prior authorization.
Drug cost: consider for prior authorization.

Step Therapy

Required Biologic Trials

For initial approval of severe eosinophilic asthma, document a previous failure, intolerance, or contraindication to each required biologic trial: benralizumab (Fasenra) or mepolizumab (Nucala), and reslizumab (Cinqair).

Failure, intolerance, or contraindication to benralizumab (Fasenra) or mepolizumab (Nucala).
Failure, intolerance, or contraindication to reslizumab (Cinqair).

Step Therapy

Renewal Product Comparison

At renewal, demonstrate support for using provider-administered Exdensur over all specified provider-administered trial products.

Nucala 100 mg vial
Fasenra 30 mg/mL prefilled syringe
Cinqair 100 mg/10 mL vial

Documentation Required

Initial Clinical Documentation

For an initial request, submit documentation establishing the diagnosis and clinical need. For severe eosinophilic asthma, include the required biomarker evidence, exacerbation or lung-function history, and prior treatment response or biologic-use history.

Diagnosis of severe eosinophilic asthma or another FDA-labeled or compendia-supported indication.
One qualifying biomarker: baseline blood eosinophils ≥150 cells/microliter, FeNO ≥20 parts per billion on high-dose inhaled or daily oral corticosteroids, or sputum eosinophils ≥2% on high-dose inhaled or daily oral corticosteroids.
Systemic corticosteroid dependence when required by the asthma criteria.
Uncontrolled asthma history, including at least two severe exacerbations, a serious exacerbation requiring hospitalization, mechanical ventilation, emergency or urgent care, worsening with corticosteroid taper, or baseline FEV1 <80% predicted.
Alternatively, document use of an asthma biologic immunomodulator within the prior 12 months, as applicable.
Document current or prior controller therapy, adherence, intolerance or contraindication, continuation of asthma control therapy, specialist involvement, and absence of FDA-labeled contraindications.

Documentation Required

Combination and Renewal Documentation

For combination requests and renewals, document that the combination is permitted by prescribing information and provide supporting evidence when another immunomodulatory agent will be used. Renewal requests must also establish prior approval, clinical benefit, current asthma-control therapy and compliance when applicable, specialist involvement, and no FDA-labeled contraindication.

Combination therapy: submit clinical trials, phase III studies, or guideline support when required.
Renewal: member was previously approved through the plan’s prior authorization process.
Renewal: member has had clinical benefit with Exdensur.
For severe eosinophilic asthma, member is treated within the past 90 days and compliant with asthma control therapy.
Prescriber is a specialist or has consulted with a specialist.
Member has no FDA-labeled contraindication to Exdensur.

Denial Risk

Failure to Meet Initial Clinical Criteria

Continuation may be denied when the initial clinical eligibility requirements are not established. The request must support the qualifying diagnosis, required biologic history, biomarkers or alternative indication, disease severity or treatment history, controller-therapy requirements, specialist involvement, and absence of contraindications.

No documented prior failure, intolerance, or contraindication to the required biologic trials.
No qualifying biomarker, exacerbation or lung-function history, biologic-use history, or other required clinical evidence.
Required controller therapy, adherence, corticosteroid exception, specialist, or contraindication criteria are not met.

Denial Risk

Unsupported or Contraindicated Combination Therapy

Coverage may be denied when Exdensur is contraindicated for the member or when combination therapy lacks adequate support. If another immunomodulatory agent will be used, the prescribing information must not prohibit the combination and supporting clinical evidence must accompany the request.

FDA-labeled contraindication to Exdensur.
Prescribing information limits the proposed combination.
No submitted clinical trials, phase III studies, or guideline support for combination therapy.

Denial Risk

Failure to Meet Renewal Criteria

Renewal may be denied when the member was not previously approved, has not benefited from therapy, is not adherent to required asthma-control therapy, lacks specialist involvement, or does not satisfy the concomitant-use and contraindication requirements.

No prior plan approval or no documented clinical benefit.
For severe eosinophilic asthma, current treatment or compliance with asthma-control therapy is not documented.
Prescriber is neither a relevant specialist nor documented as having consulted one.
Concomitant-use requirements or absence of FDA-labeled contraindications are not met.

Billing Rule

Dosing Limit Exceeded

Do not submit or expect authorization for quantities exceeding the plan limit of 100 billable HCPCS units in any 6-month period.

Maximum: 100 billable HCPCS units every 6 months.

Denial Risk

Prohibited Concomitant Immunomodulators

Exdensur must not be used concomitantly with the listed immunomodulators and biologic immunomodulators. Document that the member will not receive these agents together, or address the exception requirements for a permitted combination; failure to do so may result in denial.

Abrilada, Actemra, Adalimumab, Adbry, Amjevita, Anzupgo, Arcalyst, Avsola, Avtozma, Benlysta, Bimzelx, Cibinqo, Cimzia, Cinqair, Cosentyx, Cyltezo, Dupixent, Ebglyss, Enbrel, Entyvio, Exdensur, Fasenra, Hadlima, Hulio, Humira, Hyrimoz, Icotyde, Idacio, Ilaris, Ilumya, Imuldosa, Inflectra, Infliximab, Kevzara, Kineret, Leqselvi, Litfulo, Nemluvio, Nucala, Olumiant, and Omlyclo.
Additional listed agents include Omvoh, Opzelura, Orencia, Otezla, Otezla XR, Otulfi, Pyzchiva, Remicade, Renflexis, Rhapsido, Riabni, Rinvoq, Rituxan, Rituxan Hycela, Ruxience, Saphnelo, and Selarsdi.

Denial Risk

Prohibited Concomitant Therapy

The plan identifies the following agents as contraindicated or prohibited for concomitant use with Exdensur. Requests involving these therapies may be denied or not authorized unless the policy’s combination-therapy requirements are satisfied.

Simlandi, Simponi, Simponi ARIA, Skyrizi, Sotyktu, Spevigo, Starjemza, Stelara, Steqeyma, Taltz, Tezspire, Tofacitinib, Tofidence, Tremfya, Truxima, Tyenne, Tyruko, Tysabri, Ustekinumab, Velsipity, Wezlana, Xeljanz, Xeljanz XR, Xolair, Yusimry, Zeposia, and Zymfentra.
The list includes brand and generic products where identified in the policy.

Denial Risk

Prohibited Concomitant Biologic or Immunomodulator Therapy

Concomitant use with the following biologic or immunomodulator therapies is listed as contraindicated. Verify the medication list before submitting or renewing authorization.

Simponi, Simponi ARIA, Skyrizi, Sotyktu, Spevigo (subcutaneous injection), Starjemza, Stelara, Steqeyma, Taltz, Tezspire, Tofacitinib, Tofidence, Tremfya, and Truxima.

Denial Risk

Additional Prohibited Concomitant Agents

Do not request Exdensur for concomitant use with the additional listed agents below; the policy identifies these therapies as contraindicated concomitant therapy.

Tyenne (tocilizumab-aazg)
Tyruko (natalizumab-sztn)
Tysabri (natalizumab)
Ustekinumab

Denial Risk

Other Prohibited Concomitant Agents

The following agents are also listed as contraindicated for concomitant use and should be addressed in the medication reconciliation and authorization request.

Velsipity (etrasimod)
Wezlana (ustekinumab-auub)

Denial Risk

Contraindicated Concomitant Therapy

Concomitant use with Spevigo or Starjemza, among the agents listed below, is contraindicated under the policy and may result in denial or nonauthorization.

Spevigo (spesolimab-sbzo) subcutaneous injection
Starjemza (ustekinumab-hmny)
Stelara (ustekinumab)
Steqeyma (ustekinumab-stba)
Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tofacitinib
Tofidence (tocilizumab-bavi)
Tremfya (guselkumab)
Truxima (rituximab-abbs)
Tyenne (tocilizumab-aazg)
Tyruko (natalizumab-sztn)
Tysabri (natalizumab)
Ustekinumab
Velsipity (etrasimod)
Wezlana (ustekinumab-auub)

Denial Risk

Avoid Contraindicated Concomitant Agents

Avoid concomitant use with the remaining listed agents, including Taltz and Tezspire. Confirm that none of these therapies will be administered with Exdensur before submitting the request.

Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tofacitinib and Xeljanz/Xeljanz XR
Tremfya (guselkumab)
Truxima (rituximab-abbs)
Tyenne (tocilizumab-aazg)
Tyruko (natalizumab-sztn)
Tysabri (natalizumab)
Ustekinumab, Velsipity, and Wezlana
Xolair (omalizumab)
Yusimry (adalimumab-aqvh), Zeposia (ozanimod), and Zymfentra (infliximab-dyyb)

Severe Asthma Exacerbation

Treatment requiredSystemic corticosteroid treatment

Alternate descriptionSteroid burst

Clinical eventAsthma exacerbation