CurrentViva HealthPolicy IC-P0831

Exdensur (depemokimab-ulaa) — Prior Authorization for Severe Eosinophilic Asthma

Prior authorization policy for Exdensur (depemokimab-ulaa) subcutaneous injections for members (clinical focus on severe eosinophilic asthma and related eosinophilic pulmonary conditions) governing coverage, renewal, dosing, and concomitant therapy restrictions.

Policy Summary

PayerViva Health

PolicyExdensur (depemokimab-ulaa) — Prior Authorization for Severe Eosinophilic Asthma

Policy CodePolicy IC-P0831

Change TypeNo material changes

Effective Date02/03/2026

Next Review Date03/03/2027

Key ActionObtain prior authorization (valid for 12 months) and document baseline eosinophil/FeNO/sputum results and prior biologic trials as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100 mgdose every 6 months

12 moinitial and renewal authorization length

J3590, C9399HCPCS codes listed

00173-0927NDC for 100 mg/mL

5 ICD-10covered diagnosis codes

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Coverage Criteria for Exdensur (depemokimab-ulaa)

Initial Therapy

Target Agent(s) will be approved when ALL of the following are met:

Continuation or New Use

Continuation of therapy (option A): Member treated with the requested agent within the past 90 days (starting on samples is not approvable) OR prescriber states member treated with the requested agent within the past 90 days and is at risk if therapy changed
New use - Severe eosinophilic asthma (option B)
- Biologic prior trial: Member has had a previous failure, intolerance, or contraindication to a trial of benralizumab (Fasenra) OR mepolizumab (Nucala), and where specified reslizumab (Cinqair)
- Diagnostic confirmation: ONE of: baseline blood eosinophils >= 150 cells/microliter OR FeNO >= 20 ppb while on high-dose inhaled corticosteroids or daily oral corticosteroids OR sputum eosinophils >= 2% while on high-dose inhaled corticosteroids or daily oral corticosteroids OR patient is dependent on systemic corticosteroids
- Evidence of uncontrolled asthma: ONE of: two or more systemic corticosteroid bursts in the past 12 months OR a serious exacerbation requiring hospitalization, mechanical ventilation, or ER/urgent care in the past 12 months OR asthma controlled at baseline that worsens when inhaled/systemic steroids are tapered OR baseline FEV1 < 80% predicted; OR prior use of an FDA-labeled or compendia-supported biologic for asthma within the past 12 months may satisfy this
- Background therapy and prescriber: Member will continue background asthma control therapy in combination with the requested agent; member has been treated with adequate inhaled corticosteroid and adjunct controller therapy as required (e.g., maximally tolerated ICS for ≥3 months with adherence documented as 90 days within the past 120 days, plus LABA/LAMA/LTRA/theophylline as indicated); prescriber is a specialist or has consulted a specialist; and concomitant immunomodulatory therapy restrictions apply (see prohibitions and permitted combination conditions)
- Contraindications: Member does NOT have any FDA-labeled contraindications to the requested agent

Operational notes: Compendia allowed: AHFS, DrugDex (1 or 2a), or NCCN (1 or 2a). Documentation must support prior biologic trials, baseline biomarkers, systemic steroid dependence, exacerbation history, lung function, and adherence/intolerance as applicable.

Renewal Therapy

Renewal Criteria

Renewal: Member previously approved via the plan's prior authorization process AND member demonstrated clinical benefit with the requested agent

Ongoing disease management: If diagnosis is severe eosinophilic asthma, member is currently treated within the past 90 days and is compliant with asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline); prescriber is a specialist or has consulted a specialist; concomitant therapy restrictions observed; and member has no FDA-labeled contraindications to the requested agent

Concomitant therapy conditions: Either the member will NOT be using the requested agent with another immunomodulatory agent OR, if used in combination, the prescribing information does not limit combination use AND there is supporting evidence for combination therapy (clinical trials, phase III studies, or guidelines must be submitted)

The policy lists an extensive set of agents that must not be used concomitantly with the requested therapy. These include multiple monoclonal antibodies, JAK inhibitors, and other immunomodulators such as adalimumab products (e.g., Abrilada, Amjevita, Humira and biosimilars), tocilizumab and its variants (Actemra, Tofidence), infliximab products (Inflectra, Remicade, Renflexis, Zymfentra), and interleukin-targeting biologics (for example dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, omalizumab, and others) as well as small-molecule immunomodulators (for example tofacitinib, baricitinib, upadacitinib, and similar agents).

A subset of agents are explicitly labeled in the document as contraindicated as concomitant therapy (examples include mepolizumab (Nucala), omalizumab (Xolair/Omlyclo), rituximab products, and multiple JAK inhibitors and interleukin modulators). Providers must not prescribe these agents concurrently with the requested therapy except where clinical justification is documented and allowed by plan exceptions.

Because the list is extensive and includes brand names and biosimilars, prescribers and reviewers should consult the detailed agent lists in the policy when assessing concomitant therapy. The policy also places the requested agent (Exdensur) itself on the not-to-be-used-concomitantly list, reinforcing that concurrent use with many other biologics or immunomodulators is prohibited per the coverage rules.

Medicare coverage is governed separately. For Medicare Part B beneficiaries, coverage and documentation must comply with the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 and with any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Where such CMS documents exist, their coverage and prior authorization requirements take precedence for Medicare claims; use the CMS Medicare Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx) to identify applicable NCDs/LCDs/LCAs.

Coding and Diagnostic Codes

HCPCS codesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals (Hospital Outpatient Use Only)

NDCNDC

00173-0927-xx

Exdensur 100 mg/mL single-dose, prefilled pen or syringe

Covered Diagnosis Codes (ICD-10)ICD-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

Medicare Part B Covered Diagnosis CodesICD-10

N/A	Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

inv-09: Baseline blood eosinophil count — single value threshold

Threshold>= 150 cells/microliter (baseline, prior to therapy)

ContextRequired as one option to confirm diagnosis of severe eosinophilic asthma

TimingBaseline value must be measured prior to initiation of the requested agent

inv-10: FeNO threshold — biomarker requirement

Threshold>= 20 parts per billion (FeNO) while on high‑dose inhaled corticosteroids or daily oral corticosteroids

Context

Provider Actions, Documentation & Billing Guidance

Prior Authorization

Prior Authorization Validity

Prior authorization is required and will be issued for 12 months initially and for 12-month renewals thereafter.

Initial prior authorization validity: 12 months (365 days).
Renewal prior authorization validity: 12 months (365 days).

Note

Follow Applicable Medicare NCD/LCD/LCA

Where Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs) exist, the coverage rules and any prior authorization requirements specified in those documents apply and take precedence for Medicare members.

Follow applicable Medicare NCDs, LCDs, and LCAs for Part B drugs and biologicals.
Compliance with Medicare coverage documents is required where applicable.

Definitions & Administration

inv-21: Administration — subcutaneous injection site guidance

Permitted injection sitesSubcutaneous injection into the upper arm, thigh, or abdomen (avoid a 2‑inch/5 cm area around the navel)

RouteSubcutaneous (SC) administration

Dose frequency contextDose prescribed as 100 mg every 6 months (administration guidance applies to each SC dose)

inv-22: NCD/LCD/LCA definitions — CMS policy documents that define Medicare coverage terms

NCDNational Coverage Determination — CMS policy document that defines Medicare coverage and claims payment rules

LCDLocal Coverage Determination — contractor‑level policy that defines Medicare coverage within a MAC jurisdiction

Background

Exdensur (depemokimab-ulaa) is a subcutaneous biologic indicated for severe eosinophilic asthma with a recommended dose of 100 mg administered once every 6 months. The product is supplied as a 100 mg/mL single-dose prefilled pen or syringe and is given by subcutaneous injection into the upper arm, thigh, or abdomen per the administration guidance.