CurrentCignaPolicy N/A

Immunologicals - Exdensur Prior Authorization Policy

Prior authorization policy for Exdensur (depemokimab-ulaa) subcutaneous injection for add-on maintenance treatment of severe eosinophilic asthma in patients ≥ 12 years; defines initial and continuation approval criteria, exclusions, prescriber requirements, and approval durations.

Policy Summary

PayerCigna

PolicyImmunologicals - Exdensur Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNew Policy

Effective DateN/A

Next Review DateDec 30, 2025

Key ActionObtain prior authorization with documentation of age, blood eosinophil levels and timing, ≥3 months prior controller therapy, evidence of uncontrolled asthma, and specialist prescribing/consultation; initial approvals for 6 months and continuation approvals for 1 year.

SourceLink

POLICY UPDATE CHANGES

New Policy created with review date 12/30/2025.

1Covered Indications (Asthma)

6Initial approval duration (months)

12Continuation approval duration (months)

12Minimum age (years)

Coverage Summary

Prior authorization policy for Exdensur (depemokimab-ulaa) subcutaneous injection as an add-on maintenance treatment for severe eosinophilic asthma in patients ≥ 12 years. Defines criteria for initial and continuation approvals, exclusions (including concurrent use with other monoclonal antibody therapies), prescriber requirements (prescribed by or in consultation with an allergist, immunologist, or pulmonologist), and approval durations (initial therapy and continuation timelines as specified). The policy is a new prior authorization policy reviewed on 12/30/2025.

Thresholds

Age≥ 12 years

Blood eosinophil level≥ 150 cells/µL (within previous 6 weeks or prior to monoclonal antibody therapy)

Initial therapy prior treatment duration≥ 3 consecutive months of combination therapy (inhaled corticosteroid + at least one additional controller)

FEV1< 80% predicted

FEV1/FVC< 0.80

Continuation therapy prior Exdensur duration≥ 6 months prior Exdensur therapy

Medical Necessity Criteria

FDA-Approved Indication - Asthma

Approve Exdensur for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy (Approve for 6 months)
- Patient is ≥ 12 years of age≥ 12 years
- Blood eosinophil requirement
  - Patient has a blood eosinophil level ≥ 150 cells per microliter within the previous 6 weeks≥ 150 cells/µL within previous 6 weeks
  - Patient had a blood eosinophil level ≥ 150 cells per microliter prior to treatment with Exdensur or another monoclonal antibody therapy that may alter blood eosinophil levels≥ 150 cells/µL prior to monoclonal antibody therapy
- Prior controller therapy requirement
  - Patient has received at least 3 consecutive months of combination therapy with BOTH of the following (a and b)≥ 3 months
  - a) An inhaled corticosteroid
  - b) At least one additional asthma controller or asthma maintenance medication
- Evidence of uncontrolled asthma at baseline
  - Patient experienced two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous year2+ bursts systemic corticosteroids in previous year
  - Patient experienced one or more asthma exacerbation(s) requiring a hospitalization, an emergency department visit, or an urgent care visit in the previous year1+ hospitalization/ED/urgent care in previous year
  - Patient has a forced expiratory volume in 1 second (FEV1) < 80% predictedFEV1 < 80% predicted
  - Patient has an FEV1/forced vital capacity (FVC) < 0.80FEV1/FVC < 0.80
- The medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist
  Initial approval requires specialist prescribing or consultation
B) Currently Receiving Exdensur (Approve for 1 year)
- Patient has already received at least 6 months of therapy with Exdensur≥ 6 months prior Exdensur therapy
- Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler
- According to the prescriber, the patient has responded to therapy (examples: decreased exacerbations, decreased symptoms, decreased hospital/ED/urgent care visits, decreased requirement for oral corticosteroid therapy)

nodes are JSON-encoded CriteriaNode strings

Approval durations

Initial approval duration (months)6

Continuation approval duration (months)12

Conditions Not Covered / Not Medically Necessary

Exdensur is considered not medically necessary for any other use(s) including:

ALL of the following

Concurrent use of Exdensur with another Monoclonal Antibody Therapy (efficacy and safety of concurrent use not established)

nodes are JSON-encoded CriteriaNode strings

Not indicated for the relief of acute bronchospasm or status asthmaticus.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Exdensur. Initial approval requires prescribing by or consultation with an allergist, immunologist, or pulmonologist. Approvals are provided for specified durations.

Initial approval duration: 6 months
Continuation approval duration: 1 year

Documentation Required

Clinical documentation to support criteria

Document age, blood eosinophil levels (with timing), prior controller therapy (at least 3 consecutive months including an inhaled corticosteroid plus an additional controller), evidence of uncontrolled asthma at baseline (exacerbations, hospital/ED/urgent care visits, FEV1 or FEV1/FVC), and that the medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist. For continuation therapy, document at least 6 months of prior Exdensur therapy and clinical response to treatment.

Age (≥ 12 years)
Blood eosinophil level and timing (e.g., ≥ 150 cells/µL within previous 6 weeks or prior to monoclonal antibody therapy)
Prior controller therapy: ≥ 3 consecutive months including an inhaled corticosteroid + at least one additional controller
Evidence of uncontrolled asthma at baseline: exacerbation history (≥2 systemic corticosteroid bursts or ≥1 hospitalization/ED/urgent care), FEV1 and/or FEV1/FVC
Prescribing specialist: allergist, immunologist, or pulmonologist
For continuation: ≥ 6 months prior Exdensur therapy and documentation of clinical response (e.g., decreased exacerbations, symptoms, or oral corticosteroid requirement)

Denial Risk

Denial for non-FDA or unsupported uses

Claims for uses that do not meet the stated criteria or for concurrent use of Exdensur with another monoclonal antibody therapy (efficacy and safety not established) will be considered not medically necessary and may be denied.

Concurrent use with another monoclonal antibody therapy is an example of a denial reason

Background, Evidence & Definitions

Exdensur is an interleukin (IL)-5 antagonist monoclonal antibody indicated as an add-on maintenance treatment for severe eosinophilic asthma in adults and pediatric patients ≥ 12 years of age. In pivotal asthma studies, patients were generally required to have elevated eosinophils at baseline (e.g., peripheral blood eosinophil count ≥ 150 cells/µL at screening or ≥ 300 cells/µL at some time during the previous year), and across the studies efficacy was assessed at Week 52. Exdensur is not indicated for relief of acute bronchospasm or status asthmaticus.

Label	Value
Pivotal trial eosinophil requirement
Peripheral blood eosinophil count ≥ 150 cells/µL at screening or ≥ 300 cells/µL at some time during previous year
Efficacy assessment timing
Week 52

Term	Definition
Baseline
Defined as prior to receiving Exdensur or another monoclonal antibody therapy for asthma.
Monoclonal antibody therapies that may alter blood eosinophil levels
Includes Exdensur, Adbry (tralokinumab-ldrm), Cinqair (reslizumab), Dupixent (dupilumab), Ebglyss (lebrikizumab-lbkz), Fasenra (benralizumab), Nemluvio (nemolizumab-ilto), Nucala (mepolizumab), Tezspire (tezepelumab-ekko), Xolair (omalizumab).