CurrentBlue Cross Blue Shield - IowaPolicy N/A

Dupixent (dupilumab) coverage and prior authorization criteria

Criteria and documentation requirements for prior authorization and continued coverage of Dupixent for multiple labeled and compendial indications for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyDupixent (dupilumab) coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis‑specific documentation, prior therapy history, and dosing consistent with FDA‑recommended regimens.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical authorization period for most indications

2025-10-04current effective date

12 monthstypical continuation authorization period

4 syringes/28dinitiation quantity limit

2 syringes/28dmaintenance quantity limit

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EoE maintenance limit

Coverage Criteria and Dosing

A. Moderate-to-severe atopic dermatitis — Continuation

Moderate-to-severe atopic dermatitis - Continuation Therapy: Authorization of 4 months may be granted for members 6 months of age or older who have previously received a biologic or targeted synthetic drug for atopic dermatitis in the past year, or for ongoing treatment when initial criteria were met and member had clinical benefit without exceeding the maximum FDA-approved dose and while not using concomitant biologics or JAK inhibitors.

B. Moderate-to-severe asthma — Continuation

Moderate-to-severe asthma - Continuation Therapy: Authorization of 6 months may be granted for members 6 years of age or older who have previously received a biologic drug for asthma, or for ongoing treatment when initial criteria were met and member demonstrates continued clinical benefit, will continue background maintenance asthma treatments, will not use Dupixent concomitantly with other biologics for asthma, and will not exceed the FDA-approved dose for the indication.

C. Chronic rhinosinusitis with nasal polyposis (CRSwNP) — Continuation

CRSwNP - Continuation Therapy: Authorization of 6 months may be granted for members 12 years and older who previously received a biologic for CRSwNP, or for ongoing treatment when initial criteria were met and member continues to use daily intranasal corticosteroid (unless contraindicated), will not exceed 300 mg every other week, and will not use Dupixent concomitantly with other biologics indicated for CRSwNP.

D. Eosinophilic Esophagitis (EoE) — Continuation

Eosinophilic Esophagitis - Continuation Therapy: Authorization of 6 months may be granted for members 1 year of age and older (≥15 kg) when initial diagnostic criteria (clinical features plus esophageal biopsy ≥15 eosinophils/HPF) were met, member had inadequate response to prior PPI or topical/systemic corticosteroids unless contraindicated, member continues to receive clinical benefit, and maintenance dosing does not exceed 300 mg weekly.

E. Prurigo nodularis (PN) — Continuation

Prurigo Nodularis - Continuation Therapy: Authorization of 6 months may be granted for members 18 years and older when initial criteria were met (diagnosis at least 6 weeks, repeated itch-scratch cycle, ≥20 nodules, prior inadequate response or intolerance to listed topical, phototherapy, or systemic treatments), member demonstrates clinical benefit on maintenance dosing not to exceed 300 mg every other week, and Dupixent is not used concomitantly with other biologics or JAK inhibitors for PN.

F. Chronic obstructive pulmonary disease (COPD) — Continuation

Chronic Obstructive Pulmonary Disease - Continuation Therapy: Authorization of 6 months may be granted for members 18 years and older when initial criteria were met (confirmed COPD by spirometry, eosinophil count ≥300 cells/µL, inadequate control despite ≥3 months of maximally tolerated background controller therapy), member demonstrates clinical benefit, will continue background LAMA-LABA and inhaled glucocorticoid unless contraindicated, and will not exceed the FDA-approved dose.

G. Immune checkpoint inhibitor-related toxicity

Immune checkpoint inhibitor-related toxicity

Authorization of 6 months may be granted when member has immune-therapy related severe (G3) pruritus refractory to at least 1 month of treatment with gabapentinoids.
Authorization of 12 months may be granted when requested for additional therapy for moderate (G2) or severe (G3) bullous dermatitis related to immune checkpoint inhibitor therapy.

H. Chronic Spontaneous Urticaria (CSU) — Continuation

Chronic Spontaneous Urticaria - Continuation Therapy: Authorization of 6 months may be granted for members 12 years and older who remain symptomatic despite up-dosed second-generation H1 antihistamine therapy, have been evaluated for other causes of urticaria, have had spontaneous symptoms for ≥6 weeks, demonstrate clinical benefit on Dupixent within the FDA-labeled dosing (not exceeding 300 mg every 2 weeks), and will not use concomitant biologics for the same indication.

I. Bullous Pemphigoid — Continuation

Bullous Pemphigoid - Continuation Therapy: Authorization of 12 months may be granted for members 18 years and older when diagnosis was confirmed by DIF or immune serology, member had moderate to severe disease, either prior inadequate response to super-high potency topical or oral corticosteroid or such therapies are not advisable, member demonstrates continued clinical benefit on therapy, and ongoing use does not exceed FDA dosing limits.

Billing and Code References

Codes referencedmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in this document portion

Baseline Blood Eosinophil Count — COPD

COPD eosinophil threshold>= 300 cells per microliter

Use contextBaseline blood eosinophil count required for COPD initial authorization criteria

DocumentationReport most recent baseline eosinophil value in prior authorization documentation

Baseline Blood Eosinophil Count — Asthma Criterion

Asthma eosinophil threshold>= 150 cells per microliter

Use contextBaseline blood eosinophil count may satisfy asthma criterion when combined with inadequate control on inhaled corticosteroid plus controller therapy

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests (initial and continuation) must meet the indication‑specific clinical criteria in this policy and include the documentation listed below. Typical authorization durations: initial authorizations are commonly 4 or 6 months depending on indication (e.g., 4 months for certain atopic dermatitis scenarios; 6 months for asthma, CRSwNP, EoE, PN, COPD, CSU), and continuation authorizations may be 12 months when continued clinical benefit is demonstrated.

Prior authorization is required and will be reviewed against indication‑specific criteria.
Typical initial approval durations are 4 or 6 months by indication; continuation approvals may be granted for up to 12 months when criteria are met.

Documentation Required

Documentation Required for Prior Authorization

Provide complete clinical documentation at the time of submission to avoid delays or denial. Required items vary by indication but generally include: diagnosis, relevant objective test results, prior treatment history (drugs, doses, dates, response), and clinician chart notes documenting current disease activity and rationale when standard therapies are not advisable.

Background and Scope

Dupixent (dupilumab) is a monoclonal antibody approved for multiple type 2 inflammatory conditions including moderate‑to‑severe atopic dermatitis, certain eosinophilic and type‑2 asthma phenotypes, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis (PN), COPD with an eosinophilic phenotype, chronic spontaneous urticaria (CSU), and bullous pemphigoid. Coverage in this policy aligns with FDA‑approved indications and requires meeting the diagnosis‑specific clinical and prior therapy criteria described elsewhere in the policy.

For respiratory indications, limitations of use are noted: Dupixent is not indicated for relief of acute bronchospasm or status asthmaticus. For each indication, dosing and frequency vary by age and weight and the policy requires adherence to the FDA‑recommended dosing regimens and specified quantity limits.

Definitions and Terms

FDA-Approved Indications (Definitions)

Atopic dermatitisModerate-to-severe atopic dermatitis in patients aged 6 months and older when not adequately controlled with topical prescription therapies or when those therapies are not advisable

AsthmaAdd-on maintenance treatment for moderate-to-severe asthma in patients aged 6 years and older with an eosinophilic phenotype or with oral corticosteroid–dependent asthma

Chronic rhinosinusitis with nasal polyposis (CRSwNP)Add-on maintenance treatment for patients 12 years and older with inadequately controlled CRSwNP

Eosinophilic esophagitis (EoE)Treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with EoE

Prurigo nodularis (PN)Treatment of adult patients with prurigo nodularis

Chronic obstructive pulmonary disease (COPD)Add-on maintenance treatment of adult patients with inadequately controlled COPD and an eosinophilic phenotype

Policy Revision History

2025-10-04Effective dateLatest

Policy became effective on October 4, 2025.

2025-09Policy review

Policy reviewed in September 2025.

2025-09Policy revision

Policy revised in September 2025.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyDupixent (dupilumab) coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis‑specific documentation, prior therapy history, and dosing consistent with FDA‑recommended regimens.

SourceLink

On This Page

Age applicabilityApplies to members 6 years of age or older under the asthma initial criteria

EoE Biopsy Diagnostic Threshold

EoE biopsy threshold>= 15 intraepithelial esophageal eosinophils per high power field

Diagnostic requirementEsophageal biopsy demonstrating >=15 eosinophils/HPF is required to confirm EoE diagnosis for authorization

Age/weight noteApplies to patients aged 1 year and older and weighing at least 15 kg per EoE criteria

Quantity Limit — EoE Maintenance

EoE maintenance quantity limit4 syringes/pens per 28 days

Product formDupixent 300 mg/2 mL prefilled syringe or pen-injector (maintenance quantity applies to EoE regimens)

Exceedance consequenceRequests exceeding this quantity limit may be denied

Failure to submit required documentation may delay or deny the request.
Include chart notes or medical records showing diagnosis, objective test results (e.g., biopsies, DIF or serology for bullous pemphigoid; esophageal biopsy for EoE; spirometry for COPD; blood eosinophil counts for asthma/COPD where applicable).
Include claims or medication history documenting prior therapies, dosing, duration, and response; if a required prior therapy is not advisable, submit documentation explaining the clinical reason.

Billing Rule

Quantity Limit Exceedance

Requests that exceed established quantity or dosing limits may be denied. Confirm the requested dosing and quantity match the FDA‑approved regimen and the policy's quantity limits before submission.

Maintenance EoE limit: 4 syringes/pens per 28 days.
Do not exceed indication‑specific maximum dosing (e.g., most indications limit to 300 mg every 2 weeks or weekly as specified by age/weight).
Requests exceeding quantity limits (for example, >4 syringes/pens per 28 days for EoE maintenance) may be denied.
Loading doses and age/weight exceptions are defined in the policy — ensure the request aligns with those provisions.

Documentation Required

Bullous Pemphigoid — Diagnostic Documentation Required

For bullous pemphigoid, the diagnosis must be confirmed and documented. Submit objective diagnostic testing and clinical features to support the diagnosis.

Diagnosis must be confirmed by either a Direct Immunofluorescence (DIF) study or immune serologic testing (e.g., IIF, ELISA).
Include chart notes documenting characteristic clinical features (e.g., urticarial/eczematous/erythematous plaques, bullae, pruritus) and disease severity (moderate to severe).
Provide prior therapy history (e.g., response to super‑high potency topical corticosteroid or oral corticosteroid) or documentation explaining why those therapies are not advisable.

Documentation Required

Chronic Spontaneous Urticaria (CSU) — Required Documentation

For Chronic Spontaneous Urticaria (CSU), document persistent symptoms despite optimized antihistamine therapy and evaluation for other causes. Include duration and prior treatment details.

Member must be ≥12 years of age.
Documentation must show persistent symptoms for at least 6 weeks (spontaneous wheals, angioedema, or both).
Chart notes or records must show inadequate response to up‑dosing of a second‑generation H1 antihistamine (up to 4× the recommended dose) for at least 2 weeks, and evaluation for other causes of urticaria.
Requested dose must be within FDA‑labeled dosing and not exceed 300 mg every 2 weeks.

Chronic spontaneous urticaria (CSU)Treatment of adults and pediatric patients aged 12 years and older with CSU who remain symptomatic despite H1 antihistamine treatment

Compendial Uses (Definitions)

Immune checkpoint inhibitor-related toxicitiesCompendial use: immune checkpoint inhibitor-related toxicities (e.g., ICI-related severe pruritis or bullous dermatitis) are considered

Context for considerationCompendial uses are evaluated when ICI-related toxicities are refractory to recommended supportive or guideline-based therapies

Case‑by‑case assessmentDocumentation of severity, prior therapy attempts, and response is required for compendial use review

Chronic Spontaneous Urticaria (CSU) — Definition

Symptom durationSpontaneous onset of wheals (hives), angioedema, or both for at least 6 weeks

Prior therapy failurePersistent symptoms despite up‑dosing a second‑generation H1 antihistamine (up to 4x) for at least 2 weeks

Diagnostic evaluationEvaluation for other causes of urticaria (e.g., bradykinin-related angioedema, IL-1–associated syndromes) is required

Bullous Pemphigoid — Definition

Required diagnostic testingDiagnosis confirmed by direct immunofluorescence (DIF) or immune serologic tests (e.g., IIF, ELISA)

Characteristic clinical featuresDocumentation of urticarial/eczematous/erythematous plaques, bullae, and pruritus supports diagnosis

Severity and prior therapy contextMember must have moderate to severe disease and inadequate response to super‑high potency topical corticosteroid or oral corticosteroid unless such treatments are not advisable

Loading Dose Exceptions (Definitions)

Pediatric atopic dermatitis (6 months–5 years)Loading doses do not apply to patients 6 months to 5 years of age with atopic dermatitis

Pediatric asthma (6–11 years)Loading doses do not apply to patients 6–11 years of age with asthma

EoE and CRSwNPLoading doses do not apply to eosinophilic esophagitis or chronic rhinosinusitis with nasal polyposis

Implementation noteWhen loading doses are not used, follow the indicated age/weight maintenance dosing as specified in FDA‑recommended regimens