Prior Authorization Criteria — DUPIXENT (dupilumab)
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This document defines prior authorization requirements and clinical criteria for coverage of Dupixent (dupilumab) across its FDA-indicated uses for West Virginia Bureau for Medical Services members. It applies to prescribers requesting PA for Dupixent under the payer's pharmacy prior authorization process.
No material clinical or coverage changes in this revision.
Coverage Criteria for Dupixent (dupilumab)
Atopic Dermatitis
Covered when ALL of the following are met for Atopic Dermatitis
Initial approval 90 days; continuation requires documentation of satisfactory patient response (including current affected BSA and severity of symptoms).
Asthma
Covered when ALL of the following are met for Asthma
Initial approval 90 days; continuation requires documentation of satisfactory patient response and continued compliance on inhaled therapy.
CRSwNP
Covered when ALL of the following are met for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Continuation requires documentation of reduction/elimination of nasal polyps and patient adherence to therapy.
Eosinophilic Esophagitis
Covered when ALL of the following are met for Eosinophilic Esophagitis (EoE)
Initial approval 90 days; continuation requires documentation of significant reduction in dysphagia symptoms.
Prurigo Nodularis
Covered when ALL of the following are met for Prurigo Nodularis (PN)
Initial approval 90 days; continuation requires documentation of satisfactory patient response and compliance on therapy.
COPD (eosinophilic phenotype)
Covered when ALL of the following are met for COPD with eosinophilic phenotype
Initial approval 90 days; continuation requires documentation of satisfactory patient response and compliance on therapy.
Other indications
Other FDA indications noted in label
All other indications require case-by-case review by the medical director.
Requests for use of Dupixent that do not meet the indication-specific criteria outlined in this policy will be reviewed on a case-by-case basis by the medical director. This includes any request for an FDA-labeled indication when the submission lacks required documentation of prescriber specialty, patient age per FDA labeling, required prior therapy trials, or objective laboratory/clinical thresholds specified in the criteria (for example, affected BSA for atopic dermatitis, tissue eosinophil counts for EoE, or blood eosinophil thresholds for asthma/COPD).
Per the policy, all indications not explicitly detailed in the coverage criteria section must undergo medical director review prior to authorization; providers should submit comprehensive clinical documentation to support medical necessity when requesting review.
Dupixent is not indicated for relief of acute bronchospasm or status asthmaticus. Use of Dupixent for immediate relief of bronchospasm or treatment of status asthmaticus is outside the labeled indications and is not an appropriate use per the FDA-labeled limitations of use.
Key Coding and Clinical Thresholds
Provider Requirements and Documentation
Prior authorization required — submit PA request form
Prior authorization is required for Dupixent. Providers must submit the payer’s Prior Authorization Request Form when requesting coverage.
Required prior therapy trials per indication
Document trials and failures of the conventional therapies specified for the requested indication before approval; approvals require evidence of inadequate response to the listed prior agents per indication.
- Atopic dermatitis: minimum 30-day trials of two agents (medium‑to‑high potency topical corticosteroid, Elidel, Eucrisa, or tacrolimus) within the last 12 months.
- Asthma: documented adherence to LABA + high‑dose ICS in last 90 days prior to approval.
- CRSwNP: inadequate control after ≥3 months of intranasal steroid therapy.
- EoE: 90‑day trial with inadequate response to topical/systemic glucocorticoids unless contraindicated.
- Prurigo nodularis: trial with inadequate response to a super potent topical corticosteroid or intralesional corticosteroid.
- COPD: at least 3 months of standard triple inhaled therapy (LAMA + LABA + ICS) at stable dose for ≥1 month prior to request.
AD documentation — diagnosis, BSA, areas, severity
For atopic dermatitis include the documented diagnosis of moderate‑to‑severe AD and specific clinical details: affected body surface area (BSA), areas of involvement, and severity of symptoms.
- Ensure affected BSA is documented (approval requires ≥10%).
- Include current BSA and severity for continuation requests.
Asthma documentation — inhaled therapy adherence and eosinophil evidence
For asthma include documentation of adherence to a LABA + high‑dose ICS regimen in the last 90 days, plus objective evidence of eosinophilic phenotype or chronic oral corticosteroid reliance.
- Provide sputum eosinophils ≥3% OR blood eosinophil count ≥150 cells/mcL (past 6 weeks) or ≥300 cells/mcL (past 12 months) OR claims data showing continual reliance on oral corticosteroids in the last 90 days.
EoE documentation — biopsy, symptoms, and steroid trial
For eosinophilic esophagitis include histologic confirmation and symptom history plus prior steroid trial documentation.
- Provide esophageal biopsy showing tissue eosinophil count ≥15 eos/hpf.
- Document dysphagia symptoms or prior esophageal dilation.
- Document a 90‑day trial with inadequate response to topical/systemic glucocorticoids unless contraindicated.
COPD documentation — eosinophils, exacerbations, and triple‑therapy proof
For COPD with eosinophilic phenotype include recent eosinophil count, exacerbation history, and proof of prior triple inhaled therapy adherence.
- Provide blood eosinophil count ≥300 cells/mcL within the prior 12 months.
- Document ≥2 moderate OR ≥1 severe exacerbation within the past 12 months (definitions provided in policy).
- Provide evidence the patient was on LAMA + LABA + ICS for ≥3 months at a stable dose for ≥1 month prior to request (LAMA‑LABA allowed if ICS contraindicated).
Denial risk if indication criteria or documentation are not met
Requests that do not meet the indication‑specific criteria or that lack required specialty or clinical documentation may be denied.
- Common denial reasons include: age outside FDA label, missing required prior therapy trials, absent lab thresholds (e.g., eosinophil or tissue counts), or missing prescriber specialty documentation.
Background on Dupixent
Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist with multiple FDA-approved indications across dermatology, pulmonology, gastroenterology, and immunology. The labeled indications include moderate-to-severe atopic dermatitis (ages 6 months and older), add-on maintenance therapy for eosinophilic phenotype asthma (ages 6 years and older), chronic rhinosinusitis with nasal polyps (ages 12 years and older), eosinophilic esophagitis (ages 1 year and older meeting biopsy criteria), prurigo nodularis (adults), COPD with an eosinophilic phenotype (adults), chronic spontaneous urticaria (>=12 years), and bullous pemphigoid (adults). Specific limitations of use noted in the label include that Dupixent is not for relief of acute bronchospasm or status asthmaticus.
Clinical Definitions and Thresholds
Initial Authorization Requirements
Initial therapy
Initial authorization requirements and duration
Renewal and Continuation Requirements
Continuation therapy
Continuation/renewal requirements per indication
Step Therapy Requirements
| Indication | Required prior therapy trials (failure/inadequate response) before Dupixent approval |
|---|---|
| Must have failed minimum 30-day trials of two agents in the last 12 months: medium-to-high potency topical corticosteroid (trial required unless affected area is sensitive), Elidel, Eucrisa, or tacrolimus. If topical steroid not used due to sensitive area, two other agents from the list are still required prior to approval. | |
| Documented adherence to LABA + high‑dose ICS in the last 90 days PLUS one of: sputum eosinophils ≥3% OR blood eosinophils ≥150 cells/mcL (within 6 weeks) or ≥300 cells/mcL (within 12 months) OR claims evidence of continual oral corticosteroid reliance in last 90 days; prior failure/inadequate control on LABA+high‑dose ICS is required. | |
| Inadequately controlled after ≥3 months of intranasal steroid therapy (trial of at least 3 months required) before Dupixent approvable as add‑on therapy. | |
| 90‑day trial with inadequate response to topical/systemic glucocorticoids (unless contraindicated) is required prior to approval; histologic criterion (≥15 eos/hpf) and symptoms/dilation history also required. | |
| Trial with inadequate response/treatment failure to a super‑potent topical corticosteroid or intralesional corticosteroid (unless contraindicated) is required; also require WINRS ≥7 and ≥20 nodules. | |
| Must have been on standard‑of‑care triple inhaled therapy (LAMA + LABA + ICS) for ≥3 months at stable dose for ≥1 month prior (LAMA‑LABA allowed if ICS contraindicated); blood eosinophils ≥300 cells/mcL within prior 12 months and history of exacerbations required. |
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