UnitedHealthcare Dupixent Prior Auth Policy Update

Coverage Criteria by Indication

Initial Therapy - Atopic Dermatitis

Initial authorization for moderate-to-severe atopic dermatitis — covered when ALL of the following are met

Atopic dermatitis initial: (1) Diagnosis of moderate-to-severe chronic atopic dermatitis.

Prior topical therapy trials: (2) History of failure, contraindication, or intolerance to two of the following topical therapy classes; document drug, date of trial, and/or contraindication: medium/high/very-high potency topical corticosteroid; topical calcineurin inhibitor; crisaborole (Eucrisa).two classes

Certain topical agents (Elidel, Protopic/tacrolimus ointment, and Eucrisa) require prior authorization.

No concurrent biologic/JAK: (3) Patient is not receiving Dupixent in combination with a biologic immunomodulator (e.g., tralokinumab) or a Janus kinase inhibitor (e.g., upadacitinib, tofacitinib, abrocitinib) for treatment of the same indication.

Prescriber requirement: (4) Prescribed by a dermatologist, allergist, or immunologist.

Reauthorization - Atopic Dermatitis

Reauthorization for atopic dermatitis — covered when ALL of the following are met

Clinical response: (1) Documentation of positive clinical response to Dupixent therapy.

No concurrent biologic/JAK: (2) Patient is not receiving Dupixent in combination with listed biologics or Janus kinase inhibitors for the same indication.

Prescriber requirement: (3) Prescribed by a dermatologist, allergist, or immunologist.

Authorization will be issued for 12 months.

Initial Therapy - Asthma

Initial authorization for moderate-to-severe asthma — covered when ALL of the following are met

Diagnosis: (1) Diagnosis of moderate-to-severe asthma.

Uncontrolled asthma definition: (2) Asthma classified as uncontrolled or inadequately controlled by at least one of: poor symptom control (e.g., ACQ >1.5 or ACT <20), ≥2 systemic corticosteroid bursts ≥3 days in prior 12 months, asthma-related emergency treatment or hospitalization, airflow limitation (post-bronchodilator FEV1 <80% predicted with reduced FEV1/FVC), or current dependence on oral corticosteroids.

Eosinophilic phenotype OR oral steroid dependence: (3) Submission of medical records documenting either baseline peripheral blood eosinophils ≥150 cells/μL (eosinophilic phenotype) or current dependence on oral corticosteroids for asthma.≥150 cells/μL

Background ICS therapy:

Reauthorization - Asthma

Reauthorization for asthma — covered when ALL of the following are met

Clinical response: (1) Documentation of positive clinical response to Dupixent demonstrated by at least one: reduced exacerbation frequency; decreased rescue medication use; increased percent predicted FEV1; reduction in severity/frequency of asthma symptoms; or reduced oral corticosteroid requirements.

Continuing ICS therapy: (2) Dupixent is being used in combination with an ICS-containing maintenance medication.

No concurrent biologic classes: (3) Patient is not receiving concurrent anti-IL-5, anti-IgE, or TSLP inhibitor therapy for the same indication.

Prescriber requirement: (4) Prescribed by an allergist, immunologist, or pulmonologist.

Authorization will be issued for 12 months.

Initial Therapy - CRSwNP

Initial authorization for chronic rhinosinusitis with nasal polyposis (CRSwNP) — covered when ALL of the following are met

Symptom duration and criteria: (1) Two or more CRSwNP symptoms for >12 weeks: nasal mucopurulent discharge; nasal obstruction/congestion; facial pain/pressure/fullness; reduction or loss of smell.

Objective findings: (2) One of: nasal endoscopy or sinus CT showing purulent mucus/edema in middle meatus or ethmoid regions; polyps in nasal cavity or middle meatus; radiographic mucosal thickening or opacification.

Polyp or surgery history: (3) Either bilateral nasal polyposis OR prior surgical removal of bilateral nasal polyps.

Prior surgery or systemic therapy or failed trials: (4) One of: prior sinus surgery; systemic corticosteroids for CRSwNP in past 2 years; or failure of two classes (nasal saline irrigation, intranasal corticosteroids, antileukotriene agents).

Reauthorization - CRSwNP

Reauthorization for CRSwNP — covered when ALL of the following are met

Clinical response: (1) Documentation of positive clinical response to Dupixent therapy.

Continuation with intranasal corticosteroids: (2) Patient will continue add-on therapy with intranasal corticosteroids.

No concurrent biologic classes: (3) Patient is not receiving Dupixent in combination with anti-IL-5, anti-IgE, or TSLP inhibitor therapies for the same indication.

Prescriber requirement: (4) Prescribed by an allergist, immunologist, otolaryngologist, or pulmonologist.

Authorization will be issued for 12 months.

Initial Therapy - Eosinophilic Esophagitis

Initial authorization for eosinophilic esophagitis (EoE) — covered when ALL of the following are met

Diagnosis: (1) Diagnosis of eosinophilic esophagitis.

Symptoms: (2) Patient is experiencing symptoms related to esophageal dysfunction (e.g., dysphagia, food impaction, chest pain, refractory heartburn, upper abdominal pain).

Histology: (3) Submission of medical records documenting eosinophil-predominant inflammation on esophageal biopsy with peak ≥15 intraepithelial eosinophils per high power field (or 60 eosinophils per mm2).≥15 eos/HPF

Submit biopsy documentation; absence may trigger denial.

Rule out secondary causes: (4) Secondary causes of esophageal eosinophilia have been ruled out.

Reauthorization - Eosinophilic Esophagitis

Reauthorization for EoE — covered when ALL of the following are met

Clinical or objective improvement: (1) Documentation of positive clinical response evidenced by improvement in at least one of: symptoms (dysphagia, chest pain, heartburn), histologic measures (intraepithelial eosinophil count), or endoscopic measures (edema, furrows, exudates, rings, strictures).

No concurrent biologic classes: (2) Patient is not receiving Dupixent in combination with anti-IL-5, anti-IgE, or TSLP inhibitor therapies for the same indication.

Prescriber requirement: (3) Prescribed by or in consultation with a gastroenterologist or allergist.

Authorization will be issued for 12 months.

EoE Initial Therapy

Eosinophilic Esophagitis (EoE) — Initial Authorization

EoE initial criteria: (1) Diagnosis of eosinophilic esophagitis; (2) Symptoms related to esophageal dysfunction (e.g., dysphagia, food impaction, chest pain, refractory heartburn, upper abdominal pain); (3) Medical records documenting eosinophil-predominant inflammation on esophageal biopsy with peak >=15 eos/HPF (or 60 eos/mm2); (4) Secondary causes of esophageal eosinophilia ruled out; (5) Mucosal eosinophilia isolated to the esophagus and symptoms persisted after an 8-week trial of at least one: proton pump inhibitor or topical (esophageal) corticosteroid; (6) Patient not receiving Dupixent in combination with anti-IL-5, anti-IgE, or TSLP inhibitor for same indication; (7) Prescribed by gastroenterologist or allergist.see individual nodes

All conditions must be met

EoE Reauthorization

EoE — Reauthorization

EoE reauth criteria: (1) Documentation of positive clinical response to Dupixent (improvement in symptoms, histologic measures, or endoscopic measures); (2) Patient not receiving Dupixent in combination with anti-IL-5, anti-IgE, or TSLP inhibitor for same indication; (3) Prescribed by or in consultation with a gastroenterologist or allergist; Authorization issued for 12 months.

All conditions must be met

Prurigo Nodularis Initial Therapy

Prurigo Nodularis — Initial Authorization

Prurigo initial criteria: (1) Diagnosis of prurigo nodularis; (2) ≥20 nodular lesions; (3) History of failure, contraindication, or intolerance to prior treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical capsaicin); (4) Patient not receiving Dupixent in combination with biologic immunomodulators or Janus kinase inhibitors for the same indication; (5) Prescribed by a dermatologist, allergist, or immunologist.20 nodules

Authorization will be issued for 12 months.

Prurigo Nodularis Reauthorization

Prurigo Nodularis — Reauthorization

Prurigo reauth criteria: (1) Documentation of positive clinical response to Dupixent; (2) Patient not receiving Dupixent in combination with biologic immunomodulators or Janus kinase inhibitors for the same indication; (3) Prescribed by a dermatologist, allergist, or immunologist.

Authorization will be issued for 12 months.

COPD Initial Therapy

COPD with eosinophilic phenotype — Initial Authorization

COPD initial criteria: (1) Diagnosis of COPD; (2) Medical records documenting post-bronchodilator FEV1/FVC <0.7, post-bronchodilator FEV1 % predicted ≥30% and ≤70%, and baseline peripheral blood eosinophils ≥300 cells/μL; (3) Uncontrolled COPD demonstrated by either: ≥2 exacerbations in prior year requiring systemic corticosteroids/antibiotics OR ≥1 exacerbation resulting in hospitalization/observation >24 hours; (4) Exacerbations occurred while on maintenance therapy (triple LAMA+LABA+ICS OR dual LAMA+LABA with failure/contraindication/intolerance to ICS); (5) Symptoms of chronic productive cough ≥3 months in past year; (6) Dupixent used as add-on maintenance with listed inhaled therapies; (7) Patient not receiving Dupixent in combination with anti-IL-5, anti-IgE, or TSLP inhibitor for same indication; (8) Prescribed by allergist, immunologist, or pulmonologist.FEV1/FVC<0.7; FEV1% 30-70; eos>=300/µL

All conditions must be met

COPD Reauthorization

COPD — Reauthorization

COPD reauth criteria: (1) Documentation of positive clinical response to Dupixent demonstrated by at least one: reduction in exacerbation frequency; increase in percent predicted FEV1; reduction in COPD symptom severity/frequency; or reduction in oral corticosteroid requirements; (2) Dupixent is being used as add-on maintenance with specified inhaled therapy; (3) Patient not receiving Dupixent in combination with anti-IL-5, anti-IgE, or TSLP inhibitor for same indication; (4) Prescribed by an allergist, immunologist, or pulmonologist.

Authorization will be issued for 12 months.

Urticaria Initial Therapy

Chronic Spontaneous Urticaria — Initial Authorization

Urticaria initial criteria: (1) Diagnosis of chronic spontaneous urticaria; (2) Either: remains symptomatic despite at least a 2-week trial of two H1-antihistamines OR remains symptomatic despite at least a 2-week trial of combination regimens including a second-generation H1-antihistamine plus another agent (another second-generation H1, a first-generation H1, an H2-antihistamine, or a leukotriene modifier); (3) Patient is not receiving Dupixent in combination with omalizumab for the same indication; (4) Prescribed by an allergist, dermatologist, or immunologist.2-week antihistamine trials

All conditions must be met

Urticaria Reauthorization

Urticaria — Reauthorization

Urticaria reauth criteria: (1) Documentation of positive clinical response to Dupixent (e.g., reduction in exacerbations, itch severity, hives); (2) Patient not receiving Dupixent in combination with omalizumab for the same indication; (3) Prescribed by an allergist, dermatologist, or immunologist.

All conditions must be met

Bullous Pemphigoid Initial Therapy

Bullous Pemphigoid — Initial Authorization

Bullous pemphigoid initial criteria: (1) Diagnosis of bullous pemphigoid; (2) Prescribed by a dermatologist, allergist, or immunologist.

Both conditions required

Bullous Pemphigoid Reauthorization

Bullous Pemphigoid — Reauthorization

Bullous pemphigoid reauth criteria: (1) Documentation of positive clinical response to Dupixent; (2) Prescribed by a dermatologist, allergist, or immunologist.

Both conditions required; authorization will be issued for 12 months.

Reauthorization

Covered for reauthorization when ALL of the following are met

Reauthorization criteria: (1) Documentation of positive clinical response to Dupixent therapy; AND (2) Prescribed by a dermatologist, allergist, or immunologist.

Authorization issued for 12 months; for CT, KY, and MS business a 30-day trial requirement may apply in certain cases.

Dupixent (dupilumab) has a specific limitation of use: it is not indicated for relief of acute bronchospasm or status asthmaticus and is not indicated for other forms of urticaria. Requests for Dupixent solely to treat acute bronchospastic events or non‑specified urticarias should be denied as they fall outside the approved and covered indications.

Dupixent will not be approved when used concurrently with certain other biologic immunomodulators or JAK inhibitors for the same indication. Examples explicitly listed in the policy include: anti‑interleukin‑5 agents (e.g., mepolizumab, benralizumab, reslizumab), anti‑IgE therapy (omalizumab/Xolair), and TSLP inhibitor (tezepelumab/Tezspire), as well as other named biologic immunomodulators (e.g., tralokinumab, nemolizumab) and JAK inhibitors (e.g., upadacitinib/Rinvoq, tofacitinib/Xeljanz, abrocitinib/Cibinqo). Concurrent use with these agents for the same treated condition precludes approval and must be documented as not occurring for initial or reauthorization requests.

Coverage decisions for Dupixent are subject to external requirements and plan‑specific terms. State mandates, federal regulatory requirements, and the member's benefit plan may affect coverage determinations, and other policies or utilization management programs may also apply. For Connecticut, Kentucky, and Mississippi business a 30‑day trial requirement is specified in certain cases. Providers should verify member benefits and applicable mandates when submitting authorization requests.

Key Coding and Diagnostic Thresholds

Peripheral blood eosinophil level for asthma

Peripheral blood eosinophil threshold (asthma)≥ 150 cells/μL

ContextDefines eosinophilic asthma phenotype for Dupixent eligibility when submitted as baseline (pre-dupilumab) peripheral blood value.

Required documentationSubmission of medical records (chart notes, laboratory values) documenting the baseline eosinophil count.

Eosinophilic esophagitis histologic threshold

EoE histologic thresholdPeak ≥15 intraepithelial eosinophils per high power field (or 60 eosinophils per mm2)

Clinical significanceRequired to support a diagnosis of eosinophilic esophagitis for Dupixent initial authorization.

Required Provider Actions and Documentation

Prior Authorization

Prior authorization required; concurrent therapy exclusion

Prior authorization is required and will be granted only when indication-specific diagnostic criteria, prior-therapy trials, prescriber-type requirements, and documentation requirements are met. Providers must NOT co-administer Dupixent with listed biologics or JAK inhibitors for the same indication; this concurrent-therapy exclusion applies at initial authorization and reauthorization.

Concurrent therapy exclusion applies across indications (examples below).
Concurrent biologics include but are not limited to: Adbry (tralokinumab), Nucala (mepolizumab), Cinqair (reslizumab), Fasenra (benralizumab), Xolair (omalizumab), Tezspire (tezepelumab).
Concurrent JAK inhibitors include examples such as Rinvoq (upadacitinib), Xeljanz (tofacitinib), Cibinqo (abrocitinib), topical ruxolitinib (Opzelura).

Documentation Required

EoE diagnostic documentation and required supporting records

For eosinophilic esophagitis (EoE) initial authorization, submit medical records documenting esophageal biopsy showing eosinophil‑predominant inflammation with a peak ≥15 intraepithelial eosinophils per high power field (HPF) or ≥60 eosinophils/mm2, and documentation that secondary causes of esophageal eosinophilia have been ruled out. Also provide records showing symptoms of esophageal dysfunction (e.g., dysphagia, food impaction) and that mucosal eosinophilia persisted after an adequate trial (typically 8 weeks) of at least one of: a proton pump inhibitor or topical (esophageal) corticosteroid.

Background and Scope

Dupixent (dupilumab) is an interleukin‑4 receptor alpha antagonist indicated for multiple type‑2 inflammatory conditions as add‑on maintenance or primary therapy per FDA labeling. Covered indications addressed in this policy include moderate‑to‑severe atopic dermatitis, certain phenotypes of moderate‑to‑severe asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, selected cases of chronic spontaneous urticaria, bullous pemphigoid, and COPD with an eosinophilic phenotype. Note that Dupixent is not for acute bronchospasm or status asthmaticus and is not indicated for other non‑specified forms of urticaria; EoE diagnoses require esophageal biopsy documentation showing a peak of ≥15 intraepithelial eosinophils per high‑power field and other indication‑specific diagnostic and prior‑therapy requirements must be met before authorization.

Definitions and Reference Tables

Dupixent (dupilumab)

Drug class and mechanismDupixent is an interleukin-4 receptor alpha antagonist (dupilumab).

Indications summaryIndicated as specified add-on maintenance or primary therapy for atopic dermatitis, asthma (eosinophilic or OCS-dependent), CRSwNP, EoE, prurigo nodularis, COPD with eosinophilic phenotype, CSU, and bullous pemphigoid.

Limitation of useNot indicated for relief of acute bronchospasm or status asthmaticus and not indicated for other forms of urticaria.

EoE histologic threshold

EoE diagnostic thresholdEosinophilic esophagitis is supported by esophageal biopsy with peak ≥15 intraepithelial eosinophils per high power field (or 60 eosinophils per mm2).

Associated requirementsSecondary causes must be ruled out; mucosal eosinophilia isolated to the esophagus; symptoms persisted after an 8‑week PPI or topical steroid trial.

Initial Therapy - General and Condition-Specific

Initial Therapy Criteria

Initial therapy criteria are indication-specific and require meeting all listed items per condition.

See indication-specific initial nodes: Refer to the condition-specific initial authorization criteria captured above (e.g., Atopic Dermatitis, Asthma, CRSwNP, EoE).

All listed conditions per indication must be met.

Initial authorization general

Initial authorization criteria vary by indication and require diagnosis confirmation, prior therapy trials or failure, exclusion of specified concurrent biologics/JAK inhibitors, and prescriber specialty.

Diagnostic and prior therapy requirements: Refer to the condition-specific initial authorization nodes for exact diagnostic criteria, required prior therapy trials (e.g., two topical classes for atopic dermatitis; 8-week PPI or topical steroid for EoE), and documentation requirements.

All listed items per indication must be satisfied.

Reauthorization and Continuation Criteria

Continuation/Restart Criteria

Reauthorization requires documentation of positive clinical response and continuation of background controller therapy as applicable.

Atopic dermatitis continuation: Documentation of positive clinical response; no concurrent biologic/JAK for same indication; prescriber specialty required.

Authorization = 12 months.

Asthma continuation: Clinical response by listed measures; continued ICS-containing maintenance therapy; no concurrent specified biologics; prescriber specialty required.

Authorization = 12 months.

CRSwNP continuation: Clinical response; continued intranasal corticosteroids; no concurrent specified biologics; prescriber specialty required.

Authorization = 12 months.

Step Therapy and Prior Trials

Prior therapy / documentation requirement
Document trials of required prior therapies (drug name, dates of trial, or documented contraindication/intolerance)

Required trial	Duration / notes
At least a 2-week trial of a single H1-antihistamine (e.g., fexofenadine, loratadine, cetirizine) or history of contraindication/intolerance	Document symptomatic persistence after the 2‑week trial or documented intolerance/contraindication

Topical agent	Prior authorization requirement / note
Elidel (pimecrolimus)	Requires prior authorization
Protopic (tacrolimus) ointment	Requires prior authorization
Eucrisa (crisaborole)	Requires prior authorization

Policy Revision History

as of document effective 2025-11-01reference_tables_includedLatest

Topical corticosteroid relative potencies and inhaled corticosteroid low/medium/high daily dosing tables are provided as reference (Table 1 and Table 2) for management of atopic dermatitis and asthma.

OpenPayer

Dupixent (dupilumab) prior authorization and medical necessity

Coverage Criteria by Indication

Key Coding and Diagnostic Thresholds

Required Provider Actions and Documentation

Background and Scope

Definitions and Reference Tables

Initial Therapy - General and Condition-Specific

Reauthorization and Continuation Criteria

Step Therapy and Prior Trials

Policy Revision History