Dupixent (dupilumab) prior authorization and medical necessity
Defines UnitedHealthcare prior authorization and medical necessity criteria for Dupixent (dupilumab) for multiple indications (atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, and others) and specifies prescriber types, combination therapy exclusions, and authorization durations for affected members and providers.
Policy Summary
PayerUnitedHealthcare
PolicyDupixent (dupilumab) prior authorization and medical necessity
Key ActionPrior authorization requires meeting indication-specific diagnostic and therapeutic trial criteria and documentation of positive clinical response for reauthorization.
Added criteria to include new indication for chronic spontaneous urticaria.
Added criteria to include new indication for chronic obstructive pulmonary disorder.
Increased authorizations for eosinophilic esophagitis to 12 months.
Clarified topical steroid potency in atopic dermatitis with no change to clinical intent or coverage criteria.
12 monthsstandard authorization duration for chronic indications
≥15 eos/HPFEoE histologic threshold
≥150 cells/μLAsthma eosinophil threshold
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Not for acute bronchospasm
Limitation of use
Specialists listedPrescriber specialties required
multipleIndication additions (2017–2025)
Coverage Criteria by Indication
inv-01: Initial Therapy - Atopic Dermatitis — Covered when ALL of the following are met
Covered when ALL of the following are met
Atopic dermatitis initial: (1) Diagnosis of moderate-to-severe chronic atopic dermatitis.
Topical therapy trials: (2) History of failure, contraindication, or intolerance to two of the following therapeutic classes (document drug, date of trial, and/or contraindication): medium/high/very-high potency topical corticosteroid; topical calcineurin inhibitor; crisaborole (Eucrisa).2 classes
No combination therapy: (3) Patient is not receiving Dupixent in combination with a biologic immunomodulator (e.g., tralokinumab) or a Janus kinase inhibitor (e.g., upadacitinib, tofacitinib, topical ruxolitinib, abrocitinib) for the same indication.
Prescriber specialty: (4) Prescribed by one of the following: dermatologist, allergist, or immunologist.
inv-02: Reauthorization - Atopic Dermatitis — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
Clinical response: (1) Documentation of positive clinical response to Dupixent therapy.
No combination therapy: (2) Patient is not receiving Dupixent in combination with a biologic immunomodulator (e.g., tralokinumab) or a Janus kinase inhibitor (e.g., upadacitinib, tofacitinib, topical ruxolitinib, abrocitinib) for the same indication.
Prescriber specialty: (3) Prescribed by one of the following: dermatologist, allergist, or immunologist.
Authorization will be issued for 12 months.
inv-03: Initial Therapy - Asthma — Covered when ALL of the following are met
Covered when ALL of the following are met
Diagnosis: (1) Diagnosis of moderate-to-severe asthma.
Uncontrolled asthma features: (2) At least one of the following uncontrolled/inadequately controlled features: poor symptom control (ACQ>1.5 or ACT<20); ≥2 systemic corticosteroid bursts (≥3 days each) in prior 12 months; asthma-related emergency treatment or hospitalization; airflow limitation with FEV1 <80% predicted (with reduced FEV1/FVC); or current dependence on oral corticosteroids.
Phenotype or steroid dependence: (3) One of the following: documentation that asthma is an eosinophilic phenotype with baseline peripheral blood eosinophils ≥150 cells/μL (pre-dupilumab) OR patient is currently dependent on oral corticosteroids for asthma.>=150 cells/μL
Concomitant controller:
inv-04: Reauthorization - Asthma — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
Clinical response: (1) Documentation of positive clinical response to Dupixent therapy as demonstrated by at least one: reduction in exacerbation frequency; decreased rescue medication use; increase in percent predicted FEV1 from baseline; reduction in severity/frequency of asthma symptoms; or reduction in oral corticosteroid requirements.
Concomitant ICS: (2) Dupixent is being used in combination with an ICS-containing maintenance medication.
No combination with certain biologics: (3) Patient is not receiving Dupixent in combination with anti‑IL‑5 therapy, anti‑IgE therapy, or a TSLP inhibitor for the same indication.
Authorization will be issued for 12 months.
Prescriber specialty:
inv-05: Initial Therapy - CRSwNP — Covered when ALL of the following are met
Covered when ALL of the following are met
Diagnosis and symptoms: (1) Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) with two or more symptoms for >12 weeks: nasal mucopurulent discharge; nasal obstruction/ congestion; facial pain/pressure/fullness; or reduction/loss of smell.
Objective findings: (2) One of the following endoscopy or CT findings: purulent mucus or edema in middle meatus/ethmoid; nasal polyps; or radiographic mucosal thickening/partial or complete opacification of paranasal sinuses.
Polyp history: (3) Either presence of bilateral nasal polyposis OR prior bilateral nasal polyp removal.
Prior surgery or steroids or medical trials: (4) One of the following: prior sinus surgery; systemic corticosteroids for CRSwNP in previous 2 years; or inability to obtain relief after trial of two classes (e.g., nasal saline irrigations, intranasal corticosteroids, antileukotrienes).
inv-06: Reauthorization - CRSwNP — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
Clinical response: (1) Documentation of positive clinical response to Dupixent therapy.
Concomitant intranasal steroid: (2) Continued use as add-on maintenance therapy in combination with intranasal corticosteroids.
No combination with certain biologics: (3) Patient is not receiving Dupixent in combination with anti‑IL‑5, anti‑IgE, or TSLP inhibitor for the same indication.
Authorization will be issued for 12 months.
Prescriber specialty: (4) Prescribed by one of the following: allergist, immunologist, otolaryngologist, or pulmonologist.
inv-07: Initial Therapy - Eosinophilic Esophagitis — Covered when ALL of the following are met
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).
Biopsy confirmation: (3) Submission of medical records documenting eosinophil‑predominant inflammation on esophageal biopsy with peak value ≥15 intraepithelial eosinophils per HPF (or 60 eos/mm2).>=15 eos/HPF
Rule out secondary causes: (4) Secondary causes of esophageal eosinophilia have been ruled out.
inv-08: Reauthorization - Eosinophilic Esophagitis — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
Clinical or objective response: (1) Documentation of positive clinical response to Dupixent therapy 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).
inv-09: Eosinophilic Esophagitis - Initial Authorization — Covered when ALL of the following are met
Covered when ALL of the following are met
ALL of the following
diagnosis: Diagnosis of eosinophilic esophagitis
symptoms: Patient is experiencing symptoms related to esophageal dysfunction (e.g., dysphagia, food impaction, chest pain, refractory heartburn, upper abdominal pain)
histology: Submission of medical records documenting eosinophil‑predominant inflammation on esophageal biopsy with peak value >=15 eos/HPF (or 60 eos/mm2)>=15 eos/HPF
secondary_causes:
inv-10: Eosinophilic Esophagitis - Reauthorization — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
ALL of the following
clinical_response: Documentation of positive clinical response to Dupixent evidenced by improvement in symptoms, histologic measures, or endoscopic measures
Examples: dysphagia improvement, decreased eosinophil count, improvement in edema/furrows/rings
no_concurrent_biologics: Patient is not receiving Dupixent in combination with anti‑IL‑5, anti‑IgE, or TSLP inhibitor therapies for same indication
prescriber: Prescribed by or in consultation with a gastroenterologist or allergist
Authorization issued for 12 months
inv-11: Prurigo Nodularis - Initial Authorization — Covered when ALL of the following are met
Covered when ALL of the following are met
ALL of the following
diagnosis: Diagnosis of prurigo nodularis
lesion_count: Patient has >=20 nodular lesions>=20 nodules
prior_treatment: History of failure, contraindication, or intolerance to previous prurigo nodularis treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical capsaicin).
no_concurrent_therapies:
inv-12: Prurigo Nodularis - Reauthorization — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
ALL of the following
clinical_response: Documentation of positive clinical response to Dupixent therapy
no_concurrent_therapies: Patient is not receiving Dupixent in combination with specified biologic immunomodulators or JAK inhibitors for the same indication
prescriber: Prescribed by one of the following: dermatologist, allergist, or immunologist
Authorization for 12 months
inv-13: COPD with Eosinophilic Phenotype - Initial Authorization — Covered when ALL of the following are met
Covered when ALL of the following are met
ALL of the following
diagnosis: Diagnosis of COPD
spirometry: Post‑bronchodilator FEV1/FVC < 0.7 and post‑bronchodilator FEV1 % predicted between 30% and 70%.FEV1/FVC < 0.7; FEV1% 30-70
inv-14: COPD with Eosinophilic Phenotype - Reauthorization — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
ALL of the following
clinical_response: Documentation of positive clinical response to Dupixent (e.g., reduced exacerbations, increased percent predicted FEV1, reduced symptoms, or reduced oral corticosteroid needs).
background_therapy: Dupixent continues as add‑on maintenance with appropriate LAMA/LABA/ICS or LAMA+LABA therapy.
no_concurrent_biologics: Patient is not receiving Dupixent in combination with anti‑IL‑5, anti‑IgE, or TSLP inhibitor therapies for the same indication
prescriber:
inv-15: Chronic Spontaneous Urticaria - Initial Authorization — Covered when ALL of the following are met
Covered when ALL of the following are met
ALL of the following
diagnosis: Diagnosis of chronic spontaneous urticaria
prior_antihistamine_trials: Patient remains symptomatic despite at least a 2‑week trial of (or has contraindication/intolerance to) two H1‑antihistamines OR remains symptomatic despite a 2‑week trial of specified combination antihistamine strategies as described (e.g., escalation to combination second‑generation H1s, first‑generation H1, H2 antagonist, or leukotriene modifier).
Includes examples: fexofenadine, diphenhydramine, loratadine, cetirizine; famotidine; montelukast
no_concurrent_omalizumab: Patient is not receiving Dupixent in combination with Xolair (omalizumab) for the same indication.
inv-16: Chronic Spontaneous Urticaria - Reauthorization — Reauthorization covered when ALL of the following are met
Reauthorization covered when ALL of the following are met
ALL of the following
clinical_response: Documentation of positive clinical response to Dupixent (e.g., reduction in exacerbations, itch severity, hives).
no_concurrent_omalizumab: Patient is not receiving Dupixent in combination with Xolair (omalizumab) for the same indication.
prescriber: Prescribed by one of the following: allergist, dermatologist, or immunologist
inv-17: Bullous Pemphigoid - Initial Authorization — Covered when BOTH of the following are met
Covered when BOTH of the following are met
ALL of the following
diagnosis: Diagnosis of bullous pemphigoid
prescriber: Prescribed by one of the following: dermatologist, allergist, or immunologist
inv-18: Bullous Pemphigoid - Reauthorization — Reauthorization covered when BOTH of the following are met
Reauthorization covered when BOTH of the following are met
ALL of the following
clinical_response: Documentation of positive clinical response to Dupixent therapy
prescriber: Prescribed by one of the following: dermatologist, allergist, or immunologist
inv-19: Reauthorization — Reauthorization — Covered when ALL of the following are met
Reauthorization — Covered when ALL of the following are met
Reauthorization requirements: (1) Documentation of positive clinical response to Dupixent therapy AND (2) Dupixent is prescribed by a dermatologist, allergist, or immunologist.
Authorization will be issued for 12 months; state mandates and member‑specific benefit plans may modify coverage. For CT, KY, and MS business a 30‑day trial will be required.
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 coverage where the indication is acute bronchospasm, status asthmaticus, or non‑chronic/other urticaria should be evaluated against this exclusion and may be denied when the request is for one of these uses.
Concurrent use of Dupixent with other biologic or targeted immunomodulatory therapies for the same indication is prohibited. Examples called out in the policy include anti‑interleukin‑5 agents (e.g., reslizumab, benralizumab, mepolizumab), anti‑IgE therapy (e.g., omalizumab/Xolair), and thymic stromal lymphopoietin (TSLP) inhibitors (e.g., tezepelumab). Similar combination prohibitions are applied across indications such as COPD, chronic spontaneous urticaria, CRSwNP, prurigo nodularis, eosinophilic esophagitis, asthma, and bullous pemphigoid and are required to be absent for approval and reauthorization.
The policy language and reference list have been updated to clarify the list of agents not to be used in combination with Dupixent across indications. The program references revisions to the combination‑therapy restrictions and removal/clarification of prior bypass provisions; the full policy sections and references should be consulted for the specific agents and indication‑level details.
Apply indication-specific criteria: See the indication‑specific initial authorization criteria for atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, and other covered diagnoses; each requires diagnosis confirmation, relevant objective testing or biopsy where specified, required prior therapy trials when applicable, and prescriber specialty.
Reauthorization and Continuation Criteria
inv-48: Continuation/Reauthorization — Reauthorization requires documentation of positive clinical response and continued use with indicated concomitant therapies; authorizations noted.
Reauthorization requires documentation of positive clinical response and continued use with indicated concomitant therapies; authorizations noted.
Clinical response: Documentation of positive clinical response to Dupixent as specified per indication (see indication‑specific reauthorization criteria).
Authorization issued for 12 months in multiple indications.
Continuation therapy: Documentation of positive clinical response required for reauthorization; reauthorization period typically 12 months (except where state mandates specify otherwise).
For Connecticut, Kentucky and Mississippi business only a 30‑day trial will be required.
Prior authorization is required for initiation and reauthorization of therapy. Authorization will be issued for 12 months. Provider must submit documentation supporting the diagnosis and prior therapy trials; requests that lack a documented diagnosis and required prior therapy information may be denied or returned for additional information.
Authorization period: 12 months (state mandates and member benefit plan may affect coverage).
Requests missing documented diagnosis or lacking documentation of required prior therapy trials (drug name, dates, reason for failure/intolerance/contraindication) may be denied or returned for more information.
Documentation Required
Required prior topical or medical therapy trials
For atopic dermatitis and other relevant indications, approval requires documentation of failure, contraindication, or intolerance to two topical therapy classes. Document drug name(s), trial dates, and reason for failure/intolerance/contraindication.
Provider Requirements, Documentation, and Denial Triggers
Prior authorization will only be approved when the request meets the indication‑specific diagnostic and therapeutic trial criteria outlined in the coverage criteria (e.g., atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis).
Refer to the indication sections for required documentation, prior therapy trials, and prescriber specialty.
Prior Authorization
PA requires diagnostic thresholds, prior trials, prescriber specialty, and no disallowed combinations
Prior authorization requires meeting diagnosis‑specific criteria including required diagnostic thresholds, documentation of prior therapy trials or failures where specified, appropriate prescriber specialty, and absence of disallowed concurrent biologic/targeted therapies.
Examples: eosinophil thresholds for EoE, blood eosinophils for asthma/COPD, lesion counts for prurigo nodularis, and antihistamine trial documentation for urticaria.
Patient must not be receiving disallowed concurrent biologic/targeted therapies for the same indication.
Key Clinical Thresholds and Code-Adjacent Values
Eosinophils on esophageal biopsy — threshold
ThresholdPeak ≥15 intraepithelial eosinophils per high power field (HPF) (or 60 eosinophils/mm2)
ContextRequired for biopsy confirmation of eosinophilic esophagitis in initial authorization.
DocumentationSubmission of medical records (chart notes, pathology) documenting the peak value on esophageal biopsy.
UseDefines eosinophilic asthma phenotype for Dupixent initial authorization when documented in records.
Quick Action Callouts
Note
Intake checklist: verify PA, diagnosis, prior trials, prescriber specialty, and no disallowed combos
For intake staff: verify that prior authorization is requested and that the submission includes indication‑specific diagnostic documentation, required prior therapy trial documentation, prescriber specialty, and absence of prohibited concurrent biologic/targeted therapies.
Check that topical trial details (drug and dates), biopsy reports, spirometry, and eosinophil counts are attached when applicable.
If documentation is incomplete, the request is at risk for denial or delay.
Note
Authorization duration and reauthorization documentation (condensed)
Condensed: authorizations are typically issued for 12 months; reauthorization requires documentation of positive clinical response appropriate to the indication.
State mandates and member benefit plans may modify duration; CT, KY, and MS business may require a 30‑day trial instead of standard requirements.
Background and Drug Information
Background: Dupixent (dupilumab) is an interleukin‑4 receptor alpha antagonist approved for multiple type‑2 inflammatory conditions including moderate‑to‑severe atopic dermatitis, certain eosinophilic asthma phenotypes and oral corticosteroid–dependent asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis, prurigo nodularis, COPD with an eosinophilic phenotype, chronic spontaneous urticaria, and bullous pemphigoid. The policy specifies indication‑specific diagnostic thresholds (for example, an esophageal biopsy showing a peak of ≥15 intraepithelial eosinophils per HPF for eosinophilic esophagitis), required prior therapy trials, prescriber specialty requirements, and that Dupixent is not indicated for acute bronchospasm or status asthmaticus. Program changes noted in the references include additions of indications over time and updates to authorization periods and combination‑therapy guidance.
Definitions and Phenotype Criteria
Dupixent (dupilumab) — drug class
Drug classInterleukin-4 receptor alpha antagonist
AgentDupixent (dupilumab)
MechanismMonoclonal antibody targeting IL-4Rα to inhibit IL-4/IL-13 signaling in type 2 inflammation.
Eosinophilic asthma phenotype — definition
DefinitionEosinophilic asthma phenotype defined by baseline peripheral blood eosinophils ≥150 cells/μL or dependence on oral corticosteroids for asthma.
DocumentationSubmission of medical records documenting baseline (pre-dupilumab) peripheral blood eosinophil level ≥150 cells/μL or chart notes showing oral corticosteroid dependence.
Policy Revision History
2025-06-01update
Added criteria to include new indication for chronic spontaneous urticaria and updated approval duration for prurigo nodularis; updated coverage criteria for concomitant use and added Nemluvuo to example biologic list.
2025-11-01updateLatest
Increased authorizations for eosinophilic esophagitis to 12 months and referenced in program change log (effective date of document).
2025-03-01
Policy Summary
PayerUnitedHealthcare
PolicyDupixent (dupilumab) prior authorization and medical necessity
Key ActionPrior authorization requires meeting indication-specific diagnostic and therapeutic trial criteria and documentation of positive clinical response for reauthorization.
(4) Dupixent will be used in combination with either a maximally dosed ICS/LABA combination or an appropriately dosed ICS plus an additional controller medication.
Examples: Advair/AirDuo, Symbicort, Breo; or ICS plus LABA/leukotriene modifier/theophylline
No combination with certain biologics: (5) Patient is not receiving Dupixent in combination with anti‑IL‑5 therapy, anti‑IgE therapy, or a TSLP inhibitor for the same indication (e.g., mepolizumab, reslizumab, benralizumab, omalizumab, tezepelumab).
Prescriber specialty: (6) Prescribed by one of the following: allergist, immunologist, or pulmonologist.
(4) Prescribed by one of the following: allergist, immunologist, or pulmonologist.
2 classes
Concomitant intranasal steroid: (5) Dupixent will be used as add-on maintenance therapy in combination with intranasal corticosteroids.
Examples: fluticasone, mometasone, triamcinolone
No combination with certain biologics: (6) Patient is not receiving Dupixent in combination with anti‑IL‑5, anti‑IgE, or TSLP inhibitor for the same indication.
Prescriber specialty: (7) Prescribed by one of the following: allergist, immunologist, otolaryngologist, or pulmonologist.
Authorization will be issued for 12 months.
Prior therapy: (5) Mucosal eosinophilia isolated to the esophagus and symptoms persisted after an 8‑week trial of at least one: proton pump inhibitor (e.g., pantoprazole, omeprazole) or topical (esophageal) corticosteroid (e.g., budesonide, fluticasone).8 weeks
No combination with certain biologics: (6) Patient is not receiving Dupixent in combination with anti‑IL‑5, anti‑IgE, or TSLP inhibitor for the same indication.
Prescriber specialty: (7) Prescribed by one of the following: gastroenterologist or allergist.
Secondary causes of esophageal eosinophilia have been ruled out
prior_trials: Symptoms have persisted after an 8‑week trial of at least one: proton pump inhibitor or topical esophageal corticosteroid8 weeks
prescriber: Prescribed by a gastroenterologist or allergist
Patient is not receiving Dupixent in combination with specified biologic immunomodulators or JAK inhibitors for the same indication (e.g., tralokinumab, nemolizumab, upadacitinib, tofacitinib, abrocitinib).
prescriber: Prescribed by one of the following: dermatologist, allergist, or immunologist
Authorization for 12 months
exacerbation_history:
Uncontrolled COPD with either ≥2 exacerbations in previous year requiring systemic corticosteroids/antibiotics or ≥1 exacerbation resulting in hospitalization in past year.
symptom_duration: Symptoms of chronic productive cough for at least 3 months in the past year.>=3 months
background_therapy: Dupixent to be used as add‑on maintenance with triple LAMA/LABA/ICS therapy or dual LAMA+LABA when ICS contraindicated/intolerant.
Examples: Breztri, Trelegy, Anoro
no_concurrent_biologics: Patient is not receiving Dupixent in combination with anti‑IL‑5, anti‑IgE, or TSLP inhibitor therapies for the same indication
prescriber: Prescribed by one of the following: allergist, immunologist, or pulmonologist
Prescribed by one of the following: allergist, immunologist, or pulmonologist
Authorization issued for 12 months
prescriber: Prescribed by one of the following: allergist, dermatologist, or immunologist
Step therapy examples and specific escalation requirements that must be documented prior to approval for certain indications.
Chronic spontaneous urticaria (prior to Dupixent): Trial of H1-antihistamines required — either:
• At least two separate H1-antihistamine trials (at least 2 weeks each) with continued symptoms despite therapy; OR
• Escalation to combination regimens: a second-generation H1-antihistamine plus one of the following taken in combination — a different second-generation H1-antihistamine, a first-generation H1-antihistamine, an H2-antihistamine, or a leukotriene modifier (e.g., montelukast).
Document dates, doses, and reason for failure/intolerance/contraindication.
Note
Alternative therapies and PA for topical agents
Alternative therapies and prior authorization for topical agents: certain topical agents used as required prior therapies have their own prior authorization requirements.
Elidel (pimecrolimus), Protopic (tacrolimus ointment), and Eucrisa (crisaborole) are considered alternative topical therapies but themselves require prior authorization when used.
For eosinophilic esophagitis, medical management trials (PPI for 8 weeks or topical esophageal corticosteroids) must be documented prior to approval.
State-specific variation: for Connecticut, Kentucky, and Mississippi business a 30-day trial is acceptable for the specified topical/alternative therapies where noted.
Prior Authorization
Authorization and reauthorization period and requirements
Prior authorization is required for Dupixent; reauthorization requires documentation of positive clinical response and authorizations are typically issued for 12 months (state mandates and plan variations may apply).
For Connecticut, Kentucky, and Mississippi business a 30‑day trial requirement may apply instead.
Reauthorization must include documentation of clinical improvement per indication.
Billing Rule
Prior authorization may be required for some prior topical agents
Certain topical agents (Elidel, Protopic/tacrolimus ointment, and Eucrisa) referenced as prior therapy options require prior authorization themselves; tried/failed alternatives are supported by FDA labeling.
If prior trials include Elidel, Protopic (tacrolimus), or Eucrisa, note these agents require prior authorization.
Document that alternative(s) tried/failed are supported by FDA labeling where applicable.
Documentation Required
Document prior topical trials and phenotype measures
Providers must document prior topical therapy trials for atopic dermatitis and relevant objective measures (e.g., baseline peripheral blood eosinophils for asthma phenotype or oral steroid dependence where indicated).
Atopic dermatitis: document drug name, date of trial, and/or contraindication for two topical therapy classes.
Asthma: document baseline peripheral blood eosinophil level (≥150 cells/μL) or oral corticosteroid dependence as applicable.
Documentation Required
EoE and other objective documentation: submit biopsy and chart notes
Submit medical records documenting esophageal biopsy eosinophil counts (peak ≥15 intraepithelial eosinophils per HPF or 60 eos/mm2) for eosinophilic esophagitis and include chart notes documenting prior therapy trials.
EoE: biopsy report must show peak ≥15 eos/HPF (or 60 eos/mm2) and record an 8‑week trial of PPI or topical esophageal corticosteroid.
COPD: include spirometry and blood eosinophil level documentation when applicable.
Note
Reauthorization requires documentation of positive clinical response
Documentation of positive clinical response to Dupixent therapy is required for reauthorization across indications; reauthorization decisions rely on evidence of symptomatic, histologic, or objective improvement as specified per indication.
Examples of acceptable evidence include reduced exacerbation frequency, improved FEV1, decreased rescue medication use, reduced itch/hives, or improved eosinophil counts/endoscopic findings for EoE.
Chart notes should specifically describe the clinical response being used to justify continued therapy.
Requests lacking a documented diagnosis that meets the indication‑specific criteria (for example, moderate‑to‑severe atopic dermatitis; moderate‑to‑severe asthma with uncontrolled features; CRSwNP with required symptom/duration/findings; EoE with biopsy‑confirmed ≥15 eos/HPF) are at risk for denial.
Ensure diagnostic criteria listed in each indication section are explicitly documented in submitted records.
Denial Risk
Triggers for denial: missing trials, concurrent prohibited therapies, or wrong prescriber
Denial may be triggered by missing required diagnostic documentation, failure to document prior therapy trials or failures, lack of positive response documentation on reauthorization, or concurrent use of prohibited biologic/targeted therapies.
Also at risk: prescriptions not written by an approved specialist type for the indication.
Examples of prohibited concurrent therapies include anti‑IL‑5 agents, anti‑IgE (omalizumab), and TSLP inhibitors for the same indication.
Denial Risk
Reauthorization denial risk: no documented positive response or non‑specialist prescriber
Failure to document a positive clinical response to prior Dupixent therapy at reauthorization or failure to have the medication prescribed by an approved specialist may result in denial of continued therapy.
Prescriber specialty requirements vary by indication (e.g., dermatologist for atopic dermatitis; allergist/immunologist or pulmonologist for asthma; gastroenterologist or allergist for EoE).
Authorization is typically issued for 12 months when reauthorized.
Alternate criterion
Or patient is currently dependent on oral corticosteroids for asthma (meets phenotype/steroid-dependence criterion).
DocumentationSubmission of medical records (chart notes, laboratory values) documenting pre-dupilumab eosinophil level.
COPD spirometry — objective thresholds
Spirometry criteriaPost-bronchodilator FEV1/FVC < 0.7 and post-bronchodilator FEV1 % predicted between 30% and 70%
ContextRequired objective documentation for COPD initial authorization along with eosinophil level and exacerbation history.
DocumentationSubmission of medical records (chart notes) documenting post-bronchodilator spirometry values.
Prurigo nodularis lesion count — threshold
Threshold>=20 nodular lesions
IndicationRequired lesion count for initial authorization of Dupixent for prurigo nodularis.
Prior treatmentsHistory of failure, contraindication, or intolerance to prior therapies (e.g., topical corticosteroids, calcineurin inhibitors, capsaicin) required in addition to lesion count.
Use in criteria
Serves as one pathway to meet phenotype/steroid-dependence requirement in initial asthma authorization.
Histologic thresholdPeak ≥15 intraepithelial eosinophils per HPF (or 60 eosinophils per mm2)
ApplicationRequired biopsy confirmation for eosinophilic esophagitis initial authorization.
Related requirementsSecondary causes must be ruled out and symptoms must persist after an 8‑week PPI or topical esophageal steroid trial.
COPD eosinophilic phenotype — definition
DefinitionEosinophilic COPD phenotype defined by baseline peripheral blood eosinophil level ≥300 cells/μL.
UseRequired along with spirometry and exacerbation history for Dupixent initial authorization in COPD.
DocumentationSubmit pre-dupilumab eosinophil laboratory values in medical records to confirm phenotype.
update
Increased authorizations for eosinophilic esophagitis to 12 months as recorded in the program change log.
2025-06-01addition
Added chronic spontaneous urticaria as a covered indication (material change) and updated authorization duration for prurigo nodularis.
2025-11-01additionLatest
Referenced program change log entry adding multiple indication updates (including prior additions) and noting material changes across the policy effective 2025-11-01.