Loading...

mhn Dupilumab coverage update: Prior Auth | OpenPayer

ModifiedmhnPolicy CP.CPA.360

Dupilumab (Dupixent) coverage criteria

Medical necessity and coverage criteria for Dupixent (dupilumab) across FDA‑approved and select off‑label indications for members of Centene-affiliated health plans (commercial line of business).

Policy Summary

Payermhn

PolicyDupilumab (Dupixent) coverage criteria

Policy CodePolicy CP.CPA.360

Change TypeAdded CSU, added BP, revised COPD FEV1 range

Effective DateMar 1, 2025

Next Review Date

Key ActionSubmit prior authorization with indication‑specific documentation and weight/age dosing details; include chart notes and supporting labs.

SourceLink

POLICY UPDATE CHANGES

For COPD, revised postbronchodilator FEV1 requirement from 30-70% to 20-80% to align with Nucala.

Added new indication for chronic spontaneous urticaria (CSU) per updated prescribing information.

Added new indication for bullous pemphigoid (BP) per updated prescribing information and P&T-approved guidance.

For atopic dermatitis (AD), changed topical agent triple step redirection to double step redirection and added immunologist as an option to list of prescriber requirements.

9+FDA‑approved indications listed

6 monthstypical approval duration

CP.CPA.360reference number

Dose ceilings

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Initial Therapy — Atopic Dermatitis

Covered when ALL of the following are met

Atopic Dermatitis Initial: 1. Diagnosis of atopic dermatitis affecting either (a) ≥10% body surface area OR (b) involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas; 2. Prescribed by or in consultation with a dermatologist, allergist, or immunologist; 3. Age ≥ 6 months; 4. Failure of both: (a) one formulary medium to very high potency topical corticosteroid used ≥ 2 weeks; AND (b) one non‑steroidal topical therapy (topical calcineurin inhibitor or Eucrisa) used ≥ 4 weeks unless contraindicated; 5. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 6. Dose does not exceed indication‑specific age/weight dosing as listed in the policy.see node text

Dose table and concurrency exclusion detailed in policy.

Initial Therapy — Asthma

Covered when ALL of the following are met

Asthma Initial: 1. Diagnosis of asthma AND one of the following: (a) absolute blood eosinophil count ≥ 150 cells/mcL within the past 3 months; OR (b) currently receiving maintenance systemic glucocorticoids for ≥ 4 weeks; 2. Prescribed by or in consultation with an allergist, immunologist, or pulmonologist; 3. Age ≥ 6 years; 4. ≥ 2 exacerbations in the last 12 months requiring oral/systemic corticosteroid or urgent care/ER/hospital admission despite adherent controller therapy (medium‑ to high‑dose ICS plus LABA or LTRA if LABA contraindicated); 5. Dupixent is prescribed concurrently with an ICS plus either a LABA or LTRA; 6. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 7. Dose does not exceed indication‑specific limits by age/weight.

Asthma Dose Limits: Initial (one‑time) dose age ≥ 12 years: 600 mg; Maintenance: age ≥ 12 years: 300 mg every other week; age 6–11 years and weight ≥ 30 kg: 200 mg every other week; age 6–11 years and weight 15 to < 30 kg: 300 mg every 4 weeks.see node text

Prescriber specialty and concurrency exclusions apply.

Initial Therapy — CRSwNP

Covered when ALL of the following are met

CRSwNP Initial: 1. Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) with documentation of: (a) nasal polyps; (b) bilateral disease; and (c) signs/symptoms for ≥ 12 weeks; 2. Prescribed by or in consultation with an allergist, immunologist, or otolaryngologist; 3. Age ≥ 12 years; 4. Required systemic corticosteroids for symptom control within the last 2 years unless contraindicated; 5. Failure of maintenance therapy with at least two intranasal corticosteroids, one of which must be Xhance in adults, each used ≥ 4 weeks unless contraindicated; 6. Dupixent prescribed concurrently with an intranasal corticosteroid unless contraindicated; 7. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 8. Dose does not exceed 300 mg every other week.

CRSwNP Dose: Dose ceiling: 300 mg every other week.300 mg q2w

Prescriber specialty and prior intranasal steroid failures required.

Initial Therapy — Eosinophilic Esophagitis

Covered when ALL of the following are met

EoE Initial: 1. Diagnosis of eosinophilic esophagitis confirmed by ≥ 15 eosinophils per high‑power field on endoscopic biopsy; 2. Prescribed by or in consultation with an allergist, immunologist, or gastroenterologist; 3. Age ≥ 1 year; 4. Weight ≥ 15 kg; 5. Member does not have hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis; 6. Failure of one of the following unless contraindicated: proton pump inhibitor OR corticosteroid; 7. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 8. Dose does not exceed weight‑based limits: weight 15 to < 30 kg: 200 mg every other week; weight 30 to < 40 kg: 300 mg every other week; weight ≥ 40 kg: 300 mg every week.

EoE Approval Duration: Approval duration: 6 months.

Initial Therapy — Prurigo Nodularis

Covered when ALL of the following are met

Prurigo Nodularis Initial: 1. Diagnosis of prurigo nodularis with both: (a) numeric rating scale > 7 (0–10) for itch; AND (b) ≥ 20 nodular lesions on both legs and/or both arms and/or trunk; 2. Prescribed by or in consultation with a dermatologist; 3. Age ≥ 18 years; 4. Failure of a ≥ 2‑week course of medium to very high potency topical corticosteroid unless contraindicated; 5. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 6. Dose does not exceed: initial one‑time 600 mg; maintenance 300 mg every other week; Approval duration: 6 months.

Initial Therapy — COPD

Covered when ALL of the following are met

COPD Initial: 1. Diagnosis of COPD evidenced by either: (a) postbronchodilator FEV1/FVC < 0.7; OR (b) postbronchodilator FEV1 ≥ 20% and ≤ 80% predicted; 2. Age ≥ 18 years; 3. Blood eosinophil count ≥ 300 cells/µL; 4. History of ≥ 2 moderate or ≥ 1 severe exacerbations in past 12 months; 5. Failure of triple inhaled therapy (LABA + LAMA + ICS) for ≥ 3 months OR if ICS contraindicated, failure of LABA + LAMA for ≥ 3 months; 6. Provider attestation that member is concomitantly receiving triple or appropriate double therapy; 7. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 8. Dose does not exceed 300 mg every other week.

Initial Therapy — Chronic Spontaneous Urticaria

Covered when ALL of the following are met

CSU Initial: 1. Diagnosis of chronic spontaneous urticaria; 2. Prescribed by or in consultation with a dermatologist, immunologist, or allergist; 3. Age ≥ 12 years; 4. Failure of both: (a) two antihistamines (including one second‑generation) at maximum doses each used ≥ 2 weeks; AND (b) a leukotriene receptor antagonist in combination with an antihistamine at maximum doses ≥ 2 weeks; 5. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 6. Dose does not exceed age/weight‑based limits: adults initial 600 mg then 300 mg q2w; age 12–17 weight ≥ 60 kg initial 600 mg then 300 mg q2w; age 12–17 weight 30 to < 60 kg initial 400 mg then 200 mg q2w.

Initial Therapy — Bullous Pemphigoid

Covered when ALL of the following are met

Bullous Pemphigoid Initial: 1. Diagnosis of bullous pemphigoid confirmed histologically, serologically, or by immunofluorescence; 2. Prescribed by or in consultation with a dermatologist; 3. Age ≥ 18 years; 4. Inadequate response to at least one corticosteroid at up to maximally indicated doses unless contraindicated; 5. Failure of at least one non‑steroidal immunosuppressive agent at up to maximally indicated doses unless contraindicated; 6. Prescribed in combination with a tapering course of oral corticosteroid; 7. Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 8. Dose does not exceed initial 600 mg one‑time and maintenance 300 mg every other week; Approval duration: 6 months.

Initial Therapy — Immunotherapy-related Pruritus (off-label)

Covered when ALL of the following are met

ICI-related Pruritus Initial: 1. Diagnosis of immune checkpoint inhibitor–related toxicity that is either: (a) severe (G3) pruritus; OR (b) bullous dermatitis that is moderate (G2), severe (G3), or life‑threatening (G4); 2. Prescribed by or in consultation with an oncologist; 3. For severe (G3) pruritus, failure to respond to a gabapentinoid after 1 month; 4. For moderate (G2) bullous dermatitis, failure to respond to ≥ 3 days of prednisone or methylprednisolone; 5. Dupixent is not prescribed concurrently with listed biologics (Cinqair, Fasenra, Nucala, Xolair, Tezspire); 6. Dose is within FDA maximum for any approved indication or is supported by practice guidelines/peer‑reviewed literature for the off‑label use (prescriber must submit supporting evidence); 7. Prescribed regimen must be FDA‑approved or recommended by NCCN; Approval duration: 6 months.

Dosing regimens by indication and age/weight

Dosing regimens by indication and age/weight (regimens presented; coverage requires meeting indication and corresponding dosing tier):

Atopic dermatitis (Adults): Initial dose: 600 mg SC followed by 300 mg SC every other week.

Adult regimen per dosing table.

Atopic dermatitis (Adolescents 6-17): Weight 15 to < 30 kg: initial 600 mg then 300 mg every 4 weeks; 30 to < 60 kg: initial 400 mg then 200 mg every other week; ≥ 60 kg: initial 600 mg then 300 mg every other week.weight tiers

Adolescent regimen per dosing table.

Atopic dermatitis (Pediatrics 6 months–5 years): Weight 5 to < 15 kg: 200 mg SC every 4 weeks; weight 15 to < 30 kg: 300 mg SC every 4 weeks.weight tiers

Pediatric regimen per dosing table.

Coverage of Dupixent is limited to the FDA‑approved and selected off‑label indications listed in this policy and requires that all indication‑specific criteria be met, including required prescriber specialty, objective diagnostic thresholds (e.g., ≥10% BSA for atopic dermatitis, ≥15 eos/hpf for eosinophilic esophagitis, or specified blood eosinophil counts for asthma/COPD), prior therapy failures or contraindications, and dosing that does not exceed the indicated age/weight‑based ceilings. Requests must document adherence to step‑therapy and prior treatment requirements where specified (for example, topical corticosteroid and non‑steroidal topical failure for atopic dermatitis, intranasal corticosteroid failures for CRSwNP, PPI or corticosteroid trial for EoE, and inhaled triple therapy for COPD).

Dupixent may not be prescribed concurrently with another biologic immunomodulator or a Janus kinase (JAK) inhibitor across all covered indications; concurrent use is an exclusion that will result in denial. Prior authorization is required and requires submission of supporting clinical documentation (e.g., chart notes, labs, biopsy reports) demonstrating that the member meets the full set of approval criteria for the requested indication, including relevant objective findings and prescriber attestation of concurrent controller therapies where required.

Dupixent is not authorized for relief of acute bronchospasm or status asthmaticus. Requests for use in acute bronchospasm or status asthmaticus should be denied and referred to appropriate acute emergency treatment pathways.

Known hypersensitivity to Dupixent or any of its excipients is a contraindication and will preclude coverage. Documented history of anaphylaxis or other hypersensitivity reactions to Dupixent or its components must be provided and will result in denial.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements or exceptions before submitting authorization requests for Medicaid members.

If the requested use is not listed among the covered diagnoses/indications in this policy and does not meet the criteria in the off‑label use policy, coverage is not authorized under this policy. For uses not reflected here, follow the applicable off‑label or no‑coverage policies (e.g., CP.CPA.09 or CP.CPA.190) and provide sufficient documentation of efficacy and safety per those policies to support any exception requests.

Non‑FDA‑approved indications that are not addressed within this policy are not authorized unless the prescriber submits adequate evidence of efficacy and safety consistent with the off‑label use policy. Off‑label requests must include supporting documentation (peer‑reviewed literature, practice guideline recommendations, or formulary exception rationale) and conform to the plan’s off‑label review process.

Coding

Policy Identifiermixed

CP.CPA.360

Policy reference number

Referenced HCPCS/NDCHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified drugs or biologicals

inv-26: Absolute blood eosinophil count (asthma threshold)

Asthma eosinophil thresholdAbsolute blood eosinophil count ≥ 150 cells/mcL within the past 3 months

Alternative asthma criterionCurrent maintenance systemic glucocorticoid treatment for ≥ 4 weeks (qualifies if present instead of eosinophil threshold)

Prescriber requirement (context)Prescribed by or in consultation with an allergist, immunologist, or pulmonologist

inv-27: COPD eosinophil threshold

COPD eosinophil thresholdBlood eosinophil count ≥ 300 cells/µL

Clinical contextDocumentation of eosinophilic phenotype required as part of COPD coverage criteria

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required — indication-specific criteria and prescriber specification

Prior authorization is required for Dupixent. Provider must submit documentation (e.g., office chart notes, relevant labs, pathology, prior therapy documentation) demonstrating that the member meets the indication‑specific criteria listed in Section I (Initial Approval Criteria) or Section II (Continuation Therapy / Renewal) as applicable. Requests must specify the exact indication being treated and include the prescriber specialty when required by the indication (e.g., dermatology, allergy/immunology, pulmonology, otolaryngology, gastroenterology). Missing or incomplete documentation may result in denial.

Prior authorization required for all indications listed in this policy
Submit supporting documentation: chart notes, labs, biopsy reports, prior treatment records, and documentation of response for renewals
Indication-specific prescriber requirement (see criteria for each diagnosis)

Documentation Required

Prior authorization requirements (per-indication) — documentation for continuity of care and current therapy

Background

Dupilumab is an interleukin‑4 receptor alpha antagonist that inhibits IL‑4 and IL‑13 signaling and is indicated for multiple type‑2 inflammatory conditions. The product is indicated for moderate‑to‑severe atopic dermatitis, asthma with eosinophilic phenotype or oral‑steroid dependence, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, eosinophilic COPD, chronic spontaneous urticaria, and bullous pemphigoid; selected off‑label use for immune checkpoint inhibitor–related pruritus is addressed with specific criteria. Indication‑specific diagnostic thresholds, prescriber specialty, prior therapy requirements, and dosing limits (age/weight tiers and maximum maintenance doses) are detailed in the criteria sections and must be met for coverage.

Definitions

inv-49: EoE definition — biopsy threshold (≥15 eos/hpf)

EoE biopsy definitionEosinophilic esophagitis is confirmed by ≥ 15 intraepithelial eosinophils per high-power field on endoscopic biopsy

Diagnostic confirmation siteRequirement specified as histologic count on endoscopic biopsy

Approval duration contextEoE initial approval duration: 6 months

inv-50: Atopic dermatitis qualifying involvement (≥10% BSA or involvement of special areas)

Atopic dermatitis qualifying involvement≥ 10% body surface area OR involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas

Age thresholdApplies to patients age ≥ 6 months as per initial therapy criteria