ModifiedCentenePolicy CP PHAR.336

Dupilumab (Dupixent) coverage

Defines medical necessity criteria, prior authorization, dosing limits, and continuity/renewal requirements for Dupixent across multiple FDA-approved and select off-label indications for Centene Medicaid lines of business in NC.

Policy Summary

PayerCentene

PolicyDupilumab (Dupixent) coverage

Policy CodePolicy CP PHAR.336

Change TypeMultiple material updates (new indications, criteria revisions, exclusions clarified)

Effective DateJun 1, 2017

Next Review Date

Key ActionPrior authorization required; provider must document that member meets the specific indication-based criteria including diagnosis, prior therapy failures, prescriber specialty, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

Criteria added for new FDA indication of eosinophilic esophagitis (EoE) and pediatric age expansion in atopic dermatitis (AD).

For atopic dermatitis removed oral systemic therapy step criterion per updated guideline and competitor analysis.

Added off-label indication and criteria for immunotherapy-related pruritus per NCCN.

Added newly approved COPD, chronic spontaneous urticaria (CSU), and bullous pemphigoid (BP) indications to criteria.

Modified concurrent-use prohibition to include non-asthma biologic immunomodulators and JAK inhibitors.

9+indications addressed

6–12 moapproval durations

specifieddose caps

hypersensitivity

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multiplerecent additions

Coverage Criteria and Indication-Specific Requirements

Initial Approval — CRSwNP

Initial Approval — Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) — ALL required criteria for initial coverage

ALL of the following

Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) with documentation of all of the following: disease is bilateral; presence of nasal polyps; signs and symptoms (e.g., nasal congestion/obstruction, loss of smell, rhinorrhea) for ≥ 12 weeks.
Prescribed by or in consultation with an allergist, immunologist, or otolaryngologist.
Member has required the use of systemic corticosteroids for symptom control within the last 2 years, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B for examples).
Failure of maintenance therapy with at least two intranasal corticosteroids, each used for ≥ 4 weeks; for adults, one of the tried intranasal corticosteroids must be Xhance, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B for examples).
Dupixent is prescribed concurrently with an intranasal corticosteroid, unless contraindicated or clinically significant adverse effects are experienced.
Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor (examples: Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair, Olumiant, Rinvoq, Cibinqo, Opzelura).
Dose does not exceed 300 mg every other week.
Prescriber attestation or documentation that the above criteria are met.

Prurigo Nodularis — Continuation

Prurigo Nodularis — Continuation Therapy — ALL required criteria for ongoing coverage

ALL of the following

Current authorization or documentation of initial criteria fulfillment for prurigo nodularis (PN).
Prescribed by or in consultation with a dermatologist.
Documented clinical benefit from Dupixent therapy (e.g., reduction in itch score, lesion count, or other objective/validated measure) since initiation of therapy.
Dupixent is not being used concurrently with another biologic immunomodulator or a JAK inhibitor (examples as listed in policy).
Dose does not exceed the approved maintenance regimen: 300 mg every other week following an initial 600 mg dose.

Chronic Obstructive Pulmonary Disease — Continuation

Chronic Obstructive Pulmonary Disease (COPD) — Continuation Therapy — ALL required criteria for ongoing coverage

ALL of the following

Member meets baseline COPD criteria for approval (postbronchodilator FEV1/FVC < 0.7 and postbronchodilator FEV1 ≥ 20% and < 80% predicted; documentation of eosinophilic phenotype with blood eosinophils ≥ 300 cells/µL; age ≥ 18 years; history of ≥ 2 moderate or ≥ 1 severe exacerbations in the past 12 months).
Member is receiving and documented to be adherent to concomitant maintenance inhaled therapy: triple therapy (LABA + LAMA + ICS) or dual LABA + LAMA if ICS is contraindicated; provider attestation required.
Documented clinical benefit from Dupixent since initiation (e.g., reduction in exacerbation frequency, improvement in symptoms, or other objective measures), or other clinical justification for continued therapy.
Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor (examples as listed in policy).

Chronic Spontaneous Urticaria — Continuation

Chronic Spontaneous Urticaria (CSU) — Continuation Therapy — ALL required criteria for ongoing coverage

ALL of the following

Member meets baseline CSU criteria for approval (diagnosis of CSU; age ≥ 12 years; prescribed by or in consultation with a dermatologist, immunologist, or allergist; prior failure of therapies as required by initial criteria including at least two antihistamines and additional adjunctive therapies as specified).
Member has not received anti-IgE (omalizumab) for CSU during the current course of treatment if required by initial-approval pathway, unless clinical justification is provided.
Documented clinical benefit from Dupixent since initiation (e.g., improvement in wheals/angioedema, reduction in itch), or other objective measures demonstrating response to therapy.
Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor (examples as listed in policy).

Bullous Pemphigoid — Continuation

Bullous Pemphigoid (BP) — Continuation Therapy — ALL required criteria for ongoing coverage

ALL of the following

Member meets baseline BP criteria for approval (diagnosis confirmed histologically, serologically, and/or by immunofluorescence; prescribed by or in consultation with a dermatologist; age ≥ 18 years).
Failure of at least one non-steroidal immunosuppressive agent (e.g., azathioprine, mycophenolate mofetil, methotrexate) at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced, or documentation why such agents are not appropriate.
Dupixent is prescribed in combination with a tapering course of oral corticosteroid as indicated by initial-approval guidance, unless contraindicated.
Documented clinical benefit from Dupixent since initiation (e.g., reduction in blistering, improvement in disease control), or other objective evidence supporting continued therapy.

Immunotherapy‑Related Pruritus (off‑label) — Continuation

Immunotherapy‑Related Pruritus (off‑label) — Continuation Therapy — ALL required criteria for ongoing coverage

ALL of the following

Member meets the off‑label initial criteria for immunotherapy-related toxicity (diagnosis of immune checkpoint inhibitor–related toxicity presenting as severe [G3] pruritus or moderate–severe bullous dermatitis per Appendix E) and was prescribed by or in consultation with an oncologist.
For severe (G3) pruritus: documentation that the member has not responded to a gabapentinoid (e.g., gabapentin, pregabalin) after 1 month of therapy prior to initiation, per current NCCN-based criteria; for moderate (G2) bullous dermatitis: documentation that the member has not responded to ≥ 3 days of prednisone or methylprednisolone as specified in initial criteria, unless contraindicated.
Documented clinical benefit from Dupixent since initiation for the immunotherapy-related toxicity (reduction in pruritus severity, improvement in skin findings, or other objective measures), or other justification for continued therapy.
Dupixent is not prescribed concurrently with the specified biologic immunomodulators or Tezspire (see policy).

Other indications

Other indications — coverage routing and off‑label handling

ANY of the following

If the requested indication is addressed by the formulary/PDL coverage criteria for the member's line of business, follow the relevant formulary policy (e.g., CP PMN.255 for Medicaid or the commercial formulary guidance).
If the requested use is for a non‑formulary indication or is not specifically listed in the policy and sufficient documentation of efficacy and safety exists, the request must be evaluated per the off‑label use policy for the relevant line of business (CP.PMN.53 for Medicaid).
If the drug has undergone a recent label change (within the last 6 months) not yet reflected in this policy, follow the referenced update routing guidance in this policy (consult appropriate internal policy references).

Provider Requirements, Prior Authorization, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must obtain prior authorization and document the indication for use and that the member meets all approval criteria before initiating therapy unless continuity of care provisions apply.

Prior authorization required for all indications listed in this policy.
Failure to obtain and submit required documentation may result in denial.

Prior Authorization

Indication- and Dosing-Specific Prior Authorization

Indication- and dosing-specific prior authorization is required. Providers must document the diagnosis, the specific indication being treated, and the age- and weight-based dosing regimen being requested.

Document the exact indication (e.g., atopic dermatitis, CRSwNP, EoE, prurigo nodularis, COPD, CSU, bullous pemphigoid, immunotherapy-related pruritus).
Include pediatric age and weight to support the requested dose and regimen.
Specify product presentation (pre-filled pen or syringe) when relevant.

Billing Codes, Dosing Limits, and Key Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J0597

Injection, dupilumab, 300 mg

Referenced prescribing informationmixed

N/A	Prescribing information reference (Dupixent Prescribing Information, Regeneron Pharmaceuticals, Inc.; FDA label available)

Unclassified drug HCPCS codes referencedHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified drugs or biologicals

inv-30: Blood eosinophil count thresholds for asthma and COPD

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

COPD blood eosinophil thresholdBlood eosinophil count >= 300 cells/uL (eosinophilic phenotype) as required for COPD indication

Unit conversion noteLab results for blood eosinophil counts can be converted into cells/mcL using the provided unit conversion calculator referenced in the policy

inv-31: EoE histology threshold (eosinophils per high-power field)

EoE histology thresholdDiagnosis of EoE confirmed by >= 15 intraepithelial eosinophils per high-power field (eos/hpf) on endoscopic biopsy

Background and Definitions

Background: Dupilumab is an interleukin‑4 receptor alpha and interleukin‑13 antagonist approved for multiple type‑2 inflammatory conditions. Indications addressed in this policy include moderate‑to‑severe atopic dermatitis (pediatric and adult age expansions), asthma with an eosinophilic phenotype, eosinophilic esophagitis (EoE), chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis (PN), chronic spontaneous urticaria (CSU), COPD with eosinophilic phenotype, and bullous pemphigoid (BP). The FDA labeling also specifies that Dupixent is not for relief of acute bronchospasm or status asthmaticus and lists limitations of use that inform the coverage criteria.

inv-55: Definition — Dupilumab as IL-4/IL-13 antagonist

Dupilumab mechanism of actionDupilumab is an interleukin-4 receptor alpha and interleukin-13 antagonist

Indication scopeIndicated for multiple type 2 inflammatory diseases including atopic dermatitis, asthma (eosinophilic phenotype), EoE, CRSwNP, PN, CSU, COPD (eosinophilic phenotype), and BP

Not for acute bronchospasmLimitation of use: Not for the relief of acute bronchospasm or status asthmaticus

Policy Summary

PayerCentene

PolicyDupilumab (Dupixent) coverage

Policy CodePolicy CP PHAR.336

Change TypeMultiple material updates (new indications, criteria revisions, exclusions clarified)

Effective DateJun 1, 2017

Next Review Date

SourceLink

On This Page

Prescriber attestation or documentation supporting continued clinical response and ongoing need for therapy.

Dose does not exceed 300 mg every other week.

Approval duration for continuation up to 6 months, with prescriber documentation required to justify ongoing benefit at each renewal.

Dose does not exceed the approved maintenance regimen per age/weight: generally 300 mg every other week for adults following initial 600 mg dose; pediatric/weight-based maintenance per labeling.

Approval duration for continuation up to 6 months, with documentation of ongoing response required for renewal.

Dupixent is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor (examples as listed in policy).

Dose does not exceed the approved maintenance regimen: 300 mg every other week following an initial 600 mg dose.

Approval duration for continuation up to 6 months; prescriber documentation required at renewal to demonstrate ongoing therapeutic benefit.

Dose is within FDA maximum limits for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use; prescriber must submit supporting evidence for the off‑label continuation.

Approval duration for continuation up to 6 months; prescriber documentation required at renewal to demonstrate ongoing benefit and safety.

Step Therapy

Required Prior Therapeutic Failures / Step Requirements

Prior therapeutic failures and step requirements must be documented where required by indication. Providers must show prior use of required topical/systemic agents or intranasal steroid trials before approval for specified indications.

Atopic dermatitis: failure of two medium-to-very-high potency topical corticosteroids of different molecular identities (each ≥ 2 weeks) AND one non-steroidal topical therapy (e.g., tacrolimus, pimecrolimus, crisaborole) for ≥ 4 weeks unless contraindicated.
CRSwNP: failure of maintenance therapy with at least two intranasal corticosteroids (one Xhance in adults), each used ≥ 4 weeks; requirement reduced from three to two intranasal steroids per policy update.
Prurigo nodularis: failure of a ≥ 2-week course of a medium-to-very-high potency topical corticosteroid unless contraindicated.
Bullous pemphigoid: failure of at least one non-steroidal immunosuppressive agent (e.g., azathioprine, mycophenolate mofetil, methotrexate) at up to maximally indicated doses unless contraindicated.

Step Therapy

Preferred Alternatives / Step Options

Preferred alternatives and step options: refer to the formulary, PDL, and Appendix B for therapeutic alternatives and to the relevant no-coverage or non-formulary policies when the agent is not on the formulary.

If drug is on formulary/PDL, follow no coverage criteria policy CP.PMN.255 (Medicaid) or formulary rules for other lines of business.
If drug is not on formulary, refer to non-formulary policy CP.PMN.16 or off-label policy CP.PMN.53 as applicable.
Appendix B lists preferred topical and systemic alternatives used in step therapy examples.

Documentation Required

Supportive Clinical Documentation Required

Documentation requirement: providers must submit supporting clinical documentation (office notes, labs, imaging, pathology, prior therapy records) to demonstrate that the member meets all approval and continuation criteria.

Include objective measures of response for continuation requests (e.g., reduction in exacerbations, improvement in itch scores, decreased nodule count, improved symptoms).
For biopsy-confirmed diagnoses (e.g., EoE, bullous pemphigoid), submit pathology or serologic reports when required.
Failure to submit adequate documentation may result in denial.

Documentation Required

Supporting Evidence for Off‑Label Dosing

Supporting evidence for off‑label dosing/uses: when requesting dose increases beyond FDA-labeled limits or off‑label indications (e.g., immunotherapy-related pruritus), the prescriber must submit supporting practice guidelines or peer-reviewed literature.

Off‑label requests must reference applicable guidelines (e.g., NCCN) or peer-reviewed studies that justify the dosing and demonstrate efficacy/safety.
If requesting continuation for an off‑label indication, provide documentation of prior benefit and clinical rationale.

Prior Authorization

Continuation / Continuity Documentation and Requirements

Prior authorization requirement — continuity and continuation: for continuation approvals, the member must be currently receiving therapy via the Centene benefit or have previously met initial approval criteria, and documentation must demonstrate continued clinical benefit.

Continuation requests must document that the member is responding positively to therapy (examples: symptom improvement, objective measures).
If enrolled in continuity of care regulations for a state/product, note the applicable addendum and provide documentation per state requirements.
Approval durations are specified by indication (commonly 12 months for many continuations; see indication-specific criteria).

Step Therapy

Step Therapy and Guideline-Aligned Sequencing

Step therapy and guideline-aligned sequencing: placement of dupilumab should align with disease-specific guideline-recommended sequencing (e.g., severe asthma after optimization of high-dose ICS/LABA and other controller therapy; atopic dermatitis after topical steps unless guideline removal applies).

For severe asthma, follow GINA guidance: consider dupilumab for patients ≥ 6 years with exacerbations or poor control despite high-dose ICS/LABA and appropriate eosinophilic biomarkers or need for maintenance oral corticosteroids.
Atopic dermatitis: oral systemic therapy step requirement was removed per updated guideline; continue to require topical steps as specified.
Refer to Appendices and current guideline statements when evaluating step sequencing.

Step Therapy

Intranasal Steroid Trial Modification (CRSwNP)

Intranasal steroid trial modification for CRSwNP: the intranasal corticosteroid trial requirement has been modified to require two intranasal steroids (previously three); document trials of two different intranasal corticosteroids (one Xhance in adults) each used for ≥ 4 weeks unless contraindicated.

Per policy update, require two intranasal steroid trials for CRSwNP maintenance failure documentation.
Ensure documentation specifies duration (≥ 4 weeks each) and any contraindications or adverse events preventing use.

Patient age >= 1 year for EoE indication

Weight minimumWeight >= 15 kg required for EoE dosing categories

inv-32: Maximum dose — dose cap (e.g., does not exceed 300 mg Q2W for specified indications)

Maximum maintenance dose capDose does not exceed 300 mg every other week for specified indications (e.g., COPD, PN, BP continuation limits)

EoE maximum dosing noteFor EoE in patients >= 40 kg dosing may be up to 300 mg weekly per weight-based regimen (EoE-specific exception documented)

Continuation dose increasesIf request is for a dose increase in continuation requests, new dose must not exceed the 300 mg Q2W cap unless supported by indication-specific dosing allowed in policy (e.g., EoE weight-based schedules)

inv-33: CSU dosing by age/weight bands — adult and adolescent dosing examples

CSU adult dosing (≥18 years or weight ≥60 kg)Initial one-time 600 mg then maintenance 300 mg every other week

CSU adolescent dosing (age 12–17; weight 30 to <60 kg)Initial one-time 600 mg then maintenance 200 mg every other week

CSU pediatric/weight notePrescribing should document age and weight to ensure dosing matches the policy's age/weight-based CSU regimen

inv-34: PDC adherence threshold used in continuity/renewal consideration

PDC adherence threshold for continuity/renewalPDC >= 0.8 (equivalent to 144 of the last 180 days) used as the adherence measure for continuity/renewal consideration

PDC definitionPDC is calculated as the sum of days covered in a time frame divided by the number of days in the time frame (policy example uses 180 days)

ImplicationProviders should document adherence (pharmacy fill records) when submitting continuation requests to demonstrate PDC threshold met

inv-35: Postbronchodilator FEV1 percentage threshold referenced for COPD

Postbronchodilator FEV1 thresholdPostbronchodilator FEV1 >= 20% and < 80% of predicted (with postbronchodilator FEV1/FVC ratio < 0.7) for COPD eligibility

Approval durationApproval duration for COPD initial and continuation described as 6–12 months depending on context (policy notes 6 months for initial COPD)

Alignment notePostbronchodilator FEV1 requirement revised to 20–80% to align with comparator (Nucala) per policy updates

inv-56: Definition — PN (Prurigo nodularis)

PN definitionPrurigo nodularis (PN)

PN clinical contextPN referenced as an FDA-approved indication for adult patients with diagnostic and severity criteria (e.g., Worst-Itch NRS >=7) in the policy

Appendix referenceSee Appendix B and dosing tables for therapeutic alternatives and dosing regimens for PN

inv-57: Definition — CSU (Chronic spontaneous urticaria)

CSU definitionChronic spontaneous urticaria (CSU)

Typical presentationCSU is characterized by spontaneous onset of wheals, angioedema, or both for more than 6 weeks due to an unknown cause (see Appendix D)

Policy age eligibilityDupilumab indication includes patients 12 years and older for CSU per prescribing information and policy updates

inv-58: Definition — BP (Bullous pemphigoid)

BP definitionBullous pemphigoid (BP)

Confirmation methodsDiagnosis of BP is confirmed histologically, serologically (anti-BP180/230 IgG by ELISA), or by immunofluorescence per policy criteria

Treatment contextDupilumab is an FDA-approved indication for adult patients with BP; policy includes prior therapy requirements and continuation criteria

inv-59: Definition — WI‑NRS (Worst Itch‑Numeric Rating Scale)

WI-NRS definitionThe Worst Itch Numeric Rating Scale (WI-NRS) is a single-item, patient-reported measure assessing worst itch in the prior 24 hours on a 0–10 scale

Use caseUsed to quantify itch severity for indications such as PN and other pruritic skin disorders in the policy (e.g., WI-NRS >=7 for PN)

Relation to PP-NRSPP-NRS and WI-NRS are similar single-item measures assessing peak/worst itch intensity over the prior 24 hours

inv-60: Definition — JAK (Janus kinase inhibitor)

JAK definitionJAK refers to Janus kinase (inhibitor)

Concurrent-use prohibitionPolicy prohibits concurrent prescription of Dupixent with a JAK inhibitor (examples listed in the criteria)

ExamplesPolicy lists example JAK inhibitors (Olumiant, Rinvoq, Cibinqo, Opzelura) when describing concurrent-use exclusions

inv-61: Definition — PP‑NRS / WI‑NRS patient-reported measures (0-10 scales) used in pruritus

PP‑NRS / WI‑NRS scalePP-NRS and WI-NRS are 0–10 patient-reported single-item measures assessing worst/peak itch intensity over the prior 24 hours

Clinical useThese scales are used in pruritic skin disorders to document itch severity for eligibility and response (e.g., PN WI-NRS >=7)

InterpretationHigher scores indicate greater itch severity; policy aligns PN threshold with comparator agents' worst-itch NRS thresholds

inv-62: Definition — NCCN pruritus grading (G1-G4) used to classify pruritus/bullous dermatitis severity

NCCN pruritus grading purposeNCCN grading scales classify pruritus and bullous dermatitis severity (G1–G4) by extent and impact on activities of daily living

Grade definitionsG2 = moderate (intermittent, skin changes limiting instrumental ADLs); G3 = severe (intense/widespread, limiting self-care ADLs or sleep)

Policy applicationNCCN grades are referenced in the policy for immunotherapy-related pruritus and bullous dermatitis eligibility and step requirements

inv-63: Definition — EoE (Eosinophilic esophagitis) — policy updated for new FDA indication and pediatric extension

EoE definition and policy updateEosinophilic esophagitis (EoE) — policy updated to add new FDA indication and pediatric extension; criteria require diagnosis confirmed by >=15 eos/hpf and age >=1 year with weight-based dosing

Indication specificsPolicy includes weight-based dosing for EoE (200 mg q2w for 15–<30 kg; 300 mg q2w for 30–40 kg; 300 mg weekly for >=40 kg)

ExclusionsMember must not have hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis to meet EoE criteria

inv-64: Definition — PN update note aligning worst-itch NRS threshold

PN worst-itch NRS updatePN initial approval criteria updated to require Worst-Itch Numeric Rating Scale >= 7 (0–10), aligning the threshold with comparator agents

PN age eligibilityPolicy indicates PN approval for adult patients (age >=18 years)

PN continuation dosing capContinuation requests for PN must ensure dose increases do not exceed 300 mg every other week