CurrentNeighborhood Health Plan of Rhode IslandPolicy 1690-A

Dupixent

Defines clinical coverage criteria, documentation and authorization durations for dupilumab (Dupixent) for multiple FDA-approved indications and certain compendial uses; specifies prescriber specialty requirements and continuation criteria. Applicable to the listed payer products referenced by the document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDupixent

Policy CodePolicy 1690-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes/medical records documenting affected areas, prior medications tried and objective test results (e.g., blood eosinophils, spirometry, endoscopy/biopsy) as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

9FDA-Approved Indications listed

13References listed

6Common documentation reqs

4–12Typical initial auth (months)

Coverage Summary

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Coverage stance: covered_with_criteria — Dupilumab (Dupixent) is covered when the member meets the indication-specific clinical and objective criteria in this policy for FDA-approved indications and select compendial uses. The policy defines authorization durations, required documentation, prescriber specialty requirements, and continuation benchmarks for each indication. Indication-specific criteria (initial and continuation) are provided in the following sections of this document.

Key objective thresholds

Affected body surface area (BSA)>= 10% BSA or involvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Baseline blood eosinophil for asthma>= 150 cells/μL (baseline) when paired with inadequate control on optimized inhaled therapy)

Absolute blood eosinophil count for COPD>= 300 cells/μL prior to initiating therapy

EoE histologic threshold>= 15 intraepithelial esophageal eosinophils per high power field

Prurigo nodularis lesion count>= 20 nodular lesions

Endoscopic nasal polyp score (NPS)Total NPS >= 5 with minimum score of 2 for each nostril

Meltzer Clinical Score>= 2 in both nostrils

Spirometry COPD confirmationFEV1/FVC < 0.7 post-bronchodilation

Atopic Dermatitis — Initial and Continuation Criteria

Atopic Dermatitis — Initial Criteria

Covered when ALL of the following are met:

ALL of the following

Patient is 6 months of age or older.
Affected body surface area (BSA) is greater than or equal to 10% OR one or more crucial body areas are affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas).
AND the member meets ONE of the following:
- Member has had an inadequate treatment response to one of the following within the past year: a medium‑potency to super‑high‑potency topical corticosteroid (see Appendix A for topical steroid potency reference).
  Appendix A topical steroid reference applies where topical potency is referenced.
- Member has had an inadequate treatment response to a topical calcineurin inhibitor within the past year.
- Member has had an inadequate treatment response to a topical JAK inhibitor within the past year.
- Member has had an inadequate treatment response to a topical PDE‑4 inhibitor within the past year.
- Use of medium‑potency to super‑high‑potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, or topical PDE‑4 inhibitor is not advisable for the member (e.g., due to contraindication, prior intolerance, or potency not appropriate for the member's age).
  Appendix A topical steroid reference applies where topical potency is referenced.
Documentation: chart notes or medical record showing affected area(s) and BSA; chart notes or claims history supporting previous medications tried, including response, or documentation of clinical reason therapy is not advisable.

Atopic Dermatitis — Continuation Criteria

Covered when ALL of the following are met:

ALL of the following

Patient is currently receiving Dupixent for atopic dermatitis.
There is documentation of positive clinical response to therapy (e.g., improvement in signs/symptoms such as pruritus, reduction in lesions or BSA, improved patient-reported outcomes).<= 12 months
Chart notes or medical record documentation supporting positive clinical response required for continuation requests.
If applicable, documentation of prior biologic or systemic targeted synthetic AD therapy within the past year may support a 4‑month authorization (e.g., prior Adbry, Ebglyss, Nemluvio, Cibinqo, Rinvoq).

Asthma — Initial and Continuation Criteria

Asthma - Initial Authorization (6 months)

Authorization of 6 months may be granted for members 6 years and older (or 6 months if prior biologic for asthma in past year) when ALL criteria are met.

ALL of the following

ANY of the following
- Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment
- One or more asthma exacerbations resulting in hospitalization or emergency medical care visit(s)
- Poor symptom control (frequent symptoms or reliever use, activity limitation, night waking)
ONE of
- Baseline blood eosinophil count >= 150 cells/μL AND inadequate asthma control despite optimized treatment with both: medium-to-high-dose inhaled corticosteroid AND an additional controller (LABA, LAMA, leukotriene modifier, or sustained-release theophylline).>= 150 cells/μL
  Baseline eosinophil threshold applied
- Inadequate asthma control despite optimized treatment with: high-dose inhaled corticosteroid, additional controller, and oral glucocorticoids (oral glucocorticoids for most days during previous 6 months [e.g., 50% of days, 3 steroid bursts in previous 6 months]).
Member will continue to use maintenance asthma treatments (inhaled corticosteroid and additional controller) in combination with dupilumab.

Asthma - Continuation (12 months)

Authorization of 12 months may be granted when BOTH criteria are met.

Asthma control has improved on dupilumab as demonstrated by at least ONE of: reduction in frequency or severity of symptoms/exacerbations; reduction in daily maintenance oral corticosteroid dose.

Member will continue to use maintenance asthma treatments in combination with dupilumab.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) — Initial and Continuation

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) - Initial (6 months)

Authorization of 6 months may be granted for members 12 years and older when ALL criteria are met (or 6 months if prior biologic in past year).

Member has bilateral nasal polyposis and chronic sinusitis symptoms despite intranasal corticosteroid treatment for at least 4 weeks unless contraindicated or not tolerated.

ONE of

Prior sino-nasal surgery
Prior treatment with systemic corticosteroids within the last two years was ineffective, unless contraindicated or not tolerated

ONE of objective findings

Bilateral nasal endoscopy, anterior rhinoscopy, or CT showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril.
Meltzer Clinical Score of 2 or higher in both nostrils.>= 2 in both nostrils
Total endoscopic nasal polyp score (NPS) of at least 5 with minimum score of 2 for each nostril.Total NPS >= 5 with minimum 2 per nostril

ONE of symptom-related

Rhinorrhea (anterior/posterior)
Reduction or loss of smell
Facial pain or pressure

Member will continue to use a daily intranasal corticosteroid while being treated with dupilumab unless contraindicated or not tolerated.

Concurrent intranasal corticosteroid required

CRSwNP - Continuation (12 months)

Authorization of 12 months may be granted when BOTH criteria are met.

Member has achieved or maintained a positive clinical response evidenced by improvement in signs and symptoms (e.g., nasal congestion, polyp size, loss of smell, rhinorrhea, sino-nasal inflammation, hyposmia, facial pressure/pain, reduction in corticosteroid use).

Member will continue daily intranasal corticosteroid while being treated with dupilumab unless contraindicated or not tolerated.

Concurrent intranasal corticosteroid required

Eosinophilic Esophagitis (EoE) — Initial and Continuation

Eosinophilic Esophagitis (EoE) - Initial (6 months)

Authorization of 6 months may be granted for members >=1 year and >=15 kg when ALL criteria are met.

Member is experiencing symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, vomiting, abdominal pain, food refusal, failure to thrive).

Diagnosis confirmed by esophageal biopsy with >= 15 intraepithelial esophageal eosinophils per high power field.>= 15 eos/HPF

ONE of prior therapies tried

Proton pump inhibitor (PPI)
Swallowed topical corticosteroid therapies (e.g., budesonide, fluticasone), unless contraindicated or not tolerated

EoE - Continuation (12 months)

Authorization of 12 months may be granted when member has achieved or maintained a positive clinical response.

Member has achieved or maintained a positive clinical response evidenced by improvement in signs and symptoms of EoE (e.g., dysphagia, heartburn, chest pain, emesis).

Prurigo Nodularis (PN) — Initial and Continuation

Prurigo Nodularis - Initial (6 months)

Authorization of 6 months may be granted for members 18 years and older when ALL criteria are met (or 4 months if prior biologic in past year).

Member has pruritus lasting at least 6 weeks.

Member has a history or signs of repeated itch-scratch cycle (e.g., scratching, picking, or rubbing).

Member has a minimum of 20 nodular lesions.>= 20 nodular lesions

ONE of prior therapies tried

Medium to super-high potency topical corticosteroid (see Appendix A)
Appendix A topical steroid potency reference applies
Topical calcineurin inhibitor
Phototherapy (e.g., UVB, PUVA)
Pharmacologic treatment with methotrexate or cyclosporine
Clinical reasons to avoid methotrexate/cyclosporine listed in Appendix B
Intolerance or clinical reason to avoid listed therapies

Prurigo Nodularis - Continuation (12 months)

Authorization of 12 months may be granted when member has achieved or maintained a positive clinical response.

Low disease activity (clear or almost clear skin).

Reduction in pruritus intensity and improvement in extent and severity of nodular lesions.

Chronic Obstructive Pulmonary Disease (COPD) — Initial and Continuation

Chronic Obstructive Pulmonary Disease (COPD) - Initial (12 months)

Authorization of 12 months may be granted for members 18 years and older when ALL criteria are met (or 12 months if prior biologic in past year).

Diagnosis confirmed by spirometry showing FEV1/FVC < 0.7 post-bronchodilation.FEV1/FVC < 0.7 post-bronchodilation

Member demonstrates classic signs or symptoms of COPD (e.g., dyspnea, wheezing, chest tightness, fatigue, activity limitation, cough with or without sputum production, chronic bronchitis).

Member has an absolute blood eosinophil count of at least 300 cells/μL prior to initiating therapy.>= 300 cells/μL

ONE of exacerbation history

At least two moderate exacerbations resulting in treatment with systemic glucocorticoids, antibiotics, or both.
One or more severe exacerbation(s) requiring hospitalization or an emergency medical care visit.

ONE of current maintenance therapy

Member is currently receiving maintenance inhaled triple therapy (ICS + LAMA + LABA).
Member is currently receiving a LAMA and LABA and has a contraindication to ICS.

Member will continue to use maintenance COPD treatments in combination with dupilumab.

COPD - Continuation (12 months)

Authorization of 12 months may be granted when BOTH criteria are met.

Member has achieved or maintained a positive clinical response as evidenced by improvement in signs and symptoms (e.g., decrease in exacerbations, improvement in prebronchodilator FEV1) or stabilization of disease.

Member will continue to use maintenance COPD treatments in combination with dupilumab.

Chronic Spontaneous Urticaria (CSU) — Initial and Continuation

Chronic Spontaneous Urticaria (CSU) - Initial (6 months)

Authorization of 6 months may be granted for members 12 years and older when ALL criteria are met (or 6 months if prior biologic in past year).

Member remains symptomatic despite up-dosing of a second-generation H1 antihistamine for at least 2 weeks.

Member has been evaluated for other causes of wheals/angioedema (including bradykinin-related angioedema and IL-1-associated urticarial syndromes).

Member has experienced spontaneous onset of wheals, angioedema, or both for at least 6 weeks.

CSU - Continuation (12 months)

Authorization of 12 months may be granted when member has experienced a positive clinical response since initiation.

Member has experienced a positive clinical response (e.g., improved symptoms, decrease in weekly urticaria activity score [UAS7]) since initiation of therapy.

Immune Checkpoint Inhibitor-Related Toxicities — Initial/Continuation

Immune Checkpoint Inhibitor-Related Toxicities - Initial/Continuation (12 months)

Authorization of 12 months may be granted when dupilumab will be used for severe (G3) pruritus (after failure of gabapentinoids in 1 month) or as additional therapy for severe (G3)/life-threatening (G4) bullous dermatitis.

Requested medication will be used for severe (G3) pruritus if no response to gabapentinoids in one month OR as additional therapy for severe (G3) or life-threatening (G4) bullous dermatitis.

Authorization duration: 12 months

Bullous Pemphigoid (BP) — Initial and Continuation

Bullous Pemphigoid - Initial (12 months)

Authorization of 12 months may be granted for members 18 years and older when ALL criteria are met.

Diagnosis confirmed by either direct immunofluorescence (DIF) study OR immune serological test(s) (e.g., IIF, ELISA).

Member demonstrates characteristic clinical features of bullous pemphigoid (e.g., urticarial/eczematous/erythematous plaques, bullae, pruritus).

Member has moderate to severe disease.

ONE of prior therapies or contraindication

Super-high potency topical corticosteroid (see Appendix A)
Appendix A topical steroid potency reference applies
Oral corticosteroid
Use of super-high potency topical corticosteroid or oral corticosteroid is not advisable for the member (e.g., contraindications, prior intolerances).

Bullous Pemphigoid - Continuation (12 months)

Authorization of 12 months may be granted when BOTH criteria are met.

Low disease activity (absence of new or established lesions).

Reduction in pruritus intensity and improvement in extent and severity of lesions.

Other General Conditions

For all indications

Member cannot use dupilumab concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

If member is a current smoker or vaper, counsel on harmful effects and cessation options (informational).

Exclusions / Unproven Uses: The policy does not list additional therapeutic exclusions beyond the prohibition on combined biologic/targeted synthetic therapy for the same indication; other indications not listed are considered experimental/investigational and not medically necessary. Provider note: Do not use dupilumab concomitantly with any other biologic or targeted synthetic drug for the same indication — document and justify any prior or concurrent biologic use per prior authorization guidance.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required with specific documentation

Submit chart notes/medical records documenting affected area(s) and body surface area (where applicable); prior medications tried with drug names, dose, frequency, and duration; and clinical reasons to avoid prior therapies when applicable. For relevant indications include pre-treatment blood eosinophil count (where applicable); nasal endoscopy/CT findings, Meltzer score, endoscopic nasal polyp score (NPS) for CRSwNP; esophageal biopsy eosinophil count for EoE; spirometry for COPD; and documentation of prior exacerbations or hospitalizations as specified in the indication criteria.

Affected area(s) and BSA (where applicable)
Prior medications tried with drug, dose, frequency, duration
Clinical reason to avoid prior therapies (if applicable)
Pre-treatment blood eosinophil count (where applicable)
CRSwNP objective tests: nasal endoscopy/CT, Meltzer score, NPS
EoE: esophageal biopsy eosinophil count
COPD: spirometry and documentation of exacerbations/hospitalizations

Documentation Required

Continuation documentation

For continuation/renewal requests, provide chart notes or medical record documentation demonstrating a positive clinical response since initiation of dupilumab. Examples include low disease activity or clear/almost clear skin, improvement in disease-specific signs and symptoms (e.g., reduced redness/itching/oozing for atopic dermatitis; improved asthma control or reduced oral steroid use; reduced polyp size or nasal congestion for CRSwNP; improved dysphagia for EoE; decreased pruritus and nodular lesion severity for PN; decreased exacerbations or improved FEV1 for COPD; reduced UAS7 for CSU).

Note

Prescriber specialty requirement

Dupilumab must be prescribed by or in consultation with the listed specialists depending on indication. Required specialties include: dermatologist or allergist/immunologist for atopic dermatitis; allergist/immunologist or pulmonologist for asthma; allergist/immunologist or otolaryngologist for CRSwNP; gastroenterologist or allergist/immunologist for EoE; dermatologist or allergist/immunologist for prurigo nodularis; pulmonologist or allergist/immunologist for COPD; allergist/immunologist or dermatologist for chronic spontaneous urticaria; dermatologist, hematologist, or oncologist for immune checkpoint inhibitor-related toxicity and bullous pemphigoid.

Billing Rule

Concomitant biologic prohibition

Do not use dupilumab concomitantly with any other biologic drug or targeted synthetic drug for the same indication. Concurrent use for the same indication may result in claim risk or denial.

Documentation Required

Baseline labs and objective testing

Obtain and submit baseline blood eosinophil counts for applicable indications prior to initiating therapy. Also obtain and submit indication-specific objective diagnostic tests as required prior to initiation: spirometry (FEV1/FVC < 0.7 post-bronchodilation) for COPD; endoscopy and esophageal biopsy with intraepithelial eosinophil count for EoE; and nasal endoscopy/CT with NPS or Meltzer score for CRSwNP.

Clinical Evidence & References

Evidence summary: Primary referenced evidence includes the Dupixent package insert (Regeneron; June 2025) and multiple guideline and trial references supporting use across indications. Guideline and trial citations in the policy include NEJM randomized trials and systematic guidance (e.g., GINA 2024, EUFOREA, NCCN Compendium) and relevant specialty society guidelines.

The policy cites specific clinical trials and trial identifiers supporting indications (examples listed in the policy include NCT04183335, NCT04202679, NCT04394351, NCT04456673, NCT04206553) and key journal references (e.g., NEJM 2016/2018 trials and NEJM 2023 COPD trial, ACG 2025, J Allergy Clin Immunol. 2023). These sources form the basis for the indication-specific criteria and continuation benchmarks contained in the policy.

Background

Background / approved indications: Dupilumab is approved for multiple type 2 inflammatory conditions including atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis (PN), chronic spontaneous urticaria (CSU), bullous pemphigoid (BP), and COPD with an eosinophilic phenotype. The policy provides indication-specific clinical and objective criteria required for initial and continuation authorization and references topical corticosteroid potency groupings (Appendix A) and examples of clinical reasons to avoid systemic agents (Appendix B).

Definitions

Optimized dosesUse of inhaled corticosteroid plus additional controller at doses and duration appropriate per guideline (members should be receiving inhaled therapies and controllers for at least the prior 3 months; oral glucocorticoid exposure criteria specified where applicable)

Positive clinical responseIndication‑specific improvement such as reduced exacerbations, reduced corticosteroid use, lower disease activity (e.g., clear or almost clear skin), or improved symptom scores

OpenPayer

Dupixent

Coverage Summary

Atopic Dermatitis — Initial and Continuation Criteria

Asthma — Initial and Continuation Criteria

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) — Initial and Continuation

Eosinophilic Esophagitis (EoE) — Initial and Continuation

Prurigo Nodularis (PN) — Initial and Continuation

Chronic Obstructive Pulmonary Disease (COPD) — Initial and Continuation

Chronic Spontaneous Urticaria (CSU) — Initial and Continuation

Immune Checkpoint Inhibitor-Related Toxicities — Initial/Continuation

Bullous Pemphigoid (BP) — Initial and Continuation

Other General Conditions

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence & References

Background

Revision History