CurrentNeighborhood Health Plan of Rhode IslandPolicy 1690-A

Dupixent (dupilumab) coverage — prior authorization and coverage criteria

Defines prior authorization, documentation, and covered indications for dupilumab (Dupixent) for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDupixent (dupilumab) coverage — prior authorization and coverage criteria

Policy CodePolicy 1690-A

Key ActionSubmit prior authorization with chart notes documenting diagnosis, prior medication trials (or clinical reasons to avoid them), and condition‑specific objective findings.

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9+FDA indications

4–12 monthsAuthorization lengths

12 monthsContinuation auth period

1 mo–18+Age ranges

ProhibitedConcomitant biologics

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Coverage Criteria for Dupilumab (Dupixent)

General coverage criteria

Covered when ALL of the following are met (per indication and documentation requirements):

General coverage: Indication is FDA-approved or specified compendial use and all approval criteria are met; member has no exclusions to the prescribed therapy.

See indication-specific documentation requirements in the authorization/documentation sections; requests may be denied if criteria are not met or member is using another biologic/targeted synthetic for the same indication.

Atopic Dermatitis — Initial

Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis in members 6 months of age or older when both of the following criteria are met:

Atopic dermatitis initial criteria: Affected body surface is greater than or equal to 10% BSA OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected; AND member has either: (1) inadequate treatment response within the past year to one of: a medium-potency to super-high potency topical corticosteroid, a topical calcineurin inhibitor, a topical JAK inhibitor, or a topical PDE-4 inhibitor; OR (2) those topical therapies are not advisable for documented clinical reasons (e.g., contraindication or prior intolerance).BSA >= 10% or crucial areas involved

Authorization of 4 months may be granted; prior biologic or systemic targeted synthetic use in the past year may also qualify for a 4-month authorization.

Asthma — Initial

Authorization of 6 months may be granted for treatment of moderate-to-severe asthma in members 6 years of age or older when all of the following criteria are met:

Asthma initial criteria: Member has uncontrolled asthma demonstrated by at least one of: two or more exacerbations requiring oral/injectable corticosteroids in the past year; one or more exacerbations resulting in hospitalization or ED visit; or poor symptom control (frequent symptoms or reliever use, activity limitation, night waking); AND member meets either: (A) baseline blood eosinophil count >=150 cells/µL and inadequate control despite optimized medium-to-high‑dose inhaled corticosteroid plus an additional controller; OR (B) inadequate control despite optimized high‑dose inhaled corticosteroid plus additional controller and use of oral glucocorticoids most days during the prior 6 months (e.g., ~50% of days); AND member will continue maintenance asthma treatments in combination with the requested medication.blood eosinophils >=150 cells/µL (option A)

Authorization duration: 6 months; member must continue inhaled corticosteroid and additional controller when treated.

CRSwNP — Initial

Authorization of 6 months may be granted for treatment of CRSwNP in members 12 years and older when all of the following criteria are met:

CRSwNP initial criteria: Member has bilateral nasal polyposis and chronic sinusitis symptoms despite at least 4 weeks of intranasal corticosteroid therapy (unless contraindicated or not tolerated); AND member has either prior sino-nasal surgery or prior ineffective systemic corticosteroid treatment within the last 2 years (unless contraindicated); AND objective findings consistent with polyps such as bilateral endoscopy/CT showing polyps below the middle turbinate, Meltzer Clinical Score >=2 in each nostril, or total endoscopic nasal polyp score (NPS) >=5 with >=2 per nostril; AND member will continue daily intranasal corticosteroid therapy while on treatment (unless contraindicated or not tolerated).Meltzer score >=2 per nostril; total NPS >=5 with >=2 per nostril

Eosinophilic Esophagitis — Initial

Authorization of 6 months may be granted for treatment of EoE in members 1 year and older (>=15 kg) when all of the following criteria are met:

EoE initial criteria: Member has symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, vomiting, abdominal pain, food refusal, failure to thrive); AND diagnosis confirmed by esophageal biopsy showing at least 15 intraepithelial esophageal eosinophils per high power field; AND member has had an inadequate response to either a proton pump inhibitor or swallowed topical corticosteroid therapy (e.g., budesonide, fluticasone) unless contraindicated or not tolerated.>=15 eosinophils per HPF

Prurigo Nodularis — Initial

Authorization of 6 months may be granted for treatment of prurigo nodularis in members 18 years and older when all of the following criteria are met:

Prurigo nodularis initial criteria: Member has pruritus lasting at least 6 weeks and history or signs of a repeated itch–scratch cycle; AND member has a minimum of 20 nodular lesions; AND member has either: (1) inadequate response to one of the following: a medium‑to‑super‑high potency topical corticosteroid, a topical calcineurin inhibitor, phototherapy (e.g., UVB, PUVA), or pharmacologic treatment with methotrexate or cyclosporine; OR (2) intolerance or a documented clinical reason to avoid those therapies (see Appendix B).>=20 nodules

COPD — Initial

Authorization of 12 months may be granted for treatment of COPD in members 18 years and older when all of the following criteria are met:

COPD initial criteria: Diagnosis confirmed by spirometry showing post‑bronchodilation FEV1/FVC < 0.7; member has classic COPD signs/symptoms; AND absolute blood eosinophil count >=300 cells/µL prior to initiating therapy; AND inadequately controlled disease demonstrated by either at least two moderate exacerbations (requiring systemic glucocorticoids and/or antibiotics) or one or more severe exacerbations requiring hospitalization or ED visit in the past year; AND member is receiving maintenance inhaled triple therapy (ICS+LAMA+LABA) or is receiving LAMA+LABA with a contraindication to ICS; member will continue maintenance COPD treatments in combination with the requested medication.eosinophils >=300 cells/µL; FEV1/FVC <0.7

Chronic Spontaneous Urticaria — Initial

Authorization of 6 months may be granted for treatment of chronic spontaneous urticaria in members 12 years and older when all of the following are met:

CSU initial criteria: Member remains symptomatic despite up‑dosing a second‑generation H1 antihistamine for at least 2 weeks (per guideline dosing strategies); AND member has been evaluated for alternative causes of wheals/angioedema; AND spontaneous onset of wheals/angioedema (or both) for at least 6 weeks.duration >=6 weeks

Immune Checkpoint Inhibitor-Related Toxicity — Initial

Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor‑related toxicity when the requested medication will be used as specified below:

ICI‑related toxicity initial criteria: Severe (Grade 3) pruritus refractory to gabapentinoids after one month OR severe (Grade 3) or life‑threatening (Grade 4) bullous dermatitis requiring additional therapy.

Bullous Pemphigoid — Initial

Authorization of 12 months may be granted for treatment of bullous pemphigoid in members 18 years and older when all of the following are met:

Bullous pemphigoid initial criteria: Diagnosis confirmed by direct immunofluorescence or immune serologic testing (e.g., IIF, ELISA); member demonstrates characteristic clinical features and has moderate‑to‑severe disease; AND either inadequate response to a super‑high potency topical corticosteroid or an oral corticosteroid OR those therapies are not advisable for documented clinical reasons (e.g., contraindication or prior intolerance).

Continuation Therapy — General

Continuation/maintenance authorizations vary by indication and generally require evidence of positive clinical response and ongoing baseline therapy where applicable.

Atopic dermatitis continuation: Member has achieved or maintained a positive clinical response (e.g., low disease activity, clear or almost clear skin, or improvement in signs/symptoms of atopic dermatitis).

Asthma continuation: Member has improved asthma control on the requested medication as evidenced by reduction in frequency/severity of symptoms or exacerbations or reduction in daily maintenance oral corticosteroid dose; AND member will continue maintenance asthma treatments (inhaled corticosteroid plus additional controller) with the requested medication.

CRSwNP continuation: Member has achieved or maintained a positive clinical response evidenced by improvement in CRSwNP signs/symptoms (e.g., nasal congestion, polyp size, smell, rhinorrhea, sino‑nasal inflammation, facial pressure/pain, or reduced corticosteroid use); AND member will continue daily intranasal corticosteroid unless contraindicated or not tolerated.

Continuation therapy criteria — Authorization overview

Authorization of 12 months may be granted for continuation of treatment when the following indication‑specific criteria are met:

Asthma (continuation): Member is >=6 years and has improved asthma control on the requested medication as shown by reduction in symptoms/exacerbations or reduction in maintenance oral corticosteroid dose; AND member will continue maintenance asthma treatments in combination with the requested medication.age >=6 years

12‑month authorization

CRSwNP (continuation): Member is >=12 years and has achieved/maintained a positive clinical response evidenced by improvement in CRSwNP signs/symptoms; AND member will continue daily intranasal corticosteroid unless contraindicated or not tolerated.age >=12 years

12‑month authorization

EoE (continuation): Member is >=1 year, weighs at least 15 kg, and has achieved/maintained a positive clinical response evidenced by improvement in EoE signs/symptoms.

The policy specifies limitations of use for dupilumab: it is not indicated for the relief of acute bronchospasm or status asthmaticus and it is not indicated for treatment of other forms of urticaria, therefore these acute uses are not appropriate indications for coverage. Additionally, the policy treats non‑listed indications as compendial/experimental status: immune checkpoint inhibitor‑related toxicities are listed as a compendial use, while all other indications not listed are considered experimental/investigational and not medically necessary unless specifically supported by the policy criteria.

For dermatologic conditions such as atopic dermatitis and prurigo nodularis the policy frames these limitations within the indication‑specific criteria (e.g., requirement for affected BSA or minimum nodules and prior topical/systemic therapies) and therefore acute bronchospasm/status asthmaticus and other urticaria forms remain explicitly excluded from covered uses.

The document excerpt does not list additional explicit exclusions beyond the stated limitations of use and investigational language. Coverage decisions are governed by the indication‑specific approval criteria (for example, atopic dermatitis and prurigo nodularis criteria) and by the general policy language; no separate exclusion list is provided in the cited sections.

Appendix material (e.g., Appendix B) provides clinical reasons that may justify avoiding certain systemic agents (methotrexate, cyclosporine) but does not itself establish an exclusion to coverage of the requested medication.

The policy requires that a member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication. Requests will be denied if the member is receiving another biologic or targeted synthetic agent for the identical indication.

Appendix B lists clinical reasons that may justify avoiding pharmacologic treatment with methotrexate or cyclosporine (for example: pregnancy or planning pregnancy, breastfeeding, chronic liver disease, drug interactions, risk of treatment‑related toxicity, significant comorbidity, hypersensitivity, or prior intolerance). These examples are intended to support documentation when a clinician elects not to use those systemic agents, but the appendix itself does not state a formal exclusion to using the requested medication.

Per the policy, all indications not listed among the FDA‑approved or specified compendial uses are considered experimental/investigational and not medically necessary. In other words, indications outside those enumerated in the policy are not covered.

Age, Weight, Biomarker Thresholds and Diagnostic Criteria

Age / Weight / Biomarker thresholds — examples across indications

Youngest minimum age (example)6 months for atopic dermatitis (FDA-approved)

EoE minimum age and weight>= 1 year of age and weight >= 15 kg required for EoE treatment/continuation

Asthma minimum age>= 6 years for initiation and continuation of asthma therapy

Pre-treatment biomarker (asthma)Baseline blood eosinophils >= 150 cells per microliter for eosinophilic asthma phenotype

Pre-treatment biomarker (COPD)Absolute blood eosinophil count >= 300 cells per microliter for COPD with eosinophilic phenotype

EoE biopsy eosinophil count — diagnostic threshold

Diagnostic biopsy threshold>= 15 intraepithelial esophageal eosinophils per high power field

Required clinical featureSymptoms of esophageal dysfunction (e.g., dysphagia, food impaction, vomiting, abdominal pain, food refusal, failure to thrive)

Prior therapy requirementInadequate response to a proton pump inhibitor or swallowed topical corticosteroid unless contraindicated or not tolerated

Asthma blood eosinophil threshold

Asthma blood eosinophil threshold>= 150 cells per microliter (baseline) for eosinophilic asthma phenotype

Clinical contextUsed when member has uncontrolled asthma despite medium-to-high-dose inhaled corticosteroid plus controller therapies

Documentation neededPre-treatment absolute blood eosinophil count must be documented in chart notes or medical record

COPD blood eosinophil threshold

COPD blood eosinophil threshold>= 300 cells per microliter prior to initiating therapy

COPD clinical requirementEosinophil threshold applies with spirometrically confirmed COPD and inadequately controlled disease

Documentation neededChart notes or medical record documentation showing absolute blood eosinophil count prior to initiating therapy

COPD spirometry criterion

Spirometry criterionPost-bronchodilation FEV1/FVC < 0.7 confirms COPD diagnosis

Measurement contextRequired as part of diagnostic confirmation prior to initiating therapy for COPD

Related requirementsMust accompany classic COPD signs/symptoms and documented exacerbation history

Minimum weight for EoE continuation

Minimum weight for EoE continuation>= 15 kg (required for initiation and continuation in EoE)

Minimum age for EoE>= 1 year of age

Continuation evidenceMember must have achieved or maintained a positive clinical response to continue therapy

Minimum age for asthma continuation

Minimum age for asthma continuation>= 6 years for continuation authorization

Continuation evidenceAsthma control must have improved on the requested medication (reduced symptoms/exacerbations or reduced maintenance oral corticosteroid dose)

Ongoing therapy requirementMember must continue maintenance asthma treatments in combination with the requested medication

Prior Authorization, Documentation, and Step-Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation requests. Submit clinical documentation to initiate review; requests lacking required documentation may be delayed or denied. Authorization durations vary by indication per the policy criteria.

Prior authorization required for covered indications
Authorization durations vary by indication (see indication-specific criteria for 4, 6, or 12 month terms)

Documentation Required

Required Documentation for Prior Authorization

Initial requests must include baseline diagnostic and prior-therapy documentation. Continuation requests must include evidence of positive clinical response. If prior therapies are not advisable, include clinical rationale or documentation referencing Appendix B where applicable.

Initial requests: chart notes/medical records showing affected area(s) and BSA where applicable
Initial requests: pre-treatment labs (e.g., absolute blood eosinophil count) when specified by indication
Initial requests: diagnostic confirmation (e.g., endoscopic biopsy with eosinophil count for EoE; nasal endoscopy/CT or NPS for CRSwNP; DIF or serology for bullous pemphigoid)
Initial requests: documentation or claims history of prior medications/therapies tried including drug, dose, frequency, duration, and response
Continuation requests: chart notes documenting positive clinical response (symptom reduction or objective improvement per indication)
If therapy is not advisable: document clinical reason to avoid specific prior therapy (see Appendix B examples)

Denial Risk

Denial Triggers

Requests may be denied if approval criteria are not met, required documentation is missing, or the member has exclusions to the prescribed therapy. Lack of chart notes, medical records, or claims history demonstrating prior therapies and responses can trigger denial.

Denial triggers: missing or incomplete documentation to demonstrate indication-specific baseline or prior therapy
Denial triggers: failure to meet step-therapy / prior treatment requirements for the indication
Denial triggers: member exclusions to the prescribed therapy per plan benefits

Documentation Required

Documentation of Prior Therapy Required

Documentation of prior therapy is required for most indications. Provide chart notes, medical records, or claims history that show prior medication(s) or therapies tried, including dose, frequency, duration, and clinical response. If a prior medication is not appropriate, clearly document the clinical reason.

Provide prior medication name, dose, frequency, duration, and response
If prior therapy was not tried due to contraindication, intolerance, or other clinical reason, include supporting documentation (see Appendix B)

Denial Risk

Concomitant Biologic/Targeted Synthetic Use

The requested medication may not be used concomitantly with another biologic or targeted synthetic drug for the same indication. Confirm absence of other overlapping biologic/targeted synthetic therapy in the chart or claims history.

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

Note

Exceptions to Systemic Agent Use

Appendix B lists clinical examples that may justify bypassing step-therapy requirements or avoiding systemic agents (e.g., methotrexate, cyclosporine). When applicable, include documentation supporting the clinical reason (e.g., pregnancy, liver disease, drug interaction, prior intolerance).

Examples include: alcohol use disorder or chronic liver disease, drug interactions, risk of treatment-related toxicity, pregnancy or planning pregnancy, breastfeeding, significant comorbidity (e.g., liver/kidney disease, blood dyscrasias, uncontrolled hypertension), hypersensitivity, history of intolerance or adverse event
Use Appendix B clinical reasons to support exceptions to systemic agent use or step therapy

Note

Not Applicable / Reference Content

Not applicable content in source chunks (included for completeness): topical corticosteroid potency group listings (Appendix A) and detailed potency entries. These are reference materials used to determine prior topical treatment adequacy.

Appendix A: Topical corticosteroid potency groupings (reference list of agents and potencies)
Appendix B: Clinical reasons to avoid systemic agents (see above)

Background and Context

Dupilumab (Dupixent) is a biologic therapy approved and used for multiple type‑2 inflammatory conditions. The policy lists covered FDA indications and specified compendial uses including moderate‑to‑severe atopic dermatitis (approved for adults and pediatric patients from 6 months of age), certain eosinophilic and allergic diseases such as eosinophilic esophagitis (EoE) with diagnostic biopsy criteria, chronic rhinosinusitis with nasal polyps, asthma, chronic spontaneous urticaria, prurigo nodularis, chronic obstructive pulmonary disease (COPD), immune checkpoint inhibitor‑related dermatologic toxicities, and bullous pemphigoid when the indication‑specific criteria are met. The policy also reiterates limitations of use — notably that dupilumab is not indicated for relief of acute bronchospasm or status asthmaticus and is not indicated for treatment of other forms of urticaria — and requires documentation of indication‑specific objective findings (for example, biopsy showing ≥15 intraepithelial esophageal eosinophils per high power field for EoE or spirometry with FEV1/FVC <0.7 for COPD) as part of prior authorization review.

Definitions and Clinical Measures

Limitations of use

Acute bronchospasm/status asthmaticusNot indicated for relief of acute bronchospasm or status asthmaticus

Other forms of urticariaNot indicated for treatment of other forms of urticaria (outside chronic spontaneous urticaria indication)

ScopeUses not listed as FDA-approved or specified compendial uses are considered experimental/investigational and not medically necessary

Eosinophilic Esophagitis (EoE) definition

Biopsy criterion>= 15 intraepithelial esophageal eosinophils per high power field required to confirm EoE diagnosis

Symptom requirementSymptoms of esophageal dysfunction (e.g., dysphagia, food impaction, vomiting, abdominal pain, food refusal, failure to thrive)

Prior therapy requirementInadequate response to proton pump inhibitor or swallowed topical corticosteroid therapy unless contraindicated or not tolerated

COPD diagnostic confirmation

COPD diagnostic confirmationSpirometry showing post-bronchodilation FEV1/FVC < 0.7

Associated findingsDiagnosis also requires classic COPD signs/symptoms and exacerbation history for treatment consideration

DocumentationSpirometry result must be in the medical record prior to initiating therapy

UAS7 — weekly urticaria activity score definition

UAS7 definitionWeekly Urticaria Activity Score (UAS7) — a weekly score used to quantify urticaria symptom burden and treatment response

Use in policyDecrease in UAS7 is listed as evidence of positive clinical response for continuation of therapy in CSU

Clinical applicationUsed to monitor symptom improvement since treatment initiation

FEV1 — definition and measurement context

FEV1 definitionForced expiratory volume in 1 second (FEV1) — objective measure of pulmonary function used in COPD/asthma assessment

Measurement contextImprovement in prebronchodilator FEV1 cited as evidence of positive clinical response for COPD continuation

Relation to spirometryFEV1 is used in calculating FEV1/FVC ratio for COPD diagnostic confirmation

Topical corticosteroid potency groups — Group VI / Low potency and Group VII / Least potent examples

Group VI — Low potency examplesBetamethasone valerate 0.1% lotion; Desonide 0.05% (cream, lotion, foam); Fluocinolone acetonide 0.01% (cream, solution, shampoo, oil); Triamcinolone acetonide 0.025% (cream, lotion)

Group VII — Least potent examplesHydrocortisone (various forms/strengths): examples include Hydrocortisone 2.5% cream, 2% lotion, 1% cream/ointment/gel, 0.5% cream/ointment

Potency grouping useTopical corticosteroid potency groups listed to inform prior therapy and step-therapy requirements

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDupixent (dupilumab) coverage — prior authorization and coverage criteria

Policy CodePolicy 1690-A

Key ActionSubmit prior authorization with chart notes documenting diagnosis, prior medication trials (or clinical reasons to avoid them), and condition‑specific objective findings.

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

age >=1 year; weight >=15 kg

12‑month authorization

Prurigo nodularis (continuation): Member is >=18 years and has achieved/maintained a positive clinical response evidenced by low disease activity (clear or almost clear skin) OR reduction in pruritus intensity and improvement in nodular lesions.age >=18 years

12‑month authorization

COPD (continuation): Member is >=18 years and has achieved/maintained a positive clinical response evidenced by improvement in COPD signs/symptoms (e.g., decreased exacerbations, improved prebronchodilator FEV1) or stabilization; AND member will continue maintenance COPD treatments (e.g., ICS with LAMA and LABA, or LAMA and LABA) with the requested medication.age >=18 years

12‑month authorization

Chronic spontaneous urticaria (continuation): Member is >=12 years and has experienced a positive clinical response since initiation (e.g., improved symptoms, decreased UAS7).age >=12 years

12‑month authorization

Immune checkpoint inhibitor‑related toxicities (continuation): All ages: member is using the medication for severe (G3) pruritus or severe (G3)/life‑threatening (G4) bullous dermatitis and achieves/maintains a positive clinical response evidenced by low disease activity or improvement in signs/symptoms.none specified

12‑month authorization

Bullous pemphigoid (continuation): Member is >=18 years and has achieved/maintained a positive clinical response evidenced by low disease activity (e.g., absence of new or established lesions) OR reduction in pruritus intensity and improvement in extent/severity of lesions.age >=18 years

12‑month authorization