Neighborhood Health Plan RI Dupilumab Coverage

Coverage Criteria for Dupilumab (Dupixent)

Indication eligibility

Covered when ALL indication-specific approval criteria and documentation requirements are met

Covered Indications: Patient has one of the listed indications: moderate-to-severe atopic dermatitis (>=6 months), add-on maintenance moderate-to-severe eosinophilic asthma (>=6 years), CRSwNP (>=12 years), eosinophilic esophagitis (>=1 year and >=15 kg), prurigo nodularis (>=18 years), or add-on maintenance eosinophilic COPD (>=18 years)age and weight restrictions listed per indication

Refer to indication-specific documentation requirements in authorization.documentation

Initial therapy — Atopic dermatitis

Atopic dermatitis — initial authorization (4 months) for members >=6 months with prior biologic/targeted therapy in past year OR when criteria below are met:

Age/previous therapy option: Authorization of 4 months may be granted for members 6 months of age or older who have previously received a biologic or targeted synthetic drug indicated for moderate-to-severe atopic dermatitis in the past year.age >=6 months OR prior biologic/targeted drug in past year

Disease severity and prior topical therapy: Affected body surface area >=10% OR crucial body areas affected; AND either inadequate response to a medium-to-super-high potency topical corticosteroid or a topical calcineurin inhibitor in the past year OR medical reason/contraindication to those topical therapies.BSA >=10% or crucial area involvement; prior inadequate response or contraindication to topical steroid and/or calcineurin inhibitor

See Appendix A for topical potency listing.

Initial therapy — Asthma

Asthma — initial authorization (6 months) for members >=6 years when all criteria met:

Exacerbation or poor control: Member has uncontrolled asthma demonstrated by at least one of: two or more exacerbations requiring oral/injectable corticosteroids, one or more exacerbations resulting in hospitalization or emergency care, or poor symptom control (frequent symptoms or reliever use, activity limitation, night waking) within the past year.events within past year

Eosinophils and controller optimization option: Either baseline blood eosinophils >=150 cells/µL with inadequate control despite optimized medium-to-high dose inhaled corticosteroid plus an additional controller, OR inadequate control despite optimized high-dose inhaled corticosteroid plus additional controller and oral glucocorticoids for most days during prior 6 months.eosinophils >=150 cells/µL OR high-dose ICS + OCS requirement

Members should have been on inhaled corticosteroid and additional controller for at least the previous 3 months.

Concomitant therapy:

Initial therapy — CRSwNP

Chronic rhinosinusitis with nasal polyps (CRSwNP) — initial authorization (6 months) for members >=12 years when all criteria met:

Disease and prior treatment: Bilateral nasal polyposis and chronic sinusitis symptoms despite intranasal corticosteroid treatment for at least 2 months unless contraindicated; AND CRSwNP despite prior sino-nasal surgery OR prior systemic corticosteroids within last 2 years was ineffective unless contraindicated.intranasal corticosteroid >=2 months; prior surgery or systemic steroid trial

Objective polyp evidence: Either bilateral endoscopy/anterior rhinoscopy/CT showing polyps reaching below the lower border of the middle turbinate in each nostril, OR Meltzer Clinical Score >=2 in both nostrils, OR total endoscopic nasal polyp score (NPS) >=5 with minimum 2 per nostril.NPS >=5 with >=2 per nostril OR Meltzer >=2 per nostril

Symptoms and maintenance: Member has nasal blockage/congestion plus at least one additional symptom (rhinorrhea, reduction or loss of smell, facial pain/pressure) AND will continue daily intranasal corticosteroid while on therapy unless contraindicated.

Initial therapy — EoE

Eosinophilic esophagitis (EoE) — initial authorization (6 months) for members >=1 year and >=15 kg when all criteria met:

Age-specific symptom requirement: Either age 1 to <11 years with clinical manifestations (e.g., vomiting, heartburn, abdominal pain, food refusal, failure to thrive) OR age >=11 years with history of an average of at least 2 episodes of dysphagia to solids per week.age-based symptom criteria

Histologic confirmation: Diagnosis confirmed by esophageal biopsy demonstrating at least 15 intraepithelial esophageal eosinophils per high power field.>=15 eosinophils/HPF

Prior therapy failures: Inadequate response to both a proton pump inhibitor and systemic or topical oral corticosteroid therapies (e.g., swallowed budesonide or fluticasone), unless contraindicated or not tolerated.PPI + steroid trial

Initial therapy — Prurigo nodularis

Prurigo nodularis — initial authorization (6 months) for members >=18 years when all criteria met:

Duration and signs: Pruritus lasting at least 6 weeks AND history or signs of repeated itch–scratch cycle (e.g., scratching, picking, rubbing) AND a minimum of 20 nodular lesions.>=6 weeks pruritus; >=20 nodules

Prior therapy or intolerance: Either inadequate response to one of: medium-to-super-high potency topical corticosteroid, topical calcineurin inhibitor, phototherapy (e.g., UVB, PUVA), or systemic pharmacologic treatment with methotrexate or cyclosporine; OR intolerance/clinical reason to avoid topical steroids/calcineurin inhibitors or methotrexate/cyclosporine.prior therapy failed or contraindicated

See Appendix A/B for specific agent lists.

Initial therapy — COPD

Chronic obstructive pulmonary disease (COPD) — initial authorization (12 months) for members >=18 years when all criteria met:

Spirometric and clinical confirmation: Diagnosis confirmed by spirometry showing FEV1/FVC < 0.7 post-bronchodilation AND classic signs or symptoms of COPD (e.g., dyspnea, wheeze, cough, activity limitation).FEV1/FVC <0.7

Eosinophil count: Absolute blood eosinophil count >=300 cells/µL prior to initiating therapy.>=300 cells/µL

Exacerbation history: Either at least two moderate exacerbations treated with systemic glucocorticoids/antibiotics OR one or more severe exacerbation(s) requiring hospitalization or emergency visit in the last year.events in last year

Initial therapy — Immune checkpoint inhibitor-related toxicity

Immune checkpoint inhibitor-related toxicity — initial authorization varies by presentation:

Severe pruritis (G3): Authorization of 6 months may be granted for refractory severe (G3) immune checkpoint inhibitor–related pruritis.refractory G3 pruritis

Compendial use; document indication-specific evidence.

Bullous dermatitis (G2 or G3): Authorization of 12 months may be granted when the medication is used as additional therapy for moderate (G2) or severe (G3) bullous dermatitis related to immune checkpoint inhibitors.G2 or G3 bullous dermatitis

Compendial use; document indication-specific evidence.

Continuation therapy

Continuation / maintenance authorization — general pattern (12 months unless otherwise noted):

Positive clinical response required: Continuation authorizations (commonly 12 months) require documentation that the member has achieved or maintained a positive clinical response, defined per indication (e.g., low disease activity, symptom improvement, reduced exacerbations or steroid use, improved FEV1, reduced polyp size or symptoms).evidence of positive clinical response

Continuation durations specified per indication.

Maintain background therapy: For applicable indications members must continue maintenance/background therapies (e.g., intranasal corticosteroid for CRSwNP; inhaled controllers for asthma; inhaled COPD therapy) while receiving the requested medication.continue concomitant standard therapy

This medication is not indicated for relief of acute bronchospasm or status asthmaticus. Requests for use specifically to treat acute bronchospasm or status asthmaticus should be denied and alternative acute bronchodilator or emergency therapies should be used per emergency treatment guidelines.

For all covered indications, concomitant use with any other biologic drug or targeted synthetic drug for the same indication is prohibited. Prior authorization requests that propose concurrent therapy with another biologic or targeted synthetic agent for the same condition will be subject to denial.

Clinical circumstances that may affect systemic treatment choices are noted; examples include pregnancy or planning pregnancy, breastfeeding, alcohol use disorder or alcoholic/chronic liver disease, drug interactions, significant comorbidity (e.g., severe liver or kidney disease, blood dyscrasias, uncontrolled hypertension), hypersensitivity, or a history of intolerance or adverse events. These considerations may influence whether alternative therapies are preferred and should be documented when relevant to the prior authorization decision.

Uses not listed among the FDA-approved indications or supported compendial uses in this policy are considered experimental/investigational and not medically necessary. Prior authorization requests for indications outside those explicitly covered should be denied absent compelling, guideline-supported compendial justification.

Coding and Objective Criteria

No codes in appendixmixed

No codes listed

Blood eosinophil count thresholds for asthma and COPD

Asthma blood eosinophil thresholdBaseline absolute blood eosinophil count ≥150 cells/µL required as one pathway to eligibility for add‑on maintenance asthma.

COPD blood eosinophil thresholdAbsolute blood eosinophil count ≥300 cells/µL prior to initiating therapy for eosinophilic COPD.

Documentation requirementBaseline blood eosinophil count must be documented in chart notes/medical record for initial requests where applicable.

EoE histologic threshold (≥15 intraepithelial esophageal eosinophils per high power field)

EoE histologic thresholdDiagnosis confirmed by esophageal biopsy showing ≥15 intraepithelial esophageal eosinophils per high‑power field (HPF).

Age/weight eligibility linked to biopsy

Provider Actions and Prior Authorization Requirements

Note

No PA rules in this appendix

This appendix does not establish separate no-prior-authorization (No PA) rules — prior authorization requirements described in the main policy apply. The references and prescribing information are provided for clinical context only.

Denial Risk

No concomitant biologic/targeted synthetic therapy

The requested medication may not be used concomitantly with another biologic drug or targeted synthetic agent for the same indication. Concurrent use for the same diagnosis may result in denial of the request.

Documentation Required

Indication-specific documentation required

Initial requests must include indication‑specific documentation as applicable: for atopic dermatitis, chart notes showing affected areas and body surface area; for asthma/COPD, documentation of symptoms, exacerbation history, FEV1/spirometry and baseline absolute blood eosinophil count; for CRSwNP, nasal endoscopy/CT findings or Meltzer/NPS scores; for EoE, endoscopic biopsy with intraepithelial esophageal eosinophil count; for prurigo nodularis, documentation of symptoms and lesion counts. Continuation requests must include chart notes showing a positive clinical response (reduced symptoms, improved disease activity) and, where noted, relevant longitudinal measures (e.g., exacerbation frequency, FEV1 improvement, eosinophil trends). If a required prior therapy is not provided because it is not advisable, include clinical rationale.

Definitions and Objective Criteria

Compendial use — uses supported by compendia considered covered when approval criteria met (e.g., ICI-toxicity)

Compendial uses coveredUses supported by recognized compendia (e.g., immune checkpoint inhibitor‑related toxicities) are considered covered when all approval criteria and documentation requirements are met.

Scope limitationAll compendial uses must still meet the policy’s indication‑specific clinical criteria and required documentation to be eligible.

Not automatically covered therapiesIndications not listed in FDA‑approved or compendial uses are considered experimental/investigational and not medically necessary.

EoE diagnostic threshold — ≥15 intraepithelial eosinophils per high power field

EoE diagnostic histologyEosinophilic esophagitis diagnosis requires esophageal biopsy demonstrating ≥15 intraepithelial esophageal eosinophils per high‑power field.

Background

Dupilumab is approved for multiple type 2 inflammatory conditions and is covered when all indication-specific criteria are met. Indications addressed in this policy include moderate-to-severe atopic dermatitis (age ≥6 months), add-on maintenance therapy for moderate-to-severe eosinophilic asthma (age ≥6 years), chronic rhinosinusitis with nasal polyps (CRSwNP, age ≥12 years), eosinophilic esophagitis (EoE, age ≥1 year and ≥15 kg), prurigo nodularis (adults), and certain immune checkpoint inhibitor–related toxicities. The agent is not indicated for acute bronchospasm or status asthmaticus and coverage requires meeting the specific documentation and prior therapy requirements described elsewhere in the policy.

Revision History

September 2024reference_updateLatest

Updated reference list to include Dupixent package insert (September 2024) and recent guideline/clinical trial citations.

2024document_revision

Document dated/revision identifiers updated (Dupixent SGM 1690-A P2024d_R) reflecting 2024 content and references.

March 15, 2024reference_accessed

OpenPayer

Dupilumab (Dupixent) — Coverage Criteria