CurrentPremera BluecrossPolicy N/A

Dupixent (dupilumab) — Coverage Criteria (Pharmacy/Medical Policy)

Criteria and coverage rules for Dupixent (dupilumab) as pharmacy/medical benefit for multiple indications (atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, bullous pemphigoid, COPD) for Premera Bluecross members.

Policy Summary

PayerPremera Bluecross

PolicyDupixent (dupilumab) — Coverage Criteria (Pharmacy/Medical Policy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, age, prior therapy trials or intolerances, exacerbation history or spirometry, eosinophil results or steroid dependence, and dosing within stated maintenance ranges.

SourceLink

6+Indications listed

>=6 moMinimum age (AD)

BSA >=10%AD BSA threshold

<80%Asthma FEV1 criterion

>150 /mcLEosinophil threshold

300 mg

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Max adult maintenance dose

Coverage Criteria

Atopic dermatitis — Initial Therapy

Dupixent may be considered medically necessary when ALL of the following are met:

AD initial criteria: Patient is aged 6 months or older AND has a diagnosis of atopic dermatitis involving at least 10% body surface area (BSA) (exception may be granted for extensive recalcitrant facial involvement, pustular hands/feet, or genital involvement) AND for individuals aged 2 years and older there is inadequate response or intolerance to 1 topical calcineurin inhibitor (e.g., pimecrolimus or tacrolimus)BSA >= 10% (exceptions allowed)

From policy text (chunk 4)

Asthma — Initial Therapy

Dupixent may be considered medically necessary for moderate-to-severe asthma when ALL of the following are met:

Asthma baseline requirements: Patient is aged 6 years or older AND using maximum tolerated doses of an inhaled corticosteroid AND using an inhaled long-acting beta-agonist (LABA)age >= 6 years

From policy text (chunks 5,6)

Asthma severity/impact (meet 1): One of: 2 or more asthma exacerbations in the prior 12 months requiring oral corticosteroids; OR 1 or more exacerbation requiring hospitalization/ED/urgent care in the prior 12 months; OR FEV1 < 80% predicted; OR FEV1/FVC < 0.80; OR asthma that worsens on tapering oral corticosteroidssee items

From policy text (chunks 6,15)

Asthma phenotype or steroid dependence (meet 1): One of: dependence on oral corticosteroids of at least 5 mg/day prednisone equivalent; OR eosinophilic phenotype with at least one of: blood eosinophils >150 cells/mcL; sputum eosinophils >=3%; OR oral corticosteroid–dependent asthma where eosinophil testing cannot be performedsee items

From policy text (chunk 6,16)

Asthma dosing limits: Prescribed maintenance dose does not exceed age/weight maxima: adults/adolescents >=12 years: max maintenance 300 mg every other week; pediatric 6–11 years (body weight 15 to <30 kg): max maintenance 300 mg every 4 weeksdosing by age/weight

From policy text (chunks 6,52)

Initial therapy / Medical necessity

Covered when ALL of the following medical necessity conditions are met:

Age/dosing: For adults and adolescents >=12 years: maximum maintenance dose 300 mg every other week; For pediatric 6-11 years and body weight 15 to <30 kg: maximum maintenance dose 300 mg every 4 weeks.

From policy dosing sections

Clinical severity requirement: Member meets at least ONE of: 2 or more asthma exacerbations in previous 12 months requiring oral corticosteroids; OR >=1 exacerbation requiring hospitalization/ED/urgent care in prior 12 months; OR FEV1 <80% predicted; OR FEV1/FVC <0.80; OR asthma worsens on tapering oral corticosteroids.

From chunks 149,159

Phenotype or steroid dependence: AND meets ONE of: dependence on oral corticosteroids (>=5 mg/day prednisone equivalent); OR eosinophilic phenotype with at least ONE of: blood eosinophils >150 cells/mcL; sputum eosinophils >=3%; OR oral corticosteroid dependent and unable to discontinue steroids to perform eosinophil testing.

From chunks 150,160

Medical Necessity Criteria

Covered when ALL of the following are met (medical necessity):

Overall requirement: Medical necessity is met

Top-level statement

Clinical disease activity within prior 12 months: Meets at least one: (1) 2 or more asthma exacerbations requiring oral corticosteroids in prior 12 months; (2) 1 or more exacerbation requiring hospitalization, ED, or urgent care in prior 12 months; (3) FEV1 <80% predicted; (4) FEV1/FVC <0.80; (5) asthma worsens upon tapering oral corticosteroids.

From chunks 194-196

Phenotype / steroid dependence: Meets at least one: (1) dependence on oral corticosteroids >=5 mg/day prednisone equivalent; (2) eosinophilic phenotype with >=1 of: blood eosinophils >150 cells/mcL; sputum eosinophils >=3%; or unable to discontinue oral corticosteroids to perform eosinophil testing.

From chunks 195-196

For atopic dermatitis, coverage requires documentation that the patient has a diagnosis of atopic dermatitis involving at least 10% body surface area (BSA). An exception to the >=10% BSA requirement may be allowed when there is documented extensive, recalcitrant involvement of the face, pustular involvement of the hands or feet, or genital involvement that interferes with normal sexual function. For individuals aged 2 years and older, documentation of an inadequate response or intolerance to one topical calcineurin inhibitor (for example, pimecrolimus or tacrolimus) is required.

No explicit exclusions are stated in this portion of the policy text.

No explicit exclusions are present in the extracted text for this section.

This section does not specify explicit exclusion conditions.

No explicit exclusions are stated in these policy excerpts.

No explicit exclusions are present in this excerpt of the policy.

No explicit exclusions are detailed in the chunks cited for this part of the policy.

The policy does not support dosing that exceeds the stated maximum maintenance doses by age/weight. Specifically, for adults and adolescents aged >=12 years the maximum maintenance dose is 300 mg every other week, and for pediatric patients aged 6–11 years (body weight 15 to <30 kg) the maximum maintenance dose is 300 mg every 4 weeks. Dosing above these ceilings is outside the policy dosing limits.

No explicit exclusions are listed in these chunks of the policy.

Use that does not meet the stated medical necessity criteria described in the policy is not covered. The policy requires fulfillment of the enumerated clinical criteria (exacerbation history, objective pulmonary function thresholds, eosinophilic phenotype or oral corticosteroid dependence) and adherence to dosing limits for approval.

Per the policy, use is not medically necessary if the patient does not meet the required combination of exacerbation, lung function, oral corticosteroid dependence, or eosinophilic phenotype criteria described for asthma.

The policy states that requests failing to meet the required clinical criteria would be considered not medically necessary; approvals require meeting the enumerated exacerbation, pulmonary function, steroid-dependence, or eosinophilic phenotype criteria and dosing within specified limits.

Therapy that does not satisfy the listed exacerbation, physiologic (spirometry), phenotype (eosinophilic) or dosing criteria is considered not medically necessary under the policy.

This excerpt does not contain an explicit 'not medically necessary' statement; however, elsewhere the policy clarifies that failure to meet the clinical criteria or dosing limits will render use unsupported.

Use is not supported when the patient does not meet the listed qualifying criteria — for example, required exacerbation history, objective pulmonary function impairment (e.g., FEV1 <80% predicted or FEV1/FVC <0.80), oral corticosteroid dependence (>=5 mg/day prednisone equivalent), or evidence of an eosinophilic phenotype (blood eosinophils >150 cells/mcL or sputum eosinophils ≥3%).

Requests that do not meet the exacerbation, lung function, steroid-dependence, or eosinophilic phenotype criteria are not supported by the medical necessity criteria in these policy passages.

Use beyond the specified dosing limits or use without meeting the stated clinical eligibility criteria (exacerbation history, pulmonary function impairment, steroid dependence, or eosinophilic phenotype) is considered not medically necessary.

Initial Therapy Criteria

Initial therapy

Initial coverage criteria vary by indication; examples below reflect policy statements in this section.

AD initial: Patient >=6 months; atopic dermatitis involving >=10% BSA (or allowed exception); for individuals >=2 years inadequate response or intolerance to 1 topical calcineurin inhibitorBSA >=10% (exceptions allowed)

From policy text (chunk 4)

Asthma initial: Patient >=6 years; using maximum tolerated inhaled corticosteroid and an inhaled LABA; meets exacerbation/FEV1/eosinophil or steroid-dependence criteria; dosing within age/weight limitsage >=6 years

From policy text (chunks 5,6)

Initial Therapy

Initial coverage requires meeting medical necessity criteria below

Continuation and Maintenance Criteria

Continuation therapy

Continuation requires ongoing documentation of benefit and dosing within maintenance ranges.

Continuation therapy general: Maintenance dosing must not exceed specified maximums by age/weight AND ongoing clinical benefit should be documented (e.g., reduction in exacerbations or steroid-sparing)

Maintenance Therapy

Maintenance dosing guidance

Maintenance dosing: Adults/adolescents >=12 years: 300 mg every other week. Pediatric 6–11 years weighing 15 to <30 kg: 300 mg every 4 weeks.

From chunks 41-42

Maintenance dosing

Continuation (maintenance) dosing must conform to age/weight-based maximums.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests. Submit documentation of diagnosis, patient age, prior therapy trials (or intolerance), exacerbation history or objective lung function/phenotype data as applicable, and that the prescribed maintenance dose is within the policy limits.

Prior authorization required with documentation of diagnosis, age, prior therapy failures/intolerance, and dosing within stated maintenance ranges
Asthma prior authorization to verify medical necessity and adherence to dosing limits
Documentation demonstrating patient meets medical necessity criteria (exacerbations OR lung function/phenotype)
Documentation that patient meets asthma medical necessity criteria (exacerbation history, pulmonary function, phenotype)
Documentation that member meets asthma severity/exacerbation and phenotype criteria and prescribed dose is within limits
Clinical criteria and dosing limits required for authorization
Documentation of meeting medical necessity criteria for asthma including exacerbation history, lung function or OCS dependence
Approvals based on meeting specified clinical criteria and dosing limits
Documentation of qualifying exacerbation history OR objective measures (FEV1 <80% predicted or FEV1/FVC <0.80) or eosinophilic phenotype

Step Therapy Requirements

Step	Requirement
1
Trial and inadequate response or intolerance to 1 topical calcineurin inhibitor (e.g., pimecrolimus or tacrolimus) for atopic dermatitis in individuals aged ≥2 years; for asthma, patient must be using maximum tolerated inhaled corticosteroid and an inhaled long-acting beta-agonist (LABA)

Step	Requirement
1
No explicit step therapy steps are specified in these sections; coverage decisions for the referenced content are based on meeting clinical medical necessity criteria rather than a defined step sequence

Step	Requirement
1
No explicit prior medication trial steps listed in these extracted sections; authorization is determined by meeting the clinical criteria (exacerbation history, lung function, eosinophilic phenotype, or steroid dependence)

Step	Requirement
1
Step 1: (no additional detail provided in the extracted chunk) — see medical necessity criteria for required clinical findings

Step	Requirement
1
No explicit step therapy sequence described in these chunks; criteria emphasize phenotype/exacerbation and dosing limits rather than prior step failures

Step	Requirement
1
No explicit prior step-therapy requirements are present in this excerpt; coverage is contingent on meeting the medical necessity criteria

Step	Requirement
1
No explicit step therapy steps provided in these chunks; evaluate against clinical criteria and dosing limits

Step	Requirement
1
Policy requires meeting one of several clinical pathways (exacerbation history, objective lung function impairment, oral corticosteroid dependence, or eosinophilic phenotype) rather than following an explicit sequential prior-medication failure pathway

Step	Requirement
1
No explicit prior step-therapy failure requirements are stated in these chunks; approval is based on meeting the documented clinical eligibility criteria

Quantity and Dosing Limits

inv-154: Dupixent (dupilumab) — 300 mg (general statement)

ProductDupixent (dupilumab) 300 mg

Formulation300 mg per dose (subcutaneous)

Indications in policy scopeMultiple indications including atopic dermatitis and asthma as described in policy

inv-155: Dupixent (dupilumab) — 300 mg (maintenance dosing reference)

Maintenance dose (≥12 years)300 mg every other week

Maintenance dose (6–11 years, 15 to <30 kg)300 mg every 4 weeks

Dose ceiling noted

Clinical Thresholds and Coding Values

inv-29: Atopic dermatitis BSA — >= 10% (exception for certain recalcitrant localized disease)

Atopic dermatitis BSA threshold>= 10% body surface area (exception allowed for extensive recalcitrant facial, pustular hand/foot, or genital involvement)

Minimum age for AD coverageIndividual is aged 6 months or older

Prior therapy (>=2 yrs) for ages ≥2For individuals aged 2 years and older, inadequate response or intolerance to 1 topical calcineurin inhibitor is required

inv-30: Blood eosinophil count — > 150 cells/mcL

Blood eosinophil threshold> 150 cells/mcL

ContextUsed to define eosinophilic phenotype for asthma eligibility

Site of Care

Note

Background

Dupixent (dupilumab) is described in the policy as an anti-inflammatory biologic indicated for multiple type 2 inflammatory conditions. The coverage logic requires indication‑specific clinical criteria: for atopic dermatitis, documentation of moderate‑to‑severe disease (typically >=10% BSA or qualifying localized recalcitrant disease) and prior topical therapy failure where applicable; for asthma, the policy requires meeting exacerbation and/or physiologic severity criteria plus evidence of an eosinophilic phenotype or oral corticosteroid dependence, with dosing constrained to the specified maintenance maxima (for example, 300 mg every other week for adults/adolescents and 300 mg every 4 weeks for certain pediatric weight bands).

Definitions

inv-110: Atopic dermatitis (AD) — definition and typical policy threshold (>=10% BSA or certain localized disease)

Atopic dermatitis (AD) definitionChronic skin condition; policy requires moderate-to-severe disease typically defined as >=10% BSA or certain recalcitrant localized disease

Eosinophilic phenotype (asthma)Asthma subtype defined by blood eosinophils >150 cells/mcL or sputum eosinophils >=3%

Oral corticosteroid dependent asthmaChronic OCS therapy (>=5 mg/day prednisone equivalent) or inability to discontinue steroids

inv-111: Eosinophilic phenotype (asthma) — defined by elevated blood or sputum eosinophils (>150 cells/mcL or >=3%)

Eosinophilic phenotype — blood thresholdBlood eosinophils >150 cells/mcL

Eosinophilic phenotype — sputum threshold

Revision History

Policy Summary

PayerPremera Bluecross

PolicyDupixent (dupilumab) — Coverage Criteria (Pharmacy/Medical Policy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

Dose limits by age/weight:

For adults/adolescents >=12 years: maximum maintenance dose 300 mg every other week. For pediatric 6–11 years (15 to <30 kg): maximum maintenance dose 300 mg every 4 weeks.

Dose ceilings specified in policy (chunks 194-196)

Initial coverage criteria: See Medical Necessity Criteria: patient must meet qualifying exacerbation or spirometry criteria AND phenotype/OCS dependence criteria AND dosing within specified maximums

Reference to coverage.criteria_sets (chunks 41,42,52)

Initial therapy

Initial coverage requires meeting exacerbation/lung function/steroid dependence/eosinophilic phenotype criteria and adherence to dosing limits.

Initial therapy eligibility: Patient meets clinical criteria (exacerbation history or objective lung function impairment) AND meets phenotype or oral corticosteroid dependence requirements AND prescribed dose is within age/weight maximums

From chunks 59-60

Initial therapy

Initial therapy medical necessity requirements

Exacerbation/pulmonary criteria: 2 or more exacerbations in previous 12 months requiring oral corticosteroids; OR >=1 exacerbation requiring hospitalization/ED/urgent care in prior 12 months; OR FEV1 <80% predicted; OR FEV1/FVC <0.80; OR asthma worsens on tapering oral corticosteroids.

Phenotype/steroid dependence: Oral corticosteroid dependence >=5 mg/day prednisone equivalent; OR eosinophilic phenotype with blood eosinophils >150 cells/mcL or sputum eosinophils >=3%; OR oral corticosteroid–dependent asthma where eosinophil testing cannot be obtained.

Initial therapy

Initial coverage requires meeting exacerbation/physiologic/phenotype criteria and adherence to age/weight dosing limits.

Initial therapy: Member must meet the clinical exacerbation or physiologic impairment AND phenotype or steroid-dependence criteria, and prescribed dosing must not exceed age/weight maxima

From chunks 95-96

Initial Therapy Criteria

Initial coverage criteria for Dupixent in asthma

Eligibility: Requires medical necessity plus meeting one exacerbation/lung function criterion AND one steroid-dependence/eosinophilic phenotype criterion as detailed in coverage criteria

From chunks 113-114

Initial therapy / dosing

Dosing limits: For adults and adolescents >=12 years: maximum maintenance dose 300 mg every other week; For pediatric patients 6–11 years and body weight 15 to <30 kg: 300 mg every 4 weeks

From chunks 131,133

Initial Therapy Criteria

Initial therapy eligibility mirrors medical necessity criteria:

Severity and phenotype: Patient meets severity criteria (exacerbation history or objective pulmonary impairment) AND meets phenotype/steroid dependence criteria (oral corticosteroid dependence >=5 mg/day or eosinophilic phenotype as defined)

From chunks 149,159

Initial Therapy

Initial therapy is covered when the medical necessity criteria are met and dosing does not exceed age/weight maximums.

Initial therapy criteria: Must meet clinical exacerbation or lung function impairment OR steroid dependence or eosinophilic phenotype, and dosing within age/weight maxima (see dosing limits)

From chunks 194-196

Maintenance dosing rules: Adults/adolescents >=12 years: maximum maintenance dose 300 mg every other week. Pediatric 6–11 years (15 to <30 kg): maximum maintenance dose 300 mg every 4 weeks.

From chunk 60

Maintenance dosing

Continuation/maintenance dosing limits

Maintenance dosing adults/adolescents: Maximum maintenance dose for adults and adolescents (>=12 years) is 300 mg every other week.

Maintenance dosing pediatric 6–11 yrs: For pediatric individuals aged 6 to 11 years and body weight 15 to <30 kg, maintenance dose is 300 mg every 4 weeks.

CONTINUATION CRITERIA

Continuation implied to require ongoing adherence to dosing limits and continued clinical benefit; explicit continuation rules are not present in all sections.

Continuation: Continued coverage contingent on documentation of clinical benefit and adherence to dosing limits (see maintenance dosing)

Maintenance Dosing

Continuation/maintenance dosing guidance

Maintenance dosing by age/weight: Adults/adolescents >=12 years: 300 mg every other week maximum maintenance dose. Pediatrics 6–11 years and 15 to <30 kg: 300 mg every 4 weeks maximum maintenance dose.

Continuation Therapy

Continuation requires ongoing documentation of clinical benefit and adherence to the dosing schedule; maintenance dose limits apply (see dosing).

Maintenance Dosing Limits

Continuation/maintenance dosing limits based on age and weight:

Adults/adolescents >=12: Maximum maintenance dose: 300 mg every other week.

From chunks 150-151

Pediatric 6-11 years (15 to <30 kg): Maximum maintenance dose: 300 mg every 4 weeks.

From chunks 150-151

Continuation Therapy

Continuation should remain within the maximum maintenance dosing defined by age/weight and based on ongoing clinical benefit and steroid-sparing effect.

Continuation: Continued coverage contingent on continued clinical benefit and adherence to dosing limits (300 mg every other week for >=12 years; 300 mg every 4 weeks for 6–11 years weighing 15 to <30 kg)

Continuation therapy

Continuation requires ongoing documentation that dosing remains within limits and clinical benefit or ongoing need is present.

Continuation requirements

Continued use within the maximum maintenance dosing by age/weight
Documentation of clinical response or continued need (e.g., exacerbation reduction, steroid-sparing)

Demonstrate member meets asthma severity and phenotype criteria and dosing does not exceed limits

Documentation Required

Atopic Dermatitis Documentation and BSA Requirement

Provide documentation of atopic dermatitis extent and prior topical therapy trials where required. For atopic dermatitis, include body surface area (BSA) involvement (≥10% BSA) or an approved exception (extensive recalcitrant facial, pustular hand/foot, or genital involvement). For individuals aged ≥2 years, document trial and inadequate response or intolerance to at least one topical calcineurin inhibitor. Failure to document required BSA or prior topical therapy may result in denial.

Atopic dermatitis: document age, diagnosis, and BSA (≥10% BSA required or approved exception)
For ages ≥2 years document trial and inadequate response or intolerance to 1 topical calcineurin inhibitor (e.g., pimecrolimus or tacrolimus)
Absence of documented AD involving ≥10% BSA (or approved exception) may trigger denial

Documentation Required

Asthma Documentation and Required Clinical Evidence

For asthma, document use of maximum tolerated inhaled corticosteroid plus an inhaled long-acting beta-agonist (LABA) when applicable, plus prior exacerbation history or physiologic criteria. Include evidence of prior 12-month exacerbations (oral corticosteroid courses, ED/hospital/urgent care visits), spirometry results (FEV1 and FEV1/FVC), oral corticosteroid dose/dependence, and blood or sputum eosinophil counts when relevant. Lack of these elements may lead to denial for failure to meet medical necessity criteria.

Asthma: document use of maximum tolerated inhaled corticosteroid and an inhaled LABA
Document prior 12-month exacerbation history (number of oral corticosteroid-requiring exacerbations, hospital/ED/urgent care visits)
Provide spirometry: FEV1 percent predicted and FEV1/FVC ratio if used for eligibility
Document oral corticosteroid dependence (≥5 mg/day prednisone equivalent) if applicable
Include blood eosinophil (>150 cells/mcL) or sputum eosinophils (≥3%) when relevant
Failure to show use of max tolerated ICS + LABA or to provide exacerbation/FEV1/eosinophil data may result in denial

Step Therapy

Step Therapy / Sequencing

Step therapy / sequencing: where specified, prior trial and inadequate response or intolerance to required topical therapies for atopic dermatitis is required; for asthma eligibility, meeting one of several clinical pathways (exacerbations, lung function impairment, steroid dependence, or eosinophilic phenotype) is required. If step-therapy prerequisites apply but are not documented, authorization may be denied.

Step therapy prerequisites — trial and inadequate response or intolerance to specified topical therapies for atopic dermatitis
For asthma, authorization is granted when the member meets one of the specified clinical pathways (exacerbations, lung function impairment, steroid dependence, or eosinophilic phenotype)
Requests lacking documented step therapy / sequencing where required are at risk for denial

Denial Risk

Denial Risk Summary

Denial risk summary: requests that do not meet the policy clinical criteria (insufficient exacerbation history, missing spirometry or eosinophil data, lack of required prior therapy trials, or prescribed dose exceeding maximum maintenance limits) are at high risk for denial. Ensure all criteria and supporting documentation are submitted at time of prior authorization.

Denial triggers — failure to meet medical necessity criteria such as number/severity of exacerbations, spirometry thresholds (FEV1 <80% predicted or FEV1/FVC <0.80), or eosinophilic phenotype criteria
Failure to document medical necessity criteria (exacerbations, hospital/ED/urgent care visits, spirometry, oral corticosteroid dependence, or eosinophil results) may lead to denial
Absence of documentation showing trials of required prior therapies for atopic dermatitis or use of max tolerated ICS + LABA for asthma may result in denial
Prescribed maintenance dose above policy maximums (adult/adolescent 300 mg every other week; pediatric weight-based dosing limits) may trigger denial

Policy specifies maximum maintenance dosing by age/weight

inv-156: Dupixent (dupilumab) — 300 mg (maintenance/dosing reference)

Maximum maintenance dose (adolescents/adults)300 mg every other week

Pediatric 6–11 years (15 to <30 kg)300 mg every 4 weeks

RequirementMaintenance dosing must conform to age/weight-based maximums

inv-157: Dupilumab — 300 mg (maintenance reference)

Maintenance dose (adults/adolescents ≥12)300 mg every other week

Maintenance dose (pediatric 6–11 yrs, 15–<30 kg)300 mg every 4 weeks

Policy noteContinuation contingent on clinical benefit and adherence to dosing limits

inv-158: dupilumab — 300 mg (maintenance reference)

Standard maintenance (≥12 years)300 mg every other week

Alternate pediatric interval (6–11 years, 15 to <30 kg)300 mg every 4 weeks

Quantity guidance300 mg is the referenced dose used throughout policy quantity limits

inv-159: Dupixent (dupilumab) — 300 mg (maintenance reference)

Maximum maintenance dose (adults/adolescents)300 mg every other week

Pediatric (6–11 yrs, 15 to <30 kg)300 mg every 4 weeks

Dose interpretation~600 mg/month for q2w adult dosing; 300 mg/month for q4w pediatric dosing

inv-160: dupilumab — 300 mg every other week for ≥12 years; 300 mg every 4 weeks for 6–11 years (15 to <30 kg)

Adolescents/Adults (≥12 years)300 mg every other week (maximum maintenance dose)

Pediatric (6–11 years; 15 to <30 kg)300 mg every 4 weeks (maximum maintenance dose)

Policy requirementPrescribed maintenance dosing must not exceed age/weight maxima

inv-161: dupilumab — per dosing schedule (reference to schedule-based dosing limits)

Dosing schedule requirementDosing limits applied per age/weight schedule in policy (q2w for ≥12 yrs; q4w for 6–11 yrs 15–<30 kg)

Authorization implicationPrior authorization verifies prescribed dose aligns with schedule-based limits

ContinuationOngoing approvals contingent on adherence to schedule-based dosing limits

inv-162: Dupilumab — 300 mg (maintenance reference)

Referenced maintenance dose300 mg (policy references this dose for maintenance across indications)

ApplicationUsed as basis for quantity limits and dosing ceilings

Frequency noteExact frequency determined by age/weight per policy (q2w or q4w)

inv-163: dupilumab — 300 mg (maintenance reference)

Maintenance dose referenced300 mg (policy recurrently references this as the unit dose)

Dose ceiling enforcementPolicy disallows maintenance dosing above the stated maxima by age/weight

Use in calculationsDose frequency (q2w vs q4w) determines monthly quantity for limits

Alternative when sputum not availableBlood eosinophils >150 cells/mcL can serve as phenotype marker when sputum testing not done

inv-31: FEV1 — < 80% predicted

FEV1 threshold< 80% predicted

PurposeOne qualifying spirometry criterion for asthma medical necessity

DocumentationRecent FEV1 percent predicted should be provided in prior 12 months where used

inv-32: FEV1/FVC ratio — < 0.80

FEV1/FVC ratio threshold< 0.80

PurposeAlternate spirometric qualifier for asthma medical necessity

DocumentationRecent FEV1/FVC should be provided if used to support eligibility

inv-33: Sputum eosinophil — >= 3%

Sputum eosinophil threshold>= 3%

RoleCriterion to define eosinophilic phenotype for asthma eligibility

Use caseUsed when sputum testing is available or preferred

inv-34: Blood eosinophil count — > 150 cells/mcL (duplicate chunk)

Blood eosinophil threshold (dup)> 150 cells/mcL

Repeated useReferenced across multiple asthma criteria sections as phenotype cutoff

Documentation recommendationInclude lab report showing value when used for authorization

inv-35: Sputum eosinophil count — >= 3% (duplicate chunk)

Sputum eosinophil count (dup)>= 3%

FunctionUsed with blood eosinophils to establish eosinophilic phenotype

AlternativeCan substitute for blood eosinophil when available

inv-36: FEV1 percent predicted — < 80% predicted

FEV1 percent predicted (dup)< 80% predicted

UseQualifies as one of the exacerbation/physiologic criteria for asthma

RecordProvider should document FEV1 percent predicted when used for eligibility

inv-37: FEV1/FVC ratio — < 0.80

FEV1/FVC ratio (dup)< 0.80

UseAlternate lung function criterion for asthma eligibility

DocumentationInclude recent spirometry result when used

inv-38: Blood eosinophil count — > 150 cells/mcL

Blood eosinophil threshold (repeat)> 150 cells/mcL

Clinical applicationDefines eosinophilic phenotype pathway for asthma approval

When OCS-dependentMay be used if patient can discontinue OCS for testing; if not, steroid-dependence pathway applies

inv-39: FEV1 percent predicted — < 80%

FEV1 percent predicted (short)< 80%

PurposeOne qualifying objective measure for asthma medical necessity

EvidenceProvider should supply spirometry data from prior 12 months when applicable

inv-40: FEV1/FVC ratio — < 0.80

FEV1/FVC ratio (short)< 0.80

PurposeObjective lung function criterion for asthma eligibility

DocumentationRecent spirometry supporting this ratio should be provided

inv-41: Blood eosinophil count — > 150 cells/mcL

Blood eosinophil threshold (policy)> 150 cells/mcL

ConsensusConsistently used across policy sections to identify eosinophilic phenotype

Provider actionAttach blood eosinophil lab results when submitting prior authorization

inv-42: Sputum eosinophil — >= 3%

Sputum eosinophil threshold (policy repeat)>= 3%

RoleUsed to define eosinophilic asthma phenotype when available

DocumentationProvide sputum eosinophil report if used for eligibility

inv-43: Oral corticosteroid dependence — >= 5 mg per day prednisone or equivalent

Oral corticosteroid dependence threshold>= 5 mg per day prednisone equivalent

DefinitionChronic OCS use at this dose with inability to taper qualifies as steroid-dependent pathway

DocumentationProvider must document daily OCS dose when claiming steroid dependence

inv-44: FEV1 percent predicted — < 80% predicted

FEV1 percent predicted (policy)< 80% predicted

UseObjective lung function criterion for asthma medical necessity

EvidenceProvide spirometry results to support claim

inv-45: FEV1/FVC ratio — < 0.80

FEV1/FVC ratio (policy)< 0.80

UseAlternate spirometric qualifier for asthma eligibility

DocumentationInclude recent FEV1/FVC when used

inv-46: Blood eosinophil — > 150 cells/mcL

Blood eosinophil threshold (repeat)> 150 cells/mcL

ApplicationUsed in eosinophilic phenotype pathway across asthma criteria

Provider noteDocument counts when submitting for authorization

inv-47: Sputum eosinophil count — >= 3%

Sputum eosinophil count (repeat)>= 3%

RoleAlternate phenotype marker when blood eosinophil testing is not used

DocumentationProvide sputum eosinophil report if relied upon

inv-48: Blood eosinophil — > 150 cells/mcL

Blood eosinophil count (policy)>150 cells/mcL

Clinical relevanceKey criterion for defining eosinophilic asthma phenotype

ActionInclude lab evidence in prior authorization submissions

inv-49: FEV1 — < 80% predicted

FEV1 percent predicted (short repeat)<80% predicted

UseObjective measure to satisfy severity criterion

Provider requirementAttach spirometry when used for eligibility

inv-50: FEV1/FVC ratio — < 0.80

FEV1/FVC ratio (short repeat)< 0.80

UseAlternate lung function criterion for asthma medical necessity

DocumentationProvide recent spirometry when used

inv-51: Blood eosinophil count — > 150 cells/mcL

Blood eosinophil count (repeat)>150 cells/mcL

ContextEosinophilic phenotype criterion across multiple sections

NoteAlso used when considering OCS-dependent patients who cannot discontinue steroids for testing

inv-52: Sputum eosinophil count — >= 3%

Sputum eosinophil percentage>=3%

RoleDefines eosinophilic phenotype when available

DocumentationProvide sputum results if used for eligibility

inv-53: FEV1 percent predicted — < 80% predicted

FEV1 percent predicted (repeat)<80% predicted

PurposeObjective lung function qualifier for asthma

Provider actionInclude spirometry report to support claim

inv-54: FEV1/FVC ratio — < 0.80

FEV1/FVC ratio (repeat)< 0.80

UseAlternate spirometry threshold for eligibility

EvidenceRecent FEV1/FVC measurement recommended

inv-55: Blood eosinophil count — >150 cells/mcL

Blood eosinophil count (repeat)>150 cells/mcL

PolicyConsistently cited as eosinophilic phenotype cutoff

Provider instructionAttach supporting lab evidence to authorization request

inv-56: Sputum eosinophil count — >=3%

Sputum eosinophil count (repeat)>=3%

UseUsed to identify eosinophilic phenotype when available

AlternativeCan be substituted when blood counts are not diagnostic

inv-57: FEV1 percent predicted — <80% predicted

FEV1 percent predicted (policy repeat)<80% predicted

RoleObjective lung function pathway for asthma eligibility

DocumentationProvide FEV1 % predicted when used for prior authorization

inv-58: FEV1/FVC ratio — <0.80

FEV1/FVC ratio (policy repeat)<0.80

UseAlternate spirometric criterion for medical necessity

Provider noteInclude recent spirometry when claiming this criterion

inv-59: Blood eosinophil count — >150 cells/mcL

Blood eosinophil count (final) >150 cells/mcL

ConsistencyReferenced throughout policy as eosinophilic phenotype cutoff

Submission tipInclude lab documentation for authorization

inv-60: Sputum eosinophil percentage — >=3%

Sputum eosinophil percentage (final)>=3%

UseAlternate eosinophilic phenotype marker

DocumentationAttach sputum eosinophil report if used

inv-61: Oral corticosteroid dependence — >=5 mg/day prednisone equivalent

Oral corticosteroid dependence definition>=5 mg/day prednisone equivalent (inability to taper)

RoleQualifies patient under steroid-dependence pathway for asthma eligibility

DocumentationSpecify daily OCS dose when submitting prior authorization

inv-62: FEV1 percent predicted — <80% predicted

FEV1 percent predicted (end)<80%

UseObjective pulmonary function criterion for eligibility

EvidenceProvide spirometry in documentation where applicable

inv-63: FEV1/FVC ratio — <0.80

FEV1/FVC ratio (end)<0.80

UseAlternate spirometry threshold for asthma medical necessity

DocumentationProvide recent FEV1/FVC when used

inv-64: Blood eosinophil count — >150 cells/mcL

Blood eosinophil threshold (definition) >150 cells/mcL

Definition useUsed repeatedly to define eosinophilic phenotype across policy sections

Provider guidanceLab evidence recommended for prior authorization

Sputum eosinophils >=3%

Steroid-dependent alternativeOral corticosteroid–dependent asthma where eosinophil testing cannot be obtained

inv-112: Asthma with eosinophilic phenotype — presence of elevated blood eosinophils (>150 cells/mcL) or sputum eosinophils (>=3%)

Asthma with eosinophilic phenotype — definitionPresence of elevated blood eosinophils (>150 cells/mcL) or sputum eosinophils (>=3%)

Clinical implicationUsed as one pathway to qualify for dupilumab in asthma

DocumentationProvide blood or sputum eosinophil results when used for eligibility

inv-113: Eosinophilic phenotype — asthma characterized by elevated eosinophils (>150 cells/mcL or >=3% sputum)

Eosinophilic phenotype (concise)Asthma characterized by elevated eosinophils (>150 cells/mcL blood or >=3% sputum)

Use in policyDefines phenotype eligibility for dupilumab in asthma

Alternative pathwaySteroid dependence pathway applies when eosinophil testing can't be done

inv-114: Eosinophilic phenotype — blood eosinophil >150 cells/mcL or sputum >=3%

Eosinophilic phenotype thresholdsBlood eosinophils >150 cells/mcL OR sputum eosinophils >=3%

Clinical noteEither marker is sufficient to define phenotype when documented

Provider actionAttach relevant lab reports for authorization

inv-115: Eosinophilic phenotype — blood eosinophil >150 cells/mcL or sputum >=3% or OCS-dependent asthma

Eosinophilic phenotype — expandedBlood eosinophil >150 cells/mcL or sputum >=3% or oral corticosteroid–dependent asthma

Policy implicationAll are accepted pathways to qualify for dupilumab in asthma

DocumentationProvide evidence for at least one criterion to support approval

inv-116: Oral corticosteroid dependence — use of at least 5 mg per day prednisone or equivalent with inability to taper

Oral corticosteroid dependence definitionUse of at least 5 mg per day prednisone (or equivalent) with inability to taper without worsening asthma

RoleQualifies patient under steroid-dependence pathway for dupilumab

Documentation neededState daily OCS dose and inability to taper in authorization

inv-117: blood eosinophil threshold — >150 cells/mcL

Blood eosinophil threshold (standalone)>150 cells/mcL

UsagePrimary lab threshold for eosinophilic phenotype across policy

Provider tipAttach lab evidence when relying on this threshold

inv-118: FEV1 threshold — <80% predicted

FEV1 threshold (definition)FEV1 <80% predicted

PurposeOne objective pulmonary function criterion for asthma eligibility

DocumentationProvide spirometry report showing percent predicted

inv-119: Eosinophilic phenotype — defined as blood eosinophil >150 cells/mcL or sputum >=3% or OCS-dependent asthma

Eosinophilic phenotype (condensed)Defined as blood eosinophil >150 cells/mcL or sputum >=3% or OCS-dependent asthma

Policy useUsed to establish eligibility pathway for dupilumab in asthma

Provider documentationSubmit one qualifying measure to demonstrate phenotype

inv-120: Eosinophilic phenotype — blood eosinophils >150 cells/mcL or sputum >=3%

Eosinophilic phenotype thresholds (concise)Blood eosinophils >150 cells/mcL or sputum eosinophils >=3%

Clinical implicationEither threshold qualifies for the eosinophilic phenotype pathway

DocumentationAttach corresponding lab values in authorization request

inv-121: Eosinophilic phenotype — blood eosinophil >150 cells/mcL or sputum >=3%

Eosinophilic phenotype (repeat)Blood eosinophil >150 cells/mcL or sputum >=3%

Alternate pathwayOCS-dependent asthma when testing cannot be performed

Provider actionDocument which criterion is used to support eligibility

inv-122: Oral corticosteroid dependent asthma — chronic OCS therapy (>=5 mg/day) or inability to discontinue

Oral corticosteroid dependent asthma (definition)Chronic OCS therapy (>=5 mg/day prednisone equivalent) or inability to discontinue without exacerbation

Role in policyCounts as phenotype/steroid-dependence pathway for dupilumab approval

DocumentationProvide OCS dose and clinical rationale for dependence

inv-123: eosinophilic asthma — eosinophilic phenotype (definition)

Eosinophilic asthma (term)Eosinophilic phenotype as used in policy

ThresholdsBlood eosinophil >150 cells/mcL or sputum >=3%

UseDefines eligibility pathway for dupilumab in asthma

inv-124: blood eosinophil count >150 cells/mcL — threshold used for eligibility

Blood eosinophil eligibility threshold>150 cells/mcL

Policy significanceUsed as minimum lab cutoff for phenotype-based approvals

Provider requirementInclude the lab result in prior authorization documentation