CurrentAgency for Health Care AdministrationPolicy N/A

Dupixent (dupilumab) Coverage and Prior Authorization

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This policy governs prior authorization for Dupixent in Florida Medicaid fee-for-service and establishes initial and continuation coverage criteria for specified allergic, inflammatory, pulmonary, dermatologic, and gastrointestinal conditions.

Policy Summary

PayerAgency for Health Care Administration

PolicyDupixent (dupilumab) Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all applicable indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9Initial-therapy indications

1 yearAuthorization length

5Continuation indications

≥300COPD eosinophil threshold

≥150

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CurrentAgency for Health Care AdministrationPolicy N/A

Dupixent (dupilumab) Coverage and Prior Authorization

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Policy Summary

PayerAgency for Health Care Administration

PolicyDupixent (dupilumab) Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all applicable indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9Initial-therapy indications

1 yearAuthorization length

5Continuation indications

≥300COPD eosinophil threshold

≥150

Asthma eosinophil threshold

Not coveredCombination biologic therapy

Coverage Criteria

Initial Therapy — Allergic Fungal Rhinosinusitis

Covered for allergic fungal rhinosinusitis when all of the following are met.

Allergic Fungal Rhinosinusitis: Patient is at least 6 years of age; has a documented diagnosis of AFRS; has a history of sinonasal surgery; has sinus opacification on the Lund Mackay sinus CT scan with a score ≥9 for unilateral polyps or >12 for bilateral polyps; and has a nasal polyps score ≥2 for unilateral polyps or ≥3 for bilateral polyps.Age ≥6; LMK ≥9 unilateral or >12 bilateral; NPS ≥2 unilateral or ≥3 bilateral

All listed requirements apply.

Initial Therapy — Atopic Dermatitis

Covered for atopic dermatitis when all of the following are met.

Atopic Dermatitis: Patient is at least 6 months of age; has a documented diagnosis of atopic dermatitis; has completed a minimum 4-week trial of at least one preferred medium- to very-high-potency topical steroid with inadequate response or intolerance; and has completed a minimum 4-week trial of at least one preferred topical calcineurin inhibitor with inadequate response or intolerance.Age ≥6 months; each specified topical trial ≥4 weeks

Both prerequisite topical therapy trials are required.

Initial Therapy — Asthma

Covered for asthma when all of the following are met.

Asthma: Patient is at least 6 years of age; has moderate to severe asthma with an eosinophilic phenotype or is oral-corticosteroid dependent; therapy is prescribed by or provided in consultation with an allergist, pulmonologist, or immunologist; if the eosinophilic phenotype is used, blood eosinophils are ≥150 cells/mcL; and the patient has ongoing asthma symptoms despite a minimum 3-month trial of inhaled corticosteroid plus LABA combination therapy.Age ≥6; eosinophils ≥150 cells/mcL when applicable; ICS/LABA trial ≥3 months

The eosinophil threshold applies to the eosinophilic phenotype pathway.

Initial Therapy — Bullous Pemphigoid

Covered for bullous pemphigoid when all of the following are met.

Bullous Pemphigoid: Patient is at least 18 years of age; has bullous pemphigoid proven by biopsy and confirmed by pathology report; the condition is rapidly progressing, extensive, or debilitating; and corticosteroids or immunosuppressive agents have failed, or the patient has experienced significant complications from standard treatment such as diabetes or steroid-induced osteoporosis.Age ≥18

Biopsy and pathology confirmation are required.

Initial Therapy — COPD

Covered for chronic obstructive pulmonary disease when all of the following are met.

Chronic Obstructive Pulmonary Disease: Patient is at least 18 years of age; has COPD with an eosinophilic phenotype; has a baseline blood eosinophil count ≥300 cells/mcL; has moderate to severe airflow limitation confirmed by pulmonary function tests such as FEV1/FVC ratio or FEV1 performed within the past 6 months; and, while on maintenance triple therapy with ICS, LABA, and LAMA, has had moderate to severe COPD exacerbations and chronic productive cough for at least 3 months, with both occurring within the past year.Age ≥18; eosinophils ≥300 cells/mcL; pulmonary function tests within 6 months; cough ≥3 months

The 3 months of cough need not be consecutive.

Initial Therapy — CRSwNP

Covered for chronic rhinosinusitis with nasal polyposis when all of the following are met.

Chronic Rhinosinusitis with Nasal Polyposis: Patient is at least 12 years of age; has a diagnosis of chronic rhinosinusitis with nasal polyposis; is inadequately controlled with first-line therapy for inflammation of the paranasal sinuses lasting more than 12 weeks; and Dupixent is used as add-on therapy to intranasal or oral corticosteroids, nasal saline irrigations, and 3–4-week courses of antibiotics.Age ≥12; sinus inflammation >12 weeks; antibiotic courses 3–4 weeks

Progress notes or diagnosis codes may document the diagnosis.

Initial Therapy — CSU

Covered for chronic spontaneous urticaria when all of the following are met.

Chronic Spontaneous Urticaria: Patient is at least 2 years of age; has documented CSU persisting for more than 6 weeks; the underlying cause has been examined and is not another allergic condition; and the patient has tried and failed a first- or second-generation antihistamine alone or with an H2 antagonist.Age ≥2; duration >6 weeks

All listed requirements apply.

Initial Therapy — Eosinophilic Esophagitis

Covered for eosinophilic esophagitis when all of the following are met.

Eosinophilic Esophagitis: Patient is at least 1 year of age and weighs at least 15 kg; has a diagnosis of eosinophilic esophagitis; therapy is prescribed by or provided in consultation with an allergist, pulmonologist, immunologist, or gastroenterologist; has an eosinophil count ≥15 eosinophils per high-power microscopy field; and has dysphagia or a prior history of esophageal dilation.Age ≥1; weight ≥15 kg; tissue eosinophils ≥15 eos/hpf

The diagnosis requirement applies to the request.

Initial Therapy — Prurigo Nodularis

Covered for prurigo nodularis when all of the following are met.

Prurigo Nodularis: Patient is at least 18 years of age; has documented prurigo nodularis with at least 20 nodular lesions; has tried phototherapy; has tried at least one preferred medium- to very-high-potency topical steroid with inadequate response or intolerance; and has tried at least one preferred immunosuppressive agent, including cyclosporine, methotrexate, azathioprine, cyclophosphamide, or tacrolimus.Age ≥18; ≥20 nodular lesions

All listed prerequisite therapies are required.

Continuation Therapy — General Requirements

Continuation coverage requires all general continuation conditions.

General Continuation Requirements: Initial approval criteria were met at therapy initiation; Dupixent is not used with another biologic; dosing is appropriate according to labeling or supported by compendia; and the patient has not experienced treatment-restricting adverse effects.Authorization length: 1 year

These requirements apply to continuation therapy for all indications.

Continuation Therapy — AFRS, Atopic Dermatitis, BP, CRSwNP, and CSU

Continuation coverage for these indications requires documented clinical improvement.

Indication-Specific Continuation Response: For AFRS, atopic dermatitis, bullous pemphigoid, CRSwNP, or CSU, treatment with Dupixent has resulted in clinical improvement documented in progress notes. Atopic dermatitis examples include clinical reduction in pruritus and flares.Clinical improvement documented in progress notes

The applicable indication-specific response must be documented.

Continuation Therapy — Asthma

Continuation coverage for asthma requires all of the following.

Asthma Continuation: Treatment has resulted in clinical improvement documented in progress notes, demonstrated by at least one of decreased rescue-medication use, decreased exacerbation frequency, or reduced asthma-related symptoms; continued ICS plus LABA combination therapy is documented; and the patient is periodically reassessed for the need to continue therapy based on disease severity and/or asthma control.At least 1 documented improvement measure

An exacerbation is worsening asthma requiring increased inhaled corticosteroid dose or systemic corticosteroid treatment.

Chronic Rhinosinusitis with Nasal Polyposis

Continuation therapy for chronic rhinosinusitis with nasal polyposis requires documented clinical improvement.

Clinical Response: Treatment with Dupixent has resulted in clinical improvement documented in the progress notes.Clinical improvement documented in progress notes

Chronic Spontaneous Urticaria

Continuation therapy for chronic spontaneous urticaria requires documented clinical improvement.

Clinical Response: Treatment with Dupixent has resulted in clinical improvement documented in the progress notes.Clinical improvement documented in progress notes

Eosinophilic Esophagitis

Continuation therapy for eosinophilic esophagitis requires documented clinical improvement.

Clinical Response: Treatment with Dupixent has resulted in clinical improvement documented in the progress notes.Clinical improvement documented in progress notes

Prurigo Nodularis

Continuation therapy for prurigo nodularis requires documented clinical improvement by either of the following measures.

Clinical Response

Reduced itch intensity: Reduction in itch intensity
Reduced nodules: Reduction in number of nodules

Chronic Obstructive Pulmonary Disease

Continuation therapy for COPD requires all listed response and concomitant-treatment criteria.

COPD Continuation Criteria

Reduced exacerbations: Reduction in COPD exacerbations
Pulmonary function improvement: Significant improvement in pulmonary function tests compared to baseline
Maintenance triple therapy: Continuation of maintenance triple therapy while on DupixentICS + LABA + LAMA

Dupixent must not be used in combination with other biologics, including Xolair, Remicade, Enbrel, Humira, or similar agents.

Initial Therapy Criteria

Initial Therapy — Indication-Specific Criteria

Initial coverage requires all criteria applicable to the requested indication.

Indication-Specific Initial Criteria: Meet the age, diagnosis, severity, laboratory, specialist, prerequisite-treatment, and documentation requirements for the requested indication.Varies by indication

See the applicable indication-specific criteria set.

Continuation Therapy Criteria

General Continuation Requirements

All continuation requests must meet the following requirements.

General Continuation Requirements: Initial approval criteria were met at initiation; Dupixent is not combined with another biologic; dosing is consistent with labeling or supported by compendia; and no treatment-restricting adverse effects have occurred.One-year authorization

Applies across indications.

Indication-Specific Continuation

For AFRS, atopic dermatitis, bullous pemphigoid, CRSwNP, and CSU, continuation requires documented clinical improvement.

Clinical Response: Progress notes document clinical improvement with Dupixent; for atopic dermatitis, examples include reduced pruritus and flares.Clinical improvement

Clinical Thresholds and Measures

Lund Mackay Sinus CT Score

Unilateral polypsLund Mackay sinus CT score ≥9

Bilateral polypsLund Mackay sinus CT score >12

Required findingEvidence of sinus opacification on the Lund Mackay sinus CT scan

Nasal Polyps Score

Unilateral polypsNasal polyps score ≥2

Bilateral polypsNasal polyps score ≥3

AssessmentNasal polyps score (NPS)

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Dupixent. Initial approval is limited to one year and requires the applicable indication-specific criteria and supporting clinical documentation to be submitted.

Approval requires documentation supporting the requested indication and all applicable clinical criteria.
Dosing must be consistent with labeling or supported by compendia.

Documentation Required

Indication-Specific Response Documentation

For continuation requests, submit progress notes documenting clinical response to Dupixent and any indication-specific response measures. Documentation must support ongoing medical necessity and include the required concomitant therapy when applicable.

AFRS, atopic dermatitis, bullous pemphigoid, CRSwNP, CSU, and EoE: document clinical improvement in progress notes.

Policy Background

Dupixent (dupilumab) is used to treat multiple chronic inflammatory and allergic conditions. This policy establishes prior-authorization requirements for initial and continuation therapy across specified dermatologic, respiratory, sinonasal, gastrointestinal, and allergic conditions. Continuation of therapy requires documented clinical improvement; COPD continuation also requires objective pulmonary improvement and continued maintenance therapy.

Required Prerequisite Therapies

Indication	Required prerequisite therapy	Duration	Failure or response requirement
Atopic dermatitis	At least one preferred medium- to very-high-potency topical steroid and at least one preferred topical calcineurin inhibitor	Minimum 4 weeks for each therapy	Inadequate response or intolerance to each therapy

Indication	Required prerequisite therapy	Duration	Failure or response requirement
Asthma	Inhaled corticosteroid plus long-acting beta2-agonist (LABA) combination therapy	Minimum 3 months	Ongoing asthma symptoms

Indication	Required prerequisite therapy	Duration	Failure or response requirement
Chronic spontaneous urticaria (CSU)	First- or second-generation antihistamine alone or in combination with an H2 antagonist	Not specified	Trial and failure

Indication	Required prerequisite therapy	Duration	Failure or response requirement
Prurigo nodularis	Phototherapy; at least one preferred medium- to very-high-potency topical steroid; and at least one preferred immunosuppressive agent	Not specified	Inadequate response or intolerance to the topical steroid; failure of the immunosuppressive-agent trial

Indication	Required prerequisite therapy	Duration	Failure or response requirement
Bullous pemphigoid	Standard treatment with corticosteroids or immunosuppressive agents	Not specified	Failure of corticosteroids or immunosuppressive agents, or significant complications from standard treatment, such as diabetes or steroid-induced osteoporosis

Indication	Required prerequisite therapy	Duration","Dupixent use requirement
Chronic rhinosinusitis with nasal polyposis (CRSwNP)	Intranasal or oral corticosteroids, nasal saline irrigations, and antibiotic courses	Antibiotic courses: 3–4 weeks	Inadequately controlled with first-line therapy; Dupixent must be added to the first-line regimen

Policy Summary

PayerAgency for Health Care Administration

PolicyDupixent (dupilumab) Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all applicable indication-specific criteria are met.

SourceLink

On This Page

Apply to the relevant indication.

Asthma Continuation

Asthma continuation requires all of the following.

Asthma Continuation: Progress notes document clinical improvement shown by decreased rescue-medication use, decreased exacerbation frequency, or reduced asthma-related symptoms; continued ICS plus LABA use is documented; and the patient is periodically reassessed for continued need based on disease severity and asthma control.At least one improvement outcome

An exacerbation is worsening asthma requiring increased inhaled corticosteroid dose or systemic corticosteroid treatment.

Chronic Rhinosinusitis with Nasal Polyposis

Continuation requires documented clinical improvement.

Clinical Response: Treatment with Dupixent has resulted in clinical improvement documented in the progress notes.Clinical improvement documented in progress notes

Chronic Spontaneous Urticaria

Continuation requires documented clinical improvement.

Clinical Response: Treatment with Dupixent has resulted in clinical improvement documented in the progress notes.Clinical improvement documented in progress notes

Eosinophilic Esophagitis

Continuation requires documented clinical improvement.

Clinical Response: Treatment with Dupixent has resulted in clinical improvement documented in the progress notes.Clinical improvement documented in progress notes

Prurigo Nodularis

Continuation requires documented clinical improvement by at least one response measure.

Clinical Response

Reduced itch intensity: Reduction in itch intensity
Reduced nodules: Reduction in number of nodules

Chronic Obstructive Pulmonary Disease

Continuation requires objective COPD improvement and continued maintenance triple therapy.

COPD Continuation Criteria: Reduction in COPD exacerbations, significant improvement in pulmonary function tests compared to baseline, and documented continuation of maintenance triple therapy while on Dupixent.ICS + LABA + LAMA

Maintenance triple therapy consists of an inhaled corticosteroid, long-acting beta agonist, and long-acting muscarinic antagonist.

Asthma Blood Eosinophil Count

Minimum count≥150 cells/mcL

Applicable pathwayEosinophilic phenotype asthma

DocumentationBlood eosinophil count documentation is required

COPD Blood Eosinophil Count

Minimum baseline count≥300 cells/mcL

Applicable conditionCOPD with an eosinophilic phenotype

DocumentationBaseline blood eosinophil count documentation is required

Eosinophilic Esophagitis Tissue Eosinophil Count

Minimum tissue count≥15 eosinophils per high-power microscopy field

Abbreviation≥15 eos/hpf

Applicable conditionEosinophilic esophagitis

Prurigo Nodularis Lesions

Minimum lesion count≥20 nodular lesions

Applicable conditionDocumented prurigo nodularis

AssessmentNodular lesion count

Asthma: document decreased rescue-medication use, fewer exacerbations, or reduced asthma-related symptoms, and continued inhaled corticosteroid/LABA use.

Prurigo nodularis: document reduced itch intensity or reduced number of nodules.

COPD: document reduced exacerbations, significant improvement in pulmonary function compared with baseline, and continued maintenance triple therapy.

Step Therapy

Atopic Dermatitis Topical Therapy Trials

For atopic dermatitis, document the required topical-treatment trials and inadequate response or intolerance before requesting Dupixent.

At least 4 weeks of a preferred medium- to very-high-potency topical corticosteroid, with inadequate response or intolerance.
At least 4 weeks of a preferred topical calcineurin inhibitor, with inadequate response or intolerance.

Step Therapy

Asthma Controller Therapy Trial

For asthma, document ongoing symptoms despite a minimum three-month trial of combination inhaled corticosteroid and long-acting beta2-agonist therapy.

The trial must be an inhaled corticosteroid plus LABA combination.
For an eosinophilic phenotype, submit blood eosinophil documentation of at least 150 cells/mcL.

Step Therapy

CRSwNP First-Line Therapy

For CRSwNP, document inadequate control with first-line therapy and that Dupixent will be used as add-on treatment to the patient's current first-line regimen.

First-line therapy includes intranasal or oral corticosteroids, nasal saline irrigations, and 3- to 4-week courses of antibiotics.
Submit documentation of the current first-line therapy.

Step Therapy

CSU Antihistamine Trial

For CSU, document a trial and failure of antihistamine therapy before requesting Dupixent.

Trial of a first- or second-generation antihistamine alone or in combination with an H2 antagonist.
Document that the patient failed the trial.

Step Therapy

Prurigo Nodularis Prerequisite Therapy

For prurigo nodularis, document the required prerequisite therapies before requesting Dupixent.

Trial of phototherapy.
Trial of at least one preferred medium- to very-high-potency topical steroid.
Trial of at least one preferred immunosuppressive agent: cyclosporine, methotrexate, azathioprine, cyclophosphamide, or tacrolimus.

Step Therapy

Bullous Pemphigoid Standard-Treatment Failure

For bullous pemphigoid, document failure of standard treatment or significant complications from standard treatment before requesting Dupixent.

Corticosteroids or immunosuppressive agents must have failed, or the patient must have experienced significant complications such as diabetes or steroid-induced osteoporosis.

Documentation Required

Prerequisite-Treatment Documentation

When prerequisite trials are specified, clinical documentation of those trials is required with the request. Documentation should identify the therapy, duration when specified, treatment outcome, and any intolerance or complication.

Submit documentation for required topical-steroid, calcineurin-inhibitor, inhaled corticosteroid/LABA, antihistamine, phototherapy, topical-steroid, immunosuppressive-agent, and standard-treatment trials, as applicable.
For CRSwNP, submit current first-line therapy documentation.
For bullous pemphigoid, submit documentation of treatment failure or significant treatment complications.

Documentation Required

Asthma Laboratory Documentation

For asthma with an eosinophilic phenotype, submit laboratory documentation of the blood eosinophil count.

Required threshold: at least 150 cells/mcL.

Documentation Required

COPD Laboratory and Pulmonary-Function Documentation

For COPD, submit laboratory and pulmonary-function documentation supporting the eosinophilic phenotype and airflow limitation.

Baseline blood eosinophil count must be at least 300 cells/mcL.
Pulmonary-function testing, such as FEV1/FVC ratio and FEV1, must have been performed within the past 6 months and confirm moderate to severe airflow limitation.

Documentation Required

CRSwNP Current-Therapy Documentation

For CRSwNP, document the patient's current first-line therapy to establish that Dupixent is being used as add-on treatment.

Submit current use of intranasal or oral corticosteroids, nasal saline irrigations, and 3- to 4-week courses of antibiotics, as applicable.

Documentation Required

Eosinophilic Esophagitis Documentation

For EoE, submit documentation supporting the diagnosis and required disease features.

Eosinophil count must be at least 15 eosinophils per high-power microscopic field (eos/hpf).
Document symptoms of dysphagia or a prior history of esophageal dilation.
Diagnosis must be documented; prescribing may be by or in consultation with an allergist, pulmonologist, immunologist, or gastroenterologist.

Documentation Required

Bullous Pemphigoid Diagnostic Documentation

For bullous pemphigoid, submit diagnostic documentation confirming the condition by biopsy and pathology report.

The diagnosis must be proven by biopsy.
Include the confirming pathology report.

Documentation Required

Continuation Response Documentation

Continuation requests must document that initial approval criteria were met, Dupixent remains appropriately dosed, the patient has not experienced treatment-restricting adverse effects, and the patient is responding to therapy. Patients should be periodically reassessed for continued treatment based on disease severity and, for asthma, level of control.

Submit progress notes documenting clinical improvement for the applicable indication.
For asthma, document response through reduced rescue-medication use, fewer exacerbations, or reduced asthma-related symptoms.
Document continued inhaled corticosteroid/LABA combination therapy for asthma.

Documentation Required

Document Clinical Response

Document indication-specific clinical improvement in progress notes for each continuation request.

AFRS, atopic dermatitis, bullous pemphigoid, CRSwNP, CSU, and EoE: document clinical improvement.
Asthma: document decreased rescue-medication utilization, decreased exacerbation frequency, or reduced symptoms such as wheezing, shortness of breath, coughing, fatigue, sleep disturbance, or symptoms on awakening.
Prurigo nodularis: document reduced itch intensity or reduced number of nodules.

Documentation Required

Document COPD Response and Concomitant Therapy

For COPD continuation, document improvement in lung function and exacerbation control compared with baseline, together with continued maintenance triple therapy.

Document reduced COPD exacerbations and significant improvement in pulmonary-function tests compared with baseline.
Document continued inhaled corticosteroid, LABA, and LAMA therapy while receiving Dupixent.

Unsupported block type: denial_risk

Denial Risk

Indication Criteria Not Met

Requests may be denied when the applicable indication-specific requirements are not satisfied or cannot be supported by documentation.

AFRS: age, diagnosis, prior sino-nasal surgery, required LMK sinus CT score, and nasal-polyp score criteria must be met.
Atopic dermatitis, asthma, BP, COPD, CRSwNP, CSU, EoE, and prurigo nodularis: all applicable age, diagnosis, disease-severity, laboratory, pulmonary-function, prerequisite-therapy, and specialist or response requirements must be met.
CRSwNP requires inadequate control with first-line therapy and current first-line therapy documentation.
COPD requires eosinophilic phenotype, eosinophil count of at least 300 cells/mcL, recent pulmonary-function testing, qualifying exacerbations and cough, and maintenance triple therapy.
EoE requires at least 15 eos/hpf plus dysphagia or prior esophageal dilation; BP requires biopsy confirmation and a pathology report.

Denial Risk

Continuation Criteria Not Met

Continuation requests may be denied when continuation requirements are not met or when the request lacks evidence of ongoing medical necessity.

Initial approval criteria were not met at initiation or cannot be verified.
Required clinical improvement or indication-specific response documentation is absent.
Dupixent is being combined with another biologic, dosing is not label- or compendia-supported, or treatment-restricting adverse effects have occurred.