Currentmedical mutual - ohioPolicy 201704_MRx

Dupixent (dupilumab) — Corporate prior authorization and site-of-care policy

Corporate drug policy for prior authorization and site-of-care management of Dupixent for multiple FDA‑approved indications; affects prescribers and facilities seeking medical or pharmacy benefit coverage from Medical Mutual - Ohio.

Policy Summary

Payermedical mutual - ohio

PolicyDupixent (dupilumab) — Corporate prior authorization and site-of-care policy

Policy CodePolicy 201704_MRx

Change TypeNo material change

Effective DateMay 21, 2017

Next Review DateJul 17, 2025

Key ActionObtain prior authorization and document specialist prescribing or consultation per indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultipleIndications listed

Prior authCoverage process

RestrictionSite-of-care

UsuallySpecialist required

J3590, C9399Codes requiring approval

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Coverage Criteria for Dupixent (dupilumab)

Asthma

Covered when ONE of the following indication-specific branches is met.

Asthma Initial criteria: i. Patient is ≥ 6 years of age; AND ii. Patient meets ONE of the following (a or b): a) Patient meets ONE of the following (1 or 2): (1) Patient has a blood eosinophil level ≥ 150 cells per microliter within the previous 6 weeks; OR (2) Patient had a blood eosinophil level ≥ 150 cells per microliter prior to treatment with Dupixent or another monoclonal antibody therapy that may alter blood eosinophil levels; OR b) According to the prescriber, the patient has oral (systemic) corticosteroid-dependent asthma (e.g., received ≥ 5 mg oral prednisone or equivalent per day for ≥ 6 months); AND iii. Patient has received at least 3 consecutive months of combination therapy with BOTH of the following: a) an inhaled corticosteroid; AND b) at least one additional asthma controller or asthma maintenance medication; AND iv. Patient has uncontrolled asthma as demonstrated by ONE or more of: a) two or more exacerbations requiring systemic corticosteroids in the prior year; OR b) one or more exacerbations requiring hospitalization/ED/urgent care in the prior year; OR c) FEV1 < 80% predicted; OR d) FEV1/FVC < 0.80; OR e) asthma that worsens on tapering systemic corticosteroids; AND v. Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist.

Asthma Continued Therapy

Asthma Continued criteria: i. Patient has already received at least 6 months of therapy with Dupixent; AND ii. Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler; AND iii. Patient has responded to therapy as determined by the prescriber (examples: decreased exacerbations, symptoms, hospitalizations, or oral steroid requirement).

Atopic Dermatitis

Covered when ONE of the following branches is met.

Atopic Dermatitis Initial

Atopic Dermatitis Initial criteria: i. Patient is ≥ 6 months of age; AND ii. Patient meets ONE of the following: a) atopic dermatitis involvement ≥ 10% body surface area; OR b) both (1) moderate to severe hand and/or foot atopic dermatitis AND (2) patient is ≥ 12 years of age; AND iii. Patient meets two of the following three: a) did not respond adequately to (or is not a candidate for) a 3-month minimum trial of topical agents; OR b) did not respond adequately to (or is not a candidate for) a 3-month minimum trial of at least one systemic agent; OR c) did not respond adequately to (or is not a candidate for) a 3-month minimum trial of phototherapy; AND iv. Medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist.

Atopic Dermatitis Continued

Atopic Dermatitis Continued criteria: i. Patient has already received at least 4 months of therapy with Dupixent; AND ii. Patient has responded to therapy as determined by the prescriber (examples: marked improvement in erythema, induration/papulation/edema, excoriations, lichenification, reduced pruritus, decreased need for other therapies, or reduced BSA).

Bullous Pemphigoid

Bullous Pemphigoid Initial criteria: i. Patient is ≥ 18 years of age; AND ii. Diagnosis confirmed by serum tests detecting circulating anti-basement membrane zone antibodies via indirect immunofluorescence (IIF) and enzyme-linked immunosorbent assay (ELISA); AND iii. Patient had an inadequate response to, or is unsuitable for, stand-alone treatment with oral corticosteroids; AND iv. Medication is prescribed by or in consultation with a dermatologist.
Bullous Pemphigoid Continued criteria: i. Patient has already received at least 6 months of therapy with Dupixent; AND ii. Patient has experienced a beneficial clinical response defined by one of: decreased area of skin involvement; decreased lesions including blisters/erosions; decreased urticaria; decreased erythema; or reduced/no need for systemic or topical corticosteroid therapy.

Chronic Obstructive Pulmonary Disease (COPD)

COPD

COPD Initial criteria: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of the following: a) blood eosinophil level ≥ 300 cells/µL within the previous 6 weeks; OR b) blood eosinophil level ≥ 300 cells/µL prior to treatment with Dupixent or another monoclonal antibody therapy that may alter eosinophil levels; AND iii. Patient meets ONE of the following: a) has received at least 3 consecutive months of combination therapy with ALL of: inhaled LABA, inhaled LAMA, and inhaled corticosteroid (ICS); OR b) has received at least 3 consecutive months of combination therapy with an inhaled LABA and inhaled LAMA and, according to the prescriber, has a contraindication to an inhaled corticosteroid; AND iv. According to the prescriber, patient has signs or symptoms of chronic bronchitis (e.g., chronic productive cough) for ≥ 3 months in the previous 12 months; AND v. Patient meets ONE of the following: a) experienced two or more COPD exacerbations requiring systemic corticosteroid and/or antibiotic in the prior 12 months (with at least one treated with systemic corticosteroid) while on combination therapy with ICS+LAMA+LABA (or LAMA+LABA if ICS contraindicated); OR b) experienced one or more COPD exacerbations requiring hospitalization in the prior 12 months; AND vi. Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist.
COPD Continued criteria: i. Patient has already received at least 6 months of therapy with Dupixent; AND ii. Patient continues to receive combination therapy with an inhaled LABA and LAMA (single-entity or combination inhalers acceptable); AND iii. Patient has experienced a beneficial clinical response defined by one of: reduced COPD symptoms; reduced COPD exacerbations; reduced COPD-related hospitalizations; reduced ED/urgent care visits; or improved lung function parameters.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

CRSwNP

CRSwNP Initial criteria: i. Patient is ≥ 12 years of age; AND ii. Chronic rhinosinusitis with nasal polyps evidenced by direct exam, endoscopy, or sinus CT; AND iii. Patient has experienced two or more symptoms (nasal congestion, obstruction, discharge, or loss of smell) for at least 12 weeks; AND iv. Patient has received at least 4 weeks of intranasal corticosteroid therapy AND will continue intranasal corticosteroid therapy with Dupixent; AND v. Patient meets ONE of: a) at least one systemic corticosteroid course (≥5 days) within previous 2 years; OR b) contraindication to systemic corticosteroids; OR c) prior surgery for nasal polyps; AND vi. Medication prescribed by or in consultation with an allergist, immunologist, or otolaryngologist (ENT).
CRSwNP Continued criteria: i. Patient has already received at least 6 months of therapy with Dupixent; AND ii. Patient continues to receive therapy with an intranasal corticosteroid; AND iii. Patient has responded to therapy as determined by the prescriber (examples: reduced polyp size, improved nasal congestion, reduced sinonasal symptoms, improved sense of smell).

Chronic Spontaneous Urticaria

Chronic Spontaneous Urticaria Initial criteria: i. Patient is ≥ 12 years of age; AND ii. Patient has had urticaria for > 6 weeks with symptoms > 3 days/week despite daily non-sedating H1 antihistamine therapy titrated up to 4x the standard dose; AND iii. Medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist.
Chronic Spontaneous Urticaria Continued criteria: i. Patient has already received at least 6 months of therapy with Dupixent; AND ii. Patient has experienced a beneficial clinical response defined by one of: decreased itch severity; decreased number of hives; or decreased size of hives.

Eosinophilic Esophagitis

EoE Initial criteria: i. Patient is ≥ 1 year of age; AND ii. Patient weighs ≥ 15 kg; AND iii. Diagnosis confirmed by endoscopic biopsy demonstrating ≥ 15 intraepithelial eosinophils per high-power field; AND iv. Patient does not have a secondary cause of eosinophilic esophagitis; AND v. Patient has received at least 8 weeks of therapy with a proton pump inhibitor; AND vi. Patient meets one of the following: a) received at least 8 weeks of topical (esophageal) corticosteroid; OR b) has adrenal insufficiency; OR c) has history of oral candidiasis; AND vii. Patient has tried dietary modifications to treat/manage EoE OR provider has determined patient is not an appropriate candidate for dietary modifications; AND viii. Medication is prescribed by or in consultation with an allergist or gastroenterologist.
EoE Continued criteria: i. Patient has already received at least 6 months of therapy with Dupixent; AND ii. Patient has experienced a beneficial clinical response defined by one of: reduced intraepithelial eosinophil count; decreased dysphagia/pain on swallowing; or reduced frequency/severity of food impaction.

Eosinophilic Esophagitis — Continuation Therapy

Prurigo Nodularis

Prurigo Nodularis Initial criteria: i. Patient is ≥ 18 years of age; AND ii. Patient has ≥ 20 identifiable nodular lesions in total on both arms and/or both legs and/or trunk; AND iii. Patient has experienced pruritus for ≥ 3 months; AND iv. Patient meets ONE of the following: a) PN is not medication-induced or secondary to a non-dermatologic condition; OR b) secondary cause has been identified and adequately managed; AND v. Patient meets two of the following three: a) did not respond adequately to (or is not a candidate for) a 3-month minimum trial of topical agents; OR b) did not respond adequately to (or is not a candidate for) a 3-month minimum trial of at least one systemic agent; OR c) did not respond adequately to (or is not a candidate for) a 3-month minimum trial of phototherapy; AND vi. Medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist.

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Prurigo Nodularis — Initial and Continuation

Approve for 6 months if BOTH of the following are met

Prurigo Nodularis initial: Patient is >=18 years; has >=20 identifiable nodular lesions on specified body areas; has experienced pruritus >=3 months; PN is not medication-induced or secondary to non-dermatologic cause OR secondary cause identified and managed; meets two of three prior therapy failure/candidate criteria; medication prescribed by or in consultation with allergist, immunologist, or dermatologist

Prior therapies: 3-mo trials of topical agents, at least one systemic agent, and phototherapy; must meet two of three

Prurigo Nodularis response (continuation): For patients currently receiving Dupixent: must have had >=6 months therapy and experienced a beneficial clinical response defined by reduced nodular lesion count, decreased pruritus, or reduced lesion size>=6 months

Continuation approvals for 1 year if response demonstrated

Management of Immune Checkpoint Inhibitor-Related Toxicity

Approve for 6 months if BOTH are met

ICI-related toxicity: Patient has been receiving an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, nivolumab/relatlimab-rmbw, etc.); AND Patient has refractory and severe (grade 3) pruritus (intense or widespread, constant, limiting self-care activities or sleep)grade 3

Duration: 6 months

The policy specifies a Limitation of Use for Dupixent: it is not indicated for the relief of acute bronchospasm or status asthmaticus. The Limitation of Use applies to asthma-related acute events and is explicitly noted in the indication summary for both asthma and COPD where acute bronchospasm relief is not an approved use.

Concurrent use of Dupixent with other monoclonal antibody therapies or with Janus kinase (JAK) inhibitors (oral or topical) is not recommended because efficacy and safety of these combinations have not been established. The policy lists example monoclonal antibodies and JAK inhibitors and instructs that such combinations are conditions for which coverage is not recommended.

The policy also clarifies that Dupixent is not indicated for the management of peanut allergy and that available studies have not demonstrated sufficient benefit to support coverage for peanut allergy management.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. The policy notes that these criteria will be updated as new evidence becomes available and that uses outside the listed, evidence-supported indications should not be approved under the current policy.

Based on current evidence summarized in the policy, Dupixent is not recommended for management of peanut allergy. The policy references clinical trial data showing lack of meaningful desensitization with Dupixent monotherapy and limited benefit when combined with peanut oral immunotherapy, supporting the exclusion of peanut allergy as an approved indication.

Coding and Billing Codes

Listed HCPCS CodesHCPCS

J3590	HCPCS unspecified code (listed in policy header)
C9399	HCPCS unclassified drug or biological (listed in policy header)

Prior authorization HCPCS CodesHCPCSCovered

J3590	Unclassified biologic
C9399	Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

Product NDCsNDC

00024-5914-xx	Dupixent 300 mg/2 mL single-dose pre-filled syringe with needle shield (2-pack) NDC
00024-5918-xx	Dupixent 200 mg/1.14 mL single-dose pre-filled syringe with needle shield (2-pack) NDC
00024-5911-xx	Dupixent 100 mg/0.67 mL single-dose pre-filled syringe with needle shield (2-pack) NDC
00024-5915-xx	Dupixent 300 mg/2 mL single-dose pre-filled Pen (2-pack) NDC
00024-5919-xx	Dupixent 200 mg/1.14 mL single-dose pre-filled Pen (2-pack) NDC

inv-19: Blood eosinophil thresholds — asthma and COPD thresholds and timing

Asthma blood eosinophil threshold≥150 cells/µL within the previous 6 weeks (or ≥150 cells/µL prior to treatment with Dupixent or another monoclonal antibody that may alter counts)

COPD blood eosinophil threshold≥300 cells/µL within the previous 6 weeks (or ≥300 cells/µL prior to treatment with Dupixent or another monoclonal antibody that may alter counts)

Timing for eosinophil measurementWithin the previous 6 weeks, or use a documented pre‑treatment value if monoclonal antibody therapy may have altered counts

inv-20: Eosinophilic esophagitis biopsy threshold — ≥15 intraepithelial eosinophils per high-power field

Eosinophilic esophagitis biopsy thresholdDiagnosis confirmed by endoscopic biopsy demonstrating ≥15 intraepithelial eosinophils per high‑power field

Diagnostic requirement contextBiopsy requirement is part of initial therapy criteria for EoE (age ≥1 year and weight ≥15 kg also required)

Related testing noteSecondary causes of EoE must be excluded (examples listed in policy) prior to approval

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Site-of-Care

Prior authorization is required for Dupixent when billed under the medical benefit (HCPCS J3590, C9399). Site-of-care management applies and administration is restricted to non-hospital facility-based locations unless site-of-care exception criteria are met. Initial requests must be submitted with documentation that meets the criteria in this policy; nurse reviewers will authorize when criteria are met and physician review will occur for requests that do not meet criteria.

Prior approval required for HCPCS J3590 and C9399
Site-of-care restrictions apply; see site-of-care exception criteria

Prior Authorization

Prior Authorization Required for Unclassified Codes

When Dupixent is billed using unclassified HCPCS (J3590) or unclassified hospital outpatient drug code (C9399), prior approval is required and requests will be subject to review to confirm the drug is Dupixent and that criteria are met. Claims may pend with remark codes (e.g., M3M, M4M) and will be adjudicated per the Corporate Medical Policy.

HCPCS J3590 and C9399 require prior approval
Claims may pend with Remark Code M3M or M4M

Step Therapy

Required Prior / Concomitant Therapies

Required prior or concomitant therapies vary by indication. Examples include: for asthma — documented trials of an inhaled corticosteroid plus at least one additional controller/maintenance medication (minimum 3 months); for eosinophilic esophagitis — at least 8 weeks of proton pump inhibitor therapy and trial of topical (esophageal) corticosteroid unless contraindicated; for chronic rhinosinusitis with nasal polyps — at least 4 weeks of intranasal corticosteroid and continued concomitant intranasal corticosteroid therapy. For some indications, systemic corticosteroid dependence or prior use may also be required as noted in the indication-specific criteria.

Asthma: ≥3 months ICS + additional controller/maintenance therapy
Eosinophilic esophagitis: ≥8 weeks PPI and topical esophageal steroid trial (or documented contraindication)
Chronic rhinosinusitis with nasal polyps: ≥4 weeks intranasal corticosteroid and continued concomitant use

Documentation Required

Diagnosis Confirmation and Specialist Prescriber Requirements

For several indications, diagnostic confirmation is required prior to approval. Examples include bullous pemphigoid (diagnosis confirmed by serum testing for circulating anti-basement membrane zone antibodies via IIF and ELISA) and eosinophilic esophagitis (diagnosis confirmed by endoscopic biopsy demonstrating ≥ 15 intraepithelial eosinophils per high-power field). Prescriptions for initial therapy should be by or in consultation with a specialist appropriate to the condition (e.g., dermatologist, allergist, gastroenterologist).

Bullous pemphigoid: IIF and ELISA serum testing required to confirm diagnosis
Eosinophilic esophagitis: endoscopic biopsy with ≥15 intraepithelial eosinophils per HPF required
Specialist prescriber or consultation required for initial therapy

Denial Risk

Documentation Supporting Medical Necessity and Denial Risk

The Company may request additional documentation to support medical necessity and to complete coverage determinations. Requested documentation may include patient medical records, diagnostic test results (e.g., biopsy reports, laboratory values such as blood eosinophil counts), treatment history, and provider credentials. The Company may deny reimbursement if the drug or services are not medically necessary, investigational, experimental, outside the member’s coverage, or if billing practices are inappropriate or excessive. Providers are responsible for supplying requested documentation; participating providers may be required to write off charges denied as not medically necessary.

Documentation may include patient records, test results, and provider credentials
Company may deny reimbursement if services are not medically necessary, investigational, or outside benefit coverage
Participating providers may be required to write off charges denied as not medically necessary

Denial Risk

Drug Combination Exclusions

Dupixent is not recommended for concurrent use with other monoclonal antibody therapies or with Janus Kinase (JAK) inhibitors (oral or topical). Examples of monoclonal antibodies and JAK inhibitors are listed in the policy; combination use with these agents is not supported due to lack of established safety and efficacy.

Do not prescribe Dupixent concurrently with other monoclonal antibody therapies (e.g., Adbry, Cinqair, Ebglyss, Fasenra, Nemluvio, Nucala, Tezspire, Xolair)
Do not prescribe Dupixent concurrently with JAK inhibitors (e.g., Cibinqo, Leqselvi, Rinvoq, Opzelura)

Background

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist that modulates type 2 inflammatory signaling. It has multiple FDA-approved indications as an add-on maintenance treatment across allergic, dermatologic, and respiratory conditions, including asthma (≥6 years), atopic dermatitis (≥6 months), bullous pemphigoid (≥18 years), COPD with eosinophilic phenotype (≥18 years), CRSwNP (≥12 years), chronic spontaneous urticaria (≥12 years), eosinophilic esophagitis (≥1 year and ≥15 kg), and prurigo nodularis (≥18 years).

Definitions and Key Terms

inv-31: Baseline definition — Baseline defined as prior to receiving Dupixent or another monoclonal antibody therapy for asthma.

Baseline definition (asthma)Baseline is defined as prior to receiving Dupixent or another monoclonal antibody therapy for asthma.

Examples of monoclonal antibodiesExamples include Dupixent, Cinqair, Fasenra, Nucala, Tezspire, and Xolair (these may alter eosinophil counts)

Use of baseline valuesPre‑treatment (baseline) eosinophil values may be used when recent values are affected by prior monoclonal antibody therapy

inv-32: Beneficial clinical response — Defined per indication by clinical or histologic measures (e.g., EoE response metrics).

General definitionBeneficial clinical response is defined per indication by clinical or histologic measures (examples differ by disease)

EoE example responsesReduced intraepithelial eosinophil count; decreased dysphagia/pain on swallowing; or reduced frequency/severity of food impaction

Prurigo nodularis example responsesReduced nodular lesion count; decreased pruritus; or reduced nodular lesion size

inv-33: Initial vs Continuation Therapy — Initial approvals prerequisites and durations vs continuation response-based criteria.

Initial therapy — prerequisitesInitial approvals require indication‑specific prerequisites (examples: age requirements, diagnostic confirmation, prior therapy trials such as ≥3 months of inhaled corticosteroid + additional controller for asthma; EoE requires biopsy ≥15 eos/hpf and prior PPI/topical steroid trials)

Initial approval durationTypically approve initial therapy for 6 months for many indications (some initial approvals may be 4 months per indication-specific language)

Continuation therapy — requirementsContinuation generally requires the patient has received ≥6 months of Dupixent and documented beneficial clinical response; continuation approvals are typically for 1 year

Continuation evidenceResponse assessment may include symptom improvement, reduced exacerbations or steroid use (asthma), histologic improvement (EoE), or lesion/pruritus reduction (prurigo nodularis)