Dupixent (dupilumab)

POLICY NUMBER

L.5.01.513

Dupixent (dupilumab)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Dupixent (dupilumab) is a human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by binding to the IL-4R alpha subunit shared by IL-4 and IL-13 receptor complexes. This reduces IL-4 and IL-13 cytokine-induced inflammatory response, such as the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE.

Dupixent (dupilumab) is indicated for the following:

• Treatment of individuals aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable;

• As an add-on maintenance treatment in individuals with moderate-to-severe asthma aged 6 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma;

• As an add-on maintenance treatment in individuals 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP);

• Treatment of eosinophilic esophagitis in patients at least 1 year of age and weighing at least 15kg;

• Treatment of adults with prurigo nodularis;

• As an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Related policies -

• Interleukin-5 Antagonist Monoclonal Antibodies

• Atopic Dermatitis

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Criteria

Dupixent (dupilumab) may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual has a diagnosis of moderate-to-severe atopic dermatitis and ALL of the following:

      1. The individual is at least 6 months of age or older;

      2. ONE of the following:

         1. The individual has at least 10% body surface area involvement; OR

         2. The individual has involvement of the palms of the hands and/or soles of the feet;

      3. ONE of the following:

         1. The individual has tried and failed (see definition of Failure in Policy Guidelines section) a systemic immunosuppressant or phototherapy for atopic dermatitis within the last 180 days (e.g., methotrexate, azathioprine, mycophenolate mofetil, cyclosporine);

         2. The individual has tried and failed (see definition of Failure in Policy Guidelines section) at least a medium-potency topical steroid for a minimum of 4 weeks AND a topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) for maintenance therapy for a minimum of 6 weeks within the last 180 days;

         3. The individual has a documented intolerance, FDA-labeled contraindication, or hypersensitivity to all systemic immunosuppressants, phototherapies, mid-potency topical steroids, AND topical calcineurin inhibitors; OR

         4. The individual’s medication history includes use of another biologic immunomodulator agent for the treatment of AD.

      4. The prescriber has assessed and documented the individual's baseline pruritus and other symptom severity (e.g., erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification); AND

      5. The individual will be using standard maintenance therapy (e.g., topical emollients, good skin care practices) in combination with the requested agent;

   2. The individual has a diagnosis of moderate-to-severe asthma and ALL of the following:

      1. The individual is 6 years of age or older;

      2. ONE of the following:

         1. The individual has eosinophilic type asthma and ONE of the following:

            1. Baseline (prior to therapy with the requested agent) eosinophilic blood count ≥150 cells/microliter while on high-dose inhaled corticosteroids or daily oral corticosteroids;

            2. Fraction of exhaled nitric oxide (FeNO) of 20 parts per billion or higher while on high-dose inhaled corticosteroids or daily oral corticosteroids; OR

            3. Sputum eosinophils 2% or higher while on high-dose inhaled corticosteroids or daily oral corticosteroids; OR

         2. The individual has oral corticosteroid-dependent asthma;

      3. The individual has uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:

         1. Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months;

         2. Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months;

         3. Controlled asthma that worsens when the doses of inhaled or systemic corticosteroids are tapered; OR

         4. The individual has a baseline forced expiratory volume (FEV1) <80% predicted;

      4. ONE of the following:

         1. The individual is NOT currently being treated with the requested agent AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months AND has been adherent for 90 days within the past 120 days;

         2. The individual is currently being treated with the requested agent and ONE of the following:

            1. Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms AND has been adherent for 90 days within the past 120 days; OR;

            2. Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months AND has been adherent for 90 days within the past 120 days; OR

         3. The individual has a documented intolerance, FDA-labeled contraindication, or hypersensitivity to ALL inhaled corticosteroids;

      5. ONE of the following:

         1. The individual is currently being treated (>3 months) AND has been adherent for 90 days within the past 120 days with ONE of the following:

            1. A long-acting beta-2 agonist (LABA);

            2. A leukotriene receptor antagonist (LTRA);

            3. Long-acting muscarinic antagonist (LAMA); OR

            4. Theophylline; OR

         2. The individual has a documented intolerance, hypersensitivity, or FDA-labeled contraindication to ALL of the following: LABA, LTRA, LAMA, AND theophylline; AND

      6. The individual will continue asthma control therapy (e.g., ICS, ICS/LABA, LABA, LTRA, LAMA, theophylline) in combination with the requested agent;

   3. The individual has a diagnosis of chronic obstructive pulmonary disease (COPD) and ALL of the following:

      1. The individual’s diagnosis was confirmed by spirometry with a post-bronchodilator FEV1/FVC ratio less than 0.7;

      2. The individual has a post-bronchodilator FEV1 between 30 to 70% predicted;

      3. The individual has a baseline (prior to therapy with the requested agent) blood eosinophilic count of 300 cells/microliter or higher;

      4. The individual has a history of inadequately controlled COPD while on COPD inhaled maintenance therapy as demonstrated by ONE of the following:

         1. Frequent COPD exacerbations requiring one or more courses of systemic corticosteroids within the past 12 months; OR

         2. A severe COPD exacerbation requiring hospitalization, mechanical ventilation, or visit to the emergency room/urgent care within the past 12 months;

      5. ONE of the following:

         1. The individual is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months AND has been adherent for 90 days within the past 120 days; OR

         2. The individual has an intolerance, hypersensitivity, or FDA-labeled contraindication to ALL inhaled corticosteroids;

      6. ONE of the following:

         1. The individual is currently treated with a long-acting muscarinic antagonist (LAMA) AND a long-acting beta-2 agonist (LABA) used in combination for at least 3 months AND has been adherent for 90 days within the past 120 days; OR

         2. The individual has an intolerance, hypersensitivity, or FDA-labeled contraindication to ALL long-acting muscarinic antagonists (LAMA) and long-acting beta-2 agonists (LABA); AND

      7. The individual with continue COPD inhaled maintenance therapy (e.g., ICS/LAMALABA triple therapy, LAMA/LABA) in combination with the requested agent;

   4. The individual has a diagnosis of inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) and ALL of the following:

      1. The individual is 12 years of age or older;

      2. Diagnosis was confirmed by ONE of the following:

         1. Anterior rhinoscopy or endoscopy; OR

         2. Computed tomography (CT) of the sinuses;

      3. The individual has at least TWO of the following symptoms consistent with chronic rhinosinusitis (CRS):

         1. Nasal discharge (rhinorrhea or post-nasal drainage);

         2. Nasal obstruction or congestion;

         3. Loss or decreased sense of smell (hyposmia); OR

         4. Facial pressure or pain;

      4. The individual has had symptoms consistent with chronic rhinosinusitis (CRS) for at least 12 consecutive weeks;

      5. ONE of the following:

         1. The individual has tried and had an inadequate response to ONE intranasal corticosteroid therapy (e.g. fluticasone nasal spray, mometasone nasal spray) after at least 4 weeks of continuous treatment; OR

         2. The individual has an intolerance, hypersensitivity, or FDA-labeled contraindication to ALL intranasal corticosteroids; AND

      6. The individual is currently treated with standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) and will continue to use a daily standard nasal polyp maintenance therapy in combination with the requested agent;

   5. The individual has a diagnosis of eosinophilic esophagitis (EoE) and ALL of the following:

      1. The individual is ≥1 year of age and weighs at least 15kg;

      2. The individual’s diagnosis has been confirmed by ALL of the following:

         1. ≥15 eosinophils per high-power field on esophageal biopsy;

         2. Signs and symptoms of esophageal dysfunction [e.g., dysphagia, food impaction, chest pain, GERD like symptoms, abdominal pain, vomiting, early satiety]; AND

         3. Exclusion of non-EoE disorders than may contribute to esophageal eosinophilia [e.g., GERD, eosinophilic gastrointestinal diseases (EGIDs), celiac disease, Crohn's disease, hypereosinophilic syndrome (HES), achalasia, vasculitis, pemphigoid vegetans, connective tissue disease, graft versus host disease];

      3. ONE of the following:

         1. The individual has tried and had an inadequate response to dietary modifications to treat/manage eosinophilic esophagitis (e.g., elimination diet); OR

         2. The provider has determined the individual is not an appropriate candidate for dietary modifications; AND

      4. ONE of the following:

         1. The individual has had an inadequate response to 8 weeks of one standard corticosteroid therapy used in the treatment of EoE (i.e., swallowed fluticasone MDI, budesonide oral suspension, swallowed budesonide nebulizer suspension);

         2. The individual has tried and had an inadequate response to at least 8 weeks of therapy with ONE proton pump inhibitor (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole); OR

         3. The individual has a documented intolerance, hypersensitivity, or FDA-labeled contraindication to ALL standard corticosteroid therapies and ALL PPI therapies; OR

   6. The individual has a diagnosis of prurigo nodularis (PN) and ALL of the following:

      1. The individual is ≥18 years of age;

      2. ALL of the following:

         1. Presence of ≥20 firm, nodular lesions;

         2. Pruritus [WI-NRS ≥7 on a scale of 0 to 10] has lasted at least 6 weeks; AND

         3. History and/or signs of repeated scratching, picking, or rubbing; AND

      3. ONE of the following:

         1. The individual has tried and had an inadequate response to at least a medium-potency topical corticosteroid used in the treatment of PN after at least a 2-week duration of therapy; OR

         2. The individual has a documented intolerance, hypersensitivity, or contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of PN;

2. The prescriber is or has consulted with a specialist in the area of the individual's diagnosis (e.g., dermatologist, pulmonologist, otolaryngologist, allergist, gastroenterologist, immunologist);

3. The individual does not have an FDA-labeled contraindication to therapy with the requested agent;

4. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti-IgE antibody, JAK inhibitors, Otezla, etc.);

5. Dupixent (dupilumab) will be obtained through a BCBSMS network DSP-pharmacy; AND

6. The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage.

Length of Approval:12 months

Renewal Criteria

Dupixent (dupilumab) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for therapy through the BCBSMS PA process;

2. ONE of the following:

   1. The individual has a diagnosis of moderate-to-severe atopic dermatitisand BOTH of the following:

      1. The individual has had a reduction or stabilization from baseline in at least ONE of the following:

         1. Affected body surface area;

         2. Flares; OR

         3. Pruritus, erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification; AND

      2. The individual will continue standard maintenance therapies (e.g., topical emollients, good skin care practices) in combination with the requested agent to aid in the prevention of flares;

   2. The individual has a diagnosis of moderate-to-severe asthmaand BOTH of the following:

      1. The individual has had improvement or stabilization with the requested agent from baseline as indicated by ONE of the following:

         1. Increase in percent predicted FEV1;

         2. Decrease in the dose of inhaled corticosteroids required to control the individual's asthma;

         3. Decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma; OR

         4. Decrease in number of hospitalizations or visits to urgent care or emergency room due to exacerbations of asthma; AND

      2. The individual is currently treated within the past 90 days and is compliant with asthma control therapy (e.g., inhaled corticosteroids, LABA, LTRA, LAMA, theophylline);

   3. The individual has a diagnosis of chronic obstructive pulmonary disease (COPD) and BOTH of the following:

      1. The individual has had improvements or stabilization with the requested agent from baseline as indicated by ONE of the following:

         1. Decrease in the frequency of COPD exacerbations;

         2. Increase in percent predicted FEV1; OR

         3. Reduction in severity or frequency of COPD-related symptoms (e.g., dyspnea, wheezing, cough, sputum volume, and/or decrease in sputum purulence); AND

      2. The individual is currently treated within the past 90 days and is compliant with COPD inhaled maintenance therapy (e.g., inhaled corticosteroid/LAMA/LABA triple therapy, LAMA/LABA);

   4. The individual has a diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) and BOTH of the following:

      1. The individual has had clinic benefit with the requested agent indicated by ONE of the following:

         1. Reduction in severity or frequency of CRS symptoms (e.g., decreased nasal congestion/rhinorrhea, improved sense of smell, decreased facial pressure/pain); OR

         2. Reduction in nasal polyp size or sinus opacification; AND

      2. The individual will continue standard daily intranasal nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with the requested agent;

   5. The individual has a diagnosis of eosinophilic esophagitis (EoE) and has a documented positive response indicated by at least ONE of the following:

      1. Reduction in severity of frequency of EoE symptoms (e.g., dysphagia, food impaction, heartburn); OR

      2. Improved histology or endoscopy measures (e.g., esophageal intraepithelial eosinophil count, edema, furrows, rings, strictures);

   6. The individual has a diagnosis of prurigo nodularis (PN) and has a documented positive response from baseline indicated by at least ONE of the following:

      1. Reduction in pruritus and/or excoriations;

      2. Reduction in nodular lesion count; OR

      3. Reduction in nodular lesion size;

3. The individual does not have an FDA-labeled contraindication to therapy with the requested agent;

4. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti-IgE antibody, JAK inhibitor, Otezla);

5. Dupixent (dupilumab) will be obtained through a BCBSMS network DSP-pharmacy;

6. The prescriber is or has consulted with a specialist in the area of the individual's diagnosis (e.g., dermatologist, pulmonologist, otolaryngologist, allergist, gastroenterologist, immunologist); AND

7. The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage.

Length of Approval: 12 months

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for ≥3 months use unless otherwise stated) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines individual medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If individual is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the individual and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

10/01/2017: New policy added.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

03/30/2018: Policy title changed from "Injectable Atopic Dermatitis" to "Dupixent."

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Dupixent" to "Atopic Dermatitis." Added drug name to the top of the policy. Policy description updated regarding indications for Dupixent (dupilumab). Added link to related policy. Policy section updated to add that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Sources section updated. Effective 01/01/2019.

05/18/2020: Policy statement regarding initial criteria updated to change patient age from "18 years old or older" to "12 years of age or older." Added reference to see Policy Guidelines for definition of failure. For initial criteria, added statement that the patient is not currently being treated with another biologic immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, etc.), Xeljanz / Xeljanz XR, or Otezla. For renewal criteria, added statement that the patient is not currently being treated with another biologic immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, etc.) or Otezla. Policy Exceptions updated regarding State Health Plan members. Policy Guidelines updated regarding medication failure.

06/30/2020: Policy description and statement updated to change the patient age requirement from "12 years of age or older" to "6 years of age or older." Source updated.

10/23/2020: Policy title changed from "Atopic Dermatitis" to "Dupixent (dupilumab)." Policy description updated regarding indications for Dupixent (dupilumab). Policy statement criteria for initial and renewal evaluation extensively revised. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and to define medication failure. Added information regarding BCBSMS request for medical records to determine medical necessity. Code Reference section updated to add HCPCS codes C9399 and J3590.

03/11/2022: Medically necessary policy statement criteria revised for moderate-to-severe atopic dermatitis, moderate to severe eosinophilic asthma or corticosteroid-dependent asthma, and chronic rhinosinusitis with nasal polyposis. Renewal criteria updated. Policy Guidelines updated regarding medication failure. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

03/01/2024: Updated related medical policy link in Policy Description.

10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Dupixent (dupilumab). Policy language updated to change "member" to "individual." Medically necessary indication for moderate-to-severe atopic dermatitis changed from "6 years" to "6 months." Medically necessary indication for moderate to severe eosinophilic asthma or corticosteroid-dependent asthma changed from "12 years" to "6 years." Added medically necessary and renewal criteria for eosinophilic esophagitis (EoE) and prurigo nodularis (PN). Added gastroenterologist as a specialist. Sources updated.

06/03/2025: Policy reviewed by Pharmacy & Therapeutics (P&T) Committee; no changes.

08/01/2025: Policy effective 10/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Dupixent (dupilumab). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Initial and renewal criteria updated regarding moderate-to-severe atopic dermatitis, moderate-to-severe asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis (PN), prescriber requirements, and immunomodulatory agents. Initial length of approval changed from "6 months" to "12 months." Sources updated. Policy update effective 10/01/2025.

SOURCE(S)

1. Clinical manifestations and diagnosis of eosinophilic esophagitis (EoE). UpToDate. Last updated September 15, 2023. https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-eosinophilic-esophagitis-eoe?search=eosinophilic%20esophagitis&source=search_result&selectedTitle=1%7E126&usage_type=default&display_rank=1

2. Dellon ES, Muir AB, Katzka DA, et al. ACG Clinical Guideline: Diagnosis and Management of Eosinophilic Esophagitis. Am J Gastroenterol 2025; 120:31. DOI: 10.14309/ajg.0000000000003194

3. Dupixent prescribing information. Sanofi-Aventis U.S. LLC. April 2024. Last accessed August 2024.

4. Prurigo nodularis. UpToDate. Last updated November 7, 2023. https://www.uptodate.com/contents/prurigo-nodularis?search=Prurigo%20Nodularis%20&source=search_result&selectedTitle=1%7E41&usage_type=default&display_rank=1

5. Treatment of eosinophilic esophagitis (EoE). UpToDate. Last updated Mar 13, 2024. https://www.uptodate.com/contents/treatment-of-eosinophilic-esophagitis-eoe?search=eoe%20treatment&source=search_result&selectedTitle=1%7E150&usage_type=default&display_rank=1#H2895691 .

6. Ulrike von Arnim, Luc Biedermann, Et al. Monitoring Patients With Eosinophilic Esophagitis in Routine Clinical Practice - International Expert Recommendations. Clinical Gastroenterology and Hepatology 2023;21:2526–2533.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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