Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Dupixent SGM 1690-A P2025d
Drug
DUPIXENT(dupilumab)
Policy:
Indications
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications1
Treatment of adult and pediatric patients 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. Dupixent can be used with or without topical corticosteroids
Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma
Add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)
Treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE)
Treatment of adult patients with prurigo nodularis (PN)
Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
Treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment
Treatment of adult patients with bullous pemphigoid (BP)
Limitations of Use
Not indicated for the relief of acute bronchospasm or status asthmaticus.
Not indicated for treatment of other forms of urticaria.
Compendial Uses25
Immune checkpoint inhibitor-related toxicities
All other indications are considered experimental/investigational and not medically necessary.
Documentation
Submission of the following information is necessary to initiate the prior authorization review:
Atopic Dermatitis
Initial requests
Chart notes or medical record documentation showing affected area(s) and body surface area (where applicable).
Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Asthma
Initial requests
Chart notes or medical record documentation showing pre-treatment blood eosinophil count (where applicable).
Chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency, and duration.
Continuation requests
Chart notes or medical record documentation supporting improvement in asthma control.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Initial requests
Chart notes or medical record documentation showing nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) details (e.g., polyps location, size), Meltzer Clinical Score, or endoscopic nasal polyp score (NPS) (where applicable).
Chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency, and duration. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Eosinophilic Esophagitis (EoE)
Initial requests
Chart notes or medical record documentation showing endoscopic biopsy details including intraepithelial esophageal eosinophil count.
Chart notes, medical record documentation, or claims history supporting previous medications tried. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Prurigo Nodularis (PN)
Initial requests
Chart notes or medical record documentation of symptoms (e.g., pruritus, nodular lesions) (where applicable).
Chart notes, medical record documentation, or claims history supporting previous therapies tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Chronic Obstructive Pulmonary Disease (COPD)
Initial requests
Chart notes or medical record documentation demonstrating classic signs and/or symptoms of COPD.
Chart notes, medical record documentation, or claims history of previous medications tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Chart notes or medical record documentation showing absolute blood eosinophil count prior to initiating therapy with the requested medication.
Chart notes or medical record documentation of moderate or severe exacerbations within the last year.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Chronic Spontaneous Urticaria (CSU)
Initial requests
Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy.
Continuation requests
Chart notes or medical record documentation supporting positive response to therapy.
Immune Checkpoint Inhibitor-Related Toxicities
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Bullous Pemphigoid (BP)
Initial requests
Chart notes or medical record documentation demonstrating clinical features of bullous pemphigoid.
Chart notes, medical record documentation, or claims history of previous medications tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Prescriber Specialties
This medication must be prescribed by or in consultation with one of the following:
Atopic dermatitis: dermatologist or allergist/immunologist
Asthma: allergist/immunologist or pulmonologist
Chronic rhinosinusitis with nasal polyps: allergist/immunologist or otolaryngologist
Eosinophilic esophagitis: gastroenterologist or allergist/immunologist
Prurigo nodularis: dermatologist or allergist/immunologist
Chronic obstructive pulmonary disease: pulmonologist or allergist/immunologist
Chronic spontaneous urticaria: allergist/immunologist or dermatologist
Immune checkpoint inhibitor-related toxicity and bullous pemphigoid: dermatologist, hematologist, or oncologist
Coverage Criteria
Atopic Dermatitis1-3,7,10,16
Authorization of 4 months may be granted for members 6 months of age or older who have previously received a biologic (e.g., Adbry, Ebglyss, Nemluvio) or systemic targeted synthetic drug (e.g., Cibinqo, Rinvoq) indicated for moderate-to-severe atopic dermatitis in the past year.
Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis in members 6 months of age or older when both of the following criteria are met:
Affected body surface is greater than or equal to 10% body surface area OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected.
Member meets either of the following:
Member has had an inadequate treatment response with one of the following in the past year:
A medium potency to super-high potency topical corticosteroid (see Appendix A)
A topical calcineurin inhibitor
A topical Janus kinase (JAK) inhibitor
A topical phosphodiesterase-4 (PDE-4) inhibitor
The use of medium potency to super-high potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, and topical PDE-4 inhibitor are not advisable for the member (e.g., due to contraindications, prior intolerances, potency not appropriate for member’s age).
Asthma1,4-6,11
Authorization of 6 months may be granted for members 6 years of age or older who have previously received a biologic drug (e.g., Nucala, Cinqair) indicated for asthma in the past year.
Authorization of 6 months may be granted for treatment of moderate-to-severe asthma in members 6 years of age or older when all of the following criteria are met:
Member has uncontrolled asthma as demonstrated by experiencing at least one of the following within the past year:
Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment
One or more asthma exacerbation(s) resulting in hospitalization or emergency medical care visit(s)
Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma)
Member meets either of the following criteria:
Member has a baseline blood eosinophil count of at least 150 cells per microliter and inadequate asthma control despite current treatment with both of the following medications at optimized doses:
Member has inadequate asthma control despite current treatment with all of the following medications at optimized doses (Members should be receiving treatment with an inhaled corticosteroid and additional controller for at least the previous 3 months, and oral glucocorticoids for most days during the previous 6 months [e.g., 50% of days, 3 steroid bursts in the previous 6 months]):
Oral glucocorticoids (at least 5 mg per day of prednisone/prednisolone or equivalent)
Member will continue to use maintenance asthma treatments (i.e., inhaled corticosteroid and additional controller) in combination with the requested medication.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)1,8,9,12,17,18,33
Authorization of 6 months may be granted for members 12 years of age or older who have previously received a biologic drug (e.g., Nucala, Xolair) indicated for CRSwNP in the past year.
Authorization of 6 months may be granted for treatment of CRSwNP in members 12 years of age or older when all of the following criteria are met:
Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 4 weeks unless contraindicated or not tolerated.
Member has CRSwNP despite one of the following:
Prior sino-nasal surgery
Prior treatment with systemic corticosteroids within the last two years was ineffective, unless contraindicated or not tolerated
Member has one of the following:
A bilateral nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril.
Meltzer Clinical Score of 2 or higher in both nostrils.
A total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostril.
Member has symptoms of nasal blockage, congestion, or obstruction plus one of the following additional symptoms:
Rhinorrhea (anterior/posterior)
Reduction or loss of smell
Facial pain or pressure
Member will continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.
Eosinophilic Esophagitis (EoE)1,13-15,27,28,32
Authorization of 6 months may be granted for treatment of EoE in members 1 year of age or older, weighing at least 15 kg, when all of the following criteria are met:
Member is experiencing symptoms of esophageal dysfunction (e.g., dysphagia, food impaction, vomiting, abdominal pain, food refusal, failure to thrive).
Diagnosis has been confirmed by esophageal biopsy as characterized by 15 or more intraepithelial esophageal eosinophils per high power field.
Member has had an inadequate treatment response to either of the following:
Proton pump inhibitor
Swallowed topical corticosteroid therapies (e.g., budesonide, fluticasone [powder or suspension for inhalation]), unless contraindicated or not tolerated
Prurigo Nodularis19-22
Authorization of 6 months may be granted for members 18 years of age or older who have previously received a biologic drug (e.g., Nemluvio) indicated for prurigo nodularis in the past year.
Authorization of 6 months may be granted for treatment of prurigo nodularis in members 18 years of age or older when all of the following criteria are met:
Member has pruritus lasting at least 6 weeks.
Member has a history or signs of repeated itch-scratch cycle (e.g., scratching, picking, or rubbing).
Member has a minimum of 20 nodular lesions.
Member meets either of the following:
Member has had an inadequate response to one of the following:
A medium to super-high potency topical corticosteroid (see Appendix A)
A topical calcineurin inhibitor
Phototherapy (e.g., UVB, PUVA)
Pharmacologic treatment with methotrexate or cyclosporine
Member has had an intolerance or a clinical reason to avoid either of the following:
Medium to super-high potency topical corticosteroid (see Appendix A) and topical calcineurin inhibitor
Pharmacologic treatment with methotrexate and cyclosporine (see Appendix B)
Authorization of 12 months may be granted for members 18 years of age or older who have previously received a biologic drug (e.g., Nucala) indicated for COPD in the past year.
Authorization of 12 months may be granted for treatment of COPD in members 18 years of age or older when all of the following criteria are met:
Diagnosis has been confirmed by spirometry showing forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 0.7 post-bronchodilation.
Member demonstrates classic signs or symptoms of COPD (e.g., dyspnea, wheezing, chest tightness, fatigue, activity limitation, cough with or without sputum production, chronic bronchitis).
Member has an absolute blood eosinophil count of at least 300 cells per microliter prior to initiating therapy with the requested medication.
Member has inadequately controlled COPD as demonstrated by experiencing either of the following in the last year:
At least two moderate exacerbations resulting in treatment with systemic glucocorticoids, antibiotics, or both.
One or more severe exacerbation(s) requiring hospitalization or an emergency medical care visit.
Member meets either of the following:
Member is currently receiving maintenance inhaled triple therapy (i.e., inhaled corticosteroid [ICS], long-acting muscarinic antagonist [LAMA], and long-acting beta2-agonist [LABA]).
Member is currently receiving a LAMA and LABA, and has a contraindication to ICS.
Member will continue to use maintenance COPD treatments (e.g., ICS with LAMA and LABA, LAMA and LABA) in combination with the requested medication.
Chronic Spontaneous Urticaria (CSU)1,34,35
Authorization of 6 months may be granted for members 12 years of age or older who have previously received a biologic drug (e.g., Xolair) indicated for CSU in the past year.
Authorization of 6 months may be granted for treatment of CSU in members 12 years of age or older when all of the following criteria are met:
Member remains symptomatic despite treatment with up-dosing (in accordance with EAACI/GA2LEN/EuroGuiDerm/APAAACI guidelines) of a second-generation H1 antihistamine (e.g., cetirizine, fexofenadine, levocetirizine, loratadine) for at least 2 weeks.
Member has been evaluated for other causes of wheals (hives) and/or angioedema, including bradykinin-related angioedema and interleukin-1-associated urticarial syndromes (auto-inflammatory disorders, urticarial vasculitis).
Member has experienced a spontaneous onset of wheals (hives), angioedema, or both, for at least 6 weeks.
Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the requested medication will be used for severe (G3) pruritus if no response to gabapentinoids in one month.
Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the requested medication will be used as additional therapy for severe (G3) or life-threatening (G4) bullous dermatitis.
Bullous Pemphigoid36-38
Authorization of 12 months may be granted for treatment of bullous pemphigoid in members 18 years of age or older when all of the following criteria are met:
Diagnosis has been confirmed by either of the following:
Member demonstrates characteristic clinical features of bullous pemphigoid (e.g., urticarial or eczematous or erythematous plaques, bullae, pruritus).
Member has moderate to severe disease.
Member meets either of the following:
Member has had an inadequate treatment response with either of the following:
A super-high potency topical corticosteroid (see Appendix A)
An oral corticosteroid
The use of super-high potency topical corticosteroid or oral corticosteroid is not advisable for the member (e.g., contraindications, prior intolerances).
Continuation of Therapy
Atopic Dermatitis1-3,10
Authorization of 12 months may be granted for members 6 months of age or older (including new members) who are using the requested medication for moderate-to-severe atopic dermatitis when the member has achieved or maintained a positive clinical response as evidenced by low disease activity (i.e., clear or almost clear skin), or improvement in signs and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting).
Asthma1,4-6,11
Authorization of 12 months may be granted for continuation of treatment of moderate-to-severe asthma in members 6 years of age or older when both of the following criteria are met:
Asthma control has improved on the requested medication as demonstrated by at least one of the following:
A reduction in the frequency or severity of symptoms and exacerbations
A reduction in the daily maintenance oral corticosteroid dose
Member will continue to use maintenance asthma treatments (i.e., inhaled corticosteroid and additional controller) in combination with the requested medication.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)1,8,9,12
Authorization of 12 months may be granted for continuation of treatment of CRSwNP in members 12 years of age or older when both of the following are met:
Member has achieved or maintained a positive clinical response with the requested medication as evidenced by improvement in signs and symptoms of CRSwNP (e.g., improvement in nasal congestion, nasal polyp size, loss of smell, anterior or posterior rhinorrhea, sino-nasal inflammation, hyposmia or facial pressure or pain, reduction in corticosteroid use).
Member will continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.
Eosinophilic Esophagitis (EoE)1,13-15
Authorization of 12 months may be granted for continuation of treatment of EoE in members 1 year of age or older, weighing at least 15 kg, when member has achieved or maintained a positive clinical response with the requested medication as evidenced by improvement in signs and symptoms of EoE (e.g., dysphagia, heartburn, chest pain, emesis).
Prurigo Nodularis19-22
Authorization of 12 months may be granted for members 18 years of age or older (including new members) who are using the requested medication for prurigo nodularis when the member has achieved or maintained a positive clinical response as evidenced by either of the following:
Low disease activity (i.e., clear or almost clear skin)
Reduction in pruritus intensity and improvement in extent and severity of nodular lesions
Authorization of 12 months may be granted for continuation of treatment of COPD in members 18 years of age or older when both of the following criteria are met:
Member has achieved or maintained a positive clinical response as evidenced by improvement in signs and symptoms of COPD (e.g., decrease in exacerbations, improvement in pre-bronchodilator FEV1) or stabilization of disease.
Member will continue to use maintenance COPD treatments (e.g., ICS with LAMA and LABA, LAMA and LABA) in combination with the requested medication.
Chronic Spontaneous Urticaria1,34-35
Authorization of 12 months may be granted for continuation of treatment of chronic spontaneous urticaria in members 12 years of age or older, when the member has experienced a positive clinical response (e.g., improved symptoms, decrease in weekly urticaria activity score [UAS7]) since initiation of therapy).
Immune Checkpoint Inhibitor-Related Toxicities25
Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for immune checkpoint inhibitor-related severe (G3) pruritus, severe (G3) or life-threatening (G4) bullous dermatitis, and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.
Bullous Pemphigoid36-38
Authorization of 12 months may be granted for continuation of treatment of bullous pemphigoid in members 18 years of age or older, when the member has achieved or maintained a positive clinical response as evidenced by either of the following:
Low disease activity (e.g., absence of new or established lesions)
Reduction in pruritus intensity and improvement in extent and severity of lesions
Other
For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
Note: If the member is a current smoker or vaper, they should be counseled on the harmful effects of smoking and vaping on pulmonary conditions and available smoking and vaping cessation options.
Appendix
Appendix A: Relative Potency of Select Topical Corticosteroid Products7
Hydrocortisone (base, greater than or equal to 2%)
Cream, Ointment, Solution
2.5%
VII. Least potent (Group 7)
Hydrocortisone (base, greater than or equal to 2%)
Lotion
2%
VII. Least potent (Group 7)
Hydrocortisone (base, less than 2%)
Cream, Ointment, Gel, Lotion, Spray, Solution
1%
VII. Least potent (Group 7)
Hydrocortisone (base, less than 2%)
Cream, Ointment
0.5%
VII. Least potent (Group 7)
Hydrocortisone acetate
Cream
2.5%
VII. Least potent (Group 7)
Hydrocortisone acetate
Lotion
2%
VII. Least potent (Group 7)
Hydrocortisone acetate
Cream
1%
Appendix B: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate or Cyclosporine23,24
Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
Drug interaction
Risk of treatment-related toxicity
Pregnancy or currently planning pregnancy
Breastfeeding
Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)
Hypersensitivity
History of intolerance or adverse event
Place of Service:
Outpatient
The above policy is based on the following references:
Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; June 2025.
Sidbury R, Alikhan A, Bercovitch L, et. al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.
Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375:2335-2348.
Castro M, Corren J, Pavord ID, et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018;378(26):2486-2496.
Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378(26):2475-2485.
Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2024 update. Available at: https://ginasthma.org/wp-content/uploads/2024/05/GINA-2024-Strategy-Report-24_05_22_WMS.pdf. Accessed March 1, 2025.
Topical Corticosteroids. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; July 18, 2024. Accessed November 9, 2024.
gov. National Library of Medicine (US). Identifier NCT02912468. A Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps (SINUS-24) 2016 Sep 23. Available from: https://clinicaltrials.gov/ct2/show/NCT02912468.
gov. National Library of Medicine (US). Identifier NCT02898454. A Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps (SINUS-52) 2016 Sep 13. Available from: https://clinicaltrials.gov/ct2/show/NCT02898454.
Fishbein AB, Silverberg JI, Wilson EJ, et al. Update on atopic dermatitis: Diagnosis, severity assessment, and treatment selection. J Allergy Clin Immunol Pract. 2020;8(1): 91-101.
Cloutier MM, Dixon AE, Krishnan JA, et al. Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. JAMA. 2020;324(22): 2301-2317.
Bachert C, Han JK, Wagenmann M, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36.
Lucendo AJ, Molina-Infante J, Arias A, et al. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017;5(3):355-358.
Gonsalves NP, Aceves S. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7.
gov. National Library of Medicine (US). Identifier NCT03633617. Study to determine the efficacy and safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) 2022 May 27. Available from: https://clinicaltrials.gov/ct2/show/NCT03633617.
gov. National Library of Medicine (US). Identifier NCT03346434. Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 months to <6 years with Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL) 2022 Jun 10. Available from: https://clinicaltrials.gov/ct2/show/NCT03346434.
Fokkens WJ, Lund VJ, Hopkins C, et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020;58(Suppl S29):1-464.
Hopkins C. Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2019;381(1):55-63.
gov. National Library of Medicine (US). Identifier NCT04183335. Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME). 2022 February 17. Available from: https://clinicaltrials.gov/ct2/show/NCT04183335.
gov. National Library of Medicine (US). Identifier NCT04202679. Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2). 2022 September 28. Available from: https://clinicaltrials.gov/ct2/show/NCT04202679.
Ständer HF, Elmariah S, Zeidler C, et al. Diagnostic and treatment algorithm for chronic nodular prurigo. J Am Acad Dermatol. 2020;82(2):460-468.
Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760.
Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; November 6, 2024. Accessed November 10, 2024.
Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; November 7, 2024. Accessed November 10, 2024.
NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®). Management of Immune Checkpoint-Related Toxicities. Version 1.2025. Available at: www.nccn.org. Accessed March 3, 2025.
gov. National Library of Medicine (US). Identifier NCT04394351. Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (EoE KIDS). 2023 June 05. Available from: https://clinicaltrials.gov/ct2/show/NCT04394351.
Lucendo AJ, Sánchez-Cazalilla M. Adult versus pediatric eosinophilic esophagitis: important differences and similarities for the clinician to understand. Expert Rev Clin Immunol. 2012;8(8):733-45.
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2024 Report). Available at: https://goldcopd.org/2024-gold-report/. Accessed March 2025.
Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023;389(3):205-214.
gov. National Library of Medicine (US). Identifier NCT04456673. Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients with Moderate to Severe COPD with Type 2 Inflammation (NOTUS). Last updated October 15, 2024. Accessed 2025 March 12. Available from: https://clinicaltrials.gov/ct2/show/NCT04456673.
Dellon E, Muir AB, Katzka DA, et al. ACG Clinical Guideline: Diagnosis and Management of Eosinophilic Esophagitis. AJC. 2025;120(1):p31-59.
Rank MA, Chu DK, Bognanni A, et al. The Joint Task Force on Practice Parameters GRADE guidelines for the medical management of chronic rhinosinusitis with nasal polyposis. J Allergy Clin Immunol. 2023 Feb;151(2):386-398.
Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022 Mar;77(3):734-766.
Borradori L, Van Beek N, Feliciani C, et al. Updated S2 K guidelines for the management of bullous pemphigoid initiated by the European Academy of Dermatology and Venereology (EADV). J Eur Acad Dermatol Venereol. 2022 Oct;36(10):1689-1704.
gov. National Library of Medicine (US). Identifier NCT04206553. A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid (LIBERTY-BP). Last updated February 6, 2025. Accessed 2025 July 1. Available from: https://clinicaltrials.gov/study/NCT04206553.
Murrell DF, Joly P, Werth VP, et al. Study Design of a Phase 2/3 Randomized Controlled Trial of Dupilumab in Adults with Bullous Pemphigoid: LIBERTY-BP ADEPT. Adv Ther. 2024 Jul;41(7):2991-3002.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
