Subject: Dupixent SGM 1690-A P2026b

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)

·        Treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery

·        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 2 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 Uses²

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 pretreatment 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.

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 (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 (where applicable).
• Chart notes or medical record documentation showing absolute blood eosinophil count prior to initiating therapy with the requested medication (where applicable).
• Chart notes or medical record documentation of moderate or severe exacerbations within the past 12 months (where applicable).

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.

Bullous Pemphigoid (BP)

Initial requests

·        Chart notes, medical record documentation, or laboratory results of direct immunofluorescence (DIF) study or immune serological tests.

·        Chart notes or medical record documentation demonstrating clinical features of bullous pemphigoid.

·        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.

Immune Checkpoint Inhibitor-Related Toxicities

Continuation requests

Chart notes or medical record documentation supporting positive clinical response.

Allergic Fungal Rhinosinusitis (AFRS)

Initial requests

·        Chart notes or medical record documentation of specific IgE serology or skin testing.

·        Chart notes, medical record documentation, or test results of nasal endoscopy confirming nasal polyposis.

·        Chart notes or medical record documentation of endoscopic nasal polyp score (NPS).

·        Chart notes, medical record documentation, or test results of computed tomography (CT) scan results demonstrating signs of disease.

·        Chart notes or medical record documentation of Lund Mackay (LMK) score.

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, prurigo nodularis, and chronic spontaneous urticaria: dermatologist or allergist/immunologist

·        Asthma: allergist/immunologist or pulmonologist

·        Chronic rhinosinusitis with nasal polyps and allergic fungal rhinosinusitis: allergist/immunologist or otolaryngologist

·        Eosinophilic esophagitis: gastroenterologist or allergist/immunologist

·        Chronic obstructive pulmonary disease: pulmonologist or allergist/immunologist

·        Immune checkpoint inhibitor-related toxicity and bullous pemphigoid: dermatologist, hematologist, or oncologist

Coverage Criteria

Atopic Dermatitis^1,3-8

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 12 months.

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 12 months:

·        A medium potency to super-high potency topical corticosteroid (see Appendix A)

·        A topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus)

·        A topical Janus kinase (JAK) inhibitor (e.g., Opzelura)

·        A topical phosphodiesterase-4 (PDE-4) inhibitor (e.g., Eucrisa, Zoryve)

·        A topical aryl hydrocarbon receptor agonist (e.g., Vtama)

§  The use of medium potency to super-high potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, topical PDE-4 inhibitor, and topical aryl hydrocarbon receptor agonist are not advisable for the member (e.g., due to contraindications, prior intolerances, potency not appropriate for member’s age).

Asthma^1,9-12

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 12 months. Member will continue to use maintenance asthma treatments (e.g. inhaled corticosteroid [ICS] and additional controller) in combination with the requested medication.

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 12 months:

§  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:

• Medium-to-high-dose ICS (see Appendix B and C)
• Additional controller (i.e., long-acting beta₂-agonist [LABA], long-acting muscarinic antagonist [LAMA], leukotriene modifier, or sustained-release theophylline)

§  Member has inadequate asthma control despite adherence to current treatment with all of the following medications at optimized doses (Members should be receiving treatment with an ICS 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]):

• High-dose ICS (see Appendix B and C)
• Additional controller (i.e., LABA, LAMA, leukotriene modifier, or sustained-release theophylline)
• Oral glucocorticoids (at least 5 mg per day of prednisone/prednisolone or equivalent)

• Member will continue to use maintenance asthma treatments (e.g., ICS and additional controller) in combination with the requested medication.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)^1,13-16

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 12 months. Member will continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.

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 past 24 months 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)^1,17-20

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])

Prurigo Nodularis (PN)^1,21-25

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 12 months.

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 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 (e.g., pimecrolimus, tacrolimus)

·        Phototherapy (e.g., UVB, PUVA)

·        Pharmacologic treatment with methotrexate or cyclosporine

§  Member has had an intolerance or a clinical reason to avoid all of the following:

·        Medium to super-high potency topical corticosteroids (see Appendix A)

·        Topical calcineurin inhibitors

·        Phototherapy

·        Pharmacologic treatment with methotrexate and cyclosporine (see Appendix D)

Chronic Obstructive Pulmonary Disease (COPD)^1,26,27,33

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 12 months. Member will continue to use maintenance COPD treatments (e.g., ICS with LAMA and LABA, LAMA and LABA) in combination with the requested medication.

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 past 12 months:

§  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., ICS, LAMA, 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)^1,28

Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic drug (e.g., Xolair) indicated for CSU in the past 12 months.

Authorization of 12 months may be granted for treatment of CSU in members 2 years of age or older when all of the following criteria are met:

·        Member has been evaluated for other causes of wheals (hives) and/or angioedema, including bradykinin-related angioedema (e.g., angiotensin-converting-enzyme [ACE]-inhibitor induced angioedema, hereditary angioedema) and interleukin-1-associated urticarial syndromes (e.g., auto-inflammatory disorders, urticarial vasculitis).

·        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 experienced a spontaneous onset of wheals (hives), angioedema, or both, for at least 6 weeks.

Bullous Pemphigoid (BP)^1,29

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:

§  Direct immunofluorescence (DIF) study

§  Immune serological test(s) (e.g., indirect immunofluorescence microscopy [IIF], ELISA)

·        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 a super-high potency topical corticosteroid or oral corticosteroid is not advisable for the member (e.g., contraindications, prior intolerances).

Immune Checkpoint Inhibitor-Related Toxicities^2,30

Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the requested medication will be used for moderate (G2) to 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 moderate (G2) bullous dermatitis if the diagnosis of bullous pemphigoid is confirmed by biopsy or serology.

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) or life-threatening (G4) bullous dermatitis as a steroid-sparing measure if bullous pemphigoid is confirmed.

Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the requested medication will be used for severe (>30% body surface area) lichen planus and lichenoid diseases.

Allergic Fungal Rhinosinusitis (AFRS)^1,31,32

Authorization of 12 months may be granted for treatment of allergic fungal rhinosinusitis in members 6 years of age and older weighing at least 15 kilograms (kg) when all of the following criteria are met:

·        Member has a history of sino-nasal surgery.

·        Member had a positive fungal stain of sinus contents removed at the time of surgery.

·        Member has had IgE mediated inflammatory response to fungal hyphae (specific IgE serology or skin test), evidence of sensitization to fungus by skin testing, or positive fungal-specific IgE in serum.

·        Member has had nasal polyposis confirmed by nasal endoscopy.

·        Member has an endoscopic nasal polyp score (NPS) of greater than or equal to 2 out of 4 for unilateral polyps or greater than or equal to 3 out of 8 for bilateral polyps.

·        Member has had a characteristic CT scan which includes any of the below signs:

§  Hyperdensities

§  Bony demineralization

§  Bone erosion of sinus

·        Member has evidence of sinus opacification with a Lund Mackay (LMK) score of greater than or equal to 9 for members with unilateral polyps and greater than 12 for members with bilateral polyps.

·        Member has the presence of eosinophilic mucin without invasion.

Continuation of Therapy

Atopic Dermatitis^1,3-8

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 and who achieve or maintain 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).

Asthma^1,9-12

Authorization of 12 months may be granted for 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 and/or severity of symptoms and exacerbations

§  A reduction or discontinuation in the daily maintenance oral corticosteroid dose

·        Member will continue to use maintenance asthma treatments (e.g., ICS and additional controller) in combination with the requested medication.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)^1,13-16

Authorization of 12 months may be granted for 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 an 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)^1,17-20

Authorization of 12 months may be granted for 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 Nodularis^1,21-25

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 and who achieve or maintain 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

Chronic Obstructive Pulmonary Disease (COPD)^1,26,27

Authorization of 12 months may be granted for 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 an 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 Urticaria (CSU)^1,28

Authorization of 12 months may be granted for treatment of chronic spontaneous urticaria (CSU) in members 2 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.

Bullous Pemphigoid^1,29

Authorization of 12 months may be granted for treatment of bullous pemphigoid in members 18 years of age or older who achieve or maintain 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

Immune Checkpoint Inhibitor-Related Toxicities^2,30

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for immune checkpoint inhibitor-related moderate (G2) to severe (G3) pruritus, moderate (G2), severe (G3), or life-threatening (G4) bullous dermatitis, or severe (>30% body surface area) lichen planus and lichenoid diseases, and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.

Allergic Fungal Rhinosinusitis (AFRS)^1,31,32

Authorization of 12 months may be granted for treatment of allergic fungal rhinosinusitis in members 6 years of age or older weighing at least 15 kg when the member has achieved or maintained a positive clinical response as evidenced by an improvement in signs and symptoms of AFRS (e.g., reduced nasal congestion/blockage, return or improvement of smell, reduction of nasal polyps, minimal or no eosinophilic mucin, decreased sinus opacification, lower Lund-Mackay score).

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 Products⁸

Potency	Drug	Dosage form	Strength
I. Super-high potency (group 1)	Augmented betamethasone dipropionate	Ointment, Lotion, Gel	0.05%
I. Super-high potency (group 1)	Clobetasol propionate	Cream, Gel, Ointment, Solution, Cream (emollient), Lotion, Shampoo, Foam Aerosol, Spray Aerosol, Solution (scalp)	0.05%
I. Super-high potency (group 1)	Fluocinonide	Cream	0.1%
I. Super-high potency (group 1)	Flurandrenolide	Tape	4 mcg/cm2
I. Super-high potency (group 1)	Halobetasol propionate	Cream, Lotion, Ointment, Foam	0.05%
II. High potency (group 2)	Amcinonide	Ointment	0.1%
II. High potency (group 2)	Augmented betamethasone dipropionate	Cream	0.05%
II. High potency (group 2)	Betamethasone dipropionate	Ointment	0.05%
II. High potency (group 2)	Clobetasol propionate	Cream	0.025%
II. High potency (group 2)	Desoximetasone	Cream, Ointment, Spray	0.25%
II. High potency (group 2)	Desoximetasone	Gel	0.05%
II. High potency (group 2)	Diflorasone diacetate	Ointment, Cream (emollient)	0.05%
II. High potency (group 2)	Fluocinonide	Cream, Ointment, Gel, Solution	0.05%
II. High potency (group 2)	Halcinonide	Cream, Ointment, Solution	0.1%
II. High potency (group 2)	Halobetasol propionate	Lotion	0.01%
III. High potency (group 3)	Amcinonide	Cream	0.1%
III. High potency (group 3)	Betamethasone dipropionate	Cream	0.05%
III. High potency (group 3)	Betamethasone valerate	Ointment	0.1%
III. High potency (group 3)	Betamethasone valerate	Foam	0.12%
III. High potency (group 3)	Desoximetasone	Cream, Ointment	0.05%
III. High potency (group 3)	Diflorasone diacetate	Cream	0.05%
III. High potency (group 3)	Fluocinonide	Cream (aqueous emollient)	0.05%
III. High potency (group 3)	Fluticasone propionate	Ointment	0.005%
III. High potency (group 3)	Mometasone furoate	Ointment	0.1%
III. High potency (group 3)	Triamcinolone acetonide	Cream, Ointment	0.5%
IV. Medium potency (group 4)	Betamethasone dipropionate	Spray	0.05%
IV. Medium potency (group 4)	Clocortolone pivalate	Cream	0.1%
IV. Medium potency (group 4)	Fluocinolone acetonide	Ointment	0.025%
IV. Medium potency (group 4)	Flurandrenolide	Ointment	0.05%
IV. Medium potency (group 4)	Fluticasone propionate	Cream	0.05%
IV. Medium potency (group 4)	Hydrocortisone valerate	Ointment	0.2%
IV. Medium potency (group 4)	Mometasone furoate	Cream, Lotion, Solution	0.1%
IV. Medium potency (group 4)	Triamcinolone acetonide	Cream, Paste (mouth/throat), Ointment	0.1%
IV. Medium potency (group 4)	Triamcinolone acetonide	Ointment	0.05%
IV. Medium potency (group 4)	Triamcinolone acetonide	Aerosol Spray	0.2 mg per 2-second spray
V. Lower-mid potency (group 5)	Betamethasone dipropionate	Lotion	0.05%
V. Lower-mid potency (group 5)	Betamethasone valerate	Cream	0.1%
V. Lower-mid potency (group 5)	Desonide	Ointment, Gel	0.05%
V. Lower-mid potency (group 5)	Fluocinolone acetonide	Cream	0.025%
V. Lower-mid potency (group 5)	Flurandrenolide	Cream, Lotion	0.05%
V. Lower-mid potency (group 5)	Fluticasone propionate	Lotion	0.05%
V. Lower-mid potency (group 5)	Hydrocortisone butyrate	Cream, Lotion, Ointment, Solution	0.1%
V. Lower-mid potency (group 5)	Hydrocortisone probutate	Cream	0.1%
V. Lower-mid potency (group 5)	Hydrocortisone valerate	Cream	0.2%
V. Lower-mid potency (group 5)	Prednicarbate	Cream (emollient), Ointment	0.1%
V. Lower-mid potency (group 5)	Triamcinolone acetonide	Lotion	0.1%
V. Lower-mid potency (group 5)	Triamcinolone acetonide	Ointment	0.025%
VI. Low potency (group 6)	Alclometasone dipropionate	Cream, Ointment	0.05%
VI. Low potency (group 6)	Betamethasone valerate	Lotion	0.1%
VI. Low potency (group 6)	Desonide	Cream, Lotion, Foam	0.05%
VI. Low potency (group 6)	Fluocinolone acetonide	Cream, Solution, Shampoo, Oil	0.01%
VI. Low potency (group 6)	Triamcinolone acetonide	Cream, lotion	0.025%
VII. Least potent (group 7)	Hydrocortisone (base, greater than or equal to 2%)	Cream, Ointment, Lotion, Solution	2.5%
VII. Least potent (group 7)	Hydrocortisone (base, greater than or equal to 2%)	Cream, Gel, Lotion	2%
VII. Least potent (group 7)	Hydrocortisone (base, less than 2%)	Cream, Ointment, Liquid, Lotion, 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, Ointment	1%

Appendix B: Examples of Medium- and High-Dose ICS (Alone or in Combination with LABA) for Adults and Adolescents (12 Years and Older)¹¹

Drug	Dosage Form	Medium-Dose Total Daily Dose	High-Dose Total Daily Dose
Beclomethasone dipropionate	Pressurized metered-dose inhaler (pMDI), standard particle size hydrofluoroalkane propellant (HFA)	>500-1000 mcg	>1000 mcg
Beclomethasone dipropionate	Dry-powder inhaler (DPI) or pMDI, extra-fine particle size HFA	>200-400 mcg	>400 mcg
Budesonide	DPI or pMDI, standard particle size HFA	>400-800 mcg	>800 mcg
Ciclesonide	pMDI, extra-fine particle size HFA	>160-320 mcg	>320 mcg
Fluticasone furoate	DPI	100-200 mcg	200 mcg
Fluticasone propionate	DPI or pMDI, standard particle size HFA	>250-500 mcg	>500 mcg
Mometasone furoate	DPI or pMDI, standard particle size HFA	200-400 mcg	>400 mcg

 

Appendix C. Examples of Medium- and High-Dose ICS (Alone or in Combination with LABA) for Children 6 to 11 Years¹¹

Drug	Dosage Form	Medium-Dose Total Daily Dose	High-Dose Total Daily Dose
Beclomethasone dipropionate	pMDI, standard particle size HFA	>200-400 mcg	>400 mcg
Beclomethasone dipropionate	pMDI, extra-fine particle size HFA	>100-200 mcg	>200 mcg
Budesonide	DPI or pMDI, standard particle size HFA	>200-400 mcg	>400 mcg
Budesonide	Nebules	>500-1000 mcg	>1000 mcg
Ciclesonide	pMDI, extra-fine particle size HFA	>80-160 mcg	>160 mcg
Fluticasone furoate	DPI	50 mcg	Not applicable
Fluticasone propionate	DPI or pMDI, standard particle size HFA	>100-200 mcg	>200 mcg
Mometasone furoate	pMDI, standard particle size HFA	100 mcg	200 mcg

Appendix D: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate or Cyclosporine^24,25

·        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:

1.      Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; April 2026.

2.     The NCCN Drugs & Biologics Compendium® © 2026 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March 10, 2026.

3.     Eichenfield LF, Tom WL, Chamlin SL, et. al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.

4.     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.

5.     Davis DMR, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. J Am Acad Dermatol. 2024;90(2):e43-e56.

6.     Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014;71:1218-1233.

7.     Davis DMR, Frazer-Green L, Alikhan A, et al. Focused update: Guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. 2025;93(3):745.e1-745.e7.

8.     Comparison of Representative Topical Corticosteroid Preparations (Classified According to the United States System). Drug Facts and Comparisons. Facts and Comparisons. UpToDate Inc. https://fco.factsandcomparisons.com. Accessed November 7, 2025.

9.     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.

10.  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.

11.    Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2025 update. Available at: https://ginasthma.org/reports. Accessed March 6, 2026.

12.   Cloutier MM, Dixon AE, Krishnan JA, Lemanske Jr RF, Pace W, and Schatz M. Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. JAMA. 2020;324(22): 2301-2317.

13.   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.

14.   Fokkens WJ, Lund VJ, Hopkins C, et al. European position paper on rhinosinusitis and nasal polyps 2020. Rhinology. 2020;58(Suppl S29):1-464.

15.   Hopkins C. Chronic rhinosinusitis with nasal polyps. N Engl J Med. 2019;381(1):55-63.

16.   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 151(2):386-398.

17.   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.

18.   Gonsalves NP, Aceves S. Diagnosis and treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2020;145(1):1-7.

19.   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):733-745.

20. Dellon E, Muir AB, Katzka DA, et al. ACG clinical guideline: diagnosis and management of eosinophilic esophagitis. Am J Gastroenterol. 2025;120(1):31-59.

21.   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.

22.  Ständer S, Pereira MP, Berger T, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42.

23.  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.

24.  Cyclosporine. Drug Facts and Comparisons. Facts and Comparisons. UpToDate Inc. https://fco.factsandcomparisons.com. Accessed November 13, 2025.

25.  Methotrexate. Drug Facts and Comparisons. Facts and Comparisons. UpToDate Inc. https://fco.factsandcomparisons.com. Accessed November 13, 2025.

26.  Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2026 Report). Available at:https://goldcopd.org/2026-gold-report-and-pocket-guide. Accessed March 2026.

27.  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.

28.  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.

29.  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;36(10):1689-1704.

30. NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®). Management of Immune Checkpoint-Related Toxicities. Version 1.2026. Available at: www.nccn.org. Accessed March 10, 2026

31.   Glass D, Amedee RG. Allergic fungal rhinosinusitis: a review. Ochsner J. 2011;11:271-275.

32.  Luong A, Levy J, Wise S, et al. Dupilumab efficacy in adults and children aged 6 and over with allergic fungal rhinosinusitis (LIBERTY-AIMS). Annals of allergy, asthma and immunology. 2025; 135(5): S100-S101.

33.  Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. N Engl J Med. 2024;390(24):2274-83.

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.

October 13, 2026