Oscar Dupixent (dupilumab) (PG026) Form

Dupixent (dupilumab) is a human monoclonal antibody that is approved for use in the treatment of eczema, eosinophilic esophagitis, sinus inflammation with nasal polyps, and to prevent the symptoms of asthma. This biologic agent works by decreasing inflammation. Dupixent (dupilumab) is indicated: 1. for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis 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. 2. as an 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 (Limitations of Use - Dupixent is not indicated for the relief of acute bronchospasm or status asthmaticus). 3. as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE). for the treatment of adult patients with prurigo nodularis (PN). 4. 5. 1 Definitions “Asthma” is defined by the The National Asthma Education and Prevention Program (NAEPP) guidelines as “a chronic inflammatory disease of the airways in which many cells and cellular elements play a role: in particular mast cells, neutrophils, eosinophils, T lymphocytes, macrophages, and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes of coughing (particularly at night or early in the morning), wheezing, breathlessness, and chest tightness. The episodes are usually associated with widespread but variable airflow obstruction that is reversible either spontaneously or as a result of treatment.” Depending on symptoms and pulmonary function testing, asthma can be further classified into different severity such as mild intermittent, mild persistent, moderate persistent, and severe persistent. “Dysphagia” is trouble swallowing. “Eczema” is a condition that can cause skin on different parts of the body to be itchy, inflamed and rough. It is also commonly referred to as "atopic dermatitis." “Eosinophilic esophagitis” is a condition caused by allergy cells called ‘eosinophils’ infiltrating into the esophagus, leading to esophageal dysfunction. “Exacerbations” is trouble breathing. In asthma, this is sometimes called an asthma attack or acute bronchospasm. This is usually because the air passages have become more tight and narrow than normal, causing coughing, shortness of breath, and wheezing. “Nasal polyps” are growths that form in the nose or the sinuses. They can be large or small, are usually found in both sides of the nose, and can make it hard to breathe through the nose. “Phenotype” is a recognizable pathophysiologic characteristic. Asthma has phenotypes such as allergic asthma or eosinophilic asthma. “Prurigo nodularis (PN)” is an uncommon skin disease that causes itchy hard lumps (called nodules) to form on the skin. Its cause is unknown, and the associated itching (pruritus) can become so severe that people may scratch to the point of bleeding or pain. “Worst-Itch Numeric Rating Scale (WI-NRS)” is a useful, quick, and validated tool to reliably measure itch severity, rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). 2 Clinical Indications The Plan considers Dupixent (dupilumab) medically necessary when ALL of the following criteria are met for the applicable indication listed below: Medical Necessity Criteria for Initial Authorization Atopic dermatitis, moderate to severe 1. Dupixent (dupilumab) is being prescribed by or in consultation with a specialist in dermatology, allergy or immunology; AND 2. The member is 6 months of age or older; AND 3. The member’s affected body surface area (BSA) before treatment meets ONE of the following: a. b. is equal to or greater than 10%; or is less than 10% but sensitive body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected; AND 4. The member is unable to use, or has adequately tried and failed ONE of the following topical therapies for at least 8 weeks each in the past 365 days: a. A topical corticosteroid (TCS) from medium potency (group III to IV) classes to higher potencies (groups I to II) classes (see Table 2); and/or b. Tacrolimus ointment; and/or c. Eucrisa (crisaborole) [PA may be required, please check the member’s Plan-specific Formulary]; AND 5. Dupixent (dupilumab) will not be used concomitantly with other biologics (e.g., Adbry, Cibinqo, or Rinvoq) in the treatment of atopic dermatitis; AND 6. Dupixent (dupilumab) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND 7. Clinical chart documentation is provided for review to substantiate the above-listed requirements. If the above prior authorization criteria are met, Dupixent (dupilumab) will be approved for 4 months initially. Asthma, moderate to severe: ● with an eosinophilic phenotype; or ● oral corticosteroid (OCS)-dependent (regardless of phenotype) 1. The member is 6 years of age or older; AND 2. The member meets ONE of the following criteria: 3 a. The member has experienced two or more (≥2) exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) within the last 12 months AND the member is unable to use or has tried and failed ALL of the following at optimized# doses: i. ii. high-dose inhaled corticosteroids (ICS); and adjunctive therapy (in combination with inhaled corticosteroid), such as ONE of the following: 1. Long-Acting Beta-2 Agonists (LABA), such as formoterol or salmeterol; or 2. Leukotriene Receptor Antagonist (LTRA), such as montelukast (Singulair) or zafirlukast (Accolate); or 3. extended-release theophylline; and iii. oral/systemic corticosteroids (at least 5 mg per day of prednisone/prednisolone or equivalent); or #member should be receiving treatment with inhaled corticosteroid and additional controller (adjunctive therapy) for at least the previous 3 months, and oral/systemic corticosteroids for most days during the previous 6 months [e.g. 50% of days, 3 steroid bursts in the previous 6 months] b. Clinical chart documentation is provided showing BOTH of the following: i. ii. baseline blood eosinophil count of at least 150 cells per microliter; and inadequate asthma control (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) within the last 12 months AND the member is unable to use or has tried and failed BOTH of the following at optimized doses for at least three (3) months: 1. high-dose inhaled corticosteroids (ICS); and 2. adjunctive therapy (in combination with inhaled corticosteroid), such as ONE of the following: a. Long-Acting Beta-2 Agonists (LABA), such as formoterol or salmeterol; or b. Leukotriene Receptor Antagonist (LTRA), such as montelukast (Singulair) or zafirlukast (Accolate); or c. extended-release theophylline; AND 3. Clinical chart documentation is provided showing ALL of the following: a. the member’s pre-treatment FEV1 and Asthma Control Questionnaire (ACQ); and b. documentation or attestation that the member is currently smoke-free; and c. Dupixent (dupilumab) will not be used as monotherapy; and d. Dupixent (dupilumab) will not be used concomitantly with other biologics (e.g., Cinqair, Fasenra, Nucala or Xolair) in the treatment of asthma; AND 4 4. Dupixent (dupilumab) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND 5. Clinical chart documentation is provided for review to substantiate the above listed requirements. If the above prior authorization criteria are met, Dupixent (dupilumab) will be approved for 6 months. Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) 1. The member is 18 years of age or older; AND 2. The member has a bilateral nasal endoscopy or anterior rhinoscopy showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril; AND 3. The member has nasal obstruction AND ONE of the following additional symptom(s): a. Rhinorrhea (anterior/posterior); or b. Reduction or loss of smell; AND 4. The member has CRSwNP despite ONE of the following: a. Prior sino-nasal surgery; or b. Tried and failed treatment with systemic corticosteroids within the last two years, unless the member is unable to use systemic corticosteroids; AND 5. The member has bilateral nasal polyposis and chronic symptoms of sinusitis AND the member is unable to use or has tried and failed intranasal corticosteroid treatment for at least two (2) months; AND 6. Dupixent (dupilumab) will be used together with a daily intranasal corticosteroid as part of the member’s treatment plan, unless the member is unable to use intranasal corticosteroid; AND 7. Dupixent (dupilumab) is being prescribed within within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND 8. Clinical chart documentation is provided for review to substantiate the above listed requirements. If the above prior authorization criteria are met, Dupixent (dupilumab) will be approved for 6 months. Eosinophilic Esophagitis 1. Dupixent (dupilumab) is being prescribed by or in consultation with a specialist in gastroenterology, allergy or immunology; AND 2. The member is 12 years of age or older; AND 3. The member weighs at least 40 kg (88 lbs); AND 4. Clinical chart documentation is provided showing ALL of the following: a. The member has a documented diagnosis of eosinophilic esophagitis (EoE) by endoscopy; and b. The member has eosinophil-predominant inflammation on esophageal biopsy, showing 15 or more eosinophils per high-power field (or approximately 60 eosinophils per mm2); and 5 c. Secondary (other) causes or contributors of esophageal eosinophilia has been excluded; and d. The member has symptoms related to esophageal dysfunction (e.g, abdominal pain, chest pain, food impaction, heartburn, solid food dysphagia, weight loss, vomiting); and e. The member has on average at least 2 episodes of dysphagia per week; AND 5. The member is unable to use, or has tried and failed BOTH of the following for at least two (2) months: a. proton pump inhibitor therapy, such as omeprazole or esomeprazole; and b. swallowed inhaled respiratory corticosteroid therapy, such as fluticasone or budesonide suspension; AND 6. Dupixent (dupilumab) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND 7. Clinical chart documentation is provided for review to substantiate the above listed requirements. If the above prior authorization criteria are met, Dupixent (dupilumab) will be approved for 6 months. Prurigo Nodularis (PN) 1. Dupixent (dupilumab) is being prescribed by or in consultation with a specialist in dermatology; AND 2. The member is 18 years of age or older; AND 3. The member has a documented diagnosis of prurigo nodularis (PN) AND BOTH of the following: a. Severe or very severe pruritis intensity (e.g., an average worst itch score of greater than or equal to (≥) 7 on the Worst Itch Numeric Rating Scale (WI-NRS) ranging from 0 to 10); and b. A minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk; AND 4. The member is unable to use, or has tried and failed a 2-week course of ONE topical corticosteroid (TCS) from medium potency (group III to IV) classes to higher potencies (groups I to II) classes (see Table 2). If the above prior authorization criteria are met, Dupixent (dupilumab) will be approved for 6 months. Medical Necessity Criteria for Reauthorization All prior authorization renewals will be reviewed for the following indications to determine if continuation of therapy is medically necessary. Chart documentation and supporting labwork should be provided with any reauthorization requests to substantiate medical necessity. Prior Authorization may be extended based on the diagnosis, documentation of the response to therapy, and pharmacy claims record. Atopic dermatitis, moderate to severe Authorization of 12 months may be provided for members 6 months of age or older when recent chart documentation (within the past 4 months) is provided showing ALL of the following criteria are met: 6 1. The member’s condition has improved on Dupixent (dupilumab) treatment based upon the prescriber’s assessment as demonstrated by at least one of the following: a. decreased disease activity (e.g., a reduction in BSA%); or b. symptomatic improvement (e.g., redness, itching, oozing/crusting); AND 2. Dupixent (dupilumab) will not be used concomitantly with other biologics (e.g., Adbry, Cibinqo, or Rinvoq) in the treatment of atopic dermatitis; AND 3. Dupixent (dupilumab) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature. Asthma, moderate to severe: ● with an eosinophilic phenotype; or ● oral corticosteroid (OCS)-dependent (regardless of phenotype) Authorization of 12 months may be provided for members 6 years of age or older when recent chart documentation (within the past 6 months) is provided showing ALL of the following criteria are met: 1. The member’s condition has improved on dupilumab treatment based upon the prescriber’s assessment as demonstrated by at least one of the following: a. A reduction in the frequency and/or severity of symptoms and exacerbations; or b. A reduction in the daily maintenance oral corticosteroid dose; AND 2. The member’s most current FEV1 and Asthma Control Questionnaire (ACQ); AND 3. Dupixent (dupilumab) will not be used as monotherapy; AND 4. Dupixent (dupilumab) will not be used concomitantly with other biologics (e.g., Cinqair, Fasenra, Nucala or Xolair) in the treatment of asthma; AND 5. Dupixent (dupilumab) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature. Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) Authorization of 12 months may be provided for members 18 years of age or older when recent chart documentation (within the past 6 months) is provided showing ALL of the following criteria are met: 1. The member’s condition has improved on Dupixent (dupilumab) treatment based upon the prescriber’s assessment as demonstrated by symptomatic improvement of CRSwNP (e.g., improvement in nasal congestion, nasal polyp size, loss of smell, anterior or posterior rhinorrhea, sinonasal inflammation, hyposmia and/or facial pressure or pain or reduction in corticosteroid use); AND 2. The member will continue consistent use of intranasal corticosteroids while on Dupixent (dupilumab) therapy, unless the member is unable to use intranasal corticosteroid; AND 3. Dupixent (dupilumab) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature. 7 Eosinophilic Esophagitis Authorization of 12 months may be provided for members 12 years of age or older weighing at least 40 kg when recent chart documentation (within the past 6 months) is provided showing ONE of the following criteria are met: 1. The member has experienced complete regression of disease; OR 2. The member has documented improvement in clinical symptoms (e.g, abdominal pain, chest pain, food impaction, heartburn, solid food dysphagia, weight loss, vomiting); OR 3. Documentation of lessened eosinophilic infiltration in esophagus; OR 4. The member has experienced reduced incidence or recurrence of food impaction Prurigo Nodularis (PN) Authorization of 12 months may be provided for members 18 years of age or older when recent chart documentation (within the past 3 months) is provided showing ALL of the following criteria are met: 1. The member’s condition has improved on Dupixent (dupilumab) treatment based upon the prescriber’s assessment as demonstrated by ONE of the following: a. a clinically meaningful reduction in itch from baseline; or b. achieved clear or almost clear skin; or c. improvements in measures of overall health-related quality of life, skin pain, and symptoms of anxiety and depression; AND 2. Dupixent (dupilumab) is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature. Table 1: Dupixent (dupilumab) dosage and retreatment information Indication Body weight Initial dose Subsequent dose Atopic Dermatitis (pediatric: age 6 months to 5 years) Atopic Dermatitis (pediatric: age 6 months to 5 years) 5 to less than 15 kg 200 mg (one 200 mg injection) every 4 weeks 15 to less than 30 kg 300 mg (one 300 mg injection) every 4 weeks Atopic Dermatitis (pediatric: age 6 to 17 years) 15 to less than 30 kg Atopic Dermatitis (pediatric: age 6 to 17 years) 30 to less than 60 kg 600 mg (two 300 mg injections) 400 mg (two 200 mg injections) 300 mg every 4 weeks 200 mg every 2 weeks Atopic Dermatitis (pediatric: age 6 to 17 years) 60 kg or more 600 mg (two 300 mg injections) 300 mg every 2 weeks 8 Atopic Dermatitis (adult) Asthma (pediatric: age 6 to 11years) 15 to less than 30 kg 600 mg (two 300 mg injections) 300 mg every 2 weeks 100 mg 300 mg 100 mg every 2 weeks 300 mg every 4 weeks Asthma (pediatric: age 6 to 11 years) ≥30 kg 200 mg 200 mg every 2 weeks Asthma (age 12 years or greater) Asthma (oral corticosteroid-dependent, or with co-morbid moderate- to-severe atopic dermatitis, or adults with co-morbid chronic rhinosinusitis with nasal polyposis) Chronic rhinosinusitis with nasal polyposis (CRSwNP) Eosinophilic esophagitis Prurigo Nodularis 400 mg (two 200 mg injections) 200mg every 2 weeks 600 mg (two 300 mg injections) 300mg every 2 weeks 600 mg (two 300 mg injections) 300mg every 2 weeks 300mg 300 mg 300 mg every 2 weeks 300 mg once weekly 600 mg (two 300 mg injections) 300 mg every 2 weeks Table 2: Topical Corticosteroid Potency NOTE: The following chart is only for approximate comparative purposes. Please check product-specific information to best assess product potency, which can also be affected by a multitude of factors (e.g., formulation, site of application, member and disease-specific factors) Group Potency Steroid Strength Dosage Form I Very High Betamethasone dipropionate (augmented) 0.05% Gel, Lotion, and Ointment Clobetasol propionate 0.05% Cream, Emollient Cream, Foam, Gel, Lotion, Ointment, Spray, and Solution 9 Desoximetasone 0.25% Spray Diflorasone diacetate 0.05% Ointment Fluocinonide Flurandrenolide 0.1% 0.05% Cream Tape Halobetasol propionate 0.05% and 0.01% Cream, Foam, Lotion and Ointment II High Amcinonide Betamethasone dipropionate (augmented) Betamethasone dipropionate 0.1% 0.05% Ointment Cream 0.05% Ointment Desoximetasone 0.25% Cream and Ointment Desoximetasone 0.05% Gel Diflorasone diacetate 0.05% Cream, and Emollient Cream Fluocinonide Halcinonide 0.05% 0.1% Cream, Gel, Ointment, and Solution Cream, Ointment, and Solution Triamcinolone acetonide 0.5% Ointment III Upper Medium Amcinonide Betamethasone dipropionate 0.1% 0.05% Cream and Lotion Cream Betamethasone valerate 0.12% Foam Betamethasone valerate 0.1% Ointment Fluocinonide 0.05% Emollient Cream Fluticasone propionate 0.005% Ointment Mometasone furoate 0.1% Ointment Triamcinolone acetonide 0.5% Cream Triamcinolone acetonide 0.1% Ointment 10 IV Medium Betamethasone 0.05% Spray dipropionate Clocortolone pivalate 0.1% Cream Desoximetasone 0.05% Cream and Ointment Fluocinolone acetonide 0.025% Ointment Flurandrenolide 0.05% Ointment Hydrocortisone valerate 0.2% Ointment Mometasone furoate 0.1% Cream, Lotion, and Solution Triamcinolone acetonide 0.1% Cream and Spray V Lower Medium Betamethasone dipropionate 0.05% Lotion Betamethasone valerate 0.1% Cream and Lotion Desonide 0.05% Gel and Ointment Fluocinolone acetonide 0.025% Cream Fluocinolone acetonide 0.01% Shampoo Flurandrenolide 0.05% Cream and Lotion Fluticasone propionate 0.05% Cream and Lotion Hydrocortisone butyrate 0.1% Cream, Lotion, Ointment, and Solution Hydrocortisone probutate 0.1% Hydrocortisone valerate 0.2% Cream Cream Prenicarbate 0.1% Emollient Cream and Ointment Triamcinolone acetonide 0.1% Lotion Triamcinolone acetonide 0.025% Ointment VI Low Alclometasone dipropionate 0.05% Cream and Ointment Desonide 0.05% Cream, Lotion, and Foam Fluocinolone acetonide 0.01% Cream, Oil, and Solution 11 Triamcinolone acetonide 0.025% Cream and Lotion VII Lowest Hydrocortisone acetate 0.5% and 1% Cream and Ointment Hydrocortisone base 0.5% to 2.5% Cream, Lotion, Ointment, Solution, and Spray Experimental or Investigational / Not Medically Necessary Dupixent (dupilumab) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Additionally, the safety and efficacy of this medication in patients younger than the approved age for each indication has not been established.