Subject: Specialty Quantity Limit Dupixent 1692-H 2022b
Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for
the most common uses of the medication. If the member’s
plan allows a quantity limit exception review for the requested
medication, coverage of an additional quantity may be
provided up to the exception limit with prior authorization.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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Exception Limit*
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FDA-recommended dosing
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Dupixent 200 mg/ 1.14 mL pre-filled syringe/pen
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2 syringes/pens per 28 days
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2 syringes/pens per 14 days
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Atopic dermatitis: • Adults and pediatrics 6 years to 17 years of age weighing ≥ 60 kg: Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week. • Pediatrics 6 years to 17 years of age: º 30 to < 60 kg: Initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week. º 15 to < 30 kg: Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every 4 weeks. • Pediatrics 6 months to 5 years of age: º 15 to < 30 kg: 300 mg every 4 weeks º 5 to < 15 kg: 200 mg every 4 weeks
Asthma: • Adults and adolescents (12 years and older): º Initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week, or º Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week º Patients with oral corticosteroid- dependent asthma, or with co- morbid moderate-to-severe atopic dermatitis for which Dupixent is indicated: initial dose of 600 mg (two 300 mg injections) followed by 300 mg every other week • Pediatrics (6 to 11 years of age): º ≥ 30 kg: 200 mg every other week º 15 to < 30 kg: 100 mg every other week or 300 mg every four weeks º Patients with asthma and co- morbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis
Chronic rhinosinusitis with nasal polyposis (CRSwNP) for adults: • 300 mg every other week • Adult patients with chronic rhinosinusitis with nasal polyposis and moderate-to-severe asthma for which Dupixent is indicated: initial dose of 600 mg (two 300 mg injections) followed by 300 mg every other week
Eosinophilic esophagitis: • Adult and adolescents (12 years and older), weighing ≥ 40 kg: 300 mg every week
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Dupixent 300 mg/ 2 mL pre-filled syringe/pen
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4 syringes/pens per 28 days
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2 syringes/pens per 14 days
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Dupixent 100 mg/ 0.67 mL pre-filled syringe
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2 syringes per 28 days
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N/A
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* Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.
Place of Service:
Outpatient
The above policy is based on the following references:
- Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; June 2022.
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.
July 15, 2022