Subject: Specialty Quantity Limit Dupixent 1692-H P2024d_R

Drug

DUPIXENT  (dupilumab)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Medication	Standard Limit	Exception Limit
Dupixent (dupilumab) 200 mg/1.14 mL pre-filled syringe/pen	2 syringes/pens per 28 days	2 syringes/pens per 14 days
Dupixent (dupilumab) 300 mg/2 mL pre-filled syringe/pen	4 syringes/pens per 28 days	N/A
Dupixent (dupilumab) 100 mg/0.67 mL pre-filled syringe	2 syringes per 28 days	N/A

FDA-recommended dosing

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:

• 30 to < 60 kg: Initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week
• 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:

• 15 to < 30 kg: 300 mg every 4 weeks
• 5 to < 15 kg: 200 mg every 4 weeks

Asthma:

Adults and pediatrics 12 years and older:

• Initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week, or
• Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week
• Patients with oral corticosteroid-dependent asthma, or with co-morbid moderate-to-severe atopic dermatitis, or with co-morbid chronic rhinosinusitis with nasal polyposis for which Dupixent is indicated: Initial dose of 600 mg (two 300 mg injections) followed by 300 mg every other week

Pediatrics 6 years to 11 years of age:

• ≥ 30 kg: 200 mg every other week
• 15 to < 30 kg: 300 mg every four weeks
• Patients with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis

Chronic rhinosinusitis with nasal polyps (CRSwNP):

Adults and pediatrics 12 years and older:

• 300 mg every other week
• 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 (EoE):

Adults and pediatrics 1 year and older:

• 15 to < 30 kg: 200 mg every other week
• 30 to < 40 kg: 300 mg every other week
• ≥ 40 kg: 300 mg every week

Prurigo Nodularis for adults:

Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week

Chronic Obstructive Pulmonary Disease (COPD) for adults:

300 mg every other week

Place of Service:

Outpatient

The above policy is based on the following references:

1. Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; September 2024.

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.

November 24, 2024