Sanofi’s atopic dermatitis drug Dupixent gets expanded coverage for treating children under 5

Sanofi Korea’s Dupixent Prefilled Injection 200 and 300 mg (dupilumab, recombinant) will get coverage and special calculation favor from health insurance for severe atopic dermatitis in infants and children aged six months and older from Thursday.

Previously, Dupixent was covered for pediatric severe atopic dermatitis patients six years of age and older. The latest notice by the Ministry of Health and Welfare expands coverage to patients six months of age and older, providing a new option for treating patients with severe infantile atopic dermatitis.

Dupixent is the first and only targeted biologic approved in the U.S. and Korea as of August 2024 for treating moderate-to-severe atopic dermatitis in patients six months and older.

Atopic dermatitis has a high incidence in infants and children, with about 85 percent of adult patients developing the disease before the age of five years. However, there have been limited long-term safe treatment options for patients with severe atopic dermatitis under five, and even topical treatments for patients with atopic dermatitis before two lacked clinical evidence.

The criteria for Dupixent in infants and children six months to five years of age are first-line topical therapy (moderate corticosteroids or calcineurin inhibitors) for at least four weeks with inadequate control or side effects; and an Eczema Severity Assessment Score (EASI) of 21 or higher before the initiation of Dupixent. A history of topical treatment within four months before starting Dupixent and an EASI of 21 or greater at the time of topical treatment. In addition, a photograph of the affected area should be available to determine severity at the time of EASI measurement.

Relaxed reimbursement criteria apply to infants and children aged six months to five years. Unlike children six or older, adolescents, and adults, they do not need to demonstrate that their atopic dermatitis symptoms have been present for some time. This could be interpreted as reflecting clinical differences due to their younger age.

According to Sanofi Korea, the severe atopic dermatitis calculation exception reduces the copayment to 10 percent for infants and children six months to five years who qualify for coverage,

In the LIBERTY AD PRESCHOOL phase 3 study, Dupixent improved skin lesions and patient quality of life in patients with moderate-to-severe atopic dermatitis in infants and children six months to five years. At week 16, 28 percent of patients in the Dupixent arm achieved an IGA score of 0 or 1 (no or few lesions) compared to 4 percent in the placebo arm, demonstrating a significant improvement in lesions (P<0.0001). Dupixent also significantly improved quality of life, with a pediatric skin quality of life index (CDLQI) improvement of 10 points compared to 2.5 points in the placebo arm (P<0.0001).

“With this expansion, Dupixent offers a new treatment paradigm for atopic dermatitis in infants and children, for whom there is no alternative to topical ointment,” Sanofi Korea CEO Bae Kyung-eun said. “Dupixent is the only treatment available in the U.S. for treating severe atopic dermatitis in patients six months and older. We are committed to continuing to innovate the treatment of atopic dermatitis and other dermatologic conditions as a type 2 inflammation therapy.”