Sanofi’s Dupixent Expands Insurance Coverage for Children and Teens in Korea |

Sanofi Korea said on Monday that Dupixent 200 and 300 mg prefilled syringes (ingredient: dupilumab) were eligible for health insurance benefits from Saturday last week, for children aged six or older with severe atopic dermatitis.

Patients in this age group have a high disease burden, but limited treatment options that can be used safely. The symptom control and consistent safety profile of Dupixent for children and adolescents aged six years or older has been confirmed in a Phase 3 clinical study.

As a result, the Health Insurance Review and Assessment Service (HIRA) recognized the appropriateness of Dupixent’s drug benefits on January 12.

In each age group, patients with dermatitis must meet certain criteria to be eligible for insurance benefits.

Dupixent is indicated for patients 12 to 17 years of age who have had severe chronic atopic dermatitis for at least three years that has been inadequately controlled after first-line treatment with topical therapies such as moderate to severe corticosteroids or calcineurin inhibitors. with an Eczema Severity Scale Index (EASI) of 23 or greater.

The drug is also indicated in this age group for those who have received systemic immunosuppressive agents such as cyclosporine or methotrexate for at least three months and have not shown a 50% or greater decrease in EASI , or if these agents cannot be used due to side effects.

Therefore, history of topical and systemic immunosuppressive agents should be confirmed six months prior to Dupixent administration.

Meanwhile, children aged 6 to 11 years should be symptomatic for at least one year with an EASI score of 21 or higher before initiating Dupixent. In this case, they must demonstrate that first-line topical treatments have failed to manage symptoms for at least four weeks or cannot be used due to side effects.

These criteria are adjusted to reflect clinical differences between pediatric, adult and adolescent patients with severe chronic atopic dermatitis.

Dupixent became the first drug expanded to be eligible for the Risk Sharing Agreement (RSA), excluding cancer and rare diseases, in recognition of the severity of severe atopic dermatitis and its therapeutic innovation in January 2020.

RSAs manage the financial risk and health outcomes of new drugs, with payers and manufacturers sharing the costs to achieve expanded coverage. As a result, Dupixent is covered by a combination of three risk-sharing schemes, namely Reimbursement, Direct Reimbursement and Reimbursement of Upfront Treatment Fees.