'Dupixent,' the final stages of reimb expansion for children

younger than 6 years

The MOHW has ordered the negotiations…soon to start drug pricing negotiations

Demonstrated efficacy in 6 months and above through a phase 3 trial

Sanofi Korea’s Dupixent (dupilumab)

Dupixent is about to enter the last hurdle of expanding insurance reimbursement coverage for young children.

 

According to industry sources, the Ministry of Health and Welfare (MOHW) has recently ordered drug pricing negotiations for Sanofi Korea’s Dupixent (dupilumab).

 

Consequently, a tug-of-war between the government and Sanofi is about to start.

 

Dupixent is covered by reimbursement for severe atomic dermatitis over the age of 6 years.

 

If it completes the drug pricing negotiations and secures expanded reimbursement, prescriptions will become available to infants six months and above.

 

This indication was approved in South Korea in November 2022.

 

There have been talks about the unmet needs of Dupixent’s reimbursement expansion toward young children.

 

Notably, the Severe Atopic Dermatitis Association (SADA) issued a statement urging the coverage of Dupixent for young children aged 6 months to younger than 6 years with severe atopic dermatitis.

 

85-90% of atopic dermatitis manifests symptoms at the age of five, and for severe cases, the disease persists until adulthood and relapses.

 

However, treatments approved for children under the age of five are limited to topical treatments, and the patients with symptoms uncontrolled with topical treatments have limited treatment options due to long-term skin retractions and infection risks.

 

Meanwhile, Dupixent demonstrated its efficacy towards young children through the LIBERTY AD PRESCHOOL Phase 3 trial.

 

This study evaluated the efficacy and safety of Dupixent in patients aged 6 months to younger than 6 years with atopic dermatitis who have inadequate responses to topical treatment.

 

At 16 weeks, 28% of patients treated with Dupixent in combination with topical corticosteroids (TCS) showed a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S), demonstrating a significant improvement in atopic dermatitis compared to 4% of the placebo group.

 

Consequently, it met the primary efficacy endpoint.

 

Furthermore, 53% of patients accomplished EASI-75, the secondary endpoint, in the Dupixent plus TCS combination therapy group, significantly higher than the 11% in the placebo group.

 

Dupixent plus TCS combination therapy also improved the WSI-NRS (Worst Scratch and Itch Numerical Rating Scale) score by 49.4% compared to the placebo group’s 2.2%, demonstrating significant improvements in the common symptom of itchiness in atopic dermatitis.