Atopic dermatitis drug Ebglyss reimbursed from next month

Completes drug pricing negotiations with the NHIS

Third biological agent approved for reimbursement after Dupixent, Adtralza

With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ‘Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)’ complete, the drug is expected to be listed for reimbursement next month in Korea.

 

Once listed, the number of biological agents available for atopic dermatitis will increase from two—Dupixent (dupilumab) and Adtralza (tralokinumab)—to three.

 

According to industry sources on the 13th, the NHIS recently updated its website with news of the agreement made on Ebglyss Autoinjector.

 

In August 2024, the Ministry of Food and Drug Safety approved this drug as a treatment for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older (weighing at least 40 kilograms) who are inadequately controlled by topical therapies or for whom such treatments are not recommended.

 

In February, the drug’s reimbursement application was approved by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service.

 

At the time, the condition was attached that the adequacy of its reimbursement would be recognized if the company accepted the price below the initially assessed value.

 

Lilly Korea accepted such a price and began negotiations with the National Health Insurance Service in March." It is highly likely that Ebglyss waived drug price negotiations as it accepted a price below the weighted average price of existing atopic dermatitis drugs covered by the national health insurance, and would only have negotiated the estimated claims amount with the NHIS.

 

Ebglyss demonstrated its clinical efficacy and safety profile in a pivotal Phase III clinical trial and is expected to become a first-line treatment option for patients with atopic dermatitis in Korea.

 

The clinical studies on which the approval was based on are the Phase III ADvocate-1, ADvocate-2 and ADhere trials.

 

The trials evaluated the clinical efficacy and safety of Ebglyss in 1062 adults and adolescents with moderate-to-severe atopic dermatitis.

 

In ADvocate-1 and ADvocate-2, which evaluated Ebglyss as a monotherapy, Ebglyss improved outcomes, with 58.8% and 52.1% (16.2% and 18.1%, respectively in the placebo arm) achieving Eczema Area and Severity Index (EASI) 75; and 38.3% and 30.7% (9% and 9.5%, respectively in the placebo arm) achieving EASI 90 during the induction period (weeks 0-16) compared to placebo.

 

Also, after one year of maintenance therapy (Week 52), 81.7% of the Ebglyss arm achieved EASI 75 (vs.

 

66.4% in the placebo arm) and 66.4% achieved EASI 90 (vs.

 

41.9% in the placebo arm), demonstrating significant symptom improvement in the long term.

 

The most commonly reported adverse events following treatment with Ebglyss were conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eye (1.4%), with the majority of adverse events being mild or moderate and not leading to treatment discontinuation.

 

Recently, the government has applied reimbursement for cross-administration of biological agents and JAK inhibitors used to treat severe atopic dermatitis, and Ebglyss is expected to benefit from this as well.

 

Patients are also expected to benefit from the increased biological agent options and lower drug prices.