The drug regulator expanded approval for Dupixent (ingredient: dupilumab), a treatment for severe atopic dermatitis, from adults to adolescents aged 12 or more. However, the drug's high cost makes it difficult for adolescent patients to get the treatment, patients said.

The government allowed health insurance benefits for Dupixent in adults with atopic dermatitis in January. It broadened the scope of approval from adults to adults and adolescents aged 12 or more.

However, adolescent patients cannot get the insurance benefit, meaning that they have to pay the drug's full price.

Dupixent’s price is so high that parents of adolescent patients with severe atopic dermatitis suffer from growing financial burdens, observers said.

On Monday, a petitioner demanded the government allow Dupixent reimbursement for adolescent patients on the website of Cheong Wa Dae.

“My child’s skin is falling like dandruff, and he can’t even sweat because of the thickened skin. He can't sleep because of itching. If he scratches it, the skin gets ulcerated and stained with blood clots,” the petitioner wrote.

For adult patients, Dupixent under the health insurance coverage costs about 10 million won ($8,343) a year at a tertiary hospital. However, an adolescent patient has to spend nearly 20 million won because reimbursement is available only for adults, the petitioner said.

“I can’t afford the treatment cost. I feel heartbroken as a poor parent,” the petitioner added.

The petitioner went on to say that the parent would borrow money to use Dupixent for the child, hoping that the child could sleep comfortably for just a few months. “I desperately hope that the government could approve insurance benefits for adolescents,” the petitioner said.

The online petition garnered 267 votes as of Monday. It needs 200,000 people’s participation to get an official response from the presidential office.

According to the Health Insurance Review and Assessment Service (HIRA), an adolescent aged 12 or more who started Dupixent treatment after the change of approval conditions in April will be eligible for reimbursement if the patient turned 18. However, the patient needs to meet the necessary criteria, including disease assessment for insurance benefit.

Dupixent is reimbursable as the first-line treatment for those with atopic dermatitis whose disease is not adequately controlled with topical therapies for four weeks or longer, and who do not respond to a systemic immunosuppressant for more than three months, or those who cannot use such drug due to side effects.

Patients can also receive insurance benefits only when their Eczema Area and Severity Index (EASI) score is 23 or higher.

key@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>