Abbvie Korea said Thursday that the Ministry of Food and Drug Safety has extended insurance coverage for Humira, its anti-inflammatory treatment in treating patients with severe acute hidradenitis suppurativa if the patient maintains progress.
Hidradenitis suppurativa (HS), also known as acne inversa, is a skin disease characterized by the occurrence of swollen lumps.
Under the new coverage, if there is no increase in the number of abscesses or discharge fistulas after 12 weeks of use of Humira, and if the total abscess and inflammatory- nodule count is decreased by more than 50 percent, the patient can continue to receive insurance benefits if the evaluation results maintain in the 24-week interval evaluation.
The revision of this insurance benefit comes after the PIONEER phase 3 open-label extension study. The study showed that long-term treatment of moderate to severe hidradenitis suppurativa patients with Humira every week intervals for 168 weeks showed that the therapy maintained the therapeutic effect in 52.3 percent of patients.
Until now, the ministry covered up to 36 weeks for Hurley stage 3 patients, 18 years and older, diagnosed with hidradenitis suppurativa for at least a year at two or more different sites, and the sum of abscess and inflammatory nodules was three or more. The patients also had to have had received an antibiotics treatment for at least three months to little effect or had to stop due to adverse events.
“We hope that the expanded insurance coverage for Humira can help patients suffering from the hidradenitis suppurativa,” Abbvie Korea Medical Director Jung Soo-jin said.
Humira, a TNF-α monoclonal antibody, is one of the world’s most purchased biomedicine with an estimated 18 trillion won ($15 billion) in sales.
It has applications for a wide variety of diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and uveitis.
The drug is the first and only biologic agent approved in Korea for treating hidradenitis suppurativa.