Cosentyx gains reimbursement for hidradenitis suppurativa

1 year after reapplying for reimbursement

Reimbursement expanded to cover hidradenitis suppurativa from December

First new treatment option to be introduced in 10 years since Humira

Cosentyx, the first new treatment option for hidradenitis suppurativa in 10 years since Humira, has succeeded in expanding its reimbursement one year after reapplying for reimbursement in Korea.

 

The Ministry of Health and Welfare recently announced that it will expand the reimbursment criteria for Novartis Korea's interleukin (IL)-17A inhibitor Cosentyx (secukinumab) for hidradenitis suppurativa (HS) starting next month (December), through a partial amendment to the ‘Detailed Rules on the Standards and Methods for Applying Health Insurance Benefits.’ Specifically, hidradenitis suppurativa patients can use Cosentyx with reimbursement if they satisfy one of the following criteria: ▲ Adults with a diagnosis of over 1 year ▲ Lesions in two or more distinct areas, with a total of three or more abscesses and inflammatory nodules ▲ Insufficient therapeutic effect or adverse effects despite at least 3 months of antibiotic treatment.

 

The process of expanding Cosentyx’s reimbursement was not smooth.

 

Novartis originally submitted a reimbursement application after expanding its indication for Cosentyx to hidradenitis suppurativa in 2023, but voluntarily withdrew the application due to a lack of progress.

 

Subsequently, in the European Hidradenitis Suppurativa Foundation (EHSF) practice guidelines presented at the 2024 European Academy of Dermatology and Venereology (EADV) Annual Congress, the EHSF recommended Cosentyx as a first-line biologic treatment option for patients with moderate-to-severe hidradenitis suppurativa (HS) and those with an inadequate response to prior systemic therapies.

 

This led to the resubmission of the reimbursement expansion application in November of the same year, and the company gained success 1 year after resubmitting the application.

 

Until now, AbbVie Korea’s Humira (adalimumab) has been virtually the only treatment option available for hidradenitis suppurativa in Korea.

 

The introduction of Cosentyx, an IL inhibitor with a different mechanism of action that is also recommended as a first-line therapy, can become a viable option in managing hidradenitis suppurativa.

 

Meanwhile, Cosentyx has demonstrated its clinical utility through the Phase III SUNNY (SUNSHINE, SUNRISE) trial, which was conducted on 1,084 patients with moderate-to-severe hidradenitis suppurativa.

 

Results showed that the HiSCR achievement rate in the Cosentyx group was 45% in the SUNSHINE study and 42% in the SUNRISE study when the drug was administered every 2 weeks at 16 weeks of treatment, which was a significant improvement compared to the placebo group’s 34% and 31%, respectively.

 

In the SUNRISE study, even when the drug was administered every 4 weeks, the HiSCR achievement rate for Cosentyx was 46%, which was significantly higher than the 31% in the placebo group, and the HiSCR achievement rate of Cosentyx improved steadily until the 52nd week of treatment.

 

Cosentyx also showed significant effects in improving patients' pain.

 

According to the results of the SUNNY study, the NRS30 achievement rate at Week 16 of treatment was 39% in the group that received Cosentyx every 2 weeks and 36% in the group that received it every 4 weeks.

 

On the other hand, only 27% of the placebo group achieved NRS30.

 

Also, by week 52 of treatment, 79.6% of the Cosentyx arm, who were administered Cosentyx every 2 weeks, and 72.7% of those who were administered every 4 weeks, did not experience disease exacerbation.