The reimbursement process for Cosentyx and Taltz

as first-line therapy for ankylosing spondylitis has been pending for over a year

Since the conclusion of the HIRA discussion in February

Treatment options are needed for patients who are unsuitable for TNF-α inhibitors

The insurance reimbursement registration process for IL-17A inhibitors as first-line treatment for ankylosing spondylitis has been at a standstill for a long time.

 

As a result of the investigation, the two IL-17A inhibitors approved in Korea, Cosentyx of Novartis Korea and Taltz of Lilly Korea completed discussions on expanding the HIRA level of coverage in February, but the application has not yet been implemented.

 

These drugs simultaneously submitted applications for reimbursement expansion based on the ‘ASAS-EULAR axSpA treatment recommendations 2022’ in July last year.

 

Interleukin drugs are already available for prescription as first-line treatment for ankylosing spondylitis in more than 30 countries.

 

In Korea, both drugs are approved for reimbursement only as second-line therapy after a prescription for a TNF-α inhibitor.

 

According to the ASAS-EULAR guidelines revised last year, IL-17A inhibitors were upgraded to the same recommendation grade (A) and level of evidence (1a) as TNF-α inhibitors.

 

It was mentioned that both agents are currently being used as first-line biological agents for the treatment of ankylosing spondylitis, and it was officially confirmed that the therapeutic positions between the two agents are the same.

 

Additionally, in the case of TNF-α inhibitors, there are concerns about tuberculosis.

 

For this reason, treatment for latent tuberculosis must precede the use of TNF-α inhibitors.

 

However, despite anti-TB treatment, the occurrence of tuberculosis due to the use of TNF-α inhibitors is still reported in several studies.

 

Therefore, for some patients who are at high risk of infection, such as tuberculosis, or who have comorbid conditions, such as heart failure, for which it is difficult to prescribe TNF-α inhibitors, other treatment options are needed.

 

Hong Seung-jae, insurance director of the Korean Society of Rheumatology (Department of Rheumatology, Kyung Hee University Hospital), said, "IL-17A inhibitors are already widely used as first-line treatments overseas, and the 2022 overseas treatment guidelines also state that for patients with ankylosing spondylitis accompanied by skin diseases such as psoriasis, IL-17A inhibitors are already widely used as first-line treatments overseas.

 

“As 17A inhibitors are recommended with priority over TNF-α inhibitors, we hope that coverage for IL-17A inhibitors will be expanded in Korea as soon as possible so that we can provide customized treatment tailored to patient characteristics,” he said.

 

Meanwhile, the number of ankylosing spondylitis patients has rapidly increased by nearly 50% over the past 10 years (35,592 in 2013, 52,616 in 2022).

 

It is a disease that mainly develops at a young age, and domestic patients go through a waiting period of about 40 months until they receive an accurate diagnosis.

 

In addition, the disability level of ankylosing spondylitis is the highest level 2, making it a serious disease that qualifies people with severe disabilities and even exemption from military service.

 

Among domestic ankylosing spondylitis patients, 72.6% are male, and one in two male patients are in their 30s and 40s, and are most socially active, so there are concerns about a decline in occupational ability due to symptoms.

 

In fact, in a study targeting domestic patients, patients were absent from work due to their symptoms, and the annual cost of lost productivity time due to this was approximately 14 million won, and this increased as disease severity and functional limitations increased.

 

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