IL inhibitor reimb as 1st-line Tx for ankylosing spondylitis

receives reimbursement approval in Korea

MOHW issues amendment to its reimbursement list… reimbursement will be extended from next month

Provides an alternative for patients who show inadequate response to TNF-α inhibitors

Interleukin inhibitors may soon be available as first-line treatment for ankylosing spondylitis in Korea.

 

On the 20th, the Ministry of Health and Welfare announced an amendment notice that contains a plan to expand insurance reimbursement for the 2 IL-17A inhibitors approved in Korea - Novartis Korea's 'Cosentyx (secukinumab)' and Lilly Korea's 'Taltz (ixekizumab)’ – as treatments for ankylosing spondylitis.

 

With the notification, the reimbursement standard extension for the two drugs, which had remained pending for over a year, is expected to be implemented within the year.

 

Novartis and Lilly both submitted an application for reimbursement extension for their respective drugs based on the ‘ASAS-EULAR axSpA treatment recommendations 2022’ in July last year.

 

Although the actual process for their reimbursement extension was completed earlier this year, time was wasted due to a delay in final approval on the Ministry of Health and Welfare’s part.

 

Interleukin inhibitors are available with reimbursement as a first-line treatment for ankylosing spondylitis in over 30 countries.

 

In Korea, both drugs are currently only approved for use with reimbursement in the second-line treatment setting, after patients are prescribed TNF-α inhibitors.

 

The grade of recommendation and level of evidence for IL-17A inhibitors were raised to Grade A and 1a in the 2022 update of the ASAS-EULAR recommendations, to the same level as TNF-α inhibitors.

 

The guidelines referred to how both agents are currently being used as first-line biological agents to treat ankylosing spondylitis and officially confirmed their equal therapeutic positions as treatments for ankylosing spondylitis.

 

Moreover, the use of TNF-α inhibitors is associated with tuberculosis.

 

So patients had to undergo prior therapy to treat latent tuberculosis before using TNF-α inhibitors.

 

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

 

Therefore, another treatment option was dire for patients who are at high risk of infection such as tuberculosis, or who have comorbidities, such as heart failure, and have complications in being prescribed TNF-α inhibitors.

 

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 occurs at a young age, and domestic patients go through about 40 months of wait until they receive an accurate diagnosis.

 

In addition, patients can receive a disability level up to Level 2 at the highest, rendering it a serious disease and eligible for exemption from military service.