Illaris for 13 pts, re-challenge to enter insurance benefit

Discussions on registration are difficult due to fewer target patients and complicated indications

UK, Canada skip PFS limited cost-effectiveness assessment

Illaris, a treatment for vulva diseases with only 13 patients in Korea, will try again to enter the insurance benefit zone.

 

According to related industries, Novartis Korea submitted an application for Ilaris' benefit in April and is under discussion.

 

However, the registration process is still expected to be difficult.

 

The drug has already undergone two pay procedures but has not achieved its purpose.

 

Ilaris, licensed in Korea in 2015, is a treatment for hereditary recurrence syndrome, and detailed diseases are divided according to abnormal genes.

 

Specifically, Ilaris can be prescribed for ▲CAPS, TRAPS, HIDS/MKD, and FMF ▲ Systemic JIA in Korea.

 

Among them, CAPS is classified again as ▲FCAS/FCU ▲MWS▲NOMID/CINCA.

 

As there are so few target patients and the indications are complicated, it is not easy to discuss the benefits.

 

The number of patients corresponding to various indications of Ilaris is extremely small.

 

Some indications of Illaris do not even have a disease code or have been recently registered.

 

In the case of CAPS, a drug called Kineret is used through the KODC.

 

It is a drug that comes through the center rather than officially approved by the MFDS in Korea, and there are some disruptions in supply, but the communication channel is unclear and there is a limit to supply improvement.

 

In addition, in the case of FMF, colchicine is recommended as the primary treatment, but this drug is not available in Korea.

 

Ilaris is licensed for use in FMFs where colchicine is contraindicated or does not show an appropriate response to the highest drug dose of colchicine.

 

However, since colchicine has not been introduced in Korea, it is difficult to use Illaris if the permission and salary problems of Kolkisin are not resolved even if the benefit is applied later.

 

In order to solve this problem, the association is known to have applied for an increase in the salary of the drug.

 

Since the HIRA regulations define alternative drugs as drugs included in the same treatment range in terms of permission and salary standards, it is not expected that Illaris will be able to devise a reimbursed strategy by viewing Kineret, an unlicensed emergency drug currently used only for CINCA.

 

"There are many difficulties in many ways because the target diseases that require treatment for Illaris are detailed and the number of patients is too small," said Jeong Dae-Chul, chairman of the KCPCI (Pediatric and Adolescent Department at Seoul St.

 

Mary's Hospital).

 

"It is a pity for the medical staff that there are patients who are considering immigration to countries where Ilaris can be prescribed." It remains to be seen whether the drug "Ilaris" for very few patients will achieve good results this time.

 

Ilaris is an IL-1 inhibitor recommended by international guidelines for the treatment of hereditary recurrence syndrome and is the only approved treatment in both domestic and U.S.

 

FDA and European EMA.

 

Ilaris is used as a benefit in a total of 30 countries based on the therapeutic effect and safety confirmed through clinical research.

 

In Italy, Switzerland, and the United Kingdom, patients have benefited from the treatment of Illaris since 2009 in Canada and 2011 in Japan.

 

In the UK and Canada, where Health Technology Assessment (HTA) is carried out to register new drugs like Korea, Illaris excludes cost-effectiveness evaluation and applies salaries only for PFS (CAPS, TRAPS, HIDS/MKD, FMF) indications.