Reimb for Ilaris unclear... benefits 13 patients in Korea

Discussion sluggish since the company reapplied for reimbursement in 1H

Treatment options other than Kineret required... improves treatment cycle

As well expected, no progress has been made in reimbursing ‘Ilaris,’ an orphan drug that affects 13 patients in Korea.

 

According to industry sources, reimbursement discussions for Ilaris (canakinumab), Novartis Korea’s Hereditary recurrent fever syndrome treatment that the company applied for in the first half of the year is making slow progress.

 

The company had reapplied after receiving a non-reimbursement decision from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in 2017, but the government nor the company seems to be finding a way.

 

Among the various specific syndromes that accompany a hereditary recurrent fever, Ilaris is approved in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF) due to contraindication, intolerance or lack of efficacy.

 

Although the drug had demonstrated an improvement in quality of life and convenience in administration with its 6-times-a-year administration in CAPS patients, the drug had difficulty proving its cost-effectiveness, being a treatment for an ultra-rare condition and because a relatively cheaper option ‘Kineret (anakinra)’ is being supplied through the Korea Orphan & Essential Drug Center.

 

In fact, Novartis first applied for reimbursement in 2017 after it was initially approved in 2015.

 

However, the company did not proceed with the reimbursement process again until recently after the setback in 2017.

 

Anticipation had risen for its reimbursement with the reapplication filed this time but to no avail.

 

Unlike Kineret which is administered every day, Ilaris offers a more convenient option to patients and carers alike, as it is administered every 8 weeks.

 

Dae-Chul Jeong, Professor of Pediatrics at Seoul St.Mary’s Hospital, said, “Access to such treatments needs to be improved so that patients with hereditary recurrent fever in Korea are guaranteed the same right to receive treatment as other patients with rare diseases.

 

In addition, “Patients with hereditary recurrent fever are diagnosed after a difficult journey.

 

We need to provide social attention and support so that patients can maintain the quality of life with their families without being discouraged at the threshold of treatment." Meanwhile, in a clinical study, 97% of the patients that were administered Ilaris 150mg achieved a complete clinical response by Week 8 through a single administration during the open-label study period.

 

In the double-blind, placebo-controlled study period, all patients who were administered Ilaris 150mg every 8 weeks maintained their complete response without relapse for over 6 months.

 

Also, in a real-world study that was conducted in France that compared 68 adult and pediatric patients that received at least one dose of Ilaris at baseline, at 6 months and 12 months, over 40% of patients with CAPS who were treated with Ilaris showed an improvement in vitality such as social function, human relationship, and sexual activity, and the patient care period of carers reduced significantly.