Whether Ilaris for 10 will receive reimb gains attention

A treatment for around ten patients in Korea

Reimbursement Standard Subcommittee review in progress…whether it will be applied PE exemption remains key

Rep. Sun-Woo Kang requests rapid listing of treatments in the National Assembly Audit

Attention is focused on whether progress will be made on discussions for the insurance reimbursement of 'Ilaris', a treatment that is used by around ten patients in Korea.

 

According to industry sources, reimbursement discussions for Novartis Korea’s Ilaris (canakinumab) are currently being negotiated between the government and pharmaceutical companies at the Drug Reimbursement Standards Subcommittee stage.

 

Half a year had passed since the company reapplied for reimbursement in line with the addition of its pediatric indications in April at registration.

 

The company had failed to list the drug for reimbursement two times.

 

A bumpy road lies ahead for its reimbursement still.

 

The current focus of Ilaris’s reimbursement discussion is whether or not the drug can be applied the pharmacoeconomic evaluation exemption system.

 

Ilaris's listing will become more difficult if its reimbursement evaluation is not carried out through the PE exemption track, Ilaris was initially approved in 2015 as a hereditary recurrent fever syndrome treatment.

 

Its disease type is specified according to the mutated gene.

 

Among the various specific syndromes that accompany 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), and ▲ Systemic juvenile idiopathic arthritis (JIA).

 

Among these, CAPS is further classified into ▲Familial Cold Autoinflammatory Syndrome FCAS)/ Familial Cold Urticaria (FCU), ▲Muckle-Wells Syndrome (MWS), ▲Neonatal Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurologic Cutaneous and Articular.

 

Due to the very small number of subject patients and complex indications, it was difficult to progress discussions for its reimbursement.

 

The number of patients who are applied the various indications for Ilaris is extremely small.

 

Some indications for Ilaris do not even have disease codes or are only recently registered.

 

In fact, the number of domestic patients that can use Ilaris is estimated to be around 13.

 

Due to Ilaris’s non-reimbursement, patients have been receiving a treatment they can with an alternative that is not really an alternative.

 

Patients with CAPS have been using ‘Kineret’ which is being supplied through the Korea Orphan & Essential Drug Center.

 

As this drug has not been officially approved by the Ministry of Food and Drug Safety and is being supplied through the center, when supply disruptions occur, no entity in Korea has the obligation to ensure its supply, rendering the communication channel unclear and limits to improving its supply.

 

In the case of FMF, colchicine is recommended as a first-line treatment but is not available in Korea.

 

Ilaris is approved for use in patients with FMF who are contraindicated, intolerant, or achieved inadequate response with the highest-dose colchicine.

 

However, since colchicine has not been introduced domestically, it will be difficult for FMF patients to use Ilaris, even if it receives reimbursement if colchicine's approval and reimbursement issues are not resolved.

 

To solve this problem, an academic society applied for non-reimbursed off-label use of colchicine and reimbursement extension for the drug.

 

In addition, voices calling for Ilaris’s reimbursement listing had risen in the recent NA audit.

 

The National Assembly’s Health and Welfare Committee audit of the National Health Insurance Service and the Health Insurance Review and Assessment Service, Rep Sun-woo Kang of the Democratic Party of Korea, said, "Patients are spending KRW 80 million to as much as KRW 100 million a year to purchase non-reimbursed drugs.

 

We ask the government to promptly list the drug for reimbursement to improve the quality of life for children and ease the financial burden borne by the patients' families.” Therefore, it remains to be seen whether the company and health authorities can reach a consensus and achieve reimbursement listing for ‘Ilaris’, a drug for a very small number of patients.