Novartis’ 'Ilaris' will be reconsidered for the DREC review

On April 4th

The DREC held in February decided on reimbursement appropriateness for Ilaris under certain conditions

Documentation requirements were not met…Will approval for listing be granted after eight years?

Novartis

The rare disease drug 'Ilaris Injection (canakinumab, Novartis Korea)' will be reconsidered for review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) after two months.

 

Ilaris is a drug used to treat a rare disease called 'periodic fever syndromes (PFS)' for which there are ten patients in South Korea.

 

The drug received domestic approval in August 2018 but has not cleared the reimbursement hurdle.

 

According to industry sources on the 2nd, Ilrais is anticipated to be reconsidered for review by the DREC, which is scheduled for April 4th.

 

According to industry sources on the 2nd, Ilaris will be reconsidered for review by the DREC.

 

In the DREC held in February, the drug was recognized for appropriateness of reimbursement under the condition of submitting additional documents.

 

The DREC decided Ilaris has reimbursement appropriateness for indications in ▲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) ▲Active Systemic Juvenile Idiopathic Arthritis (SJIA).

 

However, the DREC required the submission of CAPS, TRAPS, and FMF documents.

 

Yet, Novartis failed to submit related documents within the deadline, so the decision on the appropriateness of reimbursement was postponed.

 

Novartis has requested reevaluation and will be reviewed by the DREC again after two months.

 

Ilaris is an IL-1 inhibitor recommended for the treatment of periodic fever syndromes (PFS) by international guidelines.

 

It is the only drug to receive approval for this treatment from South Korea, the U.S.

 

FDA, and the European EMA.

 

With clinically proven treatment effectiveness and safety, Ilaris is covered by reimbursement in 30 countries.

 

However, Ilaris faced challenges in acquiring reimbursement coverage in South Korea.

 

Its attempts to secure reimbursement were unsuccessful in 2017 and 2022.

 

Now, Ilrais is being considered for the third time.

 

Patients strongly demand reimbursement coverage for the drug, which is highly priced at KRW 20 million per administration.

 

The patients’ families have posted a petition for Ilaris reimbursement listing on the government’s online petition website called, Cheongwon24.

 

Attention is focused on whether the drug will receive the reimbursement appropriateness decision from this DREC review and proceed to the drug price negotiations with the National Health Insurance Service (NHIS).

 

If negotiations for drug pricing succeed, Ilaris will be covered by reimbursement.