Orphan drug Ilaris receives conditional pass for reimb again

Again caught by the condition that requires post-marketing evidence submission…whether Novartis will accept the condition remains key to Ilaris’s reimbursement

Redeliberation conducted after the company filed an objection to February's deliberation results…but received the same decision

Although the government restarted reimbursement discussions for Novartis Korea's orphan drug Ilaris Inj (canakinumab) after 2 months, the results were the same.

 

According to the "Results of the 4th 2024 Drug Reimbursement Review Committee Deliberations," which was released on the 4th by the Health Insurance Review and Assessment Service, Ilaris was deemed adequate for reimbursement for the following indications: ▲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 (SJIA).

 

However, the approval came with a condition.

 

Further evidence for the three indications - CAPS, TRAPS, and FMF - must be submitted for the reimbursed use of the drug.

 

At the DREC meeting in February, Ilaris was deemed adequate for reimbursement subject to submission of further evidence, but Novartis filed an appeal, putting the decision on hold.

 

Novartis then requested a reevaluation and received another DREC review after 2 months, but the results remained unchanged.

 

Ilaris, which was deemed adequate for reimbursement along with Enhertu Inj, is a treatment for a rare disease called periodic fever syndrome, which affects only 13 patients in Korea.

 

It is a drug that HIRA President Jung-Gu Kang said he would make efforts for prompt reimbursement during the National Assembly audit in October last year.

 

Ilaris is the only IL-1 inhibitor recommended by international guidelines for the treatment of hereditary periodic fever syndrome and is approved by both the U.S.

 

FDA and the European EMA.

 

Based on the efficacy and safety of the drug confirmed through clinical studies, it is being reimbursed in a total of 30 countries.

 

However, it is facing difficulties in receiving reimbursement approval in Korea.

 

Novartis made two previous attempts for Ilaris’s reimbursement in 2017 and 2022 but failed both attempts.

 

This is its third attempt.

 

Ilaris is also an expensive drug, costing KRW 8 million to KRW 100 million per year for once every 8-week dose.

 

If Novartis accepts DREC’s decision this time, the reimbursement process for Ilaris will progress rapidly, but if it doesn't, its reimbursement will again be at a standstill.

 

Meanwhile, ‘Orkedia Tab 1mg, 2mg, (Orkedia Tab),’ Kyowa Kirin Korea’s treatment of secondary hyperparathyroidism in patients on maintenance dialysis was deemed adequate for reimbursement by DREC at the same meeting.

 

In the case of Santen Pharm Korea’s ‘Rhopressa Ophthalmic Soln.

 

0.02% (Netarsudil Mesylate),’ which is a treatment for open-angle glaucoma and ocular hypertension, the drug was deemed adequate for reimbursement if the company accepted a price lower than the evaluated price.

 

Takeda Pharmaceutical Korea’s ovarian cancer treatment ‘Zejula Cap.

 

100mg (niraparib tosylate monohydrate)’ was reviewed for RSA coverage expansion, but DREC determined its adequacy to be unclear.