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Ilaris’s reimb again at a standstill… bumpy road ahead
by Eo, Yun-Ho Mar 12, 2024 05:48am
The road to reimbursement for ‘Ilaris,’ a treatment used by around ten patients in Korea, continues to be bumpy ahead. According to Dailypharm’s coverage, the government’s ‘reimbursement adequacy’ decision made for Novartis Korea’s Ilaris (canakinumab) has been put on hold after the company failed to meet the government's request for additional data. The drug, which is a treatment for hereditary recurrent fever syndrome, had previously received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. Novartis has since requested the government to revisit the data submission requirements to the extent possible, and has recently filed a request with HIRA for Ilaris’s reimbursement. Ilaris is indicated 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). The indications for CAPS, TRAPS, and FMF were deemed conditionally adequate for reimbursement by the DREC last month. At the time HIRA set out evidence submission and follow-up management as conditions for the reimbursement of these indications. In general, the condition set out by DREC is ‘accepting a price below the appraised value'. It is rare for a drug to be approved with such strict conditions. Given the circumstances, the government's requirements are likely to be difficult for the company to meet. The question is to what extent Novartis can accommodate the additional data requested by the government, and whether HIRA will accept the amount of data that the company believes it can submit rather than all of the data and grant reevaluations. Since being approved in 2015, Ilaris has already failed two reimbursement attempts. With patients waiting more than eight years, it will be interesting to see if the government and the pharmaceutical company can reach an agreement and move toward expanding coverage. A Novartis official said, "We are fully aware of the patients’ wait. As this is our third reimbursement attempt, we are exploring all measures available for reimbursement listing, and requested reevaluation so that the post-submitted evidence requirement presented by HIRA be adjusted to a realistically achievable level.