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One-shot Zolgensma fulfills terms of its RSA contract

By Kim, Jung-Ju | translator Alice Kang

22.12.06 06:18:12

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HIRA requests monitoring reports for patients in healthcare institutions

The company is required to submit data on the patient response after administration and efficacy evaluation every 6 months for 5 years


Zolgensma (onasemnogene abeparvovec), the ultra-high-priced ¡®one-shot treatment¡¯ that succeeded in receiving reimbursement in Korea in May this year, will start fulfilling the terms of its risk-sharing agreements (RSA) contract.

If the drug was administered at the time its reimbursement was approved in Korea, the medical institutions that administered Zolgensma would need to prepare a report on the effectiveness of the drug every 6 months and submit it to the Health Insurance Review and Assessment Service for 5 years.

HIRA¡¯s New Drug Performance Management Division issued a notice to the hospital community that contains the ¡®Operation Plan for the Performance Management of Zolgensma

Kim, Jung-Ju(jj0831@dailypharm.com)
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