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  • Additional evidences asked for 3 patients using Spinraza
  • by Lee, Hye-Kyung | translator Byun Kyung A | Oct 6, 2020 06:23am
HIRA disclosed August Healthcare Review & Assessment Committee deliberation outcomes
The South Korean health authority has asked three preliminary approval applicants seeking to use spinal muscular atropy (SMA) treatment Spinraza with coverage to submit supplementary evidences.

After the initial approval on reimbursed use of Spinraza, the applicant has to hand in monitoring report every four months before administering the maintenance dose. As a result, 28 out of 31 cases of the monitoring report have been cleared, and three cases have been ended.

On Sept. 29, Health Insurance Review and Assessment Service (HIRA, President Kim Sun-min) disclosed the outcomes of four pre-administration reimbursement review cases deliberated by the Healthcare Review & Assessment Committee in August.

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