3 reimbursed Spinraza use applications from Oct. all cleared

HIRA discloses review cases by Treatment Review and Assessment Committee

Four applications for Soliris all denied

The South Korean health authority has approved of all three cases submitted preliminary approval applications from last month seeking to use spinal muscular atropy (SMA) treatment Spinraza with coverage.

 

Four months after a reimbursement approval, the drug user has to submit an administration monitoring reports for approval on maintenance dose.

 

And the health authority also granted approval on all 24 cases of the monitoring reports.

 

On Nov.

 

30, the Health Insurance Review and Assessment Service (HIRA, President Kim Sun-min) disclosed the results of October cases reviewed by the Treatment Review and Assessment Committee.

 

One of the most expensive new drugs in the world, Sprinraza costs 92.35 million won per 5 ml vial and it requires a healthcare institute to apply for pre-administration approval for reimbursed use.

 

In last month, a 17-year-old male patient, a 25-year-old female patient and a 10-year-old male patient submitted the application.

 

Especially the 10-year-old had received the approval before for the fifth administration, after administering initial dosage (four doses), but reapplied for the approval as he refused to visit the healthcare institute with the concern of COVID-19.

 

HIRA official said, “As the patient has halted the administration for about eight months (skipped two doses), it would be effective to administer in four-month interval, according to the pharmaceutical company’s clinical trial report, to maintain the optimal exposure of cerebrospinal fluid, because Spinraza’s efficacy increases when the fluid exposure is higher.

 

Considering the current situation of COVID-19 and the main healthcare provider’s opinion, additional dose administering 14 days after resuming the administration is approved.”

Before the Spinraza review, the committee reviewed pre-administration applications on reimbursed use of Soliris (eculizumab).

 

And four new applications from last month and one case of reevaluation were denied.

 

Last month, the HIRA Treatment Review and Evaluation Committee disclosed four review cases on the uses of Spinraza, ventricular assist device (VAD), allogeneic hematopoietic stem cell transplant and Soliris.

 

Other details of the Treatment Review and Evaluation Committee’s deliberation can be found on HIRA website (www.hira.or.kr) or the healthcare institute business portal website (biz.hira.or.kr).