6 cases of Ultomiris & 1 case of Spinraza were pre-approved

The HIRA released a case of deliberation by the Medical Review and Assessment Committee last month

Benefits for pre-approval of six new PNH patients for Ultomiris administration were approved and four cases were rejected.

 

There were no applications for new salary administration for Soliris, but two applications for pre-approval for new aHUS patients were not accepted.

 

In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), one application for new patient benefits and two data supplementations were decided.

 

Of the 25 monitoring reports, 23 were approved and 2 were disapproved.

 

The HIRA conducted deliberation on six items, including Soliris and Ultomiris, and whether hospitalization fees were recognized.

 

According to the results of the deliberation on the 2nd, Soliris decided to approve 33 PNH monitoring applications, to disapprove 2 new aHUS cases, to disapprove 1 retrial, to approve 2 monitoring cases, and to disapprove 1 case.

 

Ultomiris has approved 6 out of 10 new patient approval applications for PNH, 4 disapproval, 3 re-deliberation, and 1 monitoring approval.

 

Soliris is 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price per year alone is 400 million won.

 

Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered.

 

Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the deliberation.

 

If it is intended to be administered after 60 days, it must be re-applied.

 

In one case, data supplementation was requested, and in the other case, data supplementation was required as it was necessary to confirm whether the patient could receive spinal canal injection stably due to the long course of the disease.

 

Spinraza is an ultra-high-priced new drug of 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of salary.

 

Details of the deliberation can be found in the case of www.hira.or.kr or biz.hira.or.kr > Comprehensive Review Standards Service> Criteria> Review Standards> Public Deliberation.