1 ‘Soliris’ and 4 ‘Ultomiris’ cases seek prior approval

Results of cases deliberated by HIRA’s Healthcare Review and Assessment Committee in January disclosed

The 3 applications filed for preliminary approval of reimbursement to use ‘Ultomiris (ravulizumab)’ in new patients with paroxysmal nocturnal hemoglobinuria (PNH), and 1 application for re-deliberation were approved, and 2 cases of appeals that were filed were dismissed by Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee.

 

In the same disease class, no new applications were filed for newly reimbursed administration of ‘Soliris (eculizumab),’ but 1 of the new preliminary approval applications filed for reimbursement in new patients with atypical hemolytic uremic syndrome (aHUS) was approved.

 

This January, the Healthcare Review and Assessment Committee deliberated cases for Soliris, Ultomiris, mid-to-long-term hospitalization due to external injury, etc., mid-to-long-term hospitalization for pain control, short-term hospitalization due to external injury, F-18 FDG PET for liver cancer, internal nasal splints used for endoscopic transnasal transsphenoidal hypophysectomy of pituitary tumor, ventricular assist device treatment, medical and selective insurance benefit for hemopoietic stem cell transplantation, and medical insurance benefit for immune tolerance induction therapy.

 

Results that were disclosed on the 4th show that for Soliris, 22 PNH monitoring requests were approved, 1 new request for aHUS indication approved, 4 disapproved, 1 re-administration approved, and 4 monitoring cases approved.

 

For Ultomiris, 3 requests to reimburse new patients with PNH were approved, 1 re-deliberation approved, and 2 appeals were dismissed.

 

Soliris, which has an insurance cap of 5,132,364 won per vial (30ml), costs around 400 million won per year in drug expenses if 3 vials are administered bi-weekly for a year.

 

Ultomiris was listed for reimbursement at 5,598.942 won per vial on June 7th last year, and patients must receive a maintenance dose every 8 weeks 2 weeks after receiving the initial dose.

 

As Soliris and Ultomiris are both ultra-high-priced drugs, a preliminary approval system is conducted to determine eligibility for medical care benefits.

 

Institutions that apply for the preliminary approval must administer the said Soliris or Ultomiris within 60 days of receiving notification of the deliberation results, and must resubmit an application if it wishes to administer the drugs after 60 days.

 

Also, the long-term care institutions that receive the approval for Soliris or Ultomiris’s medical care benefit need to submit a monitoring report every 6 months, with those using Soliris for aHUS being required to additionally submit initial monitoring reports 2 months into treatment.

 

Further details of the deliberation can be found on HIRA’s website (www.hira.or.kr) or business portal (biz.hira.or.kr.>comprehensive review criteria service > criteria > review criteria > Open deliberation cases).