Qarziba’s reimb standard has been set before approval

The 1st drug for a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations”

The CDRC set a reimbursement standard for treating neuroblastoma in young children over 12 months

Considering the Korean Academy of Medical Sciences suggestions, the CDRC improved the reimbursement standards for 6 anticancer therapy items

The reimbursement standard has been set for Qarziba (dinutuximab, Recordati Korea), which was designated as the 1st drug for a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,” even though it has not yet received approval from the Ministry of Food and Drug Safety (MFDS).

 

Qarziba is used for treating neuroblastoma in young children over 12 months.

 

The Health Insurance Review and Assessment Service (HIRA) held the 4th Cancer Disease Review Committee (CDRC) meeting 2024 on May 29 and announced this review result.

 

Qarziba was considered for a review as a novel drug.

 

It has been assigned to a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations.” The process for product approvals, reimbursement coverage reviews, and drug price negotiations are being conducted concurrently.

 

The MFDS has completed the safety and efficacy review and is currently processing the product approval.

 

Even though the drug has not yet received product approval, a reimbursement standard has been set because it was designated as part of a pilot project.

 

The CDRC set the reimbursement standard for this drug for young children over 12 months with ▲ A high-risk neuroblastoma who had received bone marrrow removal therapy and a stem cell transplantation therapy after showing partial adverse reactions following chemostheray ▲Recurrent and refractory neuroblastma.

 

The CDRC review results for Qarziba, nexatin inj plus Loicosodium inj plus FU inj Choongwae, nexatin inj plus Xeloda tab, and Trisenox Inj plus Vesanoid Soft Cap.

At the meeting, CDRC also approved a reimbursement expansion proposal for nexatin inj plus Loicosodium inj plus FU inj Choongwae or nexatin inj plus Xeloda tab.

 

Additionally, the CDRC passed a reimbursement expansion proposal for Trisenox Inj plus Vesanoid Soft Cap.

 

The committee also considered opinions by the Korean Academy of Medical Sciences and drafted a reimbursement standard improvement proposal reflecting current clinical settings.

 

The reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items).

The HIRA stated that it has considered the opinions of the Korean Medical Association and the Korean Academy of Medical Sciences regarding reimbursement standards and is proactively pursuing a review to improve pharmaceuticals, activities, and treatment materials through communication with the medical industry and academics.

 

For anticancer therapy, the CDRC’s task force team reviewed 6 items.

 

As a result, reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items).

 

The CDRC delivered partial approval of Lutathera inj use coverage, limiting to application by clinics.

 

Additionally, the CDRC approved reimbursement for the use of Lutathera inj use, limited to application by clinics, exceeding the standard approval.