Qarziba (dinutuximab), first drug to be approved, evaluated and negotiated, to be reviewed by Pharmaceutical Benefits Review Committee
[Daily Pharma] Qarziba (dinutuximab, Recordati Korea), the first drug in the parallel licensing, evaluation and negotiation pilot project, will be reviewed again by the Pharmaceutical Benefits Review Committee.
The drug was last reviewed in August but was deemed unaffordable. The drug has since been re-evaluated by the pharmaceutical company and will be reviewed again.
According to industry sources on Thursday, Qarziba is on the agenda for the committee’s 10th meeting.
Qarziba is the first drug in the Parallel Review, Evaluation and Negotiation pilot project. The project will support rapid insurance registration by conducting KFDA approval, drug price evaluation and drug price negotiation in parallel to expedite approval, drug price evaluation, drug price negotiation and notification to the Ministry of Health and Welfare.
As a result, it has been able to set salary standards prior to approval. On 29 May, the 4th Cancer Disease Review Committee set the reimbursement criteria for children aged 12 months or older with high-risk neuroblastoma who have undergone bone marrow aspiration therapy and stem cell transplantation after a partial response or worse following induction chemotherapy, and for relapsed or refractory neuroblastoma.
The drug was approved by the KFDA on 19 June. The approval period was also shortened from 115 days to 90 days as it was designated for the Global Innovative Product Fast Track (GIFT) support system.
Qarziba’s expected reimbursement approval was held up by the Pharmaceutical Council, which deliberates on reimbursement adequacy. At the 8th meeting of the committee, held on 8 August, Qarziba was found not to be reimbursable for paediatric neuroblastoma.
Following this decision, the pharmaceutical company applied to the Pharmaceutical Council for a re-evaluation, as the law allows for a re-evaluation within 30 days of the Council’s decision.
The review panel re-evaluated the application based on the details of the application and the drug was reviewed again by the KPCA. If the decision is again non-beneficial, it will undermine the purpose of the approval, assessment and negotiation pilot to support accelerated coverage.
A dramatic benefit determination would increase the likelihood of coverage within a year and a half of application. This would halve the time it normally takes to apply for approval, which can take up to three years. Qarziba was selected as the first drug to be approved, assessed and negotiated in parallel in June last year and is undergoing the national registration process.
It is expected that Qarziba will be reviewed again by the Drug Review Committee this time,’ said an industry insider. If the price is found to be reasonable, it is expected that the negotiation of the public-private partnership under the approval-evaluation-negotiation pilot project will be fast-tracked and could be submitted to the Health Insurance Policy Review Committee as early as this year.
