Orphan drug 'Bylvay Cap' wins reimb approval after reeval

Bylvay Cap passed the DREC review on July 10 as a designated drug for the concurrent approval-evaluation-negotiation pilot project

HLB Pharma's Citrelin ODT receives conditional approval if the company accepts a price below the evaluated amount

'Bylvay Cap,' which is being considered for the expedited reimbursement listing process as a designated drug for 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,' received reimbursement appropriateness decision after reevaluation.

 

Consequently, Bylvay Cap will be subjected to negotiation with the National Health Insurance Service (NHIS) before its inclusion in the reimbursement list.

 

Health Insurance Review and Assessment Service (HIRA) stated that it has held the 7th Drug Reimbursement Evaluation Committee (DREC) meeting on July 10 and decided as such.

 

During the meeting, the DREC decided on the reimbursement appropriateness for Bylvay Cap 200, 400, 600, and 1200 μg (odevixibat sesquihydrate).

 

Drug Reimbursement Evaluation Committee (DREC)

Bylvay Cap is used to treat progressive familial intrahepatic cholestasis (PFIC).

 

This drug was designated as the first concurrent approval-evaluation-negotiation pilot project in 2023.

 

The criteria for the concurrent approval-evaluation-negotiation pilot project were drugs with sufficient efficacy intended for treating cancer or rare diseases with a life expectancy of less than one year, as well as those proving superior survival·treatment effectiveness for over two years when alternative treatments are not available.

 

Bylvay Cap obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) in August 2024 and entered into the reimbursement evaluation process.

 

Yet, the reimbursement evaluation process has been uneasy.

 

A complaint was heard from an expert who attended the reimbursement review meeting from the evaluation stage.

 

In the DREC meeting held last April, a conclusion was not reached, and it was decided to re-evaluate.

 

It was only today, three months later, that it passed the DREC review.

 

As drugs under the concurrent approval-evaluation-negotiation pilot project undergo a one-stop process without following separate stages, Bylvay is likely to have already entered negotiations with the NHIS.

 

If the NHIS negotiations are completed, patients will be able to receive National Health Insurance coverage for this drug immediately after review by the Health Insurance Policy Review Committee.

 

Meanwhile, the DREC decided on HLB Pharma's Citrelin ODT to receive a conditional approval, stating that reimbursement appropriateness if the company accepts a price below the evaluated amount.

 

This drug is used for 'improving ataxia caused by spinocerebellar degeneration.'