Will 'Bylvay' be listed in the second half the year?

The 1st drug in the Concurrent Approval-Evaluation-Negotiation Pilot Program

Has passed the Drug Reimbursement Evaluation Committee (DREC) in July and is currently undergoing drug price negotiation

Attention has been drawn to establishing the success of expedited review pilot program

Attention has been drawn to whether Bylvay, the first drug in the Concurrent Approval-Evaluation-Negotiation Pilot Program, will be approved for the reimbursement listing.

 

Ipsen Korea is currently in negotiations with the National Health Insurance Service (NHIS) over the drug price for Bylvay (odevixibat), a treatment for pruritus in patients aged 3 months and older with Progressive Familial Intrahepatic Cholestasis (PFIC).

 

Bylvay recently passed the Health Insurance Review & Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee (DREC) in July after a second review.

 

It had previously been sent back for re-deliberation at the DREC in April.

 

The government initiated the first phase of the Concurrent Approval-Evaluation-Negotiation Pilot Program in October of last year, selecting two drugs as its initial targets: 'Qarziba (dinutuximab),' a treatment for pediatric rare diseases, and Bylvay.

 

The Concurrent Approval-Evaluation-Negotiation Pilot Program is a system designed to support swift insurance listing by conducting the Ministry of Food and Drug Safety (MFDS) approval, HIRA reimbursement evaluation, and NHIS drug price negotiation in parallel.

 

However, questions were raised about the program's effectiveness in expediting drug listings when Bylvay initially failed to pass the first reimbursement hurdle.

 

The review for Qarziba, the other drug in the first phase of the program, was also briefly halted at the DREC.

 

Now that Bylvay has entered the final stage of negotiation, it remains to be seen if the Concurrent Approval-Evaluation-Negotiation Pilot Program can live up to its name by Bylvay's successful reimbursement listing.

 

Meanwhile, the efficacy of Bylvay was proven in the Phase 3 ASSERT study, which was conducted on pediatric and adolescent patients up to 17 years of age.

 

The study results showed that Bylvay met its primary endpoint by significantly reducing pruritus compared to the placebo.

 

It also significantly improved the key secondary endpoints, including the mean serum bile acid concentrations at weeks 20 and 24 compared to placebo.

 

These effects of Bylvay were sustained for up to 24 weeks of treatment.