AHA drug Obizur to soon receive reimb in Korea

Company completes drug pricing negotiations with the NHIS

Accepts a set price to skip insurance price ceiling negotiations

Conditionally passed DREC review in October last year

Takeda Pharmaceuticals Korea’s hemophilia drug Obizur is expected to soon be reimbursed in Korea.

 

The company was found to have completed pricing negotiations with the National Health Insurance Service recently.

 

The drug received conditional approval from the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in October last year.

 

According to industry sources on the 11th, Takeda Pharmaceuticals Korea recently completed negotiations with the NHIS on Obizur’s reimbursement and is set to be reported to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare soon.

 

Obizur can be reimbursed in Korea in the month following the HIPDC report.

 

Obizur is used to treat bleeding in adult patients with acquired hemophilia A.

 

At the DREC meeting that was held in October, the committee determined Obizur’s reimbursement was adequate at a price below the appraised value.

 

The importer, Pharmaceuticals Korea, is understood to have accepted this condition.

 

The company also accepted a price less than 100% of the weighted average price of its substitute, thus omitting negotiations on its insurance ceiling price.

 

Therefore, the company only needed to negotiate the estimated claims amount with the NHIS.

 

If reimbursed, Obizur’s reimbursement process will be complete in one year since its marketing authorization in March last year, serving as a good example of expedited reimbursement.

 

Unlike existing bypassing agents, Obizur replaces blood coagulation Factor VIII with AHA indications.

 

Its unique mechanism of action allows Obizur to become the only AHA drug that can stably monitor patients’ blood factor VIII levels using standard assays, enabling individually tailored dosing.

 

In a prospective, non-randomized, open-label Phase II/III study of 28 patients with AHA that evaluated the safety and efficacy of Obizur, all patients that were treated with Obizur had a positive response to treatment at 24 hours after initial dosing.

 

A positive response was one where bleeding had stopped or was reduced, with clinical improvement or with factor VIII activity above a pre-specified target.

 

Takeda Pharmaceuticals Korea said, “Obizur is a gene recombinant therapy that was produced by deleting the B-domain from a porcine factor VIII that is comparable to human Factor VIII.

 

Therefore, the inhibitory antibodies in the human body do not readily recognize the treatment, allowing Obizur to replace the inactivated human coagulation factor VIII to help blood clotting and control bleeding.