Will oral anemia drugs for dialysis patients be reimbursed?

AZ’s 'Evrenzo', the first drug approved in Korea, recently withdrew its license

JW Pharmaceutical’s ‘Enaroy’ and Mitsubishi’s ‘Vadanem’ have no news of being deliberated by DREC

AstraZeneca recently withdrew Evrenzo, an oral treatment for anemia in chronic kidney disease, from the Korean market

Industry interest in rising on whether oral treatments used to treat anemia in dialysis patients will be covered by health insurance in Korea.

 

The drugs have long been approved in Korea since 2020, but one of the products recently withdrew its license.

 

The other two have yet to be reviewed for reimbursement, raising interest.

 

According to industry sources on the 3rd, AstraZeneca dropped the license for its Evrenzo Tab (Roxadustat, AstraZeneca), which is used to treat symptomatic anemia in patients with chronic kidney disease, on April 30.

 

The market withdrawal comes more than 3 years after its approval in July 2021.

 

The drug was praised for improving the convenience of anemia treatment for patients with kidney disease who previously had to depend on injections by switching to oral medication.

 

Historically, patients with chronic kidney disease have been given injections to stimulate red blood cell production called erythropoietin (EPO) or erythropoiesis-stimulating agents (ESA) to treat anemia, a common complication of chronic kidney disease.

 

However, Evrenzo was developed as an oral formulation that works by activating hypoxia-inducible factor (HIF), a gene involved in erythropoiesis that regulates gene expression and raised expectations on improving the convenience of treatment for the patients.

 

After Evrenzo, JW Pharmaceuticals received approval for Enaroy in November 2022, and Mitsubishi Tanabe Pharma Korea received approval for Vadanem in March last year.

 

Both are reportedly working to list their respective drugs for reimbursement.

 

Under these circumstances, Evrenzo's market withdrawal has raised concerns that the authorities may have a negative stance toward the reimbursement of oral anemia drugs for chronic kidney disease.

 

The reimbursement of these drugs also rose as an issue at the National Assembly audit held in October last year.

 

At the time, Democratic Party lawmaker Sun-woo Kang questioned the denial of reimbursement, to which the HIRA responded that the drugs had not been reviewed for reimbursement in key reference countries and lacked clinical evidence.

 

In a written QA, the HIRA said, "Although the drugs are oral formulations unlike existing ESA preparations that are injectables, additional advantages such as the convenience of dosing in hemodialysis patients, which is the target patient group for approval, are unclear.

 

Although it may be potentially useful in some patient groups such as cancer patients for whom ESA administration increases the risk of tumor progression and recurrence and patients with adverse reactions or poor response to high-dose ESA therapy, it lacks direct clinical evidence of effectiveness and safety in these patient groups.” HIRA added that it would review any additional evidence of their therapeutic benefit in future reapplications or supplemental data submitted, as well as the results of overseas assessments, but was not deliberated by the Drug Reimbursement Evaluation Committee on reimbursement adequacy thereafter.

 

However, as Vadanem received US FDA approval in March and reapplied for reimbursement, it remains of interest whether HIRA will start a reimbursement review for the drug soon.