Oral renal anemia drug meets reimb listing terms

Expected to be the new treatment option

EPO injectables have dominated a KRW 100 billion market for the past 30 years…prescriptions on the rise

Licensed oral renal anemia drugs 'Vadanem·Enaroy' cost 30% less than conventional drugs

FDA granted approval of Vadanem, with proven safety…oral formulation has the benefit of reducing costs·convenience for administration

Mitsubishi Tanabe Pharma and JW Pharmaceutical have filed an application to the Health Insurance Review and Assessment Service (HIRA) for drug pricing of licensed renal anemia drugs, Vadanem and Enaroy.

An application for drug pricing has been filed for two items of renal anemia drugs that are equivalent in efficacy to conventional EPO injections but cost much less.

 

New treatment options are expected to become available.

 

According to industry sources, Mitsubishi Tanabe Pharma and JW Pharmaceutical have filed an application to the Health Insurance Review and Assessment Service (HIRA) for drug pricing of licensed renal anemia drugs, Vadanem and Enaroy.

 

The insurance pricing of these drugs is about KRW 1.2 million, which is about KRW 300,000-500,000 lower annually than EPO injections.

 

It is expected to significantly save the finances of the National Health Insurance.

 

Furthermore, the efficacy of these drugs demonstrated equivalence (non-inferiority) to a comparator drug through clinical trials.

 

The adverse reactions are similar to or less than those of the existing drugs.

 

It is considered to be the new treatment option.

 

If these two drugs were to secure indications for nondialysis patients, it was expected that they would quickly gain market share due to the improvements in administration convenience compared to injectables.

 

However, it is a disappointing that they were only approved for indications for dialysis patients.

 

However, for over the past 30 years, the market has been virtually monopolized by three first-generation erythropoiesis-stimulating agents (ESAs), which are Epoetin alfa, Darbepoetin alfa, and Methoxy polyethylene glycol, and epoetin beta.

 

These have seen annual growth rates exceeding 10%.

 

Consequently, the introduction of an oral formulation is seen as a response to the demands of the current era.

 

Under these circumstances, AstraZeneca voluntarily withdrew its Evrenzo Tab (roxadustat), approved by the Ministry of Food and Drug Safety (MFDS) in 2021, due to various complications, including drug pricing issues.

 

Anemia is caused by decreased kidney function and EPO production capacity, followed by lowered hematopoiesis.

 

Renal anemia is accompanied by oxygen depletion due to decreased red blood cells, and it is commonly accompanied by in tiredness, decreased appetite, insomnia, and depression.

 

It reduces the quality of life and impacts the mortality rate of patients.

 

There are over 700 million patients with chronic renal kidney disease worldwide, and 1 out of 7 patients experience anemic symptoms.

 

The remaining available drugs are Enaroy Tab (Enarodustat) and Vadanem Tab (vadadustat), which were approved in Korea in 2022 and 2023, respectively.

 

If these drugs fail to be listed for reimbursement, Korean patients who suffer from renal anemia and doctors will permanently have no options for oral treatments.

 

Considering that these drugs are priced 30% less than injectable formulations and have improved convenience of administration, with equivalent effectiveness, it would be a major loss as a nation.

 

According to the National Health Insurance Service (NHIS) data, the number of patients with chronic kidney disease in Korea increased 36.9%, from 206,061 patients in 2017 to 282,169 patients in 2021.

 

The increase was particularly steep in patients in their 80s, up 82.8%.

 

Dialysis patients are also on the rise exponentially.

 

Listing of competitive and new drugs may be justified as the National Health Insurance finance spent on approximately 100,000 patients amounts to KRW 3 trillion.

 

“We expect the progress will be made soon because the initiation of negotiations related to listing was centered on whether Mitsubishi Tanabe Pharma’s Vadanem will be granted U.S.

 

FDA approval and the direction of insurance pricing of the drug in European regions,” an industry expert said.

 

Vadanem received FDA approval in March and is expected to receive a pricing decision in Europe between May and June.

 

In August last year, Vadanem made a second attempt for the U.S.

 

FDA approval for indication in 'anemia treatment (hemodialysis plus peritoneal dialysis) in adult patients with chronic kidney disease under hemodialysis,' and the FDA granted approval based on the absence of safety issues.

 

Vadanem and Enaroy are hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) enzyme (HIF-PH) inhibitors.

 

These inhibitors have mechanisms of improving hemoglobin levels by activating 'erythropoietin (EPO)' and reducing 'hepcidin,' a hormone responsible for iron metabolism.

 

Meanwhile, the EPO formulation, developed 30 years ago, is the only available treatment for renal anemia.

 

Third generation injectables with extended intervals of administration have been launched recently.

 

However, many patients do not respond to these treatments, experience changes in blood pressure, and have adverse reactions, such as nausea and vomiting.

 

Thefore, there is a need for treatments with new mechanism.