Vadanem for renal anemia makes its 'third attempt at reimb'

Won MFDS approval in 2023 and FDA approval in 2024…listed in European countries

The weighted average price of the substitute drug has been priced at KRW 1 million to 1.2 million…likely to save the insurance finance compared to EPO injectables

Demonstrated comparable (non-inferior) effects to a control drug…regarded as a new treatment option as an oral drug

There has been an increase in patients who do not respond to conventional drugs…due to side effects, treatments with new mechanisms are needed

Mitsubishi Tanabe Pharma

Attention has been drawn to the oral renal anemia drug Vadanem as the company completed meeting procedural requirements and attempts again to obtain reimbursement listing.

 

According to industry sources, Mitsubishi Tanabe Pharma recently submitted Vadanem's drug pricing application to the Health Insurance Review and Assessment Service (HIRA).

 

After obtaining approval from the Ministry of Food and Drug Safety (MFDS) in March 2023, Vadanem is making a third attempt at insurance reimbursement.

 

After Vadanem obtained FDA approval in March 2024, it was listed in Germany for its demonstrated safety and efficacy.

 

In January, it also secured a prescription recommendation from the U.K health authority As a result, Vadanem secured all medical health technology evidence required by the Korean health authority's listing criteria.

 

Therefore, it is anticipated to be accepted.

 

Mitsubishi Tanabe Pharma suggests a weighted average price of the substitute as about KRW 1 million to 1.2 million.

 

Because the suggested price is about KRW 300,000 to 500,000 lower than the conventional EPO injectables, it has been evaluated to contribute significantly to saving the National Health Insurance finance.

 

The efficacy of the drug was demonstrated through comparative effects (non-inferior) to a control drug.

 

The side effect of the drug was reported to be similar to conventional drugs.

 

Thus, it is being regarded as a new treatment choice.

 

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.

 

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.

 

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

 

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.

 

Vadanem is a hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) enzyme (HIF-PH) inhibitor.

 

It works by improving hemoglobin levels by activating 'erythropoietin (EPO)' and reducing 'hepcidin,' a hormone responsible for iron metabolism.

 

The domestic market for renal anemia drugs has been dominated by erythropoiesis-stimulating agents (ESAs).

 

Hypoxia-inducible factor prolyl hydroxylase enzyme (HIF-PH) inhibitors are demonstrating potential after AstraZeneca·JW Pharmaceuticals·Mitsubishi Tanabe Pharma obtained approval from the MFDS for Evrenzo Tab (roxadustat)·Enaroy Tab (Enarodustat)·Vadanem Tab (vadadustat) in 2021·2022·2023, respectively.

 

During this process, AstraZeneca withdrew from the launching of Evrenzo Tab in South Korea due to substantially lower drug pricing than the prime cost.

 

According to a document on pharmaceutical distribution performance, external sales of renal anemia drugs amount to KRW 100 billion.

 

The overseas market for all types of HIF-PHI prescriptions is worth KRW 10 trillion.