Anemia drug ‘Vadanem’ makes 2nd attempt at reimb listing

Mitsubishi Tanabe Pharma’s new drug

Vadanem is expected to acquire FDA approval and be priced in Europe in April or May

It is expected to be priced reasonably, aiming for a weighted average price of the substitute drug

Related oral drugs may be added to the listing process

Mitsubishi Tanabe Pharma

Vadanem, Mitsubishi Tanabe Pharma’s new tablet anemia drug, will likely receive approval from the U.S.

 

Food and Drug Administration by early April and make a second attempt at getting a reimbursement listing in Korea.

 

If the company gets the drug reasonably priced comparable to a weighted average price of the substitute during drug pricing negotiation with the Health Insurance Review and Assessment Service (HIRA), the drug will be recorded as the first new anemia drug in tablet form to be commercialized in Korea.

 

According to the pharmaceutical industry, Vadanem (vadadustat) has been re-submitted for U.S.

 

approval for the indication of ‘Treating anemia in adult patients with chronic kidney disease who are receiving dialysis.’ The FDA is conducting a positive review of the submission.

 

Furthermore, listing Vadanem, which received European approval in May 2023, for EU drug pricing is proceeding smoothly.

 

Considering its ongoing FDA approval and European listing schedule, Mitsubishi Tanabe Pharma aims to negotiate with the HIRA for drug pricing within May.

 

However, insurance reimbursement will be available for its known original efficacy in treating anemia in dialysis patients but not in non-dialysis patients.

 

EPO ingredient, developed 30 years ago, is the only new anemia drug available.

 

The products are available as third-generation injection forms with longer administration duration.

 

Increasing demand for new mechanism-based treatments arose due to patients' unresponsiveness to conventional drugs and side effects such as changes in blood pressure and vomiting.

 

Vadanem, which acquired the BLA from the Ministry of Food and Drug Safety (MFDS), is an anemia drug for treating adult patients with chronic kidney disease who are receiving dialysis.

 

It inhibits Hypoxia-inducible factor (HIF) prolyl hydroxylase and promotes Erythropoiesis.

 

HIF is a protein that responds to decreased oxygen supply in cells.

 

When starting Vadanem treatment, patients must have sufficient storage ions and be checked for levels of transferrin saturation (TSAT) and ferritin.

 

The starting reference dose is below 10 g/dL hemoglobin (Hb) for patients who had not previously been treated with erythropoiesis-stimulating agents (ESA).

 

It is possible to switch patients who are receiving ESA to this medication.

 

Vadadustat is orally administered at an initial dose of 300 mg once daily, and after treatment, the dose can be gradually increased depending on the patient's condition.

 

The maximum dose is 600 mg once daily.

 

The need for expedited approval processes for innovative drugs related to kidney disease is driven by the necessity to expand treatment options for patients and reduce health insurance expenses.

 

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

 

Particularly noteworthy is the 82.8% surge among individuals in their 80s during the same period.

 

The number of patients undergoing dialysis is increasing exponentially.

 

The NHIS spends nearly KRW 3 trillion on approximately 100,000 patients.

 

Moreover, patient adherence is expected to increase as Vadanem is an oral tablet, unlike conventional erythropoiesis-stimulating agents that are administered only via injection.

 

Another oral formulation erythropoiesis-stimulating agent similar to Vadanem is JW Pharmaceutical's Enaroy Tab (enarodustat, approved in Korea in 2022).

 

Enaroy Tab is scheduled to undergo reimbursement listing based on the weighted average price of the substitute drug.

 

AstraZeneca's new erythropoiesis-stimulating agent Evrenzo Tab, containing the active ingredient roxadustat, received approval in Korea in 2021.

 

However, due to the company's policy of pricing orphan drugs at a high cost, it seems they have stopped conducting economic evaluations and proposals for a weighted average price of the substitute drug.