Reimb of renal anemia drug in progress upon FDA approval

Mitsubishi Tanabe Pharma’s Vadanem receives US FDA approval this month… will soon receive pricing in Europe

JW Pharmaceutical’s Enaroy also soon expected to start drug pricing negotiations

Injectables dominate KRW 100 billion renal anemia drug market..."Release of tablets expand treatment options for the patients and reduce healthcare costs.”

The discussions on the insurance reimbursement of tablet-type renal anemia drugs are expected to gain momentum.

 

As Korea’s health authorities were eyeing whether to start pricing negotiations for Mitsubishi Tanabe Pharma’s Vadanem based on the FDA’s approval decision in the U.S.

 

and pricing decision in Europe, the FDA approval is expected to accelerate the drug’s negotiation process in Korea.

 

According to industry sources, Vadanem was approved by the FDA on the 27th and is expected to receive pricing in Europe as early as April.

 

Vadanem already received approval from the Ministry of Food and Drug Safety last year.

 

The same year, the company applied for US approval of the drug for the indication ‘as a treatment for adult patients with chronic kidney disease who are receiving dialysis (peritoneal dialysis, hemodialysis), which the FDA has recently granted approval for.

 

Currently, oral renal anemia drugs that are about to be commercialized in Korea include Vadanem (vadadustat) and JW Pharmaceutical's Enaroy (enarodustat).

 

If the companies find a reasonably weighed average price compared with their alternatives at the drug pricing negotiation stage with the National Health Insurance Service, they may become the first reimbursed oral renal anemia drug option available in Korea.

 

However, it is expected that insurance benefits for non-dialysis patients other than hemolytic anemia, which is the efficacy of the drug, will be limited.

 

What gains attention is whether AstraZeneca's Evrenzo (roxadustat), which was the first drug to be approved in Korea in 2021, will be withdrawn from the market.

 

The failure of Evrenzo’s landing in Korea, which was the first oral renal anemia drug that marked the start of the approvals, is due to the company's decision to reject the domestic pharmacoeconomic evaluation results and the weighted average price of its alternatives based on its headquarters' high pricing policy for orphan drugs.

 

In other words, the company has no plan to launch the drug at a low price in the barren market environment.

 

The reason why innovative new drugs related to renal diseases require expedited listing is to expand patient treatment options and save health insurance finances.

 

According to the National Health Insurance Service data, the number of patients with chronic kidney disease in Korea increased by 36.9% from 206,061 in 2017 to 282,169 in 2021 and surged 82.8% among those in their 80s.

 

The number of hemodialysis patients is also growing exponentially, and healthcare expenditures spent on the 100,000 patients currently approaching KRW 3 trillion.

 

Until now, the existing market for renal anemia drugs has been mainly dominated by erythropoiesis-stimulating agents (ESAs) and has formed a KRW 100 billion market in Korea.

 

The existing injectables mainly consist of 3 substances: epoetin alfa (recombinant human erythropoietin), darbepoetin alfa, and methoxy polyethylene glycol-epoetin beta.

 

The development of oral tablet formulations by companies in Korea and abroad is raising expectations on the introduction of new treatment options in the renal anemia treatment market that is currently dominated by injectables.

 

Enaroy and Vadanem are hypoxia-inducible factor-proly hydroxylase (HIF-PH) inhibitors that work by activating the erythropoietin (EPO), a hormone that promotes red blood cell production, and reducing hepcidin, a hormone that regulates iron metabolism, to improve hemoglobin levels.

 

Both drugs are available in tablet (pill) form, which offers the advantage of improving dosing compared to traditional injections, as well as increasing the cost-effectiveness in patient care.