Public opinion grows on if PO kidney tx should be covered

Bayer's Kerendia submitted to committee, Academia, National Assembly, all-out pressure

New treatment option in the spotlight due to change in formulation

There is also a 10-20% reduction in drug costs compared to existing injections worth KRW 100 billion

Bayer chronic kidney disease treatment Kerendia.

 

This drug is a disease-related disease that has emerged for the first time in 20 years

As first-in classes related to kidney disease are blocked by insurance registration review barriers, it seems urgent to improve the system through social consensus.

 

A drug related to this is Kerendia, Bayer's chronic renal failure treatment that was newly introduced for the first time in 20 years.

 

Renal anemia that occurs due to abnormal kidney function can be mentioned, including the recently approved AstraZeneca Evrenzo (2021), JW Pharmaceutical Eronai (2022), and Mitsubishi Danabe Vadanem (2023).

 

The reasons why a rapid registration process for innovative new drugs related to kidney disease is required are to expand patient treatment options and reduce health insurance finances.

 

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

 

The number of hemodialysis patients is also showing an exponential increase, and the health insurance budget currently spent on approximately 100,000 patients is close to 3 trillion won.

 

Compared to existing renal anemia treatments that are distributed only as injections, it is expected that patient compliance will also significantly increase because it is in the form of an oral pill.

 

The news that Kerendia has been submitted to the pharmaceutical review committee provides some hope for the insurance listing of these drugs related to comprehensive kidney disease.

 

This is a result of approximately one and a half years after approval (May 2022) due to the expression of opinions from all directions, including not only the developer, but also the nephrology society, the National Assembly, and patient groups.

 

Therefore, discussions on drug price negotiation for Kerendia, which was recognized as appropriate for coverage of chronic kidney disease with type 2 diabetes at the 11th pharmaceutical reimbursement evaluation committee, are gaining momentum, giving strength to the justification for listing renal anemia treatment drugs.

 

The reason why health authorities actively reviewed the adequacy of Kerendia's benefits was to reduce social costs.

 

When chronic kidney disease progresses to end-stage renal failure, treatment progresses to hemodialysis, peritoneal dialysis, kidney transplantation, and surgery, which costs around 30 million won per year, which goes against public opinion to overcome this by actively intervening in drug therapy in the process.

 

We are doing it together.

 

AstraZeneca, JW Pharmaceutical, and Mitsubishidanabe obtained approval from the Ministry of Food and Drug Safety for tablet-type renal anemia treatments Evrenzo, Eronai Tablet, and Badanem in 2021, 2022, and 2023, respectively.

 

These drugs are expected to have equivalent effects compared to injectable drugs and contribute to reducing health insurance costs but are still pending HIRA review

As can be seen in the Kerendia case, tablet-type renal anemia treatments also require an emphasis on drug efficacy and cost-effectiveness and a quick reimbursement process is required.

 

It is known that tablet-type renal anemia treatment drugs can achieve financial savings of about 10 to 20% compared to existing injection drugs, based on clinical data on anemia treatment in dialysis patients, even if patients with general kidney disease are excluded.

 

Some are concerned about issues related to blood clots, but according to the industry, existing drugs appear to be in a similar situation, so it is almost a logical contradiction to use this as an issue to put a brake on drug price negotiations.

 

The only treatment for renal anemia is EPO, which was developed about 30 years ago, and recently, even third-generation injectable drugs with extended administration intervals have been released.

 

As the number of patients who do not respond to existing medications is gradually increasing, new treatment mechanisms are required due to side effects such as blood pressure changes and nausea and vomiting.

 

It is understood that JW Pharmaceutical's Eronai and Mitsubishi Badanem are attempting to be listed at the average price among alternative drugs.

 

AstraZeneca Evrenzo appears to have virtually suspended all proposals for PE and alternative drug weighted average prices based on the headquarters' high orphan drug price policy.