The number of reimbursed drugs is the lowest in 33 months

Changes brought about by tightening regulations

2923 fewer since October 2020

A sharp drop in new entry generics due to the reorganization of the drug price system and regulations on joint development

The number of medicines listed on the health insurance benefit list is the smallest in about three years.

 

New-entry drugs have decreased significantly due to the price reorganization of generic drugs and joint development regulations.

 

The size of the reimbursed drug has been greatly reduced due to the reorganization of items such as microbial or unclaimed deletion of drug benefits.

 

Prior to the reorganization of the drug price system, reimbursed drugs exploded, but they are rapidly recovering to the previous level.

 

According to the HIRA on the 8th, a total of 23,604 drugs were registered as of the 1st of this month.

 

It decreased by 1,057 in a month from 24,661 in the previous month.

 

The health authorities delete drugs that have not claimed insurance benefits in the past two years or have not reported production or import performance for three years from the payroll list.

 

The number of medicines has been on a steady decline since it hit 26,527 in October 2020.

 

It has decreased by 2,923 in the past two years and one month.

 

This means that there have been 2,923 more withdrawals or exits from the market than new entries into health insurance benefits over the past two years.

 

In November 2018, the number of reimbursed drugs was recorded at 26,689, but in October 2020, the number increased by 5,838 in a year and 11 months to 26,527.

 

During this period, new entries overwhelmed the number of withdrawals from the market, with the size of salary-listed drugs expanding by 28.2%.

 

In the 22 months from November 2018 to October 2020, the number of salary-listed drugs decreased compared to the previous month only once on November 8 and December 2019.

 

In other words, the remaining 21 months have all increased the size of salary-listed drugs compared to the previous month.

 

During this period, the average number of unproduced and unclaimed drug benefits was deleted twice a year, but the number of new entries was higher.

 

The number of times listed drugs has decreased from the previous month 16 times in 25 months from October 2020 to this month.

 

Since August last year, the number of drugs listed has decreased for six consecutive months.

 

Currently, the number of drugs listed has fallen to 25,694 in February 2020, the lowest in 33 months.

 

It is analyzed that the overall number of listed drugs has continued to decline as the speed of the health authorities' continuous arrangement of reimbursed drug items has advanced to the new entry.

 

Recently, the number of new generics has decreased significantly.

 

According to the Ministry of Food and Drug Safety, the number of Rx drugs licensed from January to October this year was 942, an average of 94 per month.

 

Last year, 1,603 Rx drugs were licensed, recording an average of 134 per month, down 41.2% in a year.

 

Compared to the 2,616 Rx drug licenses (218 per month on average) in 2020, it has fallen to less than half in two years.

 

The number of Rx drug permits was 1,562 in 2018, recording an average of 130 per month, but in 2019, it soared to an average of 350 per month.

 

Since then, it has been gradually decreasing.

 

It is analyzed that the number of permits for generic drugs, which account for the largest proportion of Rx drugs, has decreased.

 

The reorganization drug price system, which took effect in July 2020, focuses on maintaining the 53.55% upper limit of the current original drug before the expiration of the patent only when generic products meet both the direct performance of BA Test and the use of registered raw materials.

 

The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the registration period is delayed.

 

If more than 20 generics are listed in the specific ingredient market, the upper limit of newly listed items will be up to 85% of the existing lowest price.

 

It is analyzed that the approval of the manufacturing consignment generic for the entire process has decreased significantly due to the structure in which the drug price drops significantly if pharmaceutical companies do not develop the generic themselves and perform BA tests.

 

Some say that the regulation on joint drug development, which took effect in July last year, has promoted the decline in generic permits.

 

The revised Pharmaceutical Act, which was passed at the plenary session of the National Assembly in May last year, limits the number of IMDs and generics that can be approved as a single clinical trial.

 

If all manufacturing processes are manufactured the same with the same prescription and manufacturing method at the same manufacturer as the pharmaceutical company that directly conducted the BA test, the use of BA data will be limited to three times.

 

This means that only four generics can be licensed with one BA test.

 

Clinical trial data can also be agreed on up to three items other than medicines by direct pharmaceutical companies.

 

In the past, when certain pharmaceutical companies received generic permits through BA test, dozens of pharmaceutical companies often received consignment generic permits with the same data, but joint development regulations made it impossible to "unlimited generic replication." It is analyzed that pharmaceutical companies received generic permits indiscriminately regardless of marketability before tightening regulations, and there are many cases that lead to market withdrawal without sales performance.