2,000 reimbursed items were registered for 3 months

836 reimbursed items will be registered next month

Pharmaceuticals have launched generic products enormously ahead of the new drug price system.

 

In the last three months, about 2000 generics have been licensed and listed.

 

It is to receive upper limit price before applying cascading drug price system that the later it is registered, the lower the price.

 

The government's restrictions on generics have led to the release of many generics.

 

According to the MOHW's announcement on the 28th, “The Amendment of the Pharmaceutical reimbursed list and the upper limit price table”, from August 1st, a total of 836 products will be newly added to the health insurance reimbursement list.

 

Most of the new drugs listed are generics.

 

Products listed in August are Pregabalin (14), Gabapentin (13), Aceclofenac (6), and Celecoxib (7).

 

More than 100 eye drops have been newly registered, and it is identified as newly registered products by dose among previously approved products.

 

For eye drops, the upper limit price should be separately listed in the reimbursed list by dose.

 

In particular, small and medium-sized pharmaceutical companies were actively launching generic products.

 

Kims Pharma registered 48 generics in August.

 

Union Korea Pharm (40), SCD Pharm (36), Reyon (36), Mothers Pharm (31), Kukje pharm (27), Korea United Pharm (22), DHP Korea (20) ), Lite pharm (20), Pharvis Korea (20) have newly registered eye drops, and many small-sized companies have registered generics.

 

Number of new monthly registered drugs (unit: # of Drug, data: The MOHW)

The number of new drugs listed in August is the highest this year.

 

From January to May of this year, about 300 medicines were newly added to the reimbursed list every month.

 

Following the list of 558 in June and 653 in July, the number of products on the list is increasing rapidly.

 

In the last three months, more than 2000 generics have been newly registered.

 

The intention is to receive upper limit price before the new price system is implemented.

 

The new generic drug price system, which has been in effect since last month, includes cascading drug price system that lowers the upper limit as the registration period is delayed.

 

If more than 20 generics are listed in a particular generic market, the upper limit for new listed items will be up to 85% of the existing lowest price.

 

According to the MOHW, the previous drug price system is applied to the products that were registered in May.

 

Most products listed in August are products that have been registered in May.

 

This means that generic drugs that have been registered for benefits since June will receive a lower price than existing products due to the cascading drug price system.

 

Since there are more than 20 generics in the majority of patent expiration drug markets, generics listed from September are forced to receive lower drug prices than before.

 

Since the cascading drug price system does not apply only to generic products listed in August, the application in May is the last chance to receive the previous high price.

 

In fact, until May, generic approval has been increased significantly.

 

There were an overwhelming number of products that were approved by other companies as a consignment method without direct production.

 

According to the MFDS, a total of 1399 generics were approved in the first half of this year through a full-process consignment method.

 

This is the number of generics licensed through another company's bioequivalence study data.

 

In January and February, 161 and 206 consigned generics were approved, respectively, and exceeded 300 in April and May.

 

In 2013, the number of consigned generic licenses began to increase, but since the government's generic license and drug price regulation policies began to be established last year, the consigned generics are approved.

 

In 2012, 50 licensed generics were licensed, but in 2013, the number was 500, a 10-fold increase in a year.

 

In 2015 and 2016, there were more than 1,000 generics licensed for consignment.

 

In 2017 and 2018, 681 and 751 commissioned generics were approved, respectively.

 

Last year, 3,173 consignment generics were approved.

 

It was more than twice as many as 1,306 cases in 2016.

 

From last year to the first half of this year, there were 4,572 consigned generics.

 

According to the HIRA, the total number of registered drugs in August this year is 26,328.

 

It is the largest for 8 consecutive months.

 

It increased by 3,066 from 27,754 in December last year, and more than 3,000, up from 20,689 in November 2018, a year and nine months ago.

 

Despite the government's movement to regulate generics, many generics were released.

 

However, starting in September, the number of new generics are expected to drop significantly.

 

It is analyzed that pharmaceutical companies are equipped with as many generics as possible prior to the implementation of the cascading drug system.

 

In fact, there were 12 licensed generics in June with the cascading drug price system, less than a tenth of the previous month.