Covered drugs decreased due to generic drug price system

The number of drugs covered by health insurance in November has decreased in 11 months since last December

With the implementation of the new drug price system, new generic drugs have decreased

Number of drugs on the monthly list of health insurance benefits (unit: number, source: the HIRA)

The soaring number of medicines covered by health insurance showed a sharp decline.

 

As the number of new generic licenses decreased due to the implementation of the new drug price system, the number of covered drugs decreased in 11 months.

 

According to the HIRA on the 8th, as of November 1, the total number of drugs on the health insurance benefit list was 25,830, down 697 from the previous month's 26, 527.

 

It was only 11 months since December last year that the number of covered drugs has decreased from the previous month.

 

Health insurance-covered drugs have increased for 10 consecutive months from December of last year to October of this year.

 

During this period, the number of covered drugs increased by 3,265 from 23,262 to 26,527.

 

From the end of 2018, the number of covered drugs started to soar.

 

From November 2018 to last month, except for No.

 

1, there was an increase every month.

 

In November 2018, the number increased from 20,689 to 26,527 in two years.

 

As the number of newly listed drugs decreased, the total number of covered drugs also decreased.

 

From January to August, the total number of drugs registered for new benefits was 3,632.

 

This means that an average of 454 items per month are newly listed on the health insurance benefit list.

 

The previous drug price system was applied to the reimbursed list in May, but 836 items were listed in August.

 

However, the number of new listings has declined sharply from September.

 

In September, the number of newly-listed drugs was 122, a decrease of more than 700 from the previous month, and in October and November, it was only 108 and 60, respectively.

 

The number of drugs listed for new benefits per month (Unit: number, Source: the MOHW)

This is a change that emerged from the implementation of the new drug price system.

 

According to the reorganized drug price system, which took effect in July, generic products can maintain the 53.55% upper limit compared to the original drug before the expiration of the patent only when both the direct conduct of the bioequivalence test and the use of the registered drug substance are satisfied.

 

A stepped drug price system has also been introduced, in which the upper limit is lowered as the registration period is delayed.

 

In fact, the government's policy to strengthen generic regulations has led to a surge in new generic licenses by pharmaceutical companies for about two years.

 

In this year, a total of 1,631 generics were licensed until last May.

 

On average, 326 generics per month received new licenses.

 

However, after a sharp decline to 73 cases in June, 70 cases in July and 50 cases in August showed a marked decline.

 

According to the MOHW, the previous drug price system will be applied to products applied for the list in May.

 

Generics, which have been approved since June and applied for the registration, are said to receive low drug prices by applying the new drug price system.

 

This is the background of the sharp decline in the number of new generic licenses from June.

 

The MFDS' attempts to strengthen licensing regulations have contributed to the licensing of a bunch of generics.

 

In recent years, with the recommendation of the Regulatory Reform Committee of the Office for Government Policy Coordination, the strengthening of regulations on the joint bioequivalence test was unsuccessful, but applications for generic licenses increased sharply shortly after the plan to strengthen the biometrics regulation was disclosed earlier last year.

 

In the industry, it is also evaluated that as a result of the intensive approval of generics for pharmaceutical companies in the government's regulatory reinforcement movement, the areas for further entry into the market have significantly decreased.

 

This means that most of the generics that pharmaceutical companies can sell were licensed before the tightening of regulations.

 

From December 2018 to May this year, a total of 5,611 generics were newly entered.

 

On average, 312 generics were released per month.