Record number of reimbursed drugs listed in 1 yr

aftermath of the war between generic diabetes drugs

No. of reimbursed drugs increased by 497 in 2 months…largest increase since October last year

500 sitagliptin products listed… Added in bulk after patent expiration in September

Unlimited consignment was possible as the agreements were made prior to the enforcement of joint development regulations

The number of drugs listed for health insurance reimbursement reached a record high in one year.

 

After the generic market for the diabetes treatment drug ‘Januvia’ opened up, the number of reimbursed drugs expanded rapidly.

 

With single-agent and combination-drug generics of Januvia that were approved under consignment contracts signed before the enforcement of joint development regulations pouring in, the amount of reimbursed drugs, which had been on a decline after the reform of the drug pricing system, rebounded.

 

According to the Health Insurance Review and Assessment Service on the 12th, a total of 23,924 drugs were listed for reimbursement as of the 1st of this month.

 

This is a 291 increase in one month from the 23,633 that were listed until last month.

 

Last August, the total number of drugs listed for reimbursement was 23,427, which increased by 206 in September, followed by an increase of over 200 this month.

 

Over the past 2 months, the number of drugs listed for reimbursement increased by 497 in total.

 

This is the largest market expansion in one year after recording 24,661 in October last year.

 

No.

 

of drugs listed for reimbursement by month

Recently, a large number of generic products containing the diabetes treatment ‘sitagliptin’ were listed for reimbursement.

 

Sitagliptin is the active substance in the DPP-4 inhibitor diabetes drug, 'Januvia'.

 

According to the Ministry of Health and Welfare, 284 medicines containing sitagliptin were listed for reimbursement on the 1st.

 

Also, a total of 278 combination drugs that contain sitagliptin and another diabetes drug, metformin, in 7 dosage combinations, were listed.

 

6 types of sitagliptin and dapagliflozin combination drugs were also listed on the 1st.

 

Dapagliflozin is the active substance in the diabetes treatment Forxiga.

 

A large number of sitagliptin generics were listed last month after Januvia’s patent expiry.

 

On the 2nd of last month, 236 sitagliptin-containing drugs, including 163 single-agent sitagliptin drugs, were listed on Korea’s reimbursement list.

 

In fact, over the past 2 months, the number of drugs containing sitagliptin has increased significantly in the reimbursement list.

 

The overall amount of drug coverage, which had been decreasing due to the government's drug price and licensing regulations, has rebounded with the expiration of Januvia's patent.

 

The number of drugs listed for reimbursement has been on a decline since reaching an all-time high of 26,527 in October 2020.

 

Last August, the total number of drugs listed for reimbursement was 23,427, which was a decrease of 3,100 in 2 years and 10 months.

 

This indicates that over the past 2 years and 10 months, 3,100 more drugs were withdrawn or removed from the market than those newly listed for reimbursement under Korea’s health insurance.

 

The reform of the drug pricing system in 2020 triggered this reduction in the number of new listings.

 

The main point of the reform enforced in July 2020 was that only generics that satisfy both the ‘direct bioequivalence testing’ and ‘Regulation on Registration of Drug Substances (DMF)’ requirements may receive the highest price among generics at 53.55% of the original drug’s price.

 

Also, the reform contains a stepped drug pricing system that lowers the price ceiling of generic drugs according to their listing period.

 

If more than 20 generic drugs are listed in the market for a specific ingredient, the ceiling price for newly listed items thereafter can only be set by up to 85% of the existing lowest price.

 

As the price of drugs falls drastically under this structure if the generic drug company does not develop the generic drug itself or conduct bioequivalence tests, the approval of generics that are wholly manufactured under consignments has decreased significantly.

 

The regulatory barriers to licensing have also increased.

 

With the implementation of the revised Pharmaceutical Affairs Act in July 2021, the number of incrementally modified new drugs and generic drugs that can be approved through a single clinical trial has been restricted.

 

The new regulation, the so-called '1+3' regulation, contains provisions to limit the number of IMDs and generics that can be approved through a single clinical trial.

 

If all manufacturing processes are manufactured identically with the same prescription and manufacturing method at the same manufacturing facility as the pharmaceutical company that directly conducted the bioequivalence test, the use of its bioequivalence data is limited to 3 times.

 

This means that only 4 generic drugs can be approved through 1 bioequivalence test.

 

Its clinical trial data can also be used for 3 other items in addition to the one by the company that directly carried out the trial.

 

Before the reform, when a specific pharmaceutical company passed a bioequivalence test and received approval for a generic product, dozens of pharmaceutical companies often received generic approval using the same data.

 

However, the joint development regulations rendered the ‘unlimited data copying for generic approvals' impossible.

 

However, unlimited consignment of the recently approved sitagliptin preparation was possible because the contract was made before the implementation of development regulations.

 

Consignment contracts entered into by pharmaceutical companies before the enforcement of joint development regulations are valid.

 

In fact, many generics have received approval before the enforcement of joint development regulations, and are waiting to be listed with reimbursement upon expiration of the original drug's patent.

 

According to the Ministry of Food and Drug Safety, a total of 785 drugs contain sitagliptin.

 

Of these, 629 have been approved after 2020.

 

72 and 118 were approved in 2020 and 2021, respectively.

 

Last year, 254 sitagliptin preparations were approved, and an additional 185 items were approved this year.