Price cuts for 35 generics suspended…only 0.5% of all

Only 3% of the companies that receive price cuts filed claims… minimum number of items among the 7,000

Price cut executions on 13 of Hutecs Korea’s items are suspended until June next year

Second official stay of execution ordered after Medica Korea…additional stay of executions on drug price cuts may follow

The second case of suspension of execution of price cuts among 7,000 generic drugs emerged on the 5th.

 

The price cuts for 12 generic items from Hutecs Korea will be suspended for 9 months.

 

The number of products for which drug price reductions have been suspended, including the 17 drugs whose price cuts have been temporarily suspended, has increased to 35.

 

However, the number of items that received a stay of execution is so small that it only accounts for 0.5% of all the generics that received price cuts.

 

According to the Ministry of Health and Welfare on the 25th, the price cuts for 13 Hutecs Korea’s items will be suspended until June 30 next year.

 

The prices of A Cet SR Tab, Alzpezil Tab 5mg, Lyreca Cap 75mg·25mg·50mg, Exforte Tab.

 

5/160mg, Amolvikar Tab 5/20mg·5/40mg·1/40mg, and Crestibe Tab.

 

10/5mg·10/10mg have been reduced by up to 15% on the 5th, but their prices will be kept at the level before the price reduction for 9 months.

 

The MOHW announced price cuts for about 7,000 drugs from the 5th through a partial amendment announcement of the ‘drug reimbursement list and reimbursement ceiling price table.’ However, Hutecs Korea filed an administrative lawsuit and suspension of execution, claiming that it could not accept the drug price cuts for 13 items, after which the court decided to put the drug price cuts on hold.

 

As a result, price cuts for 17 items from two companies received a stay of execution for 7 to 9 months after filing an administrative lawsuit.

 

Previously, the Seoul Administrative Court decided to suspend Medica Korea's drug price cuts for 5 items, including Telmisartan Tab 40mg, until April 30, 2023.

 

In the case of Hutex Korea, this is the first case where the drug price cut was reverted due to a lawsuit after the drug price cut had been implemented.

 

Not only Medica Korea, but also Abbott Korea, SS Pharm, NBK Phparm, and Youngil Pharm filed a lawsuit to cancel the drug price cut, which resulted in a temporary suspension of execution before the drug price cuts were implemented.

 

The products for which the companies filed lawsuits to cancel the drug price cuts had their drug prices reduced due to procedural inadequacies even though they submitted data that met the highest price requirements, such as conducting bioequivalence tests, and thus pursued legal action.

 

For example, there was one case where a drug’s price was reduced after a bioequivalence test was performed and the conversion was completed because the company did not submit the change permit.

 

There are also cases where the company conducted bioequivalence tests that cost hundreds of millions of won, but permit changes were not completed due to schedule delays.

 

Also, even though companies proved that they fulfilled the requirements for the use of registered APIs, some have been classified as being subject to drug price cuts by raising issues over other ingredients listed in the authorization permit.

 

However, among the total 7,355 drugs whose prices have been reduced, the number of products whose execution of price cuts has been suspended accounts for only 0.5%.

 

There are a total of 179 pharmaceutical companies subject to drug price cuts, and only 3.4% of them filed administrative lawsuits.

 

As there is no legal justification to claim unfairness in the drug price reduction process, the number of administrative lawsuits filed by pharmaceutical companies is expected to be minimal.

 

Hutecs Korea filed a lawsuit to cancel only 13 of its 153 products that received drug price cuts, which amounts to only 8.5%.

 

Hutecs Korea reduced the price of three dosage forms of Exforte tablets but filed a lawsuit to cancel the price cut for only one, 10/160mg dose, product.

 

Medica Korea filed a lawsuit to cancel only 5 of the 91 products that were set to receive drug price cuts, which amounts to only 5.5%.

 

This means that it accepted drug price cuts for 86 of its items.

 

However, it is highly likely that the number of products for which drug price cuts will be suspended will continue to increase.

 

The temporary stay of execution of price cuts made for the 15 items from 3 companies may receive a formal stay of execution before the end of the provisional suspension period.

 

The execution of drug price cuts for 3 items, including Abbott Korea's Lypsta Plus Tab 10/5mg, has been suspended until the 28th of this month.

 

The drug price reduction for 9 items including SS Pharm's S-nofen Tab, 2 items including NBK Pharmaceutical's Cebicox Cap 200mg, and 3 items including Youngil Pharmaceutical's Necfo Tab 5/160mg will be put on hold until the 29th.

 

With cases of drug price cut suspensions rising, there is a possibility that other pharmaceutical companies may also file additional administrative lawsuits.

 

This is because the companies can reduce financial losses during the suspension of the execution period, regardless of the success or failure of the drug price cut cancellation lawsuit.

 

For example, the 35 items for which drug price cuts were suspended did not incur any losses due to price reductions.