Reevaluation difficult for Ildong and Abbott’s Lypsta

Unclear whether the drug meets pricing requirements due to the drug’s co-development status

Abbott conducted the bioequivalence tests in the approval process but Ildong submitted the Phase III trial results

Unclear whether the drug meets the price ceiling reevaluation criteria as well.. attention is focused on the court’s decision

There are slightly ambiguous aspects to Abbott Korea's ‘Lypsta Plus Tab,’ whose drug price was lowered on the 5th after the insurance price ceiling reevaluations.

 

This drug was jointly developed between Abbott Kore and Ildong Pharmaceutical, and the bioequivalence test data among the clinical trial data was submitted by Abbott.

 

Perhaps for this reason, Abbott opposed the price cut and filed for a stay of execution, due to which the drug price will be maintained as is the 28th.

 

According to industry sources on the 13th, The price of Lypsta Plus Tab’s 10/5mg formulation had been lowered from KRW 895 to KRW 761; the 10/10mg formulation from KRW 1,251 to KRW 1,063; and the 10/20mg formulation from KRW 1,263 to KRW 1,074.

 

However, the execution of the price cut is set to be suspended until the 28th due to Abbott’s application for a stay of execution.

 

The drug is a combination drug for hyperlipidemia that combines rosuvastatin and ezetimibe.

 

Lypsta and 'Droptop Tab’ were jointly developed by Ildong and Abbott.

 

During the reevaluations conducted this time, a price reduction could only be avoided if the company proves that it has conducted its own bioequivalence test or clinical trial, even for jointly developed products, In a Q&A session before the reevaluation, HIRA said, “Even for drugs that were developed through joint clinical trials, in-house bioequivalence test or an in-house clinical trial must be conducted, and data of such proof be submitted to meet the standard requirements.

 

In the case of products approved through clinical trials, the clinical trial has to be conducted under the supervision of the marketing authorization holder (pharmaceutical company).’ However, HIRA added that the standard requirements do not apply if the product that was approved through joint clinical trials is the first product to be listed for reimbursement in Korea.

 

However, Lypsta is not the first product reimbursed in its class.

 

Rosuzet is the first product that was ever listed, and Lypsta was released two years after Rosuzet’s reimbursement.

 

However, HIRA’s self-bioequivalence test verification requirements are a little ambiguous.

 

This is because the two companies divided the clinical trials and shared the results with each other.

 

For example, Ildong Pharmaceutical submitted drug interaction test and therapeutic confirmatory clinical trial data among quality assessment data, non-clinical trial data, and clinical trial data, and Abbott submitted the biopharmaceutics test data among clinical trial data.

 

Excerpt from Lypsta

In other words, Abbott conducted the Phase I bioequivalence test, and Ildong conducted the Phase III therapeutic confirmation trial.

 

The two items were shared between the companies and the drug was approved in December 2017.

 

This aspect is indicated in the approval report disclosed by the Ministry of Food and Drug Safety.

 

It is understood that health authorities concluded that although there was a bioequivalence test submitted by Abbott, the core clinical trial was conducted by Ildong Pharmaceutical, its joint development partner, therefore the data did not meet the standard requirements.

 

During reevaluations, Ildong Pharmaceutical's 'Droptop’ was excluded from receiving drug price cuts for meeting the standard requirements.

 

With an administrative suit in place, whether Lypsta Plus Tab meets the standard requirements is expected to depend on the court's judgment in the future.