Reevaluation deadline for listed drugs extended 5 months...

Will accept data submitted within the objection period

MOHW makes a final report to HIPDC... will conduct monthly bioequivalence monitoring, encourage the rapid submission of data

The government finalized its plan to extend the deadline for reimbursed price reevaluations of listed drugs that are subject to conduct bioequivalence tests and made a final report to the top legislative organization for the national health insurance.

 

The finalized plan will extend the data submission period of listed drugs that are subject to reevaluations by 5 months, and companies that submit review results during the objection period for the Drug Reimbursement Evaluation Committee’s review after exceeding the submission deadline will also be accepted.

 

The objection period on the Drug Reimbursement Evaluation Committee’s judgment will be around the end of May, and the final announcement period for the drug price cuts is scheduled for December next year.

 

The Ministry of Health and Welfare held a Health Insurance Policy Deliberation Committee meeting on the 29th and reported the ‘Changes regarding the reevaluation of the upper limit (standards) set for pharmaceuticals.’ The reevaluation of listed drugs was made as a follow-up measure after the introduction of the stepped new drug pricing system that links approvals with drug price to ensure the quality of generic drugs and countermeasures against the flood of generics in the wake of the detection of impurities in valsartan-containing drugs in 2018.

 

Since July 2020, all new generics introduced are applied a stepped pricing system under the new drug pricing system when determining its insurance price.

 

The essence of the standard is to prove the results after conducting in-house bioequivalence tests.

 

However, due to the spread of COVID-19, the bioequivalence tests that were to be conducted by the companies were not progressable due to difficulty recruiting subjects and the increase of confirmed COVID-19 cases among subjects which led to discontinuation or delays in trials and disrupted system implementation.

 

Industry voices on the need for deadline extensions and deferred evaluations increased further due to the time taken in designating reference drugs necessary to demonstrate the bioequivalence of sterile drug products.

 

Accordingly, the MOHW and the Ministry of Food and Drug Safety discussed flexibly adjusting the reevaluation procedure and schedule to facilitate smoother operations since May.

 

In comprehensive consideration of the special circumstances that include preserving the consistency in insurance finances and the drug pricing system, equity with new products, and the prolonged COVID-19 outbreak, the MOHW decided to partially modify the data submission deadline and evaluation period, but with the goal of completing the schedule within 2023.

 

According to the HIPDC report, the data submission deadline for existing items had been extended with a condition in consideration of the COVID-19 situation.

 

The extension will be applied to 10,000 tablet preparations among oral prescription drugs and suppositories that are subject to bioequivalence tests.

 

Among these drugs, if their bioequivalence tests have been delayed due to COVID-19, etc., the company may submit the test result report to the MFDS by February next year or submit the review results by end of May to HIRA within the planned objection period on HIRA’s Drug Reimbursement Evaluation Committee review, will be deemed to have met the final requirements.

 

If the companies are unable to demonstrate bioequivalence within the set period, their drug’s price will be reduced as of July 1st next year.

 

Authorities plan to identify progress made for bioequivalence tests by company and month within the second half of the year so that submission of bioequivalence test reports will not be concentrated in a specific period, and encourage prompt data submission to the MFDS upon completion.

 

Adjustments to the reevaluation period will also follow.

 

The government will also adjust HIRA's reevaluation period in consideration of the current designation status of reference drugs and MFDS's review schedule.

 

The data submission deadline to HIRA is by July next year, and HIRA's evaluation period will be adjusted from July next year to November.

 

With the changes, the drug price reduction announced for unproven products will be made around December next year.

 

The MOHW will continue to monitor the progress of bioequivalence tests and the designation status of reference drugs and consult with MFDS and other related associations on issues to guide companies to disperse the submission of their reports.