[Reporter's view] Consistency in the post evaluation

Re-evaluation of drugs is underway.

 

The move is aimed at preventing waste of health insurance benefits due to insufficient drugs to verify efficacy.

 

Accordingly, the MFDS is playing a leading role in re-evaluating clinical trials and the HIRA is playing a leading role in re-evaluating the adequacy of benefits.

 

The problem is that there is no consistency in selecting the target drug as the re-evaluation is carried out separately.

 

The MFDS goes through clinical re-evaluation procedures if it fails to prove that it is currently not used in developed countries, the United States, the United Kingdom, France, Italy, Japan, Germany, Switzerland, and Canada, called A8 during the license renewal process.

 

The HIRA is also based on the benefit performance of A8 countries.

 

However, compared to the MFDS, it is excluded from the re-evaluation only if there are two or more countries' performance.

 

However, the HIRA started re-evaluating the adequacy of benefits from the 2020 Choline alfoscerate, a brain function improvement drug.

 

In addition, it targets ingredients worth more than 0.1% of the annual claims and about 20 billion won, so there are not many ingredients subject to revaluation per year.

 

Six ingredients were selected this year and eight next year.

 

The agency in charge of drug approval and registration conducted re-evaluation on different criteria, making it impossible to ensure consistency in the results.

 

Of course, the MFDS verifies the efficacy and the HIRA evaluates the appropriateness of benefits, but basically, it is the same to determine whether the drug is effective or not.

 

The verification of 'clinical usefulness' is the most important indicator for both institutions.

 

Enteron, which went through a re-evaluation last year, was recognized for its appropriateness in treating ophthalmic disorders such as retinal and choroid circulation.

 

The MFDS is also conducting a clinical re-evaluation of the indications, and in the process, the efficacy and effect were limited due to eye disorders in diabetic patients.

 

Streptokinase and Streptodornase, which are subject to revaluation this year, are expected to produce clinical revaluation results next year.

 

This is also a situation where we cannot guarantee the results of this year and next year.

 

Basically, if the MFDS grants a drug license, the HIRA will establish standard based on the license.

 

However, this basic procedure is ignored in the revaluation.

 

Whether the MFDS verifies its efficacy through clinical re-evaluation or not, the re-evaluation will be conducted separately.

 

Conversely, clinical re-evaluation proceeds regardless of clinical usefulness in re-evaluation.

 

It is meaningless for drugs that have not been recognized for their clinical usefulness in revaluation and have been expelled from benefit to be recognized for their efficacy in clinical revaluation.

 

Pharmaceutical companies with Streptokinase and Streptodornase, which are undergoing clinical re-evaluation, are worried about this.

 

Some think that the HIRA is an affiliated organization of the MOHW, and the MFDS is a different independent ministry, so each of them tried to demonstrate their capabilities in the re-evaluation.

 

It is unlikely that the problem will be solved because there is no ministry to adjust this.

 

Anyway, drug licensing and benefit evaluation should be done by an independent institution to be a better choice for national health.

 

The important thing is to keep the basics.

 

The MFDS determines the exact efficacy of the drug, and the HIRA determines whether to pay based on this and applies it to post-reevaluation.