Incentives for phase 3 among Koreans raise public opinion

Health authorities and industry, introducing and reviewing drug price regulations related to Japan, Taiwan, and France

Up to 60% premium for overseas cases, innovation, usefulness, and treatment method improvement

Positive effect on industrial and national economic development, such as encouraging R&D and job creation

In order to prepare a reasonable drug price calculation for new drugs that have undergone phase 3 clinical trials in Korea, attention is focused on whether the special drug price system of Japan, Taiwan, and France can be applied and introduced.

 

According to the industry, the public-private consultative body for improving the drug price system is conducting in-depth discussions to form a consensus on the introduction of a positive incentive system for innovative new drugs developed in Korea and to derive positive results.

 

Furthermore, the basis for preferential drug prices for domestic new drugs, such as Article 17-2 of the 'Special Act on the Promotion and Support of the Pharmaceutical Industry' amended in December 2018, such as 'preferential treatment in addition to the maximum amount of drugs', is already in place.

 

It is expected that it will be able to be institutionalized from next year.

 

The purpose of the clinical drug pricing system for Koreans is to evaluate the appropriate value of new drugs by raising them from 90% to 95-100% of the current alternative drug market price in the case of skipping drug price negotiations for new drugs that have undergone phase 3 clinical trials for patients residing in Korea.

 

is wearing Institutional strengths include ▲securing evidence for safety, efficacy, and clinical usefulness for Koreans, ▲easiness of tracking and management of clinical trials, improvement of R&D capabilities according to the full domestic clinical staff, ▲upgrade and employment of clinical trial institutions creation, and ▲compensation for contributions to the development of new drugs suitable for the health conditions and diseases of Koreans.

 

Then, how about the case of Japan, which is most actively operating such a system?

 

In this regard, Japan's additional system is largely classified and applied into four categories: innovation, usefulness, marketability, children, and preferential introduction.

 

The usefulness bonus is a drug that meets two of the three requirements of the innovativeness supplement and can receive an incentive benefit of 5 to 60% depending on the detailed application criteria.

 

Additives for children (5~20%) are drugs for which the contents of children and infants are explicitly included in the dosages related to the main or corresponding efficacy of the new listing, and drugs for which the comparator of the new drug is not subject to the additives for children.

 

belong to this category Priority introduction (10%) includes new drugs approved for the first time in Japan and drugs with new mechanisms different from similar drugs already approved in foreign countries (US, UK, Germany, France) and Japan.

 

It is understood that France determines the addition by focusing on improvements such as medical benefits, clinical value, and dental efficacy as well as the reduction of side effects.

 

CT oversees technical reviews such as SMR and ASMR under the Ministry of Health, and CEPS determines drug prices through negotiations with pharmaceutical companies after consultation with the committee.

 

When negotiating drug prices, the level of clinical benefit improvement of drugs, the price of alternative drugs, the expected amount of use, and the predictable status of prescriptions are reviewed from various angles.

 

Contracts regarding refunds in case of exceeding expected usage and expenditures are made, and drug prices and drug expenditures are made accordingly.

 

The level of clinical benefit improvement is classified into 5 grades according to the degree of improvement compared to existing treatments, and the drug price is determined according to the grade.

 

New drug pricing categories in Taiwan are divided into Group 1, group 2A, and Group 2B.

 

Group 1 is determined by the median price of drugs in A10 countries, and Groups 2A and 2B are finalized considering the lowest price in A10 countries, drug prices in countries of origin, relative comparison prices of foreign prices, and comparison of drug administration costs.

 

As for the additional requirements, premiums of up to 15% are given for domestic clinical trials (10%), domestic economic evaluation (maximum 10%), pediatric drugs (maximum 15%), and improvement in therapeutic effect, safety, and convenience of taking.

 

The public-private consultative body for improving the drug price system is composed of officials from the Ministry of Health and Welfare, the Korea Pharmaceutical Bio Association, and the Global Pharmaceutical Industry Association.

 

It is understood that the government is working on a plan to improve and classify the new drug price system, such as maintaining the period for adding the maximum amount of drugs to stabilize the supply of drugs.