How can the domestic drug price system be improved?

Italy applies different types of RSA for different indications, Suggestions for "the most feasible way"

As drugs that target specific genes or activate the immune system to treat diseases have been released, the use of one drug for various types of cancer has become more frequent.

 

As of 2018, 75% of target anticancer drugs are multiple indications, and in the case of immune anticancer drugs, thousands of single and combined clinical trials for various carcinomas are reached.

 

There are many opinions that the current drug price system needs to be changed.

 

This is because, as indications are added, only the factors that lower the drug price increase, reducing the patient's access to new drugs.

 

How can the domestic drug price system be improved?

 

To find the clues, Dailypharm held the 40th Future Forum on the 11th at the Moonjeong-dong office building under the theme of 'prerequisites for introducing drug prices by indications'.

 

From left, Professor Dongcheol Seo (Chair), Professor Mihye Park, Secretary Kyungho Choi, Manager Younghee Lee, and Chiyoung Ryu

The forum was attended by Professor Seo Dong-cheol of the College of Pharmacy at Chung-Ang University.

 

Park Mi-hye, professor of the College of Pharmacy at Sungkyunkwan University, Choi Kyung-ho, secretary of the Department of Health and Welfare Insurance and Pharmaceutical Affairs Department, Lee Young-hee, head of the Drug Price System Improvement Department of the Health Insurance Corporation, and Ryu Chi-young, director of the Korea Global Pharmaceutical Industry Association (KRPIA), attended.

 

Prof.

 

Mi-Hye Park, who came out as a speaker on this day, analyzed the drug price system for each foreign indications under the theme of 'A measure of valuation when expanding indications of new drugs-Focusing on immune anti-cancer drugs and targeted anti-cancer drugs', and suggested the most suitable method for the domestic environment.

 

Currently, Korea is maintaining or lowering drug prices in consideration of the additional usage (additional financial requirements) of already approved drugs.

 

This is a method that recognizes only the first value assigned at the time of listing of the first salary and not the value of other indications.

 

For this reason, as the standard is expanded, the drug price gradually decreases.

 

Based on the standard anticancer drug, as the number of supplementary extensions increased, the tendency of drug price cuts was more pronounced, and as indications increased, the dropping rate was found to be greater.

 

Professor Park Mi-hye

Prof.

 

Park pointed out that the current method, which does not recognize the value of additional indications, is also contrary to the 'value-based evaluation system', which determines whether or not to pay benefits based on relative clinical usefulness and cost-effectiveness when listing new drugs.

 

.This is because even if an unlicensed drug proves high value in a new indication, it is excluded

 

.There are also concerns about this

 

.Professor Park Mi-hye explained, "If the value of the additional indication is higher and it is not recognized as a drug price, there is a possibility that pharmaceutical companies will not promote the expansion of the standard." In the light of research by Cole et al., "If the value of each indication is recognized, high-value indications can receive high drug prices

 

.Therefore, pharmaceutical companies will be more active in research and development on new indications, so that patients' treatment options can be wider

 

.Therefore, social welfare can be further increased.” Differential structure of drug prices by actual indication, such as Australia and Italy How to determine reimbursement of multiple indication drugs abroad

 

?As a result of an analysis of the survey published this year by Professor Park by the OECD, it was found that there are no countries that explicitly operate the drug price system by indication, but some countries are implementing a structure in which the price of drugs by indications is substantially different for certain drugs

 

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As a result of the OECD survey, Australia, France, Greece, and Italy said that when an indication is added, they concluded a new RSA and the drug price was substantially different

Norway and the UK charge all indications at that price when cost-effective

 

.Australia and Germany calculate single-weighted pricing for each indication, reflecting the cost-effectiveness of the patient group for each indication when determining drug prices for multiple indications

 

.In addition, Italy, Belgium, France, Switzerland, etc

 

.negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different

 

.Professor Park said, "Typically, Australia is making changes by calculating a single weighted average price by referring to the Medicare data collected during the prescription period." "Also, Italy has established a registry very well for nearly 20 years, so that which drug is suitable for any indication of a patient

 

.It is possible to track how much it has been used

 

.Based on this, different types of risk-sharing drugs are implemented for each indication even for the same drug." In addition, Italy, Belgium, France, Switzerland, etc

 

.negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different With the increasing number of anticancer drugs with multiple indications, what is the most appropriate drug price system considering the domestic environment

 

?Prof

 

.Park disclosed the results of the survey to practitioners related to drug prices of pharmaceutical companies registered with the Korea Global Pharmaceutical Industry Association (KRPIA), the Korea Biopharmaceutical Association (KoBIA), and the Korea Pharmaceutical Bio Association (KPBMA)

 

.System 3 is the most supported from▲ Calculation of a single weighted average price according to the value of each indication (system 1), ▲ application of a different risk-sharing system for each indication (system 2), and ▲ different drug prices for each indication (system 3)

 

.Professor Park said, "The majority of respondents evaluated the current system as negative in terms of improving access to new drugs and reflecting appropriate values, and more than 90% agreed with System 2, which received an overall positive evaluation in the direction of system improvement." He said that the way to give different drug prices is practically limited

 

.Based on this, Professor Park proposed to introduce a method that practically differentiates drug prices by applying different types of risk-sharing system for each indication, as in Italy

 

.Professor Park said, "In Korea, RSA is already being implemented, and since 2018, selective benefits have been introduced to medicines, and a system that differentiates the level of reimbursement for each patient has been established, so it seems to be a sufficiently accessible policy." Even when considering harmony, it is considered the most feasible solution." He added, "Currently, the RSA application is operated on a relatively strict basis, so it is difficult to apply it to all drugs for which indications are expanded

 

.This part requires coordination." Professor Park said, "In the future, the possibility of expansion of the indications for anticancer drugs is very high, but the potential risk is left alone

 

.If this situation is repeated, the damage will eventually be suffered by the patients

 

.It is time for a future-oriented policy alternative."