RWD & RWE will be important means of use in post-evaluation

The government said, "If it used well, the flexibility may be increased beyond unconditional regulations in the benefit stage."

The quality of the site, which will be the standard, such as standardization of medical records at hospitals where data will be calculated.

Limited replacement is appropriate as a means of supplementing proven RC The quality of the site, which will be the standard, such as standardization of medical records at hospitals where data will be calculated.

 

The task of government insurance authorities and the private sector is to increase patient access to very expensive and innovative new drugs, in other words, to make benefit entry smoother and faster.

 

The government, the National Assembly, and the pharmaceutical community continue to consider revitalizing related systems such as the "the approval-benefit linkage system" and "post-registration evaluation," but the emergence of ultra-high-priced drugs cannot be covered by our evidence-based insurance system.

 

The RWD and the work of processing it as RWE, and the movement and discussion to further systematize the evaluation area after the approach by reflecting the results in the policy are important.

 

However, when this mechanism is actively used, there are many tasks to be prepared in the future, such as eliminating concerns about other harsh regulations or affecting all new drugs in the current system with RCT, and standardizing detailed standards in domestic clinical sites, which are one of private medical institutions.

 

Several panels participated in the Innovation Research Symposium hosted by the HIRA on the 4th.

 

Standards should be prepared at the level of field practice such as detailed standards, and guidelines.

 

Like Kymriah, the emergence of ultra-high-priced drugs makes it possible to predict the future trend direction of new drug development and insurance-listed drugs.

 

Therefore, it is clear that RWD and RWE will be important means of use in post-evaluation to enhance patient access and coverage when second, third, and fourth drugs challenge benefits one after another.

 

On the premise of this justification, panels agree that detailed practical standards such as qualitative standardization and data collection at the current level and different medical records of private medical institutions should be established.

 

Taking the case of Kymriah as an example, Bang Young-joo, an honorary professor at Seoul National University (CEO of Bang & Ock Consulting), said, "Kymriah is a drug that cannot be waited until 1,000 clinical patients are recruited.

 

Since clinical characteristics and recruitment limits are different for each drug, we need to prepare a sample size setting standard.

 

Park Jong-heon, head of the big data operation office at the NHIS, also mentioned the importance of setting practical standards through cases.

 

When the corporation conducted a post-evaluation study of immuno-cancer drugs in the past, it conducted a study by linking health insurance-clinical data, and each hospital had different methods of providing data and doctors.

 

Director Park said, "There are enough laws in place.

 

However, he said, "I think it is necessary to form a sufficient consensus on the importance of RWD and RWE," and emphasized, "Since related guidelines have not been made, micro-linked methods and practical discussions such as standardization are needed." "Another regulation following RCT, limited use" vs "flexibility to enter benefits may be secured" The industry and the government's position on RWD and RWE was quite different.

 

This could be an opportunity to make the hurdle barrier more flexible in the long run, as it is essential for the post-evaluation of ultra-high-priced drugs with high uncertainty, and questions about whether the new drug must be reevaluated as RWD's base production even after entering the benefit.

 

First, Kim Joon-soo, chairman of the KRPIA Policy Committee, mentioned the case that Nice in the UK also prefers RCT and uses RWD limitedly if additional data are required when uncertainty is high in terms of cost effectiveness, such as anticancer drugs and rare disease treatments.

 

Chairman Kim also stressed, "RCT is designed under the condition of pre-blocking for intermediate variables, so RWE is based on daily data, so it is not high in terms of reliability and low in level of evidence due to various environmental conditions and influencing variables." Lee Eun-young, director of Korea alliance of patients organization, said, "RCT is designed to be licensed and registered with data, but I know that RWE has emerged because the design and clinical results do not match at the clinical site.

 

In addition, the government emphasized the justification for application.

 

The government, which has introduced high-priced drugs into salaries, needs to look back on whether they were of appropriate value and reasonable cost afterwards.

 

Choi Kyung-ho, an insurance drug officer at the MOHW, said, "Even if RCT is appropriate, I think RWE is necessary when registering ultra-high-priced drugs like Kymriah."