HIRA 'Ease entry of new drugs and strengthen post-evals'

Jung-Gu Kang, President of the Health Insurance Review and Assessment Service

Shared HIRA’s plans with reporters on the 6th... reconfirmed HIRA’s plan to conduct the external reference pricing reevaluations within the year

HIRA President Jung-Gu Kang is answering questions from the press corp on June 6

Jung-Gu Kang, President of the Health Insurance Review and Assessment Service, said that he will lower the barriers to entry for new drugs while strengthening post-listing evaluations.

 

For this, Kang explained that HIRA had established the ‘Pharmaceutical Performance Assessment Department’ to improve the management system of high-priced drugs.

 

Regarding the external reference pricing reevaluations, Kang said that the reevaluations will be conducted this year, but that the specific date of its implementation is unclear.

 

He added that it will take time for their review.

 

President Kang said so at a meeting with its press corp at HIRA headquarters in Wonju on June 6.

 

Kang said, “Drugs that have waived pharmacoeconomic evaluations, immunotherapy drugs that have been studied for a short period of time, or drugs for rare and incurable diseases should be evaluated after being listed.

 

We need to conduct long-term follow-up on the effect of these drugs to continue reimbursing effective drugs and removing or switching ineffective drugs.” Regarding the external reference pricing reevaluations that will be conducted using foreign drug prices,Gook-Hee Kim, Director of the Pharmaceutical Benefits Department at HIRA, said, "We are in discussions with the industry to come up with a reasonable and transparent plan.

 

We plan to conduct the reevaluations within the year, but may only be able to release the specific implementation plan at a later time.” The following is a full transcript of Dailypharm’s interview with President Kang.

 

Q.

 

You have been working on a number of projects since your first year in office.

 

What significant achievements and regrets have you had since your appointment?

 

I would like to start by saying that my focus in my first year in office was on the ‘people.’ We sought to help more people benefit through adequate compensation for essential healthcare, which was also a key national agenda.

 

In the lowest low fertility rate crisis, we focused on providing compensation for critically ill and emergency pediatric patients and strengthening the pediatric care system and delivery infrastructure while expanding reimbursement to the public by listing serious diseases such as cancer and brain diseases.

 

While expediting the reimbursement listing of ultra-high-priced drugs, we also contributed to protecting health insurance finances through patient-level performance management.

 

Q.

 

Your organization had completed reorganization in the past year and began full-scale implementation on January 1 of this year.

 

What was the main point and direction of this reorganization?

 

HIRA’s new mission is to ‘Contribute to the Health and well-being of the people by establishing safe and advanced medical environments.’ The reorganization was conducted as a key part of our efforts to achieve this mission.

 

To this end, we have established the Health Insurance Innovation Center, a dedicated organization to review and carry out national tasks such as preventing gaps in essential healthcare and improving the irrationalities in the medical service fee system.

 

We will improve the existing insurance system by remedying the imbalances in the fee-for-service fees and developing various payment systems to create a sustainable compensation system.

 

Also, to improve the management of high-priced drugs that weigh heavily on health insurance finances, we established the Pharmaceutical Performance Assessment Department.

 

We defined high-priced drugs and prepared a performance management system for those drugs to ensure that the system stays effective in protecting public health as well as in managing health insurance expenditures.

 

The 2nd Comprehensive National Health Insurance Plan contains a plan to re-evaluate drug prices by comparing them to overseas prices.

 

I understand that the HIRA prepared its proposal at the end of last year and is in discussions with the pharmaceutical industry.

 

Could you brief us on the time of its implementation, approximate method of reevaluation, and target drugs?

 

(Gook-Hee Kim, Director of the Pharmaceutical Benefits Department) Regarding the external reference pricing reevaluations, we are holding discussions with the industry to come up with a reasonable and transparent method.

 

I believe it will be carried out within the year, but will be able to share the specific timeframe later.

 

When looking at the drug pre-approval review system, quite a few drugs with a very low number of new approvals stand out.

 

I think it can be quite frustrating on the patients’ part to be rejected in the pre-approval process.

 

There needs to be a way to fundamentally remedy this, and I would like to ask for your opinion.

 

Also, could you tell us when the fair compensation on the value of new drugs that were also mentioned in the 2nd Comprehensive National Health Insurance Plan will be implemented?

 

Pre-approval is possible only for the right indications.

 

Therefore, the doctors would first need to accurately file for the right indication.

 

There are also discontinuation criteria, so we need consent on that.

 

Regarding the recent issues in drug reimbursement review, I would like to mention that the pharmaceutical companies first need to submit the required data accurately.

 

A part of the misunderstanding comes from that.

 

The pharmaceutical companies also need to cooperate.

 

We have been working to shorten the review process to within 150 days.

 

So what we want to do is lower the barriers to entry and strengthen the post-approval evaluation process for high-priced intractable diseases and anticancer drugs.

 

The drugs that have waived pharmacoeconomic evaluations should be followed up to see how these drugs are working and if they are effective.

 

Immunotherapies, targeted therapies, and treatment for rare intractable diseases have not been studied on a large scale, so we need to collect a lot of data and evaluate them after the drugs are on the market.

 

Due to opinions on facilitating smoother entry of drugs that have verified their effect through post-evaluations, we are conducting research on that.

 

Through long-term follow-up of listed drugs, we need to continue reimbursing effective drugs and removing or switching ineffective drugs.