“The framework to list ultra-expensive new drugs exists"

“‘Pre-listing Post-evaluation system’ can be the solution to listing advanced medicines in Korea”

"The basis of the system is ‘evaluation’… how and to whom the system should be applied is important”

“Modifying and utilizing the current system is important… need to consider making adjustments for the new era”

We are living in an era where a single injection may completely cure cancer.

 

The catch is that the 'single dose' would cost 500 million won.

 

Such ultra-expensive advanced new drugs are not an item of our dreams – it is already within our reach.

 

In addition to the CAR-T (Chimeric Antigen Receptor T cells) therapy Kymriah (tisagenlecleucel) that was approved in Korea, dozens of other gene therapy and cell therapy candidate drugs are also under development, some of which are being developed by domestic biopharmaceutical companies.

 

The regulatory authorities have also passed the ‘Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ in 2019 to reflect the changes in the new era.

 

However, for these paradigm-shifting advanced medicines that overturn the existing concept of drug therapy to be used in real life, the lingering issue of their ultra-high ‘drug price’ needs to be resolved.

 

How should the company that wants rightful compensation for the innovation, and the government that needs to take care of the public’s health with a limited budget, reach a consensus on the matter?

 

Professor Hyung Ki Lee, SNUH

In search of the answer, government and industry officials gathered at the 41st Pharmaceutical Industry Future Forum, "Finding the correct solution for the ultra-expensive drug listing system," held by Dailypharm at its Moonjeong-dong office.

 

Dr.

 

Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital, chaired the event.

 

Various industry and government officials including Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea participated as panelists for discussion.

 

◆ Now is the time to fully implement the Pre-listing Post-evaluation system = The key to pre-listing and post-evaluation is ‘speed.’ The system allows drugs to skip the deliberation on the appropriateness of reimbursement and be listed first, then decide whether to continue its reimbursement by evaluating the efficacy, use amount, etc.

 

based on real-world data.

 

The system would speed up the listing process, however, it may also cloud the transparency of the process.

 

People are voicing concerns about whether the cancellation mechanism of already-listed drugs would definitely work, and whether the patients will be able to accept the reimbursement discontinuation of drugs they have been taking.

 

There also lies the controversy over the method of accumulating RWD or RWE data and its and reliability.

 

Officer Kyungho Choi, MOHW

At the event, Deputy Director Choi said, “The ‘continuity of care’ issue of pre-listing post-evaluation drugs cannot be ignored from the government’s perspective.

 

There are problems such as difficulties in adjusting drug prices when the pharmaceutical companies do not accept the evaluation results, as well as the issue of the system weakening the drug negotiation power of NHIS.” However, the industry had a strong aspiration to implement the system as a means to ‘introduce ultra-expensive drugs to Korea.’ Of the three industry panelists that participated in the forum, KRPIA director Min-Young Kim, and Novartis's Departement Head Jae-Ho Jeong pointed to the pre-listing post-evaluation system as the top priority solution.

 

Kim explained, “The system can be well-managed.

 

We already have had experienced similar cases like ‘Evoltra,’ the first therapy to be listed under the Risk Sharing Agreement (RSA).

 

The government was unable to evaluate the cost-effectiveness of Evoltra at the time of its listing, and the drug was listed under conditional coverage with evidence development.

 

After 4 years, the company underwent data collection and a re-evaluation process maintains its reimbursement.” “The pre-listing post-evaluation system needs to be accepted as a type of RSA.

 

The industry has long conducted negotiations and signed agreements with HIRA and NHIS for the stable supply of its products," added Jeong.

 

"The government should show some trust based on its accumulated experience with the companies.

 

The potential risks and countermeasures can be discussed while conducting a pilot project.”

Executive Director Minyoung Kim, KRPIA

The government has consistently maintained a conservative attitude on implementing the pre-listing post-evaluation system.

 

However, at the forum, MOHW did not rule out the possibility of implementing such a system.

 

Deputy Director Choi said, “I agree that now is the time to seriously consider the implementation of such systems.

 

If the industry proposes a detailed action plan, we will review the plan with HIRA and NHIS.

 

However, one thing that I hope the industry also bears in mind is that the continuity of care is not an issue that impacts the listing or delisting of a single drug product; It is an issue that needs to be considered collectively for the sustainability of NHI finances.” ◆ Considerations on ‘cost-effectiveness,’ the first criteria considered in drug evaluations = Cost-effectiveness is central to Korea’s reimbursement listing system.

 

Industry officials agree that is an essential criterion for the system while pointing out that too much stress is being laid solely on cost-effectiveness.

 

In addition to cost-effectiveness, the Principles on Determining Eligibility of Long-term Care Benefits list factors such as medical significance (clinical utility) and social benefits as factors for consideration.

 

However, industry officials say that these other factors are not sufficiently reflected during reimbursement evaluations.

 

At the forum, Director Hyeon-seok Na from JW Pharmaceutical Corp.

 

said, “The industry does feel that the government is too focused on cost-effectiveness.

 

Such focus on cost-effectiveness would lead so many drugs to be not approved for reimbursement listing.

 

We hope that the weight of other factors such as social benefit should be increased”

Senor Manager Hyeon-seok Na, JW Pharm.

Professor Hyung-Ki Lee who chaired the event added, “This reminds me of a paper published by HIRA.

 

It was a 2006 study that tracked the standards used by HIRA in deciding reimbursement for drugs.

 

Results showed that drugs that had lower prices were listed and at a faster rate than those with high clinical utility.” Cost-effectiveness is a staple topic in the discussion of improving the domestic drug reimbursement system.

 

The difficulty in demonstrating cost-effectiveness leads to requests for improving the ICER threshold and the exemption of PE assessment.

 

On this, the government’s response is that considerations of cost-effectiveness are just a matter of order.

 

“The government does not solely focus on cost-effectiveness in the reimbursement decision-making process.

 

For a drug to receive reimbursement, it first needs to prove its clinical utility,” said Choi.

 

”Only drugs that are determined to be clinically effective are then evaluated for their cost-effectiveness.

 

The strict evaluation criteria may be worth discussing; however, it does not mean that we have had made no efforts to resolve the issue.”