[Reporter's View] Innovation exists in treating all diseases

Innovation exists, even in treating non-life-threatening conditions

When discussing Korea’s insurance reimbursement system, the qualifier “life-threatening” has long been a source of frustration.

 

It is no exaggeration to say that, for the pharmaceutical industry, this phrase has been the number one target for removal since the very beginning.

 

This was the case in determining eligibility for the Risk Sharing Agreement (RSA) and the exemption from pharmacoeconomic evaluation, and recently, even the preferential treatment for innovative drugs that allow the application of a flexible ICER threshold—another long-standing aspiration—has seen the phrase “life-threatening” implicitly applied in a different form.

 

However, it is now necessary to question the very notion that a disease must be life-threatening to be considered serious.

 

In particular, new drugs for chronic diseases, which are indirect causes of death for a large number of people due to comorbidities and complications, have long been left neglected in Korea’s reimbursement system.

 

Although there are already many old drugs on the market and the number of new drugs being developed has decreased, the new drugs that represent a paradigm shift are being neglected.

 

The breast cancer treatment Trodelvy was the first innovative drug to receive preferential treatment and ICER benefits, and was added to the reimbursement list in June.

 

According to reports, the threshold for Trodelvy was set at KRW 70 million.

 

This is an unprecedented amount.

 

The Health Insurance Review and Assessment Service has stated that it does not use explicit thresholds, but it is well established that since the pharmacoeconomic evaluation system was first introduced in 2007 that the ICER threshold has been set at KRW 25 million for general drugs and KRW 50 million for anticancer drugs, based on the per capita GDP of KRW 25 million at the time, and has remained since for 18 years.

 

In fact, according to HIRA's announcement last year, the ICER values for drugs submitted for pharmacoeconomic evaluation from 2019 to 2023 ranged from KRW 12.06 million to KRW 36.1 million for general drugs and KRW 25.88 million to KRW 47.92 million for anticancer drugs.

 

This is why Trodelvy’s reimbursement listing is a significant milestone.

 

However, such milestones should not become extremely rare cases.

 

Providing benefits that cannot be applied in real life is meaningless.

 

The criteria for receiving ICER benefits include three requirements, one of which states, “Significant clinical improvement must be recognized in final outcome measures such as extended survival.” Although the term “survival” implies “life-threatening,” it was not explicit.

 

And in November last year, Kook-Hee Kim, Director of the Pharmaceutical Management Division at HIRA, said, “If innovativeness of a drug needs to be recognized in consideration of the severity of the disease and the social burden of the disease, the ICER threshold can be raised even if all three requirements are not met,” suggesting the possibility of flexible screening.

 

In July, Minister Eun-kyung Jeong, who was appointed as the new Minister of Health and Welfare under President Jae-myung Lee’s administration, also mentioned the case of Trodelvy during her confirmation hearing in the National Assembly and expressed her agreement with the need for policy changes to recognize innovation.

 

Under these circumstances, Mounjaro, which has been attracting public attention as a treatment for obesity, recently submitted a reimbursement application for its diabetes indication.

 

While its weight-loss effect is well-known, Mounjaro's achievements in the diabetes field are also significant.

 

Beyond blood sugar control targets, 6 out of 10 patients achieved normal blood sugar levels without an increased risk of hypoglycemia, reaching the ultimate treatment goals of preventing cardiovascular complications and reducing mortality.

 

It even demonstrates the potential for “remission” in diabetes.

 

However, assuming that the normal listing process is followed, it seems extremely unlikely that Mounjaro will be granted reimbursement for diabetes.

 

As mentioned earlier, chronic diseases are already mainly treated with off-patent drugs.

 

Given that these drugs are the comparators, it is difficult to predict a bright future for the entry of a new biopharmaceutical in the area.

 

New drugs and drug prices are currently facing a critical turning point.

 

Amidst the Trump administration's pressure on South Korea's drug pricing policy and the flood of high-priced drugs, concerns about “Korea passing” are growing, and future policy directions could have a significant impact on public health.

 

With Korea already a foot into a super-aged society, it is crucial to make policy decisions from a long-term perspective to build a sustainable society capable of overcoming future health crises.

 

We place our hopes in the Lee administration's pledge to “create a country where no one worries about illness.”