"In South Korea, not all orphan drugs are reimbursed by the National Health Insurance Service primarily because they are different from drugs to treat rare diseases from the legal perspective", talked Prof. Lee at the 7th K-Life Bio Forum, held on September 26, 2023 at the National Assembly, co-sponsored by the Korean Pharmaceutical Association and Congressman Min-Suk Kim, the Democratic Party of Korea. Prof. Lee continued saying "This is why so many orphan drugs cannot be accessed by those who need them desperately although the orphan drugs have been approved the the Ministry of Food and Drug Safety, the regulatory authority in South Kore." Furthermore, Prof. Lee pointed out the drawbacks of reimbursement decision made by the HIRA solely dependent upon the evaluation of cost-effectiveness based on incremental cost-effectiveness ratio or ICER. "We need other funding mechanisms than the national health insurance for patients with rare diseases to get access faster to the orphan drugs they cannot live a quality life without", Prof. Lee stressed. Several news paper articles reported what Prof. Lee presented at the Forum, one of which can be found here. 

Prof. Howard Lee was invited to an online forum organized by the Federation Peruana de Enfermedades Raras or FEPER on February 28, 2023. In his talk, Prof. Lee summarized the current drug lags for orphan drugs in South Korea, followed by the challenges and issues for delayed and less-satisfactory reimbursement of orphan drugs. Prof. Lee concluded his talk by proposing new policies and systems to increase the accessibility of orphan drugs in South Korea. They included:1) reduce drug lags, particularly approval lags by the regulatory agency, by continuously innovating and harmonizing regulation, 2) ensure orphan drugs be reimbursed as soon as possible, and 3) fill the gap between the legal status of orphan drugs and the reimbursement policy for drugs to treat rare diseases.

In the 8th Global Bio Conference sponsored by the Korea Ministry of Food and Drug Safety on September 6, 2022, Prof. Howard Lee emphasized the unique nature of biologics in comparison with conventional small-molecule drugs, particularly in terms of their clinical safety and accessibility. "The safety of biologics should be ascertained even after they are approved for marketing since they are way different from the traditional chemistry-based drugs", Prof. Lee argued. Prof. Lee further pointed out the uniqueness of biologics by saying "We have to be well prepared not only for the utility, but for the potential safety issues in every single biologic, which is anticipated to be more frequently used in a clinical setting." Prof. Lee also addressed the reimbursement for biologics because they are typically more expensive although their efficacy can be dramatic.

More details about Prof. Lee's presentation at the GBC can be found at the following online articles: 1 and 2. 

Prof. Howard Lee argued that the current dichotomy between 'orphan drugs' and 'treatments for orphan disease' has severely aggravated the lower reimbursement rate by the National Health Insurance Service for orphan drugs, particularly for children. This argument came out from a forum Prof. Lee was invited to at the National Assembly on July 13, 2022. Prof. Lee continued the reimbursement decision for orphan drugs cannot solely be dependent upon cost-effective analysis because the society has to pay ethical and humanitarian attention to children with orphan diseases and their families, not to mention their pains and frustrations. Prof. Lee's plenary talk was well received by the press too, and his full presentation can be watched by clicking the YouTube link below.  

DailyPharm, an online journalism company, interviewed Prof. Howard Lee as to how new drug accessibility can be increased by easing the current strict criteria for health insurance reimbursement in Korea. More specifically, Prof. Lee argued the ICER cutoff should be lifted much higher to adequately reflect the economic developments over the past decades. Prof. Lee also discussed time has already come to decide if the nation sticks to an old paradigm of ‘reimbursing everything’ in healthcare, which is absolutely unsustainable financially. Prof. Lee urged the Korean government to show leadership developing a society-wide consensus to build a new fund to support patients with life-threatening diseases, who are likely to die soon unless treated with new, innovative drugs, almost all of which are prohibitively expensive.

The details of Prof. Lee’s interview can be found by clicking this link.

Prof. Lee discussed several ways to increase patient accessibility to advanced biotherapeutics at an online forum on July 9, 2021, sponsored by the National Assembly of the Republic of Korea. The forum was primarily motivated by the recent introduction of innovative advanced biotherapeutics such cell/gene therapy, CAR-T, immunooncology treatment, and antibody-drug conjugate. 

Following the main discussant's overview on the issues, Prof. Lee pointed out that the current health insurance reimbursement system in Korea is not suitable for advanced biotherapeutics, most of which are likely to fail the so-called cost-effectiveness test set and required by the Health Insurance Review and Assessment Service or HIRA because of their astronomical costs. For example, a typical round of treatment with KYMRIAH® or tisagenlecleucel by Novartis will cost a patient ~$500,000 although it is a life-saving drug for patients with rare, but highly fatal form of lymphoma (adults) and leukemia (children). 

Prof. Lee's speech and his follow-up discussion can be watched at YouTube as below. 

Prof. Howard Lee chaired a forum, organized and sponsored by DailyPharm, an online-only journalism company focusing on the pharmaceutical industry, on April 12, 2021. The title of the forum was 'Reimbursement System for High-Priced Drugs in Korea', which has become an issue as more and more advanced therapeutics such as cell and/or gene therapies are introduced as a breakthrough treatment option. The forum had four panelists, three of whom represented the pharmaceutical industry and one the Korea Ministry of Health and Welfare. 

It was a coincidental and timely event because Prof. Lee and Yoona Choi have been working an a research project with an aim to increase patient access  to new drugs in Korea. This project was sponsored by the Future Health Network, and the second round of the research project is under discussion. The results of the first round of the project has been published in a peer-reviewed Journal as a research article. 

The details of the forum can be read and watched here.

The Korean Academy of Health Policy and Management (KAHPM) invited Prof. Lee as chair to a session at the Annual Fall Conference, November 6, 2020. The title of the session Prof. Lee moderated was 'Individualized Reimbursement Model for Innovative Breakthrough Medicines: Introduction to Policies in Advanced Countries', where Prof. Hye-Young Kang, Department of Pharmacy, College of Pharmacy, Yonsei University, gave an overview presentation. There were three panelists in the session, each representing the pharmaceutical industry, government, and press, respectively. Due to the Covid-19 pandemic, the conference was presented online.  

In her talk, Prof. Kang pointed out that the current reimbursement scheme in Korea, particularly for innovative medicines, has been approached primarily from the cost containment aspect, emphasizing the balance between patients access to innovative drugs and cost. "This is the right time to talk more about drawing a social consensus as to what kinds of extra funding mechanisms other than the nationwide health insurance are available to supplement the limited accessibility to innovative drugs in Korea", Prof. Kang added. 

The full session can be watched here.

Prof. Howard Lee has officially expressed strong disapproval of the reimbursement for 'cheobyak' or the mixture of herbal (or natural products-derived) drugs. In a roundtable provoked by the impending reimbursement decision of cheobyak by the Korea National Health Insurance Service against the objections by medical and scientific societies altogether, Prof. Lee raised intense disagreement with the government policy to support reimbursement of cheobyak. Prof. Lee argued that cheobyak has never been shown to be efficacious and safe through scientific assessments by the regulatory agency such as the Ministry of Food and Drug Safety in Korea, not to mention its uncertain quality as a medicine. He continued, discussing "The cost-effectiveness of any cheobyak has never been validly studied and confirmed, which is the minimal requirement for any drug approved and listed for health insurance reimbursement in Korea." 

A summary of Prof. Lee's presentation at the roundtable can be found in many newspaper articles, one example of which is here. Additionally, his full presentation has been uploaded to YouTube as seen below:        

Prof. Howard Lee proposed health insurance reimbursement for the combination therapy of DPP4 inhibitors and SGLT2 inhibitors, irrespective of their labels as approved by the Korea Ministry Food and Drug Safety (MFDS), at a special session organized by the Korean Diabetes Association (KDA), in association with its Spring Conference 2019, held on May 9-11, 2019, at the HICO, Kyeongju, Korea. Unlike other countries including the USA, EU, and Japan, MFDS in Korea has approved the combination therapy of SGLT2 inhibitors with other oral hypoglycemic agents, particularly with DPP4 inhibitors, only on the basis individual drugs, not on the therapeutic class. This unique regulatory approval has contributed to the delayed reimbursement of various combination therapies involving SGLT2 inhibitors since their approvals. 

The delayed reimbursement has caused a lot of debates not only between the pharmaceutical industry and the Health Insurance Review and Assessment Service or HIRA, but also among clinicians. With this background, the KDA asked Prof. Lee to share his perspectives from the points of drug regulatory science if the reimbursement for the combination therapy of DPP4 inhibitors and SGLT2 inhibitors on the basis of therapeutic class, not on the individual drug, has any scientific and clinical rationale. Prof. Lee, based on an intensive systematic literature review focusing on the pharmacokinetics, drug-drug interactions, clinical efficacy, and safety profiles of the combination treatment with DPP4 inhibitors and SGLT2 inhibitors, discussed that it is highly unlikely any combination of the two classes would interact in a clinically meaningful and significant way. Furthermore, Prof. Lee argued that it is very likely for every combination of a DPP4 inhibitor with an SGLT2 inhibitor to result in an additional, significant, and clinically meaningful decrease in HbA1c or glycated hemoglobin. However, since not every combination has been studied for its safety profiles although it is likely to be similar to those of monotherapy, Prof. Lee proposed to perform a real world data study under the auspice of KDA, sponsored by the pharmaceutical industry, to explore and confirm the safety and efficacy profiles of the combination therapy.      

Reflecting the interest in the reimbursement issue, the conference room was full of clinicians, industry representative, and journalists even though the session was presented early in the morning on Saturday. More detailed information on the session can be found here.