scholarly journals Regenerative Medicine in South Korea: Bridging the Gap Between Authorization and Reimbursement

Author(s):  
Dong-Sook Kim ◽  
Geunwoo Lee ◽  
Hyungyung Cho ◽  
SeungJin Bae

Regenerative medicine (RM) has considerable potential to address the needs of aging-related and uncurable diseases. However, its incorporation into reimbursement of health insurance benefits poses many challenges, including uncertain evidence and insufficient investment. This paper examines the wide gap between manufacturers, regulatory bodies, and health technology bodies regarding reimbursements for RMs focused cell therapy products. In this mixed-methods study, we first analyzed the sales of RMs approved in South Korea. In addition to exploring beliefs related to the market value of RMs, in-depth interviews were conducted with 24 experts (17 from bio-industries, two from the regulatory body, three from a health technology assessment (HTA) body, and two from the Pharmaceutical Benefit Coverage Assessment Committee [PBCAC]). Lastly, we surveyed PBCAC members about the market value of RMs. In total, 15 of the 20 developed cell therapy products are on the market in South Korea, and amounted to 0.24% of total pharmaceutical expenditures in 2018. We identified a wide gap between stakeholders and regulators regarding the market value and pricing of RMs. The interviewees from the pharmaceutical manufacturer association raised the issue of rising manufacturing costs and proposed a specific pricing policy for RMs. To bridge the gap between approval and reimbursement, stakeholders demand an alternative framework of value-based pricing. Conditional health insurance reimbursement may be an alternative to the traditional process in order to generate evidence of the effects of RMs using “risk-based” or “outcome-based” approaches.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 49.2-49
Author(s):  
J. K. Ahn ◽  
J. Hwang ◽  
J. Lee ◽  
H. Kim ◽  
G. H. Seo

Background:Palindromic rheumatism (PR) has known to be three patterns of disease course: clinical remission of attacks, persistent attacks, and evolution to chronic arthritis or systemic disease. The spectrum in progression to chronic diseases of PR, however, is quite variable; rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren’s syndrome (SjS), ankylosing spondylitis (AS), relapsing polychondritis (RP), Behçet’s disease (BD), sarcoidosis, and psoriatic spondylitis and arthropathy. Because of the small numbers in case-control studies and too aged investigations, now we needs to shed new light on the fate of PR.Objectives:The aim was to investigate the epidemiology of PR and the risk of developing various rheumatic diseases compared with non-PR individuals, employing the National Health Insurance Service (NHIS) medical claims data, which covers all medical institutions of South Korea.Methods:The study used 2007-2018 claims data from the Korean Health Insurance Review and Assessment Service (HIRA). The identified 19,724 PR patients from 2010 to 2016 were assessed for the incidence rate (IR) compared with the population in the given year by 100,000 person-year (py). The date of diagnosis was the index date. After matching with non-PR individuals (1:10) for age, sex and the year of index date, we calculated the hazard ratios (HRs) with 95% confidence intervals (CIs). The risk of developing the various rheumatic diseases and adult immunodeficiency syndrome (AIDS) as the outcome diseases in PR cohort was estimated. This risk was compared with that of matched non-PR cohort.Results:Of 19,724 PR patients (8,665 males and 11,059 females), the mean age was 50.2 ± 14.9 years (47.7 ± 14.4 years in males and 52.6 ± 14.9 years in females,p< 0.001). The ratio of male to female patients with PR was approximately 1:1.28. The annual IR of PR was 7.02 (6.92-7.12) per 100,000 py (6.22 (6.09-6.35) and 7.80 (7.66-7.95) per 100,000 py in males and females, respectively). The mean duration to develop the outcome diseases was significantly shorter in PR cohort compared that of non-PR cohort (19.4 vs. 35.8 months,p< 0.001). The most common outcome disease was RA (7.34% of PR patients; 80.0% of total outcome diseases), followed by AS, SLE, BD, SjS, MCTD, DM/PM, SSc, RP, psoriatic arthropathy, and AIDS in PR cohort. The patients with PR had an increased risk of RA (HR 46.6, 95% CI [41.1-52.7]), psoriatic arthropathy (44.79 [15.2-132.4]), SLE (24.5 [16.2-37.2]), MCTD (22.0 [7.7-63.3]), BD (21.0 [13.8-32.1]), SjS (12.4 [8.5-17.9]), AS (9.0 [6.7-12.2]), DM/PM (6.1 [2.6-14.8]), and SSc (3.8 [1.5-9.6]) but not of AIDS. The risk of developing RA was greater in male patients (HR 58.9, 95% CI [45.6-76.2] vs. 43.2 [37.4-49.8],pfor interaction = 0.037) while female patients encountered a higher risk of developing AS (15.8 [8.9-28.1] vs. 7.2 [5.0-10.3],pfor interaction = 0.023). The risk of developing RA, SLE, SjS, and BD were significantly more highly affected in younger age (pfor interaction < 0.001, = 0.003, 0.002, and 0.017, at each).Conclusion:This nationwide, population-based cohort study demonstrated that patients with PR had an increased risk of developing various rheumatic diseases, not only RA but also psoriatic arthropathy. Therefore, patients with PR needs to be cautiously followed up for their potential of diverse outcome other than RA: RA, SLE, SjS, and BD in younger patients, RA in males, and AS in females, in particular.Disclosure of Interests:None declared


Author(s):  
Kenji Osafune

AbstractWith few curative treatments for kidney diseases, increasing attention has been paid to regenerative medicine as a new therapeutic option. Recent progress in kidney regeneration using human-induced pluripotent stem cells (hiPSCs) is noteworthy. Based on the knowledge of kidney development, the directed differentiation of hiPSCs into two embryonic kidney progenitors, nephron progenitor cells (NPCs) and ureteric bud (UB), has been established, enabling the generation of nephron and collecting duct organoids. Furthermore, human kidney tissues can be generated from these hiPSC-derived progenitors, in which NPC-derived glomeruli and renal tubules and UB-derived collecting ducts are interconnected. The induced kidney tissues are further vascularized when transplanted into immunodeficient mice. In addition to the kidney reconstruction for use in transplantation, it has been demonstrated that cell therapy using hiPSC-derived NPCs ameliorates acute kidney injury (AKI) in mice. Disease modeling and drug discovery research using disease-specific hiPSCs has also been vigorously conducted for intractable kidney disorders, such as autosomal dominant polycystic kidney disease (ADPKD). In an attempt to address the complications associated with kidney diseases, hiPSC-derived erythropoietin (EPO)-producing cells were successfully generated to discover drugs and develop cell therapy for renal anemia. This review summarizes the current status and future perspectives of developmental biology of kidney and iPSC technology-based regenerative medicine for kidney diseases.


Children ◽  
2021 ◽  
Vol 8 (4) ◽  
pp. 263
Author(s):  
Dong Hyun Kim ◽  
Dong Jun Ha ◽  
Yeong Seok Lee ◽  
Min Jun Chun ◽  
Young Se Kwon

There have been no large-scale studies on the epidemiology of benign convulsions with mild gastroenteritis (CwG) since the introduction of the rotavirus vaccine in South Korea in 2007. This study aimed to analyze the trends in rotavirus gastroenteritis (RVGE) and rotavirus-associated CwG (RaCwG) after rotavirus vaccination. Further, we aimed to analyze changes in norovirus gastroenteritis (NVGE) and norovirus-associated CwG (NaCwG) using nationwide data from the Korean Health Insurance Review and Assessment Service. Between 2007 and 2019, this study analyzed children aged <6 years who were diagnosed with RVGE, NVGE, RaCwG and NaCwG. The changes in the prevalence of each disease and the ratio of CwG to enteritis were analyzed and the effects of age, sex and season were also analyzed. RVGE, RaCwG, NVGE and NaCwG were diagnosed in 273,898, 4246, 35,593 and 337 patients, respectively. The prevalence of RVGE was on a decreasing trend every year, but the prevalence of NaCwG and NVGE was on an increasing trend. There was a significant annual increase in the ratio of CwG to enteritis in both viruses. In order to control the prevalence of RaCwG, measures other than the rotavirus vaccine are required and measures to prevent norovirus are necessary.


Author(s):  
G. Amato ◽  
T. Saleh ◽  
G. Carpino ◽  
E. Gaudio ◽  
D. Alvaro ◽  
...  

Abstract Purpose of Review To describe experimental liver injury models used in regenerative medicine, cell therapy strategies to repopulate damaged livers and the efficacy of liver bioengineering. Recent Findings Several animal models have been developed to study different liver conditions. Multiple strategies and modified protocols of cell delivery have been also reported. Furthermore, using bioengineered liver scaffolds has shown promising results that could help in generating a highly functional cell delivery system and/or a whole transplantable liver. Summary To optimize the most effective strategies for liver cell therapy, further studies are required to compare among the performed strategies in the literature and/or innovate a novel modifying technique to overcome the potential limitations. Coating of cells with polymers, decellularized scaffolds, or microbeads could be the most appropriate solution to improve cellular efficacy. Besides, overcoming the problems of liver bioengineering may offer a radical treatment for end-stage liver diseases.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Nam-Eun Kim ◽  
Sanghun Lee ◽  
Bo Yeon Kim ◽  
Ae Gi Hwang ◽  
Ji Hyeon Shin ◽  
...  

AbstractMedical costs have recently increased in South Korea due to the rising rate of asthma. Primary clinics serve an important role in asthma management, as they are the first stop for patients presenting with symptoms. The Health Insurance Review and Assessment Service (HIRA) in South Korea has assessed asthma-management quality since 2013, but studies are lacking on whether these assessments have been performed properly and contribute toward reducing asthma exacerbations. Therefore, we investigated whether the HIRA’s quality assessments have decreased asthma exacerbations using national health insurance claims data from 2013 to 2017 of 83,375 primary-clinic and 15,931 tertiary-hospital patients with asthma. These patients were classified into four groups based on disease severity according to the monthly prescribed amount of asthma medication using K-means clustering. The associations between HIRA assessments and asthma exacerbation were analyzed using a generalized estimating equation. Our results showed that exacerbation odds gradually decreased as the HIRA assessments progressed, especially in the mild-severity group, and that exacerbation risk among patients with asthma decreased in the order of assessment grades: “Unsatisfactory,” “Satisfactory,” and “Tertiary.” Therefore, we may conclude that asthma exacerbations may decrease with high quality asthma management; appropriate quality assessment could be helpful in reducing asthma exacerbations.


2021 ◽  
Author(s):  
Lianxu Cui ◽  
Yasmeen Saeed ◽  
Haomin Li ◽  
Jingli Yang

Traumatic brain injury (TBI) is a serious health concern, yet there is a lack of standardized treatment to combat its long-lasting effects. The objective of the present study was to provide an overview of the limitation of conventional stem cell therapy in the treatment of TBI and to discuss the application of novel acellular therapies and their advanced strategies to enhance the efficacy of stem cells derived therapies in the light of published study data. Moreover, we also discussed the factor to optimize the therapeutic efficiency of stem cell-derived acellular therapy by overcoming the challenges for its clinical translation. Hence, we concluded that acellular therapy possesses the potential to bring a breakthrough in the field of regenerative medicine to treat TBI.


Author(s):  
Javad Verdi ◽  
Mahdi Shadnoush ◽  
Ghasem Janbabai ◽  
Alireza Shoae-Hassani ◽  
Seyed Abdolreza Mortazavi-Tabatabei ◽  
...  

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