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

ABSTRACT: 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.

SUBMITTER: Kim DS

PROVIDER: S-EPMC8435711 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The scale-up of antiretroviral therapy (ART) in South Africa substantially reduced AIDS-related deaths and new HIV infections. However, its success is threatened by the emergence of resistance to non-nucleoside reverse-transcriptase inhibitors (NNRTI). The MARISA (Modelling Antiretroviral drug Resistance In South Africa) model presented here aims at investigating the time trends and factors driving NNRTI resistance in South Africa. MARISA is a compartmental model that includes the key aspects of the local HIV epidemic: continuum of care, disease progression, and gender. The dynamics of NNRTI resistance emergence and transmission are then added to this framework. Model parameters are informed using data from HIV cohorts participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) and literature estimates, or fitted to UNAIDS estimates. Using this novel approach of triangulating clinical and resistance data from various sources, MARISA reproduces the time trends of HIV in South Africa in 2005-2016, with a decrease in new infections, undiagnosed individuals, and AIDS-related deaths. MARISA captures the dynamics of the spread of NNRTI resistance: high levels of acquired drug resistance (ADR, in 83% of first-line treatment failures in 2016), and increasing transmitted drug resistance (TDR, in 8.1% of ART initiators in 2016). Simulation of counter-factual scenarios reflecting alternative public health policies shows that increasing treatment coverage would have resulted in fewer new infections and deaths, at the cost of higher TDR (11.6% in 2016 for doubling the treatment rate). Conversely, improving switching to second-line treatment would have led to lower TDR (6.5% in 2016 for doubling the switching rate) and fewer new infections and deaths. Implementing drug resistance testing would have had little impact. The rapid ART scale-up and inadequate switching to second-line treatment were the key drivers of the spread of NNRTI resistance in South Africa. However, even though some interventions could have substantially reduced the level of NNRTI resistance, no policy including NNRTI-based first line regimens could have prevented this spread. Thus, by combining epidemiological data on HIV in South Africa with biological data on resistance evolution, our modelling approach identified key factors driving NNRTI resistance, highlighting the need of alternative first-line regimens.

Project description:Education is undergoing profound changes due to permanent technological innovations. This paper reports the results of a pilot study aimed at developing, implementing and evaluating the course, "Applicative Use of Information and Communication Technologies (ICT) in Medicine," upon medical school entry. The Faculty of Medicine, University of Belgrade, introduced a curriculum reform in 2014 that included the implementation of the course, "Applicative Use of ICT in Medicine" for first year medical students. The course was designed using a blended learning format to introduce the concepts of Web-based learning environments. Data regarding student knowledge, use and attitudes towards ICT were prospectively collected for the classes of 2015/16 and 2016/17. The teaching approach was supported by multimedia didactic materials using Moodle LMS. The overall quality of the course was also assessed. The five level Likert scale was used to measure attitudes related to ICT. In total, 1110 students were assessed upon medical school entry. A small number of students (19%) had previous experience with e-learning. Students were largely in agreement that informatics is needed in medical education, and that it is also useful for doctors (4.1±1.0 and 4.1±0.9, respectively). Ability in informatics and use of the Internet in education in the adjusted multivariate regression model were significantly associated with positive student attitudes toward ICT. More than 80% of students stated that they had learned to evaluate medical information and would use the Internet to search medical literature as an additional source for education. The majority of students (77%) agreed that a blended learning approach facilitates access to learning materials and enables time independent learning (72%). Implementing the blended learning course, "Applicative Use of ICT in Medicine," may bridge the gap between medicine and informatics upon medical school entry. Students displayed positive attitudes towards using ICT and gained adequate skills necessary to function effectively in an information-rich environment.

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

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