ABSTRACT
The COVID-19 pandemic has had a major impact on all citizens, industries, governments, and academia, and has provided an opportunity to consider the intrinsic value of various resources and activities. The pharmaceutical industries are making a concerted effort to prevent and treat against COVID-19 with rapid research and development to address the emerging need for vaccines and therapeutic drugs for infectious diseases. In terms of HTA, previous guidelines for evaluating the value of vaccines and therapeutics have focused on cost-effectiveness, but the experience of the pandemic has led to the need to consider factors other than cost and utility, which are quantitative evaluations. With the pandemic experience, values that should be considered in addition to the quantitative evaluation of cost and utility were discussed in terms of previously published papers and industry perspectives.
ABSTRACT
OBJECTIVE: This study presented the analysis period, the complexity of combined therapy and comparator choice as the key limitations in the economic evaluation of new drugs, and discussed programs for coping with these limitations. METHODS: This study evaluated the post-evaluation, risk-sharing agreement, extra funding program, and flexible incremental cost-effectiveness ratio (ICER) threshold as actions or programs that would increase accessibility to costly new drugs. The study also presented the cases of other countries. The application of the post-evaluation was considered to deal with high uncertainty regarding new drugs. RESULTS: The risk-sharing agreement was introduced in European countries as well as South Korea and has been responsible for the shift from using the financial schemes to outcome-based schemes. The drug funding program has had troubled in securing stable extra funds. The application of higher ICER in the economic evaluation of expensive and innovative oncology drugs was criticized because of the inequity between oncology patients and patients with other diseases. CONCLUSION: Therefore, introducing and applying actions that would increase the accessibility to costly new drugs in South Korea have been deemed necessary after careful reviews and discussions with various stakeholders (insurer, policy makers, pharmaceutical companies and patients).
ABSTRACT
Annual medical expenditure in Japan is continuously increasing. This may be caused by technology advancement as well as population ageing. Some new and high cost technologies, including new drugs, have been introduced. In order to balance technology advancement with medical expenditure, economic evaluation of new technologies is one way to approach the issue. In 2016 a pilot program stared at the Central Social Insurance Medical Council to evaluate cost effectiveness of some drugs and medical devices. In the pilot program, companies of selected products were asked to submit primary data and analyses to the Ministry of Health, Labour and Welfare. The ministry, together with some experts, reviewed the submitted data and re-analyzed if necessary. After these assessment process, not only cost effectiveness of each product, but also ethical or social aspects are considered in the appraisal phase. Finally results will be used to adjust reimbursement prices in the 2018 price revision. In the council, some issues toward full implementation of the new system will be discussed by 2019.
ABSTRACT
Phosphodiesterase (PDE) 4 inhibitors have been shown to induce the cAMP-mediated signaling pathway by inhibiting cAMP hydrolysis. This study investigated the effect of a PDE4 inhibitor on the expression of the inducible cAMP early repressor (ICER), which is an endogenous inhibitor of CRE- mediated transcription, in osteoblastic cells. RT-PCR analysis revealed that rolipram, a PDE4 inhibitor, stimulates the ICER mRNA in a dose dependent manner. The induction of ICER mRNA expression by rolipram was suppressed by the inhibitors of protein kinase A (PKA) and p38 MAPK, suggesting the involvement of PKA and p38 MAPK activation in ICER expression by rolipram. It was previously shown that rolipram induced the expression of TNF-related activation-induced cytokine (TRANCE, also known as RANKL, ODF, or OPGL) in osteoblasts. This paper provides evidences that a transcriptional repressor like ICER might modulate TRANCE mRNA expression by rolipram in osteoblasts.