Asian innovation in pharmaceutical and medical device industry - beyond tomorrow.

The Asian region has passed a long and rocky road during the past several decades to establish itself as the second leading regional biotech market globally. China has become the second largest pharmaceutical market while Japan holds a strong second position as the global hub for medical devices development and innovation. Pharmaceutical expenditure continues to outpace real GDP growth in most of these countries. The trend is likely to be continued for a decade ahead, driven by a myriad of factors ranging from aging populations, rapidly growing welfare and increased citizen expectations raising demand for novel medicines and technologies. Satisfaction of these unmet needs in terms of supply is coming from the large multinational companies in wealthier among these societies. Domestic born and largely state-owned manufacturing industries continue to play a crucial role in an array of middle-income countries. Global biotech hub of Singapore is hosting over 1.5 times more headquarters of large pharmaceutical companies than Beijing, Tokyo, Shanghai and Hong Kong combined together. Japanese Takeda, Astellas, Daiichi Sankyo and Otsuka and Chinese Sinopharm, Guangzhou Pharmaceuticals Corporation, SPH and Yunnan Baiyao are now enlisted in leading Top 25 pharmaceutical companies rankings as per their annual net revenues in 2020-2021. Global industry landscape is evolving with ever more Asian companies obtaining the sharp innovative competitiveness leading development of cutting-edge medical technologies. Asian societies demand for pharmaceuticals and medical services continue to be characterized with unmet needs and striving to increase supply capacities. Financial obstacles of affordability of life saving medicines to the ordinary citizens shall be gradually overcome with an array of reimbursement strategies and extended insurance coverage policies. Observing the broad landscape throughout Asian region, we may witness that optimism in terms of domestic real GDP growth and consecutive biotech industry forecasts remains firmly rooted in years to come. Biosimilars are not a focus of the paper.

Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future.

INTRODUCTION: Prevalence rates for diabetes mellitus continue to rise, which, coupled with increasing costs of complications, has appreciably increased expenditure in recent years. Poor glycaemic control including hypoglycaemia enhances complication rates and associated morbidity, mortality and costs. Consequently, this needs to be addressed. Whilst the majority of patients with diabetes have type-2 diabetes, a considerable number of patients with diabetes require insulin to help control their diabetes. Long-acting insulin analogues were developed to reduce hypoglycaemia associated with insulin and help improve adherence, which can be a concern. However, their considerably higher costs have impacted on their funding and use, especially in countries with affordability issues. Biosimilars can help reduce the costs of long-acting insulin analogues thereby increasing available choices. However, the availability and use of long-acting insulin analogues can be affected by limited price reductions versus originators and limited demand-side initiatives to encourage their use. Consequently, we wanted to assess current utilisation rates for long-acting insulin analogues, especially biosimilars, and the rationale for patterns seen, across multiple Asian countries ranging from Japan (high-income) to Pakistan (lower-income) to inform future strategies. METHODOLOGY: Multiple approaches including assessing utilization and prices of insulins including biosimilars among six Asian countries and comparing the findings especially with other middle-income countries. RESULTS: Typically, there was increasing use of long-acting insulin analogues among the selected Asian countries. This was especially the case enhanced by biosimilars in Bangladesh, India, and Malaysia reflecting their perceived benefits. However, there was limited use in Pakistan due to issues of affordability similar to a number of African countries. The high use of biosimilars in Bangladesh, India and Malaysia was helped by issues of affordability and local production. The limited use of biosimilars in Japan and Korea reflects limited price reductions and demand-side initiatives similar to a number of European countries. CONCLUSIONS: Increasing use of long-acting insulin analogues across countries is welcomed, adding to the range of insulins available, which increasingly includes biosimilars. A number of activities are needed to enhance the use of long-acting insulin analogue biosimilars in Japan, Korea and Pakistan.

Predictors of (in)efficiencies of Healthcare Expenditure Among the Leading Asian Economies - Comparison of OECD and Non-OECD Nations.

PURPOSE: The goal of this study was to assess the effectiveness of healthcare spending among the leading Asian economies. METHODS: We have selected a total of nine Asian nations, based on the strength of their economic output and long-term real GDP growth rates. The OECD members included Japan and the Republic of Korea, while the seven non-OECD nations were China, India, Indonesia, Malaysia, Pakistan, the Philippines, and Thailand. Healthcare systems efficiency was analyzed over the period 1996-2017. To assess the effectiveness of healthcare expenditure of each group of countries, the two-way fixed effects model (country- and year effects) was used. RESULTS: Quality of governance and current health expenditure determine healthcare system performance. Population density and urbanization are positively associated with a healthy life expectancy in the non-OECD Asian countries. In this group, unsafe water drinking has a statistically negative effect on healthy life expectancy. Interestingly, only per capita consumption of carbohydrates is significantly linked with healthy life expectancy. In these non-OECD Asian countries, unsafe water drinking and per capita carbon dioxide emissions increase infant mortality. There is a strong negative association between GDP per capita and infant mortality in both sub-samples, although its impact is far larger in the OECD group. In Japan and South Korea, unemployment is negatively associated with infant mortality. CONCLUSION: Japan outperforms other countries from the sample in major healthcare performance indicators, while South Korea is ranked second. The only exception is per capita carbon dioxide emissions, which have maximal values in the Republic of Korea and Japan. Non-OECD nations' outcomes were led by China, as the largest economy. This group was characterized with substantial improvement in efficiency of health spending since the middle of the 1990s. Yet, progress was noted with remarkable heterogeneity within the group.

Cost-effectiveness and resource allocation (CERA) 18 years of evolution: maturity of adulthood and promise beyond tomorrow.

Since its inception in 2003, Cost Effectiveness and Resource Allocation journal has come a long way over the past 18 years. Possibly much longer than many of its contemporaries in the blossoming science of health economics might have anticipated. Today, entering 2020 it celebrates the Age of Maturity. We believe that in the third decade of XXI century the interdisciplinary science of health economics, will rejuvenate and come back to us younger than ever from its early historical roots almost a century ago. The spreading of economic globalization in several distinctive ways, either led by multinational business corporations or newly emerged Asian leadership, or both, is likely to make challenges for contemporary health systems far more serious. The fourth industrial revolution (cyber physical systems and artificial intelligence technology) and accelerated innovation in the field of E-Health and digital health, will probably change the workflow in medical and health care, and inevitably transform the labour market in the upcoming decades. So, let us be up to the task. Let us provide academic centres, industry-sponsored pharmaceutical and medical device innovation hubs, and governing authorities alike, with a powerful forum for debate on cost-effective resource allocation in the years to come.

Effect of pecuniary costs and time costs on choice of healthcare providers among caregivers of febrile children in rural Papua New Guinea.

BACKGROUND: User fees, transportation costs, and time costs impair access to healthcare by rural communities in low and middle income countries. However, effects of time costs on demand for healthcare are less understood than effects of user fees for health providers. In addition, prospective patients might not know about all health services available. This study aims to investigate how the family caregivers of febrile children respond to the pecuniary costs and time costs in their choice of health providers in rural Papua New Guinea. METHODS: Using an original questionnaire, we surveyed households in the catchment area surrounding Dagua Health Center in East Sepik Province, Papua New Guinea, during February-March 2015. We estimated the probability of choosing one among four categories of providers (i.e., the health center, aid posts, village health volunteers [VHVs], or home-treatment) via a mixed logit model in which we restrict alternatives to those for which family caregivers knew cost information. RESULTS: Of 1173 family caregivers, 96% sought treatment for febrile children from four categories of providers. Almost all knew the location of the health center and a health volunteer, but only 50% knew the location of aid posts. Analysis by discrete choice model showed that pecuniary costs and time costs were inversely associated with the probability of choosing any type of provider. We then changed pecuniary costs and time costs counterfactually to calculate and compare the probability of choosing each provider. Time costs affected the choice more than pecuniary costs, and individual heterogeneity appeared among caregivers with respect to pecuniary costs. When pecuniary or time costs of VHVs are altered, substitution between VHVs and home-treatment appeared. CONCLUSIONS: Our findings suggest that policies to increase awareness of aid posts and reduce time costs in addition to treatment fees for each category of healthcare provider could help developing economies to improve access to essential healthcare services.

Reimbursement pricing for new medical devices in Japan: Is the evaluation of innovation appropriate?

OBJECTIVES: In Japan, strong reimbursement pricing control measures for existing medical device products have rendered new medical device reimbursement pricing critical for manufacturers. Few studies have been conducted on this aspect; therefore, this paper (1) clarifies whether evaluation of innovation is appropriate or not and (2), if not, investigates its background. METHODS: In this research, 319 C1/C2 government decisions for new medical devices in the 10 years from April 2008 to March 2018 were analyzed. Evaluation of innovation was considered in terms of the reimbursement price, as well as the foreign average price ratio. RESULTS: Considering the degree of evaluation of innovation, the average premium rate for the similar function category comparison method was 10.2% during 2008 to 2010 (this means the newly set reimbursement price was 10.2% higher than that of corresponded exiting categories); it declined consistently thereafter, to 3.2% during 2016 to 2018. Moreover, evaluation of innovation by the foreign average price (FAP) ratio was 1.04 in 2008 to 2010, consistently decreasing to 0.88 in 2016 to 2018. The period from product approval to the non-Special Designated Treatment Material (non-STM) (a part of technical fee) price listing is much longer than that of the STM (own reimbursement price) listing. CONCLUSION: Several reasons were considered for the decline in innovation evaluation: (1) the lowering of the FAP upper limit ratio, (2) the possibility that there was not enough evidence at the time of price listing, (3) and the more rigorous standards to create a new separate functional category. However, some aspects were attributable to reimbursement system reform.

Comparison of Health Service Utilization for Febrile Children Before and After Introduction of Malaria Rapid Diagnostic Tests and Artemisinin-Based Combination Therapy in Rural Papua New Guinea.

BACKGROUND: In Papua New Guinea (PNG), a malaria treatment policy using rapid diagnostic tests (RDTs) plus artemisinin-based combination therapy (ACT) was widely introduced to rural communities in 2012. The objectives of the study were to evaluate the effect of this RDT/ACT introduction to a rural PNG population on health service utilization and to compare factors associated with health service utilization before and after the RDT/ACT introduction. METHODS: Household surveys with structured questionnaires were conducted before and after the introduction of RDT/ACT in a catchment area of a health center in East Sepik Province, PNG. We interviewed caregivers with children less than 15 years of age and collected data on fever episodes in the preceding 2 weeks. Using propensity score matching, febrile children before the introduction of RDT/ACT were matched to febrile children after the introduction. Then, the adjusted difference in the proportion of health service utilization [i.e., the average treatment effect (ATE) of the introduction of RDT/ACT on health service utilization] was estimated. We also employed a multilevel Poisson regression model to investigate factors influencing the use of health services. RESULTS: Of 4,690 children, 911 (19%) were reported to have a fever episode. The unadjusted proportion of health service utilization was 51.7 and 57.2% before and after the RDT/ACT introduction, respectively. After matching, no significant difference in the health service utilization was observed before and after the introduction of RDT/ACT (ATE: 0.063, 95% confidence interval -0.024 to 0.150). Multilevel regression analysis showed that the consistent factors associated with a higher utilization of health services were severe illness and being female. CONCLUSION: The utilization of health services was not significantly different before and after the introduction of RDT/ACT. Villagers may have neither sufficient informations on the new protocol nor high acceptance of RDT/ACT. The observed gender bias in health service utilization could be due to female caregivers' preferences toward girls.

Analysis of Regional Variation in the Scope of Eligibility Defined by Ages in Children's Medical Expense Subsidy Program in Japan.

Children's medical expense subsidy programs are programs run by local governments that use public monies to reduce or eliminate the copayments for children's medical treatment including pharmaceutical cost (typically 20% for preschoolers and 30% thereafter). Currently, all prefectures and municipalities in Japan provide subsidies for infants' and children's medical expenses, but scope on ages of eligibility, income limits, and copayment requirements vary. The fact that these programs are run by local governments has given rise to differences in the costs borne by households with children, depending on the jurisdiction in which they live. Therefore, although it would be desirable to gain society's understanding of such variation, the factors have not been fully studied. This analysis investigates what factors could impact such variation. In it, we looked at 219 municipalities in the prefectures in the Kanto region, focusing on the gap from the average age eligibility of municipalities, which reflects the scope of eligibility. Neither a regression analysis using the instrumental variable method to account for simultaneous decision bias nor an ordered logit analysis with rank of coverage as an order variable revealed that differences in copayments by locale had any impact on the scope of age eligibility. Residents' income and the number of children tended to narrow scope of eligibility for subsidies, but the strength of local government finances were not a significant factor of influence. In designing these programs, local government bodies take into account the local population's ability to pay and the number of eligible people, but their awareness of the local government's financial condition seems to be scant. Local governments are currently moving to expand their children's medical expense subsidy programs, but in the future they will need to pay more attention to balancing an expanded scope of eligibility by ages with the maintenance of local government fiscal discipline. In addition, copayments have not been adequately linked to the expansion of eligibility, so it would be advisable to clearly demonstrate the reason for this limit in order to eliminate perceptions of unfairness.

The Choice of Healthcare Providers for Febrile Children after Introducing Non-professional Health Workers in a Malaria Endemic Area in Papua New Guinea.

BACKGROUND: Disease burden of malaria in Papua New Guinea (PNG) is the highest in Asia and the Pacific, and prompt access to effective drugs is the key strategy for controlling malaria. Despite the rapid economic growth, primary healthcare services have deteriorated in rural areas; the introduction of non-professional health workers [village health volunteers (VHVs)] is expected to improve antimalarial drug deliveries. Previous studies on PNG suggested that distance from households negatively affected the utilization of health services; however, price effect on healthcare demand decisions has not been explored. Empirical studies on household's affordability as well as accessibility of healthcare services contribute to policy implications, such as efficient introduction of out-of-pocket costs and effective allocation of health facilities. Therefore, we investigate price responsiveness and other determinants of healthcare provider choice for febrile children in a malaria endemic rural area wherein VHVs were introduced. METHODS: Cross-sectional surveys were conducted using a structured questionnaire distributed in a health center's catchment area of East Sepik Province in the 2011/2012 rainy seasons. Caretakers were interviewed and data on fever episodes of their children in the preceding 2 weeks were collected. Mixed logit model was employed to estimate the determinants of healthcare provider choice. RESULTS: Among 257 fever episodes reported, the main choices of healthcare providers were limited to self-care, VHV, and a health center. Direct cost and walking distance negatively affected the choice of a VHV and the health center. An increase of VHV's direct cost or walking distance did not much affect predicted probability of the health center, but rather that of self-care, while drug availability and illness severity increased the choice probability of a VHV and the health center. CONCLUSION: The results suggest that the net healthcare demand increases with the introduction of a VHV. Allocations from the government's budget are required to sustain VHV activities because the introduction of a small user fee could impede the utilization of a VHV. A large travel cost related to the choice of the health center suggests that resource allocation is required for the expansion of formal healthcare providers to adequately operate a referral system.