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Development of Hospital Formulary in Japan - Current Trends and Issues
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VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 8 0 7 – A 9 1 8
and region. Conclusions: Districts are grappling with the inefficiency, in the form of shortage or expiry, in free medicines distribution. Rigorous needs assessment study, better coordination between centre and districts, and increased procurement efficiency are the order of the day. Because we interviewed only the officials from districts, there is the possibility of bias in their answers; so a follow-up study with all stakeholders on board is warranted. PHP9 Suggestion on Critical Illness Insurance in China Zhu L, Xu H, Cui X Sanofi China, Shanghai, China
Objectives: Since 2012, China piloted a state-run critical illness cover, which reimbursed for approximately 50% of medical costs. In 2015, Zhejiang Province had taken 15 expensive drugs into the critical illness list, most of these are patented cancer drugs. The article aims to introduce, compare and analyze the design of Zhejiang’s Critical Illness Insurance to conclude the suggestion and prospects. It may provide references to other province, to make this policy more practical and efficiency in China, promoting social health and equality. Methods: Followed by the provincial plan published on Feb 2015, The 7 city plans were published from Apr 2015 to Sept 2015. All plans determined that the payment amount will be segmented calculated. The article summarizes and compares the financing level, deductible and cap lines between these cities. Results: 3 cities determined the financing level: 2 cities were from 15 CNY to 40 CNY per capita annually; the rest equaled 0.2% of BMI premium. All cities determined deductible, which calculated deductible based on urban per capita disposable income. All cities determined cap line: 6 cities were from 200,000 CNY to 450,000 CNY and the rest were no cap. Conclusions: 1. Since the central government did not define what critical illness insurance can reimburse, some provincial governments just selected certain disease which public opinion concentrated. While it should be ranked by disease burden 2. The government should pay more efforts on improving reimbursable access not only price control, especially for the exclusive treatment drugs of the same indication but clinical need personalized. However, the main challenge is still how to balance the income and expenditure, besides the financial compensation at all levels, it’s better to have a top-design which could apply the actuarial or pharmacoeconomics tools to make this policy more cost effective and sustainable. PHP10 Online Pharmacy Regulation in India: A Cross Sectional Survey on Perceptions of Health Care Students/Professionals Peringadi Vayalil M, Rajesh V, Rajan MS, Girish T Manipal University, Manipal, Udupi Dist., India
Objectives: To investigate the opinions and views of Indian healthcare students/ professionals on regulation of online pharmacies in India. Methods: A structured online questionnaire was designed in google form and sent to a total of 150 participants during November 2015- February 2016. The questionnaire was validated by two experts. It consists of total 11 items which included 7 items with Likert scale (1-Strongly agree & 5- Strongly Disagree) and 4 items were to opt for either Yes/ No. Results: The total response rate was 36% (N= 54) which comprised of 33.3% (N= 18) of students. And among the professionals; predominant respondents were academicians (40.7%; N= 22/54). Most of the respondents(59.2%) believed that the medicines would be cheaper through online pharmacies; nevertheless majority of the respondents (81.5%) believed that there would be an increased potential for drug abuse through online pharmacies. As far as regulation was concerned; there was a unanimous call for forming a separate body for quality assurance of drugs dispensed through online pharmacies and for linking the online pharmacy websites only through regulatory authorities official website as most of them (90.8%) believed that even the traditional offline pharmacies are not well regulated in India. 94.4% (N= 51) of the respondents opined that the online pharmacies should be completely handled by qualified pharmacists only. There was mixed response regarding the influence of online pharmacy on patient medication compliance. Conclusions: This survey is the first of its kind to our knowledge in investigating the opinions of healthcare professionals regarding online pharmacy regulation in Indian scenario. The major drawback of online pharmacies perceived by healthcare students/professionals is the increased potential for drug abuse and lack of structured mechanism for quality control of drugs dispensed through the online pharmacies. This study also paves light on the lack of efficient regulation of traditional offline pharmacies in India which intricate the online pharmacy regulation to greater extends.
PHP11 Development of Hospital Formulary in Japan - Current Trends and Issues Hamashima Y1, Hamashima C2 1University of Tokyo Hospital, Tokyo, Japan, 2National Cancer Center, Tokyo, Japan
Objectives: In Japan, more than 18,000 medicines are subject to reimbursement with medical fees. People can have access to any drug among more than 18,000 medicines, regardless of the type of public health insurance they subscribe to. The prescription depends on each doctor’s attitude towards medication and hospital formulary (HF). Since April 2016, The Ministry of Health, Welfare and Labour announced that they will introduce health-economic evaluation for approval of drug. On the other hand, there is no explicit criterion for development HF and it remains questionable whether each hospital selects each medicine objectively. We will offer an overview of the current trends of Japanese formularies and consider what requires for improvement. Methods: The PubMed and Igaku-Chuo-Zasshi were used to search the reference related to HF in Japan from 2000 to 2015. Results: There are 34 surveys found on development of Japanese hospital formulary. Most of them mainly discuss how to develop a book of formulary rather than how to select
medicines. Some studies pointed out that many facilities lay weight on the frequency of prescription although they consider recommendations from clinical guidelines. In addition, several researches suggest the tendencies which they are more sensitive to medical cost, whereas quarter of them do not perform any pharmacoeconomic analysis. Conclusions: The paucity of research on development of HF suggests a lack of interest in the topic in Japan. In order to have a fair allocation of health and monetary resources, we need to review the role and making process of HF. Minimum requirements to develop Japanese HF should also be considered. PHP12 How Does Pricing and Access of Innovative Oncology Agents in China Compare with Other Asian Markets? Sherwin G, Akpinar P, Yap B, Lu V, Im Y ICON plc, LONDON, UK
Objectives: According to the National Central Cancer Registry of China, there are > 4 million new cancer cases and nearly 3 million cancer deaths in China in 2015. Although the Chinese government has initiated a number of reforms in recent years to improve coverage of patients with severe diseases, oncology drug access remains a significant issue with many innovative drugs not being included on either the national or provincial lists for reimbursement. Consequently, manufacturers often set the price of oncology drugs free of government mandates which usually apply to reimbursed products. In contrast, in markets where governments fund cancer treatment (South Korea, Japan, Taiwan), all medicines are assessed and undergo price setting/negotiation. This research explores the price differences for oncology agents across different types of markets with consideration for funding and level of patient access. Methods: Conducted extensive secondary research to review the prices of recently launched (< 5 years) oncology agents and the level of patient access across selected Asian markets (China, Japan, South Korea and Taiwan. We compared the uptake of drugs and attempted to identify drivers for access and funding. Results: The price differential across Asian markets is correlated with lack of reimbursement, i.e., higher prices in countries where there is no likelihood of reimbursement. In contrast, in countries where these drugs are reimbursed, prices are tightly controlled and subject to regular price cuts. Affordability remains the major challenge for access to cancer drugs. Conclusions: Currently, innovative cancer drugs are outside the reach of most Chinese due to slow regulatory approval and limited public reimbursement. As the government aims to reimburse more oncology therapies, new mechanisms for evaluation and funding will be needed. Asian markets with ability to secure patient access to medicines at regulated prices can be useful models for China as the government looks to improve the system. PHP13 What Impact is the Evolving Health Care Landscape Having on Access to Innovative Medicines in China? Sherwin G, Akpinar P, Yap B ICON plc, LONDON, UK
Objectives: China only accounts for around 3% of global revenue generated by major pharmaceutical companies worldwide; undermined in part by the complex and highly fragmented regulatory, market access / procurement, and pricing environment. Limited access to innovative medicines has created a discrepancy in the quality of healthcare provided in China, compared to the rest of the world, which the government has sought to address through recent policy reforms. We aimed to understand what impact these reforms are having on access to innovative medicines in China. Methods: Secondary research of government legislation since the 2009 healthcare reform was introduced was conducted to identify relevant policy pertaining to the regulatory, market access and pricing environment. Analysis of coverage decisions at the provincial level over the last three years, specifically in relation to innovative oncology products, was conducted to identify trends in access. Finally, primary research was conducted with a mix of stakeholders including public payers and key opinion leading oncologists. Results: Reforms to healthcare coverage have resulted in basic insurance programs covering > 95% of the population, although there remains a funding gap for reimbursement of innovative medicines, particularly those for severe illness. Consequently, specific programs have been piloted and are currently being introduced, resulting in a trend in increasing coverage for more innovative oncology drugs within some provincial reimbursement lists. Conclusions: Our results demonstrate that, although significant strides have been made in terms of insurance coverage and addressing funding gaps, there remains a significant difference in the level of access to innovative medicines within China compared to the rest of the world; therefore manufacturers will continue to face challenges in achieving broad market access to intended patient populations. However, the recent and ongoing regulatory reforms offer opportunities for foreign manufacturers willing to invest in domestic R&D, where incentives are being offered. PHP14 Assessment of Biosimilar Landscape in Korea, Malaysia, Singapore and Taiwan Chen S1, Conti CC2, Cheong J1 Singapore, Singapore, Singapore, 2GfK, London, UK
1GfK
Objectives: Biosimilar has attracted tremendous interest and controversy in the past decade. Several mature healthcare markets in Asia Pacific has not only developed regulatory frameworks to approve biosimilar, but also taken initiatives to promote utilisation. This study aims to assess the current biosimilar landscape in Korea, Taiwan, Singapore and Malaysia and explore tactics to drive biosimilar adoption. Methods: Secondary research was conducted from January to March 2016 on all available information in the public domain. Biosimilar registration frameworks from Singapore, Korea, Taiwan and Malaysia were first retrieved from respective government sources. In a systematic analysis, each framework’s definition of biosimilar,
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 8 0 7 – A 9 1 8
and region. Conclusions: Districts are grappling with the inefficiency, in the form of shortage or expiry, in free medicines distribution. Rigorous needs assessment study, better coordination between centre and districts, and increased procurement efficiency are the order of the day. Because we interviewed only the officials from districts, there is the possibility of bias in their answers; so a follow-up study with all stakeholders on board is warranted. PHP9 Suggestion on Critical Illness Insurance in China Zhu L, Xu H, Cui X Sanofi China, Shanghai, China
Objectives: Since 2012, China piloted a state-run critical illness cover, which reimbursed for approximately 50% of medical costs. In 2015, Zhejiang Province had taken 15 expensive drugs into the critical illness list, most of these are patented cancer drugs. The article aims to introduce, compare and analyze the design of Zhejiang’s Critical Illness Insurance to conclude the suggestion and prospects. It may provide references to other province, to make this policy more practical and efficiency in China, promoting social health and equality. Methods: Followed by the provincial plan published on Feb 2015, The 7 city plans were published from Apr 2015 to Sept 2015. All plans determined that the payment amount will be segmented calculated. The article summarizes and compares the financing level, deductible and cap lines between these cities. Results: 3 cities determined the financing level: 2 cities were from 15 CNY to 40 CNY per capita annually; the rest equaled 0.2% of BMI premium. All cities determined deductible, which calculated deductible based on urban per capita disposable income. All cities determined cap line: 6 cities were from 200,000 CNY to 450,000 CNY and the rest were no cap. Conclusions: 1. Since the central government did not define what critical illness insurance can reimburse, some provincial governments just selected certain disease which public opinion concentrated. While it should be ranked by disease burden 2. The government should pay more efforts on improving reimbursable access not only price control, especially for the exclusive treatment drugs of the same indication but clinical need personalized. However, the main challenge is still how to balance the income and expenditure, besides the financial compensation at all levels, it’s better to have a top-design which could apply the actuarial or pharmacoeconomics tools to make this policy more cost effective and sustainable. PHP10 Online Pharmacy Regulation in India: A Cross Sectional Survey on Perceptions of Health Care Students/Professionals Peringadi Vayalil M, Rajesh V, Rajan MS, Girish T Manipal University, Manipal, Udupi Dist., India
Objectives: To investigate the opinions and views of Indian healthcare students/ professionals on regulation of online pharmacies in India. Methods: A structured online questionnaire was designed in google form and sent to a total of 150 participants during November 2015- February 2016. The questionnaire was validated by two experts. It consists of total 11 items which included 7 items with Likert scale (1-Strongly agree & 5- Strongly Disagree) and 4 items were to opt for either Yes/ No. Results: The total response rate was 36% (N= 54) which comprised of 33.3% (N= 18) of students. And among the professionals; predominant respondents were academicians (40.7%; N= 22/54). Most of the respondents(59.2%) believed that the medicines would be cheaper through online pharmacies; nevertheless majority of the respondents (81.5%) believed that there would be an increased potential for drug abuse through online pharmacies. As far as regulation was concerned; there was a unanimous call for forming a separate body for quality assurance of drugs dispensed through online pharmacies and for linking the online pharmacy websites only through regulatory authorities official website as most of them (90.8%) believed that even the traditional offline pharmacies are not well regulated in India. 94.4% (N= 51) of the respondents opined that the online pharmacies should be completely handled by qualified pharmacists only. There was mixed response regarding the influence of online pharmacy on patient medication compliance. Conclusions: This survey is the first of its kind to our knowledge in investigating the opinions of healthcare professionals regarding online pharmacy regulation in Indian scenario. The major drawback of online pharmacies perceived by healthcare students/professionals is the increased potential for drug abuse and lack of structured mechanism for quality control of drugs dispensed through the online pharmacies. This study also paves light on the lack of efficient regulation of traditional offline pharmacies in India which intricate the online pharmacy regulation to greater extends.
PHP11 Development of Hospital Formulary in Japan - Current Trends and Issues Hamashima Y1, Hamashima C2 1University of Tokyo Hospital, Tokyo, Japan, 2National Cancer Center, Tokyo, Japan
Objectives: In Japan, more than 18,000 medicines are subject to reimbursement with medical fees. People can have access to any drug among more than 18,000 medicines, regardless of the type of public health insurance they subscribe to. The prescription depends on each doctor’s attitude towards medication and hospital formulary (HF). Since April 2016, The Ministry of Health, Welfare and Labour announced that they will introduce health-economic evaluation for approval of drug. On the other hand, there is no explicit criterion for development HF and it remains questionable whether each hospital selects each medicine objectively. We will offer an overview of the current trends of Japanese formularies and consider what requires for improvement. Methods: The PubMed and Igaku-Chuo-Zasshi were used to search the reference related to HF in Japan from 2000 to 2015. Results: There are 34 surveys found on development of Japanese hospital formulary. Most of them mainly discuss how to develop a book of formulary rather than how to select
medicines. Some studies pointed out that many facilities lay weight on the frequency of prescription although they consider recommendations from clinical guidelines. In addition, several researches suggest the tendencies which they are more sensitive to medical cost, whereas quarter of them do not perform any pharmacoeconomic analysis. Conclusions: The paucity of research on development of HF suggests a lack of interest in the topic in Japan. In order to have a fair allocation of health and monetary resources, we need to review the role and making process of HF. Minimum requirements to develop Japanese HF should also be considered. PHP12 How Does Pricing and Access of Innovative Oncology Agents in China Compare with Other Asian Markets? Sherwin G, Akpinar P, Yap B, Lu V, Im Y ICON plc, LONDON, UK
Objectives: According to the National Central Cancer Registry of China, there are > 4 million new cancer cases and nearly 3 million cancer deaths in China in 2015. Although the Chinese government has initiated a number of reforms in recent years to improve coverage of patients with severe diseases, oncology drug access remains a significant issue with many innovative drugs not being included on either the national or provincial lists for reimbursement. Consequently, manufacturers often set the price of oncology drugs free of government mandates which usually apply to reimbursed products. In contrast, in markets where governments fund cancer treatment (South Korea, Japan, Taiwan), all medicines are assessed and undergo price setting/negotiation. This research explores the price differences for oncology agents across different types of markets with consideration for funding and level of patient access. Methods: Conducted extensive secondary research to review the prices of recently launched (< 5 years) oncology agents and the level of patient access across selected Asian markets (China, Japan, South Korea and Taiwan. We compared the uptake of drugs and attempted to identify drivers for access and funding. Results: The price differential across Asian markets is correlated with lack of reimbursement, i.e., higher prices in countries where there is no likelihood of reimbursement. In contrast, in countries where these drugs are reimbursed, prices are tightly controlled and subject to regular price cuts. Affordability remains the major challenge for access to cancer drugs. Conclusions: Currently, innovative cancer drugs are outside the reach of most Chinese due to slow regulatory approval and limited public reimbursement. As the government aims to reimburse more oncology therapies, new mechanisms for evaluation and funding will be needed. Asian markets with ability to secure patient access to medicines at regulated prices can be useful models for China as the government looks to improve the system. PHP13 What Impact is the Evolving Health Care Landscape Having on Access to Innovative Medicines in China? Sherwin G, Akpinar P, Yap B ICON plc, LONDON, UK
Objectives: China only accounts for around 3% of global revenue generated by major pharmaceutical companies worldwide; undermined in part by the complex and highly fragmented regulatory, market access / procurement, and pricing environment. Limited access to innovative medicines has created a discrepancy in the quality of healthcare provided in China, compared to the rest of the world, which the government has sought to address through recent policy reforms. We aimed to understand what impact these reforms are having on access to innovative medicines in China. Methods: Secondary research of government legislation since the 2009 healthcare reform was introduced was conducted to identify relevant policy pertaining to the regulatory, market access and pricing environment. Analysis of coverage decisions at the provincial level over the last three years, specifically in relation to innovative oncology products, was conducted to identify trends in access. Finally, primary research was conducted with a mix of stakeholders including public payers and key opinion leading oncologists. Results: Reforms to healthcare coverage have resulted in basic insurance programs covering > 95% of the population, although there remains a funding gap for reimbursement of innovative medicines, particularly those for severe illness. Consequently, specific programs have been piloted and are currently being introduced, resulting in a trend in increasing coverage for more innovative oncology drugs within some provincial reimbursement lists. Conclusions: Our results demonstrate that, although significant strides have been made in terms of insurance coverage and addressing funding gaps, there remains a significant difference in the level of access to innovative medicines within China compared to the rest of the world; therefore manufacturers will continue to face challenges in achieving broad market access to intended patient populations. However, the recent and ongoing regulatory reforms offer opportunities for foreign manufacturers willing to invest in domestic R&D, where incentives are being offered. PHP14 Assessment of Biosimilar Landscape in Korea, Malaysia, Singapore and Taiwan Chen S1, Conti CC2, Cheong J1 Singapore, Singapore, Singapore, 2GfK, London, UK
1GfK
Objectives: Biosimilar has attracted tremendous interest and controversy in the past decade. Several mature healthcare markets in Asia Pacific has not only developed regulatory frameworks to approve biosimilar, but also taken initiatives to promote utilisation. This study aims to assess the current biosimilar landscape in Korea, Taiwan, Singapore and Malaysia and explore tactics to drive biosimilar adoption. Methods: Secondary research was conducted from January to March 2016 on all available information in the public domain. Biosimilar registration frameworks from Singapore, Korea, Taiwan and Malaysia were first retrieved from respective government sources. In a systematic analysis, each framework’s definition of biosimilar,