- Email: [email protected]
Title: Access to Orphan and Ultra-Orphan Drugs in China
A826
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
PHP69 Upcoming Regulations on Insurance Reimbursement Standard in China: Chanllanges and Opportunites for Mncs MI M1, Suponcic S2, Wang M3, LIU Y1 Life Sciences, Shanghai, China, 2Navigant Life Sciences, Lawrenceville, NJ, USA, 3Navigant Life Sciences, London, UK
1Navigant
Objectives: On 1 June 2015, Chinese regulators (National Development and Reform Commission, Ministry of Human Resources and Social Security, National Health and Family Planning Commission) removed the price ceiling of most drugs in hopes of establishing a market-driven pricing system that will help keep medical costs in check. In order to better control the drug expenditure of medical insurance funds, the drug price established through the public bidding process for new drug purchasing establishes the reimbursement cap, which is called the “reimbursement standard”. And, under a new therapeutic reference pricing policy, only price will be used to differentiate products if they are considered similar. Thus, sustainable access to products may be at risk. The objective of this research is to understand how this system is being applied and implemented across provinces. Methods: Secondary research analysis reviewed the policy, its evolution and the reimbursement standard achieved in three pilot areas, Chongqing, Jiangsu and Zhejiang. In-depth interviews were conducted with relevant government stakeholders to understand variation in provincial policy and implementation results across the pilot areas. Results: At the national level, MOHRSS has designed a top-down framework utilizing the reimbursement standard. Local pooling areas will enact this framework through tailored policies at the provincial and municipal level. However, MOHRSS has little historical drug procurement data to predict or anticipate the likely bids and hence establish the optimal reimbursement cap. Therefore, sustainable access to innovative products may only be achieved if companies collect real world data and conduct pharmaco-economic (PE) studies to support value-based decision-making and assist MOHRSS in establishing optimal reimbursement caps at the local level. Conclusions: Under the new pricing, procurement and reimbursement mechanism, sustainable access to products will require strategic initiatives to substantiate the differentiated value of innovative products and motivate the need for a separate reimbursement standard for differentiated products.
outstanding policies are implemented should be monitored. It remains to be seen if the passing of new public legislation will impact broader patient access to such rare disease treatments in China. PHP72 How much do the insured citizens know about the personal account of china’s urban employees’ basic medical insurance and what are their needs? Evidence from guizhou, china Wu H1, Yi L2, Ran X1 1Guizhou Medical University, Guiyang, China, 2Department of human resources and social security of Guizhou province, Guiyang, China
Objectives: The aim of this study is to provide evidences for the reform of personal account of China’s urban employees’ basic medical insurance (UEBMI). Methods: A questionnaire was designed to collect the information about social-demographic characteristics, health status and behaviors of the insured citizens. Additionally, a series of questions regarding the familiarities, usages and extra demands of the personal account of UEBMI were also included. Results: A total of 635 questionnaires were completed by the people from Guizhou, and 538 of them were valid for further analysis. The personal accounts were rarely or never used by 53.50% of respondents, and 9.90% of respondents even didn’t activate the account. Being healthy is the main reason for these results. However, the respondents who aged more than 65 are more likely to use up the personal account every month. About 30% of respondents didn’t know that part of funds in the personal account actually come from their own incomes. Meanwhile, the same proportion of respondents didn’t know exactly about when to use the account. 84.73% of respondents expected that the fund in the account could be used to improve the insurance coverage not only for the insured people but also for their families. 75.61% of respondents hope that annual physical examinations could be paid by this account. Respondents with different age or incomes had significant different preferences for the insurance coverage of account (P< 0.05). Conclusions: On the one hand, there were lots of funds saving in the account for the healthy people; on the other hand, no more funding was available for the other people, especially for the elder people. More fairness, higher insurance coverage, and family-based insurance should be the directions to further the personal account of UEBMI reform.
PHP70 A Case Study on the Development, Implementation and Outcome of Critical Disease Insurance in Shen Zhen, China
PHP73 The Role of Economic Evidence in Drug Reimbursement: South Korea
Jiang J Jinan University, Guangzhou, China
1Gyeongsang
Objectives: Shenzhen is a major city in Guangdong province, and is among the top 7 richest cities in China by per capita GDP. Shenzhen took the lead in establishing a supplementary medical insurance for major and critical diseases in China. The critical disease insurance (CDI) system aims to expand the coverage of the country’s basic health care insurance system to include the treatment of critical illness, to relieve urban and rural families of the heavy burden of catastrophic medical costs. The objective of this study is to analyze the design and development of the CDI system in Shenzhen, and provide early insights and learnings into the development of the CDI systems in other cities in China. Methods: To analyze the framework of CDI system in Shenzhen, a literature/document review and expert consultation were conducted to obtain information. Results: The Shenzhen CDI is an extension and supplementary insurance to the basic social medical insurance. It is a voluntary insurance policy with low premiums and broad coverage. For example, for outpatient drugs that are on the CDI reimbursement drug list, the reimbursement rate is 70%, up to ¥150,000 per person per year. The CDI policy guidance and regulation were set by the local government, and executed by commercial insurance institutions. The government uses commercial insurance agencies’ professional competencies and market mechanisms to improve the operating efficiency, service levels and quality of CDI. The government also emphasizes that insurance companies should only achieve controlled profit levels set by government. Conclusions: The introduction of Critical Diseases Insurance effectively reduces the burden of medical costs arising from serious illness, alleviates poverty caused by disease, and facilitates patients’ access to effective treatments to improve health outcomes. Further analyses over time will quantify the program’s effects on these endpoints.
Bae E1, Lee H2, Kwon H3, Yang B4 National University, Jinju, South Korea, 2National Health Insurance Service, Seoul, South Korea, 3Mokwon University, Daejeon, South Korea, 4Seoul National University, Seoul, South Korea
Objectives: This study investigates the factors that were considered in drug reimbursement decision making in South Korea and the role of the economic evidence in it. Methods: All recommendations made by the pharmaceutical benefit coverage assessment committee (PBCAC) as of April 2012 have been reviewed and analyzed to identify the relative importance of economic evidence. The data was retrieved from minutes of PBCAC and related documents prepared for the meeting. In case the information included in the minutes was unclear, official inquiries were filed to HIRA. Results: HIRA requires the full economic evaluation data for the drug which is improved in terms of effectiveness relative to its comparators. A total of 32 cases have been admitted as a result of their superiority over comparators, and provided the information of cost per life years gained or cost per QALYs gained. We found that the drug is highly likely to be recommended to list in case the ICER is less than 22 million won/QALY. For three exceptional cases rejected, the committee considered the submitted ratio as too uncertain to support its value for money. Some drugs were accepted, considering the severity of disease or the availability of alternative therapies, even if their ICER was higher than the other cases. Conclusions: Cost-effectiveness is a critical factor in reimbursement decision making, but the roll of full economic evaluations is limited as there are not many drugs that are superior in efficacy to existing alternatives. In that case, a price comparison is sufficient and most of them have been submitted at a lower price than the alternative drugs.
PHP71 Title: Access to Orphan and Ultra-Orphan Drugs in China
HEALTH CARE USE & POLICY STUDIES – Health Care Research & Education
Gambari J, Yang M, Chowdhury CA, Duttagupta S CBPartners, New York, NY, USA
PHP74 Evaluating the Relative Effectiveness of Two Malnutrition Risk Assessment Tools in Surgical Population at a Tertiary Care Hospital in Malaysia
Objectives: Orphan drugs face a number of access challenges in China: the absence of official legislation, slow market authorization combined with high price control, limited funding and a high rate of under-diagnosis. The objective of this analysis was to identify and synthesize the evolution of access for orphan and ultra-orphan drugs in China and identify opportunities for access in certain rare disease areas. Methods: The orphan disease and drug legislation environment in China was compared with that in USA, EU countries, Korea and Japan. In addition current policies with indirect impact on orphan diseases in China were uncovered. The pathways of funding for Orphan drugs was developed and a list of relevant products based on the products included on the provincial “Reimbursement Drug Lists” (RDL) were identified. Results: Of the 203 total FDA orphan designations approved since 2007 by the time of the analysis, 33 of them were found to be registered with the CFDA (some products were approved for multiple orphan indications by the FDA). Overall, the products approved earlier by the FDA appeared to be more likely to be registered with the CFDA. Most of the orphan analogues were seen to have some form of coverage, either from provincial insurance or city insurance. Provincial insurance coverage was determined to be the most feasible option for reimbursement of orphan drugs in China. Conclusions: Given the continued evolution in health insurance, monitoring patient access to orphan drugs and how
Khan OH1, Khan AH1, Zakaria AD2, Hashim MN2, Sulaiman SA1 1Universiti Sains Malaysia, Pulau Penang, Malaysia, 2Universiti Sains Malaysia, Kota Bharu, Malaysia
Objectives: Malnutrition in surgical population is often underestimated and remain unnoticed regardless of the fact that it contributes extensively towards major post-operative complications. Goal of the study was to assess the performance of Malnutrition Universal Screening Tool (MUST) and Nutritional Risk Index (NRI) malnutrition screening tools in comparison with serum albumin as the conventional standard for malnutrition screening in surgical wards at our setting. Methods: A prospective observational study was conducted at Hospital Universiti Sains Malaysia (HUSM) over the period of six months. Surgical patients (n= 216, Age:18-75 years; Median= 48) were screened for the malnutrition risk within 48 hours of their admission using MUST and NRI and their serum albumin levels were taken. Sensitivity and specificity testing was carried out and agreement between the tools was analyzed using Kappa (κ ) statistic. T-test and one-way ANOVA were used to estimate the significant association between tools and total length of hospital stay (LOS). SPSS version 20 was used for analysis. Results: Serum
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
PHP69 Upcoming Regulations on Insurance Reimbursement Standard in China: Chanllanges and Opportunites for Mncs MI M1, Suponcic S2, Wang M3, LIU Y1 Life Sciences, Shanghai, China, 2Navigant Life Sciences, Lawrenceville, NJ, USA, 3Navigant Life Sciences, London, UK
1Navigant
Objectives: On 1 June 2015, Chinese regulators (National Development and Reform Commission, Ministry of Human Resources and Social Security, National Health and Family Planning Commission) removed the price ceiling of most drugs in hopes of establishing a market-driven pricing system that will help keep medical costs in check. In order to better control the drug expenditure of medical insurance funds, the drug price established through the public bidding process for new drug purchasing establishes the reimbursement cap, which is called the “reimbursement standard”. And, under a new therapeutic reference pricing policy, only price will be used to differentiate products if they are considered similar. Thus, sustainable access to products may be at risk. The objective of this research is to understand how this system is being applied and implemented across provinces. Methods: Secondary research analysis reviewed the policy, its evolution and the reimbursement standard achieved in three pilot areas, Chongqing, Jiangsu and Zhejiang. In-depth interviews were conducted with relevant government stakeholders to understand variation in provincial policy and implementation results across the pilot areas. Results: At the national level, MOHRSS has designed a top-down framework utilizing the reimbursement standard. Local pooling areas will enact this framework through tailored policies at the provincial and municipal level. However, MOHRSS has little historical drug procurement data to predict or anticipate the likely bids and hence establish the optimal reimbursement cap. Therefore, sustainable access to innovative products may only be achieved if companies collect real world data and conduct pharmaco-economic (PE) studies to support value-based decision-making and assist MOHRSS in establishing optimal reimbursement caps at the local level. Conclusions: Under the new pricing, procurement and reimbursement mechanism, sustainable access to products will require strategic initiatives to substantiate the differentiated value of innovative products and motivate the need for a separate reimbursement standard for differentiated products.
outstanding policies are implemented should be monitored. It remains to be seen if the passing of new public legislation will impact broader patient access to such rare disease treatments in China. PHP72 How much do the insured citizens know about the personal account of china’s urban employees’ basic medical insurance and what are their needs? Evidence from guizhou, china Wu H1, Yi L2, Ran X1 1Guizhou Medical University, Guiyang, China, 2Department of human resources and social security of Guizhou province, Guiyang, China
Objectives: The aim of this study is to provide evidences for the reform of personal account of China’s urban employees’ basic medical insurance (UEBMI). Methods: A questionnaire was designed to collect the information about social-demographic characteristics, health status and behaviors of the insured citizens. Additionally, a series of questions regarding the familiarities, usages and extra demands of the personal account of UEBMI were also included. Results: A total of 635 questionnaires were completed by the people from Guizhou, and 538 of them were valid for further analysis. The personal accounts were rarely or never used by 53.50% of respondents, and 9.90% of respondents even didn’t activate the account. Being healthy is the main reason for these results. However, the respondents who aged more than 65 are more likely to use up the personal account every month. About 30% of respondents didn’t know that part of funds in the personal account actually come from their own incomes. Meanwhile, the same proportion of respondents didn’t know exactly about when to use the account. 84.73% of respondents expected that the fund in the account could be used to improve the insurance coverage not only for the insured people but also for their families. 75.61% of respondents hope that annual physical examinations could be paid by this account. Respondents with different age or incomes had significant different preferences for the insurance coverage of account (P< 0.05). Conclusions: On the one hand, there were lots of funds saving in the account for the healthy people; on the other hand, no more funding was available for the other people, especially for the elder people. More fairness, higher insurance coverage, and family-based insurance should be the directions to further the personal account of UEBMI reform.
PHP70 A Case Study on the Development, Implementation and Outcome of Critical Disease Insurance in Shen Zhen, China
PHP73 The Role of Economic Evidence in Drug Reimbursement: South Korea
Jiang J Jinan University, Guangzhou, China
1Gyeongsang
Objectives: Shenzhen is a major city in Guangdong province, and is among the top 7 richest cities in China by per capita GDP. Shenzhen took the lead in establishing a supplementary medical insurance for major and critical diseases in China. The critical disease insurance (CDI) system aims to expand the coverage of the country’s basic health care insurance system to include the treatment of critical illness, to relieve urban and rural families of the heavy burden of catastrophic medical costs. The objective of this study is to analyze the design and development of the CDI system in Shenzhen, and provide early insights and learnings into the development of the CDI systems in other cities in China. Methods: To analyze the framework of CDI system in Shenzhen, a literature/document review and expert consultation were conducted to obtain information. Results: The Shenzhen CDI is an extension and supplementary insurance to the basic social medical insurance. It is a voluntary insurance policy with low premiums and broad coverage. For example, for outpatient drugs that are on the CDI reimbursement drug list, the reimbursement rate is 70%, up to ¥150,000 per person per year. The CDI policy guidance and regulation were set by the local government, and executed by commercial insurance institutions. The government uses commercial insurance agencies’ professional competencies and market mechanisms to improve the operating efficiency, service levels and quality of CDI. The government also emphasizes that insurance companies should only achieve controlled profit levels set by government. Conclusions: The introduction of Critical Diseases Insurance effectively reduces the burden of medical costs arising from serious illness, alleviates poverty caused by disease, and facilitates patients’ access to effective treatments to improve health outcomes. Further analyses over time will quantify the program’s effects on these endpoints.
Bae E1, Lee H2, Kwon H3, Yang B4 National University, Jinju, South Korea, 2National Health Insurance Service, Seoul, South Korea, 3Mokwon University, Daejeon, South Korea, 4Seoul National University, Seoul, South Korea
Objectives: This study investigates the factors that were considered in drug reimbursement decision making in South Korea and the role of the economic evidence in it. Methods: All recommendations made by the pharmaceutical benefit coverage assessment committee (PBCAC) as of April 2012 have been reviewed and analyzed to identify the relative importance of economic evidence. The data was retrieved from minutes of PBCAC and related documents prepared for the meeting. In case the information included in the minutes was unclear, official inquiries were filed to HIRA. Results: HIRA requires the full economic evaluation data for the drug which is improved in terms of effectiveness relative to its comparators. A total of 32 cases have been admitted as a result of their superiority over comparators, and provided the information of cost per life years gained or cost per QALYs gained. We found that the drug is highly likely to be recommended to list in case the ICER is less than 22 million won/QALY. For three exceptional cases rejected, the committee considered the submitted ratio as too uncertain to support its value for money. Some drugs were accepted, considering the severity of disease or the availability of alternative therapies, even if their ICER was higher than the other cases. Conclusions: Cost-effectiveness is a critical factor in reimbursement decision making, but the roll of full economic evaluations is limited as there are not many drugs that are superior in efficacy to existing alternatives. In that case, a price comparison is sufficient and most of them have been submitted at a lower price than the alternative drugs.
PHP71 Title: Access to Orphan and Ultra-Orphan Drugs in China
HEALTH CARE USE & POLICY STUDIES – Health Care Research & Education
Gambari J, Yang M, Chowdhury CA, Duttagupta S CBPartners, New York, NY, USA
PHP74 Evaluating the Relative Effectiveness of Two Malnutrition Risk Assessment Tools in Surgical Population at a Tertiary Care Hospital in Malaysia
Objectives: Orphan drugs face a number of access challenges in China: the absence of official legislation, slow market authorization combined with high price control, limited funding and a high rate of under-diagnosis. The objective of this analysis was to identify and synthesize the evolution of access for orphan and ultra-orphan drugs in China and identify opportunities for access in certain rare disease areas. Methods: The orphan disease and drug legislation environment in China was compared with that in USA, EU countries, Korea and Japan. In addition current policies with indirect impact on orphan diseases in China were uncovered. The pathways of funding for Orphan drugs was developed and a list of relevant products based on the products included on the provincial “Reimbursement Drug Lists” (RDL) were identified. Results: Of the 203 total FDA orphan designations approved since 2007 by the time of the analysis, 33 of them were found to be registered with the CFDA (some products were approved for multiple orphan indications by the FDA). Overall, the products approved earlier by the FDA appeared to be more likely to be registered with the CFDA. Most of the orphan analogues were seen to have some form of coverage, either from provincial insurance or city insurance. Provincial insurance coverage was determined to be the most feasible option for reimbursement of orphan drugs in China. Conclusions: Given the continued evolution in health insurance, monitoring patient access to orphan drugs and how
Khan OH1, Khan AH1, Zakaria AD2, Hashim MN2, Sulaiman SA1 1Universiti Sains Malaysia, Pulau Penang, Malaysia, 2Universiti Sains Malaysia, Kota Bharu, Malaysia
Objectives: Malnutrition in surgical population is often underestimated and remain unnoticed regardless of the fact that it contributes extensively towards major post-operative complications. Goal of the study was to assess the performance of Malnutrition Universal Screening Tool (MUST) and Nutritional Risk Index (NRI) malnutrition screening tools in comparison with serum albumin as the conventional standard for malnutrition screening in surgical wards at our setting. Methods: A prospective observational study was conducted at Hospital Universiti Sains Malaysia (HUSM) over the period of six months. Surgical patients (n= 216, Age:18-75 years; Median= 48) were screened for the malnutrition risk within 48 hours of their admission using MUST and NRI and their serum albumin levels were taken. Sensitivity and specificity testing was carried out and agreement between the tools was analyzed using Kappa (κ ) statistic. T-test and one-way ANOVA were used to estimate the significant association between tools and total length of hospital stay (LOS). SPSS version 20 was used for analysis. Results: Serum