It is our pleasure to present ISPOR News Across Asia July issue. This issue features a health policy article on the “Full-scale implementation of cost-effectiveness evaluation in Japan started in April 2019” and numerous HEOR and health policy updates from around the region. We also give you important information on ISPOR events and activities relating to Asia Pacific and beyond. We hope you enjoy this issue and warmly invite you to learn more about how ISPOR and ISPOR Asia Consortium are working to improve healthcare decision making in Asia Pacific, and globally.
News Across Asia Co-Editors Alex Fu, Sang Soo Lee, and Fang Zhang
Health Policy Updates
- Full-scale implementation of cost-effectiveness evaluation in Japan started in April 2019
- Policy updates from the ISPOR Asia Consortium meeting at ISPOR 2019
- Challenges facing the healthcare system in Malaysia
- New reform initiatives in South Korea
- ISPOR Regional Chapter activities update
ISPOR Member News
- ISPOR Asia Consortium events at ISPOR 2019
- ISPOR HTA Training in China – Update
- Member-reported publication
- Join ISPOR
- Call for candidates for Editor-in-Chief of Value in Health Regional Issues
- ISPOR Travel Grant deadlines
- Call for Abstracts deadlines
- Upcoming ISPOR meetings
HEALTH POLICY UPDATES
Full-scale implementation of cost-effectiveness evaluation in Japan started in April 2019
Manabu Akazawa, PhD, MPH 1), Shinya Saito, PhD, MD 2), Makoto Kobayashi, PhD 3)
1) Professor of Meiji Pharmaceutical University, and President of ISPOR Japan Chapter
2) Professor of Graduate School of Health Science, Okayama University, and Past-President of ISPOR Japan Chapter
3) COO of CRECON Medical Assessment Inc., and Secretary General of ISPOR Japan Chapter
In Japan, discussion on the utilization of cost-effectiveness evaluation for healthcare policies started in 2012, and cost-effectiveness evaluation was fully introduced from April 2019 after trial implementation was carried out from April 2016. For pharmaceutical and medical device companies aiming to sell products in Japan, it is certain that cost-effectiveness will be essential evidence. In this report, cost-effectiveness evaluation that has been fully introduced in Japan is outlined.
- History to full-scale implementation
The Central Social Insurance Medical Council (CSIMC) established the Special Committee on cost-effectiveness evaluation in May 2012 to discuss utilization of cost-effectiveness evidence for healthcare policies. Although increases of expensive health technology became of concern, little consideration had been given to cost-effectiveness as a basis for deciding on insurance reimbursement prices of health technology. CSIMC discussed the methodology, evaluation process, and pricing system based on cost-effectiveness evaluation, and trial implementation of cost-effectiveness evaluation that was initiated in April 2016. In this trial, the cost-effectiveness of products meeting the selection criteria was actually evaluated and the results were used to adjust prices. Thirteen target products of drugs and medical devices were selected; and from this trial, several critical issues were identified including differences in the methodologies, and results between manufacturer analysis and academic re-analysis. In the 2018 fiscal year, the review of issues identified through the trial and updated methodologies and processes for the full-scale implementation were discussed. Then, cost-effectiveness evaluation was fully introduced in April 2019 (full-scale implementation).
2. Structure of fully implemented cost-effectiveness evaluation
(1) Selection criteria and target products of evaluation
Trial implementation mainly targeted already listed drugs and medical devices, but newly listed products are the main targets of full-scale implementation. However, not all newly listed products are targeted, but rather products meeting the specific selection criteria become targets. Figure 1 (below) shows the selection criteria of target products for full-scale implementation. Products selected for full-scale implementation are classified into H1 to H5. For newly listed products, 3 categories (H1-H3) are set based on combinations of the presence or absence of a utility premium (innovativeness premium, usefulness premium, or improvement premium (medical devices), information disclosure level of manufacture cost below 50% (only for products priced using the cost calculation method), and projected market size. Products listed before full-scale implementation (before April 2019) priced with a utility premium and a market size of 100 billion yen or larger are also specified as target products (H4). H1-H4 are designated as representative products. When a representative product is used as comparator in price calculation, the price of the target product is to be adjusted according to the price of the representative product (H5). On the other hand, criteria for target exclusion are also set and products indicated for only rare or pediatric diseases at the time of evaluation are excluded from targets of cost-effectiveness evaluation. However, products with a large market size (35 billion yen or larger) and high unit price may be included as targets based on judgments made at the CSIMC general meeting.
Fig.1 Selection criteria for products targeted for cost-effectiveness evaluations
Figure 1 Notes:
(*1) Even if a product does not meet the selection criteria in terms of the peak sales (estimate) at the time of listing, it will be selected if its annual market size exceeds JPY 5 billion due to the expansion of the market size. In this case, it will be positioned as an H1 or H2 classification according to its annual market size.
(*2) Products for which either an innovation premium, utility premium, or improvement premium (八) (medical devices) was calculated will be targeted.
(*3) Products determined by the CSIMC General Assembly, such as products with a prominently high unit price, products for which new findings were discovered after the completion of the evaluation that would have a major impact on the evaluation, and other products for which a re-evaluation was required.
(*4) Products targeted for cost-effectiveness evaluations in the H1-H4 classification.
Source: C2H homepage https://c2h.niph.go.jp/tools/system/overview_en.pdf
(2) Process of evaluation
The flow of cost-effectiveness evaluation is as follows: 1) preliminary consultation, 2) manufacturer analysis, 3) academic re-analysis, and 4) appraisal (Figure 2). Differences in the analytical methods between manufacturer analysis and academic re-analysis were pointed out as a major issue in trial implementation. To avoid this disagreement, the analytical framework should be discussed before initiating analysis by manufacturers and an official agency called the Center for Outcomes Research and Economic Evaluation for Health (C2H, URL: https://c2h.niph.go.jp/ ) under the Ministry of Health, Labour and Welfare In the preliminary consultation, a basic policy and analytical framework (ie target population, comparator, main clinical evidence used in the analysis) are discussed and items must be followed during analysis for both manufacturer analysis and academic analysis are summarized (within 3-6 months). The manufacturer performs cost-effectiveness analysis based on the analytical framework decided in preliminary consultation. The duration of manufacturer analysis is specified as 3-6 months, and the total duration from the preliminary consultation to submitting the final manufacturer analysis is set at a maximum of 9 months. The results of manufacturer analysis are subjected to academic re-analysis (review from the viewpoint of scientific validity by an academic group). Finally, the expert committee makes an appraisal based on the results of manufacturer and academic analyses and reports to CSIMC.
(3) Methods of price adjustment for drugs
In full-scale implementation, price adjustment is performed based on Incremental Cost-Effectiveness Ratio (ICER) determined in appraisal. The target range of price adjustment is determined by the price calculation method. For a drug whose price was determined by a similar efficacy comparison method, the utility premium part is the target range of price adjustment. For a drug whose price was determined by a cost calculation method, the price adjustment target range is classified into 4 patterns based on the presence or absence of a utility premium and disclosure level. Figure 3 (below) shows the cost-effectiveness-based price adjustment method. Four categories are set based on the ICER and a price adjustment rate is set for each category. Different adjustment rates are set for the utility premium part and operating profit part. When ICER is below 5 million yen /QALY, no price adjustment is applied. When ICER is 5-7.5 yen/QALY million, 7.5-10 yen/QALY million, and 10 million yen/QALY or higher, the utility premium part is reduced by 30, 60, and 90%, respectively. Also, operating profit part is reduced by 17%, 33%, and 50% for the ICER categories, respectively.
(4) Consideration in price adjustment
From a social point of view and to avoid a heavy burden on manufacturers, various considerations are made for price adjustment.
A. Products requiring consideration in appraisal
For anticancer drugs and products with indications including rare or pediatric diseases, the reference ICER used for price adjustment are set at 7.5, 11.25, and 15 million yen, respectively (50% increases of the cut-off values).
B. Setting of maximum price reduction
The final price reduction rate is set at 10-15% of the price before adjustment. In addition, the rate is set so as to avoid being lower than the price with an ICER of 5 million yen/QALY after adjustment (a price with an ICER of 7.5 million yen/QALY for anticancer drugs).
C. Increase in drug price
When the effectiveness of the target is equivalent to or greater than that of the comparator and the cost is small, or when ICER is lower than 2 million yen /QALY, the price may be increased. However, the product has to be out of the range of general modification, such as being completely different from the comparator. To increase the price due to an ICER lower than 2 million yen/QALY, a greater effectiveness of the product than that of the comparator in the Asian population including Japanese must have been demonstrated by a clinical study, with the results accepted or published in a journal with an impact factor exceeding 15.
3. Issues in the future
It has been stated that cases to be subjected to cost-effectiveness evaluation will be accumulated to enrich the system, and the following will be conducted:
- Investigations will be performed on the expansion of the selection criteria, analysis processes, appraisal, price adjustment, and desirable utilization of the results at listing in order to make it a more efficient and highly transparent system.
- Investigations will be performed on factors and items that should be specially taken into account in the appraisal and price adjustment, based on analysis submitted from companies and rules in other countries.
More information about the full-scale implementation of cost-effectiveness evaluation in Japan and summary of results of the trial evaluations are available at the C2H homepage (https://c2h.niph.go.jp/en/).
Policy updates from the ISPOR Asia Consortium Meeting at ISPOR 2019
Adele Weston, PhD, Principal, Scientae, Melbourne, Australia
In a recent federal election in Australia, the incumbent Liberal/National coalition was returned to power. While there are unlikely to be any dramatic changes to health funding policies and processes, here are 3 ongoing reforms to watch. The supply chain and pharmaceutical pricing reforms that are currently planned by the Department of Health have not yet been agreed upon, however, there is a pilot commencing shortly. Of particular interest to manufacturers is the desire of the Department of Health to reduce the number of Special Pricing Arrangements in an effort in improve price transparency. There is currently a discussion paper in circulation, but the details remain confidential at present. Changes are likely to include a shortening of the term of such agreements, and possibly also development of criteria by which new products would be eligible to have a considerable gap between the published list price and the confidential effective price. Finally, there is bipartisan agreement regarding the need for a review of the National Medicines Policy given the changing nature of ‘medicines.’ Questions exist regarding the suitability of Australia’s HTA system to deal with complex new technologies such as CART-T that do not fit the traditional definition of a medicine.
Gordon Liu, PhD, Professor, Peking University, Beijing, China
The major concern in China healthcare is pharmaceutical pricing. In the past 5-6 years, pharmaceutical pricing was somewhat determined by the market, although government intervention was obvious. Beginning the last year, the government became more involved in pricing, particularly through a regional centralized drug procurement process in 11 cities. The primary approach is to invite pharmaceutical companies to submit applications for their generic products that passed the Generic Quality Consistence Evaluation (GQCE) to join the public bidding process. Based on the submissions for the current round of procurement, 25 products won the bidding. The drugs successfully selected are offered in return about 60% market share of the quantities in the same drug categories based on previous years data. All other manufacturers would compete only for the remaining 40% of market quantities. It is expected that the central government may conduct an official assessment of this 11-city policy pilot sometime late this summer to determine whether the policy would be extended to the national market.
Shirley Xue Li, PhD, Research Assistant Professor, University of Hong Kong, Hong Kong, China
The HPV vaccine program, government reimbursed for young girls, may be extended to other age groups. The PCV vaccine is subsidized by government for older adults, aged 65 years or above. While HTA development has not made apparent progress, discussion and initiation is being launched by health professionals and patients’ groups for the designation of rare diseases and legislation of orphan drugs. The strategies to reduce the burden on the public health system include a voluntary health insurance scheme and setting up a teaching hospital in Shenzhen, mainland China, to encourage cross border health service. The Hong Kong government is considering fully utilizing the electronic health record system to boost big data research in Hong Kong and encourage more collaborative research in the Big Bay Area.
Kavita Lamror, MPH, MD, Director of HEOR, Excelra Knowledge Solutions Private Limited, Hyderabad, India
Less than 22% of all Indians are covered under any form of health insurance, therefore India has been looking at increasing investment in the healthcare population. The Government of India launched a program in September 2018 to provide health insurance expenditure of approximately 7,100 US dollars to over 100 million families every year. This has become one of the key schemes to cover poor urban people. All healthcare training services and institutions are offered tax incentives and are exempt from service tax. The National Health Mission provides 13 billion US dollars from 2017 to 2020 to spread health services for rural and urban populations. The union budget allows approximately 185 million US dollars to establish 50,000 health and wellness centers in India. The antenatal program has been extended to pregnant women across the country, and 10 million women in the past year have taken advantage of this program. Through a public private global health partnership, Gavi HPV vaccine program was rolled out in one state in one district and extended to multiple states. The medication was initially rolled out to girls age 9-12 and is planned to be extended further. When it comes to determining the national essential list of medicines, India does not have a structured system of technology assessment. Instead, it has a single window system where the Drug Controller General of India (DCGI) provides proposals and approvals, and there will be a seamless system to evaluate drugs for inclusion of national essential list. A structure for HTA is not in place yet in India, but the Government of India is looking for a model streamlined system for HTA. The Kalam Institute of Health Technology has initiated some collaboration to study cost effectiveness and budget impact on drugs and medical devices.
Ainur Aiypkhanova, Republican Center for Healthcare Development of the Ministry of Healthcare, Kazakhstan
Kazakhstan has reformed the healthcare sector during the years 2009-2015 and established the first HTA system ever in the country. During the six-year reform, Kazakhstan hired consultants from abroad to increase the capacity of local people who could be future HTA analyst experts at the newly established HTA division within the national health policy think-tank, the Republican Center for Healthcare Development. We also developed and approved the first national regulations for the HTA system. The Ministry of Healthcare established the Joint Quality Committee in 2015 which reviews HTA results for future reimbursement decisions under public funding. The meetings of the Joint Quality Committee are chaired by the vice minister of healthcare; and the outcome of this meeting formed the foundation and first door for any drugs and new health technologies to qualify for reimbursement under the State health insurance program. However, Kazakhstan does not have a fully closed loop for HTA-based health policy-making because HTA results are not always considered for the services and drugs in the benefits package. As Kazakhstan’s income is less than in the developed countries whose HTA systems are more mature, it is critical for Kazakhstan to account for the HTA results of other countries for decision makers to spare healthcare resources. We spend 3.2% GDP on healthcare, which is much lower than in many countries, with 1.9% of GDP from government and 1.3% is private expenditure. Astonishingly, 40% of all healthcare expenditure are private and out-of-pocket sources, which is a too high burden for population. The next biggest reform the Healthcare Ministry is making is to launch a mandatory national health insurance system beginning next year. The Government will be contributing the system, as well as employers and employees. The government has announced that by 2025, 60% of government expenditure on healthcare should be on primary healthcare, prevention, and public health, and total expenditure on healthcare should reach 5% of GDP in 2024. This will change the landscape for hospitals, high technologies and expensive treatments in a direction for policy decisions fostering prevention, early diagnosis and effective noncommunicable disease management in the outpatient settings, with high reliance on primary health care (PHC) as outlined in the Astana Declaration on PHC, adopted by all World Health Organization member states in Kazakhstan in 2018. It is important to evolve according to national context, but conferences and networks such as ISPOR, help policy makers learn from each other and design the most appropriate health systems in their respective countries and regions.
Ivy Yin, MD, MBA, Market Access Director, Surgical Vision, Asia Pacific & Japan, Johnson & Johnson, Singapore
Singapore is actively striving to control the rising proportion of government expenditure on health while ensuring easier and more efficient access to primary care. The Ministry of Health (MoH) Health Promotion Board (HPB) is the main actor for national health promotion and disease prevention programs. For 2018, the total healthcare expenditure amounted to SG$10.6 billion and for 2019 the budgeted expenditure is SG$11.7 billion. The rise is expected to be driven by growth in patient subsidies, improved affordability through MediShield Life premium subsidies and financial assistance, and the implementation of CareShield Life. Raising healthcare expenditures, shortage of healthcare workers, and congestion are the key issues for healthcare in Singapore. There are three key shifts in the healthcare system beyond 2020. 1) Going beyond providing quality to enhancing value (sustainable healthcare); 2) Going beyond hospital-centric to community-based care (strengthening social and primary care); and 3) transcending healthcare to health (taking ownership of health).
Hae Sun Suh, MA, MS, PhD, Associate Professor, Pusan National University, Busan, South Korea
The positive list system for pharmaceuticals started in Nov 2006, and flexible ICER thresholds for cancer drugs or rare diseases treatments were adopted in Nov 2013. Risk sharing agreement utilization started in Jan 2015 and currently there are 16 drugs under this scheme with 3 years of utilization and 1 year for the evaluation period. The first piloted drug with risk sharing agreements will have the reevaluation conducted soon. The way to reevaluate this and future drugs will likely be a key issue for the health authorities as the analyses begin to be conducted. Starting in May 2015, some drugs were subjected to omission of economic evaluation and price negotiation requirements. Currently, 16 drugs have benefited from this new policy, including some orphan drugs. Economic evaluation in medical devices and regular reevaluation of existing drugs using real world data are also under discussion. As evidenced by these extensive efforts, the Korean Government has made it a priority to keep lessening the burden on patients with cancers and rare diseases.
Chee Jen Chang, PhD, Associate Professor, Chang Gung University, Taoyuan, Taiwan
A new guideline on the reimbursement of high-priced new cancer drugs has been announced by the National Health Insurance Administration in June of 2018. It is called “Application Principles for High Cost Oncology Drugs.” It was established considering the reimbursement issues of immune checkpoint inhibitor cancer drugs voiced by industry stakeholders and subsequent discussions led by TaSPOR (ISPOR Taiwan Chapter) in 2017 and 2018. Major requirements in the principles are: 1) Budget impact must greater than 500M NTD; 2) managed entry agreements (MEA) need to be prepared and discussed with the National Health Insurance Administration (NHIA); 3) Local pharmacoeconomic evaluation is required; and 4) All applications must be based in real-world evidence. Later in the same year, MEA policy was also announced by the NHIA and 3 financial-based and 3 outcomes-based MEAs models were suggested to be considered by industry stakeholders for future approaches. In November 2018, details of the application format of MEA were discussed by the Center for Drug Evaluation HTA group in Taiwan and it is still under discussion. In April 2019, owing to these policy announcements, immune checkpoint inhibitor cancer drugs were finally reimbursed, and there are 8 indications with limited scopes listed for reimbursement.
Surachat Ngorsuraches, PhD, Associate Professor, Auburn University, Auburn, Al, USA
Thailand is in the process of the development of the third national HTA guidelines. Experts in the field across the country have been invited to contribute to this guideline by the end of 2019. Since health expenditure in the country is still increasing at a higher rate than that of national incomes, more cost containment strategies are anticipated. The Comptroller General Office (CGD) reported from 2017 data that the health expenditure of the Civil Servant Medical Beneficiary Scheme (CSMBS) was approximately 4.5 to 4.7 times the health expenditures of the other two major schemes, including the Universal Coverage Scheme (UCS) and the Social Security Scheme (SSS). So, it is anticipated that CSMBS remains the primary target of potential upcoming measures. Recently, the Thai government has tried very hard to also control drug prices at private hospitals due to several complaints of high costs of care in these facilities.
Challenges facing the healthcare system in Malaysia
June WY Choon, Kenneth KC Lee
School of Pharmacy, Monash University Malaysia
Malaysia will become an aging nation by 2030. The aging population phenomenon which is taking place in many countries arises from significant decreases in later-life mortality. Senior citizens aged 65 years old and above are forecasted to make up a full 15.3% of Malaysia’s population or 5.8 million people by 2030.1 This group tends to have greater healthcare needs and consume more healthcare resources than other parts of the population. This demographic challenge has led to various government’s initiatives but the successful implementation of which will depend on the commitment from the government, private sector and non-governmental organizations (NGOs).
Healthcare for low income population
The Malaysia government has set up a National Protection Scheme known as MySalam in 2019 to provide free health coverage to people in the low-income category (B40) between 18-55 years old. The assistance is to provide government subsidies to cover hospital treatment and loss in productivity for at least 5 years for people who are found to have one of the 36 critical illnesses including cancer, some major surgeries, AIDS, hepatitis, organ transplants etc.2
Digital transformation in healthcare
Ever since the launch of the Multimedia Super Corridor, Malaysia’s communication and media landscape has changed significantly. Opportunities for using mobile technology have improved that the estimated mobile penetration leaped by 141.6% in recent years. With a population of 31.9 million, broadband penetration was 84.5% per 100 households and 71% adults in Malaysia owned smartphone.3 With these key drivers, the healthcare sector in Malaysia appears to be ripening for the introduction of digital healthcare. This may be an opportunity for Malaysia to advance in its healthcare system.
Access to new innovative medicines
A local study indicated that there might be more patients in need of inhibitors of the enzyme dipeptidyl peptidase IV (DPPIV inhibitors) and biological therapy for type-2 diabetes mellitus (DM) and rheumatoid arthritis (RA) than those who were currently being treated. The fraction of patients in Malaysia with access to DPPIV inhibitor therapies seemed to be plagued with a consistent level of 0.4% which was much lower than Korea (9.8%) and Taiwan (10.8%). The same was observed for RA, where only 0.21% of patients had access to biological therapies, compared to 9.2% in Taiwan and 4.9% in Korea. All the new medicines included in these analyses are provided through public funding in these countries.4 On this aspect, there is certainly a lot of room for improvement if Malaysia is to be considered as a developed country in the near future.
Under-development of primary healthcare
The primary healthcare (PHC) system in Malaysia is a hybrid one, with about 2,900 public facilities and 7,000 private facilities involved in service provision. Throughout the country, the public sector runs a broad network of health and community clinics in rural areas. This network covers about 60% of outpatient care and accounts for approximately 35% of total expenditure on primary care. The private sector, which is mainly clustered in urban and semi-urban areas, delivers about 40% of outpatient care and accounts for about 65% of total expenditure on primary care. Clearly, there are geographic variations in the access to health services with different populations. As primary healthcare is recognized as the most cost-effective way of maintaining health, health authority of Malaysia should develop new strategies so that resources are used in the most appropriate manner.
Increasing patient expectations and pressure for accountability
In line with jurisdictions around the world, the wide array of information available in the public domain in Malaysia has altered patients’ expectations and created dissatisfaction with the existing services. While there are many underlying aspects and causes of this dissatisfaction, increased expectations by patients on what healthcare services should be provided, and how public healthcare resources should be utilized are mounting. These all pose an uphill task for healthcare providers in Malaysia.
Economic downturn since 2013
The weakest spending on healthcare in Malaysia was witnessed during the period of 2013-2014 as the Malaysia Ringgit plunged to a historic low. This economic downturn has caused Malaysia to suffer a major setback from the previous years of economic growth. As a result, Malaysia faced severe challenges in financing their public expenditures from current tax revenues. This has led to increase in taxation and lower levels of growth and even reductions in public spending. These have had implications on the healthcare budget which consequently may continue to be constrained for many years to come.
- Planning Division, Ministry of Health, Malaysia 2018
- https://www.mysumber.com/skim-perlindungan-nasional.html (accessed 21 June 2019)
- MCMC, Malaysia Q4 2017
- PhAMA Malaysia. Building greater access to innovative medicines – What is next for Malaysia? Sept 2014
New Reform Initiatives in South Korea
Sang-Soo (SS) Lee, PhD, MBA, Corporate Affairs Director, Medtronic Korea, Chair of Medtronic Asia-Pacific Reimbursement Leadership Council (APRLC), and Vice President, ISPOR Korea Chapter
South Korean government completes a true “Parallel Review” program
On May 7, 2019, the Ministry of Health and Welfare (MoHW) announced their decision to introduce a new program that would allow the ‘new health technology assessment (nHTA)’ and the ‘coverage determination’ processes to occur simultaneously by making revisions to the “Rules on New Health Technology Assessment.” The new program is a follow-up measure to the MoHW announcement, “innovation of medical device regulation and medical industry promotion plan” made on July 19, 2018. The MoHW anticipates that this new program will shorten market access lead-time of new medical technologies from current maximum 490 days to maximum 390 days (note: the MoHW announced the lead-time mentioned is the calculation of the official lead-time. The actual lead-time is much longer in reality). The MoHW opened an initial 40-day public comment period through the notice of proposed rulemaking (NPRM) from May 9 to June 16. In the case of new medical technologies subject to the nHTA program, applicants (manufacturers) are required to submit coverage determination application dossiers for coverage determination to NECA. Then, the review for coverage determination application begins at HIRA simultaneously. Both agencies, NECA and HIRA, are expected to complete coverage determination when the nHTA is completed, reducing the market access lead-time of new medical technologies by about 100 days. When this new program is executed, the true “Parallel Review” program is completed. Currently, the “Parallel Review” program is run between regulatory approval and nHTA program. If the coverage determination is extended to the current program in the future, it will have the same form as the “Parallel Review” program currently running in the US. The current “Parallel Review” program is as follows.
To address the long delay in the overall review and decision-making process, MoHW convened a working group from three agencies – the Ministry of Food and Drug Safety (MFDS), the National Evidence-based Healthcare Collaborating Agency (NECA) and the Health Insurance Review and Assessment Service (HIRA), to consult widely and develop proposals for a ‘Parallel Review’ program, involving simultaneous review of both the regulatory submission (assessed by MFDS) and the nHTA application (assessed by NECA). On November 4, 2013, MoHW implemented a pilot ‘Parallel Review’ program (locally known as ‘nHTA One-Stop Service’). Ten medical technologies were selected for the pilot program which ran from November 2013 to July 2014. The feedback from the pilot program run by NECA was positive. Therefore, with the expectations of shortening market access lead-times to within a 3 to 12 month range, MoHW officially implemented the ‘Parallel Review’ program from July 30, 2014.
‘Combined regulatory and nHTA submission’
In response to a recommendation from the Regulatory Reform Committee (the body overseeing government-wide regulatory activities) that the nHTA process be streamlined and expedited, in February 2016, MoHW and MFDS piloted the use of a single application for both regulatory and nHTA assessment processes. The program was aimed at technologies that require clinical evidence for regulatory clearance purposes and clarification of their clinical indications; it is similar to the ‘Parallel Review’ program outlined above, except that MFDS receives the submission and, after successful review, issues a regulatory approval along with the nHTA approval. With this change, the regulatory and the nHTA reviews progress in parallel, and MoHW/NECA and MFDS collaborate much more closely (MFDS officials may attend the ‘Committee for nHTA’ to discuss issues related to regulatory approval, and MoHW or NECA officials (researchers) may attend MFDS meetings to discuss the design of clinical trials and other evidentiary requirements from an nHTA perspective). On February 22, 2016, MoHW implemented the pilot program of ‘Single application for combining regulatory and nHTA submissions’ and officially implemented this program on July 29, 2016.
2019 MoHW-HIRA International Symposium
On June 4, the Ministry of Health and Welfare (MoHW) and Health Insurance Review and Assessment Service (HIRA) co-hosted the 2019 MoHW-HIRA International Symposium. This symposium was held to share and discuss the subject of “improving accessibility to innovative health technologies – how to reform the regulatory system of the national health insurance (NHI) listing process,” by inviting global and local experts. The invited three global experts made their presentations and actively participated in the panel discussion. Dr. Sang-Soo Lee from Medtronic Korea participated in the panel discuss at the morning session as medical technology industry representative to share his insight and thought about the patient access of new medical technologies.
- Kathleen Buto, Independent Consultant, MedPAC Member of USA; Health Insurance Coverage of Innovative Technology in the U.S.
- Richard Stubbs, Chief Executive Officer, Yorkshire & Humber Academic Health Science Network (AHSN); Recent reform of Health Insurance Policy for Innovative Healthcare Technologies in the UK
- Shigekazu Komoto, MD, PhD, Counselor for Policy Planning Coordination, Health Insurance Bureau, Ministry of Health, Labour, and Welfare (MHLW), Japan; Health Insurance Policy for Innovative Healthcare Technologies in Japan
ISPOR Regional Chapter Activities Update
Health Technology Assessment Wet Clinic Session Held in the Philippines
In collaboration with the Philippine College of Physicians, the ISPOR Philippines Chapter, and the Pharmaceutical and Healthcare Association of the Philippines, a special HTA session was held on May 7, 2019. The session covered key issues including “Decision Making in Health under the Universal Healthcare Law: Role of HTA” and the way forward in HTA implementation from the perspectives of researchers, assessors, clinicians and patients. Key aspects were discussed on what makes good HTA as well as the new role the Philippine Department of Health is playing with the implementation of universal health coverage (UHC) such as priority setting for HTA and identifying the interventions or services to be purchased; accreditation as a process of choosing service providers, benefits package provider payment rate setting (including co-payment), and contracting arrangements. The session recommended key tools to promote quality and affordability for the UHC system. The speakers of the session included:
- Kenneth Hartigan-Go, MD, ISPOR Philippines Chapter President
- Seema Haider, MSc, PhD, Senior Director, Medical Analytics and Insights, Pfizer, USA
- Beverly Lorraine Ho, MD, MPH, Special Assistant to the Secretary for Universal Health Care, Office of the Secretary and Chief, Health Research Division, Health Policy Development and Planning Bureau, Department of Health, Philippines
- Emmanuel C. Perez, MD, MPH, FPCP, FPRA, Vice President, Philippine Rheumatology Association
- Michael L. Tee, MD, MHPEd, MBA, Board Member, Philippine Rheumatology Association
Miriam Roxas-Timonera, MD, FPCP, Internal Medicine Specialist, Head, Medical Research, Adventist Medical Center, Philippines
Antimicrobial Resistance Training in Mongolia
ISPOR Mongolia Chapter organized a one-day training entitled “Appropriate Use of Medicines, Control and Prevention of Antimicrobial Resistance” for health professionals, decision-makers and academic faculty in the health sector of Mongolia. The training was organized on 21st of June, 2019 and at the Conference hall, Shastin State Third Central Hospital of Mongolia, Ulaanbaatar city, Mongolia. More than 30 members participated including representatives from public and private organizations, the Ministry of Health, Mongolia, State Health Insurance, General Agency for Specialized Inspection, Mongolian National University and many more. Members of the training identified challenges in current health practice, specifically in relation to effectiveness and safety of locally produced antibiotics, and emphasized the need for further trainings and evidence in the field of cost-effectiveness of locally produced and imported medicines, cost-utilization of medicines, antibiotic consumption, antimicrobial resistance, health system research and international best practices around the world. Furthermore, ISPOR Mongolia Chapter informed about results of antimicrobial consumption surveys and distributed information among relevant health professionals. The training was supported by the Shastin State Third Central Hospital of Mongolia, Mongolian National University of Medical Sciences, Mongolian University of Pharmaceutical Sciences, Mongolian Association of Pharmacists and Mongolian Association of Hospital Pharmacists.
ISPOR Indonesia Forum
ISPOR Indonesia Chapter will be organizing a special forum on 24 August 2019 on the topic of Pharmacy Benefit Management Industry in the USA. The forum is presented by Dr. Norry Thomas of the University of Minnesota and Interim CEO of the Foundation for Managed Care Pharmacy.
ISPOR India-Amaravati Workshop
ISPOR India-Amaravati Chapter will be organizing the Second National Workshop on Meta Analysis and Systematic Review: A Pharmacoeconomic Perspective on the India Scenario on 19-20 July 2019. The theme of the workshop is “Methodological Challenges in Meta-Analysis and Systematic Literature Reviews” and it will take place at the Chalapathi Institute of Pharmaceutical Sciences. For more information, visit the chapter website.
Certificate in Evidence-Based Research
One of the basic skills in health economics and outcomes research is the ability to search and find relevant and robust evidence of similar studies in the scientific community. The ISPOR UAE Chapter is committed to support the development of research skills in the region and the United Arab Emirates and is therefore looking forward to participating in and promoting the upcoming Certificate in Evidence Based Research. The certificate course will be presented by TCD Research in collaboration with the University of Pretoria. It consists of three modules, namely i) Certificate in Evidence Based Medicine ii) Certificate in Biostatistics and Clinical Trials, and iii) Certificate in Systematic Review and Meta-Analysis. The courses are structured around three activities, namely a pre-course assessment via an electronic learning platform, two days face-to-face training, and a post-course assessment via the electronic learning platform. While the two-day training will cover theory, it also focusses on problem-based learning methodologies where participants are continuously exposed to real world problems to use the theory learned in a practical way. A certificate will be issued for each module and for those who successfully complete the three modules, the Certificate in Evidence Based Research will be awarded. This will be a CPD accredited course. The first module (Certificate in Evidence Based Medicine) is scheduled for 28 and 29 September 2019 in Dubai UAE. For more information please contact Dr. Ola Ghaleb AlAhdab, President ISPOR UAE Chapter (DR_Ola@mohap.gov.ae, +971 2 6520563) or firstname.lastname@example.org.
ISPOR Australia Chapter
On 8 April 2019 the ISPOR Australia Chapter (ISPOR-AC) held a special event with the support from the global ISPOR organisation entitled:” The ISPOR Women in Health Economics and Outcomes Research Initiative: Australia” at the University of Technology Sydney (UTS). The event was well-attended with people from academia and industry in the audience. The speakers were a mix of international and domestic presenters, including Professor Joanna Coast from Bristol University and ISPOR president-elect Professor Nancy Devlin. Furthermore, Professor Rosalie Viney from UTS shared her experience with being chair of the Australian PBAC Economic subcommittee for many years, and Associate Professor Kim Dalziel from the University of Melbourne spoke about participating in the Hawkness Fellowship programme. Finally, Philippa Delahoy from Pfizer Australia elaborated on her more than 20 years in industry. A panel session with all the speakers was conducted at the end of the day with Professor Jane Hall from UTS moderating a discussion on how we can ensure mentorship and sharing of experiences going forward.
ISPOR MEMBER NEWS
ISPOR Asia Consortium events in New Orleans
ISPOR Asia Consortium held a very successful open meeting for all interested in Asia Pacific at the ISPOR 2019 Conference in New Orleans. There were over 50 participants that braved the early morning hours before the plenary to learn about many interesting developments in health policy across the region presented by experts. The meeting also provided an opportunity for participants to learn about some important upcoming events for ISPOR in Asia Pacific, including the ISPOR Asia Pacific 2020 Conference. The Conference will be held on 12-15 September 2020 in Seoul, South Korea. Abstracts will open on 1 November 2020, and the Conference program theme and plenaries will be announced later in the summer, so stay tuned. For more information on the Conference and to get involved please contact email@example.com.
There was a special forum on “Drug Pricing and Value” which featured presentations on different drug pricing approaches from Mainland China, Taiwan, Japan and the United States (presenters pictured below – Dr. Makoto Kobayashi, Dr. Gordon Liu, Dr. Laura Pizzi and Dr. Churn-Shiouh Gau). The session was very well-received and had over 50 participants. Let us know which other global topics you would like ISPOR to present at their international meeting!
There was a meeting of the ISPOR Asia Consortium Industry Committee, and the committee members updated on their 2 manuscript projects on Real World Data and HTA in Asia Pacific, which they will be submitting to Value in Health Regional Issues, and they provided their suggestions on potential topics for the ISPOR Asia Pacific 2020 Conference program.
ISPOR also organized a Chapter Leadership Training, which featured a presentation on “What Makes a Good Leader and Why it Matters?” by a professional leadership speaker Laura Freebairn-Smith of Organizational Performance Group. The training had participation by ISPOR leaders from many different countries and work backgrounds and featured both didactic sessions on leadership skills as well as fun games and breakout activities. The participants learned a great deal not only about their table mates, but also about themselves, and they will undoubtedly bring back useful lessons to their own teams and groups. There will be more leadership training events in the future, so stay tuned.
To get involved and stay informed on future ISPOR Asia Consortium activities, be sure to stay connected via the e-mail list and check the Consortium website regularly.
ISPOR HTA Training in China – Update
We regret to inform our members that due to unforeseen circumstance, we are unable to offer our originally planned HTA training program in Beijing, China that was scheduled for 22-24 October, 2019. We sincerely thank those who expressed interest and support and apologize for the inconvenience. We do understand your disappointment and we were genuinely looking forward to conducting this important initiative. Please be assured that we will be exploring other ways to offer education in the region as well as partner with key institutions in China to bring the awareness and knowledge of best practices for HTA and HEOR to health care stakeholders. ISPOR will still be holding our HTA and Patient Roundtables in Beijing as planned, and ISPOR will also be participating in the National China HTA Conference on 26-27 October 2019. We will update on these events in our winter issue of News Across Asia.
For those interested in further HTA training, we want to make you aware of some other training opportunities that will be available this year:
- Short Course: ISPOR Latin America 2019 – Evaluation of Medical Devices: How to Manage HTAs | 4 Hour Short Course (Bogotá, Colombia – Thursday, 12 September 2019, 13:00 – 17:00)
- Short Course: ISPOR Europe 2019 – Introduction to Health Assessment Training | 4 Hour Short Course (Copenhagen, Denmark, Saturday, 2 November 2019, 13:00 – 17:00)
There will also be a short course on HTA that will be included in the ISPOR Asia Pacific 2020 Conference Program. More information on that program will be available later this year.
Is the lipid goal one-size-fits-all: real-world data from Hong Kong, China
Sherry Yun WANG, PhD, Monash University and Vivian Wing-Yan LEE, PharmD, The Chinese University of Hong Kong
The international guideline recommendations for low-density lipoprotein cholesterol (LDL-C) lowering were made based on the results of randomized controlled trials (RCTs), meta-analyses, and observational studies mostly in the white population. It was not clear whether these LDL-C targets could apply to other ethnic groups, for example, Asian patients(1).
The rapidly growing literature from Asian countries questioning “lower is better” hypothesis was noticed(1). Dr Lee’s team identified from more than 5000 post-percutaneous coronary intervention (PCI) patients hospitalized for acute coronary syndrome (ACS) at Prince of Wales Hospital in 2005-2015 and aimed to assess the effect of the LDL-C goal attainments of <2.6mmol/L, <1.8mmol/L, <2.0mmol/L, and ≥ 50% reduction on first major adverse cardiovascular events (MACEs) during 1-year follow-up respectively. From a pilot study on 1684 patients in 2009-2015, researchers merely observed a high correlation between the lipid goal attainment of <2.6mmol/L and the occurrence of MACEs through 1-year follow-up but lowering the lipid level from 1.8-2.6mmol/L to <1.8mmol/L did not bring any incremental clinical benefits(2). In the larger sample of 5294 post-PCI ACS patients in 2005-2015, 4638 patients who had at least one cholesterol measurement within 1-year follow-up were included in the analysis. Of this sample, 36.14%, 48.64%, and 79.50% attained the LDL-C goal of <2.6mmol/L, <2.0mmol/L and <1.8mmol/L at one year, respectively. Merely 15.95% of patients achieved the ≥ 50% reduction from baseline. They merely identify the clinical benefits associated with lipid goals of <2.6mmol/L. Lowering LDL-C to achieve more stringent lipid targets did not lead to fewer cardiovascular events, but it might create an excessive economic burden(3).
In line with existing studies, this observation from real-world data (RWD) in Hong Kong Chinese patients could add some information to the ongoing discussion of the LDL-C targets in multi-ethnic populations. The researchers suggest the future studies aiming for a positive effect of further LDL reductions try to recruit much higher numbers and follow the patients for a longer duration.
- Wang Y, Yan BP, Tomlinson B, et al. Is lipid goal one-size-fits-all: A review of evidence for recommended low-density lipoprotein treatment targets in Asian patients. European journal of preventive cardiology. 2019: 2047487319843077.
- Wang Y, Yan BP, Nichol MB, et al. Real-world study of low-density lipoprotein cholesterol levels and cardiovascular outcomes in Chinese: A retrospective cohort study in post-percutaneous coronary intervention acute coronary syndrome patients. International journal of cardiology. 2017; 249: 18-24.
- Wang Y, Yan BPY, Tomlinson B, et al. Clinical and Economic Analysis of Lipid Goal Attainments in Chinese Patients with Acute Coronary Syndrome Who Received Post-Percutaneous Coronary Intervention. Journal of atherosclerosis and thrombosis. 2018; 25: 1255-73.
Join ISPOR – to access our world class journals Value in Health, Value in Health Regional Issues and Value in Outcomes Spotlight, join global groups, participate in our special interest groups and task forces, get involved in leadership initiatives and stayed informed on HEOR news and trends, join the Society today!
Call for candidates for Editor-in-Chief of Value in Health Regional Issues
ISPOR has launched an international search for qualified candidates to serve as the Editor-in-Chief who will be responsible for the journal within its defined regional/geographic context. The new Editor-in-Chief will play a key role in determining the strategic direction and future growth of the journal in Asia, Latin America, and Central and Eastern Europe, Western Asia, and Africa. The Editor-in-Chief position is a 4-year appointment (renewable once). While there is no regional residence requirement for this position, very strong consideration will be given to candidates located outside of North America/Western European countries. A complete job description for the position can be found here. Applicants are encouraged to review and complete an application here. Deadline to apply is July 31, 2019.
- ISPOR Europe 2019: Copenhagen, 2-6 November 2019
- Monday, 5 August: Application Deadline
- Thursday, 5 September: Notification Deadline
Call for Abstracts Opening
- ISPOR Asia Pacific 2020 – 1 November 2019
Upcoming ISPOR Meetings
ISPOR Latin America 2019
12-14 September 2019, Bogotá, Colombia
Early Registration deadline: 30 July 2019