Member-Reported News: Vol. 7 No. 1 (April 2018)

Understanding the Evolving Health Care Landscape in Asia Pacific: Real World Data and HTA – ISPOR Asia Consortium Industry Committee Initiatives

Boxiong Tang, MD, PhD, Chair, ISPOR Asia Consortium Industry Committee, and Senior Director, Global Health Economics and Outcomes Research (GHEOR), Teva Pharmaceutical, Frazer, PA, USA

Given the dynamic and rapid development of HEOR within Asia Pacific, ISPOR Asia Consortium Industry Committee is undertaking numerous initiatives to understand how these changes will affect key health care stakeholders in the region. These initiatives include two research projects and two forums:

Research Projects

The Committee’s first research project, “Landscape Evaluation of Real World Data in Asia Pacific,” tackles the issue of Real World Data (RWD) to address the situation where decision makers involved with coverage and payment decision-making, clinical treatment guideline design, clinical pathway determination, evidence-based medical decision-making, and health care policy-making are increasingly seeking information from the “real-world” to identify real world clinical and economic outcomes to base their decisions on. Many of them are developing policies that integrate evidence from various RWD sources. These policies recognize the importance of real world evidence that goes beyond traditional information collected during clinical development phase in randomized controlled trials. The objectives of this project are to provide a data source platform to support RWD research in the region, to conduct a landscape evaluation of the available information on the availability of various RWD currently existing in Asia Pacific, and to understand the availability, accessibility, and perform a general quality assessment and contents evaluation of each type of RWD.

The second project, entitled “New Trends of Health Technology Assessment (HTA) Development and Value Evidence Requirement for Access and Reimbursement in Asia Pacific,” provides a mapping of current HTA processes in several Asia Pacific jurisdictions, including key requirements such as clinical effectiveness, cost effectiveness, budget impact analysis, relation to the reimbursement process, and evidence requirements. There will also be information gathered on the responsible agency or entity and decision process. Both projects explore the landscapes for China, Japan, South Korea, Taiwan, Australia, Singapore, Thailand, Malaysia and other jurisdictions. There are numerous team members working on these projects, and the planned deliverables will be a white paper and special forum presentation.

Forums

The Asia Consortium Industry Committee is also organizing two forums for ISPOR 2018 in Baltimore and ISPOR Asia Pacific 2018 in Tokyo. The forum in Baltimore is entitled “Advancing patient access to innovative health technologies in Asia Pacific – the role of real world data (RWD) in the value framework,” and it will present new developments and reimbursement negotiation cases from selected countries in Asia Pacific with emphasis on evidence requirements to support decision-making. The forum in Tokyo will present the results of the two research projects.

Moreover, last year the committee successfully organized 2 forums at the ISPOR 2017 International and EU annual meetings in Boston, US and Glasgow, Scotland entitled “New Trends of Health Technology Assessment Development and Value Evidence Requirement for Access and Reimbursement in Asia (China, Japan, South Korea, and Taiwan)” and “Innovation and Market Access In Asia-Pacific: What Evidence and Processes are Appropriate For Reimbursement? China, Japan, South Korea, Taiwan and Australia Compared.” Both forums attracted nearly 300 participants and were among the top attended forums at the conferences.

The above projects and forums demonstrate not only the great change and opportunity that exists in Asia Pacific for health care stakeholders and particularly industry members, but also the great amount of work that still needs to be done. If you are a member of pharmaceutical industry or CRO and are interested in health care in Asia Pacific, we warmly welcome you to join the ISPOR Asia Consortium Industry Committee and help us continue in this work.


Changes in Medical Device Value Framework in South Korea

 Sang-Soo Lee, PhD, MBA, Corporate Affairs Director, Medtronic Korea, Ltd., Chair of Medtronic Asia-Pacific Reimbursement Leadership Council (APRLC), Adjunct professor, Graduate School of Medical Device Management and Research, SAIHST (Samsung Advanced Institute for Health Science & Technology), Sung Kyun Kwan University, Adjunct professor, Seoul School of Integrated Sciences & Technologies (aSSIST)

The Ministry of Health and Welfare (MoHW) held the 4th Health Insurance Policy Deliberation Committee (HIPDC) on March 20, 2018 and announced a plan to improve the medical device reimbursement system. Major announcements are as follows:

  1. Establishment of management standards for rare and essential medical devices

The MoHW establishes special management measures for the stable supply of rare and essential medical devices fundamental for medical treatments. In the meantime, systematic management is inadequate for the stable supply of rare and essential medical devices, which may cause disruption to medical care if the supply is not maintained properly. Drugs are managed separately through the ‘Korea Orphan & Essential Drug Center’ (www.kodc.or.kr), but there are no specific management standards for medical devices. For some medical devices with small market size and low profitability, there were cases where supply problems occurred caused by market exit or production suspension. In the future, such medical devices will be designated as ‘rare and essential medical devices’ and ‘reimbursement pricing criteria for rare and essential medical devices’ will be stipulated to ensure stable supply. Examples of ‘rare and essential medical devices’ include:

  • Medical devices intended for children (including newborns)
  • Medical devices intended for primarily rare disease treatments
  • Medical devices intended for essentially life-threatening serious diseases
  • Medical devices approved by Ministry of Food and Drug Safety (formerly known as Korea Food and Drug Administration, KFDA) as rare medical devices
  • Other medical devices that are anticipated to cause supply problems
  1. Improvement of Value Appraisal Standard (VAS) System

The MoHW takes measures to promote the improvement of the Value Appraisal Standard (VAS) System to recognize appropriate value of technology innovation in medical devices and also appropriate reimbursement prices. In the meantime, the bar for technology improvement appraisals has been set high, and suggestions have been raised by stakeholders to recognize the appropriate value for innovative technologies and expand the value appraisal for improved or incremental technologies. Although it is not an innovative technology, the value appraisal mechanism for the medical devices with considerable improvement has been seen as insufficient, resulting in discouragement of the development of needed technology. In the last three years (2015 – 2017), 40% (8 out of 20) of Track A and 20% (2 out of 10) of Track B were granted for premium reimbursement prices through the VAS System and in particular obtaining premium prices through Track B proved to be difficult. Accordingly, MoHW will establish an appropriate reimbursement pricing system by expanding the standard for recognition of technical innovation and adding a new value appraisal element to recognize the technology development effort.

The MoHW will now increase the weights of both the patient safety element (e. g., side effect improvement) and the technology innovation element (e. g., performance improvement, procedural ease, certification of technology innovation assessment, etc.). In order to clarify the operation of the VAS System, the current VAS System will be divided into ‘Innovation Track’ and ‘Technology Improvement Track’, and the track category will be clarified. In addition, an extra premium price provision element namely ‘technology development effort’ will be newly created at VAS System. Although the value for promising technology is not yet proven, 5% premium reimbursement price will be granted for 3 years under the condition of continuous evidence generation. This extra premium price provision will be applied when one or more of necessary requirements are met. The Medical Device Expert Evaluation Committee (MDEEC) at Health Insurance Review and Assessment Service (HIRA) will assess the eligibility of extra premium price provisions for application medical devices.

Figure 1. Revision of Value Appraisal Standard (VAS) System

  1. Introduction of Re-deliberation (Appeal) Process

Re-deliberation process will be introduced to expedite the reimbursement coverage listing of medical devices and to ease the burden on patients’ out-of-pocket payments. The Independent Review Process (IRP) has been operated, which allows an applicant to request reassessment of the MDEEC assessment results if there is a disagreement in the MDEEC assessment results. However, there is a disadvantage that the applicant cannot submit additional documents, and the review period is prolonged, making it difficult to list quickly and increasing the burden on the patients’ out-of-pocket payments. When an applicant makes an application for medical device reimbursement coverage, patients remain in a state of out-of-pocket payments (non-coverage) until the MoHW makes reimbursement coverage announcement after the final decision-making. In future, MoHW plans to allow an applicant to make reasonable choices by selecting the IRP (100 days) or re-deliberation (appeal) (60 days) process. In the case of re-deliberation, applicants must submit additional documents to prove the value of application medical devices.

Figure 2. Re-deliberation (appeal) process diagram

Acronyms:

HIPDC: Health Insurance Policy Deliberation Committee ; HIRA: Health Insurance Review and Assessment Service ; IRP: Independent Review Process ; MDEEC: Medical Device Expert Evaluation Committee ; MoHW: Ministry of Health and Welfare

* Grey color indicates newly created process

  1. Establishment of Medical Device Reimbursement Price Adjustment Depending upon Foreign Exchange Rate Fluctuation

Medical device supplies are impacted by foreign exchange rate fluctuations due to raw material imports in production or finished medical device imports and the reimbursement prices have been adjusted depending upon foreign exchange rate fluctuations. Currently, medical device reimbursement prices are adjusted according to the foreign exchange rate fluctuation of the Korean won against the US dollar. There have been demands from the industry to reflect the true foreign exchange rate fluctuation for stable supplies of medical devices. Accordingly, the MoHW has decided to establish more accommodating foreign exchange rate adjustment criteria. 

Table 1. The Adjustment rate table for medical device reimbursement prices depending upon the foreign exchange rate grades




Towards Universal Health Coverage in India

Mohammad Adil, PhD, Research Scholar, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India

India spends no more than 1.4% of gross domestic product (GDP) on healthcare and over 63 million people in India fall under the poverty line every year in part due to lower healthcare expenditures. According to World Bank data, compared to the 1.4% of GDP that India spends on healthcare, China spends 3.1%, Thailand 3.2%, Sri Lanka 2% and Brazil 3.8%. The Public Health Foundation of India (PHFI) in liaison with other government organizations like the Indian Council of Medical Research released a ‘State-Wise Disease Burden Report’ in November 2017.The report showed that the national burden of non-communicable diseases which accounted for 37.9% of all deaths in 1990, increased up to 61.8%, and caused 6 in 10 deaths in India in 2016 [1]. Despite of having increasingly advanced medical technology, and top quality doctors with promoting medical tourism in India, 70% of Indians in rural areas have very limited access to quality healthcare facilities. This limited access to care for rural areas might be due to the lower share (30.5%) of government expenditure on healthcare as compared to 77% in Thailand, and 55% in China. In India, out of pocket expenditure (61% of total expenditure) might also have substantial impact on healthcare which pushes families into indebtedness and deeper poverty; moreover out-of-pocket expenditure is much lower at 34% in China and 11% in the US as compared to India [2].

Recently, the Union Cabinet of India has given a nod toward ‘Ayushman Bharat-National Health Protection Scheme’ also known as ‘Modicare’ and the Government of India ensured that ‘100 million poor and vulnerable families will get insurance coverage of as much as ₹ (Indian Rupees) 5 lakh (~$ 7,685) under Modicare’. ‘Modicare’ health insurance is in line with the ‘Obamacare’ or Affordable Care Act, which was passed in 2010 in the USA to ensure that Americans (specially middle and low income families) have access to affordable health insurance. ‘Modicare’ health insurance will be a portable scheme which can be availed of anywhere in India [3].National Health Policy had prioritized primary healthcare as the principal component of healthcare system development and proposed that 70% of the health expenditure be directed there and also stated that strategic purchasing pathways would be used to procure and pay for secondary and tertiary care services from public and private healthcare providers [4].

The Government also proposed to set up more than 150,000 health and wellness centers along with an allocation of ₹ 1,200 crore ($183,725,040). In addition, with the growing burden of tuberculosis and most patients’ inability to pay for their food requirements, the Government also allocated ₹ 600 crore ($91,862,520) to provide nutritional support for each tuberculosis patient. However, under the provision, ₹ 500 (~$ 7.68) a month will be paid through the treatment period to each patient [5]. By adding these, the Indian Government embarks toward Universal Health Coverage and also sets a target of increasing the public expenditure on healthcare as a percentage of GDP to 2.5 % by 2025 from the current level of 1.15 % [6]. To achieve such targets, public-private partnership models need to come together to ensure that the funding stays available and the work is carried out efficiently.

State governments are also trying to work in accordance with the concept of Universal Health Coverage to ensure that their citizens have better healthcare facilities. For instance, a few years ago, the Delhi state government opened more than 100 Mohalla clinics where people are getting free of cost healthcare benefits (this has been lauded by the United Nations). In a letter to Chief Minister of Delhi, Former United Nations Secretary-General Kofi Annan said that the initiative was “consistent with the Universal Health Coverage goal” of the World Health Organization [7].

References

[1] https://www.firstpost.com/india/inadequate-funding-focus-on-short-term-goals-impede-implementation-of-universal-healthcare-system-in-india-says-phfi-chief-4302007.html

[2] http://www.financialexpress.com/opinion/universal-health-coverage-heres-how-india-can-achieve-the-goal/675610/

[3]https://timesofindia.indiatimes.com/india/budget-2018-boost-for-healthcare-lessons-for-modicare-from-obamacare/articleshow/62753639.cms

[4] https://www.livemint.com/Opinion/wM3oQXQo6Cof3loUkHDw3K/Budget-2018-India-is-inching-towards-universal-health-cover.html

[5] https://www.livemint.com/Politics/c6xPyovp61xh5LczNOchkN/Budget-2018-Jaitley-announces-health-insurance-cover-of-Rs5.html

[6] https://www.firstpost.com/india/inadequate-funding-focus-on-short-term-goals-impede-implementation-of-universal-healthcare-system-in-india-says-phfi-chief-4302007.html

[7] http://www.thehindu.com/news/cities/Delhi/Kofi-Annan-praises-mohalla-clinics/article17105541.ece