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Client Confidential – Do not share
Healthcare insurance & reimbursement
landscape in ASEAN markets
Tokyo, 18th March 2015
Deallus Contact:
Carole Brückler, PhD
Partner, Head of Japan and Asia-Pacific
CaroleB@deallusconsulting.com
+65 6823 6836
Deallus Contact:
Ichiro Masuda
Principal, Head of Japan Operations
Ichiro.Masuda@deallusconsulting.com
+81 70 1542 9876
2Client Confidential – Do not share
Concept Overview
Country Discussion
ASEAN Regional trends
Conclusions and Business Opportunities
Why does Asia / ASEAN matter?
Deallus Introduction
3Client Confidential – Do not share
Concept Overview
Country Discussion
ASEAN Regional trends
Conclusions and Business Opportunities
Why does Asia / ASEAN matter?
Deallus Introduction
4Client Confidential – Do not share
Why does Asia / ASEAN matter?
5Client Confidential – Do not share
Source: Growing Healthcare
Spending In Southeast Asia
Brings Opportunity, 2014,
BDG Asia
41.6%
37.3% 37.6%
32.7%
28.9%
22.4%
11.9%
-2.1%-10.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
%Growth of Per Capita Healthcare Spending (2009-2012)
❶ 1. East Asia and Pacific
2. South East Asia
3. South Asia
4. LaTam
5. MENA
6. Sub-Saharan Africa
7. North America
8. EU
❷❸
❹
❺
❻
❼ ❽
❶ ❷ ❸ ❹ ❺ ❻ ❼
❽
Why Asian Markets Are Attractive
❶ Rising Healthcare Expenditure Expands the Healthcare Market
Healthcare spending grew substantially acrossAsia
(Top-left illustration).
Asia as a region is the fastest growing part of the
global economy. In 2001, the region accounted for
26.8% of global GDP (measured using purchasing
power parity). By 2013, that share had risen to
36.6%.
The rapid income growth means that healthcare
spending in the region is also growing faster than
anywhere else.
Whilst a steady growth of pharmaceutical market is
expected in the developed market (1-4% CAGR2012-2017),
the significant rise of healthcare spending in the key
Asian countries will lead the huge drive of pharma
market growth in the next 5-10 years (Bottom-left
illustration).
The sharpest ever rise in the healthcare spending for
the past 4 years (2009-2012) was observed in a few
Asian countries including Indonesia (67.8% CAGR),
Philippines (52.1%), Myanmar (50.5%), Malaysia
(43.6%) and Vietnam (42.7%).
The trend in the region is anticipated to continue
throughout to 2018 thanks to the region’s rapidly
growing economics, expansion of the affordable
social class.
Japan
Australia
Taiwan
South Korea
China
Malaysia
Thailand
Philippines
IndonesiaVietnam
Cambodia
Laos
Myanmar
Sri Lanka
Bangladesh
Pakistan India
Mongolia
Nepal
10
100
1,000
10,000
0.01 0.1 1 10 100 1000
2012HealthExpenditureperCapita(US$)
(Public+Private)
Pharmaceutical Market Size in 2012 (US$ Billion)
Source: The World Bank Data
Espicom The Pharmaceutical Market Reports
Frost & Sulivan, Top Five Growth Sectors in the
Asia-Pacific Healthcare Market, Global Pharma
Market Outlook – with focus on emerging
markets, IMS Health
Developed markets
Emerging markets
Nascent markets
12.8%
Asia Spending
CAGR (2012-
2018)
Asia Market
Size CAGR
(2012-2018) 7%
6Client Confidential – Do not share
Why Asian Markets Are Attractive
❷ Rapid Demographic Change Drives Healthcare Industry Growth
Asia rapidly turns to Aging Society
One of the most attractive opportunities in Asia centres on the region’s changing
age profile, of which the elderly population aged 65 and over will reach 11.6%
by 2030
Source: Asia Rising,
Healthcare, 2014, The
Economist
0%
2%
4%
6%
8%
10%
12%
0
100
200
300
400
500
600
1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030
Number of people aged 65 and over in Asia Pacific in
millions and % of the total population
■ Population of
over 65 (mln)
■ %Population
of over 65
Source: Middle Class Growth
in Emerging Markets, Earnst
& Young
Rapid growth of middle class in Asia
Two-thirds of the global middle class is expected to live in the Asia-pacific
region, up from just under one-third in 2009
Estimated total income
by band 2010 and 2020
in China (Annual
income, thousands of
people)
Aging Asia presents huge opportunities for industries that provide products and services to the
elderly
Asia stands out as being the most exciting part of the world for healthcare businesses. As growing
richer, having broader exposure to improvements in medicine, Asian countries are expected to
experience tremendous ‘ageing’ (Bottom-left illustration)
Change of wealth distribution will drive the expansion of pharmaceutical market size in the next 10
years.
A significant proportion of the new Asian middle class are also expected to be at the upper end of
the income bracket, with impressive spending power (Bottom-right illustration)
7Client Confidential – Do not share
Why Asian Markets Are Attractive
❸ Booming Foreign Investment Creates More Opportunities
Source: Asia Rising,
Healthcare, 2014, The
Economist
2.2% 1.6%
18.1% 23.8%
28.5%
29.2%
51.2% 45.4%
0%
20%
40%
60%
80%
100%
2007 2012
Share
Share of Global Expenditures on Biomedical Research in
2007 and 2012
US
Europe
Asia & Oceania
RoW
Heavy investment in R&D in the region has enabled
earlier ever access of pharmaceutical products in Asia
As perception changing on the importance of R&D
investment in the region, the value of medical
research in Asia is growing swiftly, with the Asia’s
share of global R&D expenditure rose from 18.1% to
23.8% (Bottom-Right illustration)
Market Attractiveness Rating
Addressable Market
Ease of Import
Distribution Reach
Overall
Very high High Medium Low
Market Attractiveness Rating
Vietnam
Stance of Foreign Investment
• Foreign healthcare investors
enjoy a corporate income tax rate
of 10%, tax exemption over the
first four years of a project and a
50% subsequent tax break in the
following years.
Increasing affluence and demand for better are forcing
previously protectionist Asian governments to be more
open to give leeway to foreign companies (Top-Left
illustration)
Increasing business transparency and policy
continuity has lifted the chronic risks existing in some
region, boosting market rewards in the recent years
Market Attractiveness Rating
Addressable Market
Ease of Import
Distribution Reach
Overall
Indonesia
Stance on Foreign Investment
• The Negative Investment List
currently stipulates that foreign
investors may own up to 67%
(65% previously) in healthcare
related business
Source: Healthintel Asia, 2013
EOS Intelligence insights, PharmaExec.com 2013
State of the Healthcare in South East Asia, Edelman Whitepaper
Illustrative
8Client Confidential – Do not share
Concept Overview
Country Discussion
ASEAN Regional trends
Conclusions and Business Opportunities
Why does Asia / ASEAN matter?
Deallus Introduction
9Client Confidential – Do not share
ASEAN Regional Trends
Social
• Demographic changes – wealth and age distributions
• Epidemiological transitions (M&M is no longer driven by infectious diseases
but rather NCD (diabetes, COPD, cancer etc.)
• Patient preference of branded products and private health sector, where
affordable
• High income patients cross country borders to seek high standard health
care and technologies.
Technological
Economic
Political
10Client Confidential – Do not share
ASEAN Regional Trends
Social
Technological
• Limited pharma technology, therefore the region relies on import for
innovative drugs
• Limited requirements for technology transfer into the region
• Skilled physicians in Thailand, Malaysia, Singapore which leads to medical
tourism.
• ASEAN HTA agencies have limited technical capacity but actively
developing.
Economic
Political
11Client Confidential – Do not share
ASEAN Regional Trends
Social
Technological
Economic
• Growth of middle population segment with disposable income
• Increasing cost pressures on health care budgets as cost of delivery and
drugs risk outstripping budgets
• ASEAN Economic Community
Political
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ASEAN Regional Trends
Social
Technological
Economic
Political
• Strong political commitment for Universal Health Coverage
• Struggles with the realities of implementation UHC systems
• Willingness to make more evidence-based decision making
13Client Confidential – Do not share
Concept Overview
Country Discussion
ASEAN Regional trends
Conclusions and Business Opportunities
Why does Asia / ASEAN matter?
Deallus Introduction
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Three components of insurance coverage should be considered
What does health insurance constitute of?
Height: How much is service
(pharmacy) benefit covered?
Depth: which health services
(drugs) are covered?
Breadth: population
coverage (what % of
population is
covered?)
“100% population coverage” does not always mean that
a certain drug is covered for 100% of population with
fixed reimbursement rate.
OOPs (co-payments)
Non-insured people
Non-reimbursed
drugs
15Client Confidential – Do not share
How does this compare with Japan?
Component Japan ASEAN
Breadth:
Population
coverage
It is compulsory that
Japanese citizens
subscribe a certain type
of social health
insurance.
Population coverage
ranges from 60% to
100%
Depth:
Service (drug)
coverage
Almost all drugs
approved are listed NHI
reimbursed drug price
list
Level and standard of
drug coverage differs
from market to market.
Originators drugs are
often not reimbursed
Height:
Financial
protection
(co-payment)
Typically 20-30% of co-
payment
Listed drugs are highly
subsidized although
may be subject to
government or hospital
budget
It is essential to think out of “Japan box”.
Contrasting ASEAN with the Japanese healthcare model
16Client Confidential – Do not share
It is important to understand “what HTA exactly means”
HTA is broad term and its impact changes according to its context
Procedure
Health
Program
Drug
Device
Efficacy
Cost
effective-
ness
Budget
impact
Health Policy Decision Making
Definition of Health Technology Assessment:
Health technology assessment (HTA) refers to the systematic evaluation of properties, effects,
and/or impacts of health technology. It is a multidisciplinary process to evaluate the social,
economic, organizational and ethical issues of a health intervention or health technology. The main
purpose of conducting an assessment is to inform a policy decision making. (WHO)
EthicsHTA concept
(not exhaustive)
HTA from drug reimbursement perspective
When discussing HTA, it is important to understand
from what perspective HTA is mentioned
Example:
In 1993, HTA program, Technology
Assessment and Social Security in Thailand
(TASSIT) was introduced.
The 2007 revision of NLED required input
from the Health Intervention and Technology
Assessment Program (HITAP) in Thailand.
Broader HTA: Not
impactful on drug
reimbursement per se
High impact on drug
reimbursement
17Client Confidential – Do not share
Concept Overview
Country Discussion
ASEAN Regional trends
Conclusions and Business Opportunities
Why does Asia / ASEAN matter?
Deallus Introduction
18Client Confidential – Do not share
ASEAN Region
A 650 million people economy potential
Member countries
Indonesia Philippines Thailand Vietnam Myanmar
Malaysia Singapore Brunei
Darussalam
Lao PDR Cambodia
19Client Confidential – Do not share
Indonesia
Indonesia Japan
Population in 2013 (mn people) 248.0 127.4
Urban population rate in 2013 (%) 52 92
GDP in 2013 (bn USD) 870.3 4,898.5
GDP in 2019 (bn USD) 1,230.9 5,433.4
GDP per capita in 2013 (th USD) 3,510 38,468
GDP per capita in 2019 (th USD) 4,560 43,504
THE/GDP in 2012 (%) 3.0 10.1
Pharmaceutical market CAGR
(2014-2020, %)
10.2 2.0
*GDP: Growth Domestic Product, THE: Total Health Expenditure
20Client Confidential – Do not share
Undergoing a formidable change in health insurance
2014-2019: transition to the universal health coverage
Drug Coverage HTA Situation
Public Health Insurance SituationKey indicators Indonesia Japan
Population coverage by public
financial protection schemes
60% 100%
Government expenditure of total
healthcare expenditure in 2012
(GGHE/THE)
39.6% 82.1%
OOP rate of total health
expenditure in 2012
45.3% 14%
OOP rate as % of private
expenditure on health in 2011
76.3% -
HTAs have been implemented since 2014
Since 2014, HTAs has been formally implemented and evaluate
new technology similar manner to UK-NICE. Although HTA body
evaluate cost-effectiveness from various data sources, it requires
pharma companies to submit relevant data.
At this moment, procedures and interaction with pharma
companies are discussion basis. Formal guideline is not yet
available as capacity of Indonesian HTA body is limited.
However, it is estimated some form of guideline may be issued
around 2016. As Indonesia integrated several schemes into
single payer body, impact of HTA in public health sector is high
particularly for pharmaceutical industry.
Indonesian public health system employs Diagnosis Related
Group (DRG) system which is similar to DPC system in Japan.
The government use e-catalogue system to manage medicines
in the public sector. Listing of e-catalogue and purchase price
are determined centrally and physical procurement is managed
by individual hospitals. In this system originator’s company can
join and on-patented drugs comprise about 10% in volume and
30% in expenditure. It appears that originators play in out-of-
pocket private sector in general, some of certainly participate in
public sector to enjoy public funding.
On-patented drugs have potential in public market
image
The Indonesia public health
insurance system was established
in 1968. And as of 2010,
approximately 46% of the
population was covered under the
five different schemes. In January
2014, the government committed to
provide healthcare insurance to all
citizens by 2019, merging all
existing schemes.
UHC by 2019
2010
2019
1968
46%
100%
2014
21Client Confidential – Do not share
What will the spending priorities be by 2019?
One national health insurance, single payer model will impact coverage decision.
Askes
Taspen
Jamsostek
Jamkesmas
Jamkesda
Active civil servants and dependants,
civil service and military retirees
Military workers, police and their
uncovered dependents
Private formal sector employees
(and dependents) of firms with 10 or
more employees
Poor and near-poor population,
based on individual and household
targeting
Poor and near-poor, homeless,
orphans, and non-civil service
teachers
2014 2019
Public health insurance before 2014
National Health Insurance Program
(JKN: Jamian Kesehatan Nasional)
Managed by
BPJS: the Badan Penyelenggara
Jaminan Sosial
• Single payer model
• Diagnosis-Related Group
system
• HTA involvement for
technology selection
In 2014, Indonesia reformed healthcare insurance system. 5 different schemes were integrated into
one National Health Insurance Program, also known as BPJS, the Badan Penyelenggara Jaminan
Sosial Keseehatan. This will change the complicated public health care in Indonesia and expand
population and benefit coverage. According to health policy experts in Indonesia, this ambitious goal is
“achievable”. However many operational challenges are expected.
. . . 2010
46% 60% 100%
year
population coverage
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Thailand
Thailand Japan
Population in 2013 (mn people) 68.2 127.4
Urban population rate in 2013 (%) 48 92
GDP in 2013 (bn USD) 387.3 4,898.5
GDP in 2019 (bn USD) 493.3 5,433.4
GDP per capita in 2013 (th USD) 5,676 38,468
GDP per capita in 2019 (th USD) 7,047 43,504
THE/GDP in 2012 (%) 3.9 10.1
Pharmaceutical market CAGR
(2014-2020, %)
7.0 2.0
*GDP: Growth Domestic Product, THE: Total Health Expenditure
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Thailand is a stand-out performer in delivering care at low
OOP rates
UHC was first achieved in 2001
Drug Coverage HTA Situation
Public Health Insurance SituationThailand Japan
Population coverage by public
financial protection schemes
98% 100%
Government expenditure of total
healthcare expenditure in 2012
(GGHE/THE)
76.4% 82.1%
OOP rate of total health
expenditure in 2012
13.1% 13.1%
OOP rate as % of private
expenditure on health in 2011
55.8% -
Drug benefit for all public insurance schemes is referenced to the
medicines quoted in the National List of Essential Medicines
(NLEM). A prescription of the nonessential drug if deemed
necessary. Depending on type of insurance, reimburse model
differs. While members of CSMBS enjoy fee-for-service payment,
SHI and UC enrolees receive treatment under capitation and DRG
system. The NLED is periodically updated by a subcommittee of
the National Drug Committee. Non-NLEM drugs need to be paid
out-of-pocket regardless of type of insurance enrolled.
Standard Drug List for public sector reimbursement
Although Thailand has dual system
of public and private health sector,
public sector plays a dominant role.
Since achievement of universal
health coverage, Thailand has
maintained its system though
various approaches such as strong
primary care gatekeeping and tough
negotiations with pharmaceutical
companies. OOP rate of 13.1%
stand out of ASEAN peers.
UHC already achieved in 2001
The Thai Health Intervention and Technology Assessment Program
(HITAP) is a well established HTA agency, founded in 2006. While
HITAP has no legal authority to make healthcare resource
allocation decisions itself, in its role as an advisor to the Ministry of
Public Health and other national Thai authorities, HITAP has
developed a track record in informing national policy. For example,
the 2007 revision of NLEM required cost-effectiveness evidence
produced by HITAP, which significantly impact reimbursement
decision making. HITAP is a leading HTA body in ASEAN region. It
pioneered to establish the first Asian HTA network, HTAsiaLink in
2011.
HITAP: leading HTA body in ASEAN region
CSMBS: 1980-
Government employee
10% of population
SHI: 1990-
Private sector employee
13% of population
UC: 2001-
Remaining population
74% of population
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Thailand has well established UHC system
The government employ capitation system to control health expenditure.
CSMBS recently employed DRGs for inpatient payment.
CSMBS SSS UCS
Official name
Civil Servants Medical Benefits
Scheme
Social Security Scheme Universal Coverage Scheme
Established since
Administrator
Population
coverage
Financing
sources
Financing model
Co-payment
(in principle)
1980 1990 2002
Controller General Department,
Ministry of Finance
Social Security Office (SSO),
Ministry of Labour
National Health Security Office
(NHSO)
All civil servants, permanent
public employees, retirees, and
their dependents (7.9%)
All private employees and
temporary public employees
(15.3%)
Anyone who is not covered by
the SSS and CSMBS (75.8%)
General tax revenue
Equal contributions from
employers, employees, and the
government
General tax revenue
OP: Fee-for-Service
IP: DRGs*
Capitation
OP: capitation
IP: DRGs
No (full pay without proper
referral)
No (full pay outside contractor) No (full pay in private sector)
Note: OP: out-patient, IP: in-patient, DRG: Diagnosis-related group
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Since the NLED 2007 revision, cost-effectiveness evidence
has been required
NLED publication
The National Drugs System
Development Committee
The Subcommittee for
Development of the NLED
The Working group for
coordination &
consolidation of NLED
16 Specific Working Group
for NLED selection
NLED secretariats
The Health Economic
Working Group
Endorsement of NLED
Setting concept, philosophy and criteria
Making final decision from the proposal
of all the Working groups.
Gathering information and
making recommendations
Reviewing and generating
pharmacoeconomic evidence
for selected medicines
Reviewing evidences, requesting more
information and making
recommendations
Screening drug applications submitted
by pharmaceutical companies
Gathering and generating evidence
NLED development process
Commission HITAP to conduct
pharmacoeconomic assessment
The Health Economic Working Group commissions
Health Intervention Technology Assessment Program
(HITAP), an independent research institute under the
Ministry of Public Health, to conduct pharmacoeconomic
assessment. Results of these studies are subsequently
considered by the Subcommittee for inclusion/exclusion of
these drugs from the NLED. HITAP has also developed
guidelines on pharmacoeconomic studies.
HTA process
Research projects:
Cost-utility analysis of recombinant human erythropoietin
in anemic cancer patients induced by chemotherapy
Findings:
Erythropoietin was cost-ineffective for treatment of
anemia induced by chemotherapy among cancer patients
Issues taken by:
The Subcommittee for development of the NLEM
Current policy:
Erythropoietin was not recommended for treatment of
anemia among cancer patients in Thailand
HTA study by HITAP and Current Policy
Any technology with a cost per quality-adjusted life-year
gained below the average GDP per capita is considered
acceptable for inclusion on the NLED.
Cost-effectiveness benchmark
Applicable to all three national
health insurance schemes
26Client Confidential – Do not share
20142012200920062003
Thailand is leading HTA movement in ASEAN region
HTA has evolved over this ten years and actively expanded international network
Health
Technology
Assessment
Unit
Universal
coverage
policy
NLEM
2004 revision
HITAP
established
The National
HTA guidelines
and database
collaboration
agreement
InsuranceschemeDomesticHTAsInternationalHTAs
2002 2004 2005 2007 2008 2010
NLEM
2013 revision
2011 2013 2015
ISPOR Thai
Chapter
established
NLEM
2008 revision
HTAsiaLink
established
Organized
capacity
development
meeting
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Singapore
Singapore Japan
Population in 2013 (mn people) 5.4 127.4
Urban population rate in 2013 (%) 100 92
GDP in 2013 (bn USD) 297.9 4,898.5
GDP in 2019 (bn USD) 369.1 5,433.4
GDP per capita in 2013 (th USD) 55,182 38,468
GDP per capita in 2019 (th USD) 65,701 43,504
THE/GDP in 2012 (%) 4.7 10.1
Pharmaceutical market CAGR
(2014-2020, %)
2.0 2.0
*GDP: Growth Domestic Product, THE: Total Health Expenditure
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Singapore enables drug access through private saving funds
Ongoing iterations to the insurance schemes expands options
Drug Coverage HTA Situation
Public Health Insurance SituationSingapore Japan
Population coverage by public
financial protection schemes
93% 100%
Government expenditure of total
healthcare expenditure in 2012
(GGHE/THE)
37.6% 82.1%
OOP rate of total health
expenditure in 2012
58.6% 13.1%
OOP rate as % of private
expenditure on health in 2011
94.1% -
Singapore has established Standard Drug List (SDL) since 1979.
There are two groups in the SDL. SDL group 1 drugs are essential
first-line drugs for which patients pay SG$1.40 per item per week.
SDL group 2 drugs are relatively more expensive essential drugs
for which patients pay 50% of the selling price. Although there is no
subsidy for nonstandard drugs, subsidized patients can pay for
nonstandard drugs from their Medisave and/or Medishield (in-
patients).
An annual call for applications for standard drugs inclusion is made
by the Ministry of Heath (MOH) to the public institutions. And Drug
Advisory Committee (DAC) in the MOH evaluates application.
Standard Drug List for public sector reimbursement
The government has taken balance of public and private spending
on health. Medisave is a compulsory national medical savings
scheme for individual hospitalization expenses. To complement
Medisave, Medishield was introduced to cover expensive medical
cost which cannot be covered by Medisave balance. Medisave and
Medishield are considered to be private spending which is the main
reason for high OOP rate. The government established what is
called three M schemes, by establishing Medifund which act as a
safety net for the poor. The government is currently working to
replace Medishield with Medishield Life which will be mandatory to
further strengthen health financing system in Singapore.
100% coverage by Medishield Life by end of 2015
HTA is employed in variety of health related decision making
process. It features in decision making for the SDL, licensing of
medical clinics, the Health Service Development Programme,
healthcare subsidies, and policy development. In the SDL selection
process, DAC work with the Pharmaco-economics and Drug
Utilization Unit of Health Science Authority (PMDA equivalent in
Singapore). The technology assessment of a drug is based on its
regulatory and formulary profile, incremental efficacy and safety,
relative cost-effectiveness, the financial impact of including the
drug in the SDL among with other epidemiological and clinical data.
HTA to support SDL decision making
29Client Confidential – Do not share
Singapore enables drug access through private saving funds
Ongoing iterations to the insurance schemes expands options
Healthcare Financing system in Singapore
Cash Medisave Medishield* Medi Fund Subsidy
Private financing
Others
Compulsory
national medical
savings scheme
Low-cost
catastrophic illness
insurance scheme
Social safety net for
the poor
3M schemes
Standard Drug List (SDL)
Class I: Essential 1st line drugs
Class II: relatively more
expensive essential drugs
Class Co-payment
1.40 SGD per item per
week
50% of selling price
Public financing
Medication Assistance Fund (MAF)
Assist patients with costly drugs that are not in
the SDL but have been assessed to be clinical
necessary, providing up to 75% subsidy
Drug Advisory Committee evaluates drugs with
technical assistance of the Pharmaco-
economics and Drug Utilization Unit of HSA
*Medishield will be updated to
Medishield Life by end of 2015 to
cover non-eligible population such as
people with pre-existing conditions
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Malaysia
Malaysia Japan
Population in 2013 (mn people) 29.9 127.4
Urban population rate in 2013 (%) 73 92
GDP in 2013 (bn USD) 313.2 4,898.5
GDP in 2019 (bn USD) 535.8 5,433.4
GDP per capita in 2013 (th USD) 10,457 38,468
GDP per capita in 2019 (th USD) 16,170 43,504
THE/GDP in 2012 (%) 3.9 10.1
Pharmaceutical market CAGR
(2014-2020, %)
9.0 2.0
*GDP: Growth Domestic Product, THE: Total Health Expenditure
31Client Confidential – Do not share
Full UHC access, yet the majority of growth comes from
private / OOP care
If you can afford to cut the queue…
Drug Coverage HTA Situation
Public Health Insurance SituationKey indicators Malaysia Japan
Population coverage by public
financial protection schemes
100% 100%
Government expenditure of total
healthcare expenditure in 2012
(GGHE/THE)
55.0% 82.1%
OOP rate of total health
expenditure in 2012
35.6% 14%
OOP rate as % of private
expenditure on health in 2011
79% -
HTA on drugs is still limited
Malaysia HTA Section (MaHTAS), a department of Ministry of
Health, published the drug formulary and guideline for
pharmacoeconomics in the past two years. The areas covered in
the guidelines include: the types of economic evaluation that
need to be carried out by, the costing approaches that are
acceptable, the outcome issues, discounting, sensitivity analysis,
the acceptable cost-effective ration and also the budget impact
analysis. However, due to limited capacity, the number is drugs
evaluated are limited. Recent study was to evaluate and
recommend pneumococcal vaccine for children below five yeas
old to its national immunization program.
Drugs available in the public sector are highly subsidized (80-
90%). Each public hospital has their own budget allocated and
each hospital manage within the budget. Although drugs are
highly subsidized, it is unclear that how their own budget is
allocated to drugs and it is up to their financial situation. In
private sector, majority of drugs are paid directly from patients
which drive up OOP rate in Malaysia.
Domestically available generics as well as absence on pricing
regulations further contribute to a market with high complexity.
Low OOP in public; High OOP in private
Malaysia has achieved universal health coverage through a public
healthcare system providing near-free comprehensive care
financed though general taxation. However private healthcare
system is getting popularity to meet demand of wealthier people
which, which is the reason for high OOP rate despite of the UHC
system. The government has faced challenges as to how to
balance public and private sector and maintain UHC in the country.
In 2012 the government proposed “1Care for 1Malaysia” policy
which would allow the insured to access private facilities. However,
it appear to be unsuccessful so far. The government seem to be
struggling to modify the distort of UHC in Malaysia.
Rise of private sector affect OOP rate
32Client Confidential – Do not share
Philippines
Philippines Japan
Population in 2013 (mn people) 97.5 127.4
Urban population rate in 2013 (%) 45 92
GDP in 2013 (bn USD) 272.1 4,898.5
GDP in 2019 (bn USD) 517.3 5,433.4
GDP per capita in 2013 (th USD) 2,791 38,468
GDP per capita in 2019 (th USD) 4,712 43,504
THE/GDP in 2012 (%) 4.6 10.1
Pharmaceutical market CAGR
(2014-2020, %)
9.4 2.0
*GDP: Growth Domestic Product, THE: Total Health Expenditure
33Client Confidential – Do not share
PhilHealth has a broad reach in the population
Expansions into the remaining population sectors have been mandated
Drug Coverage HTA Situation
Public Health Insurance SituationPhilippines Japan
Population coverage by public
financial protection schemes
78% 100%
Government expenditure of total
healthcare expenditure in 2012
(GGHE/THE)
37.7% 82.1%
OOP rate of total health
expenditure in 2012
52.0% 13.1%
OOP rate as % of private
expenditure on health in 2011
83.5 -
PhilHealth is responsible for the reimbursement of drugs on the
PNDF. PhilHealth manages drug cost through pre-determined
ceilings, which are decided based on the severity of the disease
and the classification of hospitals. For example, the benefit ceilings
for drugs when patients are in secondary hospital are USD75 for
case type A (simple) diseases, USD249 for case type B (moderate)
diseases, USD499 for case type C (severe) diseases. The
Philippine National Drug Formulary (PNDF) lists reimbursable
drugs under the National Health Insurance Program in addition to a
positive list, which is a compilation of non-PNDF drugs that are also
reimbursable. Please note prior instances of mandated price cuts.
Reimbursement is based on pre-determined ceilings
Philippine Health Insurance Corporation (PHIC), more commonly
knowns as PhilHealth administers the National Health Insurance
Programme. The NHIP’s target was to attain universal coverage
within 15 years of its implementation in 1995. However, as of 2012
PhilHealth covered approximately 78% of the total population.
Philippines’ decentralized healthcare service is also challenge to
support efficient comprehensive care. In 2013, the president of
the Philippines amended the National Health Insurance Act of
1995, which mandates the government to shoulder the premiums
for the insurance of the indigent and informal sectors. This is
estimated to drive coverage and benefit expansion.
Further political support to complete UHC
The first HTA attempt was initiated when the HTA Committee in
PhilHealth was established in 1999. The committee aimed to
develop reimbursement policies. One of major functions of the
committee was conduct of drug assessments to determine which
drug should be reimbursed. However, due to lack of political
support and leadership changes, HTA underwent period of silence .
Since 2009, several policies have made breakthrough to revive
HTA. Department of Health is now active partnering with NICE and
Thailand’s Health Intervention and Technology Assessment
Program. However HTA is not yet formally implemented in drug
reimbursement decision process.
HTA is not yet formally implemented on drugs
34Client Confidential – Do not share
Vietnam
Vietnam Japan
Population in 2013 (mn people) 89.7 127.4
Urban population rate in 2013 (%) 32 92
GDP in 2013 (bn USD) 170.6 4,898.5
GDP in 2019 (bn USD) 281.4 5,433.4
GDP per capita in 2013 (th USD) 2,497 38,468
GDP per capita in 2019 (th USD) 2,948 43,504
THE/GDP in 2012 (%) 6.6 10.1
Pharmaceutical market CAGR
(2014-2020, %)
15.4 2.0
*GDP: Growth Domestic Product, THE: Total Health Expenditure
35Client Confidential – Do not share
Strong public commitment to expand UHC coverage
But incentives for overconsumption of services and drugs hinder this
Drug Coverage HTA Situation
Public Health Insurance SituationVietnam Japan
Population coverage by public
financial protection schemes
65% 100%
Government expenditure of total
healthcare expenditure in 2012
(GGHE/THE)
42.6% 82.1%
OOP rate of total health
expenditure in 2012
48.8% 13.1%
OOP rate as % of private
expenditure on health in 2011
83.2% -
Current payment mechanism include fee-for-service, capitation,
and a DRG pilot. Due to market liberalization policy, hospitals
depend on their revenue from provision of their services which are
reimbursed by Vietnam Social Security which manages the SHI,
and paid by patients. Pharmaceutical sales are a good source of
hospital revenue. In fact health providers have a strong preference
for branded drugs, and drug expenditure account for 60% of total
VSS spending in 2010. VSS pays an average of 89.2% of total
pharmaceutical expenditure in hospitals. At this moment the Health
Insurance Reimbursement List (HIRL) is in favour of branded drug
manufacturers.
Strong brand preference of the reimbursement list
The national Social Health Insurance (SHI) program was
established when Health Insurance Law was passed in 2009. The
government consolidated existing scheme into one SHI program
which is, in principle, a single payer and a single pool with a unified
benefits package model. However, enrolment rates remain low,
and funds pooling is highly fragmented. High OOP rate indicates
the SHI system is not functioning well. In 2012, the Ministry of
Health produced the “Master Plan for Universal Health Coverage
from 2012-2015 and 2020” The Master Plans clearly set target to
reach SHI coverage of 70% by 2015 and 80% by 2020, and to
reduce OOPs to less than 40% of total expenditures by 2015.
Commitment to cover 80% of population by 2020
Vietnam does not have a national program for HTA or similar
evidence-based decision making process. Currently, there is no
regulated or transparent process for selecting drugs for
reimbursement, or rules about who should be on the committee to
represent different stakeholders. VSS, the payer of the SHI, has no
direct role in the benefit package decision making process.
Selection of reimbursed drugs is decentralized and subject to
hospital preference.
No HTA process in place for reimbursement
36Client Confidential – Do not share
The government commit not only population coverage but
also OOP rate
Program A
2012 2020. . . 2009
65% 80%
year
population coverage
OOP rate
Program B
Program C
Variousprograms
Healthcare Fund for Poor
Social Health Insurance
Managed by
Vietnam Social Security
• Single payer model
2015
70%
48.8% <40%
Health Insurance Law Master plan for UHC
37Client Confidential – Do not share
Concept Overview
Country Discussion
ASEAN Regional trends
Conclusions and Business Opportunities
Why does Asia / ASEAN matter?
Deallus Introduction
38Client Confidential – Do not share
Evolving HTA dynamics: Keep an eye on collaboration
mechanism to understand change and influencing factors
Various stakeholders are collaborating to develop and promote
pharmacoeconomics and HTA in Asia
International Society for
Pharmacoeconomics and
Outcomes Research
Foundation: 2011
Members:
Scope and Activities:
HTA is the main focus. Health economic is part of scope.
Annual conference
(4th conference: May 2015 in Taiwan) /
News Letters
Government / HTA agent network Multi-stakeholder network
AsiaregionalGlobal
Foundation: 2003 in Japan
Members:
Scope and Activities:
Health economic and outcome research is main focus. HTA is
a part of its scope.
Biennial Asia-Pacific conference
(7th Conference: 2016 in Singapore)/
Academic journal (Value in Health)/
News Letters/ Regional Chapters
Note: HTAi: Health Technology Assessment International , INHTA: The International Network of Agencies for Health Technology Assessment,
ISPOR: International Society for Pharmacoeconomics and Outcomes Research, HERO: Health Economic and Outcome Research This is not
exhaustive mapping.
Governments or
HTA agencies only
Various stakeholders including
academia, industry, patients
HTA HEOR HEOR HTA
HTA net Asia
*Annual meeting: 2016 in Tokyo
*
ISPORS has regional affiliation
39Client Confidential – Do not share
2015 was the plan for ASEAN economic integration
Majority of initiatives are delayed and would not be achieved by end of
2015. At this moment, no immediate impact is expected for pharma industry.
Member countries
Indonesia Philippines Thailand Vietnam Myanmar
Malaysia Singapore Brunei
Darussalam
Lao PDR Cambodia
202520202015201020001997 2003 2006
Declaration to
establish “ASEAN
community” by 2020
Declaration to
accelerate “ASEAN
community” by 2015
2014
ASEAN 2020 vision:
conceptualization of
“ASEAN community”
Post-2015 vision
2016-2025
conceptualization
Current status:
Although some components of AEC
such as tariff reduction are well
progressed, majority of initiatives are
delayed. It appears that completion of
the integration by 2015 would be
unrealistic. Given this situation, ASEAN
started to discuss post-2015 vision
2016-2025.
ASEAN Economic Community (AEC)
Initiatives Status Pharma related issues
Elimination of non-
tariff barrier
Free movement of
skilled professionals
Not progressed
Limited progress
Integration of regulatory system
MRA of product approval
Free-movement of physicians
(not started)
40Client Confidential – Do not share
ASEAN+3 countries are collaborating to share experiences
Regionally overarching forums are mutually influential, but no interfering
Although there may not be immediate impact, it is worth capturing
international dynamic and regularly assessing implication to pharma industry
ASEAN integration does not have element of national health insurance coverage. This is because, national health
insurance is rather seen as internal political issue of each member country which is against ASEAN principle of
non-interference in the internal affairs.
However, a group of wider stakeholders, ASEAN,
China, Japan, Republic of Korea, are collaborating
toward achievement of universal health coverage in
the region. In 2012 ASEAN Plus Three UHC Network
was conceptualized. The network has work plan
2014-2016 such as monitoring UHC progresses and
capacity development. The network aim to be a
platform of information sharing and guidance toward
UHC. Although they collaborate, it is unclear if they
are producing solid outcomes to achieve their goals.
Japan is particularly active in promoting UHC as the
country has long established history. For example
Japan has been collaborating with the world bank to
share its experience. They had publication on UHC in
2014. In February this year, ministry of health started
discussion on Japan’s long term healthcare vision
which includes communicating Japan’s experience to
Asian counties.
• Cost-effective viewpoint
• Influence on Asian coutries
41Client Confidential – Do not share
Why do Japanese Companies have an Advantage
in Asia?
❶ Similar Disease Pattern
42Client Confidential – Do not share
Why Japanese Pharma have advantages
❶ Similar Disease Pattern
Similar disease patterns between Japan and Asian region results in similar unmet needs, generating synergy in
prioritizing product development strategies
Japan share more similar oncology pattern with Asian market than Western markets (Bottom-Left illustration).
Change of disease patterns in less developed Asian region will attract more Japanese pharma that specialise in
chronic disease care as well (Bottom-Right illustration).
China
Lung (18%)
Stomach (16%)
Liver (16%)
Esophagus (12%)
Colorectal (7%)
Breast (6%)
H&N (3%)
Leukemia (3%)
Korea
Stomach (22%)
Lung (14%)
Liver (13%)
Esophagus (2%)
Colorectal (9%)
Breast (5%)
H&N (3%)
Cervix (4%)
Japan
Lung (13%)
Stomach (19%)
Liver (7%)
Pancreas (4%)
Colorectal (18%)
Breast (7%)
Prostate (5%)
Gall / Bile duct (3%)
United
States
Prostate (13%)
Lung (13%)
Colorectal (8%)
Melanoma (4%)
NHL (4%)
Breast (14%)
Kidney (4%)
Bladder (3%)
New Cancer Cases in East Asia Countries and the US
Asian countries share
more similarities in
disease patterns
Source: Clinical Trials in Asia Pacific – New Challenges and Opportunities, Partnerships in
Clinical Trials Asia Pacific (Singapore, 02 DEC 2009); American Cancer Society, 2015
9% 9%
2% 3%8% 13%
12%
12%
9%
15%
32% 14%
28% 35%
2008 2030
8% 7%
2% 3%
15% 20%
9% 8%
21%
23%
11% 5%
34% 35%
2008 2030
Cardiovascular disease
Infectious disease, malnutrition
Cancer
Injuries
Respiratory disease
Diabetes
Others
Development of Disease Pattern, 2008-2020
ASEAN
Western Pacific
Source: Leveraging ASEAN market,
Researchpartnership.com
43Client Confidential – Do not share
Why Japanese Pharma have advantages
❷ Advantage of multinational clinical trial design in Asia for faster
regulatory approvals
Ethnic similarity allows Japan pharma to design collaborative trials and shorten the launch gap in these
markets
The bottom-left illustrates a therapeutic area where the highest level of ethnic difference exists.
- Considerable ethnic difference between East and West, which often result in differences in clinical
practice, guideline, dosage, active control, concomitant drugs
- Even in this situation, clinical studies can be co-designed in Japan and Asia at the same thanks to low
genetic diversity (illustrated in the Bottom-right), ultimately shortening the time for Japan-focused trial
sponsors to enter the Asian market than Global sponsors who proritise US and EU market.
Phase 3
Phase 3Phase 2
Phase 1US, EU
Japan
Asia
Phase 1
Phase 2
Fully Separated Clinical Study Collaboration
Origin of
Clinical
study
Collaborate-ability between regions
Source: Tetsuomi Takano, New Strategy on Multinational Clinical Trials in China and Japan in Consideration of Ethnic Factors, JPMA
http://www.pmda.go.jp/files/000152237.pdf
Arrows indicate genetic diversification flows
Genetic diversity is
limited within the
region due to close
proximity
44Client Confidential – Do not share
Why Japanese Pharma have advantages
❸ High awareness of Japanese brands & Geographical/Cultural relatedness
Japanese companies could be benefited from high
awareness of Japanese brands stemming from
consumer products/electronics in the region (Left
illustration)
Especially large conglomerates with healthcare
divisions could enjoy an existing share of voice
Geographical proximity and similarity across
cultures and business practices between Asian
countries and Japan lower the operational
challenges of international strategy development
and implementation from HQ (Bottom illustration)
Comparison of Top 60 Brands in Global VS Asian region
Adidads Jaguar Adidas McDonald's
Amazon.com Johnson&Johnson Ajinomoto Mercedes-Benz
American Express Lexus American Express Microsoft
Apple LG Apple
Mitsubishi
Electric
AT&T L'oreal BMW Muji
Audi MasterCard Canon Nestle
Bayer McDonalds Citibank Nike
Berkshire Hathaway Mercedes-Benz CocaCola Nikon
BMW Michelin Colgate Nissan
Bridgestone Microsoft Daihatsu Nivea
Cadillac Nestle Danone Nokia
Chevrolet Nike Dell P&G
Cisco Nissan Epson Panasonic
CocaCola Nivea Gap Philips
Disney Novartis General Electrics Samsung
Ernst & Young P&G Google Sharp
ExxonMobil Pepsi H&M Shiseido
Facebook Philips Haagen-Dazs Siemens
Ford Porche Hitachi Sony
General Electric PwC Honda Starbucks
Google Samsung HP Suzuki
Gucci Shell HSBC Toshiba
H&M Siemens Hyundai Toyota
Hershey's Sony IBM Unicharm
Honda Starbucks Johnson&Johnson Unilever
HP Toyota Kao Uniqlo
HSBC Twitter Kellog's Visa
IBM Unilever KFC Xerox
Infiniti Visa LG Yahoo
Intel Volkswagen L'Oreal Yamaha
10%of
Japanese
Brands in
Global Top
60 Most
Popular
Brands in
2014
VS
35%of
Japanese
Brands in
Asian Top
60 Most
Popular
Brands in
2014
Source: Brand Asia 2014 Survey Results, Nikkei BP Consulting,
Ranking The Brands Top 100 www.rankingthebrands.com
Process-
oriented
Result-
oriented
Formal,
structured
business
setting
Casual,
less
distant
business
setting
Humility,
patience,
harmony
Confid-
ence,
demons-
trativenss
Indirect
communi
cation
Direct
commu-
nication
Team
credit
Personal
credit
Genera-
ting profit
Creating
Share-
holder
value
Commonly shared corporate
goal (●) and operational
considerations (○)
Source: How to Crack Asian Business, 2011, Fortune
21 Cultural Clues for Doing Business in Asia, 2013, The Business Journals
Asia West
45Client Confidential – Do not share
Significant changes
matched with
political commitment
Dynamic landscape: Increasing political investments and HTA
evaluation processes will create greater market opportunity
Health insurance
coverage dynamics
HTAdynamics
High
uncertainty
Relatively
established,
HTA to be
accelerated
46Client Confidential – Do not share
Country Key Take-aways
Singapore: Maintaining its position as key market entry node?
Malaysia: Is the current model sustainable?
Thailand: With UHC established, where next?
Philippines: Would further price cuts be mandated to achieve UHC?
Indonesia: Where will the UHC spending priorities be by 2019?
Vietnam: Will the price gap between brands and generics narrow?
47Client Confidential – Do not share
ASEAN Region
A 650 million people economy potential!
Member countries
Indonesia Philippines Thailand Vietnam Myanmar
Malaysia Singapore Brunei
Darussalam
Lao PDR Cambodia
48Client Confidential – Do not share
Concept Overview
Country Discussion
ASEAN Regional trends
Conclusions and Business Opportunities
Why does Asia / ASEAN matter?
Deallus Introduction
49Client Confidential – Do not share
About Deallus Consulting
Deallus Consulting improves your strategy by developing, testing and refining the key market
assumptions that underpin it. We can do this because of our focus on the Life Sciences
industry, our efficient and comprehensive research and our rigorous analysis
Deallus Global Footprint
Was Founded in London in 2004 with offices in New
York, Princeton, Los Angeles, Singapore, Tokyo and
dedicated, exclusive support in China and LATAM
Has completed over 1,000 assignments
Has over 80 Consultants
Is a Life Science specialist, with more that 80% of
our Consultants possessing a Life Science PhD
Has >90% client retention, (clients we continue to
work with since our first engagement)
Supports any decision maker or manager involved
in strategy development, right across the Product
Life Cycle, in the largest multinationals or SME’s at
Global, Regional and Affiliate level
Deallus Consulting
www.deallusconsulting.com
50Client Confidential – Do not share
Deallus Consulting
What We Do
Deallus’ expertise in strategic
management consulting spans a
range of services across product
lifecycle, in strategy development,
in business development, brand
management, market access and
manufacturing and supply chain
Deallus has extensive experience in
effectively leading and
implementing competitive
workshops consistent of scenario
planning workshops, war games,
individualized training programs and
hybrid models
Deallus’ best in class competitive
analysis is based on rigorous
research and analysis to test and
refine the assumptions, to ensure
winning strategies based on a
robust understanding of the market
www.deallusconsulting.com
51Client Confidential – Do not share
Deallus has supported its clients in optimising robust market entry
strategies for the Asian markets
• What is the total number of
patients in each indication
• What is the number of eligible
patients in each indication
• How well developed is the
healthcare infrastructure for each
indication in each of the markets?
• What is the treatment pathway for
each indication in each market?
• Who are the key influencers in each
market?
• What are the regulatory
requirements for approval
• What are the regulatory timelines
for approval in each market
• will post registration activities
be required
• What are the pricing and
reimbursement requirements for
each indication in each market?
• How does the pricing differ
depending on setting of care?
• What are the pricing timelines?
• Who are the key competitor
in the market?
• What is the competitor
strategy and impact on
your company?
• What is the competitor
market share vs your
market share?
• What are the winning sales and
marketing strategies tailored for
each market?
• What is the product penetration per
account?
• Who are the key stakeholders to
target per indication per market
• The drivers and strainers of growth
within each market?
Asian market strategy must take into account all factors affecting the market’s true potential
Patient
Population
Dynamics
Product
Registration
and Launch
Competitor
Landscape
Pricing and
Market
Access
Sales and
Marketing
Strategy
Healthcare
Landscape
52Client Confidential – Do not share
Deallus Consulting
Who We Are
Our Presence in Asia builds on a strong foundation of Project Management from JPAC HQ, with
on-the-ground support from local consultants
www.deallusconsulting.com
Anousha Kamvari, PhD
Senior Consultant, Singapore
Ju Hyoung Lim, PhD
Consultant, Singapore
Carole Bruckler, PhD
Partner, Head of Japan &
Asia Pacific
Michael Lee
Business Analysts, Singapore
Supported by other
Local Researchers
Feng Wang, PhD
Consultant, Tokyo
Hiroyuki Onoda
Associate, Singapore
Tom Chang, MBA
Associate, Singapore
Budiman Jimron, MSc
Associate, Singapore
Alicia Yang Jenkins, PhD
Ichiro Masuda
Principal, Head of Japan
Operations
Carl Qian, PhD
Associate, Singapore
3
53Client Confidential – Do not share
Deallus Consulting JPAC Team
Carole Bruckler, PhD – Partner, Head of JPAC
Carole Brückler is the Head of the Deallus Consulting Japan & Asia-Pacific operations, based in Singapore. She
has led client engagements developing regional or global product strategy for 9 of the top 10 global pharma
companies. Carole’s clients assignments have enabled business decisions reflecting market evaluations of new
products and acquired assets, pricing and reimbursement challenges, generic and biosimilars entry and landscape
assessments to validate opportunities present existing portfolios. Carole’s experience covers multiple therapy
areas, particularly Vaccines, CNS, CVM and respiratory field, as well as medical devices field.
Prior to setting up the Asia Pacific operations for Deallus consulting, she led the established European business.
Carole has also lectured at multiple Pharma industry conferences on the challenges of conducting research in the
vaccines area, in Europe, US and China. Prior to joining Deallus, Carole worked in preclinical R&D, both in a
synthetic organic setting, as well as an analytical setting in support of asthma treatments at GSK. Carole
completed her PhD in Chemical Biology at the University of Edinburgh. Carole is a joint inventor and patent holder
of this technology. In addition to her academic qualifications and professional credentials, Carole speaks several
European languages.
Ichiro Masuda – Principal, Head of Japan Operations & Representative Director
Ichiro Masuda is the Principal, Head of Japan Operations and Representative Director in the Deallus Tokyo Office.
Ichiro joined Deallus with 27+ years of experience in sales, marketing, marketing research, business development
in the pharmaceutical industry.
He spent 21 years at Eli Lilly Japan in progressively senior sales, marketing and product management roles,
before he moved to the consulting industry. At IMS Consulting, he worked in the Commercial Practice, delivering
market optimisation, resource allocation and marketing training projects. At ZS Associates, he developed the area
of strategic market research in ZS Tokyo and worked on forecasting and business development assignments,
while managing business development and client engagements.
Ichiro is a graduate of Kyoto University in Economics, a nationally registered management and healthcare
consultant, as well as a native Japanese speaker.
54Client Confidential – Do not share
Deallus Consulting JPAC Team
Anousha Kamvari, PhD – Senior Consultant
Anousha is a Senior Consultant based at our Singapore office. Anousha offers broad experience across both the
medical device and pharmaceutical industries. Her areas of expertise include strategic and operational leadership
in market entry, market analytics, pricing and reimbursement, regulatory (FDA, EMA, CFDA) and compliance
systems for medical devices including drug-device combination products and pharmaceuticals.
Prior to joining Deallus, Anousha was instrumental in advising senior management at BTG, an international
specialist healthcare company, on go no-go business case investments for multiple brands across the
Interventional Oncology franchise; at both a regional and global level.
Anousha holds a PhD in Biomaterials Engineering from University of Cambridge and a 1st class honours MEng
degree from Queen Mary University of London. She has authored two book chapters within the field of
Biomaterials Engineering.
Feng Wang , PhD – Senior Consultant
Feng is a Senior Consultant at Deallus Consulting Tokyo office, recently transferred from Deallus Global
Headquarter in London. He joined Deallus London in 2011 and since then, he has led client engagements across
wide therapy areas (Oncology, Vaccines, Urology, Ophthalmology & Biosimilars) at product and portfolio level. His
prior and ongoing projects support top 20 MNC including Japanese pharmaceutical companies in competitive
landscape analysis, product launch preparation, commercial structure benchmarking, emerging market entry
strategies as well as clinical development and new product planning. His market expertise covers EU, US and
Emerging Markets in Asia.
Feng holds a PhD in Oncology from the University of Cambridge examining the mechanism of chemotherapy
resistance in ovarian cancer and an MBioch from the University of Oxford. During his PhD, he also developed
commercial knowledge through pharma-sponsored workshops and Technology Management course at Cambridge
Judge Business School. Feng speaks English, Mandarin and basic Japanese.
55Client Confidential – Do not share
Deallus Consulting JPAC Team
Lim Ju Hyoung, PhD – Consultant
Ju Hyoung is a Consultant at Deallus Consulting, Singapore. Since joining Deallus, he has led a broad range of
projects covering Korea, China, Japan, Australia, South East Asia, as well as Europe, supporting clients by
providing bespoke insights in various therapeutic areas including infectious diseases, oncology, autoimmune
diseases, orphan diseases, etc. In addition, he has worked in a number of projects with extensive focus on
biosimilars, vaccines, aesthetic products.​
Ju Hyoung has earned a PhD in Biological Sciences from Korea Advanced Institute of Science and Technology
(KAIST) and completed a postdoctoral fellowship at Massachusetts Institute of Technology (MIT). He also spent
considerable time working with Korean biotechnology start-up companies, consulting on process optimization
projects, as well as managing collaborations with government departments to develop research proposals and
assess the commercialization potentials of these projects. He is a native speaker of Korean, and is fluent in
English.
Hiroyuki Onoda, BPharm – Associate
Hiroyuki Onoda (Hiro) is an Associate in the Deallus Singapore office. At Deallus, Hiro has supported a wide range
of projects ranging from R&D strategy, marketing strategy and competitive landscaping to supply chain optimization.
Hiro brings in-depth insights from the Japanese market to multiple projects, bridging cultural gaps and engaging
with Japanese client teams. His research and analysis has covered multiple therapy areas (oncology, hepatology,
gastroenterology, CVM & CNS) as well as vaccines and biosimilars.
Prior to joining Deallus, Hiro worked as a marketing specialist at Suzuken in Japan, the third largest domestic
pharmaceutical wholesaler, developing expertise in sales, promotion and physician engagement for a wide range of
pharmaceutical products across therapy areas, both branded and generic, including vaccines and diagnostics.
During this time he developed a deep understanding of the supply chain, sales and marketing and the Japanese
healthcare system through working with a variety of pharmaceutical companies in highly competitive environment.
Hiro is bilingual (Japanese/ English), holds a B.S. in pharmaceutical sciences & is a registered pharmacist in Japan.
56Client Confidential – Do not share
Deallus Consulting JPAC Team
Budiman Jimron, MSc – Associate
Budiman is an Associate at Deallus Consulting, Singapore. He has earned a Masters in Integrated Biosciences
from the University of Tokyo, and had considerable working experiences with Japanese consultancy firm on
market entry strategy for Japanese companies in South East Asia.
Since joining Deallus, he has worked on projects covering Indonesia, Malaysia and other APAC countries,
supporting research efforts into various therapeutic areas such as diabetic nephropathy, vector-borne diseases,
etc. He is a native speaker of Bahasa Indonesia, and is fluent in English and Japanese.
Tom Chang, MBA – Associate
Tom Chang is an Associate in the Deallus Singapore office. He is an MBA graduate of Hitotsubashi University,
Graduate School of International Corporate Strategy in Tokyo, Japan. He received his BSc from University of
British Columbia (UBC) in Vancouver, Canada.
Tom has worked in the technical side of pharmaceutical companies and brings a unique perspective of drug
development and product planning. He has experience in the Japanese Generics Market through an internship at
Mylan Seiyaku (Pharmaceutical) Ltd., where he was assigned to assist on three products, one product line
expansion and two product developments for antipsychotic and migraine attack treatments. Tom speaks English,
Mandarin and Japanese.
57Client Confidential – Do not share
Deallus Consulting JPAC Team
Carl Qian, PhD – Associate
Carl is an Associate at Deallus Consulting’s Singapore office. Since joining Deallus, he has worked on multiple
projects covering Asia Pacific and the US, supporting clients in fields such as oncology, infectious diseases,
vaccines and drug manufacturing.
Carl graduated from the PhD program in Mechanobiology from National University of Singapore. His PhD research
area was in computational biophysics. He holds a Bachelor of Science in Biological Science and a minor in
Computer Science from Fudan University in China with a thesis focusing on Breast cancer genomics. He also had
internship experience at Novartis Institute of Biomedical Research, working on antibody-based biomarker
discovery. Prior to joining Deallus, he was an Associate at SingTel Group in its Tel Aviv office, working on
innovation and business partnerships in the high-tech sector. He is fluent in English and Mandarin Chinese.
Michael Lee, MSc – Business Analyst
Michael is a Business Analyst at Deallus Consulting in Singapore. In his time with Deallus, he has been involved in
multiple projects with a primary focus in China and the rest of APAC region. Michael’s therapeutic area expertise
include virology, digestive diseases, infertility, oncology, metabolism diseases, and cardiovascular diseases.
Biosimilar and generic drug markets are two major focuses of his recent researches. Michael’s studies on
competitor dynamics monitoring, potential trends prediction, business development support, regulatory policy
research have supported commercial decision making.
Michael holds a Master of Science degree in Biochemistry and Molecular Biology from National Cheng Kung
University, Taiwan and specialized in cancer biology and metastasis mechanism. Before joining Deallus, Michael
worked on business development and training services at PPC, the leading domestic clinical research organization
in Taiwan. He also has internship experiences at Vita Genomics, Inc. and NanKang Biotech Incubation Centre on
marketing and industrial development strategies analysis. Michael is fluent in Mandarin.
58Client Confidential – Do not share
59Client Confidential – Do not share
Acronyms
AEC ASEAN Economic Community
ASEAN Association of South East Asian Nations
FDI Foreign Direct Investment
GDP Gross Domestic Product
NCD Non-communicable diseases
OOP Out of Pocket
SHI Social Health Insurance
THE Total Health Expenditure
UHC Universal Health Coverage

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  • 1. Client Confidential – Do not share Healthcare insurance & reimbursement landscape in ASEAN markets Tokyo, 18th March 2015 Deallus Contact: Carole Brückler, PhD Partner, Head of Japan and Asia-Pacific CaroleB@deallusconsulting.com +65 6823 6836 Deallus Contact: Ichiro Masuda Principal, Head of Japan Operations Ichiro.Masuda@deallusconsulting.com +81 70 1542 9876
  • 2. 2Client Confidential – Do not share Concept Overview Country Discussion ASEAN Regional trends Conclusions and Business Opportunities Why does Asia / ASEAN matter? Deallus Introduction
  • 3. 3Client Confidential – Do not share Concept Overview Country Discussion ASEAN Regional trends Conclusions and Business Opportunities Why does Asia / ASEAN matter? Deallus Introduction
  • 4. 4Client Confidential – Do not share Why does Asia / ASEAN matter?
  • 5. 5Client Confidential – Do not share Source: Growing Healthcare Spending In Southeast Asia Brings Opportunity, 2014, BDG Asia 41.6% 37.3% 37.6% 32.7% 28.9% 22.4% 11.9% -2.1%-10.0% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% %Growth of Per Capita Healthcare Spending (2009-2012) ❶ 1. East Asia and Pacific 2. South East Asia 3. South Asia 4. LaTam 5. MENA 6. Sub-Saharan Africa 7. North America 8. EU ❷❸ ❹ ❺ ❻ ❼ ❽ ❶ ❷ ❸ ❹ ❺ ❻ ❼ ❽ Why Asian Markets Are Attractive ❶ Rising Healthcare Expenditure Expands the Healthcare Market Healthcare spending grew substantially acrossAsia (Top-left illustration). Asia as a region is the fastest growing part of the global economy. In 2001, the region accounted for 26.8% of global GDP (measured using purchasing power parity). By 2013, that share had risen to 36.6%. The rapid income growth means that healthcare spending in the region is also growing faster than anywhere else. Whilst a steady growth of pharmaceutical market is expected in the developed market (1-4% CAGR2012-2017), the significant rise of healthcare spending in the key Asian countries will lead the huge drive of pharma market growth in the next 5-10 years (Bottom-left illustration). The sharpest ever rise in the healthcare spending for the past 4 years (2009-2012) was observed in a few Asian countries including Indonesia (67.8% CAGR), Philippines (52.1%), Myanmar (50.5%), Malaysia (43.6%) and Vietnam (42.7%). The trend in the region is anticipated to continue throughout to 2018 thanks to the region’s rapidly growing economics, expansion of the affordable social class. Japan Australia Taiwan South Korea China Malaysia Thailand Philippines IndonesiaVietnam Cambodia Laos Myanmar Sri Lanka Bangladesh Pakistan India Mongolia Nepal 10 100 1,000 10,000 0.01 0.1 1 10 100 1000 2012HealthExpenditureperCapita(US$) (Public+Private) Pharmaceutical Market Size in 2012 (US$ Billion) Source: The World Bank Data Espicom The Pharmaceutical Market Reports Frost & Sulivan, Top Five Growth Sectors in the Asia-Pacific Healthcare Market, Global Pharma Market Outlook – with focus on emerging markets, IMS Health Developed markets Emerging markets Nascent markets 12.8% Asia Spending CAGR (2012- 2018) Asia Market Size CAGR (2012-2018) 7%
  • 6. 6Client Confidential – Do not share Why Asian Markets Are Attractive ❷ Rapid Demographic Change Drives Healthcare Industry Growth Asia rapidly turns to Aging Society One of the most attractive opportunities in Asia centres on the region’s changing age profile, of which the elderly population aged 65 and over will reach 11.6% by 2030 Source: Asia Rising, Healthcare, 2014, The Economist 0% 2% 4% 6% 8% 10% 12% 0 100 200 300 400 500 600 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030 Number of people aged 65 and over in Asia Pacific in millions and % of the total population ■ Population of over 65 (mln) ■ %Population of over 65 Source: Middle Class Growth in Emerging Markets, Earnst & Young Rapid growth of middle class in Asia Two-thirds of the global middle class is expected to live in the Asia-pacific region, up from just under one-third in 2009 Estimated total income by band 2010 and 2020 in China (Annual income, thousands of people) Aging Asia presents huge opportunities for industries that provide products and services to the elderly Asia stands out as being the most exciting part of the world for healthcare businesses. As growing richer, having broader exposure to improvements in medicine, Asian countries are expected to experience tremendous ‘ageing’ (Bottom-left illustration) Change of wealth distribution will drive the expansion of pharmaceutical market size in the next 10 years. A significant proportion of the new Asian middle class are also expected to be at the upper end of the income bracket, with impressive spending power (Bottom-right illustration)
  • 7. 7Client Confidential – Do not share Why Asian Markets Are Attractive ❸ Booming Foreign Investment Creates More Opportunities Source: Asia Rising, Healthcare, 2014, The Economist 2.2% 1.6% 18.1% 23.8% 28.5% 29.2% 51.2% 45.4% 0% 20% 40% 60% 80% 100% 2007 2012 Share Share of Global Expenditures on Biomedical Research in 2007 and 2012 US Europe Asia & Oceania RoW Heavy investment in R&D in the region has enabled earlier ever access of pharmaceutical products in Asia As perception changing on the importance of R&D investment in the region, the value of medical research in Asia is growing swiftly, with the Asia’s share of global R&D expenditure rose from 18.1% to 23.8% (Bottom-Right illustration) Market Attractiveness Rating Addressable Market Ease of Import Distribution Reach Overall Very high High Medium Low Market Attractiveness Rating Vietnam Stance of Foreign Investment • Foreign healthcare investors enjoy a corporate income tax rate of 10%, tax exemption over the first four years of a project and a 50% subsequent tax break in the following years. Increasing affluence and demand for better are forcing previously protectionist Asian governments to be more open to give leeway to foreign companies (Top-Left illustration) Increasing business transparency and policy continuity has lifted the chronic risks existing in some region, boosting market rewards in the recent years Market Attractiveness Rating Addressable Market Ease of Import Distribution Reach Overall Indonesia Stance on Foreign Investment • The Negative Investment List currently stipulates that foreign investors may own up to 67% (65% previously) in healthcare related business Source: Healthintel Asia, 2013 EOS Intelligence insights, PharmaExec.com 2013 State of the Healthcare in South East Asia, Edelman Whitepaper Illustrative
  • 8. 8Client Confidential – Do not share Concept Overview Country Discussion ASEAN Regional trends Conclusions and Business Opportunities Why does Asia / ASEAN matter? Deallus Introduction
  • 9. 9Client Confidential – Do not share ASEAN Regional Trends Social • Demographic changes – wealth and age distributions • Epidemiological transitions (M&M is no longer driven by infectious diseases but rather NCD (diabetes, COPD, cancer etc.) • Patient preference of branded products and private health sector, where affordable • High income patients cross country borders to seek high standard health care and technologies. Technological Economic Political
  • 10. 10Client Confidential – Do not share ASEAN Regional Trends Social Technological • Limited pharma technology, therefore the region relies on import for innovative drugs • Limited requirements for technology transfer into the region • Skilled physicians in Thailand, Malaysia, Singapore which leads to medical tourism. • ASEAN HTA agencies have limited technical capacity but actively developing. Economic Political
  • 11. 11Client Confidential – Do not share ASEAN Regional Trends Social Technological Economic • Growth of middle population segment with disposable income • Increasing cost pressures on health care budgets as cost of delivery and drugs risk outstripping budgets • ASEAN Economic Community Political
  • 12. 12Client Confidential – Do not share ASEAN Regional Trends Social Technological Economic Political • Strong political commitment for Universal Health Coverage • Struggles with the realities of implementation UHC systems • Willingness to make more evidence-based decision making
  • 13. 13Client Confidential – Do not share Concept Overview Country Discussion ASEAN Regional trends Conclusions and Business Opportunities Why does Asia / ASEAN matter? Deallus Introduction
  • 14. 14Client Confidential – Do not share Three components of insurance coverage should be considered What does health insurance constitute of? Height: How much is service (pharmacy) benefit covered? Depth: which health services (drugs) are covered? Breadth: population coverage (what % of population is covered?) “100% population coverage” does not always mean that a certain drug is covered for 100% of population with fixed reimbursement rate. OOPs (co-payments) Non-insured people Non-reimbursed drugs
  • 15. 15Client Confidential – Do not share How does this compare with Japan? Component Japan ASEAN Breadth: Population coverage It is compulsory that Japanese citizens subscribe a certain type of social health insurance. Population coverage ranges from 60% to 100% Depth: Service (drug) coverage Almost all drugs approved are listed NHI reimbursed drug price list Level and standard of drug coverage differs from market to market. Originators drugs are often not reimbursed Height: Financial protection (co-payment) Typically 20-30% of co- payment Listed drugs are highly subsidized although may be subject to government or hospital budget It is essential to think out of “Japan box”. Contrasting ASEAN with the Japanese healthcare model
  • 16. 16Client Confidential – Do not share It is important to understand “what HTA exactly means” HTA is broad term and its impact changes according to its context Procedure Health Program Drug Device Efficacy Cost effective- ness Budget impact Health Policy Decision Making Definition of Health Technology Assessment: Health technology assessment (HTA) refers to the systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making. (WHO) EthicsHTA concept (not exhaustive) HTA from drug reimbursement perspective When discussing HTA, it is important to understand from what perspective HTA is mentioned Example: In 1993, HTA program, Technology Assessment and Social Security in Thailand (TASSIT) was introduced. The 2007 revision of NLED required input from the Health Intervention and Technology Assessment Program (HITAP) in Thailand. Broader HTA: Not impactful on drug reimbursement per se High impact on drug reimbursement
  • 17. 17Client Confidential – Do not share Concept Overview Country Discussion ASEAN Regional trends Conclusions and Business Opportunities Why does Asia / ASEAN matter? Deallus Introduction
  • 18. 18Client Confidential – Do not share ASEAN Region A 650 million people economy potential Member countries Indonesia Philippines Thailand Vietnam Myanmar Malaysia Singapore Brunei Darussalam Lao PDR Cambodia
  • 19. 19Client Confidential – Do not share Indonesia Indonesia Japan Population in 2013 (mn people) 248.0 127.4 Urban population rate in 2013 (%) 52 92 GDP in 2013 (bn USD) 870.3 4,898.5 GDP in 2019 (bn USD) 1,230.9 5,433.4 GDP per capita in 2013 (th USD) 3,510 38,468 GDP per capita in 2019 (th USD) 4,560 43,504 THE/GDP in 2012 (%) 3.0 10.1 Pharmaceutical market CAGR (2014-2020, %) 10.2 2.0 *GDP: Growth Domestic Product, THE: Total Health Expenditure
  • 20. 20Client Confidential – Do not share Undergoing a formidable change in health insurance 2014-2019: transition to the universal health coverage Drug Coverage HTA Situation Public Health Insurance SituationKey indicators Indonesia Japan Population coverage by public financial protection schemes 60% 100% Government expenditure of total healthcare expenditure in 2012 (GGHE/THE) 39.6% 82.1% OOP rate of total health expenditure in 2012 45.3% 14% OOP rate as % of private expenditure on health in 2011 76.3% - HTAs have been implemented since 2014 Since 2014, HTAs has been formally implemented and evaluate new technology similar manner to UK-NICE. Although HTA body evaluate cost-effectiveness from various data sources, it requires pharma companies to submit relevant data. At this moment, procedures and interaction with pharma companies are discussion basis. Formal guideline is not yet available as capacity of Indonesian HTA body is limited. However, it is estimated some form of guideline may be issued around 2016. As Indonesia integrated several schemes into single payer body, impact of HTA in public health sector is high particularly for pharmaceutical industry. Indonesian public health system employs Diagnosis Related Group (DRG) system which is similar to DPC system in Japan. The government use e-catalogue system to manage medicines in the public sector. Listing of e-catalogue and purchase price are determined centrally and physical procurement is managed by individual hospitals. In this system originator’s company can join and on-patented drugs comprise about 10% in volume and 30% in expenditure. It appears that originators play in out-of- pocket private sector in general, some of certainly participate in public sector to enjoy public funding. On-patented drugs have potential in public market image The Indonesia public health insurance system was established in 1968. And as of 2010, approximately 46% of the population was covered under the five different schemes. In January 2014, the government committed to provide healthcare insurance to all citizens by 2019, merging all existing schemes. UHC by 2019 2010 2019 1968 46% 100% 2014
  • 21. 21Client Confidential – Do not share What will the spending priorities be by 2019? One national health insurance, single payer model will impact coverage decision. Askes Taspen Jamsostek Jamkesmas Jamkesda Active civil servants and dependants, civil service and military retirees Military workers, police and their uncovered dependents Private formal sector employees (and dependents) of firms with 10 or more employees Poor and near-poor population, based on individual and household targeting Poor and near-poor, homeless, orphans, and non-civil service teachers 2014 2019 Public health insurance before 2014 National Health Insurance Program (JKN: Jamian Kesehatan Nasional) Managed by BPJS: the Badan Penyelenggara Jaminan Sosial • Single payer model • Diagnosis-Related Group system • HTA involvement for technology selection In 2014, Indonesia reformed healthcare insurance system. 5 different schemes were integrated into one National Health Insurance Program, also known as BPJS, the Badan Penyelenggara Jaminan Sosial Keseehatan. This will change the complicated public health care in Indonesia and expand population and benefit coverage. According to health policy experts in Indonesia, this ambitious goal is “achievable”. However many operational challenges are expected. . . . 2010 46% 60% 100% year population coverage
  • 22. 22Client Confidential – Do not share Thailand Thailand Japan Population in 2013 (mn people) 68.2 127.4 Urban population rate in 2013 (%) 48 92 GDP in 2013 (bn USD) 387.3 4,898.5 GDP in 2019 (bn USD) 493.3 5,433.4 GDP per capita in 2013 (th USD) 5,676 38,468 GDP per capita in 2019 (th USD) 7,047 43,504 THE/GDP in 2012 (%) 3.9 10.1 Pharmaceutical market CAGR (2014-2020, %) 7.0 2.0 *GDP: Growth Domestic Product, THE: Total Health Expenditure
  • 23. 23Client Confidential – Do not share Thailand is a stand-out performer in delivering care at low OOP rates UHC was first achieved in 2001 Drug Coverage HTA Situation Public Health Insurance SituationThailand Japan Population coverage by public financial protection schemes 98% 100% Government expenditure of total healthcare expenditure in 2012 (GGHE/THE) 76.4% 82.1% OOP rate of total health expenditure in 2012 13.1% 13.1% OOP rate as % of private expenditure on health in 2011 55.8% - Drug benefit for all public insurance schemes is referenced to the medicines quoted in the National List of Essential Medicines (NLEM). A prescription of the nonessential drug if deemed necessary. Depending on type of insurance, reimburse model differs. While members of CSMBS enjoy fee-for-service payment, SHI and UC enrolees receive treatment under capitation and DRG system. The NLED is periodically updated by a subcommittee of the National Drug Committee. Non-NLEM drugs need to be paid out-of-pocket regardless of type of insurance enrolled. Standard Drug List for public sector reimbursement Although Thailand has dual system of public and private health sector, public sector plays a dominant role. Since achievement of universal health coverage, Thailand has maintained its system though various approaches such as strong primary care gatekeeping and tough negotiations with pharmaceutical companies. OOP rate of 13.1% stand out of ASEAN peers. UHC already achieved in 2001 The Thai Health Intervention and Technology Assessment Program (HITAP) is a well established HTA agency, founded in 2006. While HITAP has no legal authority to make healthcare resource allocation decisions itself, in its role as an advisor to the Ministry of Public Health and other national Thai authorities, HITAP has developed a track record in informing national policy. For example, the 2007 revision of NLEM required cost-effectiveness evidence produced by HITAP, which significantly impact reimbursement decision making. HITAP is a leading HTA body in ASEAN region. It pioneered to establish the first Asian HTA network, HTAsiaLink in 2011. HITAP: leading HTA body in ASEAN region CSMBS: 1980- Government employee 10% of population SHI: 1990- Private sector employee 13% of population UC: 2001- Remaining population 74% of population
  • 24. 24Client Confidential – Do not share Thailand has well established UHC system The government employ capitation system to control health expenditure. CSMBS recently employed DRGs for inpatient payment. CSMBS SSS UCS Official name Civil Servants Medical Benefits Scheme Social Security Scheme Universal Coverage Scheme Established since Administrator Population coverage Financing sources Financing model Co-payment (in principle) 1980 1990 2002 Controller General Department, Ministry of Finance Social Security Office (SSO), Ministry of Labour National Health Security Office (NHSO) All civil servants, permanent public employees, retirees, and their dependents (7.9%) All private employees and temporary public employees (15.3%) Anyone who is not covered by the SSS and CSMBS (75.8%) General tax revenue Equal contributions from employers, employees, and the government General tax revenue OP: Fee-for-Service IP: DRGs* Capitation OP: capitation IP: DRGs No (full pay without proper referral) No (full pay outside contractor) No (full pay in private sector) Note: OP: out-patient, IP: in-patient, DRG: Diagnosis-related group
  • 25. 25Client Confidential – Do not share Since the NLED 2007 revision, cost-effectiveness evidence has been required NLED publication The National Drugs System Development Committee The Subcommittee for Development of the NLED The Working group for coordination & consolidation of NLED 16 Specific Working Group for NLED selection NLED secretariats The Health Economic Working Group Endorsement of NLED Setting concept, philosophy and criteria Making final decision from the proposal of all the Working groups. Gathering information and making recommendations Reviewing and generating pharmacoeconomic evidence for selected medicines Reviewing evidences, requesting more information and making recommendations Screening drug applications submitted by pharmaceutical companies Gathering and generating evidence NLED development process Commission HITAP to conduct pharmacoeconomic assessment The Health Economic Working Group commissions Health Intervention Technology Assessment Program (HITAP), an independent research institute under the Ministry of Public Health, to conduct pharmacoeconomic assessment. Results of these studies are subsequently considered by the Subcommittee for inclusion/exclusion of these drugs from the NLED. HITAP has also developed guidelines on pharmacoeconomic studies. HTA process Research projects: Cost-utility analysis of recombinant human erythropoietin in anemic cancer patients induced by chemotherapy Findings: Erythropoietin was cost-ineffective for treatment of anemia induced by chemotherapy among cancer patients Issues taken by: The Subcommittee for development of the NLEM Current policy: Erythropoietin was not recommended for treatment of anemia among cancer patients in Thailand HTA study by HITAP and Current Policy Any technology with a cost per quality-adjusted life-year gained below the average GDP per capita is considered acceptable for inclusion on the NLED. Cost-effectiveness benchmark Applicable to all three national health insurance schemes
  • 26. 26Client Confidential – Do not share 20142012200920062003 Thailand is leading HTA movement in ASEAN region HTA has evolved over this ten years and actively expanded international network Health Technology Assessment Unit Universal coverage policy NLEM 2004 revision HITAP established The National HTA guidelines and database collaboration agreement InsuranceschemeDomesticHTAsInternationalHTAs 2002 2004 2005 2007 2008 2010 NLEM 2013 revision 2011 2013 2015 ISPOR Thai Chapter established NLEM 2008 revision HTAsiaLink established Organized capacity development meeting
  • 27. 27Client Confidential – Do not share Singapore Singapore Japan Population in 2013 (mn people) 5.4 127.4 Urban population rate in 2013 (%) 100 92 GDP in 2013 (bn USD) 297.9 4,898.5 GDP in 2019 (bn USD) 369.1 5,433.4 GDP per capita in 2013 (th USD) 55,182 38,468 GDP per capita in 2019 (th USD) 65,701 43,504 THE/GDP in 2012 (%) 4.7 10.1 Pharmaceutical market CAGR (2014-2020, %) 2.0 2.0 *GDP: Growth Domestic Product, THE: Total Health Expenditure
  • 28. 28Client Confidential – Do not share Singapore enables drug access through private saving funds Ongoing iterations to the insurance schemes expands options Drug Coverage HTA Situation Public Health Insurance SituationSingapore Japan Population coverage by public financial protection schemes 93% 100% Government expenditure of total healthcare expenditure in 2012 (GGHE/THE) 37.6% 82.1% OOP rate of total health expenditure in 2012 58.6% 13.1% OOP rate as % of private expenditure on health in 2011 94.1% - Singapore has established Standard Drug List (SDL) since 1979. There are two groups in the SDL. SDL group 1 drugs are essential first-line drugs for which patients pay SG$1.40 per item per week. SDL group 2 drugs are relatively more expensive essential drugs for which patients pay 50% of the selling price. Although there is no subsidy for nonstandard drugs, subsidized patients can pay for nonstandard drugs from their Medisave and/or Medishield (in- patients). An annual call for applications for standard drugs inclusion is made by the Ministry of Heath (MOH) to the public institutions. And Drug Advisory Committee (DAC) in the MOH evaluates application. Standard Drug List for public sector reimbursement The government has taken balance of public and private spending on health. Medisave is a compulsory national medical savings scheme for individual hospitalization expenses. To complement Medisave, Medishield was introduced to cover expensive medical cost which cannot be covered by Medisave balance. Medisave and Medishield are considered to be private spending which is the main reason for high OOP rate. The government established what is called three M schemes, by establishing Medifund which act as a safety net for the poor. The government is currently working to replace Medishield with Medishield Life which will be mandatory to further strengthen health financing system in Singapore. 100% coverage by Medishield Life by end of 2015 HTA is employed in variety of health related decision making process. It features in decision making for the SDL, licensing of medical clinics, the Health Service Development Programme, healthcare subsidies, and policy development. In the SDL selection process, DAC work with the Pharmaco-economics and Drug Utilization Unit of Health Science Authority (PMDA equivalent in Singapore). The technology assessment of a drug is based on its regulatory and formulary profile, incremental efficacy and safety, relative cost-effectiveness, the financial impact of including the drug in the SDL among with other epidemiological and clinical data. HTA to support SDL decision making
  • 29. 29Client Confidential – Do not share Singapore enables drug access through private saving funds Ongoing iterations to the insurance schemes expands options Healthcare Financing system in Singapore Cash Medisave Medishield* Medi Fund Subsidy Private financing Others Compulsory national medical savings scheme Low-cost catastrophic illness insurance scheme Social safety net for the poor 3M schemes Standard Drug List (SDL) Class I: Essential 1st line drugs Class II: relatively more expensive essential drugs Class Co-payment 1.40 SGD per item per week 50% of selling price Public financing Medication Assistance Fund (MAF) Assist patients with costly drugs that are not in the SDL but have been assessed to be clinical necessary, providing up to 75% subsidy Drug Advisory Committee evaluates drugs with technical assistance of the Pharmaco- economics and Drug Utilization Unit of HSA *Medishield will be updated to Medishield Life by end of 2015 to cover non-eligible population such as people with pre-existing conditions
  • 30. 30Client Confidential – Do not share Malaysia Malaysia Japan Population in 2013 (mn people) 29.9 127.4 Urban population rate in 2013 (%) 73 92 GDP in 2013 (bn USD) 313.2 4,898.5 GDP in 2019 (bn USD) 535.8 5,433.4 GDP per capita in 2013 (th USD) 10,457 38,468 GDP per capita in 2019 (th USD) 16,170 43,504 THE/GDP in 2012 (%) 3.9 10.1 Pharmaceutical market CAGR (2014-2020, %) 9.0 2.0 *GDP: Growth Domestic Product, THE: Total Health Expenditure
  • 31. 31Client Confidential – Do not share Full UHC access, yet the majority of growth comes from private / OOP care If you can afford to cut the queue… Drug Coverage HTA Situation Public Health Insurance SituationKey indicators Malaysia Japan Population coverage by public financial protection schemes 100% 100% Government expenditure of total healthcare expenditure in 2012 (GGHE/THE) 55.0% 82.1% OOP rate of total health expenditure in 2012 35.6% 14% OOP rate as % of private expenditure on health in 2011 79% - HTA on drugs is still limited Malaysia HTA Section (MaHTAS), a department of Ministry of Health, published the drug formulary and guideline for pharmacoeconomics in the past two years. The areas covered in the guidelines include: the types of economic evaluation that need to be carried out by, the costing approaches that are acceptable, the outcome issues, discounting, sensitivity analysis, the acceptable cost-effective ration and also the budget impact analysis. However, due to limited capacity, the number is drugs evaluated are limited. Recent study was to evaluate and recommend pneumococcal vaccine for children below five yeas old to its national immunization program. Drugs available in the public sector are highly subsidized (80- 90%). Each public hospital has their own budget allocated and each hospital manage within the budget. Although drugs are highly subsidized, it is unclear that how their own budget is allocated to drugs and it is up to their financial situation. In private sector, majority of drugs are paid directly from patients which drive up OOP rate in Malaysia. Domestically available generics as well as absence on pricing regulations further contribute to a market with high complexity. Low OOP in public; High OOP in private Malaysia has achieved universal health coverage through a public healthcare system providing near-free comprehensive care financed though general taxation. However private healthcare system is getting popularity to meet demand of wealthier people which, which is the reason for high OOP rate despite of the UHC system. The government has faced challenges as to how to balance public and private sector and maintain UHC in the country. In 2012 the government proposed “1Care for 1Malaysia” policy which would allow the insured to access private facilities. However, it appear to be unsuccessful so far. The government seem to be struggling to modify the distort of UHC in Malaysia. Rise of private sector affect OOP rate
  • 32. 32Client Confidential – Do not share Philippines Philippines Japan Population in 2013 (mn people) 97.5 127.4 Urban population rate in 2013 (%) 45 92 GDP in 2013 (bn USD) 272.1 4,898.5 GDP in 2019 (bn USD) 517.3 5,433.4 GDP per capita in 2013 (th USD) 2,791 38,468 GDP per capita in 2019 (th USD) 4,712 43,504 THE/GDP in 2012 (%) 4.6 10.1 Pharmaceutical market CAGR (2014-2020, %) 9.4 2.0 *GDP: Growth Domestic Product, THE: Total Health Expenditure
  • 33. 33Client Confidential – Do not share PhilHealth has a broad reach in the population Expansions into the remaining population sectors have been mandated Drug Coverage HTA Situation Public Health Insurance SituationPhilippines Japan Population coverage by public financial protection schemes 78% 100% Government expenditure of total healthcare expenditure in 2012 (GGHE/THE) 37.7% 82.1% OOP rate of total health expenditure in 2012 52.0% 13.1% OOP rate as % of private expenditure on health in 2011 83.5 - PhilHealth is responsible for the reimbursement of drugs on the PNDF. PhilHealth manages drug cost through pre-determined ceilings, which are decided based on the severity of the disease and the classification of hospitals. For example, the benefit ceilings for drugs when patients are in secondary hospital are USD75 for case type A (simple) diseases, USD249 for case type B (moderate) diseases, USD499 for case type C (severe) diseases. The Philippine National Drug Formulary (PNDF) lists reimbursable drugs under the National Health Insurance Program in addition to a positive list, which is a compilation of non-PNDF drugs that are also reimbursable. Please note prior instances of mandated price cuts. Reimbursement is based on pre-determined ceilings Philippine Health Insurance Corporation (PHIC), more commonly knowns as PhilHealth administers the National Health Insurance Programme. The NHIP’s target was to attain universal coverage within 15 years of its implementation in 1995. However, as of 2012 PhilHealth covered approximately 78% of the total population. Philippines’ decentralized healthcare service is also challenge to support efficient comprehensive care. In 2013, the president of the Philippines amended the National Health Insurance Act of 1995, which mandates the government to shoulder the premiums for the insurance of the indigent and informal sectors. This is estimated to drive coverage and benefit expansion. Further political support to complete UHC The first HTA attempt was initiated when the HTA Committee in PhilHealth was established in 1999. The committee aimed to develop reimbursement policies. One of major functions of the committee was conduct of drug assessments to determine which drug should be reimbursed. However, due to lack of political support and leadership changes, HTA underwent period of silence . Since 2009, several policies have made breakthrough to revive HTA. Department of Health is now active partnering with NICE and Thailand’s Health Intervention and Technology Assessment Program. However HTA is not yet formally implemented in drug reimbursement decision process. HTA is not yet formally implemented on drugs
  • 34. 34Client Confidential – Do not share Vietnam Vietnam Japan Population in 2013 (mn people) 89.7 127.4 Urban population rate in 2013 (%) 32 92 GDP in 2013 (bn USD) 170.6 4,898.5 GDP in 2019 (bn USD) 281.4 5,433.4 GDP per capita in 2013 (th USD) 2,497 38,468 GDP per capita in 2019 (th USD) 2,948 43,504 THE/GDP in 2012 (%) 6.6 10.1 Pharmaceutical market CAGR (2014-2020, %) 15.4 2.0 *GDP: Growth Domestic Product, THE: Total Health Expenditure
  • 35. 35Client Confidential – Do not share Strong public commitment to expand UHC coverage But incentives for overconsumption of services and drugs hinder this Drug Coverage HTA Situation Public Health Insurance SituationVietnam Japan Population coverage by public financial protection schemes 65% 100% Government expenditure of total healthcare expenditure in 2012 (GGHE/THE) 42.6% 82.1% OOP rate of total health expenditure in 2012 48.8% 13.1% OOP rate as % of private expenditure on health in 2011 83.2% - Current payment mechanism include fee-for-service, capitation, and a DRG pilot. Due to market liberalization policy, hospitals depend on their revenue from provision of their services which are reimbursed by Vietnam Social Security which manages the SHI, and paid by patients. Pharmaceutical sales are a good source of hospital revenue. In fact health providers have a strong preference for branded drugs, and drug expenditure account for 60% of total VSS spending in 2010. VSS pays an average of 89.2% of total pharmaceutical expenditure in hospitals. At this moment the Health Insurance Reimbursement List (HIRL) is in favour of branded drug manufacturers. Strong brand preference of the reimbursement list The national Social Health Insurance (SHI) program was established when Health Insurance Law was passed in 2009. The government consolidated existing scheme into one SHI program which is, in principle, a single payer and a single pool with a unified benefits package model. However, enrolment rates remain low, and funds pooling is highly fragmented. High OOP rate indicates the SHI system is not functioning well. In 2012, the Ministry of Health produced the “Master Plan for Universal Health Coverage from 2012-2015 and 2020” The Master Plans clearly set target to reach SHI coverage of 70% by 2015 and 80% by 2020, and to reduce OOPs to less than 40% of total expenditures by 2015. Commitment to cover 80% of population by 2020 Vietnam does not have a national program for HTA or similar evidence-based decision making process. Currently, there is no regulated or transparent process for selecting drugs for reimbursement, or rules about who should be on the committee to represent different stakeholders. VSS, the payer of the SHI, has no direct role in the benefit package decision making process. Selection of reimbursed drugs is decentralized and subject to hospital preference. No HTA process in place for reimbursement
  • 36. 36Client Confidential – Do not share The government commit not only population coverage but also OOP rate Program A 2012 2020. . . 2009 65% 80% year population coverage OOP rate Program B Program C Variousprograms Healthcare Fund for Poor Social Health Insurance Managed by Vietnam Social Security • Single payer model 2015 70% 48.8% <40% Health Insurance Law Master plan for UHC
  • 37. 37Client Confidential – Do not share Concept Overview Country Discussion ASEAN Regional trends Conclusions and Business Opportunities Why does Asia / ASEAN matter? Deallus Introduction
  • 38. 38Client Confidential – Do not share Evolving HTA dynamics: Keep an eye on collaboration mechanism to understand change and influencing factors Various stakeholders are collaborating to develop and promote pharmacoeconomics and HTA in Asia International Society for Pharmacoeconomics and Outcomes Research Foundation: 2011 Members: Scope and Activities: HTA is the main focus. Health economic is part of scope. Annual conference (4th conference: May 2015 in Taiwan) / News Letters Government / HTA agent network Multi-stakeholder network AsiaregionalGlobal Foundation: 2003 in Japan Members: Scope and Activities: Health economic and outcome research is main focus. HTA is a part of its scope. Biennial Asia-Pacific conference (7th Conference: 2016 in Singapore)/ Academic journal (Value in Health)/ News Letters/ Regional Chapters Note: HTAi: Health Technology Assessment International , INHTA: The International Network of Agencies for Health Technology Assessment, ISPOR: International Society for Pharmacoeconomics and Outcomes Research, HERO: Health Economic and Outcome Research This is not exhaustive mapping. Governments or HTA agencies only Various stakeholders including academia, industry, patients HTA HEOR HEOR HTA HTA net Asia *Annual meeting: 2016 in Tokyo * ISPORS has regional affiliation
  • 39. 39Client Confidential – Do not share 2015 was the plan for ASEAN economic integration Majority of initiatives are delayed and would not be achieved by end of 2015. At this moment, no immediate impact is expected for pharma industry. Member countries Indonesia Philippines Thailand Vietnam Myanmar Malaysia Singapore Brunei Darussalam Lao PDR Cambodia 202520202015201020001997 2003 2006 Declaration to establish “ASEAN community” by 2020 Declaration to accelerate “ASEAN community” by 2015 2014 ASEAN 2020 vision: conceptualization of “ASEAN community” Post-2015 vision 2016-2025 conceptualization Current status: Although some components of AEC such as tariff reduction are well progressed, majority of initiatives are delayed. It appears that completion of the integration by 2015 would be unrealistic. Given this situation, ASEAN started to discuss post-2015 vision 2016-2025. ASEAN Economic Community (AEC) Initiatives Status Pharma related issues Elimination of non- tariff barrier Free movement of skilled professionals Not progressed Limited progress Integration of regulatory system MRA of product approval Free-movement of physicians (not started)
  • 40. 40Client Confidential – Do not share ASEAN+3 countries are collaborating to share experiences Regionally overarching forums are mutually influential, but no interfering Although there may not be immediate impact, it is worth capturing international dynamic and regularly assessing implication to pharma industry ASEAN integration does not have element of national health insurance coverage. This is because, national health insurance is rather seen as internal political issue of each member country which is against ASEAN principle of non-interference in the internal affairs. However, a group of wider stakeholders, ASEAN, China, Japan, Republic of Korea, are collaborating toward achievement of universal health coverage in the region. In 2012 ASEAN Plus Three UHC Network was conceptualized. The network has work plan 2014-2016 such as monitoring UHC progresses and capacity development. The network aim to be a platform of information sharing and guidance toward UHC. Although they collaborate, it is unclear if they are producing solid outcomes to achieve their goals. Japan is particularly active in promoting UHC as the country has long established history. For example Japan has been collaborating with the world bank to share its experience. They had publication on UHC in 2014. In February this year, ministry of health started discussion on Japan’s long term healthcare vision which includes communicating Japan’s experience to Asian counties. • Cost-effective viewpoint • Influence on Asian coutries
  • 41. 41Client Confidential – Do not share Why do Japanese Companies have an Advantage in Asia? ❶ Similar Disease Pattern
  • 42. 42Client Confidential – Do not share Why Japanese Pharma have advantages ❶ Similar Disease Pattern Similar disease patterns between Japan and Asian region results in similar unmet needs, generating synergy in prioritizing product development strategies Japan share more similar oncology pattern with Asian market than Western markets (Bottom-Left illustration). Change of disease patterns in less developed Asian region will attract more Japanese pharma that specialise in chronic disease care as well (Bottom-Right illustration). China Lung (18%) Stomach (16%) Liver (16%) Esophagus (12%) Colorectal (7%) Breast (6%) H&N (3%) Leukemia (3%) Korea Stomach (22%) Lung (14%) Liver (13%) Esophagus (2%) Colorectal (9%) Breast (5%) H&N (3%) Cervix (4%) Japan Lung (13%) Stomach (19%) Liver (7%) Pancreas (4%) Colorectal (18%) Breast (7%) Prostate (5%) Gall / Bile duct (3%) United States Prostate (13%) Lung (13%) Colorectal (8%) Melanoma (4%) NHL (4%) Breast (14%) Kidney (4%) Bladder (3%) New Cancer Cases in East Asia Countries and the US Asian countries share more similarities in disease patterns Source: Clinical Trials in Asia Pacific – New Challenges and Opportunities, Partnerships in Clinical Trials Asia Pacific (Singapore, 02 DEC 2009); American Cancer Society, 2015 9% 9% 2% 3%8% 13% 12% 12% 9% 15% 32% 14% 28% 35% 2008 2030 8% 7% 2% 3% 15% 20% 9% 8% 21% 23% 11% 5% 34% 35% 2008 2030 Cardiovascular disease Infectious disease, malnutrition Cancer Injuries Respiratory disease Diabetes Others Development of Disease Pattern, 2008-2020 ASEAN Western Pacific Source: Leveraging ASEAN market, Researchpartnership.com
  • 43. 43Client Confidential – Do not share Why Japanese Pharma have advantages ❷ Advantage of multinational clinical trial design in Asia for faster regulatory approvals Ethnic similarity allows Japan pharma to design collaborative trials and shorten the launch gap in these markets The bottom-left illustrates a therapeutic area where the highest level of ethnic difference exists. - Considerable ethnic difference between East and West, which often result in differences in clinical practice, guideline, dosage, active control, concomitant drugs - Even in this situation, clinical studies can be co-designed in Japan and Asia at the same thanks to low genetic diversity (illustrated in the Bottom-right), ultimately shortening the time for Japan-focused trial sponsors to enter the Asian market than Global sponsors who proritise US and EU market. Phase 3 Phase 3Phase 2 Phase 1US, EU Japan Asia Phase 1 Phase 2 Fully Separated Clinical Study Collaboration Origin of Clinical study Collaborate-ability between regions Source: Tetsuomi Takano, New Strategy on Multinational Clinical Trials in China and Japan in Consideration of Ethnic Factors, JPMA http://www.pmda.go.jp/files/000152237.pdf Arrows indicate genetic diversification flows Genetic diversity is limited within the region due to close proximity
  • 44. 44Client Confidential – Do not share Why Japanese Pharma have advantages ❸ High awareness of Japanese brands & Geographical/Cultural relatedness Japanese companies could be benefited from high awareness of Japanese brands stemming from consumer products/electronics in the region (Left illustration) Especially large conglomerates with healthcare divisions could enjoy an existing share of voice Geographical proximity and similarity across cultures and business practices between Asian countries and Japan lower the operational challenges of international strategy development and implementation from HQ (Bottom illustration) Comparison of Top 60 Brands in Global VS Asian region Adidads Jaguar Adidas McDonald's Amazon.com Johnson&Johnson Ajinomoto Mercedes-Benz American Express Lexus American Express Microsoft Apple LG Apple Mitsubishi Electric AT&T L'oreal BMW Muji Audi MasterCard Canon Nestle Bayer McDonalds Citibank Nike Berkshire Hathaway Mercedes-Benz CocaCola Nikon BMW Michelin Colgate Nissan Bridgestone Microsoft Daihatsu Nivea Cadillac Nestle Danone Nokia Chevrolet Nike Dell P&G Cisco Nissan Epson Panasonic CocaCola Nivea Gap Philips Disney Novartis General Electrics Samsung Ernst & Young P&G Google Sharp ExxonMobil Pepsi H&M Shiseido Facebook Philips Haagen-Dazs Siemens Ford Porche Hitachi Sony General Electric PwC Honda Starbucks Google Samsung HP Suzuki Gucci Shell HSBC Toshiba H&M Siemens Hyundai Toyota Hershey's Sony IBM Unicharm Honda Starbucks Johnson&Johnson Unilever HP Toyota Kao Uniqlo HSBC Twitter Kellog's Visa IBM Unilever KFC Xerox Infiniti Visa LG Yahoo Intel Volkswagen L'Oreal Yamaha 10%of Japanese Brands in Global Top 60 Most Popular Brands in 2014 VS 35%of Japanese Brands in Asian Top 60 Most Popular Brands in 2014 Source: Brand Asia 2014 Survey Results, Nikkei BP Consulting, Ranking The Brands Top 100 www.rankingthebrands.com Process- oriented Result- oriented Formal, structured business setting Casual, less distant business setting Humility, patience, harmony Confid- ence, demons- trativenss Indirect communi cation Direct commu- nication Team credit Personal credit Genera- ting profit Creating Share- holder value Commonly shared corporate goal (●) and operational considerations (○) Source: How to Crack Asian Business, 2011, Fortune 21 Cultural Clues for Doing Business in Asia, 2013, The Business Journals Asia West
  • 45. 45Client Confidential – Do not share Significant changes matched with political commitment Dynamic landscape: Increasing political investments and HTA evaluation processes will create greater market opportunity Health insurance coverage dynamics HTAdynamics High uncertainty Relatively established, HTA to be accelerated
  • 46. 46Client Confidential – Do not share Country Key Take-aways Singapore: Maintaining its position as key market entry node? Malaysia: Is the current model sustainable? Thailand: With UHC established, where next? Philippines: Would further price cuts be mandated to achieve UHC? Indonesia: Where will the UHC spending priorities be by 2019? Vietnam: Will the price gap between brands and generics narrow?
  • 47. 47Client Confidential – Do not share ASEAN Region A 650 million people economy potential! Member countries Indonesia Philippines Thailand Vietnam Myanmar Malaysia Singapore Brunei Darussalam Lao PDR Cambodia
  • 48. 48Client Confidential – Do not share Concept Overview Country Discussion ASEAN Regional trends Conclusions and Business Opportunities Why does Asia / ASEAN matter? Deallus Introduction
  • 49. 49Client Confidential – Do not share About Deallus Consulting Deallus Consulting improves your strategy by developing, testing and refining the key market assumptions that underpin it. We can do this because of our focus on the Life Sciences industry, our efficient and comprehensive research and our rigorous analysis Deallus Global Footprint Was Founded in London in 2004 with offices in New York, Princeton, Los Angeles, Singapore, Tokyo and dedicated, exclusive support in China and LATAM Has completed over 1,000 assignments Has over 80 Consultants Is a Life Science specialist, with more that 80% of our Consultants possessing a Life Science PhD Has >90% client retention, (clients we continue to work with since our first engagement) Supports any decision maker or manager involved in strategy development, right across the Product Life Cycle, in the largest multinationals or SME’s at Global, Regional and Affiliate level Deallus Consulting www.deallusconsulting.com
  • 50. 50Client Confidential – Do not share Deallus Consulting What We Do Deallus’ expertise in strategic management consulting spans a range of services across product lifecycle, in strategy development, in business development, brand management, market access and manufacturing and supply chain Deallus has extensive experience in effectively leading and implementing competitive workshops consistent of scenario planning workshops, war games, individualized training programs and hybrid models Deallus’ best in class competitive analysis is based on rigorous research and analysis to test and refine the assumptions, to ensure winning strategies based on a robust understanding of the market www.deallusconsulting.com
  • 51. 51Client Confidential – Do not share Deallus has supported its clients in optimising robust market entry strategies for the Asian markets • What is the total number of patients in each indication • What is the number of eligible patients in each indication • How well developed is the healthcare infrastructure for each indication in each of the markets? • What is the treatment pathway for each indication in each market? • Who are the key influencers in each market? • What are the regulatory requirements for approval • What are the regulatory timelines for approval in each market • will post registration activities be required • What are the pricing and reimbursement requirements for each indication in each market? • How does the pricing differ depending on setting of care? • What are the pricing timelines? • Who are the key competitor in the market? • What is the competitor strategy and impact on your company? • What is the competitor market share vs your market share? • What are the winning sales and marketing strategies tailored for each market? • What is the product penetration per account? • Who are the key stakeholders to target per indication per market • The drivers and strainers of growth within each market? Asian market strategy must take into account all factors affecting the market’s true potential Patient Population Dynamics Product Registration and Launch Competitor Landscape Pricing and Market Access Sales and Marketing Strategy Healthcare Landscape
  • 52. 52Client Confidential – Do not share Deallus Consulting Who We Are Our Presence in Asia builds on a strong foundation of Project Management from JPAC HQ, with on-the-ground support from local consultants www.deallusconsulting.com Anousha Kamvari, PhD Senior Consultant, Singapore Ju Hyoung Lim, PhD Consultant, Singapore Carole Bruckler, PhD Partner, Head of Japan & Asia Pacific Michael Lee Business Analysts, Singapore Supported by other Local Researchers Feng Wang, PhD Consultant, Tokyo Hiroyuki Onoda Associate, Singapore Tom Chang, MBA Associate, Singapore Budiman Jimron, MSc Associate, Singapore Alicia Yang Jenkins, PhD Ichiro Masuda Principal, Head of Japan Operations Carl Qian, PhD Associate, Singapore 3
  • 53. 53Client Confidential – Do not share Deallus Consulting JPAC Team Carole Bruckler, PhD – Partner, Head of JPAC Carole Brückler is the Head of the Deallus Consulting Japan & Asia-Pacific operations, based in Singapore. She has led client engagements developing regional or global product strategy for 9 of the top 10 global pharma companies. Carole’s clients assignments have enabled business decisions reflecting market evaluations of new products and acquired assets, pricing and reimbursement challenges, generic and biosimilars entry and landscape assessments to validate opportunities present existing portfolios. Carole’s experience covers multiple therapy areas, particularly Vaccines, CNS, CVM and respiratory field, as well as medical devices field. Prior to setting up the Asia Pacific operations for Deallus consulting, she led the established European business. Carole has also lectured at multiple Pharma industry conferences on the challenges of conducting research in the vaccines area, in Europe, US and China. Prior to joining Deallus, Carole worked in preclinical R&D, both in a synthetic organic setting, as well as an analytical setting in support of asthma treatments at GSK. Carole completed her PhD in Chemical Biology at the University of Edinburgh. Carole is a joint inventor and patent holder of this technology. In addition to her academic qualifications and professional credentials, Carole speaks several European languages. Ichiro Masuda – Principal, Head of Japan Operations & Representative Director Ichiro Masuda is the Principal, Head of Japan Operations and Representative Director in the Deallus Tokyo Office. Ichiro joined Deallus with 27+ years of experience in sales, marketing, marketing research, business development in the pharmaceutical industry. He spent 21 years at Eli Lilly Japan in progressively senior sales, marketing and product management roles, before he moved to the consulting industry. At IMS Consulting, he worked in the Commercial Practice, delivering market optimisation, resource allocation and marketing training projects. At ZS Associates, he developed the area of strategic market research in ZS Tokyo and worked on forecasting and business development assignments, while managing business development and client engagements. Ichiro is a graduate of Kyoto University in Economics, a nationally registered management and healthcare consultant, as well as a native Japanese speaker.
  • 54. 54Client Confidential – Do not share Deallus Consulting JPAC Team Anousha Kamvari, PhD – Senior Consultant Anousha is a Senior Consultant based at our Singapore office. Anousha offers broad experience across both the medical device and pharmaceutical industries. Her areas of expertise include strategic and operational leadership in market entry, market analytics, pricing and reimbursement, regulatory (FDA, EMA, CFDA) and compliance systems for medical devices including drug-device combination products and pharmaceuticals. Prior to joining Deallus, Anousha was instrumental in advising senior management at BTG, an international specialist healthcare company, on go no-go business case investments for multiple brands across the Interventional Oncology franchise; at both a regional and global level. Anousha holds a PhD in Biomaterials Engineering from University of Cambridge and a 1st class honours MEng degree from Queen Mary University of London. She has authored two book chapters within the field of Biomaterials Engineering. Feng Wang , PhD – Senior Consultant Feng is a Senior Consultant at Deallus Consulting Tokyo office, recently transferred from Deallus Global Headquarter in London. He joined Deallus London in 2011 and since then, he has led client engagements across wide therapy areas (Oncology, Vaccines, Urology, Ophthalmology & Biosimilars) at product and portfolio level. His prior and ongoing projects support top 20 MNC including Japanese pharmaceutical companies in competitive landscape analysis, product launch preparation, commercial structure benchmarking, emerging market entry strategies as well as clinical development and new product planning. His market expertise covers EU, US and Emerging Markets in Asia. Feng holds a PhD in Oncology from the University of Cambridge examining the mechanism of chemotherapy resistance in ovarian cancer and an MBioch from the University of Oxford. During his PhD, he also developed commercial knowledge through pharma-sponsored workshops and Technology Management course at Cambridge Judge Business School. Feng speaks English, Mandarin and basic Japanese.
  • 55. 55Client Confidential – Do not share Deallus Consulting JPAC Team Lim Ju Hyoung, PhD – Consultant Ju Hyoung is a Consultant at Deallus Consulting, Singapore. Since joining Deallus, he has led a broad range of projects covering Korea, China, Japan, Australia, South East Asia, as well as Europe, supporting clients by providing bespoke insights in various therapeutic areas including infectious diseases, oncology, autoimmune diseases, orphan diseases, etc. In addition, he has worked in a number of projects with extensive focus on biosimilars, vaccines, aesthetic products.​ Ju Hyoung has earned a PhD in Biological Sciences from Korea Advanced Institute of Science and Technology (KAIST) and completed a postdoctoral fellowship at Massachusetts Institute of Technology (MIT). He also spent considerable time working with Korean biotechnology start-up companies, consulting on process optimization projects, as well as managing collaborations with government departments to develop research proposals and assess the commercialization potentials of these projects. He is a native speaker of Korean, and is fluent in English. Hiroyuki Onoda, BPharm – Associate Hiroyuki Onoda (Hiro) is an Associate in the Deallus Singapore office. At Deallus, Hiro has supported a wide range of projects ranging from R&D strategy, marketing strategy and competitive landscaping to supply chain optimization. Hiro brings in-depth insights from the Japanese market to multiple projects, bridging cultural gaps and engaging with Japanese client teams. His research and analysis has covered multiple therapy areas (oncology, hepatology, gastroenterology, CVM & CNS) as well as vaccines and biosimilars. Prior to joining Deallus, Hiro worked as a marketing specialist at Suzuken in Japan, the third largest domestic pharmaceutical wholesaler, developing expertise in sales, promotion and physician engagement for a wide range of pharmaceutical products across therapy areas, both branded and generic, including vaccines and diagnostics. During this time he developed a deep understanding of the supply chain, sales and marketing and the Japanese healthcare system through working with a variety of pharmaceutical companies in highly competitive environment. Hiro is bilingual (Japanese/ English), holds a B.S. in pharmaceutical sciences & is a registered pharmacist in Japan.
  • 56. 56Client Confidential – Do not share Deallus Consulting JPAC Team Budiman Jimron, MSc – Associate Budiman is an Associate at Deallus Consulting, Singapore. He has earned a Masters in Integrated Biosciences from the University of Tokyo, and had considerable working experiences with Japanese consultancy firm on market entry strategy for Japanese companies in South East Asia. Since joining Deallus, he has worked on projects covering Indonesia, Malaysia and other APAC countries, supporting research efforts into various therapeutic areas such as diabetic nephropathy, vector-borne diseases, etc. He is a native speaker of Bahasa Indonesia, and is fluent in English and Japanese. Tom Chang, MBA – Associate Tom Chang is an Associate in the Deallus Singapore office. He is an MBA graduate of Hitotsubashi University, Graduate School of International Corporate Strategy in Tokyo, Japan. He received his BSc from University of British Columbia (UBC) in Vancouver, Canada. Tom has worked in the technical side of pharmaceutical companies and brings a unique perspective of drug development and product planning. He has experience in the Japanese Generics Market through an internship at Mylan Seiyaku (Pharmaceutical) Ltd., where he was assigned to assist on three products, one product line expansion and two product developments for antipsychotic and migraine attack treatments. Tom speaks English, Mandarin and Japanese.
  • 57. 57Client Confidential – Do not share Deallus Consulting JPAC Team Carl Qian, PhD – Associate Carl is an Associate at Deallus Consulting’s Singapore office. Since joining Deallus, he has worked on multiple projects covering Asia Pacific and the US, supporting clients in fields such as oncology, infectious diseases, vaccines and drug manufacturing. Carl graduated from the PhD program in Mechanobiology from National University of Singapore. His PhD research area was in computational biophysics. He holds a Bachelor of Science in Biological Science and a minor in Computer Science from Fudan University in China with a thesis focusing on Breast cancer genomics. He also had internship experience at Novartis Institute of Biomedical Research, working on antibody-based biomarker discovery. Prior to joining Deallus, he was an Associate at SingTel Group in its Tel Aviv office, working on innovation and business partnerships in the high-tech sector. He is fluent in English and Mandarin Chinese. Michael Lee, MSc – Business Analyst Michael is a Business Analyst at Deallus Consulting in Singapore. In his time with Deallus, he has been involved in multiple projects with a primary focus in China and the rest of APAC region. Michael’s therapeutic area expertise include virology, digestive diseases, infertility, oncology, metabolism diseases, and cardiovascular diseases. Biosimilar and generic drug markets are two major focuses of his recent researches. Michael’s studies on competitor dynamics monitoring, potential trends prediction, business development support, regulatory policy research have supported commercial decision making. Michael holds a Master of Science degree in Biochemistry and Molecular Biology from National Cheng Kung University, Taiwan and specialized in cancer biology and metastasis mechanism. Before joining Deallus, Michael worked on business development and training services at PPC, the leading domestic clinical research organization in Taiwan. He also has internship experiences at Vita Genomics, Inc. and NanKang Biotech Incubation Centre on marketing and industrial development strategies analysis. Michael is fluent in Mandarin.
  • 59. 59Client Confidential – Do not share Acronyms AEC ASEAN Economic Community ASEAN Association of South East Asian Nations FDI Foreign Direct Investment GDP Gross Domestic Product NCD Non-communicable diseases OOP Out of Pocket SHI Social Health Insurance THE Total Health Expenditure UHC Universal Health Coverage