Thrombocytopenia in CLD - Market Access Landscape - Interim - 16012015

The catalyst for
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Thrombocytopenia in
Chronic Liver DiseaseMarket Access Study in
APAC
16/01/2015
Netscribes Team
www.kantarhealth.com
2013 Kantar Health
Status update
Project status update
Stakeholder
Sub-categories
Singapore
Malaysia
Thailand
Indonesia
CLD
Epidemiology
Platelet
Transfusion
Vietnam
Philippines
WIP
WIP
CLD with
Thrombocytopenia
NA
NA
NA
NA
WIP
WIP
Status quo
NA
NA
NA
NA
WIP
WIP
WIP
WIP
National regional
guidelines
NA
CLD (all)
WIP
Invasive procedures
WIP
WIP
WIP
KOL
Current Drugs
Treatment algorithm
Pricing and Reimbursement status
Local drug listing process
WIP
WIP
Generalize for
TCP
Generalize
for TCP
WIP
WIP
Insert Presentation Title - Date
WIP
WIP
WIP
WIP
WIP
WIP
WIP
WIP
WIP
WIP
WIP
WIP
WIP
2013 Kantar Health
Data gaps
Limited data points through secondary research;

which needs to be fulfilled by KOLs in CLD with TCP
Stakeholder
Singapore
Malaysia
Thailand
Indonesia
Vietnam
Philippines
Incidence
CLD
CLD with TCP
Prevalence
CLD
CLD with TCP
Platelet transfusion regional
situation
Diagnosis and Treatment rate
Alternate therapies of
transfusion
Operational guidelines
KOLs with Invasive
procedures
CLD- Chronic liver disease, TCP- Thrombocytopenia Very limited data available
2013 Kantar Health
Executive Summary
Payers and Prescribers:

Commercial
Commercialand
and
Strategic
Rationale
Strategic
Rationale
Epidemiology
Current and
Evolving
Landscape
Key
stakeholders
Unmet Need
Thrombocytopenia
Epidemiology
Incidence (2012 Singapore vs. Malaysia vs. x vs. y):
Idiopathic thrombocytopenia:
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Emerging Landscape
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MoA Type: Drug name (company name) + drug combination, estimated launch date, phase when applicable
Prescriber
Payers
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2013 Kantar Health
Executive Summary
Primary sample size
Stakeholder
Singapor
e
Types
Malaysia
Thailand
Indonesia
Vietnam
Philippines
Total
Hematologist
Medical oncologist
Prescriber
Gastroenterologist
Hepatologist
Any other
Government
Payers
Private
Total
2013 Kantar Health
Executive Summary
Thrombocytopenia Market access:

Driver and challenges
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Driver &
Challenges
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Indonesia
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2013 Kantar Health
Agenda
Vision, Background, Objectives and Outcomes

Project Approach and Overall Research Framework
Disease Overview
Current Treatment and Market Landscape
Emerging Treatment Landscape
Platelet Transfusion Regional Guidelines
Drug listing process
Reimbursement Scenario of current approved drugs
KOL Identification
Physician and Payers (Treatment & brand choices/barriers to treatment)
2013 Kantar Health
Project Background and Objectives

Situation
Objectives
Phase I: Secondary research
Kantar Health has approached Netscribes

to evaluate market access landscape for a
Product X new oral drug that could be an
alternative to the current standard
treatment of platelet transfusion therapy.
The
disease
focus
area
is
Thrombocytopenia with chronic liver
disease undergoing invasive procedure
Understand the market, disease area, competitor

products etc.
Identify the physicians for treatment of
Thrombocytopenia (currently doing platelet transfusion
therapy) in different geography
Number of transfusions (if possible)
Number of HCC / Hep B / C numbers (if possible)
Number of Thrombocytopenia pats (if possible)
Other TBC
Product X is an orally active small molecule

TPO.
Phase II: Primary research
Product X profile:
In depth qualitative discussions with KOL and Payer/Policy

advisors to understand below mentioned data points
Thrombocytopenia (Platelet count of

<50,000uL) for patient with chronic liver
disease undergoing invasive procedure
Once- daily oral dose of a 3mg table, 7

days, before 9-14 days when invasive
procedure will be performed
To discuss the market opportunity for such a new drug

Discuss the current guidelines and treatment landscape
Understand the situation with platelet transfusion
Price of similar drugs
Possibility of being on the drug listing
Geography: Malyasia, Singapore, Thailand, Philippines, Indonesia, Vietnam

2013 Kantar Health
Project Outcomes
Key Questions
What is the prevalence/incidence of chronic liver disease by market?

What is the prevalence/incidence of thrombocytopenia by market and what is the
diagnosis rate?
Diagnosis
and
Treatment
rate of TCP
Lead KOL
profiles
What is the prevalence/incidence of thrombocytopenia among chronic liver patients by

market and what is the diagnosis rate?
What other alternatives available to platelet transfusion are being used?
Patient pool
for Product
X
Who are the key/lead KOLs involved in the invasive procedures?

Which KOLs should be targeted for interviews?
What are the regional guidelines are available for the use of platelet transfusion?
What is the pricing and reimbursement scenario for already approved drugs ( Revoledo
and Romiplate)?
What are the drug listing process of each geography?
Pricing and
Reimbursement
scenario
Regulatory
guidelines
and nuances
in each
geography

2013 Kantar Health
Agenda

Disease Overview
KOL Identification
2013 Kantar Health
10
Step 1: Identify opportunities for Product X

, by geography
1
2
Market Landscape
Clinical Landscape
4
KOL Profiling
Analytical Elements
Pricing and
Reimbursement
analysis
Sources
Current market analysis for each geography (Malaysia, Singapore, Thailand,

Philippines, Indonesia, Vietnam)
Current treatment paradigm (Dx. and Tx. rates), outcomes and current utilization
market size, market growth and key products
Current and future epidemiology and patient segments
Review pipeline competition
Focus on key competitors pursuing same segment
Create a short list of active compounds
Global and Regional Guidelines

Clinical trials.gov
WHO International Clinical Trials Registry
Platform
Company websites
Regional registries
Identify game-changers by geographies and future market landscape

Review published literature
Seek opinion of KOLs
Regional labels
Primary research
Pipeline analysis
Unmet need analysis by geographies

Challenges/Issues with current products
Issues being addressed by pipeline drugs, if any
Key Peer Reviewed Literature and syndicated

Reports
Primary Market Research
Current market and treatment landscape

2013 Kantar Health
11
Step 2: Understand the competitive intensity and

identify barriers/drivers for Product X
1
2
Market Landscape
4
KOL Profiling
Clinical Landscape
Analytical Elements
Pricing and
Reimbursement
analysis
Sources
Competitor analysis
Established benchmarks/ thresholds
Alternative therapies
Recent approvals
Trial analysis of key pipeline compounds
Regulatory guidelines
Primary research
Target Opportunity in thrombocytopenia with CLD in different invasive procedure

2013 Kantar Health
12
Step 3: To identify and profile KOLs for

conducting primary research
1
2
Market Landscape
Clinical Landscape
4
KOL profiling
Analytical Elements
Pricing and
Reimbursement
analysis
Sources
KOL profiling
Prescribers involved in treatment of thrombocytopenia
with CLD
Physicians involved in the invasive procedures
Published literature
Published papers by KOL in the area of interest
KOL profiles: Lead prescribers involved in treatment and invasive procedures

2013 Kantar Health
13
Step 4: Understand the current pricing and

reimbursement scenario with approved agents
& position for Product X
1
2
Market Landscape
Clinical Landscape
4
KOL profiling
Analytical Elements
Pricing and
Reimbursement
analysis
Sources
KOL profiling
Prescribers involved in treatment of thrombocytopenia
with CLD
Physicians involved in the invasive procedures
Regional regulatory guidelines

Primary research (Payor, Prescribers)
Pricing and Reimbursement scenario of each geography
2013 Kantar Health
14
Overall Research Framework
Treatment
Situation Analysis By Geography

Competition
Epidemiology
Market Size
Product X Opportunity Where to Play

Patient Settings
Unmet Needs
Future SoC
Game Changers
Target Opportunity How to Win

Desired Product Attributes
Clinical Development Path (Time to Market)
Product X Ideal Profile Value Proposition

Addressing Residual Unmet Needs
Clinical benefits and differentiators
Potential Opportunity Real Win Worth
Target Patient Pool
Pricing Potential
Geographic Potential
2013 Kantar Health
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Agenda

Disease Overview
KOL Identification
2013 Kantar Health
16
Disease Landscape
Orphan indication: Thrombocytopenia is a multisystem

disorder require urgent evaluation and treatment
Thrombocytopenia is a common complication in liver disease, and liver disease-related thrombocytopenia is often defined as a platelet
count < 100 109/L, including moderate (less than 100 109 /L) and severe (less than 50 109/L) thrombocytopenia 1, 2
Major mechanisms for thrombocytopenia in liver cirrhosis are:
platelet sequestration in the spleen
decreased production of thrombopoietin in the liver
For thrombocytopenia that is caused by platelet sequestration in the spleen, partial splenic embolization or laparoscopic splenectomy
are effective
Thrombopoietin agonists and targeted agents are alternative tools for noninvasively treating thrombocytopenia
A decreased platelet count can often be a diagnostic clue to unsuspected cirrhosis and to the presence of esophageal varices
Platelet
Platelet Production
Production33
Platelet
Platelet Destruction
Destruction33
Bone marrow & Myelosuppressive therapies

mmune
or idiopathic thrombocytopenic
Reduced thrombopoietin in the liver due to liver
disease (chronic hepatitis C,
cirrhosis, liver Failure)
purpura
Systemic viral or bacterial infection
HIV, HCV, HCB, Dengue
fever infects megakaryocytes, Sepsis
(ITP)
Vitamin B12 or folic acid deficiency

Numerous hereditary syndromes
Immune or idiopathic
thrombocytopenic purpura
(ITP)
Immune or idiopathic thrombocytopenic purpura

Autoimmune disorders
Disseminated intravascular coagulopathy (DIC)
Medications: drug-antibody complexes bind and
activate platelets
Heparin-induced thrombocytopenia has a rare
occurrence
Complications of thrombocytopenia1, 2
aggravate surgical or traumatic bleeding
significantly complicate routine patient care, such as liver biopsy, antiviral therapy, and medically indicated or elective
surgery for cirrhotic patients, resulting in delayed or cancelled medical management and affecting the administration of
effective treatment for several conditions (e.g., antiviral therapy for chronic hepatitis C virus (HCV) infection or chemotherapy)
Multiple factors, including splenic sequestration, reduced activity of the hematopoietic growth factor thrombopoietin (TPO), cirrhotic
coagulopathy, cirrhotic bone marrow suppression by chronic HCV infection and anti-cancer agents, and antiviral treatment with
interferon (IFN)-based therapy, can contribute to the development of thrombocytopenia in cirrhotic patients.
1. Hiromitsu Hayashi., et al; World J Gastroenterol 2014 March 14; 20(10): 2595-2605; 2. E. G. GIANNIN., et al; Aliment Pharmacol Ther. 2006 Apr 15;23(8):1055-65;
., et al, Am Fam Physician. 2012 Mar 15;85(6):612-622
pace
2013 Kantar Health
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Disease Landscape
CLD diagnosis guidelines by liver foundation;

gastroenterologist, hepatologist and radiologist
are the key stakeholders
Liver Function Tests
Liver function tests (LFTs) are basic tests that consist of a series of tests on a sample of blood done.
Liver function tests are performed in GP surgery, The most common are:
Alanine Aminotransferase (ALT)
- Provides an indication of the degree of inflammation as well as the possible causes
Aspartarte Aminotransferase (AST)
- Provides an indication of the degree of inflammation as well as the possible causes
Alkaline Phosphatase (ALP)
- Indicative of obstructive liver disease
Gamma-Glutamyl Transferase (GGT or "Gamma GT")
- Indicative of obstructive liver disease as well as alcohol usage
Bilirubin
- Suggestive of liver disease, especially in disease of the bile ducts
Albumin
- Suggestive of chronic liver disease
Clotting Studies (Prothrombin Time) - Suggestive of liver disease, especially worsening chronic liver disease if the
prothrombin time is prolonged, as the liver is significantly involved in the normal clotting of blood
Liver Ultrasound
Apart from LFTs, you may also be required to undergo a liver biopsy, patient go for ultrasound. As the ultrasound only gives a pictorial
overview of the liver, a liver biopsy is invariably the next step to definitely diagnose the liver disease.
Liver Biopsy
Liver biopsy is usually performed by a gastroenterologist, hepatologist or radiologist.
Sources: 1. Malyasian Liver Foundation
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Disease Landscape
Disease management in Thrombocytopenia

Global/International
Agent
Target disease
Recombinant Human Thrombopoietin
TCP, ITP
Romiplostim
ITP
HCV-related TCP
MDS
Eltrombopag
ITP
rhTPO
Withdrawn from clinical use
PEG-rHuMGDF
Withdrawn from clinical use
rhIL-11
Chemotherapy- induced TCP

TCP in patients with cirrhosis
TPO mimetrics (peptide TPO receptor

agonists
and nonpeptide TPO receptor agonists
TCP
E5501
HCV related TCP
TPO: Thrombopoietin; PEG-rHuMGDF: Pegylated recombinant human megakaryocyte growth and

development factor; rhIL-11: Recombinant human interleukin-11;TCP: Thrombocytopenia; ITP: Immune
thrombocytopenic purpura; HCV: Hepatitis C virus
Dose
0.2-10g/kg once a week (SC)

2g/kg once a week (SC)
Once a week (SC)
50mg once daily (PO),
IV
SC
50g/kg per day (SC)
50g/kg per day (SC)
25mg once daily (oral)
Sources: 1. Hiromitsu Hayashi., et al; World J Gastroenterol

2014 March 14; 20(10): 2595-2605
2013 Kantar Health
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Incidence of liver cancer in Malaysia is high, the

chronic HBV carrier rate varies between < 1% to
about 10%
Epidemiology
Chronic Liver Disease

Worldwide
Scenario
Hepatitis B is a major public health problem worldwide and more than 350 million people are chronic carriers,
constituting a major global threat which may lead to chronic liver diseases, cirrhosis and hepatocellular
carcinoma1
Southeast Asian Countries have the highest levels of endemicity in the world, with an estimated prevalence
ranging between 2% and 31%1
Incidence
The incidence of liver cancer in Malaysia is high, the chronic HBV carrier rate varies between < 1% to about 10%
depending on the different group2
Hepatitis B pre-disposes liver cancer and cirrhosis3
Prevalence
Worldwide data reveals that prevalence of cirrhosis is about 80-90% in persons suffering from HCC4
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection account for over 80% of HCC cases worldwide4
Of the total population, an estimated 2.5 million people suffer from chronic Hepatitis as per Malaysian Liver
Foundation (MLF)5
As per World Health Organization (WHO) estimates, 3-4 million people are infected by Hepatitis C and 150
million people are infected and are at the risk of developing liver cirrhosis or liver cancer 5
Mortality
In Malaysia, HCC is the third most common malignant neoplasm and among the 10 leading causes of death.
About 80% of HCC cases in Malaysia are HBV associated2
In 2001, the incidence rate of HCC was 2.8 per 100,000 people and the mortality rate is increasing gradually6
More than 350,000 people die every year from Hepatitis C related liver disease5
Diagnosis rate
Hepatocellular carcinoma (HCC) is the most common type of liver cancer and its diagnosis on routine stains,
except in some cases where there may be difficulty in distinguishing HCCs from metastatic carcinomas (MC) and
cholangiocarcinomas (CC)7
Treatment rate
The National Cancer Control Program aims to reduce the incidence and mortality of cancer and to improve the
quality of life of cancer patients8
Surgery (hepatectomy or liver transplantation) is the main form of curative treatment, the majority of patients are
not eligible for surgery due to extent of tumour and dysfunction of liver9
Sources: 1Shuaibu A Hudu.,et.al.Curr. Issues Mol. Biol. 16: 69-78. 2 Yap SF.,et.al.Malays J Pathol. 1994 Jun;16(1):3-6. 3 HBV Infection 4 Bahaa Eldeen Senousy Ismail.,
et.al.10.3978/j.issn.2304-3865.2013.09.03 5 Kamilari 6 MN Azmawati.,et.al.Asian Pacific J Cancer Prev, 13 (12), 6023-6026 7M S Shiran.,et.al.Malaysian J Pathol 2006; 28(2) : 87 92 8
Gerard Chin Chye Lim.,et.al.Jpn. J. Clin. Oncol. (2002) 32 (suppl 1): S37-S42.
9 FX Sundram.,et.al.Biomed Imaging Interv J. 2006 Jul-Sep; 2(3): e40
2013 Kantar Health
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Overall prevalence of chronic HBV infection in

Singapore is 910% . 35% have CHB; 13% have
CHC
Epidemiology

Worldwide
Scenario
carcinoma1
Worldwide data show that prevalence of cirrhosis in persons with HCC is about 80-90%2
Incidence
HCC is the fourth most common cancer in males and the incidence rate of HCC is 58%, 17 to 7.1 per 100,000 in
males and 47%, 2.8 to 1.5 per 100,000 in females3
In Singapore, the most common cause of liver cirrhosis is chronic Hepatitis B. Not every Hepatitis B carrier will
become cirrhotic, approximately 20-40% may suffer with cirrhosis if their condition is not monitored5
Liver cancer accounts for 7.5 per cent of all cancer incidences6
Liver cancer occurs more often in men than women6
Prevalence
Worldwide data reveals that prevalence of cirrhosis is about 80-90% in persons suffering from HCC
In Singapore, the prevalence of HBsAg has dropped since the introduction of HBV vaccination and the HBsAg
seroprevalence of unvaccinated individuals over 5 years of age is 4.5%
Four of the 1,200 samples tested positive for HBsAg, with prevalence of 0.3%. One out of three in the 7-12 years
and 13-17 years age groups, were positive for HBsAg. About 40% possessed anti-HBs ; The prevalence
decreased from 63.8% in children aged 1-6 years to 32.8% in 7-12 year olds, and 23.5% in 13-17 year olds
The overall prevalence of chronic HBV infection in Singapore is 910% . 35% have CHB; 13% have CHC
Mortality
Cancer is the leading cause of mortality in Singapore

Liver cirrhosis, which can lead to the development of liver cancer, is the 16th leading cause of death in Singapore 6
Liver cancer is the 3rd highest cause of male cancer mortality in Singapore6
Diagnosis rate
The total annual cost of chronic HBV infection complications in Singapore was US$279 million, with 58% or
US$161 million attributable to direct cost
The successful implementation of the national childhood hepatitis B immunization program in last two decades
Treatment rate
has resulted in a low prevalence of HBsAg. Singapore has achieved the World Health Organization goal in
reducing the prevalence of chronic HBV infection to below 2% among children aged 5 years and older by 2012
and to below 1%
Sources: 1. 1Shuaibu A Hudu.,et.al.Curr. Issues Mol. Biol. 16: 69-78. 2 Bahaa Eldeen Senousy Ismail.,et.al.10.3978/j.issn.2304-3865.2013.09.03 3 Dr. Sreedhar
Tirunagari.,et.al.WMC004083 4 National University Hospital; 5. National University Hospital; 6. Singapore General Hospital
2013 Kantar Health
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Prevalence of HCV infection, has decreased at a

slower rate due to lack of HCV vaccination
Epidemiology

Worldwide
Scenario
carcinoma.
In Asia, Africa and in some eastern European countries, chronic hepatitis B is the prime cause of HCC, far
outweighing the impact of chronic hepatitis C
Incidence
The estimated incidence of primary liver cancer in Thailand is very high, Liver cancer is the leading cancer in
males and third in frequency in females. The incidence rate of liver cancer in Khon Kaen is highest in the world.
The percentage of hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA) varies greatly between
regions
Chronic infections with hepatitis B virus and the liver fluke, Opisthorchis viverrini are the major risk factors for the
development of HCC and CCA, respectively
Prevalence
The prevalence of HBV and HCV infection among 295 cholangiocarcinoma (CCA) patients in Thailand was
analyzed. Hepatitis B surface antigen (HBsAg) was detected is 8.8% (26/295 cases) and antibodies to HCV (antiHCV) is 2.7% (8/295 cases) of CCA cases.
The prevalence of both HCV and HBV among CCA in Thailand is comparable to that in the general population,
suggesting that HCV and HBV infections are not serious risk factors for CCA.
In Thailand, the prevalence of HBV infection in new blood donors has decreased from 7.1% in 1988 to 2.6% in
2009. The decline in HBV prevalence is mostly the result of an effective expanded program on immunization
(EPI) against HBV; the current coverage rate with HBV vaccine in newborns is more than 98% nation-wide. The
prevalence of HCV infection, has decreased at a slower rate due to lack of HCV vaccination
Mortality
Diagnosis rate
Ultrasonically guided fine needle aspiration biopsy is quite promising for diagnosis and early detection of HCC
Treatment rate
Effective expanded program on immunization (EPI) has led to drastic decrease of HBV prevalence
Primary prevention is an important approach for prevention and control of liver cancer
Sources:
2013 Kantar Health
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Incidence of HCC is 2-8% per year in patients with

chronic hepatitis C progressed to liver cirrhosis
Epidemiology

Worldwide
Scenario
constituting a major global threat which may lead to chronic liver diseases, cirrhosis and hepatocellular carcinoma
In Japan, the United States, Latin America, Egypt and Europe, hepatitis C is the major cause of HCC. The
incidence of HCC is 2-8% per year in patients with chronic hepatitis C and established cirrhosis
Incidence
Hepatocellular carcinoma (HCC) in Indonesia ranks as the 9th most common cancers. The ratio of male and
female in HCC 2.5:1
HCC is frequently accompanied with cirrhosis and close relationship with HBV
Prevalence
Samples of 195 healthy young adults were tested for HBsAg, anti-HBc, and anti-HBs. The prevalence of HBsAg,
anti-HBc, and anti-HBs was 9 (4.6%), 62 (31.8%), and 96 (49.2%), respectively. Seventy four (37.9%) samples
were seronegative for all three parameters, indicating the susceptibility to HBV infection
The prevalence of those without detectable HBsAg or anti-HBs was 33%. Thus, the probability that a recipient
would receive HBsAg from a blood donor was calculated at 3.3%.Data from other studies were used to estimate
the risk of clinical post transfusion hepatitis in Jakarta at between 0% and 2%
Hepatitis B antigen (HBsAg) was found in 5% and hepatitis B antibody (anti-HBs) in 33% of male blood donors
from different groups in Paramaribo, Surinam. Among these ethnic groups only blood donors of Indonesian origin
had a higher prevalence of both HBsAg and anti-HBs
Mortality
Diagnosis rate
Ultrasonically guided fine needle aspiration biopsy is quite promising for diagnosis and early detection of HCC
Treatment rate
Recently, there has been an increased awareness for hepatitis B virus, especially in hepatitis B virus endemic
area, including Indonesia as part of Asia Pacific region
The patients usually come late to the doctors, and early detection is still a problem
Sources:
2013 Kantar Health
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Agenda

Disease Overview
KOL Identification
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Current Treatment Landscape
Treatment Algorithm: ITP IN ADULTS(Only guidelines available in Malaysia)

Immune-related/Idiopathic Thrombocytopenia
Acute Hemorrhage
platelets (< 30 x 109)
Refractory ImmuneThrombocytopenic purpura
Platelets (30-50 X109/L)
Prednisolone
No treatment
Prednisolone
/L
Platelets (< 30 x 109) /L
No Bleeding(No Treatment)
No treatment
Bleeding(Medical
Therapy)
platelets < 30 x 109/L

Inhibitors of platelet
IVIG
Other agents
Medical Therapy
Platelets <30 X 109L
Consider Splenectomy
Immunosuppressive drugs
clearance
No Active Bleeding
Active Bleeding
Prednisolone
Platelets >30 X 109L
Gradual Discontinuation of Therapy
Azathioprine
Dapsone
IVIG
Note- Treatment guidelines/paradigms for CLD in

thrombocytopenia will be validate from KOLs; One
of the conference report suggests that
international guidelines are well adapted in
anti-D
Malaysia i.v.
and
singapore
Sources: 1. Clinical guidelines_Ministry of Health_Malasiya; 2. Academy of Medicine of Malaysia; 3.

Conference report
Children's and pregnant women not

covered
2013 Kantar Health
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Clinical workup and staging in HCC:

Chronic Liver Disease with Thrombocytopenia
Global/International algorithm
Patient
Patient presents
presents with
with jaundice,
jaundice,
cirrhosis,
cirrhosis, loss
loss of
of appetite,
appetite, and
and weight
weight
loss
loss
Presentation
Imaging
Imaging
(CT
scan/ MRI/
(CT scan/
MRI/ USG)
USG)
Diagnosis
Resectable
Resectable
Classification
Management
Resection
Resection
X%
Suspected
Suspected diagnosis
diagnosis on
on
imaging/
imaging/ Clinical
Clinical trial
trial
Non
Non resectable
resectable
/Non metastatic
/Non
metastatic
Transplantati
Transplantati
on
on
Local
Local
therapy
therapy
RFA
RFA
TACE
TACE
PEI
PEI
Biopsy
Biopsy
Metastatic
Metastatic
X%
Chemo/
Chemo/
Targeted
Targeted
Therapy
Therapy
BSC
BSC
Criteria:
BCLC stage (US and EU5)
AJCC stage/JSH (Japan)/CUPI
(China)
Child Pugh status
Performance status
Tumor size and location
Tumor vascularity
Portal vein invasion
Renal function
Extent of metastasis
Age
Co-morbidities
% X are the number of patient

qualified for Product X
Staging
and
Prognosis
BCLC 0
BCLC A
BCLC B
TNM
Stage I
TNM
Stage II
TNM Stage
III
One of the study mentioned that Malyasia follows BCLC staging
X% Patient pool
BCLC C
BCLC D
TNM Stage IV
Opportunities identified for Product X

2013 Kantar Health
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Flow chart: Chronic Liver Diseases

Chronic Liver diseases
HCC
CCA
HCC, CCA cause liver
cirrhosis
Liver Cirrhosis
HEP B
HEP C
HEP B, HEPC, ALD, NASHM Chronic DILI cause HCC/CCA/

liver cirrhosis
NASH
ALD
Chronic DILI
HCC- Hepatocellular carcinoma; CCA- Cholangiocellular carcinoma; ALD- Alcoholic liver disease ; NASH- Non-alcoholic steatohepatitis, DILI- Drug induced liver
injury
Disease causing CC
Disease causing HCC/Liver cirr
Disease causing HCC
A
hosis
Source: Harrison's Principles of Internal Medicine; AASL guidelines 2014

2013 Kantar Health
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Product X has potential opportunity in HCC with TCA

patients prior to resection, RFA and TACE
Hepatocellular carcinoma (HCC)

Stage 0
PS=0, Child Pugh A
Very early stage (0)
Single < 2 cm
carcinoma in situ
Early stage (A)

Single nodule 5 cm or
3 nodules 3 cm,
PS=0
Single nodule
Normal
Intermediate stage (B)

multinodular, PS=0
Increased
Associated diseases
No
Advanced stage (C)

portal invasion N1,
M1, PS=1-2
1st line
Yes
Sorafenib + doxorubicin,
UFT, TS-1 (JP)
Resection
Transplantation
X%
X%
X%
X%
RFA
X%
X%
TACE
Curative treatments (30%)

5-year survival: 40-70%
Note: BCLC recommends sorafenib as SoC in advanced HCC patients, and those not benefiting
from earlier treatment options
Abbreviations: CP- Child-Pugh class; TACE-Transarterial Chemoembolization; PEI- percutaneous
ethanol injection; PS- performance status; RF- radiofrequency ablation
X% Patient pool
Terminal Stage (D)
Product X profile: On demand

product for elective treatment
Identied opportunities for HCC
Patients with Thromobocytopenia
3 nodules 3 cm
Portal pressure/ bilirubin
Stage D
PS>2, Child Pugh C
Stage A-C
PS=0-2, Child Pugh A-B
2nd line
Sorafenib; 5-FU +
Leucovorin; Capecitabine;
Oxaliplatin+ gemcitabine;
TS-1; 5-FU + Cisplatin,
UFT (in JP only)
Symptomatic
treatment
Symptomatic Tx
(50%)
Survival: < 3
months
One of the study mentioned that Malyasia follows BCLC staging

Source:1. Harrison's Principles of Internal Medicine; 2. AASL guidelines 2014; 3. Llovet et al. JNCI J Natl Cancer Inst 2008
2013 Kantar Health
28
Product X has potential opportunity in Liver

cirrhosis patients for prophylactic treatment
Liver Cirrhosis
Portal hypertension
Splenomegaly
Esophageal varices
Sequestration
Prophylactic
treatment
Acute
repture
treatment
Partial splenic
embolization
X%
Elective ligation
Injection Sclerotherapy
X%
X% Laparoscopic
splenectomy
Product X profile: On demand product for elective

treatment
Identied opportunities management of thrombocytopenia
with liver cirrhosis
% X are the number of patient
qualified for Product X
X%
Patient pool
Source:1. Harrison's Principles of Internal Medicine; 2. AASL guidelines 2014; 3. Llovet et al. JNCI J Natl Cancer Inst 2008
2013 Kantar Health
29
Tab Image Placeholder
Current Market Price
Eltrombopag is also prescribed to

refractory patients in Malaysia
Drug
Company
MoA
Molecule
Type
Patient segment
Phase
Dose and dose

frequency
250mcg Injection
Romiplostim
Amgen
TPO
receptor
agonist
Biologic
Chronic immune
thrombocytopenia
Marketed
(Nplate 250mcg Powder

For Solution For
Injection)
Price
3687.50/ vial- MYR

(Recommended Retail
Price (RRP)
1 Strip (30 tab)
Revolade
Novartis/
GSK
TPO
receptor
agonist
Small
molecule
Thrombocytopenia
Marketed
Eltrombopag Olamine 25
mg Tablet
Revolade Film-Coated
Tablet 25mg
109 MYR
(Recommended Retail
Price (RRP)
Sources: Minstry of Health Malaysia_Pharmaceutical divisions
2013 Kantar Health
30
Agenda

Disease Overview
KOL Identification
2013 Kantar Health
31
Emerging Treatment Landscape- Drugs in clinical development in Thrombocytopenia
Global
Drug
Company
MoA
Molecule Type
Patient segment
Phase
Trial Geography
Fostamatinib1
Rigel Pharmaceuticals
IgG receptor
blocker
Small molecule
NA
III
USA, EU
Bilsimod2
Anthera Pharmaceuticals
B-cell activating
factor inhibtor
(BAFF)
Biologic
Immune Thrombocytopenic
Purpura
III
US
LGD-46653
GSK/Ligand pharma
TPO receptor
agonist
Small molecule
NA
II
USA, EU
Rituximab4
Roche
CD 20 antigen
inhibotors
Biologic
Thrombotic Thrombocytopenic
Purpura
II
US
Avatrombopag5
Eisai Co., Ltd.
TPO receptor
agonist
Small molecule
Thrombocytopenia
II
Japan
SM-1016
SuppreMol
Fc gamma
receptor IIB
modulators
Biologic
Chronic adult idiopathic

thrombocytopenic purpura
II
EU
Veltuzumab7
Immunomedics
CD 20 antigen
inhibotors
Biologic
Auto-immune thrombocytopenia
I/ II
US
BI 6550648
Boehringer Ingelheim
CD 40 antigen
inhibitors
Biologic
NA
US
Sources: 1. NCT02076412; 2. NCT01609452: 3. NCT00621894; 4. NCT01554514; 5. NCT02227693; 6. ISRCTN47912914; 7. NCT00547066;
MK 87239
Antithrombotic
Merck
Sharp & Dohme
8. NCT02009761;
9. NCT01963260
agents
Corp.
Biologic
Immune
Australia, Georgia,
Note- Thrombocytopenia
No ongoing trials found in
I the Malaysia and
Purpura
Israel, Moldova
Singapore
2013 Kantar Health
32
Agenda

Disease Overview
KOL Identification
2013 Kantar Health
33
Platelet transfusion guidelines- Singapore
Prophylactic platelet transfusion

Recommendations for Prophylactic platelet
transfusion (to prevent bleeding)
Grades of recommendation
& Levels of evidence*
Patients with impaired bone marrow function when platelet

count is less than 10x109/L and there are no other risk
factors
Grade B/ Level 1+
Patients with impaired bone marrow function when platelet

count is less than 20x109 /L and there are concomitant risk
factors
Grade C/ Level 2+
Patients with dengue fever who experience a rapid fall in

platelet count or in the presence of prolonged clotting times
Grade C/ Level 2+
In individual cases where bleeding is thought to be a major

risk factor, Consultation with the haematologist or
transfusion specialist is advised. A transfusion trigger at
platelet count of 30x109/L is acceptable
Grade D/ Level 4
Patients undergoing surgery or invasive procedures (e.g.

epidural, lumbar puncture, renal biopsy, liver biopsy, central
line insertion) when the platelet count is less than 50x109/L
and there are no other associated coagulopathies
Grade C/ Level 2+
Neurosurgical and ophthalmic procedures may benefit from

a higher prophylactic platelet transfusion threshold
(100x109/L)
Grade D/ Level 4
Source: HAS-MOH Clinical
*Levels of evidence:1+ +:High quality meta-analyses,

systematic reviews of randomised controlled trials
(RCTs), or RCTs with a very low risk of bias. 1+:Well
conducted meta-analyses, systematic reviews of RCTs,
or RCTs with a low risk of bias. 1-:Meta-analyses,
systematic reviews of RCTs, or RCTs with a high risk of
bias. 2+ +:High quality systematic reviews of case
control or cohort studies. High quality case control or
cohort studies with a very low risk of confoundingor bias
and a high probability that the relationship is causal.
2+:Well conducted case control or cohort studies with a
low risk of confounding or bias and a moderate
probability that the relationship is causal. 2-:Case
control or cohort studies with a high risk of confounding
or bias and a significant risk that the relationship is not
causal. 3:Non-analytic studies, e.g. case reports, case
series. 4:Expert opinion
**Grades of recommendation: A :At least one metaanalysis, systematic review of RCTs, or RCT rated as 1+
+ and directly applicable to the target population; or A
body of evidence consisting principally of studies rated
as 1+ directly applicable to the target population, and
demonstrating overall consistency of results. B:A body
of evidence including studies rated as 2++, directly
applicable to the target population, and demonstrating
overall consistency of results; or Extrapolated evidence
from studies rated as 1+ + or 1+ . C :A body of evidence
including studies rated as 2+, directly applicable to the
target population and demonstrating overall consistency
of results; or Extrapolated evidence from studies rated
as 2+ +:D :Evidence level 3 or 4; or Extrapolated
evidence from studies rated as 2+
2013 Kantar Health
34
Geography Nuances- Platelet transfusion in each

geography
Perspectives on
Platelet transfusion
Singapore
Malaysia
Vietnam
Thailand
Current Practice
Future Practice
2013 Kantar Health
35
Agenda

Disease Overview
KOL Identification
2013 Kantar Health
36
Drug listing process- Thailand
NLED is about 50% bigger than the WHO

model list of essential medicine
Screening of Drug Applications
Submitted by Pharmaceutical Companies
National List of Essential Drugs

(NLED) Secretariats
Gathering Evidence in Terms of IsafE

(Safety and Efficacy) and Essential
Medical Cost Index (EMCI), if applicable
Requesting Information, Reviewing

Evidences and Making
16 Specific Working Groups for NLED
Recommendations for Consolidation of

NLED
Health Economic Group
Reviewing and Generating

Pharmacoeconomic Evidence for
Selected Medicines
Gathering Information and Making

Recommendations to the
Subcommittee
Coordination & Consolidation of NLED by

the Working Group
Setting Concept, Philosophy and
Sub-Committee for the Development of

National Drugs System
NLED
Development Committee appoints
Criteria for Drug Selection

Making Final Decision from the
Proposal of all the Working Groups
academics, health professionals

senior decision-makers and
representatives of the public health
National Drugs System

Development Committee
insurances schemes as members of
Endorsement of NLED and

Review
the NLED Subcommittee
NLED Publication
Sources: 1. Thidaporn.,et al International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 1098-3015/09/S4 S4S11 - Thailand
2013 Kantar Health
37
Drug listing process- Malaysia
Pharmaceutical services division is

responsible for approving NEDL in Malaysia
Screening of Drug Applications
Ministry of Health (MOH)
Submitted by Pharmaceutical
Companies
Pharmaceutical Services Divisions
Drug Selection after Consultation with

Pharmaceutical Manufacturers,
Representatives of Health Professionals
Committee Comprises of Experts in
National Essential Drugs List (NEDL) Drug

and Therapeutic Committee
and Consumer Organizations
Pharmacy, Medicine, Pharmacology,

Medicine, Public Health among Others
Appointed by MOH
Drug Selection by the Therapeutic

Committee
Names of the Drug
International Non-Proprietary Names

(INN) to be used in the NEDL
Review by Therapeutic
NEDL will be based on Standard
Committee
Treatment Guidelines
Approval by MOH
NEDL Publication
Sources: 1. National medicine policy of Malaysia
2013 Kantar Health
38
Agenda

Disease Overview
KOL Identification
2013 Kantar Health
39
xxx
WIP
2013 Kantar Health
40
Agenda

Disease Overview
KOL Identification
2013 Kantar Health
41
KOLs Singapore
Lim Seng Gee affiliated from National University Hospital

has 25+ yrs of experience in Gastroenterology
S.No
Name
Specialty
Year
Affiliations of
Exp.
1
Lim Seng Gastroenterology
Gee1
and Hepatology
NUH
2
Koo Wen
Hsin2
Medical
Oncology
NCCS
4
5
6
Gastroenterology
Yeoh Khay & Hepatology
Guan3
NUH
Lawrence Gastroenterology
Ho Khek- and Hepatology
Yu4
NUH
Lim Li Lin5 Gastroenterology
& Hepatology
NUH
Gastroenterology
Bhavesh
& Hepatology
Kishor
Doshi6
NUH
Research
Interests
Treatment of
viral hepatitis
25+ (esp. B and C),
liver disease
and liver cancer
Medical
Oncology,
25+ Colorectal,
Hepatobiliary,
Upper GI
Gastric cancer
Early detection
25+
and Biomarker
discovery
20+ GI oncology
No. of
Publications
Other Participations
Speaker Guidelines Conference
20+
Yes
Yes
Yes
NA
Yes
15 +
NA
NA
Yes
NA
Yes
10+
Yes
NA
Yes
Yes
Yes
10 +
Yes
NA
Yes
NA
Yes
Yes
NA
NA
NA
NA
Gastroenterolog
10
y & Hepatology
Gastrointestinal
diseases,
15+
6+
including
cancers
18
Clinical
Trials/
Ad. Board
Investigator
NA
NA
NA
NA
NA

Sources: 1. Gee, National University Hospital; 2. Hsin, National Cancer Centre Singapore; 3. Guan, NUH; 4 Khek-Yu, NUH ; 5. Lin, NUH; 6. Doshi, NUH
Note: All clinical trials and publications mentioned above are in CLD
2013 Kantar Health
42
KOLs Singapore
Dr. Simon Kuang affiliated to NCCS has 15 yrs of

experience in Hepatology
S.No
8
9
10
11
12
Name
Specialty
Simon Medical
Ong Yew Oncology
Kuang1
Robert
Lim2
15+
NCCS
HaematologyOncology
15+
NUH
Yong
Wei
Peng3
Wong
Kong
Min
Reuben4
HaematologyOncology
Lee
Guan
Hui5
Gastroenterology
& Hepatology
Alfred
Kow6
Affilia Year of
tions Exp.
15+
NUH
Gastroenterology
& Hepatology
10
Research
Interests
Colorectal /
Hepatobiliary /
Upper GI
No. of
Clinical Trials/
Publicati
Investigator
ons
Ad. Board
10 +
Yes
5+
Yes
NA
NA
NA
NA
5+
NA
NA
NA
NA
NA
10+
Yes
NA
NA
NA
NA
Hepatitis B,
Hepatitis C, Liver
Cancer
10
Yes
NA
Yes
Yes
Yes
Malignancies in
liver
Yes
NA
NA
NA
NA
Colorectal cancer
and pancreatic
cancer
Gastric cancer,
Hepatobiliary
cancer
Gastroenterology
& Hepatology
NA
NA
NA
Yes
NUH
10+
NUH
Surgical
Oncology
(Hepatobiliary &
9+
Pancreatic
Surgery)
NUH

Sources: 1. Kuang, National Cancer Centre Singapore: 2 . Lim, National University Hospital; 3. Peng, NUH; 4 Reuben, NUH; 5. Hul, NUH; 6. Kow, NUH
2013 Kantar Health
43
KOLs Singapore
Dr. Lim Kirton Affiliated to National University

Hospital has 8+ yrs of experience in hepatology
S.No Name
13
Specialty
Lim
Gastroenterology
Boon and Hepatology
Leng
Kieron
15
16
17
Tan
Bee
Huat
Iain2
8+
NUH
14
Year
Affiliations of
Exp.
Medical
Oncology
5+
NCCS
Chee Medical
Kian
Oncology
Tham3
NCCS
Matthe Medical Oncology
w Ng4
NCCS
HaematologyChee Oncology
Cheng
Ean5
NUH
Research
Interests
Liver
transplantation,
Hepatocellular
carcinoma and
viral hepatitis
Colorectal
cancer, with a
special interest
in non-invasive
diagnostic tests
Lymphoma
5+
No. of
Clinical
Publication
Trials/
s
Investigator
Ad. Board
1+
Yes
Yes
NA
NA
Yes
50+
NA
NA
NA
NA
NA
12+
Yes
NA
NA
NA
NA
5+
Gastric cancer
5+
Yes
NA
NA
NA
NA
3+
Gastrointestinal
Cancers, Liver,
Pancreas and
Bile Duct
Cancers
10
NA
NA
NA
NA
NA

Sources: 1. Kieron, National University Hospital; 2. Iain, National Cancer Center Singapore ; 3. Tham, NCCS; 4 Ng, NCCS; 5. Ean, NUH
2013 Kantar Health
44
KOLs Malaysia
Ramanujam has 33+ years of experience in

gastroenterology with University of Malaysia
S.No
Name
Specialty
Year
Affiliations of
Exp.
Research
Interests
Clinical
No. of
Trials/
Publications
Investigator
Ad.
Speaker
Board
Guidelines
Conference
Tindivanam
University of
Upper and Lower
Muthurangam Gastroenterology
33+
15+
Malaysia
GIT, Liver
Ramanujam1
Yes
NA
NA
NA
NA
Basri Johan
Jeet Bin
Abdullah2
Yes
NA
NA
NA
NA
Goh Khaean Gastroenterology University of

30+ Gastroenterology, 50+
Lee3
& Hepatology
Malaysia
Hepatology
NA
NA
NA
NA
NA
Chia Yook
Chin4
Gastroenterology University of
Gastroenterology
30+
30+
& Hepatology
Malaysia
(Primary Care)
Yes
NA
NA
NA
NA
Looi Lai
Meng5
Oncology
Yes
NA
NA
NA
NA
Radiation
oncology
University of
Interventional
32+
Malaysia
Radiology
University of
30+ Oncology
Malaysia
NA
Sources: 1. Ramanujam,Univ of Malaysia; 2.Abdullah, UM; 3. Lee,UM; 4 Chin, UM; 5. Meng, UM
2013 Kantar Health
45
KOLs Malaysia
Dr. Christopher Meng affiliated to University Of Malaysia

has 27 years of experience in Gastroenterology
S.No
Name
Specialty
Year
Clinical
No. of
Affiliations of Research Interests
Trials/
Publications
Exp.
Investigator
Christopher Boey Gastroenterology University

27
Chiong Meng1
& Hepatology
of Malaysia
Gastroenterology
Ganesananthan Gastroenterology Pantai

Shanmuganathan2 & Hepatology
Hospital
Mahendra Raj3
Gastroenterology Pantai
& Hepatology
Hospital
10
Lee Way Seah4
Gastroenterology University
21
& Hepatology
of Malaysia
11
Zahurin Binti
Mohamed5
Pharmacology
12
Loong Yik Yee6
Ramsay
Gastroenterology
Sime Darby 19
& Hepatology
Health Care
Ad.
Board
Yes
NA
NA
NA
NA
26
(ERCP),
Endoscopic stenting,
4
Endoscopic
ultrasound (EUS),
Yes
NA
NA
NA
NA
26
Gastroenterological
disorders
10+
Yes
NA
NA
NA
NA
Paediatric
Gastroenterology,
80
Yes
NA
NA
NA
NA
Liver Disease
16
Yes
NA
NA
NA
NA
Gastroenterology
NA
NA
NA
NA
NA
University
20
of Malaysia
10+
Sources: 1 Meng, University of Malaysia; 2 Shanmugnathan, Pantai Hospital: 3: Raj , Pantai Hsopital; 4. Seah, University Of Malaysia; 5. Mohamed, University of Malaysia: 6 Yee
, Sine Darby Health Care
2013 Kantar Health
46
KOLs Malaysia
Dr. Rosmawati Mohamed affiliated to University of

Malaysiaia has 17 years of experience in Hepatology
S.No
13
14
Name
Specialty
Year
Clinical
No. of
Affiliations of Research Interests
Trials/
Publications
Exp.
Investigator
Rosmawati Binti Gastroenterology University

of
17
Mohamed1
& Hepatology
Malaysia
University
Gastroenterology
Sanjay Rampal2
of
16
& Hepatology
Malaysia
Ad. Board
Speaker Guidelines
Conference
11 +
Yes
NA
NA
NA
NA
Gastroenterology 20+
Yes
NA
NA
NA
NA
Yes
NA
NA
NA
NA
Hepatology
15
M.V.Kudva3
Gastroenterology Pantai
& Hepatology
Hospital
16
Gallbladder
diseases, Liver
diseases
16
Rajesh Kumar
Paramasivam4
Hospital
Gastroenterology
Kuala
& Hepatology
Lumpur
15
Gastroenterology
3
& Hepatology
NA
NA
NA
NA
NA
17
Ida Normiha
Binti Hilmi5
Gastroenterology 20+
Yes
NA
NA
NA
NA
Clinical Oncology 10+
Yes
NA
NA
NA
NA
18
University
Gastroenterology
of
14
& Hepatology
Malaysia
University
Anita Zarina Binti
Clinical
Oncology
of
14
Bustam6
Malaysia
10+

Sources: 1 Mohamed, University of Malaysia; 2 Rampal, UOM: 3: Kudva, Pantai Hospital; 4. Paramsivam, Hospital Kualalampur; 5. Hilmi, UOM: 6 Bustam, UOM
2013 Kantar Health
47
KOLs Malaysia
Dr. Ho Hooi affiliated to University Of Malaysia has 13

years of experience in Hepatology
S.No
Name
Specialty
Year
Research
Affiliations of
Interests
Exp.
19.
Ho Shiaw Hooi1
Gastroenterology & University

13
Hepatology
of Malaysia
20
Pok Eng Hong2

13
Hepatology
of Malaysia
21
Lau Peng
Choong3

13
Hepatology
of Malaysia
22
Marniza Binti
Saad4
Radiology
23
Tan Huck Joo5
Sunway
Gastroenterology &
Medical
Hepatology
Centre
24
Ranjeev C K
Prabhakeran6
Subang
Gastroenterology & Jaya
Hepatology
Medical
Centre
University
13
of Malaysia
13
12
No. of
Clinical Trials/
Publications Investigator
Gastroenter
ology
(Include
6
general
hepatology)
Upper
gastrointesti 10+
nal surgery
Gastro
Disease
10+
Gastrointest
inal Cancer
Gastrointest
5+
inal Cancer
Gastrointest
inal
disorders, 5+
Hepatologic
al disorders
Colon
cancer,
Colon
polyps,
Ad.
Board
Speaker
Guidelines Conference
Yes
NA
NA
NA
NA
Yes
NA
NA
NA
NA
Yes
NA
NA
NA
NA
Yes
NA
NA
NA
NA
Yes
NA
NA
NA
NA
NA
NA
NA
NA
NA

Sources: 1. Hooi, University Of Malaysia ; 2. Hong, UOM : 3. Choong, UOM 4. Saad, UOM; 5. Joo, SMC: 6 Prabhakeran, SJMC
2013 Kantar Health
48
KOLs Singapore
Ranjeev affiliated to Subang Jaya Medical Centre has 12

years of experience in hepatology
S.No
Name
Specialty
Year
Affiliations of
Exp.
Research
Interests
Clinical
No. of
Trials/
Publications Investigato
r
Ad.
Board
Speaker
Yes
NA
NA
NA
NA
25.
C. K. Ranjeev
Subang
Gastroenterology Jaya
& Hepatology
Medical
Centre
26.
Sanjeev
Mahadeva2
11
& Hepatology
Malaysia
Gastroenterolog
20 +
y
Yes
NA
NA
NA
NA
27
Soek Siam Tan3
Gastroenterology Selayang
& Hepatology
Hospital
Autoimmune
liver disease
Yes
NA
NA
NA
NA
28
Yik Yee Ian4
10
& Hepatology
Malaysia
Yes
NA
NA
NA
NA
29
Chan Wah
Keong5
9
& Hepatology
Malaysia
Yes
NA
NA
NA
NA
30
Ho Gwo Fuang6 Oncology
Yes
NA
NA
NA
NA
12
11
University of
9
Malaysia
(ERCP),
Oesophageal
stenting
10
Upper
gastrointestinal 20+
dysfunction,
Viral Hepatitis B
and C,
Hepatocellular 18
Carcinoma
Cancer
radiotherapy
10+

Sources: 1. Ranjeev, Subhang Jaya Medical Centre ; 2. Mahadeva, University of Malaysia: 3. Tan, Selayang Hospital; 4. Ian, UOM; 5. Keong, UOM: 6 Fuang, UOM
2013 Kantar Health
49
KOLs Malaysia
Mastura Yusof affiliated to University Of Malaysia has 9

years of experience in Oncology
S.No
Name
Specialty
31
Mastura Binti Md
Oncology
Yusof1
32
Yoong Boon
Koon2
Affiliations
University of
9
Malaysia
8
& Hepatology
Malaysia
Year of
Exp.
Research
Interests
Oncology
(RadioIodine
Therapy)
No. of
Clinical
Publicati
Trials/
ons
Investigator
NA
Hepatobiliary,
12+
Liver
Ad.
Board
Speaker
NA
NA
NA
NA
NA
NA
NA
NA
NA
Sources: 1. Yusof, Univesity Of Malaysia; 2. Koon, UOM
2013 Kantar Health
50
KOLs Indonesia
Ali Sulaiman affiliated to University of Indonesia

has 50+ yrs of experience in Hepatology
S.No
1.
Name
Ali Sulaiman 1
Specialty
Hepatology
Affiliations
University of
Indonesia
Year
of
Exp.
Conference
Yes
Yes
NA
Yes
NA
NA
NA
Yes
Yes
NA
Yes
1+
NA
NA
NA
NA
NA
Yes
Yes
NA
NA
NA
1+
NA
Yes
NA
NA
NA
10+
NA
Yes
Yes
NA
NA
Gastro Entero Hepatologist
Medistra
Hospital
31+
4.
Dr Murdani
Abdullah 4
Mitra
Gastroenterol Keluarga
Hospital
ogy
29+
5.
Rino A.Gani 5
Guideli
nes
NA
Daldiyono
Harjodisatro 3
Gastroenterol RS Pondok
ogy&Hematolo Indah
gy
Dr. Cipto
Gastroenterol Mangunkusu
Ari Fahrial Syam 6 ogy
mo Hospital,
Speaker
1+
35+
3.
Ad.
Board
NA
Medistra
Hospital
L. A. Lesmana 2
No. of
Publications
50+
Gastro Entero Hepatologist
2.
Research
Interests
Clinical
Trials/
Investigator
19+
15+
NA
colorectal
malignancy, 24+
IBD
NA
NA

Sources: 1Ali Sulaiman,University of Indonesia . 2 Lesmana,Medistra Hospital 3 Daldiyono,Medistra Hospital 4 Murdani,Mitra Keluarga Hospital Kelapa Gading
5 Rino,RS Pondok Indah 6 Ari,Dr. Cipto Mangunkusumo General National Hospital
2013 Kantar Health
51
KOLs Indonesia
C.Rinaldi Lesmana affiliated to Medistra Hospital Speciality

in Gastro-entero-Hepatology
S.No
7.
Name
C. Rinaldi
Lesmana 1
HM Sjaifoellah
Noer 2
Andri Sanityoso 3
Specialty
Affiliations
Gastro Medistra
Entero Hospital
Hepatologist
Year
of
Exp.
NA
Research
Interests
NA
Clinical
Trials/
Investigator
No. of
Publications
Ad.
Board
Speaker
Guid
eline
s
Conference
1+
NA
NA
NA
NA
NA
Hepatology
Cipto
Mangunkusu
mo Hospital,
NA
NA
1+
NA
Yes
NA
NA
NA
Hepatology
FKUI-RSUPN NA
NA
2+
NA
NA
Yes
NA
Yes

Sources: 1C.Rinaldi,Medistra Hospital 2
HM Sjaifoellah,Cipto Mangunkusumo Hospital
3 Andri,FKUI-RSUPN
2013 Kantar Health
52
KOLs Vietnam
Huu Chi Nguyen affiliated to Hospital for Tropical Diseases

of HCM city has 37+ yrs of experience in hepatology
S.No
Name
1.
2.
Affiliations
37+
Family
Medicainal
Practice
Vietnam
25+
Hepatology
Pedro
L.Trigo 2
Hepatology
Specialist
Nguyen Vinh
Victoria
Gastroenterol
Healthcare
ogy and
International
Hepatology
Tuong 3
Phan Van Thai Surgeon
Year of
Exp.
Hospital for
Tropical
Diseases of
HCM city
Huu Chi
Nguyen 1
3.
4.
Specialty
FV hospital
20+
14+
Research
Interests
No. of
Publications
Ad.
Board
Speaker
Guideli
nes
Conference
NA
Yes
NA
NA
NA
Yes
NA
NA
NA
Yes
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
30+
NA
Yes
Yes
NA
NA
NA
NA
Yes
Yes
NA
NA
Viral
diseases,
particularly
5+
viral hepatitis
and
HIV/AIDS
Liver
Transplant,
11+
Liver
Disease
NA
Clinical
Trials/
Investigator
NA
Gastrological
surgeries,Liv
NA
er tumour
Medic
Medical
NA
Center, Ho
Chi Minh City.
Ho Chi Minh
Gastroenterol
City Medical
NA
ogy and
UniversityTitle - Date
Insert
Presentation
Hepatology
Hospital.
5.
Pham Thi Thu

Hepatology
Thuy 5
Hepatitis B
and C virus
Dinh Da Ly
Huong 6
Hepatitis B
and chronic
hepatitis C
Sources: 1. Nguyen, Hospital for Tropical Disease of HCM city; 2. Trigo,Family Medicainal practice Vietnam
5 Thuy,Medic Medical Centre,Ho Chi Minh City 6 Huong,Ho Chi Minh Medical University Hospital
3 Tuong.Victoria Healthcare International 4 Thai,FV hospital
2013 Kantar Health
53
KOLs Vietnam
Bui Huu Hoang affiliated from Univ.of Medicine and

Pharmacy in Gastroenterology & Hepatology
S.N
o
7.
Name
Specialty
Affiliations
University of
Gastroenter Medicine and
Bui Huu Hoang ology and Pharmacy, Ho
Hepatology Chi Minh City.
Year of
Exp.
NA
Research
Interests
Parasitosis in
the Liver, viral
hepatitis (HBV
and HCV),fatty
live
No. of
Publicatio
ns
Clinical
Trials/
Investigator
1+
NA
Ad.
Board
Speaker
Guideli
nes
Conference
Yes
Yes
NA
NA

Sources: 1 Hoang,University of medicine and pharmacy,Ho Chi Minh City.
2013 Kantar Health
54
Agenda

Disease Overview
KOL Identification
2013 Kantar Health
55
Primary Research
Primary Research Sample Size KOLs (Prescribers and Payors)
Stakeholder
Type of Interview
KOLs
Qualitative in-depth interview
Singapore
KOLs
Malaysia
KOLs
Vietnam
KOLs
Thailand
KOLs
Philippines
KOLs

Total sample size
Geography
Suggested Number of Interviews
Indonesia
X interviews
2013 Kantar Health
56
Treatment 1
20%
20%
30%
30%
Treatment 2
39%
20%
20%
% Patients
(Volume)
High
Avg. no of patient
seen/month X%
43%
31%
15%
15%
20%
20%
65%
65%
Mediu
Avg. nom
of patient
seen/month X%
Vietnam
25%
25%
35%
35%
26%
40%
40%
35%
33%
33%
15%
15%
25%
GPs
Immunologist
Avg. no of patient
seen/month X%
53%
53%
23%
Low
Medium
Avg. no of patient
seen/month X%
Low --- INFRASTRUCTURE --- High
Malaysia
Referral
36%
Thailand
Low --- Disease Burden--- High
Singapore
Patient flow across prescribers
Haematologist
Low --- SKILL SET --- High

2013 Kantar Health
57
Company X has excellent engagement across

key stakeholders
Stakeholder engagements
Patient
Engagement
Physician
Engagement
Insight 1
Medical society
Haematologist, Singapore
Com
p. 1
Insight 1
Com
p.2
Haematologist, Vietnam
Com
p.3
Insight 1
Haematologist, Malaysia
Com
p.4
2013 Kantar Health
58
Patient Pool- Target segment for Product 'X'

Incidence/Prevalence
CLD
Diagnosis rate
% of patient HCC
% of patient CCA
% of patient Hepatitis B
% of patient Hepatitis C
% of patient from other factors
like NASH/ALD
% of patients progress to Liver
cirrhosis
% of patient HCC
% of patient CCA
% of patient Hepatitis B
% of patient Hepatitis C
% of patient to NASH/ALD etc.
Treatment rate
% of patient HCC
% of patient CCA
% of patient Hepatitis B to
liver cirrhosis
% of patient Hepatitis C to
liver cirrhosis
% of patient to liver cirrhosis
% of other
patient
on Revolade
from
factors
like
%
of
patient
on
NASH/ALD
Romiplostin
% of patient on Transfusion
% of patient on other
therapies
# Patient pool for Product X
Incidence/Prevalence of Chronic Liver disease
Singapo
re
X%
Malays
ia
X%
Thaila
nd
Indone Philippi Vietnam

sia
nes
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
X
Y
Z
Diagnosis and treatment

rate will be obtained from
KOLs
2013 Kantar Health
59
Prescriber recommendation on patient perspective

Demographics
Age, Current city, Gender
Singapore
Malasiya
Insight 1
Duration of Tx.
Haematologist, Singapore
Patient journey
Specialist
Therapy
Treatment
Insight 1
Drug
Haematologist, Vietnam
Cost
Patient adherence to the treatment
Insight 1
Brand vs. Generic (preference)
Haematologist, Malaysia
2013 Kantar Health
60

Thrombocytopenia in CLD - Market Access Landscape - Interim - 16012015

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The catalyst for

2013 Kantar Health

Project status update

Insert Presentation Title - Date

Limited data points through secondary research;

Insert Presentation Title - Date

Payers and Prescribers:

Insert Presentation Title - Date

Primary sample size

Insert Presentation Title - Date

Thrombocytopenia Market access:

Insert Presentation Title - Date

Vision, Background, Objectives and Outcomes

Insert Presentation Title - Date

Project Background and Objectives

Kantar Health has approached Netscribes

Understand the market, disease area, competitor

Product X is an orally active small molecule

Phase II: Primary research

In depth qualitative discussions with KOL and Payer/Policy

Thrombocytopenia (Platelet count of

Once- daily oral dose of a 3mg table, 7

To discuss the market opportunity for such a new drug

Geography: Malyasia, Singapore, Thailand, Philippines, Indonesia, Vietnam

What is the prevalence/incidence of chronic liver disease by market?

What is the prevalence/incidence of thrombocytopenia among chronic liver patients by

Who are the key/lead KOLs involved in the invasive procedures?

Geography: Malyasia, Singapore, Thailand, Philippines, Indonesia, Vietnam

Vision, Background, Objectives and Outcomes

Insert Presentation Title - Date

Step 1: Identify opportunities for Product X

Current market analysis for each geography (Malaysia, Singapore, Thailand,

Global and Regional Guidelines

Identify game-changers by geographies and future market landscape

Unmet need analysis by geographies

Key Peer Reviewed Literature and syndicated

Current market and treatment landscape

Geography: Malyasia, Singapore, Thailand, Philippines, Indonesia, Vietnam

Step 2: Understand the competitive intensity and

Target Opportunity in thrombocytopenia with CLD in different invasive procedure

Geography: Malyasia, Singapore, Thailand, Philippines, Indonesia, Vietnam

Step 3: To identify and profile KOLs for

KOL profiles: Lead prescribers involved in treatment and invasive procedures

Geography: Malyasia, Singapore, Thailand, Philippines, Indonesia, Vietnam

Step 4: Understand the current pricing and

Regional regulatory guidelines

Pricing and Reimbursement scenario of each geography

Insert Presentation Title - Date

Overall Research Framework

Situation Analysis By Geography

Product X Opportunity Where to Play

Target Opportunity How to Win

Clinical Development Path (Time to Market)

Product X Ideal Profile Value Proposition

Insert Presentation Title - Date

Vision, Background, Objectives and Outcomes

Insert Presentation Title - Date

Orphan indication: Thrombocytopenia is a multisystem

Bone marrow & Myelosuppressive therapies

Vitamin B12 or folic acid deficiency

Immune or idiopathic thrombocytopenic purpura

Insert Presentation Title - Date

CLD diagnosis guidelines by liver foundation;