Three topics today
RWD usage in HTA
Possibilities, a view from Industry

1.Bayer HTA readinessComprehensive Support Project
Health Outcomes Research Project
9th Annual Meeting - Tokyo, June 27, 2015

2.Feedback from HTAi 2015, Oslo
3.A gift for researchers

Bruno ROSSI
Bayer Yakuhin Ltd
EFPIA Japan

A limited point of view

医薬品企業の取り組み•

Pharmaceutical•“HTA Readiness”•Organisation, Skills, Support•

Medical Device•

Alone / Industry together•

Diagnostic•

Projects and examples•Consultant

Our HTA readiness••

Domestic pharmaceuticalcompany•

Biotech venture company•“Individual company" vs.
Industry Association”

Economic considerations are
only one small part of HTA
The nine domains of HTA

Company drive + own research and contacts

Health problem and current use of technology
Description and technical characteristics

Recruit, guide and develop staff

Mix of recruit
overseasand in Japan

Present, publish, engage stakeholders

A real opportunity to learn, by doing•

Joining international projects, international staff exchange and rotations•Our own, stand-alone studies and projects in Japan

Join professional societies: ISPOR, DIA, JSPE, HTAi

Ethical analysis
Organisational aspects
Social aspects
DIA-JapanOctober 2

Different healthcare systems, values and practices requiredifferent HTA archetypes
What do we want learn, from Japan?
What do we to transpose and adopt in Japan?
National Health Insurance•

Single Payer•

Multiple Payers•

Mix of Public + Private health care providers•

Scope of patient co-pay, Complementary health insuranceTax-based•

Single payer•

Often Public providers

Parallel systems•

Private or Integrated healthcare (Managed Care)•Public (US Veterans, Medicare, etc.)

Emerging Universal Health Care Coverage

SafetyClinical Effectiveness
Cost and Economic Evaluation

Studies and publications from Japan, to be used outside of Japan•••

Relevant for Japan - Understand the context••

Affiliate of foreign
multinational•Improve ourselves continuously, attend courses•

••

•

•

Japanese multinational

Learning from meaningful examples overseas•••

AccessRationing
Prevention funded, or not?
SocietyAge
GenderCaregivers
Outcomes tracked?
Guidelines updatedand implemented?
Costs comparable?
Data
Available?
Accessible?
Consistent?

Legal aspects

Different healthcare systems, values and practices requiredifferent HTA archetypes
What do we want learn, which is useful for us in Japan?
What could we to transpose and adopt [adapt] in Japan?

Health spending in OECD
in % of GDP

Learn and practice•••••••#      !   (  %     !+ ,(+/-.0,(            !''))"""( ()) *$)** */-.0(

Global Value Dossier
Net Clinical Benefits
Economic Models (CE orrather BI)
Price Strategy
Price Submission &Negotiation
Continuous Data
Generation
Access Channels• Medical Education(Doctors, Nurses,Pharmacists,Technicians)• Patient Education(esp. if devices, AE)•Title: Comparing Patient and Physician Risk Tolerance forBleeding Events Associated with Anticoagulants in AtrialFibrillation - Evidence from the United States and Japan•

Citation: Okumura K, Inoue H, Yasaka M, et. al. Comparing
Patient and Physician Risk Tolerance for Bleeding Events
Associated with Anticoagulants in Atrial Fibrillation Evidence from the United States and Japan. Value HealthRegional 2015; 6: 65-72.

Past practices••“Silo”•Synopsis Author: Ken Okumura•Anticoagulants are crucial in preventing stroke among
patients with atrial fibrillation (AF) but are associated withbleeding risks. Re- cent studies have shown that asubstantial proportion of AF patients receive subtherapeuticlevels of anticoagulation because of concerns about
bleeding. Using a discrete-choice experiment, weevaluated how the relative importance of treatment-related
benefits and risks are perceived and vary between patientsand physicians in the U.S. and Japan. U.S. patients andphysicians were willing to accept similar levels of non-majorclinically relevant bleeding risks when they wereconsequences of preventing disabling strokes. In contrast,
Japanese patients were willing to accept four times thelevel of such risk than Japanese physicians as aconsequence of preventing disabling strokes.

Internalawareness••

Organisation•

Leadership•

Affiliate of foreign multinational•

Domestic pharmaceutical company•
••
•
•
•
•
•

•

Societal needs
Disease burden
Unmet needs
Medical PracticeComparators
Funding
Rx decision (Drs)
Patient insights
Caregiver
Product specifics, e.g.
CDx, drug-device
combination
Distribution: HP,pharmacy, physicalaccess (cold chain, RI)

Higheropportunity
to exchange
best internal
practices

GlobalProductDev.

•Process•

PeopleGlobalMarketAccess

Biotech venture company•“Individual company" vs. Industry Association”

Thank you.
Questions during the panel

•••
•••

•
••

Clinical Development
Post-Marketing
SurveillanceStudy end-points
PRO tools (usage,validation of new tools)
Epidemiology
Treatment patterns
Cost of therapy, Medical
fees, Healthcare
Resource Utilisation
Database studies
Patient profiles
Patient surveys, Patient
preference studies
Caregiver surveys

GlobalMarketing

GlobalMedicalAffairs

Input toDevelopment

Price

MarketMonitor

Requestadditional dataJapan
ProductDev.

Japan
MarketAccessJapan
MarketingJapan
MedicalAffairs

Organisation models
ProductDevelopment

MarketAccess

Proj. Management•••

RegisterExternal requirements, internal
challenges, resources and complexity
vary by company
Japanese multinational•

Areas for improvement: Working as anintegrated team, in a new environment,with new regulators and stakeholders

A particular challenge: A study comparing
Physician and Patient Preferences••

Clinical
Biostatistics
Regulatory[Pre-clin, CMC]

HE-ORPricing
Advocacy
Patients
Government
Communications
CSR

MedicalAffairsEpidemiology
PMS
PHV
Data Generation