This document discusses health technology assessment (HTA) of medical devices from an international perspective. It defines HTA as a multidisciplinary process that systematically evaluates the medical, social, economic and ethical issues related to a health technology. The document then provides an overview of HTA for medical devices in Europe, Asia Pacific countries, the US, and discusses key considerations in assessing the value of devices. It notes that device value assessments consider clinical, financial and strategic factors, and balancing benefits against adoption costs is important. The future of HTA may involve more flexible and affordable evidence development approaches tailored to devices.

1. HTA &
Medical Devices:
An International
Perspective
Christina Farup, MD, MS | April 2015

2. Definition of HTA
Health Technology Assessment...
is a multidisciplinary process that summarises information
about the medical, social, economic and ethical issues
related to the use of a health technology in a systematic,
transparent, unbiased, robust manner. Its aim is to inform
the formulation of safe, effective, health policies that are
patient focused and seek to achieve best value
EUnetHTA: http://www.eunethta.eu/about-us/faq#t287n73
Key Considerations
-What is the purpose of the HTA? How are devices reimbursed?
-Are all devices alike and should be they treated as all the same or like drugs?
-Who can best evaluate and translate the value of a device in the healthcare system and
delivery of care?
-When and how should evidence evolve for devices?

3. 2
Class III
Class IIb
Class IIa
Class I

4. European HTA - 2000
European INAHTA members 2000
1
1
2
2
4
1
1
4
4
2
1
1
4

5. European HTA – 2013
7
2
9
2
3
4
2
1
6
5
5
3
9
1
5
1
3
1
2
2
1
32
1
6
2
12
1
3
1 1
2

6. Adelaide Health Technology
Assessment (AHTA), Australia
Medical Services Advisory Committee
(MSAC), Australia, since 1998
Australian Safety and Efficacy
Register of New Interventional
Procedures - Surgical (ASERNIP-S),
Australia
Australia and New Zealand Horizon
Scanning Network (ANZHSN), Australia
AUSTRALIA
NEW ZEALAND
New Zealand Health Technology
Assessment (NZHTA), New
Zealand, since 1997
PHILIPPINES
HTA Committee of the
PhilHealth, Philippines, since
1999
JAPAN
Department of Preventive
Medicine, University of
Tokushima, Japan
SOUTH KOREA
National Evidence-based
Healthcare Collaborating
Agency, South Korea
HTA Key Lab of MOH, WHO
Collaboration Center (Fudan
University)
HTA Division, Health
Policy Development &
Research Center of MOH
HTA Division, HTA Research
Office of China Medical
Academy
Pharmacoeconimics Centers:
Peking University, Fudan
University, Pharmaceutical
Association
CHINA
HONG KONG
Office of Technology Management,
Hong Kong, since
TAIWAN
CDE Center for Drug Evaluation,
Taiwan, since 2007
THAILAND
National Health Security Office,
Thailand, since 2002
SINGAPORE
Clinical Standards and
Technology Assessment (CSTA)
branch at the Singapore Ministry
of Health, Singapore
INDONESIA
Center for Health Services
Research and Development,
Indonesia,
MALAYSIA
Kementerian Kesihatan
Malaysia (KKM), Malaysia
Introduction to HEMA, Asia Pacific, August
2011
HTA in Asia Pacific

7. Product
Advocacy
Cost-Benefit
Analysis
Oversight
6
• Submit requests for new products
• Assemble available clinical and financial data
• Provide subject-matter expertise and opinion of
products’ clinical benefits
Hospital Level
• Review all available
clinical and cost data
• Preform CER using
hospital-specific data
• Recommends
approval or denial of
request
System Level
• Collect available data
• Preform CER
• Negotiate vendor and
GPO contracts
Hospital & System Level
• Assess strategic
benefit to department,
hospital, or system
• Prioritize hospital and
system investments
• Set cost reduction &
containment targets
for materials
management
Surgeon
OR Clinicians
Surgical Services Director
Finance Director
Materials Management Director
COO
CFO
Chief of Surgery
Supply Chain Director
HTA in US= Hospital Value Assessment Committee

8. US VACs weigh the clinical, financial, and strategic benefits of
new surgical products and services against the cost of
adoption
7
Clinical
•Safety/quality
•Patient discharge status
•Outcomes
•Decreased recovery time
Financial
•Decreased OR time
•Decreased LoS
•Increased efficiency
Strategic
•Patient engagement
•Payer relationships
•Business model
•Nurse/Staff satisfaction
Price differential with current
solution
•Product cost
•Synergies with current product
portfolio and contracts
•Historical cost benchmarks
•Payer rates
Costs associated with adoption
•Administrative
•Training
•Integration
Linkage to Quality Metrics
Infection
Patient Satisfaction
Readmissions
Benefits
Costs

9. Some “Take-away” thoughts
The future potential to improve best practice
Aspects of device value are varied
– HTA assessment of value
– Hospital assessment of value
– Limitations to both
New solutions for evidence development
-affordable, practical, flexible when appropriate
More debate on when, who, why for HTA=“fit for purpose”
-more dialogue with key stakeholders: Surgeons, Providers,
Industry, Patients