cadth 2015 a2 cadth international farup

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

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Page 1: Cadth 2015 a2 cadth international farup

HTA & Medical Devices:An InternationalPerspective

Christina Farup, MD, MS | April 2015

Page 2: Cadth 2015 a2 cadth international farup

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?

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Class III

Class IIb

Class IIa

Class I

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European HTA - 2000

European INAHTA members 2000

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European HTA – 2013

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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

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Product Advocacy

Cost-Benefit Analysis

Oversight

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• 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

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US VACs weigh the clinical, financial, and strategic benefits of new surgical products and services against the cost of adoption

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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 MetricsInfectionPatient SatisfactionReadmissions

Bene

fits

Costs

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Some “Take-away” thoughtsThe 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