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#t287n73http://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

5. European HTA – 2013 7 2 9 2 3 4 2 1 6 5 5 3 9 1 5 1 3 1212 2 1 3 2 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