Value Assessment of Medical Devices Working Group
ISPOR 18th Annual European Congress Milano, Italia
The Value Assessment of Medical Devices Quick Facts
‐ The Global value of MedTech R&D is expected to reach $29.5B by 2020 ‐ The top 10 MedTech Companies are predicted to account for 35% of industry sales by 2020 ‐ Prescription drug sales are predicted to grow at 4.9% between now and 2020, with MedTech predicted to grow at 4.1% CAGR. Source: Evaluate MedTech. World Preview 2015, Outlook to 2020. 4th Edition, October 2015.
2
1
The Value Assessment of Medical Devices Top Device Areas
Source: Evaluate MedTech. World Preview 2015, Outlook to 2020. 4th Edition, October 2015.
3
The Value Assessment of Medical Devices Top Companies
Source: Evaluate MedTech. World Preview 2015, Outlook to 2020. 4th Edition, October 2015.
4
2
The Value Assessment of Medical Devices Distribution by Company Size
65% of total sales come from the 11 – rest of market.
Source: Evaluate MedTech. World Preview 2015, Outlook to 2020. 4th Edition, October 2015.
MedTech will still be SME dominated.
5
The Value Assessment of Medical Devices Devices versus Prescription Drug Sales
6
Source: Evaluate MedTech. World Preview 2015, Outlook to 2020. 4th Edition, October 2015.
3
The Value Assessment of Medical Devices R&D Spend
7
Source: Evaluate MedTech. World Preview 2015, Outlook to 2020. 4th Edition, October 2015.
Priority & Objectives Value Assessment of Medical Devices Priority: The value assessment of medical devices is a relatively unknown area with little published literature, however: i. ii. iii.
the frequency of assessments is increasing rapidly. few well documented methodologies and best practices Confusion among stakeholders
Objectives: It should be an immediate priority that value assessment of devices have consistent, transparent, and predictable methodologies for all stakeholders
8
4
Value Assessment of Medical Devices 1. Medical devices are intrinsically diverse in terms of design, usage, implementation, and application, including some being diagnostic. 2. Evidence generation capabilities and possibilities are far different to pharmaceutical evidence generation. 3. Health Care Practitioner (HCP) and user skill / expertise can impact the safety, efficacy, and subsequently, the relative effectiveness of devices 4. Value models rarely capture educational necessity, and organizational impact 5. Significantly different Product Life Cycle (PLC).
9
Likely Manuscript Structure Section & Sub-Sections 1.
Introduction: Medical Devices and their impact on healthcare
2.
Rationale for Assessment of Devices
3.
Understanding the Challenges in Determining the Value of a Device
3a) Variables impacting the PROCESS of Assessment i. Diversity of products, categories, classifications, and regions ii. Challenges in the lack of common terminology and objectives iii. How financing systems impact the process of value assessment iv. Learnings from Pharmacoeconmics / HEOR: ‘Pharma-precedence’ v. KEY: Summary of practical solutions to process challenges 3b) Variables impacting the METHODOLOGY of Assessment i. Lack of well-established assessment methodology, perspectives, and guidelines ii. Decoupling ‘pharma-precedence’ and devices iii. Disagreement on what constitutes evidence based medicine iv. KEY: Summary of practical solutions to methodology challenges 4.
General Lessons For Stakeholders & Conclusions
5. 6.
Tables & Definitions Further Readings
10
5
Goals & Stakeholders Value Assessment of Medical Devices Goal: To provide a definitional and methodological framework for the challenges facing the value assessment of medical devices and how these challenges can be overcome. A key focus will be on applicability to all stakeholders to provide transparency, consistency, and integrity to minimize the uncertainty outcomes to patient access to new medical device innovations.
Key stakeholders we will consider include: i. ii. iii. iv. v. vi.
Payers and Health technology Assessment (HTA) agencies, Procurers / Commissioners, Policy makers, Manufacturers & Designers (Industry), Health Care Practitioners / Providers) / Implementers, and Patients and Society
11
A Multi-Stakeholder Collaboration Decision Maker Contributions NICE ‐ UK ISC III ‐ Spain FDA ‐ US ZorgInstitut ‐ Netherlands Plus Comments from: GKV Spitzerverband ‐ Germany HAS ‐ France CEDIT ‐ France
Payer Manufacturer Academia
Provider Consultant
12
6
Why this is Important: A Payers Perspective – NICE, UK 1. Healthcare systems have a responsibility to get products to patients which are of value and can be afforded by the system 2. The evidence to demonstrate that value is crucial and cannot be compromised Industry Takeaway: Value claims must be substantiated!
13
What do decision makers need to know about new technologies?
14
7
What is important for NICE / HTA
15
Two Key Issues for HTA.
16
8
Typical Issues Raised for HTA Advice
17
What do decision makers need to know about new technologies?
18
9
Key Takeaways 1. We need to be clear what policy objectives HTA and economic evaluation are trying to fulfil. 2. We need to ensure stakeholders are aware of the nuances and diversity of payment policy, mechanisms to access (pathways), and training/education requirements to implement Medical Devices. 3. Industry needs to ensure value propositions are substantiated in an evidence based way. 4. Objectives must reflect the fundamentally diverse and different nature of the medical device industry and its stakeholders. 5. For the paper we need to take a more technical / scientific approach. Comments must be substantiated. 19
Value Assessment of Medical Devices
Sign up as Review Group Member • Business card to Jessica • Sign-up sheet • Website: Interest Groups • Join ISPOR Special Interest Groups Select ISPOR Medical Devices and Diagnostics
20
10
21
Co-chairs: Richard Charter, CMT, MSc, Head of Market Access & Pricing, Diabetes Care Europe, BD, Switzerland Bruce Gingles, Vice-President, Global Technology Assessment and Healthcare Policy, COOK Medical, Inc., Bloomington, IN, USA
Leadership Members: Deborah Morrison, MSc, BSc; Senior Scientific Adviser, National Institute for Health and Care Excellence, England, United Kingdom Payam Abrishami, MD, MA; National Health Care Institute, Netherlands Henry Alder, MS, MBA; Managing Director, Access to Care Partners, LLC, USA Drew Baker, BS, MBA, BA; Director, Health Policy & Reimbursement, Stryker Corp.USA Ameet Bakhai, MD; Royal Free NHS England, United Kingdom Amarpreet Chawla, PhD; Sr. Global Life Sciences Consultant, Quintiles Advisory Services, USA Diane Civic, PhD, MPH; Blue Cross Blue Shield Association, USA Michelle Costa; Reimbursement Manager, DePuy Synthes, Australia Lisa Da Deppo, PharmD, MBA, MSc; Market Access Head, UCB, Italy Melike Deger, Cochlear AG, Basel, Switzerland Ward Drennan, PhD; Research Assistant Professor, University of Washington, USA Joanna Entwistle, PhD, BSc; GfK, England, United Kingdom Sebastian Gaiser, MSc; Director Health Economics & Reimbursement EMEAC, St. Jude Medical, Belgium 22
11
Leadership Members: Sonia Garcia, Instituto de Salud Carlos III, Spain Melodi Kosaner Kließ; Scientific Publications Specialist, Vibrant MED-EL, Hearing Technology GmbH, Austria Chantale Lessard, PhD, DcomplD, MSc, BPharm, RPh; Director, Health Economics, Policy & Reimbursement, Medtronic, Canada Belinda A. Mohr, PhD, BS, MA; Health Economist, W. L. Gore & Associates, Inc., USA Nneka Onwudiwe, PhD, PharmD, MBA; PRO/PE Regulatory Reviewer, Food and Drug Administration, USA Krista A. Payne, BA, Med; Executive Director and Senior Research Scientist, Evidera, Canada Sanjoy Roy, MS; Director, Health Economics & Market Access, Johnson and Johnson Global Surgery, USA Bjoern Schwander, MSc, BSc, RN; General Manager, AHEAD GmbH, Germany Anna Teschemaker, PhD; Manager, Health Economics, Janssen Global Services, LLC., USA Roseann White, MA; Director, HEOR, Abbott Vascular, USA Carla Zema PhD; Director, Health Policy and Economics, ZOLL, Pittsburgh, PA, USA
23
24
12
