ISPOR Medical Devices and Diagnostics Special Interest Group
Value Assessment of Medical Device Working Group
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 Group:

Payam Abrishami, MD, MA; National Health Care Institute, Netherlands
Henry Alder, MS, MBA; Managing Director, Access to Care Partners, LLC, USA
Drew Baker, MPA, MBA; Director, Health Policy & Reimbursement, Stryker Corp. NJ, 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; Medical Policy Analyst Sr., Office of Medical Policy and Technology Assessment, Anthem, Inc., USA
Michelle Costa; Reimbursement Manager, DePuy Synthes, Australia
Melike Deger, Cochlear AG, Basel, Switzerland
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, RPh, BPharm; Director, Health Economics, Policy & Reimbursement, Medtronic, Canada; Lecturer, Department of Health Management, Evaluation and Policy, School of Public Heath, University of Montreal, 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 (serving in personal capacity)
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
Roseann White, MA; Director, HEOR, Abbott Vascular, USA
Carla Zema, PhD, Vice President, Precision Health Economics, Los Angeles, CA, USA

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:

  1. Payers and Health technology Assessment (HTA) agencies,
  2. Procurers / Commissioners,
  3. Policy makers,
  4. Manufacturers & Designers (Industry),
  5. Health Care Practitioners / Providers) / Implementers, and
  6. Patients and Society
Background:

Value assessment for medical devices has a growing need for a deeper understanding, and there is little available literature. There are similarities between the assessment of medical devices and for pharmaceutical products, but there are also some key methodological differences. As identified in previous work, key differences include;

  1. Medical devices are intrinsically diverse in terms of design, usage, implementation (traceability) and application, including some being diagnostic
  2. Clinical trials, particularly Randomized Controlled Trials (RCT’s), are not best suited for devices (randomization, blinding, timelines, no or inappropriate comparator, the importance of real world evidence (RWE), etc.)
  3. Health Care Practitioner (HCP) skill and expertise can impact the safety, efficacy, and subsequently, the relative effectiveness of devices
  4. Value models rarely capture educational necessity, and organizational impact
  5. Shorter Product Life Cycle (PLC) as price decreases occur soon after innovative product launches due to rapid competition entrants, incremental innovation, different patent windows across devices and device categories
  6. Rapid innovation can immediately render a prior generation of device ‘less valuable’ or cost-ineffective simply because incremental improvement
  7. Medical devices pose distinctive socio-organizational questions, which vary across devices and sometimes differ in nature from those of pharmaceuticals.

Outline

Activities:

‘Mind The Gap!’: How Should We Manage the Difference Between Regulatory and Reimbursement Evidence Requirements for Medical Devices?
November 6, 2017 – ISPOR 20th Annual European Congress, Issue Panel, Glasgow, Scotland, UK

Performance-Based Risk Sharing Agreements – Opportunities and Challenges for Medical Devices
May 23, 2017 – ISPOR 22nd Annual International Meeting, Forum Presentation, Boston, MA, USA

Understanding the Challenges Facing the Value Assessment of Medical Devices: A Multi-Stakeholder Perspective
October 31, 2016 – 19th Annual European Congress, Workshop Presentation, Vienna, Austria

Assessing the Value of Medical Devices – Choosing the Best Path Forward: Where Do We Go from Here?
May 23, 2016 – 21st International Meeting, Issue Panel Presentation, Washington, DC., USA

Work Product:

Assessing the Value of Medical Devices—Choosing the Best Path Forward: Where Do We Go From Here?

Manuscript to be submitted to Value in Health: Value Assessment of Medical Devices: A Policy Analysis for Stakeholders

Work product timeline:

Activity

Date

SIG group meet Amsterdam

November 11, 2014

TC to discuss working group project

December 11, 2014

Proposal developed and refine detailed outline through discussion of issues via teleconference

December 2014 – April 2015

Proposal submitted

May 2015

Assign sections of the manuscript to the SIG leadership members

June 2015

Develop manuscript sections

June 2015 – April 2016

Meeting at ISPOR International meeting Philadelphia, USA

May 19, 2015

Submit abstract or proposal for IP for Milan

June 23, 2015

Preparation for IP presentation Milan

October 2015

IP presentation ISPOR European Congress Milano, Italy

November 2015

Meeting ISPOR Milano, Italy

November 2015

Revisions based on IP presentation

December 2015 - May 2016

Revised manuscript sent to ISPOR SIG Review Group

July 2016

Comments reviewed and discussed

August 2016

Authors revise sections

September - November 2016

2nd review by ISPOR SIG Review Group

December 2016

Manuscript revised based on comments from membership review

January 2017

Members and chair finalize and sign off on final report

February 2017

Manuscript submitted to Value in Health

March 2017

If you would like to submit a new proposal for a manuscript and/or a tool, please send an email to: sigs@ispor.org.

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