11th Annual EU Medical Device Regulatory Affairs Conference

July 7-9, 2020 | Virtual Event

DAY TWO | WEDNESDAY, MARCH 25

8:30 REGISTRATION & COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS

9:00 OVERVIEW OF HEALTHCARE DIGITIZATION PROGRAMS IN MEMBER STATES & IMPACT ON MEDTECH REIMBURSEMENT
Whether it be the Dutch regulations for stimulating digital care, German advancement of the law for better care through digitization and innovation, or NHSX in the UK, the past year has been extremely busy with government-led healthcare digital transformation programs. In addition, Belgium and France also continue to work on implementing procedures to better address telehealth opportunities as well as mHealth products. With such a rapidly changing landscape, market access and reimbursement professionals must secure a sound strategy to remain abreast of all changes, and clear understanding of how to best position innovative medtech in evolving healthcare frameworks including artificial intelligence and machine learning-based treatment decision processes.

Christian Fulda, Partner, JONES DAY

 

9:45 CLARIFYING NICE’S EVIDENCE STANDARDS FRAMEWORK FOR DIGITAL HEALTH TECHNOLOGIES

  • United Kingdom openness to digital health technologies
  • Defining relevant evidence from NICE & NHS’ standpoints
  • Outcomes of the 2019 consultation period & survey
  • Practical view on building a digital tech reimbursement case

Lincoln Tsang, Partner, ARNOLD & PORTER

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 DISSECTING OPPORTUNITIES & LIMITATIONS IN DIGITAL HEALTH REIMBURSEMENT IN EUROPE
As device and diagnostic manufacturers increasingly develop mobile and eHealth goods, as well as software as medical devices, many questions arise relative to whether or not such technology can be reimbursed as standalone products. In particular, demonstrating optimal value of virtual technology is currently a focus point for market access professionals as much uncertainty lies in the applicability of traditional clinical studies such as RCTs. It is of the utmost importance for the industry to clearly understand what type of digital technology will trigger interest from private and government payer boards, to secure successful coverage, in addition to how to navigate unclear pathways towards reimbursement.

PART 1 – PANEL DISCUSSION: PERSPECTIVES INTO DEMONSTRATING VALUE FOR DIGITAL PRODUCTS

  • Defining evidence based on the type of technology
  • Limits of traditional clinical study frameworks
  • Cost/benefit assessment & value pitch structure
  • Incentivizing diverse payers to buy into digital tech

Markus Ott, ROCHE DIAGNOSTICS

Marcus Simon, TELEFLEX

Katleen Vandeweyer, ROCHE DIAGNOSTICS BELGIUM

Patricia Alegre, AIR LIQUIDE SANTE INTERNATIONAL

 

11:45 PART 2 – PRACTICAL WALK-THROUGH: ACHIEVING SUCCESSFUL FUNDING OF A DIGITAL DEVICE

  • Reimbursement strategy design & EU market targeting
  • Determining value in relation to the type of payer
  • Encountered pitfalls & solutions to overcome objections
  • Lessons learned & application to further EU markets

Patricia Alegre, Market Access Director, AIR LIQUIDE SANTE INTERNATIONAL

 

12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:30 EFFICIENTLY COLLABORATING WITH CLINICAL TEAMS TO ENSURE APPROPRIATE EVIDENCE GENERATION

  • Health Economics as a research function vs commercial function
  • Strategically positioning HE within clinical affairs departments
  • Embedding HE in long term evidence strategies & plans
  • Health Economics to fill short & midterm evidence gaps

Gerhard Bothma, Global Director Health Economics & Governmental Affairs
MÖLNLYCKE HEALTH CARE

 

2:15 PRACTICAL CASE STUDIES: REAL WORLD REIMBURSEMENT STRATEGIES & OUTCOMES IN EU MARKETS
With each European member state requesting a specific type of evidence to support reimbursement claims, as well as differing mechanisms for market access, reimbursement executives are continuously on the hunt for insightful strategies to apply in accessing an EU market. Shedding light onto peers’ experience is of tremendous value, as there is not one but many possible approaches to securing coverage, and obtaining an acute understanding of processes and opportunities encountered by other companies provides participants with further clarity into reimbursement scenarios applicable to product portfolios.

CASE STUDY 1:

  • Cardiac Telemedicine
  • Health Technology Assessment
  • Demonstrating patient relevant benefits
  • Critical role of technology, infrastructure & SOPs

Tino Hauser, Director Clinical Affairs & Reimbursement CENEMEA, BIOTRONIK

3:00 CASE STUDY 2:

  • Evidence generation for different stakeholders in the German healthcare system
  • Early identification of evidence gaps (i.e. systematic literature review)
  • §137e “trial regulation” consultation for evidence gap detection
  • §137e “trial regulation” submission for evidence generation
  • RWE for selective contracting negotiations with statutory health insurances
  • Alternative pathways to reimbursement (selective contracting)

Viktor Makowski, Market Access Manager DACH, TERUMO EUROPE

 

3:45 CLOSING REMARKS & CONFERENCE CONCLUSION