11th Annual EU Medical Device Regulatory Affairs Conference

July 7-9, 2020 | Virtual Event

DAY ONE | TUESDAY, MARCH 24

8:00 REGISTRATION & WELCOME COFFEE

8:45 CHAIRPERSON’S OPENING REMARKS

9:00 OPENING ICE BREAKER: MARKET INTELLIGENCE COLLECTION METHODS TO OPTIMIZE REIMBURSEMENT STRATEGIES
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussion aimed towards sharing insights into preferred informative platforms and media pertinent to the healthcare market and diagnostic coverage. Furthermore, participants in this warm-up session are given the opportunity to build contacts with industry peers, kicking off the event networking platform.

 

9:20 INTERVIEW: UNVEILING PAYER & HTA PERSPECTIVES ON MEDTECH REIMBURSEMENT IN EU MARKETS
While sharing the similar goal of granting reimbursement solely to products exhibiting the most interesting cost-benefit ratios, public and private payer boards in European member states each apply distinct product review mechanisms. The industry is often stymied by differing expectations from one member state to the next, and strives for enhanced clarity on technology assessment mechanisms, evidence requirements, value demonstration and communication streams to ultimately shed light on HTA and payer decision making processes. With the aim to continuously optimize reimbursement and market access strategies, participants in this interview session are given the opportunity to submit questions ahead of the event for the interviewees to answer live, and compare perspectives from distinct European markets.

INTERVIEWER: Markus Ott, Head of Global Market Access & Health Policy
ROCHE DIAGNOSTICS

Petra Schnell-Inderst, Senior Scientist, INSTITUTE OF PUBLIC HEALTH, AUSTRIA

Neil Smart, Vice Chair, SCOTTISH HEALTH TECHNOLOGIES GROUP
ConsultantNHS UK

Iñaki Gutiérrez-Ibarluzea, HTAi President
BIOEF, BASQUE FOUNDATION FOR HEALTH RESEARCH & INNOVATION, SPAIN

Michele Tringali, Deputy Director, HTA Program, General Health Directorate
REGIONE LOMBARDIA, ITALY

 

10:20 COFFEE & NETWORKING BREAK

 

10:45 EU ACCESS PLAN DEVELOPMENT: RATIONALIZING WHICH MARKETS TO TARGET FIRST

  • Outlining specific member state needs & requirements
  • International considerations: Focus on the USA
  • Determining which countries to target first & why
  • Maximizing the use of HE data generated in initial markets
  • Progressively moving towards more stringent countries

Herve Janssens, VP Marketing & Market Access, GTX MEDICAL

 

11:30 COMPREHENSIVE & PRACTICAL APPROACHES TO RISK SHARING & VALUE-BASED PRICING TRENDS
In the past decade, European payer boards have progressively turned towards risk sharing and value-based pricing strategies to grant access to medical device and diagnostic products, directly inspired by pharmaceutical reimbursement programs. Reimbursement and market access executives are at times unsure how to develop the dossiers to obtain approval, as well as how to engage in direct partnerships with payers. The industry is in need of clarification and furthermore a practical understanding of how to best highlight benefits of medtech products in both structures.

  • Clarifying the concept of risk sharing in EU healthcare
  • Understanding value-based models & pricing in practice
  • Addressing concerns & overall benefit for the manufacturer
  • Successfully reaching an agreement with payer boards

Richard Charter, Director EMEA, Value-Based Healthcare, VALUECONNECTED

 

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

 

1:15 PRACTICAL WALK-THROUGH OF A VALUE-BASED PRICING STRATEGY DESIGN & LAUNCH

  • Developing a plan of action & continuous adjustments
  • Securing executive hierarchy’s support & buy-in
  • Team structure to lead the effort & preparing for launch
  • Rationale for targeting certain payers first with VB strategy

Matthias Borst, EVP & Chief Sales Officer, KULZER

 

1:45 INTERVIEW: VALUE-BASED HEALTHCARE FROM THE PAYER’S PERSPECTIVE

  • Diverse interpretations of value-based agreements
  • Benefits for national & regional payer boards
  • Practical approach to industry-payer partnerships

INTERVIEWER:
Ernesto Nogueira, Managing Director, VALUECONNECTED

INTERVIEWEE:
Tom Jefferson, Scientific Coordinator, AGENAS

 

2:15 INNOVATIVE REIMBURSEMENT MODELS: PRACTICAL INSIGHT INTO DESIGNING INDUSTRY & PAYER PARTNERSHIPS
In the effort of advancing life-improving medtech to patients and practitioners, forward-thinking companies have established proactive strategies to engage and directly collaborate with private or government payers in order to facilitate, streamline and expedite access to reimbursement. This session will present industry and payer collaboration case studies for innovative payment models, focusing on the practical steps taken to initiate and achieve the partnership as well as encountered pitfalls and lessons learned.

CASE STUDY 1:

  • NUB status one for stent graft with active control in PAD
  • Defining “temporary” timeline for adoption of innovation
  • Opening dialogue with payers to push the tech forward

Maria Rachele Busca, EMEA Leader Health Economics, W. L. GORE

2:45 CASE STUDY 2:

  • Innovation cost-effectiveness & cost-saving focus to fit societal needs
  • Current pay-per-task design of the Dutch reimbursement system
  • Impact on adoption of lower cost alternatives by HCPs & rationale
  • Collaboration with insurance, government, hospital BoD & KOLs

Geeske van Oort, Clinical, Reimbursement & Quality Director, THE eNOSE COMPANY

 

3:15 COFFEE & NETWORKING BREAK

 

3:45 ANALYSIS OF THE MDR IMPACT ON REIMBURSEMENT & MARKET ACCESS IN EUROPE
The European market has been undergoing a regulatory shift with the MDR coming into force in May of 2020, and IVDR in May, 2022. The new rules demand for enhanced clinical testing and higher levels of evidence to be generated to demonstrate product safety and performance, resulting in increased costs for manufacturers to bring innovative products to EU markets. In addition, the mandatory re-registration of previously CE-marked and marketed medical technology is raising many questions relevant to the withdrawal process of marketed and reimbursed products, as well as the necessity to re-claim reimbursement for legacy products once the regulations are implemented.

  • Defining the nature & volume of “sufficient” clinical data
  • Impact of new rules for reimbursement & market access
  • Organizing trial portfolios for streamlined reimbursement
  • Mandatory device re-certification under the new rules
  • Legacy product reimbursement re-claiming considerations

Torsten Böhler, Head of Clinical Affairs, STRAUB MEDICAL

 

4:30 SOLIDIFYING REIMBURSEMENT SUCCESS BY ENGAGING IN A PRODUCT LIFECYCLE SCIENTIFIC EVIDENCE STRATEGY

  • Peer-reviewed evidence generation over the product lifecycle
  • PMS & PMCF strategy to support MDR & reimbursement
  • Cross-functional collaboration among corporate teams
  • Facilitating market adoption or maintenance & reimbursement

Patrice Becker, Global Director Scientific Communications / Surgical Innovations Medical Affairs, MEDTRONIC

 

5:00 STATUS OF A EUROPEAN HTA REGULATION PROPOSAL & SYNERGY WITH MDR
Following the effort of EUnetHTA Joint Actions, the European Commission continues to draft a proposal for a health technology assessment regulation to ultimately supersede the disparate member state coverage mechanisms and prevent duplication of HTA reviews. While promising in nature, the industry is keen to understand how and when the regulation might be implemented, as well as the manner in which it will enable swifter and more streamlined access to EU markets from a practical standpoint. In particular the focus on joint clinical assessments raises questions from manufacturers in parallel to increasing requirements for clinical testing and evidence with the MDR and IVDR.

Petra Schnell-Inderst, Senior Scientist, INSTITUTE OF PUBLIC HEALTH, AUSTRIA

 

5:30 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:15 CONTINUED NETWORKING: FACILITATED GROUP DINNER
Q1 Productions will arrange a dinner reservation at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on March 24th. Please note that dinner expenses must be covered by each participant individually.