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27 March 2019

08:00 - 19:00

Registration

27 March 2019

09:00 - 10:30

ISPOR Poland Chapter Meeting

  • Description
  • The meeting will focus on presentations discussing “HTA and reimbursement hot topics in Poland – experience sharing." All attendees of Chapter meetings must be registered for ISPOR Warsaw 2019. For questions about the scheduled Chapter meetings and to RSVP please contact EMEA@ispor.org. Seating is limited.


    By invitation only.
    Prior RSVP is required.

     


27 March 2019

11:15 - 12:45

ISPOR Ukraine Chapter Meeting

  • Description
  • The meeting program includes updates on the national drug policy and HTA implementation in Ukraine, capacity building in HEOR/HTA, topics of bioequivalence and of priority disease model, among other discussion subjects. All attendees of Chapter meetings must be registered for ISPOR Warsaw 2019. For questions about the scheduled Chapter meetings and to RSVP please contact EMEA@ispor.org. Seating is limited.


    Prior RSVP is required.


27 March 2019

12:00 - 19:00

Exhibits

27 March 2019

13:00 - 15:00

ISPOR CEE Consortium Meeting

  • Description
  • ISPOR Regional Chapter leadership representatives and members from the ISPOR CEE Consortium will meet to discuss education and research projects developed by the Consortium and provide updates on Chapters regional activities. Topic of patient engagement in the HTA and procurement activities in the CEE region will also be discussed.

    All ISPOR CEE Consortium meeting attendees need to be registered for ISPOR Warsaw 2019 and send RSVP re: CEE Consortium meeting to EMEA@ispor.org. Seating is limited.

    By invitation only.
    Prior RSVP is required.


27 March 2019

15:30 - 16:30

1st Sponsored Educational Symposium

  • Description
  • Improving Patient Access to Innovative Cancer Therapies: The Role of Managed Entry Agreements

    In recent years, innovative cancer therapies have demonstrated the potential to dramatically reduce the global cancer burden and improve patient outcomes. However, delivering these therapies to patients remains challenging in many countries; governments, payers, and industry face pressure to ensure timely access and budget predictability while maintaining incentives for future innovation.

    Flexible access agreements such as managed entry agreements (MEAs) have been identified as mechanisms to address these challenges and expedite access to innovative cancer therapies by allowing pharmaceutical companies and payers to share risks associated with the introduction of new medicines.

    This MSD-sponsored Educational Symposium will include a panel discussion on how MEAs and multi-year multi-indication agreements can be leveraged to address emerging challenges in the oncology landscape and accelerate patient access to innovative cancer therapies.

    Symposium sponsor is Merck Sharp & Dohme (MSD)

    Speakers:
    Magdalena Władysiuk, MD, Vice President, HTA Consulting, Poland
    Luka Vončina, MSc, PhD, Managing Director, Freyr Consulting, Croatia
    Tim Wilsdon, MSc, Vice President, Charles River Associates, United Kingdom
    Denis Vujicic, Managing Director, MSD, Poland
    Stanimir Hasardzhiev, MD, Secretary-General - Patient Access Partnership, Bulgaria
    Francis Arickx, Head of the Directorate Pharmaceutical Policy, National Institute for Health and Disability Insurance, Belgium

    Open to all participants.

    MSD

27 March 2019

16:30 - 16:45

Coffee Break

27 March 2019

16:45 - 17:45

2nd Sponsored Educational Symposium

  • Description
  • The implementation of sustainable biosimilar policies to increase access to biological medicines in CEE countries

    In many countries high-priced original biological medicines are unavailable or reimbursement is restricted.

    The main value proposition of biosimilar medicines in these countries is not only to save money, but to increase patient access to treatment. To increase access for patients, there is a need – especially in CEE countries - for sustainable pricing and demand-side policies on biosimilar medicines that would go beyond a sole short-term objective of cost savings to the healthcare budgets.

    In this workshop, panel members will discuss the implementation of sustainable biosimilar policies from the academic, payer, regulatory and industry perspectives.

    Symposium sponsor is Medicines for Europe. 

    Speakers:

    Rok Hren, MSc, PhD; Assistant Professor, University of Ljubljana; Slovenia
    András Inotai, Principal Researcher, Head of Pharmaceutical Policy Department - Syreon Research Institute, Hungary
    Tomáš Tesař, PharmD, PhD, MBA, Associate Professor, Union Health Insurance Fund, Slovakia
    Maarten Van Baelen, Market Access Director – Medicines for Europe
    Marcin Czech, PhD, MD, MBA, Head, Department of Pharmacoeconomics, Institute of Mother and Child, and Business School, Warsaw University of Technology, Warsaw, Poland, and former Deputy Minister of Health and Undersecretary of State, Poland


    Open to all participants.

    Medicines for EuropeG


27 March 2019

17:45 - 18:00

Coffee Break

27 March 2019

18:00 - 19:00

3rd Sponsored Educational Symposium

  • Description
  • Multi-disciplinary approaches to address the unmet need in schizophrenia

    The symposium will provide an overview on the public health importance of mental disorders, with special focus on clinical, economic and societal burden of schizophrenia. The clinical overview will highlight the current unmet medical need for schizophrenic patients with negative symptoms.

    Multidisciplinary HTA approaches - including the economic modelling framework - to evaluate therapeutic options in schizophrenia will be presented.

    Symposium sponsor is Gedeon Richter Plc.

    Speakers: 

    Prof. Dr. Zoltán Kaló, Eötvös Loránd University, Hungary  
    Prof. Dr. István Bitter PhD DSc, Semmelweis University, Hungary  
    Bertalan Németh, Syreon Research Institute, Hungary

    Open to all participants.

    Gedeon Richter

27 March 2019

19:00 - 20:00

Welcome Reception

  • Description
  • A welcome artistic performance by a local group “GAIK” at the start of the reception will feature dance repertoire that is characteristic for the South-Eastern part of Poland.

    Open to all participants.

28 March 2019

08:00 - 17:30

Registration and Exhibits

28 March 2019

08:30 - 09:00

Refreshments and Networking

28 March 2019

09:00 - 09:15

Welcome & Opening Remarks

  • Description
  • Welcome Address: Nancy Berg, ISPOR CEO & Executive Director
    Opening Remarks: Zbigniew Krol, MD,PhD, Undersecretary of State, Deputy Minister of Health, Poland


28 March 2019

09:15 - 10:30

Session 1: Aligning Evidence Requirements for Drug Authorization and Coverage – Central and Eastern European (CEE) Countries Insights

  • Description
  • The European Medicines Agency (EMA) has offered consultations that are parallel with the European network for Health Technology Assessment (EUnetHTA) since July 2017.

    The consultations allow developers of medicines to obtain feedback from regulators and health technology assessment (HTA) bodies on its evidence-generating plans to support decision-makers on the topics of marketing authorization and reimbursement of new medicines.

    The attractive or acceptable risk-benefit ratio from the EMA perspective might not easily translate into favorable comparative effectiveness and cost-effectiveness from the payers’ perspective. The regulatory approach (ie: early access, PRO based authorization, lack of hard endpoints, survival gain) implies specific consideration from the HTA perspective. Potentially, countries with a more limited healthcare budget would expect stronger evidence and less uncertainty around clinical outcomes in their coverage decision.

    The focus of the session is to reflect on the benefits of the initial consultations, while exploring the CEE countries perspectives through scientific advice from EMA and HTA bodies.



28 March 2019

10:30 - 11:00

Coffee Break

28 March 2019

11:00 - 12:30

Session 2: Health Data, Health Data, and More Health Data: From Quantity to Quality Through Cooperation

  • Description
  • Rising healthcare costs are under increased worldwide scrutiny. Efforts to improve the outcomes for money spent, and to build a value-based healthcare solution are vital. Health data is an increasingly essential ingredient to enhance health systems performance, and healthcare quality, while contributing to scientific discoveries that improve medical treatments and save lives. Value-based healthcarerequires a comprehensive informatics infrastructure for collecting, sharing and analyzing data and information for each population segment along the full cycle of care.

    Discussing and finding ways to strengthen commitment to make better use of available health data and develop new databases, to foster international cooperation in health research and cross-country databases, and ultimately to improve health systems performance and outcomes are priority topics in the CEE countries.

    The session will review the following areas:

    • Manage availability and use of personal health information to enable significant improvements in health, healthcare quality and performance,
    • Engage a greater number of countries participating in multi-country statistical and research projects, and
    • Develop greater standardization of the health data governance frameworks to improve the abilities of CEE countries to benefit from statistical and research uses of data in which there is a public interest.

    Availability, access to, and quality/type of health data needed will be discussed from the perspective of joint clinical assessment, price negotiation and procurement.



28 March 2019

12:30 - 13:30

Lunch

  • Description
  • Open to all delegates.

28 March 2019

13:30 - 15:00

Session 3: Medical Device Assessment and Procurement – Fair and Efficient Access in Countries with Limited Health Budgets

  • Description
  • The medical devices market is less regulated as seen across countries globally. Heterogeneity and specificity of many non-drug products need to be taken into account in HTA and coverage decisions. Several projects related to standardization of medical devices value assessment are underway.

    The session will provide an update on international efforts in advancing methodology and approaches to medical device assessment, present several European countries experiences, and discuss the issue of medical device assessment and procurement in the context of those healthcare systems working within restricted budgets.



28 March 2019

15:00 - 15:15

Coffee Break

28 March 2019

15:15 - 16:45

Session 4: How Far Can We Go? Finding a Common Way in Clinical Evaluation, Data Generation, and Joint Procurement and Pricing Negotiations

  • Description
  • All countries face the same problems of managing an aging population, increasing patients’ expectations, availability of promising novel and costly health technologies, and the need for evidence-based coverage decisions navigating budget limitations. Increased dialogue and cooperation between countries, decision makers and stakeholders in general is necessary.

    The challenge of the diversity of the European healthcare systems contributes to the complexity of finding an effective balance between “going it alone” and “joining forces” to support the coverage decision-making process.

    In that context, session delegates will discuss strengths, weaknesses, opportunities and threats of a joint approach to value assessment, procurement and price negotiations that impact access to health technologies in Europe.



28 March 2019

16:45 - 17:00

Closing Remarks