AGENDA DAY 2

Pharma Pricing & Market Access USA Day 2

STAKEHOLDER COLLABORATIONS

Jamie Skipper
09:00

Keynote address: The future of evidence, pricing and reimbursement in the US healthcare system and what it means to you

  • Impact of the Trump administration on the payer/buyer relationship 
  • The impact of leveraging buying power for Medicare
  • Will drug prices be significantly reduced as a result?
  • What will the effects on global R&D be?
Timothy Miller
09:20

Gene therapy and market access, welcoming in a new generation of regenerative medicine

  • Considerations for one-off payment and reimbursement strategies in gene therapies
  • What is the right pricing framework for this and future cures?
  • First fresh data from the recent Abeona gene therapy trials
Steve Clark
09:50

Putting real world evidence data to the test in real world systems

  • Real-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization
  • Since implementation of real world evidence systems, how have health care systems been impacted economically?
  • Should you be investing more in real world evidence generation!?
10:10

Networking coffee break

VALUE & AFFORDABILITY

PRICING MODELS FOR BIOLOGICS and BIOSIMILARS

EVIDENCE
10:50

From Astrology to Astronomy - The science demonstrating value of personalized medicines

  • Big Data Health Epidemiology: its progress and impacts on value
  • Population Centric Phenotypes and how we must consider them
  • Making inferences from Personal Genomes
PRICING & MARKET ACCESS
10:50

Developing a successful market access strategy in biologic and biosimilar development.

  • Review the development and trends of biologic and biosimilar from the payer’s perspective
  • Different opportunities and challenges of biologic vs biosimilar and chemical brands vs generics
  • Review the evidence needs and role of HEOR in the development of biologics and biosimilar
PRICING & MARKET ACCESS
11:10

The Biologics Price Competition and Innovation Act

  • On March 23, 2020, hundreds of approved and pending applications for biological products will face a regulatory transition as the FDA implements the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  • Are your products ready for the regulatory transition?
  • How the provision and FDA’s implementation of it may affect approved applications for biological products, their biological product pipelines, and the timing and procedures of related patent litigations
PRICING & MARKET ACCESS
11:30

Winning with biosimilars!

  • Ex-US biosimilars uptake and pricing, and what are the key take-aways?
  • Hurdles for biosimilar utilization
  • Extrapolation and interchangeability –what are the issues?
EVIDENCE
11:50

Sponsorship Available

PRICING & MARKET ACCESS
11:50

Sponsorship Available

round tables
12:10

ROUND TABLES

1) Global Market Access For Orphan Drugs - How to include developing countries

  • Durhane Wong-Rieger, President, Canadian Organization for Rare Disorders
  • Ron Marchessault, Vice President, Value and Access, Specialty Care Sanofi Genzyme
  • Ramaiah Muthyala, President, Indian Organization for Rare Diseases
  • George Wyatt, Executive Senior Consultant, Innomar Strategies, Amerisource Bergen
  • Lisa Phelps, VP Policy, NORD National Organization for Rare Diseases
  • Meryem Nimour, VP- Medical Affairs Lead – Rare Disease- Emerging Markets, Pfizer
  • Pam Gavin, Chief Operating Officer, National Organization for Rare Diseases
2) Patient led Evidence - Discussing new levels of patient centricity in pricing models
  • Bert Vrijhoef, CIO & Senior Principal, Investigator, Panaxea & Maastricht University Medical Center
  • Lauren Bartolome, HEOR fellow, Novartis
  • Nneka Onwudiwe, PRO/PE Regulatory Review Officer, US Government​
3) I/O Pricing Models- New models to stumulate a fluctuating market
  • Bhakti Arondekar, Sr Director, Outcomes & Evidence, Oncology, Pfizer
  • Alberto Batista, HEOR fellow, Jefferson College of Population Health
  • Francisco Burgin, PGY-1 Managed Care Pharmacy Resident, Humana
4) Asian Access and Reimbursement- Discussing new developments in HTA in Asia
  • Jack Shea, Director Corporate Development, Merck
  • Sean McElligott, Director, Market Access, Janssen
  • Elizabeth Richardson, Managing Associate, Duke Margolis Center for Health Policy
5) Paying for gene therapy- Single fix medication and pricing models
  • John Maslowski, President and CEO, Fibrocell
  • Timothy Miller, President, CEO and Director, Abeona Therapeutics Inc
  • Christine Lu, Associate Professor, Harvard Medical School & Harvard Pilgrim Health Care Institute
  • Marianne Hamilton Lopez, Research Director, Duke-Robert J. Margoli Centre for Health Policy
6) Brazil Focus: Market Acess and Value Generation
  • Christina Matteucci, Market Access Head, Brazil, Bristol Myers Squibb
  • Roberta Monteiro, Market Access and Commercial Director, Eisai Brasil
7) Pluralistic approaches to value - Does the one size fits all approach still work?
  • Shanthy Krishnaraja, Global Head of Health Economics and Reimbursement Strategy, CSL Behring
  • Ashley John, Senior Specialist, Advocacy and Policy, American Academy of Dermatology

8) One payer systems - Consequences of implementation

  • Stephen Smith, Reimbursement Associate, Merck
  • Asian Access and Reimbursement- Discussing new developments in HTA in Asia
  • Sean McElligott

    Sean McElligott, Director, Market Access, Janssen

  • Brazil Focus: Market access and value generation
  • Roberta Monteiro

    Roberta Monteiro, Market Access and Commercial Director Brazil, Eisai

  • Global Market Access For Orphan Drugs - How to include developing countries
  • Pamela Gavin

    Pamela Gavin, Chief Operating Officer, National Organization for Rare Disorders

  • I/O Pricing Models- New models to stumulate a fluctuating market
  • Alberto Batista

    Alberto Batista, HEOR fellow, Teva Pharmaceuticals

  • One payer systems - Consequences of implementation
  • Stephen Smith

    Stephen Smith, Reimbursement Associate, Merck

  • Patient led Evidence - Discussing new levels of patient centricity in pricing models
  • Nneka Onwudiwe PharmD PhD MBA

    Nneka Onwudiwe PharmD PhD MBA, PRO/PE Regulatory Reviewer, US Government

  • Pluralistic Approaches to Value- Does the one size fit all model still work
  • Ashley John

    Ashley John, Senior Specialist, Advocacy and Policy, American Academy of Dermatology

    12:50

    Networking Lunch

    HEALTH ECONOMICS OUTCOMES RESEARCH

    SPECIALTY & ORPHAN MEDICINES

    EVIDENCE
    14:10

    Pricing and reimbursement experiences and insights: Lessons learned to approach adaptive payer pathways

    • Understanding how to develop a culture in which Evidence will prevail 
    • How to encompass frameworks earlier cross-stakeholder engagement, regulatory tools, and iterative evidence generation through the life cycle of the medicinal product
    • Access through flexible and adaptive payer approaches to pricing and reimbursement that reflect the emerging generated evidence
    PRICING & MARKET ACCESS
    14:10

    Shining a light on the black box of Orphan Drug Reimbursement

    • Discussing abuses of the Orphan Drug reimbursement system
    • Comprehensive review of the current US Orphan reimbursement system
    • Examining the explosion of orphan drug research and development
    EVIDENCE
    14:30

    PANEL: Market access evolution in Canada – past, present, and the future

    • Ensure that prices at which pharmaceutical companies sell their patented medicines in Canada are not excessive
    • Ensuring a sustainable pharmaceutical system where payers have the information they need to make smart reimbursement choices
    • Ensuring effective access of your biosimilar into the marketplace
    Nadia Turchetta, Executive Director, Biopharmaceuticals, Sandoz Canada
    PRICING & MARKET ACCESS
    14:30

    Expanding your horizons - Orphan drug considerations in Health Technology Assessment in European countries

    • The importance of understanding international HTA systems
    • Fair prices for orphan drugs - from the payers' perspective
    • New evidence requirements throughout Europe – what do you need to do to be prepared?

    PATIENT ADVOCACY

    VACCINES

    EVIDENCE
    15:10

    PANEL: Patient Affordability: Bridge the gap between access and the patient's pocket

    • Examine how you can address Patient Affordability and alleviate coverage inequality for oral therapies
    • Develop meaningful and progressive assistance programs which address a patients’ ability to afford medication
    • Drive solutions that will relieve patient paying points as they move between different sites of care
    Shailesh Chavan, Vice President of Clinical Research, Biotest Inc
    PRICING & MARKET ACCESS
    15:10

    Variation in provider vaccine purchase prices and payer reimbursement

    • Highlighting the need for individual practices to understand their own costs and reimbursements
    • Opportunities to reduce costs and increase reimbursements
    • Evolution of new pricing strategies
    PRICING & MARKET ACCESS
    15:30

    Vaccine pricing model for pediatric immunization

    • Practical results of the pediatric vaccine market analysis
    • Developing appropriate costs for combination vaccines
    • Entering new markets with pediatric vaccines
    EVIDENCE
    15:50

    Are patient preferences being reflected in value assessment frameworks?

    • Where is the patient voice in major Value Assessment Frameworks?
    • Do the models meet the rubric created by the National Health Council?
    • Is Faster Cures/Avalere's Patient Perspective Value Framework a solution?
    PRICING & MARKET ACCESS
    15:50

    The vaccine race: science, politics and the human costs of defeating disease

    • Gaining insights into the history of vaccines and developments that have been made over the course
    • Understanding the importance of vaccines in a healthcare systems inventory
    • What are the future requirements to make vaccination programs successful
    John Maslowski
    16:10

    Closing Keynote: Assessing value frameworks for cellular and gene therapy and one off cure products

    • Understanding the impact of one off cures
    • What preliminary requirements are needed to be met to satisfy CBER FDA
    • Current work of Fibrocell and the ever growing field of cellular and gene therapies

    Closing Remarks

    Closing Remarks

    last published: 18/Sep/17 16:35 GMT