2019 Agenda

October 2, 2019
  • 7:30 AM
    Registration and Breakfast
  • 8:45 AM
    Opening Comments from the Chair
    Kaitlyn Proulx
    Managing Director, PDCI, Market Access
    John-Paul Dowson
    Director, Reimbursement Strategy, PDCI
  • 8:30 AM
    Pricing Reform in Canada
    Evaluate its Impact on your Market Access Strategy
    Douglas Clark
    Executive Director, PMPRB

    With the anticipated pricing reforms poised to become reality, it is time to assess what impact they will have on new product launches and pricing.  Elevate your understanding of how to position your product under the new guidelines.  Gain insight to help you:

    • Realistically assess your pricing options
    • Evaluate the potential ROI for Canadian product launches
    • Determine your forward strategy for the Canadian marketplace

    Successfully manage the impact of pricing reform on your company’s bottom line

  • 9:00 AM
    Keynote Roundtable:
    Prepare your Organization for Changes to Canada’s Drug Procurement Strategy
    Pamela Fralick
    President, Innovative Medicines Canada
    Sylvie Bouchard
    Director of Medication, Institut National d'Excellence en Sante et en Services Sociaux (INESSS)
    Sang Mi Lee
    Senior Manager, pCPA
    Ashley Fraser
    Principal, CRA, Charles River Associates

    There has been much discussion lately about ever-increasing drug prices and the unsustainable financial burden they place on public health budgets. To address this, a new national drug agency has been proposed that would act as a central procurement point. Does this represent the most effective solution, or are there other models that could achieve lower drug costs and value for money for Canadian
    patients?

    Learn what Canada’s forward strategy for drug price negotiations could be and how it might be accomplished

    • Learn what advantages and disadvantages multi-payer and single-payer systems represent
    • Should there be any leeway given under a single-payer system to account for local population needs?
    • Could the current system of evidence-based technology assessments stay the same or could it be streamlined under a different procurement model?
    • If there is a move toward adopting a different procurement model, how might private payers respond?

    Advance your understanding of the potential impact the new national drug agency could have on your organization.

  • 9:45 AM
    Panel Discussion: PLAs
    Position your Company to Succeed with Strategies for Negotiating Product Listing Agreements in an Uncertain Marketplace
    Helen Trifonopoulos
    Head, Health Policy and Patient Access, Novartis Oncology, Novartis Pharmaceuticals Canada Inc.
    John-Paul Dowson
    Director, Reimbursement Strategy, PDCI
    Sang Mi Lee
    Senior Manager, pCPA
    Dennis Chan
    Principal, Pathway Advisory Services

    The move toward the establishment of a national drug agency will cause some disruption to the normal approval process while its final structure takes shape.  Get the insight you need to understand what changes may be on the horizon for new drug submissions.  Walk away with knowledge that will help you:

    • Understand the current pCPA submission process and how that may evolve
    • Gain insight into any changes in how provinces will now approach PLAs
    • Position your products for the best chance of success under the emerging new system

    Be on top of new developments for PLA submissions

     

  • 10:30 AM
    Networking Break
  • 11:00 AM
    Industry Expert: RWE
    Market Access Metrics 2019
    Brad Millson
    Senior Principal, Health Access & Outcomes, IQVIA

    This session will take a data-driven approach to understand the latest market access trends.  We will examine how long it is taking at each step of the access process from HTA to pCPA and listing.  We will also examine the impact pre-NOC and other factors are having on this timeline, and discuss strategic implications to help market access managers prepare early for their launch.

  • 11:30 AM
    Keynote Address: HTA in Ireland
    Discover Similarities and Differences with Canada in Ireland’s Approach to Market Access and Reimbursement
    Dr. Michael Barry
    MB, FRCPI, Director, National Centre for Pharmacoeconomics

    Ireland’s National Centre for Pharmacoeconomics conducts evaluations of medicines submitted for reimbursement and has a similar mandate to Canadian HTA agencies. Like other countries, the NCPE is also being challenged by evaluating the cost effectiveness of high-cost drugs, including biologics.

    Gain insight into how this is being tackled outside North America by learning:

    • How cost-effectiveness is evaluated within the Irish healthcare setting
    • How the NCPE defines ‘significant budget impact’ and the criteria applied to new products to be subjected to the formal pharmacoeconomic assessment
    • The NCPE’s approach to evaluating therapies for rare diseases

    Understand how market access and reimbursement challenges are being met in a country with a healthcare system similar to Canada’s.

  • 12:00 PM
    Networking Lunch
  • 1:15 PM
    Keynote Panel: Pharmacare
    Be Prepared for Major Changes on Pricing and Market Access
    Anjila Arora
    Director, Pharmaceutical Benefits, Sun Life Financial
    Janet Yale
    President and CEO, The Arthritis Society
    Dr. Larry Lynd
    Professor and Director, Collaboration for Outcomes Research and Evaluation (CORE)UBC
    Louis Theriault
    VP Policy & Research, Innovative Medicines Canada

    There are many possible approaches that could be taken to establishing a national pharmacare program.  Understanding what direction is emerging from discussions among stakeholders as the most likely to taken once plans are actually underway, will be critical for your pricing and market access strategy.  Gain insights for your organization through discussion about:

    • What underlying principles should be prioritized in developing a national plan
    • Whether there will be greater collaboration between public and private payers to fill in the current gaps in coverage
    • What can be learned from Quebec’s universal model and whether Quebec will likely join

    Hear the latest discussions and prepare your organization for the new era in pharmacare.

     

  • 2:15 PM
    Panel Discussion: Pharmacoeconomics
    Adapt Your Company to Continuing Evolution of Pricing and Market Access for Private Payers
    Ned Pojskic
    Leader, Pharmacy & Health Provider Relations, Green Shield Canada
    John Herbert
    Director, Clinical, Research & New Solutions, Express Scripts (Canada)
    Jane Farnham
    Vice President, Strategic Partnerships, External Relations and Advocacy, BioScript Pharmacy Ltd.

    Along with the public sector, private payers have also increased their scrutiny of the effectiveness and value for money represented by the drugs they approve for their formularies.  Should a national pharmacare program be established, the use of pharmacoeconomics as an evaluative tool seems likely to increase, and provide greater harmonization between the standards of public and private payers for evaluating new drug submissions.  Gain insight that will help you craft your market access strategy by learning:

    • Whether the establishment of a national pharmacare program will foster greater collaboration between public and private payers to achieve the goal of universal coverage for Canadians
    • What role pharmacoeconomics will play going forward for private payers
    • What pharma companies can do now to optimize the ROI of their submissions to private payers

    Understand how private payer market access is changing and how you can adapt.

     

  • 2:45 PM
    Networking Break
  • 3:15 PM
    Panel Discussion: Employer Perspective
    What Employers Want and How they are Responding to Higher Drug Costs in Benefit Plans
    Joan Weir
    Director, Health and Disability Policy, Canadian Life and Health Insurance Association (CLHIA)
    Barbara Martinez
    Practice Leader, Benefits Solutions, Great-West Life

    In the face of constantly rising drug costs, employers are having to implement strategies to ensure their plans are sustainable.  Learn what measures they are adopting to address skyrocketing drug prices.  Walk away with actionable insights to inform your forward strategy by:

    • Understanding the risks presented by biologics and the resulting move toward price caps and stop-loss insurance
    • Discovering the increasing role biosimilars are expected to play in keeping costs down
    • Gaining awareness into the new relationships that are emerging with pharmacists to monitor drug plan performance

    Ensure your market access plan has the best shot at success by understanding what employers need.

  • 4:00 PM
    Panel Discussion
    Improving Incentives to Attract Drug Development to Canada for Increased Opportunities for Market Access
    Kennet Brysting
    General Manager, Gilead Sciences Canada
    Andrew Guy
    Director, Advanced Technologies Branch, Industry and Sector Strategy Division, Ontario Ministry of Economic Development, Job Creation and Trade
    Alison Drinkwater
    Senior Director, Innomar Strategies

    Canada’s relatively small market has been viewed as an obstacle to attracting drug R&D. That could change if a new approach were adopted that included incentives to conduct R&D in Canada.

    Take back to your team insights to:

    • Understand the incentives other countries have established that have proven successful in attracting R&D
    • Discover whether there is value to offering incentives, whether they will encourage innovation, and if they will ultimately lead to lower drug costs
    • Determine if there are economic arguments to offer incentives if they have a broader positive impact beyond drug costs for public health systems

    Analyze what benefits could be gained by offering incentives to attract R&D to Canada.

  • 4:45 PM
    Conference Adjourns to Day Two
  • 5:00 PM
    Evening Executive Reception
October 2, 2019
October 3, 2019
  • 7:45 AM
    Registration and Breakfast
  • 8:30 AM
    Opening Comments from the Chair
  • 8:45 AM
    Opening Keynote Address: U.S. Drug Pricing
    Prepare Your Company for the Impact and Implementation the New Patented Medicine Prices Review Board (PMPRB) Reforms
    Kimberly Robinson
    Director, Pricing and Market Access, PDCI Market Access Inc
    Dylan Lamb-Palmer
    Manager, Pricing and Data Analytics, PDCI Market Access Inc
    Sheena Gosain
    Manager, HTA and Health Economics, PDCI Market Access Inc
    Wayne Critchley
    Senior Associate , Global Public Affairs

    With the recent federal announcement that the proposed changes to the PMPRB regulations are now a reality, assessing their impact and preparing for implementation will now become a priority.  Gain in-depth information to elevate your understanding of the new drug pricing landscape.  Walk away with an action plan to hone your market access strategy for Canada by learning:

    • What the implementation timeline is and what you will need to have in place to meet it
    • How the new pricing factors will be applied and what thresholds of pharmacoeconomic value will need to be demonstrated
    • The new reporting requirements including third-party rebates

    Be sure your organization is prepared for this new market access reality

  • 9:30 AM
    Expert Insight: Path to Market
    Analyze Emerging Trends in the Path to Market for Drug/Device Combinations and Position Your New Product for Success
    Glenn Monteith
    Senior Associate, Health and Life Sciences, Global Public Affairs

    New technology has enabled the development of drug/device and biologic combination products that target specific areas of the body and some which are genetically based.  While these innovative therapies are more effective, determining the applicable regulation and path to market can be challenging.  Gain insights to:

    • Help you determine the ‘Primary Mode of Action’ that will classify your product
    • Understand where drug/device regulations intersect and current progress of The Regulatory Review of Drugs and Devices (R2D2)
    • Assess how RWE will be gathered and applied to these products particularly those that require companion diagnostics

    Anticipate and adapt to changes underway in the approval of combination products

  • 10:00 AM
    Case Study: CHEO Regional Genetics Program
    The Transformative Impact Precision Medicine Can Have for Patients, Payers and the Path to Market
    Dr Alex MacKenzie
    Senior Scientist, Children’s Hospital of Eastern Ontario (CHEO) Research Institute and Professor, Department of Pediatrics, University of Ottawa Faculty of Medicine

    Continuing developments in personalized medicine are having a transformative impact on the lives of patients with rare diseases.  The Care 4 Rare Research Program is on the forefront of this innovative shift in diagnosis and treatment.  Take away insight to help you understand how the path to treatment is evolving for patients with rare diseases by learning:

    • What advances have been made with genome sequencing and its adoption as a diagnostic tool
    • How Care 4 Rare is working with ministries of health to implement genome-wide sequencing into the diagnostic pathway for rare disease
    • What impact the work done by Care 4 Rare could have on the advancement of treatment for rare diseases of the larger population

    Prepare your organization for the transformation precision medicine will bring

  • 10:30 AM
    Networking Break
  • 11:00 AM
    Panel Discussion: Rare Disease Drug Costs
    Reinvent the Path to Market by Transforming Drug Development for Rare Diseases
    Durhane Wong-Rieger
    President & CEO, CORD
    Marina Vasiliou
    Managing Director, Biogen Canada
    Kathryn Deuchars
    Ph.D. Senior Manager, Sector Innovation & Programs and Director, Ontario Personalized Medicine Network (OPMN)
    Dr Alex MacKenzie
    Senior Scientist, Children’s Hospital of Eastern Ontario (CHEO) Research Institute and Professor, Department of Pediatrics, University of Ottawa Faculty of Medicine
    Ed Dybka
    General Manager, Ipsen Pharmaceuticals Canada Inc.
    Jane Farnham
    Vice President, Strategic Partnerships, External Relations and Advocacy, BioScript Pharmacy Ltd.
    Christine Mossa
    Director, Regulatory Affairs, Reimbursement & Value Access, Ipsen Pharmaceuticals Canada Inc.

    Developing, delivering and funding treatment for patients with rare diseases has become the single biggest challenge for payers, patients and manufacturers.  With a growing consensus that a new drug development model is needed, the question becomes what form should it take?  Get the latest on how this question may be resolved.  Shape your strategy by hearing the latest views on:

    • What options could be pursued for the funding and development of ‘orphan’ drugs so they are more affordable for payers and patients
    • What new routes to commercialization for these medications may need to be forged
    • What types of partnerships will be key to successful development going forward

     

    Understand how the drug development model could fundamentally change for rare diseases.

  • 12:00 PM
    Expert Insight: ROI of Drugs
    Assessing the ROI of New Complex Therapies for Payers and Health System Budgets
    Dr. Larry Lynd
    Professor and Director, Collaboration for Outcomes Research and Evaluation (CORE)UBC

    The extremely high cost of some new medicines has been garnering a lot of attention lately.  However, there are economic benefits of these therapies reduce patient treatments.  Gain greater understanding of the ROI new medicines represent to incorporate into your analysis and decision-making.    Walk away with insight to:

    • Enhance your understanding of the overall value proposition innovative new therapies represent to formulary management
    • Improve the perceived ROI of your new products to public and private payers
    • Achieve a broader perspective in analysing the costs of new treatments

    Get the bigger picture of the return on investment of innovative medicines.

  • 12:30 PM
    Networking Lunch
  • 1:45 PM
    Expert Insight:
    Gain Insight into the Growing Use of Medical Cannabis and Where it Fits within Canada’s Medical System
    Dr. Michael Verbora
    Chief Medical Officer, Aleafia Health Inc.
    There has been a recent surge of interest in using cannabis as an effective substitute for pharmaceuticals to treat a variety of conditions including PTSD.   Discover why some patients are switching to cannabis and why you may want to include it in your forward strategy.  Understand why interest will continue to grow by learning:
    • How the human body responds to cannabis and why it is so effective
    • About the growing body of evidence to support its use
    • How the Canadian medical cannabis system works including workplace accommodation and reimbursement from government programs such as Veterans Affairs
    Be on top of the evolution of medical cannabis and its incorporation into mainstream medicine.
  • 2:15 PM
    Case Study
    Enhance Your Understanding of Patient Patterns of Cannabis Use, and Potential Cross-sector Partnerships
    Philippe Lucas
    VP, Global Patient Research & Access, Tilray

    Research on patient patterns of use and the effectiveness of medical cannabis has not kept pace with its rate of adoption by patients.  The result is large gaps of knowledge about the types of patients who benefit most and its value as a substitute for pharmaceuticals such as opioids.  Advance your game plan with insights to help you:

    • Determine where medical cannabis fits within your health benefit plan
    • Evaluate the benefits of partnerships between mainstream pharmaceuticals and medical cannabis companies
    • Understand how market access is increasing through the education of pharmacists and physicians

    Be on top of the latest cross-sector developments in pharma and medical cannabis

  • 2:45 PM
    Networking Break
  • 3:15 PM
    Panel Discussion
    Gain Insights on the Evolving Path to Market for Biosimilars
    Sang Mi Lee
    Senior Manager, pCPA
    Chander Sehgal
    Associate Director, Innovation, Teva Canada
    Scott Gavura
    Director, Provincial Drug Reimbursement Programs, Cancer Care Ontario

    The growth of the biosimilar market has been sluggish due to a number of reasons that include regulatory requirements, production costs, patient preferences and a reluctance on the part of some physicians to prescribe them.  Yet as they represent significant cost savings, their adoption will only increase.  Heighten your awareness of the increased market impact and future direction for biosimilars. Obtain useful insights to help you:

    • Determine how the Canadian regulatory process can be better aligned with that of the EU where they receive more favourable treatment
    • Assess the impact of greater take-up rates for biosimilars on public and private formularies
    • Include greater knowledge of biosimilar advancement in your market strategy

    Improve the path to market for biosimilars and achieve lower treatment costs.

  • 4:00 PM
    Expert Insight: CUSMA
    Understand the Impact that the CUSMA Agreement Will Likely Have on Pharmaceutical Market Access and Pricing to Clarify Your Organization’s Strategy

    The new North American trade agreement extends data protection for biologics from 8 to 10 years.  While this provides greater opportunities for Brand manufacturers, it may create greater push-back from payers trying to keep their costs at sustainable levels.  Discover the probable outcome of this extended protection and fine-tune your strategy by learning:

    • What progress has been made toward ratification of the CUSMA
    • What economic impact the data protection extension could have on drug prices in Canada
    • Whether any new Canadian market developments are likely to change the upward price trajectory for new biologic medications given extended protection under CUSMA

    Prepare your company for additional data protection for biologics under USMCA.

  • 4:30 PM
    Conference Concludes
October 3, 2019
October 4, 2019
  • 9:00 AM - 12:00 PM
    Workshop A: Product Listing Agreement
    Drive Successful pCPA Strategies and PLAs to Solidify your Market Access Strategies
    Colin Vincente
    Managing Direcot, Pivina Consulting

    The pan-Canadian Pharmaceutical Alliance (pCPA) administers the formal process for getting new drugs to the marketplace.  Source insights to manage and optimize your submission.  Tap into both public and private perspectives in this interactive workshop and walk away with knowledge to:

     

    1. Understand the pCPA process and submissions
    2. Prepare for pCPA in the planning stages of your products
    3. Use pricing models to assist your product’s positional during negotiations
    4. Gain an understanding of different types of Canadian PLAs
    5. Take advantage of potential opportunities in private sector PLAs

     

    Develop your successful pCPA strategy through this hands-on interactive workshop.

  • 12:00 PM - 3:00 PM
    WORKSHOP B: New Drug Product Launch
    How to Successfully Launch Your New Drug

    Your company has spent a decade or more and large amounts of money developing a new and promising treatment. The last thing you want to see is your product falling flat on the market with sales far below expectations. This session will provide a deep dive into the essentials for a successful launch.

    Learn how to:

    1. Differentiate your drug in the market pre and post launch

    2. Coordinate across your organization to include market access,
    patient services, medical and regulatory affairs, marketing and
    sales for greatest impact

    3. Understand and eliminate internal challenges that may impede
    your success

    Make the most of your investment with a well-executed launch

  • 3:00 PM - 6:00 PM
    WORKSHOP C: Adverse Reactions
    Executing an Effective Communication Strategy

    Your product has been tested repeatedly during the clinical trial process and has been cleared to launch when shortly afterward, a patient reports and adverse reaction. Reporting is mandatory, and so is preserving your company’s stellar reputation for integrity as well as your investment.

    Create a blueprint for managing adverse reaction reporting by:

    1. Evaluating the reaction reported for severity and classification

    2. Working with patient support groups to get ahead of the
    problem and minimize impact

    3. Learning how to prepare correct documentation and reports to
    Health Canada and the Marketed Health Products Directorate

    Don’t let an adverse reaction destroy your product’s positive reputation

October 4, 2019

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