Pathways To Access & Reimbursement

Co-Chairs’ Opening Remarks

Alexis Sciuk
Canadian Health Care Solutions Lead
Pfizer

Farah Husein
Director, Evidence Generation
Scientific and Medical Affairs, Takeda Canada

Opening Keynote

Light at the End of the Tunnel—Yes or No? Examining What it Will Take to Build a More Resilient, Patient-Driven Health Care System in Canada

Louise Binder
Health Policy Consultant
Save Your Skin Foundation

Forecasting Time-to-Listing Amid the Pandemic: What to Expect and How to Mitigate Delays in the CADTH Review and pCPA Negotiation Process

Brent Fraser
Vice President, Pharmaceutical Reviews
CADTH

Dominic Tan
Senior Manager
pCPA Office

• Gain insights on how the pandemic has impacted CADTH and the pCPA and what to expect in 2022
• What manufacturers can do to reduce backlogs and expedite processes
• Examining the results of the new Targeted Negotiation Process (TNP) and implications for future negotiations
• Assess pricing and negotiation strategies, with guidance on what agencies are looking for and how they are conducting comparative analysis

Break

Innovative Contracting and Drug Pricing: How to Build a More Agile Reimbursement System in Canada

Andrea Masters
Associate Director, Pricing
Roche

Sang Mi Lee
Access Lead, Personalized Healthcare
Roche

Brad Groves
Associate Director, Managed Access
NICE.

There have been successful innovative agreements and examples of agility in the Canadian pathway to access for innovations. However, there is a lack of sharing the learnings and no guidance for industry in terms of the characteristics or scenarios where innovative agreements are of value to payors and patients. More transparency, empathy and collaboration across all stakeholders is necessary to identify and achieve shared outcomes around building a more agile reimbursement pathway in Canada. This session will explore:

• How the current environment for new products and innovative medicines coming to market is not well served by the traditional negotiation approach that relies on setting prices or capping expenditure based on anticipated volumes or estimated cost-effectiveness
• An industry developed framework based on the key challenges in opportunities in Canada
• Examples of innovative agreements developed and used by public jurisdictions outside of Canada
• Examining high-level characteristics of these types of agreements (performance-based, amortization, subscription, package, portfolio)
• Working collaboratively: How public payors and manufacturers can develop a pan-Canadian process that includes different approaches beyond simple price first dollar discounts and volume agreements to achieve timely access to new treatments while providing increased value and improved fiscal sustainability for payors
• The evolution of commercial and managed access flexibilities in the UK
• Opportunities to support access to innovative new treatments in the UK

How to Navigate Exceptions to the Co-Pay Ban under Bill 92 in Quebec

Mathieu Gagné
Partner
Fasken Martineau DuMoulin LLP

The Government of Quebec has published the final regulation restricting financial assistance to patients for drugs covered under Quebec’s basic plan. To avoid running afoul of the regulation, manufacturers will need to reassess current activities within the context of the ban and gain clarity on where exceptions will apply. This session will cover:

• Examining what the prohibition under Bill 92 covers and the implications for manufacturers and PSPs
• Interpreting criteria set out for exceptions to the co-pay ban
• How to determine if payments are permissible on humanitarian grounds, and where a continuance applies

1:1 Networking

Break

How to Optimize Data and Health Resources to Support Patient Centred Decision-Making on New and Innovative Therapies

Laurie Lambert
Lead, Real World Evidence
CADTH

Nicole Yada
Manager
HDRN Canada Partnerships

Mina Tadrous
Assistant Professor, Leslie Dan Faculty of Pharmacy
University of Toronto

Dr. Scott Klarenbach
Professor, Department of Medicine Division of Nephrology
University of Alberta

• Identifying gaps in health data across Canada
  • How to approach siloed data on apps, wearables, that could hold valuable insights and support reimbursement decisions
• Assessing the viability of a national health data registry
  • What are the key steps towards building a robust database?
  • How to build strong data governance practices that ensure patient privacy
• Explore practical examples of how RWD turned RWE can be used in reimbursement decisions

Key Industry Learnings and Good Practices Gleaned from Experienced pCPA Negotiators

Chad Jarema
Director, Pricing Strategy, Contracting and Negotiation
Merck

• General principles and practices to optimize success
• Optimizing the negotiation flow for speed
• Initial meeting checklist to hit the ground running

Break

PMPRB Implications and Takeaways for Companies

Eileen McMahon
Partner
Torys LLP

Wayne Critchley
Senior Associate
Global Public Affairs

Neil Palmer
Senior Strategic Advisor & President Emeritus
PDCI Market Access Inc.

• What are the proposed changes affecting patented medicines and how will they impact businesses?
• What are the uncertainties and predictions as to where the PMPRB changes will end up?
• What do companies do in the meantime? What are the options?
• Where do companies go from here?

Conference Adjourns

Co-Chair Opening Remarks

Alexis Sciuk
Canadian Health Care Solutions Lead
Pfizer

Farah Husein
Director, Evidence Generation
Scientific and Medical Affairs, Takeda Canada

Fireside Chat: The Vision for CADTH 2022 and Beyond

How HTA & HTM is Evolving and the Implications for Canada’s Health System and its Stakeholders

Suzanne McGurn
President and CEO
CADTH

Moderator:

Alexis Sciuk
Canadian Health Care Solutions Lead
Pfizer

In July 2020, Ms. Suzanne McGurn stepped into the role of President and CEO of CADTH. This session will focus on lessons and insights from the first 18 months at the helm, amid immense change sparked by the pandemic. Learn how CADTH has responded and continued to be “Driven by the Evidence” during this turbulent time, the agency’s top priorities for 2022 and how it will be engaging with industry.

• The importance of evidence and science has never been more visible and critical than during the pandemic, what may be the lasting impacts on decision-makers as they look forward to what a resilient and modern health care system will look like, while they continue to grapple with difficult decisions with finite resources?
• What role will organizations like CADTH play in a post-pandemic world and how is the organization reflecting and retooling to be ready to respond to the rapidly evolving needs of Canadian healthcare decision-makers?
• Building on the new relationships that have been forged amongst stakeholders – old & new – how do we maintain those relationships effectively in the future

Scaling up Canada’s Life Sciences Sector: How to Attract Investment and Retain Talent

Andrew Casey
President & CEO
BIOTECanada

Dr. Sheila Singh
Pediatric Neurosurgeon
McMaster Children's Hospital
Canada Research Chair in Human Cancer Stem Cell Biology, University Scholar
Chair, McMaster College of Health Inventors

Jason Field
President & CEO
Life Sciences Ontario

Moderator:

Pamela Fralick
President
Innovative Medicines Canada

• Understanding how stakeholders can increase growth and investment in the life sciences and pharmaceutical sector
• How to attract top-level talent and retain it
• Identifying key obstacles to commercialization for innovative therapies and how to overcome them
  • Sourcing funding for innovative research and the journey to market
  • How to build industry partnerships
  • Examining the influence of current domestic and international policies

Break

Journey Mapping: What the Patient Experience Reveals about Pathways to Access & Reimbursement

Durhane Wong-Rieger
President
CORD

In this session, Canadians living with a rare disorder will share their personal journey from the point of diagnosis through to drug access and reimbursement. A focus will put on:

• Identifying obstacles to innovative therapies
• How stakeholders within Canada’s health system can improve the patient experience
• How apply insights from the patient journey to decision-making on access and reimbursement
• Status of the National Strategy for Drugs for Rare Diseases

Case Study

Analysis of Biosimilars in Canada: How have Switch Policies Impacted Drug Spending and Health Outcomes

Dr Tijana Fazlagic
Executive Director, Therapeutic Assessment & Access, Pharmaceutical, Laboratory & Blood Services Division
BC Ministry of Health

Ontario, Quebec, and other provinces across Canada have announced that they will follow British Columbia’s lead in pursuing their own non-medical switch policies for biosimilars. There has been extensive discussion about the impact on patients, who are already stable on a biologic as well as the opportunity for significant cost savings should biosimilars achieve similar therapeutic results.

B.C. completed its phased approach to switching patients in October. This session will explore:

• What initial data indicates about the patient response to the switch to biosimilars
• How has this impacted the provincial budget?
  • Is the program on track to achieve projected savings?
• Understanding how the province will approach biologics, and where medical exceptions will be made
• How the switch to biosimilars could potentially support access to new innovation

1:1 Networking

Break

Case Study

How Stakeholders Collaborated to Achieve Timely Patient Access and Reimbursement for an Innovative Cystic Fibrosis Treatment

Dr. Mark Chilvers
Pediatric Respirologist, BCCH CF Clinic Director, Medical Director
CF Care BC

Chris McLeod
National Chair
Canadian Cystic Fibrosis Treatment Society

Expediting patient access for new, innovative treatments for rare diseases continues to be a challenge in Canada. The review and negotiation periods can be long and arduous for stakeholders who are working diligently to ensure safety and efficacy, while also grappling with the question of affordability. However, a newly developed cystic fibrosis treatment, lauded as life-sustaining for patients, secured a priority review by Health Canada, a recommendation from CADTH and successful pricing negotiations leading to PLAs for public reimbursement in several provinces. This session will examine:

• What contributed to market entry and reimbursement for Trikafta in Canada
  • Examining lessons learned for creating more timely access to other potentially life altering drugs for rare disease
  • Analyzing the details of CADTH’s recommendation and the impact on reimbursement
• Identifying barriers to drugs for rare diseases and how to improve current pathways to access and reimbursement

Top 3 Trends in the Private Payer Landscape that Could Impact your Market Access Strategy

Joan Weir
Vice President, Group Benefits
Canadian Life and Health Insurance Association

Jayson Gallant
Director, Pharmaceutical Benefits
Sun Life

Moderator:

Farah Jivraj
Head, Market Access, Policy and Stakeholder Relations
Biogen Canada

• How are payers approaching reimbursement for gene therapies and high-cost drugs?
  • Anticipating how this will impact drug plan design
  • What happens when a patient moves to a new employer/plan?
• Examining drug utilization trends emerging from the COVID-19 pandemic, and anticipating what’s coming
• Analyzing the current private payer market and how employers are approaching drug spending
• Identifying employer expectations and approaches to cost containment

Break

Where Patent Protection Intersects with Market Entry Decisions: How to Set Your Organization’s Access Strategy Up for Success in 2022

Daphne Lainson
Partner
Smart & Biggar LLP
Senior Representative, pCPA

• Assessing loss of exclusivity: managing multiple variables within the context of the global market
• Dealing with uncertainty: assessing legislative and judicial developments
• How to plan for 2022 and beyond

The Latest in U.S. Drug Pricing Reform and the Implications for Canadian Companies

Trevor Wear
Partner
Sidley Austin LLP

This session will examine the where proposals on drug pricing reform have landed and the implications for manufacturers.

• H.R. 3: Analyzing the steps being taken towards allowing government to negotiate drug prices
  • Projected impact on new drug development and generics
• Increasing drug importation, implications for Medicaid

Conference Adjourns