Pathways To Access & Reimbursement

Coffee and Connections

Women of Pharma—Market Access Networking Session

Kiersten Combs
Country President, Canada
AstraZeneca

Moderator:

Joan McCormick
Senior Principal
IQVIA Canada

Co-Chairs’ Opening Remarks

KEYNOTE

Status Report from the Canadian Drug Agency Transition Office

Susan Fitzpatrick
Head
Canadian Drug Agency Transition Office

Stakeholders from across the pharmaceutical and healthcare sector have been eagerly awaiting details of the Government of Canada’s pharmacare strategy. The Canadian Drug Agency Transition Office was established in spring of 2021 to work with provinces, territories and key stakeholders on options for a Canadian Drug Agency (CDA.) A proposal for advancing with a CDA has been informed by analysis and over 275 meetings and roundtables with key stakeholders and partners. These meetings underscored the need for national leadership in addressing key system gaps and improving the Canadian pharmaceuticals landscape for the benefit of all Canadians.

A principled approach is envisioned that prioritizes respect for jurisdiction, builds on system strengths, and focuses on the continued involvement of patients and stakeholders. This session will put a spotlight on key initiatives being undertaken by the transition office including:

• Leveraging data and analytics engagement: Understanding how provinces and territories will contribute to the creation of the Canadian Drug Agency and the scope of its mandate
• How the transition office is approaching the development of a national formulary and the implications for manufacturers, payers, and patients
• Examining progress and timelines for the creation of the Canadian Drug Agency

CADTH TOWNHALL

From Strengthening International HTA Collaboration and Stakeholder Engagement to Post Market Evaluations: Key Developments for Manufacturers to Watch in the Year Ahead

Suzanne McGurn
President and CEO
CADTH

• International Alliance: Exploring How CADTH will work together with Australia and the UK to develop and leverage HTA best practices
• Insights on how this alliance could potentially impact the assessment of product in Canada
• Understanding the implications of CADTH’s new post market evaluation (PDME) process on manufacturers
• CDR and pCODR: Examining how CADTH will strengthen stakeholder engagement on HTA changes

Morning Coffee and Networking Break

The Next Chapter of RWE in Canada: Empowering Access and Reimbursement Decisions through a National Data Strategy

Jaclyn Beca
Director, Pharmacoeconomics and RWE
Morse Consulting

Dr. Nicole Mittmann
Chief Scientist and Vice-President Evidence Standards
CADTH

Dr. Daria O’Reilly
Lead Health Economist, Pharmacy Consulting, Health Benefits Management
TELUS Health

Mina Tadrous
Assistant Professor
University of Toronto

• Assessing the real potential for RWE in Canada based on the current landscape
• Addressing the data dilemma
• Determining what different stakeholders deem as acceptable real-world data
• Identifying acceptable sources for RWD generation
• Exploring opportunities for data linkage to patient support programs
• How to build strong data governance practices that ensure patient privacy
• Examining practical examples of RWE supporting reimbursement decisions
• Discover how CADTH’s new Post-Market Drug Evaluation program will integrate this data into decision-making on drug safety, effectiveness and use for drugs already approved for reimbursement

Implementing Innovative Agreements in Canada with Lessons Learned Internationally

Karen Facey
Health Policy Consultant
RWE4Decisions

Amyn Sayani, Ph.D.
Director, Medical Evidence
Scientific Affairs
AstraZeneca Canada

Nicole Yada
Manager
ICES

• Exploring different types of innovative agreements (performance-based, amortization, subscription, package, portfolio) and determining which one is the best fit for the therapeutic drug
• Identifying obstacles to innovative agreements in Canada, and how to overcome them
• Strengthening collaboration: How public payors and manufacturers can develop a process to improve time to access to new treatments while providing increased value and improved fiscal sustainability for payors
• International Case study: Exploring success stories and lessons learned from innovative agreements developed and used by public payers outside of Canada

Networking Lunch

How to Build an Effective Rare Disease Drug Access Strategy in Canada: Examining What’s Working, What’s Not, and Alternative Pathways for Exploration

Durhane Wong-Rieger
President
CORD

Fred Little
Country Lead Rare Disease
Pfizer

Moderator:

Farah Jivraj
Head, Market Access and Stakeholder Relations
Biogen

• Identifying current rare drug accessibility and funding challenges across Canada
• International lessons
• Rare disease drug strategy: Where would federal investments have the most impact for patients?
• Exploring international best practices and innovative approaches to drug evaluation and funding models to accelerate patient access
• Determining if there are opportunities to apply these approaches in Canada, ensuring fair value for patients, payers and manufacturers

Networking Break

Benchmarking with B.C.: Analyzing How the Biosimilars Switch Policy has Impacted Drug Spending and Health Outcomes

Mark Harrison
Associate Professor
University of British Columbia

It has been three years since B.C. embarked upon its non-medical biosimilar switch policy. Since that time, Ontario, Quebec, and other provinces across Canada have indicated that they will deploy similar strategies, but little has been revealed about the tack or timeline. With B.C.’s phased approach completed, and more provinces to follow, it is a critical time to examine whether the province’s objectives are being met. This session will provide key takeaways from financial and health data. Points of discussion include:

• What data indicates about the patient response to the switch from biologics to biosimilars
• Analyzing financial savings to date, and projected impact on the provincial budget over the next few years
• Determining the implications for the market access environment

Case Study

Examining the Expansion of Private Payer Coverage for Obesity Management Drugs and the Implications for Other Therapeutic Areas

Priti Chawla
Founder & Executive Director
Obesity Matters

Rosemarie Childerhose
Director, Market Access & Government Affairs
Bausch Health

Dr. Sean Wharton

Wharton Medical Clinic

Sandra Elia
Board Chair, Director of Education & Patient Advocacy
Obesity Matters

The private payer market is starting to shift, with expanded coverage for obesity management drugs, like smoking cessation drugs before it. What was once looked at as a lifestyle issue, has evolved to reflect a deeper understanding of obesity of chronic disease.

This session will put a spotlight on how reimbursement is expanding, and what this could indicate about the market for medications in other therapeutic areas.

Conference Adjourns

Co-Chairs’ Opening Remarks

Focus on Precision Medicine Part I

Assessing the Canadian State of Readiness for Patient Access in the Age of Genomic Medicine

Don Husereau
Adjunct Professor of Medicine
University of Ottawa

• Evaluating the limitations of the current system in delivering these therapies
• Examining the case for system change regarding access to genomic therapies from a health outcome, value, and sustainability lens
• Exploring obstacles to adoption, implementation, and financing of testing technology

PART II

Pan-Canadian Panel: How to Optimize the Delivery of Genetic and Advanced Diagnostic Testing for Personalized Therapies

Harriet E Feilotter
Professor, Department of Pathology and Molecular Medicine
Queen's University Cancer Research Institute

Craig Ivany
Chief Provincial Diagnostics Officer
Provincial Health Services Authority

Paul Kryzanowski
Medical Director, Precision Medicine
The Janssen Pharmaceutical Companies of Johnson & Johnson

Moderator:

Don Husereau
Adjunct Professor of Medicine
University of Ottawa

This pan-Canadian panel discussion will explore next steps for adoption and implementation across Canada. Panelists will explore:

• Creating a proactive system of test adoption
• Assessing how to capture value in selling genetic testing services and innovations
• Developing a coordinated service planning and financial oversight plan

Morning Coffee Break

The Evolution of Drug Pricing in Canada: How to Meet the PMPRB’s New Guidelines for the Final Regulations

Daphne Lainson
Principal
Smart & Biggar LLP

Amendments to the Patented Medicines Price Review Board regulations came into force in July 2022, with a “status quo” interim approach to price assessments in the absence of new guidelines to assist manufacturers in the prepare for the changes. The most consequential change being the new basket of comparator countries for reference pricing.

This session will provide practical guidance on the pricing mechanisms being used, and key considerations for manufacturers.

• Hypothetical examples: demonstrating how the new basket of comparator countries will be used for reference-based price tests
• Examining changes to reporting requirements, and timelines for compliance
• Identifying what drugs will be subject to the new guidelines
• Will any drugs be grandfathered?

Negotiating with the pCPA in 2023: Practical Insights on Timelines, the TNP, and the Future of Value Based Agreements

Dominic Tan
Senior Manager
pan-Canadian Pharmaceutical Alliance

• Understanding how the pCPA is prioritizing negotiations
• Tracking the progress of the targeted negotiation process (TNP)
• Exploring current file load and projected timelines for the negotiation process
• Assessing how pharmaceutical drug manufacturers can help streamline negotiations
• Examining value-based agreements

Networking Lunch

Hot Topics in Digital Health and Innovation

INESSS: Quebec’s Strategy to Accelerate Access to Innovative Medicines and Health Technology

Sylvie Bouchard
Director, Drug Evaluation and Technology Assessment for Reimbursement
INESSS

• Discovering opportunities for aligned reviews to expedite access
• Devising ways for manufacturers to minimize delays in the review process for advanced therapies
• Examining evaluative methods being used for healthcare technologies

Leveraging Digital Health Tools: Assessing the Impact of New Models of Care on the Market Access Landscape

Onil Bhattacharyya
Senior Scientist
Women's College Research Institute

Louise Binder
Health Policy Consultant
Save Your Skin Foundation

• Examining how virtual care can support different patient populations and market access
• Improving access to treatment and health monitoring
• Opportunities to reduce costs
• Case study: Key takeaways from an oncology patient experience
• Assessing potential benefits and barriers to use of app-based, wearables and other digital tools
• Exploring opportunities to support reimbursement decisions by adding to the health data ecosystem in Canada

Networking Break

The Role of Pharmacists in Frontline Care: Exploring Opportunities to Expand the Scope of Practice for Timely Patient Access

Nina Lathia
Founder and CEO
Healthcare Decision Making

The role of retail pharmacies is evolving: an essential patient access point for pharmaceuticals, is now becoming more active in the delivery of front-line care. During the COVID-19 pandemic pharmacists helped alleviate pressure on the health system by administering tests and delivering vaccinations. Many provinces across Canada are now expanding pharmacists’ scope of practice to prescribe certain medications.

This session will examine current and future opportunities for pharmacists to assess, prescribe and deliver care – and the implications for both patients and manufacturers.

• Exploring how the relationships between manufacturers, pharmacies, pharmacists, and patients will evolve in a changing landscape?
• Examining the expanded role of pharmacists and how this will impact prescribing patterns and patient access
• Determining how decisions be made concerning which pharmaceuticals to stock going forward
• Assessing pharmacists’ front-line role in reducing costs and alleviating pressure on the health system as a whole
• Identifying future opportunities to expand scope of practice

Breaking Down the Latest Changes in US. Drug Pricing and the Potential Impact on the Canadian Market

Erin E. Atkins
Senior Attorney
ArentFox Schiff LLP

• Inflation Reduction Act: Overview of new Medicare drug pricing provisions in the U.S.
• Identifying what drugs will be subject to negotiation
• Analysis of the implications for drug manufacturers both in the U.S., in Canada, and worldwide
• Examining how the negotiation provisions will impact product prices
• Analyzing how these changes could impact investment in innovation in the U.S. and project impact on Canada and other markets

Conference Concludes