8th Annual Forum on Pathways to Access & Reimbursement - WEB

Attend Canada’s Premier Forum on Navigating Market Entry and Developing Effective Pricing Strategies

The pandemic has put a spotlight on gaps in Canada’s healthcare system, and further demonstrated how crucial it is to have timely access to innovative medicines. As the world emerges from a period characterized by rapid adaptation, and response, stakeholders will need to translate key lessons learned into collaborative action aimed at creating new market access pathways and drug funding models.

The Canadian Institute’s 8th Annual Pathways to Access & Reimbursement Forum will put a special focus on opportunities to drive innovation through collaboration.

On January 19-20, join drug manufacturers, payers, regulators, academia, and patient groups in Toronto for candid conversations on how to work together towards sustainable, evidence based, patient driven, market access solutions for drugs and devices.

Take part in this forward-looking forum to:

BUILD a market access and pricing plan for 2023 with insights from key regulators and industry leaders

CONNECT directly with drug review, and decision makers from CADTH, PMPRB, pCPA, and INESSS

DISCOVER the true potential of the use of RWE for HTA and reimbursement decisions in Canada

ANTICIPATE the impact of the national pharmacare strategy on patients and payers

PREPARE drugs submissions that align private payer priorities

how to improve health outcomes through improved access to

BECOME A SPONSOR

Co-Chairs

Kiersten Combs

Farah Jivraj

Head, Market Access and Stakeholder Relations Biogen

Dipti Tankala Manager, Market Access & HEOR AbbVie

Speakers

Erin E. Atkins Senior Attorney ArentFox Schiff LLP

Jaclyn Beca Director, Pharmacoeconomics and RWE Morse Consulting

Onil Bhattacharyya Senior Scientist Women’s College Research Institute

Louise Binder Health Policy Consultant Save Your Skin

Sylvie Bouchard Director, Drug Evaluation and Technology Assessment for Reimbursement

INESSS

Priti Chawla Founder & Executive Director Obesity Matters

Rosemarie Childerhose Director

Market Access & Government Affairs, Bausch Health

Country President, Canada AstraZeneca

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

Karen Facey Health Policy Consultant RWE4Decisions

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

Susan Fitzpatrick Head Canadian Drug Agency Transition Office

Mark Harrison Associate Professor University of British Columbia

Don Husereau Adjunct Professor of Medicine University of Ottawa

Craig Ivany Chief Provincial Diagnostics Officer Provincial Health Services Authority

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

About Us:

Fred Little Country Lead Rare Disease Pfizer

Joan McCormick Senior Principal IQVIA Canada

Suzanne McGurn President & CEO CADTH

Dr. Nicole Mittmann

Chief Scientist and Vice-President of Evidence Standards CADTH

Dr. Daria O'Reilly

Lead Health Economist, Pharmacy Consulting, Health Benefits Management TELUS Health

Dr. Danielle Paes

Chief Pharmacist Officer (CPO) Canadian Pharmacists Association

Durhane Wong Rieger

President & CEO CORD

Mina Tadrous Assistant Professor University of Toronto

Dominic Tan Senior Manager pan-Canadian Pharmaceutical Alliance

Dr. Sean Wharton Wharton Medical Clinic

Nicole Yada Manager ICES

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Thursday, January 19, 2023

10:15 a.m. Morning Coffee and Networking Break

10:30 a.m. SPOTLIGHT ON RWE

EARLY RISER COFFEE CONNECT Women of Pharma Networking Session

7:45 a.m

Microphone-alt Kiersten Combs, Country President, Canada, AstraZeneca

Moderator: Joan McCormick, Senior Principal, IQVIA Canada

8:45 a.m.

Opening Remarks from Chair

Microphone-alt Farah Jivraj, Head, Market Access and Stakeholder Relations, Biogen Dipti Tankala, Manager, Market Access & HEOR, AbbVie

9:00 a.m. KEYNOTE

Status Report from the Canadian Drug Agency Transition Office

Microphone-alt Susan Fitzpatrick, Head, Canadian Drug Agency Transition Office

Stakeholders from across the pharmaceutical and healthcare sectors have been eagerly awaiting details of the Government of Canada’s pharmacare strategy. The Canadian Drug Agency Transition Office was established in spring 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:

• System Coordination and stakeholder engagement: Understanding how provinces and territories will contribute to the creation of the Canadian Drug Agency and the scope of its mandate

• Leveraging data and analytics

• 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

9:30 a.m. CADTH TOWNHALL

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

Microphone-alt Suzanne McGurn, President & 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

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

Microphone-alt Dr. Nicole Mittmann, Chief Scientist and Vice-President of Evidence Standards, CADTH

Mina Tadrous, Assistant Professor, University of Toronto

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

Moderator: Jaclyn Beca, Director, Pharmacoeconomics and RWE, Morse Consulting

• Assessing the real potential for RWE in Canada based on the current landscape

• Addressing the data dilemma

» Determining what different stakeholders deem as acceptable realworld data

ƒ Identifying acceptable sources for RWD generation

ƒ Exploring opportunities for data linkage to patient support programs

ƒ 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

11:30 a.m.

Implementing Innovative Agreements in Canada with Lessons Learned Internationally

Microphone-alt Nicole Yada, Manager, ICES

Karen Facey, Health Policy Consultant, RWE4Decisions

• 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

12:15 p.m. Networking Luncheon

1:15 p.m

How to Integrate Key Stakeholder Perspectives into the Rare Disease Drug Strategy

Microphone-alt Durhane Wong Rieger, President & CEO, CORD

Fred Little, Country Lead Rare Disease, Pfizer

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

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

2:15 p.m. Afternoon Refreshment Break

2:45 p.m

DAY TWO Friday, January 20, 2023

8:50 a.m.

Opening Remarks from Chair

Microphone-alt Farah Jivraj, Head, Market Access and Stakeholder Relations, Biogen Dipti Tankala, Manager, Market Access & HEOR, AbbVie

Microscope Focus on Precision Medicine

Benchmarking

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

Microphone-alt 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

3:30 p.m CASE STUDY

Microphone-alt Rosemarie Childerhose, Director, Market Access & Government Affairs, Bausch Health

Priti Chawla, Founder & Executive Director, Obesity Matters

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

4:30 p.m. Conference Adjourns

The use of genomic medicine in diagnosis and therapy is rapidly reshaping cancer care and moving into other important therapeutic areas in Canada and around the world. While the routine adoption and use of these health technologies that enable genome-based testing holds great promise for patients and care providers, Canada still faces obstacles to fully implementing genomic medicine.

This two-part session will explore the findings of a collaborative initiative aimed at assessing where selected regions in Canada are performing well, and where they are falling behind. It will also describe how systems can work towards improving health equity, patient outcomes, and patient and care provider experiences through a nimbler approach access to technology management.

9:00 a.m PART I

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

Microphone-alt 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

9:30 a.m PART II

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

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

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

Craig Ivany, Chief Provincial Diagnostics Officer, Provincial Health Services Authority

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

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

10:30 a.m. Morning Coffee Break

11:00 a.m.

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

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?

11:45 a.m.

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

Microphone-alt Dominic Tan, Senior Manager, pan-Canadian Pharmaceutical Alliance

• Examining new evaluation criteria for negotiation

• Understanding gow 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

• Devising steps towards increasing value-based agreements for innovative medicines with limited evidence

12:15 p.m. Networking Lunch chart-line Hot Topics in Digital Health and Innovation

1:30

2:15

Leveraging Digital Health Tools: Assessing

the Impact of

New Models of Care on the Market Access Landscape

Microphone-alt Louise Binder, Health Policy Consultant, Save Your Skin

Onil Bhattacharyya, Senior Scientist, Women’s College Research Institute

• 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

3:00

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

Microphone-alt Dr. Danielle Paes, Chief Pharmacist Officer (CPO), Canadian Pharmacists Association

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

3:45

INESSS:

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

Microphone-alt 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

2:00 Afternoon Refreshment Break

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

Microphone-alt 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

4:30 Conference Concludes

Plan to visit the Expo often. It will be open before, during, and after the conference. Use this opportunity to explore new products and services from leading providers, and meet with new and existing partners over video chat.

Brennan Torregrossa

Lisa

CO-CHAIRS

Suzanne McGurn

Tanya Potashnik