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

Align your Market Access and Pricing Strategy with Insights from key decision-makers from pCPA, PMPRB, CADTH, INESSS

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8th Annual Forum on

PATHWAYS TO ACCESS & REIMBURSEMENT

January 19–20, 2023 | DoubleTree by Hilton Downtown, Toronto, ON The Future of Market Access: Driving Innovation through Collaboration

Status Report on Canada’s Pharmacare Strategy:

Featured Speakers: Susan Fitzpatrick Head Canadian Drug Agency Transition Office

Distinguished Co-Chairs: Farah Jivraj Head, Market Access and Stakeholder Relations Biogen Dipti Tankala Manager, Market Access & HEOR AbbVie

MEET IN-PERSON WITH KEY INDUSTRY STAKEHOLDERS FROM:

CADTH INESSS Pfizer Biogen

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Suzanne McGurn President & CEO CADTH

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

Kiersten Combs Country President, Canada AstraZeneca

NEW SESSIONS FOR 2023: ĉ Advanced Diagnostic Testing: Examining the Canadian state of readiness for patient access in the age of genomic medicine ĉ The Next Chapter of Real World Evidence: How to develop a national data strategy to support drug access and reimbursement decisions ĉ U.S. Drug Pricing Primer: Key changes to the U.S. Medicare program and the potential Impact on the Canadian Market ĉ Top Trends Impacting the Private Payer Market: How to align your drug submission strategy

Janssen Bausch Health Roche

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

T

he 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.

Users WHO YOU WILL MEET PHARMACEUTICAL COMPANIES Corporate Counsel/General Counsel, Vice Presidents, Officers, Directors and Managers for: » Pricing » Reimbursement » Market access » Sales » Government and regulatory affairs » Product development » Public drug programs » Pharmaceutical benefits » Pharmaceutical strategy » Drug submissions » Formulary management » Policy and economic analysis » Provider services and relations » Pharmacy

REPRESENTATIVES FROM: » Associations » Patient Advocacy Groups » Law Firms

Take part in this forward-looking forum to: ĉ BUILD a market access and pricing plan for 2023 with insights from key regulators and industry leaders ĉ CONNECT directly with drug review, and decision makers from CADTH, PMPRB, pCPA, and INESSS ĉ DISCOVER the true potential of the use of RWE for HTA and reimbursement decisions in Canada ĉ ANTICIPATE the impact of the national pharmacare strategy on patients and payers ĉ PREPARE drugs submissions that align private payer priorities ĉ EXAMINE how to improve health outcomes through improved access to advanced diagnostic testing

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SPEAKER FACULTY Co-Chairs 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

Kiersten Combs Country President, Canada AstraZeneca

Fred Little Country Lead Rare Disease Pfizer

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

Joan McCormick Senior Principal IQVIA Canada

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

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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DAY ONE

Thursday, January 19, 2023 7:45 a.m. EARLY RISER COFFEE CONNECT

Women of Pharma Networking Session Microphone-alt

Kiersten Combs, Country President, Canada, AstraZeneca

10:15 a.m. Morning Coffee and Networking Break 10:30 a.m. SPOTLIGHT ON RWE

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

Moderator: Joan McCormick, Senior Principal, IQVIA Canada

Mina Tadrous, Assistant Professor, University of Toronto

8:45 a.m.

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

Opening Remarks from Chair Microphone-alt

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

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

Dipti Tankala, Manager, Market Access & HEOR, AbbVie

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

9:00 a.m. KEYNOTE

Status Report from the Canadian Drug Agency Transition Office Microphone-alt

• Addressing the data dilemma » Determining what different stakeholders deem as acceptable realworld data

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

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

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 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

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DAY TWO

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?

Friday, January 20, 2023 8:50 a.m.

Opening Remarks from Chair Microphone-alt

• 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.

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

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

Microscope Focus on Precision Medicine 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

• Analyzing financial savings to date, and projected impact on the provincial budget over the next few years

• Evaluating the limitations of the current system in delivering these therapies

• Determining the implications for the market access environment

• Examining the case for system change regarding access to genomic therapies from a health outcome, value, and sustainability lens

3:30 p.m. CASE STUDY

• Exploring obstacles to adoption, implementation, and financing of testing technology

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

Rosemarie Childerhose, Director, Market Access & Government Affairs, Bausch Health Priti Chawla, Founder & Executive Director, Obesity Matters

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

Dr. Sean Wharton, Wharton Medical Clinic

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

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

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

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

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

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• Assessing how to capture value in selling genetic testing services and innovations • Developing a coordinated service planning and financial oversight plan

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10:30 a.m. Morning Coffee Break

2:15

11:00 a.m.

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

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.

Microphone-alt

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

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

Louise Binder, Health Policy Consultant, Save Your Skin

» 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

• 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

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

chart-line Hot Topics in Digital Health and Innovation 3:45

1:30

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

» Identifying future opportunities to expand scope of practice

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

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