9th Annual Forum on Pathways to Access & Reimbursement - DS

9th Annual Forum on

PATHWAYS TO ACCESS & REIMBURSEMENT February 12–13, 2024 • One King West, Toronto ON The Future of Market Access: Making Progress through Collaboration and Innovation Distinguished Co-Chairs Rosemarie Childerhose

Dipti Tankala

Head, Market Access & Pricing Biocon Biologics

Manager, Market Access & HEOR AbbVie

Featured Speakers:

Douglas Clark CEO pCPA

Tijana Fazlagic

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

Andrew Spiegel, Esq. Chief Executive Officer Global Colon Cancer Association

Sudha Kutty

Executive Vice President, Evidence, Products and Services CADTH

Align your market access strategy with the latest developments shaping the pharmaceutical industry!

Program Highlights for 2024 Angle-Right

Focus session on NEW Expedited Market Access Pathways in Canada: CADTH’s Time Limited Recommendation and pCPA’s Temporary Access Process

Angle-Right

A Manufacturer’s Guide to RWE Reporting: Guidance on strengthening submissions to support timely decisionmaking about pharmaceutical products

Angle-Right

Spotlight on Health Equity: Exploring opportunities to collaborate with Indigenous Communities to address gaps in Patient access

Angle-Right

Digital Therapeutics Think Tank: Forecasting the future of commercialization in Canada

Supporting Sponsor

Associate Sponsors

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New regulatory, HTA and reimbursement pathways for drugs are emerging in Canada to address unmet patient needs, faster. However, without a clear implementation plan for National Pharmacare, progress is taking place against the backdrop of system level uncertainty.

Drug manufacturers need to prepare for significant shifts in the market access landscape in the coming years, while also navigating more immediate challenges. It’s a critical time to identify opportunities to improve submissions and work with key stakeholders to expedite drug to market timelines.

Inform next steps and stay up to date with practical, timely insights on what’s happening in the industry by attending the Canadian Institute’s 9th Annual Forum on Pathways to Access and Reimbursement on February 12-13, 2024, in Toronto.

Learn from our all-star faculty as we examine the evolving role of RWE, and innovative market access mechanisms, including CADTH’s time limited recommendation and the pCPA’s temporary access process.

Start the year off with a full view of all the moving pieces impacting drug access decisions by engaging with leading manufacturers, payors, and regulators.

Take part in this advanced forum to: Angle-Right ANTICIPATE the impact of the national pharmacare on patients and payers Angle-Right CONNECT directly with decision-makers including CADTH, pCPA, and INESSS Angle-Right IDENTIFY and address potential regulatory hurdles early in your access strategy Angle-Right GAIN insights on packaging RWE to support the value proposition of your product Angle-Right ASSESS emerging tools, and technology that can support market access functions

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

SUPPORTING SPONSOR Delphic Research sees a world where our customers have the information they need, when they need it: actionable insights, relevant to them. Whether that information comes from news media, stakeholder or regulator communications, Delphic Research extracts the information that matters specifically to you – and delivers it on a daily basis. It is a vision that ensures that our customers have the knowledge they need to navigate around the world of government policy and advocacy more effectively.

With conferences in the United States, Canada, Latin America, and Europe, the C5 Group of Companies: hands-helping GLOBAL American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers SPONSORSHIP responding to challenges around the world. miss the opportunity to maximize participation or showcase your organization’s services and talent.

OPPORTUNITIES Don’t For more information please contact us at: SponsorInfo@CanadianInstitute.com

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Distinguished Faculty CO-CHAIRS

Rosemarie Childerhose Head, Market Access & Pricing Biocon Biologics Dipti Tankala Manager, Market Access & HEOR AbbVie SPEAKERS

Saad Ahmed, MD, CCFP(EM) Lecturer, Department of Family & Community Medicine University of Toronto Medical Director, Homelessness, Supported Housing, Complex Care Vancouver Coastal Health Jessica Arias Manager, Provincial Drug Reimbursement Programs, Clinical Institutes & Quality Programs Ontario Health Amine Mohammed Bouchaib Director, Patient Access Novo Nordisk Canada Inc.

Tijana Fazlagic Executive Director of Therapeutic Assessment & Access Pharmaceutical, Laboratory & Blood Services Division BC Ministry of Health Jason Grier President & CEO Delphic Research Adam Haynes Senior Manager, Value, Access & Policy Eisai Canada Dara Jospé Partner Fasken Martineau DuMoulin LLP Ben King Director, Digital Health & Innovation Santis Health Sudha Kutty Executive Vice President, Evidence, Products and Services CADTH

Chris Bonnett, MHSc, PhD Principal H3 Consulting

Keith Leclaire Chairperson PATHWAYS Indigenous Advisory Circle

Roger Chai Regional Health Policy and Patient Access Manager (Ontario) Boehringer Ingelheim

Sang Mi Lee Director of Innovative Access Solutions MORSE Consulting

Douglas Clark CEO pCPA Tim Clarke, BMath FSA FCIA President tc Health Consulting Inc. Tara Cowling President & Managing Principal Medlior Isadore Day CEO and Founder Bimaadzwin

Fiona Legere Partner McCarthy Tétrault LLP

Barbara A. Martinez National Practice Leader, Drug Solutions Canada Life Farah Meghji Patient Experience Roche Canada Brad Millson General Manager, Real World Solutions IQVIA Dr. Nicole Mittman Chief Scientist and Vice President, Scientific Evidence, Methodologies and Resources CADTH Neda Nasseri Product Director Desjardins Insurance Andrew Spiegel, Esq. Chief Executive Officer Global Colon Cancer Association Alexis Sciuk Global Market Access Policy Strategist Pfizer David Shum Director, Strategic Access and Pricing Roche Mark Smithyes National Director, Life Sciences Delphic Research

Lisa Machado Executive Director Canadian CML Network

Mia Spiegelman Vice-President of Regulatory Affairs Medtech Canada

Patrick Manfred Vice-President TACT

Helen Stevenson Founder & CEO Reformulary Group Inc.

Ursula Mann Principal and Chief Patient Officer (CPO) PatientVoicePartners

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

C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we're launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, Customer-Centric, Conscientious, and Committed.

Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success.

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Day One

MONDAY, FEBRUARY 12, 2024

7:45

Registration Opens & Continental Breakfast Served

8:50

Opening Remarks from the Co-Chairs microphone-alt Rosemarie Childerhose, Head, Market Access & Pricing, Biocon Biologics Dipti Tankala, Manager, Market Access & HEOR, AbbVie 9:00

Negotiating with a New pCPA: What the Latest Changes to the Organization Mean for Manufacturers Moving Forward microphone-alt MODERATOR: Mark Smithyes, N ational Director, Life Sciences, Delphic Research Douglas Clark, CEO, pCPA 9:45

CADTH’s New Time Limited Reimbursement Recommendation: Examining the Finer Points of the New Process and Projected Impact on Patient Access microphone-alt Sudha Kutty, Executive Vice President, Evidence, Products and Services, C ADTH CADTH has introduced a new reimbursement recommendation category to address the unmet needs of those living with a rare or debilitating illness in Canada. The introduction of the time-limited recommendation follows consultations with industry and expert advisory committees. This is an opportunity for drug manufacturers to secure a recommendation for public funding on promising pharmaceuticals for a defined period of time, helping to expedite patient access, while more evidence is collected for a final reimbursement decision.

• Overview of the new reimbursement recommendation pathway » Examining the criteria for manufacturer submissions and timelines for deliverables • Understanding how CADTH, pCPA and industry will work together to implement and streamline this process • Establishing evidence generation expectations for drug manufacturers 10:30

Morning Coffee and Networking Break

11:00

How Manufacturers Can Strengthen RWE Submissions: Promoting a Standardized Approach for Optimal Use in Regulatory and Reimbursement Decision Making microphone-alt MODERATOR: Brad Millson, General Manager, Real World Solutions, IQVIA

11:45

Examining International Examples of Early Access Pathways to Innovative Oncology Drugs microphone-alt Tara Cowling, President & Managing Principal, Medlior • Overview of market access process in UK, Italy, Germany, France, Australia, and Canada » Early access pathways in those countries from pre-HTA to post-HTA • Examining how RWE is leveraged in those pathways and countries » How public funding is utilized during conditional approval period • Exploring opportunities for Canadian data to facilitate coverage with evidence decisions 12:30

Networking Lunch

SPOTLIGHT ON ADVANCING HEALTH EQUITY AND AMPLIFYING PATIENT VOICES 1:30

PATHWAYS: Collaborating with Indigenous Leaders and Communities to Help Close the Healthcare Gap and Strive for Health Equity microphone-alt Roger Chai, Regional Health Policy and Patient Access Manager (Ontario), Boehringer Ingelheim Keith Leclaire, Chairperson, PATHWAYS Indigenous Advisory Circle Isadore Day, CEO and Founder, B imaadzwin This session will share the PATHWAYS journey to create a culturally sensitive, Indigenous-informed and collaborative framework to address healthcare gaps in Indigenous communities in Canada.

• Key points to be covered, include: • Sharing the history of PATHWAYS and key principles • Profiling impact on health outcomes through Indigenous Community identified health challenges and Community driven solutions • Showcasing the pilot sites and health outcomes from the pilot projects • Exploring next steps for this innovative partnership initiative for sustainability 2:15

Patient Inclusivity: How to Integrate Patient Voices, and Experiences for Improved Decision Making Across the Lifecycle of a Drug microphone-alt MODERATOR: Farah Meghji, Patient Experience, Pipeline and Chair, Above-Brand Patient Council, Roche Canada Ursula Mann, Principal and Chief Patient Officer (CPO), PatientVoicePartners Andrew Spiegel, Esq., C hief Executive Officer, Global Colon Cancer Association Lisa Machado, Executive Director, Canadian CML Network

Adam Haynes, Senior Manager, Value, Access & Policy, Eisai Canada

• Defining patient centric and patient inclusivity

Dr. Nicole Mittman, Chief Scientist and Vice President, Scientific Evidence, Methodologies and Resources, CADTH

• Determining how and when manufacturers should engage patients

David Shum, Director, Strategic Access and Pricing, R oche • Identifying acceptable sources of real-world data • Examining how regulators and HTA bodies are using RWE in decisionmaking about the safety and efficacy of drugs • Aligning RWE submissions with HTA expectations » Understanding how RWE is being assessed  Determining what is considered a sufficient level or proof or value proposition for recommendations » Applying RWE reporting best practices to expedite reviews and maximize relevance of submissions

» How to avoid tokenism in your approach to patient engagement » Identifying methods of engagement that empower patients to share challenges and co-create solutions » Exploring mechanisms to engage patients where pathways including POs are not available for specific conditions and disease areas • Sharing examples of what meaningful patient engagement looks and feels like » Applying patient insights from pre to post launch for improved decision making and patient experiences, and health outcomes » How to measure the impact of inclusivity on health outcomes and patient experiences

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3:00

Afternoon Networking and Refreshment Break

3:15

Weight Loss and GLP-1 Drugs: How to Manage Access and Reimbursement in An Evolving Market microphone-alt MODERATOR: Tim Clarke, President, t c Health Consulting Inc. Amine Mohammed Bouchaib, Director, Patient Access, Novo Nordisk Canada Inc. Barbara A. Martinez, National Practice Leader, Drug Solutions, Canada Life Neda Nasseri, Product Director, Desjardins Insurance There has been a steady shift in private payer market, with expanded coverage being offered for obesity management drugs, like smoking cessation drugs before it. Some GLP-1s or diabetes drugs are also being considered for use due their potential to promote weight loss.

This raises questions important questions for our panelists to discuss; appropriate use, and whether access to these costly drugs will be sustainable moving forward, as demand grows.

4:00

Where Patents Meet Market Access: Everything You Need to Know! microphone-alt Fiona Legere, P artner, M cCarthy Tétrault LLP This interactive session is tailored to cover everything your regulatory and market access team needs to know about pharmaceutical patents in Canada. Our presenters will help strengthen your understanding of how patents protect your company’s inventions and drug products: • Providing a comprehensive overview of how patents protect your inventions and drug products in Canada • Examining various aspects of drug products which can be protected by patents (e.g., compound, formulation, use, dose) • Exploring the interplay between patent litigation, the patent register, and regulatory protections like data exclusivity; and their combined significance for market access and regulatory teams 4:45

Conference Adjourns

Day Two

TUESDAY, FEBRUARY 13, 2024

7:45

Registration Opens & Continental Breakfast Served

8:50

Opening Remarks from the Co-Chairs HOW SHOULD CANADA APPROACH NATIONAL PHARMACARE? 9:00

Perspectives on Where We Go from Here: Models, Implementation, and Projected Outcomes for Patients and the Healthcare System microphone-alt Chris Bonnett, MHSc, PhD, Principal, H3 Consulting The governing liberal party has committed to introducing pharmacare legislation as part of a confidence deal with the NDP. This follows analysis, discussion, and debates on whether a single payer system or a take a fill the gaps approach would be better for Canadians, the healthcare system, and the economy, but little in the way of a concrete plan for implementation.

A recent report out from the parliamentary budgetary claims a single payer approach would cost over 30 billion but lead to economy-wide savings due to better price negotiations. It’s a critical time to revisit different perspectives on where we go from here, in terms of improving access to prescription drugs.

• Overview of the current political landscape for National Pharmacare » Identifying Canadian Drug Transition Agency’s mandate and what was accomplished • Analyzing pros and cons of the single payer approach • Anticipating potentially transformative outcomes for the private payer market • Identifying limitations to a national formulary in relations to high-cost innovative drugs and therapies 9:45

Canada’s Drug Shortage Task Team: Taking a Coordinated Approach to Prevent, Mitigate and Manage Supply Chain Disruptions

Great overview, gave me a different perspective. Got me thinking differently.

Team Lead, Pricing and Contracts, GSK

I liked the quality of the speakers.

Manager, Market Access and HTA, BMS

Overall excellent topics and speakers.

Truly enjoyed the selection of speakers and the panels.

Manager, Pricing and Contracts, Astellas

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microphone-alt Mina Tadrous, Assistant Professor, Leslie Dan Faculty of Pharmacy, U niversity of Toronto Saad Ahmed, MD, CCFP(EM), Lecturer, Department of Family & Community Medicine, University of Toronto Medical Director, Homelessness, Supported Housing, Complex Care, Vancouver Coastal Health Addressing drug shortages has been identified as a top priority for the Government of Canada. A multi stakeholder task team has been assembled to ensure patient access and prevent the detrimental impact of these shortages on the health of Canadians. This session will examine ongoing work by the task team, including: • Assessing the scale and potential impact of a drug shortage • Determining if the shortage for a drug or group of drugs is considered severe (Tier 3) • Providing timely communication and engage stakeholders through the creation of a national drug shortage list • Working with stakeholders to develop drug shortage and supply chain disruption mitigation strategies » Examining opportunities to fast-track regulatory reviews or allow for drug importation • Identifying how healthcare providers can play a role and where manufacturers not being impacted can assist with supply

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10:15

Morning Coffee and Networking Break

• Developing a DTx access strategy with insights on how regulators, public and private payers are viewing these innovations in Canada

10:45

» Forecasting the future regulatory and reimbursement landscape in Canada

Biosimilars in Canada: Assessing Barriers, and Benchmarking with Early Adopters

 Assessing how the US and Europe are approaching reimbursement for digital therapeutics

microphone-alt MODERATOR: Rosemarie Childerhose, Head, Market Access & Pricing, Biocon Biologics Tijana Fazlagic, Executive Director of Therapeutic Assessment & Access Pharmaceutical, Laboratory & Blood Services Division, BC Ministry of Health

» Examining what steps are being taken towards the development of digital formularies • Examining the role of digital therapeutics in the RWD ecosystem 2:15

Jessica Arias, Manager, Provincial Drug Reimbursement Programs, Clinical Institutes & Quality Programs, O ntario Health

Leveraging AI in Market Access: Examining Strategic Use Cases, Risks, and Regulations

Helen Stevenson, Founder & CEO, Reformulary Group Inc.

microphone-alt Jason Grier, P resident & CEO, D elphic Research

• Analyzing how the biosimilars listings differ across the country by province

• Examining current AI/ML use cases in the pharmaceutical sector

• Benchmarking with BC as the first province to implement a non-medical biosimilars switch policy

• Assessing future opportunities to support market access departments » Generating insights for your pharmaceutical access strategy

» How have switch policies impacted patients and provincial budgets • Identifying remaining barriers to access across therapeutic areas and improving clinician support • Assessing how provincial policies are impacting private plans • Learn about the Pan-Canadian Oncology Biosimilars Initiative and how it shaped the implementation of oncology biosimilars in Canada » Examining outputs from the initiative, including education materials, a real-world evidence • Analysis of trastuzumab (reference v biosimilar), and oncology-specific utilization data for Ontario 11:30

The Way Ahead for Cell and Gene Therapies: How to Create Healthcare System Infrastructure that Supports New Pathways to Access and Reimbursement microphone-alt Sang Mi Lee, Director of Innovative Access Solutions, MORSE Consulting Cell and gene therapy is an exciting and rapidly evolving area of development in the life sciences sector. These treatments can be life changing and potentially lifesaving for patients with rare diseases, and severe conditions. However, the cost of innovative treatments creates a challenge for the health system and requires new pathways to support access. Develop a strategic plan for your product and minimize hurdles with insights on: • Obstacles to adoption, implementation, and financing of testing technology • Navigating Canada’s regulatory and HTA pathways for cell and gene therapy » Building data to support decision making on cell and gene therapies • Gaps in reimbursement infrastructure for complex gene therapies » Exploring opportunities for innovative agreements 12:15

Networking Lunch

1:15

Accelerating DTx Market Access: Forecasting Future Regulatory and Reimbursement Pathways in Canada microphone-alt MODERATOR: Ben King, Director, Digital Health & Innovation, Santis Health Alexis Sciuk, Global Market Access Policy Strategist, Pfizer Mia Spiegelman, Vice-President of Regulatory Affairs, Medtech Canada • Defining digital therapeutics » Examining examples of how DTx and the potential to benefit different patient populations

 Literature searches, HTA submissions, RWE, marketing • Creating a sandbox for testing AI and machine learning technology across market access functions • Developing guardrails to mitigate legal risks when leveraging AI/ML 2:45

Afternoon Networking Break

3:00

Anticipating New Drug Pricing Guidance from the PMPRB microphone-alt Dara Jospé, Partner, Fasken Martineau DuMoulin LLP Amendments to the Patented Medicines Price Review Board regulations came into force in July 2022, with an interim approach to price assessments in the absence of new guidelines to assist manufacturers in the prepare for the changes.

After delays to the release of new guidelines a policy roundtable has been announced inviting stakeholders to share views on key themes intended to assist with the drafting process.

This session will provide an overview of the latest developments to date on drug pricing in Canada and what manufacturers can expect moving into 2024.

3:30

Examining Quebec’s Evolving Healthcare Landscape and the Potential Impact of Sweeping Changes Under Bill-15 microphone-alt Patrick Manfred, Vice President, TACT A proposed healthcare reform bill in Quebec is being hotly debated inside the legislature and fraught with controversy outside, as Quebecers consider the potential ramifications for everything from patient rights and access to medicines to language rights. The overarching proposal is to bring hospitals and university institutes under a crown corporation for a more centralized approach that achieves systemwide efficiencies in the delivery of care. Join this special focused session: • Overview on key aspects of Bill 15 with implications for access to medicines and the delivery of healthcare in the province • Identifying more controversial parts of the initial bill impacting patients and amendments that have followed • Patient rights committee involvement • Changes to the medical necessity measure • Assessing the impact on English hospital and health services 4:15

Conference Concludes

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February 21 – 22, 2024 • New York, NY

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