Pathways To Access & Reimbursement

Registration Opens and Continental Breakfast Served

Opening Remarks from the Co-Chairs

Rosemarie Childerhose
Head, Market Access & Pricing
Biocon Biologics

Dipti Tankala
Manager, Market Access & HEOR
AbbVie

Negotiating with a New pCPA: What the Latest Changes to the Organization Mean for Manufacturers Moving Forward

Douglas Clark
CEO
pCPA

Moderator:

Mark Smitheys
National Director, Life Sciences
Delphic Research

CADTH’s New Time Limited Reimbursement Recommendation: Examining the Finer Points of the New Process and Projected Impact on Patient Access

Sudha Kutty
Executive Vice President, Evidence, Products and Services
CADTH

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

Morning Coffee and Networking Break

How Manufacturers Can Strengthen RWE Submissions for Optimal Use in Regulatory and Reimbursement Decision Making

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

David Shum
Director, Strategic Access and Pricing
Roche

Moderator:

Brad Millson
General Manager
Real World Solutions
IQVIA

• Identifying acceptable sources of real-world data
• Examining how regulators and HTA bodies are using RWE in decision-making 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

Examining International Examples of Early Access Pathways to Innovative Oncology Drugs

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

Networking Lunch

PATHWAYS: Collaborating with Indigenous Leaders and Communities to Help Close the Healthcare Gap and Strive for Health Equity

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

Allison Deer
Senior Project Manager
Bimaadzwin

Keith Leclaire
Chairperson
PATHWAYS Indigenous Advisory Circle

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

Patient Inclusivity: How to Integrate Patient Voices, and Experiences for Improved Decision Making Across the Lifecycle of a Drug

Ursula Mann
Principal and Chief Patient Officer (CPO)
PatientVoicePartners

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

Lisa Machado
Executive Director
Canadian CML Network

Moderator:

Farah Meghji
Patient Experience
Roche Canada

• Defining patient centric and patient inclusivity
  • How to avoid tokenism in your approach to patient engagement
• Determining how and when manufacturers should engage patients
  • 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

Afternoon Networking and Refreshment Break

Weight Loss and GLP-1 Drugs: How to Manage Access and Reimbursement in An Evolving Market

Barbara A. Martinez
National Practice Leader, Drug Solutions
Canada Life

Neda Nasseri
Director, Drug Insurance and Health Benefits
Desjardins Insurance

Amine Mohammed Bouchaib
Director, Patient Access
Novo Nordisk

Moderator:

Tim Clarke
President
tc Health Consulting Inc.

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.

Where Patents Meet Market Access – Everything You Need to Know

Fiona Legere
Partner
McCarthy 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

Conference Adjourns

Registration Opens & Continental Breakfast Served

Opening Remarks from the Co-Chairs

Rosemarie Childerhose
Head, Market Access & Pricing
Biocon Biologics

Dipti Tankala
Manager, Market Access & HEOR
AbbVie

HOW SHOULD CANADA APPROACH NATIONAL PHARMACARE?

Perspectives on Where We Go from Here: Models, Implementation, and Projected Outcomes for Patient

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

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

Mina Tadrous
Assistant Professor
Leslie Dan Faculty of Pharmacy
University 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

Morning Coffee and Networking Break

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

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

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

Helen Stevenson
Founder & CEO
Reformulary Group Inc.

Moderator:

Rosemarie Childerhose
Head, Market Access & Pricing
Biocon Biologics

• Analyzing how the biosimilars listings differ across the country by province
• Benchmarking with BC as the first province to implement a non-medical biosimilars switch policy
  • 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

The Way Ahead for Cell and Gene Therapies: How to Create Healthcare System Infrastructure that Supports New Pathways to Access and Reimbursement

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

Networking Lunch

Accelerating DTx Market Access: Forecasting Future Regulatory and Reimbursement Pathways in Canada

Alexis Sciuk
Global Market Access Policy Strategist
Pfizer

Mia Spiegelman
Vice-President of Regulatory Affairs
Medtech Canada

Moderator:

Ben King
Director, Digital Health & Innovation
Santis Health

• Defining digital therapeutics
  • Examining examples of how DTx and the potential to benefit different patient populations
• Developing a DTx access strategy with insights on how regulators, public and private payers are viewing these innovations in Canada
  • Forecasting the future regulatory and reimbursement landscape in Canada
    • Assessing how the US and Europe are approaching reimbursement for digital therapeutics
• Examining what steps are being taken towards the development of digital formularies
• Examining the role of digital therapeutics in the RWD ecosystem

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

Jason Grier
President & CEO
Delphic Research

• Examining current AI/ML use cases in the pharmaceutical sector
• Assessing future opportunities to support market access departments
  • Generating insights for your pharmaceutical access strategy
    • 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

Afternoon Networking Break

Anticipating New Drug Pricing Guidance from the PMPRB

Dara Jospé
Partner
Fasken

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.

Examining Quebec’s Evolving Healthcare Landscape and the Potential Impact of Sweeping Changes Under Bill-15

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

Conference Concludes