PHARMA PRICING, REIMBURSEMENT AND MARKET ACCESS

Monday, April 29, 2013

8:15

Registration and Continental Breakfast

9:00

Welcoming Remarks from Insight Information

9:05

Opening Remarks from the Chair

George Wyatt, BSC. MBA
Managing Director
Wyatt Health Management

9:10

OPENING KEYNOTE PRESENTATION

Common Drug Review – A 10th Anniversary Perspective: Trajectory to Date and Directions Ahead

Chander Sehgal
Director of CDR and Optimal Use of Drugs
Canadian Agency for Drugs and Technologies in Health (CADTH)

• Patient input
• Stakeholder relations
• Transparency
• Procedural and process updates
• Evolution of CDR and CDEC

10:00

SPECIAL ADDRESS

Insights into Drug Shortages in Canada: What's Happening?

Jeff Morrison
Director, Government Relations and Public Affairs
Canadian Pharmacists Association

Systemic drug shortages have been a problem in the Canadian health care system for several years, placing undue burdens on patients and health providers alike. In response, governments, industry, health providers, wholesalers, and other stakeholders have looked for ways to address and minimize shortages, with varying degrees of success. But why are shortages happening? What have been their impacts? What has been done to address them, and what more needs to be done? This session will look at the recent history of drug shortages in Canada, with an insiders' perspective on what is being done publicly and behind the scenes to respond to one of Canada's most serious health concerns.

10:45

Networking Coffee Break

11:45

KEYNOTE PRESENTATION

New Canadian Initiatives on Therapies for Rare Diseases

Marcin Boruk
Senior Policy Analyst, Office of Legislative and Regulatory Modernization
Health Canada

11:45

Quebec Report – INESSS, BAP 15 and More

France Mignault
Director, Government Affairs
Janssen Inc.
Rx&D Inesss Committee Lead (Invited)

• Streamlining processes and approaches at INESSS
• BAP 15 formulary and implications
• PLA developments and trends
• Impact and responses to new developments

12:30

Networking Luncheon

1:45

PMPRB 25 Years On – Consumer Watchdog or Regulatory Impediment?

W. Neil Palmer
President & Principal Consultant
PDCI Market Access Inc.

• Implications and contradictions of court decisions on PMPRB compliance and enforcement policies
• Impact of international policies and price referencing on Canadian domestic pricing
• Regulatory creep – significance of PMPRB's expanding role and jurisdiction (and impact of CETA)
• Impact of provincial pricing policies on PMPRB price limits
• Successfully navigating the 2013 PMPRB compliance and enforcement process

2:30

Canadian Pricing Developments in a Changing Context

Claudia Neuber
Director of Pricing and Contracting
AstraZeneca Canada Inc.
Vice Chair, Rx&D/PMPRB Working Group
Member, PMPRB DIP Working Group

• New therapies and related pricing models
• International references and impact on developments at home
• Patient advocacy and value assessments
• Process disclosure and transparency
• What is ahead in pricing policy?

3:15

Networking Refreshment Break

3:30

pan-Canadian Oncology Drug Review (pCODR) – pCODR Update and Review of the Expert Committee Recommendations

Dr. Mona Sabharwal
Executive Director
pan-Canadian Oncology Drug Review

Dr. Judith L. Glennie
President
J.L. Glennie Consulting Inc.

• Update on pCODR operations and experiences (Mona)
  • Process review and strengths
  • Patient input initiatives
  • Evidence based review
  • Value assessment – a fine balance
• Analysis of expert committee recommendations – what's unique and lessons we can learn? (Judy)

4:15

Patient Advocacy and Engagement in the Review Process – Taking Patient Input to the Next Level

John Adams
President & CEO
CanPKU
Board Chair
Canadian Organization for Rare Disorders

Harlon Davey
Former Patient Member, Committee to Evaluate Drugs, Ontario Ministry of Health
Independent Advisor, Harlon Consulting: Promoting Health Care Literacy
Member, Operations Committee, The Best Medicines Coalition

• Patient role in drug review
• The need for opportunities for patient input into PLAs and patient use criteria
• Patient input and evidence-based decision making
• Meaningfully incorporating patient values, experiences and outcomes
• Opportunities for impactful patient submissions

5:00

Conference Adjourns for the Day

Tuesday April 30, 2013

8:30

Continental Breakfast

9:00

Chair's Opening Remarks

George Wyatt, BSC. MBA
Managing Director
Wyatt Health Management

9:05

OPENING ADDRESS

A Report from CAHR

George Wyatt, BSC. MBA
Managing Director
Wyatt Health Management

9:45

The Evolution of Pan-Canadian Drug Purchasing

Wayne Critchley
Senior Associate
Global Public Affairs

• What is the pan-Canadian Purchasing Alliance?
• Current status
• Challenges and opportunities
• Implications for stakeholders
• Where is it going?

10:15

Public Plans – Achieving that Fine Balance

Moderator:
Wayne Critchley
Senior Associate
Global Public Affairs

Dr. Judith L. Glennie
President
J.L. Glennie Consulting Inc.

Steve Long
National Director Public Policy
Shoppers Drug Mart

• Evidence based review
• Safety and outcomes focus
• Patient input and priorities
• PLA Trends
• Confidentiality and transparency
• Process issues, resources, efficiencies and costs
• Achieving balance

10:45

Networking Coffee Break

11:00

Patient Support – Some Leading Developments

William Hryniuk, MD, FRCPC
Oncologist
Vice-President (Research)
CAREpath Inc.

• Public cancer system challenges
• Cancer survival: a postal code lottery
• Emerging private care providers
• CAREpath system and results

11:30

The Ground is Moving for Private Plans – What's Next?

Moderator:
Suzanne Lepage
Principal
Suzanne Lepage Consulting

Paula Allen
Vice President, Research and Integrative Solutions
Morneau Shepell

Barbara Martinez
Benefits Solutions Practice Leader
Great-West Life

Michael Sullivan
President
Cubic Health Inc.

• Changing trends in benefits management and package design – drivers and responses
• Closed and open formularies – what gives?
• Collaborations and partnerships for better results
• Accessing specialty drugs and new therapies
• Establishing the standard for treatment and is this sustainable?
• Strategic approaches for achieving best treatment outcomes
• How are employer and employee expectations and priorities changing?
• Employer managed plans
• Employer objectives
  • tools to assist them in meeting those objectives
  • cost drivers and trends and strategies to address them
• Role of the plan manager and how it can be supported by industry
• Enhanced use of data in facilitating plan decision making
  • Budget impact analyses
  • Integrating drug/disability/absence data
  • Better evaluating and quantifying the value proposition
• Preferred customer arrangements
• Discounts and rebates

12:30

Networking Luncheon

1:30

KEYNOTE ADDRESS

Engaging Pharmacists for Better Patient Care

Steve Long
National Director Public Policy
Shoppers Drug Mart

Canada's national annual healthcare expenditure of $200 billion continues to grow by roughly 6% each year. Aging population, new equipment for diagnostics and treatment, new drug therapies, and constant health human resource wage pressures all contribute. While demand for healthcare services is soaring, the public resources to pay are finite.

Prescription drug expenditures made up $27 billion of the $200 billion total health expenditures in Canada (CIHI 2011). To sustain the health system into the future, the broader pharmacy sector must work to deliver greater value. This will include leveraging the strong portfolio of generic medications available to Canadians and the efficient distribution system and supply chain. It will require pharmacists and technicians to become more responsible and accountable for medication management, to work to their full, newly expanded, scopes of practice.

Studies have shown that for every $1 spent on pharmaceuticals and pharmacy services, $2 to $7 is saved on other healthcare costs. This presentation will outline the strategies, practical approaches and considerations being engaged to establish pivotal roles for pharmacists in providing better patient care.

2:15

Biologics and Subsequent Entry Biologics – New Review Challenges and Emerging Directions

Arvind Mani, MA, MBA
Director, Market Access and Policy Research
PDCI Market Access Inc.

Anne Tomalin
Strategic Regulatory Services
OptumInsight

• Update of subsequent entry biologics approved federally for Canada
• What is happening in Europe and the US
• Interchangeability of subsequent entry biologics/biosimilars
• Status of reimbursement for these therapies
• Key issues and opportunities associated with expanding SEB use in Canada
• Public and private drug plan manager expectations surrounding SEBs
• Clinicians views on the use of SEBs
• Payer pricing expectations for SEBs
• Emerging approaches for approvals
• Expected evolution of guidelines related to regulatory approval of SEBs

3:15

Networking Refreshment Break

3:30

Industry Perspectives – International Developments, Industry Trends, Domestic Outlook

Moderator:
W. Neil Palmer
President & Principal Consultant
PDCI Market Access Inc.

Paul Moen
President
MoenGlobal Advisors Inc.

Claudia Neuber
Director of Pricing and Contracting
AstraZeneca Canada Inc.
Vice Chair, Rx&D/PMPRB Working Group
Member, PMPRB DIP Working Group

Alan West
Partner, Life Sciences
Gowlings LLP

• PLA trends
• What is working – what is frustrating
• Review process and communication concerns
• Access, flexibility, dialogue
• Transparency and confidentiality – where is the line?
• Managing the areas of risk and exposure
• Economic and industry trends of note
• Discounting and rebates
• Bulk purchasing
• International developments and impacts
  • CETA
  • Trade talks and trade developments

4:15

CLOSING ROUNDTABLE

Action Items for Canada's Life Sciences Stakeholders and Regulators

Moderator:
Wayne Critchley
Senior Associate
Global Public Affairs

John Adams
President & CEO
Canadian PKU & Allied Disorders
Board Chair, Canadian Organization for Rare Disorders

William (Bill) Dempster
Principal
3sixty Public Affairs Inc.

Jeff Morrison
Director, Government Relations and Public Affairs
Canadian Pharmacists Association

France Mignault
Director, Government Affairs
Janssen Inc.
Rx&D Inesss Committee Lead (Invited)

• What are the top priorities for this sector in the forthcoming years?
• How will the interests be balanced, the priorities set and targets acted upon?
• How to ensure that Canada's therapeutics environment continues to thrive?

5:00

Workshop A / 9:00 am to 12 noon
PRODUCT LISTING AGREEMENTS (PLAS) AND RISK MANAGEMENT – BEYOND THE BASICS

Alan West
Partner, Life Sciences
Gowlings LLP

Julian Worsley
Partner
Heenan Blaikie LLP

The negotiation, crafting and drafting of PLAs is at the heart of effective drug reimbursement and access. From strategy development, to submission process and through to negotiation and drafting of Product Listing Agreements, the challenges at each step are considerable. This workshop will show how all these steps are connected and will explore the alternatives available to pharmaceutical companies in managing the process. Build on the basics with this in-depth session where you will learn the finer points of:

• Strategy development and submission process
• Latest legislative and case law developments
• Recent trends in contract design and terms
• Impact on contract negotiation and drafting
• Interactions of benefit programs on contract design
• Listing agreements and pricing considerations
• Key areas for flexible terms
• Strategic and business considerations

You will benefit from the expert instructions and insights of leading legal and business experts who will ensure that you have plenty of opportunities to ask questions and dialogue on issues of importance to you and your organization.

Alan West practices primarily in areas of law related to pharmaceuticals and health care. Alan's practice focuses on the regulation and pricing of drugs, biologicals and radiopharmaceuticals, and medical devices, cosmetics, food and beverages (registration, licensing, compliance, recalls, etc.). "Regulation" includes work related to development of drugs and devices from pre-clinical, clinical testing and post-marketing phases, including clinical trial agreements and protocols, research agreements, listing and pricing agreements, licensing work, advertising and promotion of drugs to health care professionals and to consumers.

Julian Worsley provides advice in respect of provincial drug formulary issues as well as pharmaceutical regulatory compliance matters relating to drug product manufacturing, advertising, marketing and distribution, GMP compliance and establishment licensing, product licensing, packaging, labelling and drug pricing. In addition, Julian advises on federal and provincial access to information/freedom of information issues in respect of drug products.

Light luncheon to be served to delegates attending both workshops

Workshop B / 1 to 4 pm
DEVELOPING YOUR GOVERNMENT RELATIONS STRATEGIES FOR IMPROVED ACCESS AND IMPACT

David Caplan
Vice Chairman
Global Public Affairs
Former Minister of Health and Long-Term Care, Ontario

William (Bill) Dempster
Principal
3sixty Public Affairs Inc.

Paul Moen
President
MoenGlobal Advisors Inc.

Effective market access strategies require industry leaders who can navigate the complex network of regulatory and reimbursement relationships, policies and processes. Learn from seasoned experts with extensive experience helping clients implement successful provincial, national and global market access strategies. Focus will be on:

• Understanding the complex market access environment
• Defining your objectives
• Identifying key strategic levers and opportunities
• Researching decision-makers and influencers
• Developing and implementing effective strategies
• Building your company's profile and relationships with public sector clients - political and public servants
• The importance of ethical and professional interaction
• Building a favorable policy ecosystem
• Common pitfalls and how to avoid them

Ensure that you benefit from this rare opportunity to hone essential skills through interactive exercises, mock discussions and ample dialogue. Specially prepared materials will be of benefit long after the session has concluded.

David Caplan brings a wealth of knowledge and experience as Vice Chair at Global Public Affairs. Prior to joining Global, David served for 14 years as MPP for Don Valley East and as Deputy Government House Leader, Minister of Public Infrastructure Renewal, and Minister of Health and Long-Term Care with the Ontario government. As Minister of Health and Long-Term Care, Caplan launched Ontario's Diabetes Strategy and oversaw the expansion of scopes of practice for pharmacists and other health professionals.

Bill Dempster As co-founder of 3Sixty Public Affairs, Bill Dempster develops and implements high-impact government relations, policy and business strategies for clients in the health and life sciences sector. Previously, Bill was a member of the federal relations and health policy team at Pfizer Canada.

Paul Moen has 20 years of experience as a corporate lawyer and strategic advisor to clients in the global economy. An expert in international trade, biotechnology and information technology, Mr. Moen has worked in both the private sector (Amgen, MerckSerono, Paladin Labs) and government, bringing a wealth of experience in public affairs, government relations and business development.

• From Pharmaceutical, Biotech, Generic and OTC Drug Companies - Presidents, Vice Presidents, Directors, Managers and Analysts of:
• Pricing
• Reimbursement
• Market Access
• Government and Regulatory Affairs
• Compliance
• Brand Managers
• Pharmacy Services
• Health Economics, Health Policy
• Submissions
• Pharmacy Services
• Contracts
• R&D
• Investor Relations
• Regulatory Affairs
• Policy and Compliance
• Marketing
• Sales
• Business Development
• National Trade

• Senior Representatives from:
• Regulators
• Public and Private Formularies
• And
• Government Representatives
• Academics
• Patient Advocates
• Lawyers
• Pricing and Reimbursement Consultants
• Pharmacists
• Association Representatives

Dear Colleague,

While exciting new therapeutic products continue to foster optimism and hope for improved healthcare outcomes, economic and demographic pressures are rapidly mounting and rendering reimbursement, listing, and pricing decisions increasingly complex and challenging. Not surprisingly, budget and economic considerations are often seen to weigh in against therapeutic and care objectives leading to difficult scenarios for industry, public and private payers and regulators alike. In addition, as the role of patients and patient advocates continues to expand, the processes used to arrive at reimbursement, pricing and listing decisions become ever more complex with increasing clinical and experiential evidence being brought to bear, in addition to economic and budgetary considerations.

There is mounting pressure as well to give greater consideration to safety and risk allocation issues as some unfortunate past events have raised questions and concerns on the part of all stakeholders.

How is industry responding to the changing economic and regulatory environment? Where is the innovation taking place that will forge directions for the future? What are the key developments that will define the trajectory as far as therapeutic products coverage and costs are concerned?

This Insight Information event will bring together representatives from all key stakeholder groups to engage in information exchange and the dialogue needed to address some of these questions. Heeding the advice of past conference participants and experts from all key groups, we have assembled a program that targets the most timely and top of mind issues for the sector. Among the participants who will be engaged in creative dialogue at this forum will be pharmaceutical company representatives, drug plan sponsors, government regulatory and oversight bodies, patient advocates and representatives and the many service providers who offer assistance and support for the important work undertaken in this challenging field.

We invite you to join us for this timely meeting of minds and for two days of intense dialogue, exchange of views and exploration of key developments and new approaches to existing challenges. You will gain practical information, strategic insights and have an excellent opportunity to forge new alliances and relationships.

We look forward to seeing you there!

George Wyatt, BSC. MBA
Managing Director
Wyatt Health Management

Sponsor

Marketing Partner

Please note: Full payment is required in advance of conference dates. Please make all cheques payable to Insight Information.