The Canadian Institute's Pharma Symposium Canada

Registration Opens and Refreshments are Served

Opening Remarks from the Conference Co-Chair

OPENING PANEL DISCUSSION Should Canada Institute a National Pharmacare Program? If so, What Should it Look Like and How Should it be Funded?

• Where are the gaps in coverage across Canada?
• What could a national pharmacare program deliver that the pCPA doesn’t?
• What constitutional issues would need to be resolved to address affordability for each province?
• Can we afford it? Can the government take over the $14 billion in health spending represented by drugs accessed through private payers? What would be the overall economic impact?
• Does not having a plan actually cost the healthcare system more in the end?
• As the number of seniors grow, what are the consequences of not acting?
• The nuts and bolts: What should a plan look like, who should have access, how should it be introduced and funded?
• If provinces decide to move to a tendering system for generics, will that lead to drug shortages as unsuccessful suppliers are shut out of the market? How should this concern be addressed?

Networking Refreshment Break

KEYNOTE ADDRESS The Strategic Review of the Patented Medicine Prices Review Board (PMPRB)

• The scope of the strategic review and the context in which it was undertaken
• Consultation timeline for Guideline Reform
• What impact will the November 2015 Federal Court of Appeal Decision have on the PMPRB’s approach to generics?

Networking Luncheon for Delegates and Speakers

The Evolution of the pan-Canadian Pharmaceutical Alliance (pCPA): What’s Next?

• What’s next now that it has an established office and is a permanent part of the industry landscape?
• How will its roles, responsibilities, and governance evolve?
• Will it take a more active role in negotiations going forward?
• Will it allow the federal government to join as was requested by the previous Conservative government?

The Evolution of the Private Payer Landscape

• Recognizing the most effective approach to attaining listing status under new private payer initiatives
• Demonstrating the value proposition of new products
• Understanding the challenges facing employers
• Increasing the opportunities for collaboration between the public and private sectors

Networking Refreshment Break

PANEL DISCUSSION The Path to Market in Canada: Can it be Streamlined and Still Deliver the Medications Canadians Need Safely and Effectively?

• Comparing the path to market in Canada to that of other countries; what can we learn?
• Are there too many hurdles now with 10 different provincial listing processes implemented and the private sector also more involved, relative to Canada’s market size?
• Have we built a machine too caught up in process without considering the end result?
• How can the current process be streamlined so that Canada is competitive as a place to invest in order to ensure Canadians have access to the latest and most effective medications?
• Should the PMPRB, CADTH and the pCPA all be under one roof since they all add time to the market entry for products?

International Trade: What the CETA and TPP Agreements Contain and their Potential Impact on the Canadian Market

• What new developments regarding patent extension are included in these agreements?
• How will these agreements benefit generics? Will the ‘double jeopardy’ situation they currently face be eliminated?
• What overall market impact can be expected?
• How does our patent protection now rank compared with that available in other countries?

Conference Adjourns

Refreshments are Served

Opening Remarks from the Conference Co-Chair

KEYNOTE ADDRESS CADTH – Opportunities in a Changing Landscape

• Navigating a path forward within a constantly changing environment for pharmaceutical HTA
• Finding a way to address the challenges of assessing orphan drugs
• Discovering new opportunities to bring forward new drugs that deliver cost-effective treatment

KEYNOTE ADDRESS Recent Developments and the Direction of Market Access in Québec

• What, if anything will change now that Québec has joined the pCPA?
• INESSS now does its own drug reviews – will they align with those done by CADTH?
• Will the consolidation of procurement organizations make it easier or more difficult for manufacturers to access the institutional market?

Networking Refreshment Break

KEYNOTE ADDRESSThe Genetic Revolution: Pursuing the Public Good While Safeguarding Individual Privacy

Strategies and Challenges for Establishing a Clear Path to Market for Biosimilars

Biosimilars represent a huge opportunity for generics as more biologics come off patent. Unfortunately, the current path to market in Canada is far too uncertain and challenging to encourage global companies to invest relative to the size of the market. How can the current situation be improved?

• What is the status of Health Canada’s review?
• Where is Canada in relation to the U.S. or Europe?
• If the Europeans have the best way of handling biosimilars, what parts of their process can we adapt to the Canadian market?

Networking Luncheon for Delegates and Speakers

Orphan Drugs: What is the Best Way to Achieve Access to Treatment for Canadians with Rare Diseases?

• Would this be a way for the federal government to get involved in a pharmacare program, since the price per patient is extraordinarily high?
• What is the overall impact of the small number of patients represented having their treatments funded?
• Is there a way for industry, patients, and payers to more effectively collaborate?
• What can we learn from other jurisdictions that do a better job of managing access to these drugs?
• Should CADTH adapt its current review criteria to accommodate the smaller clinical trial results these drugs represent and still be able to analyse effectiveness?
• The Orphan Drug Framework: What is its current status and expected impact going forward?

The Agreement between the Generics and the Provinces; Has it Been Effective? What’s on the Horizon for its Renewal?

• Has tiered pricing worked?
• What happens to pricing in this market after 2017?
• The current agreement will expire in April of 2017; should it be renewed and if so, under what terms?
• Should the agreement be scrapped and a competitive market introduced?

Networking Refreshment Break

Integrating the Pharmacist into Effective Strategies for Market Access and Optimizing Patient Outcomes

Retail pharmacies are an integral link in the chain of market access for manufacturers. With the expanded scope of practice for pharmacists, their role is also emerging as an integral part of ‘front-line’ patient care.

• How will the relationships between manufacturers, pharmacies and pharmacists evolve in a changing landscape?
• How will decisions be made concerning which pharmaceuticals to stock going forward?
• How will pharmacists respond to increasing price pressure from payers that specify they will only cover the generic drug? Are insurance companies putting patients at risk?
• Will there be an increase in potential liability issues if payers insist that a patient receives the biosimilar version of the original biologic even though the cost savings are significant?
• How effective is the pharmacists’ front-line role in bringing down health system costs? Can its impact be measured?

CONCLUDING PANEL DISCUSSION: Healthcare Economics – Connecting the Dots to Establish Actionable Strategies for Sustainable Healthcare

• An overall strategic approach is needed to determine whether a product will save the healthcare system money overall. For example, the value proposition the new hepatitis drug brings; what is its cost and budgetary impact relative to the downstream savings of curing the disease?
• Are there other ways of designing drug plans to accommodate the new, more expensive therapies?
• Can increasing collaboration between industry, patients and government get needed products to market more expeditiously and at lower cost?
• Should the government be willing to look at innovation as beneficial to the system? What value proposition does personalized medicine represent?
• What is the value proposition of re-classifying previously prescription-only products to OTC status? How could the current process be streamlined?
• What impact are pharmacists having with their expanded scope of practice?
• What responsibilities do manufacturers have toward achieving a sustainable system?
• Would governments be putting patients at risk by creating shortages of some drugs if they turn to a tendering system for generics in a bid to keep a lid on costs?

Conference Concludes