November 13th & 14th, 2017 | Arcadian Court, Toronto, ON

Payer-Specific Submissions: Customize your applications

Regulatory Uncertainty: PMPRB, CADTH and pCPA requirements

Provincial Negotiations: Tailor your PLA process

Private Payer Cost Concerns: Overcome cost constraints

Pharmacist Engagement: Tap into an under-utilized link to patients

Data Selection: Leverage data to enhance your submission

Value Propositioning: Ensure funds are allocated towards your product

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www.MarketAccessCanada.ca

Join Canada’s Most Prestigious and Definitive Event on Market Access.

Alan Birch, Drug Access Navigator, ODANO

Karen Voin, Assistant Vice President - Group Benefits and Anti-Fraud, Canadian Life and Health Insurance Association

Douglas Clark, Executive Director, Patented Medicine Prices Review Board (PMPRB)

Confirmed Speakers:

Sponsors:

New Developments in 2017

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8:30 AM Keynote Address: PMPRB Guideline Modernization

Assess Regulatory Changes to Determine Their Impact on Your Market Access StrategyPMPRB guideline modernization is underway. Explore regulatory changes that impact your market access and pricing strategy. Source intelligence to:

• Analyze the results of the consultation phase

• Explore what the published guidelines mean to your organization

• Review upcoming guidelines and update your calendar

Stay up-to-date with changing guidelines to enhance your decision-making process.

Douglas Clark, Executive Director, Patented Medicine Prices Review Board (PMPRB)

9:00 AM Panel Discussion: Data Utilization

Enhance The Value-Proposition of Your Products with Real World Evidence (RWE)Better data utilization allows drug manufacturers to leverage RWE in the decision making process. Improve patient outcomes and streamline your approval process with RWE. Create a roadmap to:

• Gather relevant data for your R&D and submission

• Advance your data-analytics

• Communicate RWE to your stakeholders

Leverage RWE to drive your approval and listing process.

9:45 AM Health Canada Update

Analyze Changes in Federal Healthcare Policy to Improve Your Market Access StrategyThe changes in federal budget and the ongoing ratification of CETA are likely impact access to prescription medications. Ensure you look at the big picture to enhance your decision-making process. Take away practical tips to:

• Assess the federal strategy to access to prescription medications

• Review changing costs of drug regulations

• Analyze the impact of CETA on your market

Familiarize yourself with new federal policies and anticipate changes in the industry.

10:45 AM Panel Discussion: Patient Advocacy

Establish How You Can Help Your Users to Optimize Access and AdherenceReconciling the urgency of patient need with a thorough HTA process is a growing a challenge. Explore what patients expect from you to improve patient outcomes. Gain insights to:

• Assess patient inputs in the evaluation of formularies

• Refine your stakeholder mapping

• Advance your stakeholder engagement process.

Ensure the patients are at the center of your strategic planning.

11:30 AM Employer Perspective

Encourage Sponsors to Cover Your Drug and Ascertain How They Can Be Incorporated into Your Access StrategyPrivate sponsors need a clear value-proposition to enhance their benefit plans. Clarify your value-proposition to ensure employees access to the best treatments. Gain practical insights to:

• Align your treatments with wellness programs

• Promote cost-reduction strategies that go beyond generic substitution

• Address short-comings of stepped drug plans

Include sponsor insights in your value-proposition to increase patient access to treatments.

12:00 PM Panel Discussion: Private Payers

Analyze Emerging Trends Among Private Payers and Adapt to ChangeThe private payer landscape is undergoing significant changes that will impact patient access and how medications are reimbursed. Strengthen your market access strategy with insights into emerging trends in the private payer landscape. Source critical information to:

• Assess trends among large employers

• Revise changes in industry leadership and emerging partnerships

• Review the solutions plan sponsors are considering

Integrate the employer’s outlook into your market access strategies.

Karen Voin, Assistant Vice President - Group Benefits and Anti-Fraud, Canadian Life and Health Insurance Association

DAY ONEMonday November 13th, 2017

7:30 AM Registration and Breakfast

8:15 AM Opening Comments from the Chair

10:15 AM Morning Break

12:30 PM Networking Lunch

1:00 PM Lunch & Learn

Driving Value Out of Upstream Data

Register today by calling 1-866-298-9343 x 200 © Strategy Institute 2017. Agenda is Subject to Change

Join the Canadian Pharmaceuticals: Legislative Demand, Regulations, Market Access & Reimbursement Network and share your views with our growing group members.

Follow and tweet @MarketAccessCA for exclusive updates and offers. Connect with other leaders attending #MarketAccess17

CHOOSE YOUR TRACKJoin your peers in sessions designed for specific types of drug.

Common Drugs Speciality Drugs

1:30 PM Case Study: Opioids

Enhance Your Outcome Assessment to Refine Your Value-Proposition Opioid abuses put the prescription of pain killers in the spotlight. Improve your Health Economic and Outcome Research to achieve sustainable market access. Source intelligence to:

• Improve your risk management

• Advance your assessment of addictions

• Prepare your substitution strategy

Sustain your market access when dealing with addictions.

2:00 PM Case Study: Marijuana

Anticipate Competition from Marijuana Usage on Your MarketAs marijuana has an impact on the demand for other drugs, manufacturers must adapt their market analysis. Adjust your commercialization planning to changes in marijuana legislation. Gain practical tips to:

• Identify your products affected by the legalization of recreational and medical marijuana

• Review current listings of medical marijuana

• Revamp your value proposition

Anticipate the impact of marijuana on your market.

2:30 PM Industry Expert

Implications of Global Trends on Pharmaceutical Pricing and Reimbursement in Canada International price referencing has always influenced the reimbursable price. Assess how international developments including the Canada-EU Trade Agreement will impact Canada’s P&R. Source critical information on:

• Evolution of HTA in Europe

• Formal and informal cooperation between HTA agencies

• Risk sharing, listing agreements

Track the evolution of European pricing and listing regimes and assess their implications for your market.

3:30 PM Panel Discussion: Public Payers

Align Your Strategy with Payer Policies to Increase the Speed of ReimbursementWith long negotiations and shrinking budgets, patients are likely to wait longer to get reimbursed. Stay in tune with payer priorities to ensure that your patients are quickly reimbursed. Develop your action plan to:

• Clarify coverage criteria

• Define and demonstrate value to the payers

• Advance your listing agreements

Adapt your value proposition to ensure the coverage of your treatments.

4:15 PM Panel Discussion

Utilize Data Analytics to Provide Superior Value Propositions to FormulariesThe advent of big data and analytics has transformed industries. You can unlock significant potential value by harnessing your data and analyzing the impact of your drugs. Source intelligence to:

• Underline the efficacy of a drug

• Increase the likelihood of being listed

• Guide research moving forward

Maximize the value of your data to benefit your market access chances.

1:30 PM Case Study: ODANO

Analyze ODANO’s Work with Patients to Anticipate the Demand Side of the MarketThe members of the Oncology Drug Access Navigators of Ontario (ODANO) facilitate cancer drug coverage. Analyze the impact of drug access navigators on patients to improve speed of reimbursement. Gain insights on:

• Educating patients

• Establishing and enhancing partnerships

• Best practice sharing among patients

Explore what drug access navigators can do to increase the speed of reimbursement.

Alan Birch, Drug Access Navigator, ODANO

2:00 PM pCODR Update

Revise pCODR Review Process to Improve Your SubmissionsCADTH announced a new process for companion diagnostic assessment in June 2017. Stay up to date with pCODR changes to improve your access. Develop an action plan to:

• Comprehend the new patient input process

• Review the importance of related companion diagnostic on your submitted drugs.

• Anticipate changes in the industry

Analyze changes in the Review Process to better strategize your submissions.

2:30 PM Industry Expert

Turning Policy into Action to Achieve your Patient Access Goals Demands on more value for healthcare dollars are driving policy and system-wide changes. Ensure you play a role in enabling patient access and quality of care. Source strategies to improve your partnership and communications with market access stakeholders:

• Building an integrated patient access strategy: start early to avoid disappointment

• Motivating decision-makers to keep the cost to the patients in mind (not just the drug budget)

• Integrating digital advocacy into your patient access plans

Strategize and plan accordingly to get the attention of market access decision-makers.

3:00 PM Afternoon Break

5:00 PM Conference Adjourns to Day Two

5:05 PM Evening Social Activities

Unwind and mingle with the delegates and speakers at our “exclusive” end-of-the-day reception. Bring your business cards!

PLENARY SESSIONS CONTINUE

Pre-Print Special OfferContact: (866) 298-9343 ext. 200registrations@strategyinstitute.com

8:30 AM Keynote: pCPA Update

Review pCPA Approach to Negotiation and Pricing to Better Prepare Your SubmissionsThe pCPA changed notably in the past few years and its approach to negotiation has evolved. Reassess your expectation and improve your submissions. Source Intelligence to:

• Enhance the use of your company’s research and marketing resources

• Improve consistency of decisions and achieve lower drug costs

• Facilitate communication between your company, the federal government and the provinces

Stay up to date with changes at pCPA to enhance your submission process.

9:15 AM Industry Expert

Improve Your Uptake and Adherence with Effective Patient Support ServicesSpecialty support programs in Canada help patients navigate healthcare insurance and reimbursement processes. Understand how to design and implement customized program solutions to help patients gain access to your medication without delay. Source critical insights to:

• Gain access to reimbursement assistance programs

• Assure your programming adherence and compliance

• Integrate clinical and logistic services to improve your patient’s experience

Support patients journey with better access to treatments.

9:45 AM Panel Discussion: Quebec Market Access

Stay Up to Date with Quebec’s Policy Changes and Its Impact On Your Approval ProcessesWith INESSS new guidelines and pre-NOC procedure review, Quebec’s regulatory framework continues to evolve quickly. Review regulatory changes to prepare your submissions and reduce delays in listing. Create a blueprint to:

• Review drugs subject to pre-NOC procedure review

• Highlight relevant changes in the new submission guideline

• Assess potential impacts of Quebec’s evaluation on Health Cana-da’s NOC

Adapt to new pre-NOC guidelines to streamline your approval process in Quebec.

DAY TWOTuesday November 14th, 2017

7:00 AM Registration and Breakfast

8:15 AM Opening Comments from the Chair

10:30 AM Morning Break

Common Drugs Speciality Drugs

11:00 AM Case Study: Mental Health

Prepare Your Submissions for Mental Health Medications to Drive Patient Access to TreatmentsThe federal government highlighted mental health as a priority of its healthcare agenda. Reinforce your mental health program to add value in your PLAs. Gather practical tips to:

• Address the impact of mental health prioritization on your products

• Comprehend PMPRB’s orientation on mental health medications

• Bolster your HEOR

Adjust to the prioritization of mental health in your commercialization planning.

11:30 AM CDR Update

Evaluate CDR’s Priority to Minimize Delays in Your SubmissionsCADTH CDR made changes to improve transparency and HTA timelines. Explore what these changes can do to streamline your submissions. Source intelligence on:

• New advanced notifications for expedited Health Canada Review

• Closer partnerships between CDR and pCPA

• Changes in the 4th HTA guidelines

Align with new CDR guidelines to advance your approval processes.

11:00 AM Case Study: Pricing

Anticipate Pressure on Price to Reduce Delays in the Listing of Your High Price DrugsAlthough Speciality drugs represent 5% of prescriptions, they represent 20-25% of the benefits paid. Review your pricing strategy to reduce delays in listing.

• Improve your HEOR

• Develop your pricing strategy for three-tiered drug plans

• Anticipate demand side for your new patents

Plan your negotiation strategy to streamline listing of your high priced drugs.

11:30 AM Case Study: Orphan Drugs

Collaborate with Stakeholders to Develop Your Products and Improve Patient OutcomesSmall markets can impede the development of orphan drugs, but collaboration can alleviate some restraints. Build partnerships to develop your new products and secure revenue opportunities. Build a roadmap to:

• Explore funding and joint research opportunities

• Gather inputs from patients

• Optimize your company’s ROI in a small market

Work with your stakeholders to Increase patient access to treatments.

CHOOSE YOUR TRACKJoin your peers in sessions designed for specific types of drug.

Register online at www.MarketAccessCanada.ca

12:00 PM Industry Expert: Health Economics

Customize your Evaluations to Develop Practical Approaches for CanadaIn response to global trends there is more need for global value dossier development and economic evaluations. Learn about the best strategies to Canadianize your economic models. Develop an action plan to:

• Evaluate stakeholder impacts to adjust your health economic modeling

• Identify comparative analogies

• Demonstrate of cost effectiveness in the Canadian context

Leverage global models effectively to deliver Canadian results.

12:30 PM Networking Lunch

Generic Drugs Brand Drugs

1:45 PM Case Study: Generic-Tier

Revamp your Generic Drugs Strategy To Enhance Your Access to MarketThe growth of evidence-based drug plans increase the importance of generic drugs. Optimize your access with specific strategies for generic-tiered coverage. Gain insights to:

• Advance your generic tier strategy

• Address the impact of three-tiered plans on your strategy

• Refine your value-proposition for patented drugs

Adapt your strategy to increase listings in evidence-based drug plans.

2:15 PM Case Study: Competitive Value Price Initiative

Reduce Your Drug Costs to Secure Access to the Generic Drugs MarketThe Pan-Canadian Competitive Value Price Initiative for Generic Drugs reduces the price by 15-18% of the brand price. Protect your market access by adapting to lower drug prices. Build a roadmap to:

• Identify product impacted by the initiative

• Review updates on the initiative

• Adjust your public payer strategy

Overcome the challenges of shrinking drug price to enhance market access.

1:45 PM Case Study: GPO

Optimize Your Access When Negotiating with Group Purchasing OrganizationsThe growing transparency at CADTH and shrinking hospital budgets are changing the perspective of GPOs. Adapt to GPO’s approach to ensure your access to hospital and community care. Create a roadmap to:

• Analyze the work of hospital review boards within GPOs

• Clarify purchase criteria

• Address cost concerns

Overcome the challenges of shrinking government budgets when dealing with GPOs.

2:15 PM Case Study: Global Price and Market Access

Refine Your Global Negotiation Strategy to Optimize Your AccessAdapting a global pricing strategy to the Canadian market continue to be a challenge. Work efficiently with global affiliates and Canadian payers to improve your negotiations. Source insights to:

• Involve your global pricing team

• Tailor your value proposition

• Advance your marketing strategy

Enhance your commercialization planning in a global context.

1:00 PM Lunch & Learn

Improving Patient Support and Adherence

2:45 PM Panel Discussion: Biosimilar

Update on Biologic Regulatory Approval Processes to Ensure Your Responsive Access StrategyHealth Canada released its revised guidance document on the approval pathway for biosimilars in December 2016. Review the new guidance to optimize your access to market. Take away new ideas to:

• Assess new options for biosimilar drugs

• Prepare your clinical and non-clinical information

• Strengthen your risk-management plans

Explore what the new Health Canada guidance means to your access to market.

3:30 PM Conference Adjourns

PLENARY SESSIONS CONTINUE

PLENARY SESSIONS CONTINUE

CHOOSE YOUR TRACKJoin your peers in sessions designed for specific types of drug.

Pre-Print Special OfferContact: (866) 298-9343 ext. 200registrations@strategyinstitute.com