PDCI Capabilities and Services

CAPABILITIES PRESENTATION
pdci.ca
©2014 PDCI Market Access Capabilities Presentation

WHY PDCI – ABOUT US
• Established in 1996, PDCI is Canada's
leading pharmaceutical pricing and
reimbursement consultancy
• Headquartered in Ottawa with a
bilingual staff of 22 experienced
consultants – including 2 senior consultants based in the Toronto
• PDCI is the only Canadian firm with core competencies in both
pricing and reimbursement
• PDCI has worked with most Pharma and Bio-Pharma companies in
Canada including many small single product companies
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PDCI MARKET ACCESS IS THE ONLY CANADIAN CONSULTING
FIRM WITH CORE COMPETENCIES AND EXPERTISE IN BOTH
PRICING AND REIMBURSEMENT
PDCI VALUE PROPOSITION

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We help Pharmaceutical & Biotechnology Companies…
Secure Comprehensive
Reimbursement Coverage
Communicate Value To Payers

…by
Incorporating value into the pricing and reimbursement
process through a scientific, evidence based approach
Leveraging experience and longstanding relationships
with payers and price regulators
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WHY PDCI – DIFFERENT FROM OTHER CONSULTANCIES
“Top Heavy” Consultancy
“N of 1” Consultancy
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Senior Consultants Junior Associates
Reimbursement Expertise Pricing Expertise
Experience with Large Pharma Experience with Start-ups
English French
WHY PDCI – DIFFERENT FROM OTHER CONSULTANCIES

PDCI SENIOR CONSULTING TEAM
Susan Neale
Director, Market
Access & Payer
Research
Ara Salazar
Manager. Market
Access
Nancy Paul-Roc
Manager, Pricing &
Market Access
Kaitlyn Proulx
Manager, Pricing &
Market Access
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Neil Palmer
President
Arvind Mani
Director, Market
Access and Policy
Research
Donna Lawrence
Manager, Health
Economics
Pieway Hwang
Senior Consultant

WHY PDCI
Knowledge
RelationshipsExperience
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WHY PDCI - KNOWLEDGE
Comprehensive – Through the development of C-MAP Canadian
Drug Benefit Plan, PDCI has a comprehensive understanding of the
Canadian public and private reimbursement requirements – essential
for completing a public/private formulary dossier.
Data Resources – PDCI has access to C-MAP Canadian Drug Claims
Online Database from most Canadian provinces and from NIHB – this
data is essential for preparing budget impact analysis models for
reimbursement submissions.
Current Knowledge – Through services such as our
TargetPharma Newsletter, PDCI staff ensure that they are aware of
any key changes to the Pharma environment on an ongoing basis.
This is important to track the latest developments in the industry.
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WHY PDCI - EXPERIENCE
• Pricing & Reimbursement: PDCI has completed an extensive number of
submissions to PMPRB, CDR, pCODR, INESSS, Federal/Provincial Drug
Plans and Private Insurers
• Budget Impact Analysis: PDCI has developed more than 30 budget impact
models (in accordance with Canadian guidelines) across a range of
therapeutic classes.
• Clinical Summaries: PDCI has developed more than 40 clinical summaries
across a range of therapeutic classes.
• Health Economics: PDCI has experience adapting core HE models to
Canada (CADTH or Ontario Guidelines) or assisting (e.g., sourcing
Canadian cost data) the adaptation of HE models to Canada.
• Therapeutic Classes: PDCI has experience with virtually all therapeutic
classes and types of therapies including:
 Orphan Drugs
 Biologics
 Oncology
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WHY PDCI - RELATIONSHIPS
• PDCI has exceptional working relationships with Canadian public drug plan
managers.
• Canadian Drug Benefits Plan Reference Guide – PDCI closely interacts
with all public drug plans in the development of this resource and all payers
receive a copy for their reference.
• Market Access Assessments – Numerous drug plan managers have
cooperated with PDCI by providing their perspectives on our analysis.
• PDCI has significant pCPA relationships and PLA negotiation experience with:
- Ontario
- Manitoba
- British Columbia
- Prince Edward Island
- Non-Insured Health Benefits (NIHB) Program
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PDCIAPPROACH
PMPRB Pricing Assessment
Reimbursement
Submissions
Clinical Profile
Comparators +
Dosing Regimen
Pricing
Clinical Summary
BIA Model
PE Model
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PDCI SERVICES IN CANADA
Support Services
Pre
Launch
Launch Post LaunchAssessment / Planning
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20
00 20
R&D , Clinical Trials
Health
Canada
Drug
Plans
Market Access
Patent Grant Patent Expiry
Patent Application
Gov’t Reimbursement
NOC & 1st Sale
NDS to Health Canada
Generic NOC
&1st Sale
Phase II
PMPRB Price Regulation
Submission & Data Filings
Phase I Phase III
• Environmental assessments
• Strategic planning
• Pricing studies
• Development of HE model
• Budget Impact Analysis
• Competitor analysis
• In-licensing assessments
• Payer / PMPRB meetings
• Adapting HE models to Canada
•Submission preparation
• Filings to PMPRB, CDR, INESSS, pCODR, PLA
•Private payer submission
• Follow-up with payers
• Price optimization
• Maintain / improve reimbursement status
• Defend against reference pricing, generics
• New indications
• Line extensions
• Reference / technical guides
• Claims and International price databases
• P&R Training / Workshops / Seminars
• Policy Analysis / Economic Research
• Ad hoc advice
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FLOW ANALYSIS OF PHARMACEUTICALS AND FUNDS
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Drug Manufacturer
Wholesaler / Distributer
Pharmacy / Chain Hospital
Patient / Beneficiary
Public Insurer / Drug Plan
Private Insurer / Drug Plan
Pharmacy Benefit Manager
Flow of Drugs
Flow of Funds
Rebates / Charge-backs /
Allowances / Reimbursement

WHAT CHALLENGES DO OUR CLIENTS FACE?
• Continuous changes and uncertainty with regards to public policy
• The emergence of different regional and national alliances within
governmental organizations
• Restrictions on new drug approvals
• Variations in Drug Plans from province to province
• Articulating and enhancing value propositions for the
public payers
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“[PDCI] did an excellent job. This is what we were looking for – an easily understandable BIA
that would open the door for further negotiations with the drug plans.”
COMMITMENT TO QUALITY & CLIENT SATISFACTION
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Post-project surveys indicate a satisfaction rate of >90%
“Great experience insights in the pricing and reimbursement landscape. Subject matter experts,
accommodating, pro-active and customer focus.”
“Thank you for your help with the Manitoba Business Case… I appreciated the
quick turn around… I look forward to working with you on future projects”
“Thanks so much for all your work …. the work you did was well received by the Drug Program.
The general format and explanation you provided made it easy to present.”
“Would easily consider PDCI for future
submission work.”
“On the cost, this was a very reasonable amount given the amount of
effort required to complete two full BIAs.”

PDCI PRODUCTS & SERVICES
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Canadian
Market Access
Services
Canadian
Pricing &
PMPRB Services
Policy Research
& Strategic
Analysis
International
Pricing &
Reimbursement
IP Damages
Litigation
Support
C-MAP Canadian
Drug Benefit
Plans Reference
Guide
Databases:
International
and Provincial
Claims

CANADIAN MARKET ACCESS SERVICES
• Reimbursement Strategies for Canada
• Formulary Submissions:
• CDR, Provincial, Federal, Private Insurers
• Price Increase Strategies for Formulary Drugs
• Budget Impact Analysis
• Medical Devices & Diagnostics
• Communications Plans / Advisory Boards
• Reimbursement Negotiations with CDR, Public / Private Drug Plans
• Government Affairs Support
• Design & Negotiation of Product Listing Agreements with Payers
• Training/Seminars/Workshops
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PRICING AND PMPRB SERVICES
• Pricing Strategies for New Medicines
• Price Increase Strategies for Existing Medicines
• Patented Medicine Prices Review Board (PMPRB)
• Strategies & Submissions
• Representation & Negotiation
• Ongoing Advice
• Training / Seminars / Workshops
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POLICY RESEARCH & STRATEGIC ANALYSIS
Price regulation policies
• Internal, external price referencing
Reimbursement policies
• Coverage policies
• Risk sharing agreements, Patient access schemes
• Generic drug policies
Pricing and market access in emerging markets
• Low income, middle income, BRIC
Comparative Analyses of International Pricing & Reimbursement Policies
• International price comparisons
• Reimbursement decision comparisons
• Trends and outlook
Intellectual Property
• Patent term extension, data protection, orphan drugs policies, TRIPS
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INTERNATIONAL PRICING AND REIMBURSEMENT
• International pricing analysis
• European Union, United States, Japan, Canada, and emerging markets
• Payer Research (in collaboration with an international network of P&R
experts)
• Competitor pricing analysis
• Developing innovative pricing strategies
• Launch sequencing
• Evaluating the risks of parallel (cross-border) trade
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IP DAMAGES LITIGATION SUPPORT
PDCI’s role in these cases includes offering expert advice, preparing expert reports (and
expert testimony when required) with respect to:
• Pharmaceutical pricing and price regulation (federal and provincial)
• Interchangeability policies
• Time to listing on provincial drug plans
• Estimating market share in the “but-for” period
PDCI’s principal consultant, Neil Palmer, has been qualified as an expert with expertise in
formulary listing, market access, reimbursement policies, and pricing regimes of the
Canadian pharmaceutical marketplace.
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C-MAP CANADIAN DRUG BENEFIT PLANS REFERENCE GUIDE
• Detailed information on formulary listing and HTA policies and procedures.
• Covers all 10 provincial prescription drug programs plus separate chapters on 4
federal drug programs.
• Detailed overviews of:
• Common Drug Review (CDR)
• pan-Canadian Oncology Drug Review (pCODR) and Provincial Cancer Programs
• Patented Medicine Prices Review Board (PMPRB)
• Federal/ Provincial/ Territorial Initiatives (e.g., PCPA)
• Blood Agencies, Public Health Vaccines
• Private drug plans in Canada
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DATABASES: INTERNATIONAL AND PROVINCIAL CLAIMS
International Pricing Database: The price database has been assembled from the official
published price lists in each country. Prices in major markets in Europe, North America, as
well as Australia are tracked on a regular basis with prices in other markets (e.g., Asia,
Latin America) sourced on an ad-hoc basis
Provincial Drug Claims Database: PDCI Market Access maintains a web-based claims
database. The database contains detailed drug claims and cost data from the year 2000
and onward for provincial and federal drug benefit plans. The database is updated on a
quarterly basis.
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QUESTIONS

CONTACT INFORMATION
340 Albert St. Suite 1950
Ottawa, ON, K1R 7Y6
Beth Resch
Director, Business Development
1.613.742.8225 ext. 28 (office)
1.613.291.2871 (mobile)
Beth.Resch@pdci.ca
W. Neil Palmer
President & Principal Consultant
1.613.742.8225 ext. 25 (office)
1.613.851.4387 (mobile)
Neil.Palmer@pdci.ca
Arvind Mani
Director, Market Access & Policy
1.613.742.8225 ext. 31 (office)
613-864-8225 (mobile)
Arvind.Mani@pdci.ca
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