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PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
PDCI Capabilities and Services
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PDCI Capabilities and Services

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  • Neil
  • Arvind
  • Transcript

    • 1. CAPABILITIES PRESENTATION pdci.ca ©2014 PDCI Market Access Capabilities Presentation
    • 2. 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 ©2014 PDCI Market Access Capabilities Presentation 2
    • 3. 3 PDCI MARKET ACCESS IS THE ONLY CANADIAN CONSULTING FIRM WITH CORE COMPETENCIES AND EXPERTISE IN BOTH PRICING AND REIMBURSEMENT ©2014 PDCI Market Access Capabilities Presentation PDCI VALUE PROPOSITION
    • 4. PDCI VALUE PROPOSITION 4 ©2014 PDCI Market Access Capabilities Presentation We help Pharmaceutical & Biotechnology Companies… Secure Comprehensive Reimbursement Coverage Communicate Value To Payers
    • 5. PDCI VALUE PROPOSITION …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 ©2014 PDCI Market Access Capabilities Presentation 5
    • 6. WHY PDCI – DIFFERENT FROM OTHER CONSULTANCIES “Top Heavy” Consultancy “N of 1” Consultancy ©2014 PDCI Market Access Capabilities Presentation 6
    • 7. 7 Senior Consultants Junior Associates Reimbursement Expertise Pricing Expertise Experience with Large Pharma Experience with Start-ups English French WHY PDCI – DIFFERENT FROM OTHER CONSULTANCIES ©2014 PDCI Market Access Capabilities Presentation
    • 8. 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 8 Neil Palmer President Arvind Mani Director, Market Access and Policy Research Donna Lawrence Manager, Health Economics Pieway Hwang Senior Consultant ©2014 PDCI Market Access Capabilities Presentation
    • 9. WHY PDCI Knowledge RelationshipsExperience 9 ©2014 PDCI Market Access Capabilities Presentation
    • 10. 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. 10 ©2014 PDCI Market Access Capabilities Presentation
    • 11. 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 11 ©2014 PDCI Market Access Capabilities Presentation
    • 12. 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 12 ©2014 PDCI Market Access Capabilities Presentation
    • 13. PDCIAPPROACH PMPRB Pricing Assessment Reimbursement Submissions Clinical Profile Comparators + Dosing Regimen Pricing Clinical Summary BIA Model PE Model 13 ©2014 PDCI Market Access Capabilities Presentation
    • 14. 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 14 ©2014 PDCI Market Access Capabilities Presentation
    • 15. FLOW ANALYSIS OF PHARMACEUTICALS AND FUNDS 15 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 ©2014 PDCI Market Access Capabilities Presentation
    • 16. 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 16 ©2014 PDCI Market Access Capabilities Presentation
    • 17. “[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 17 ©2014 PDCI Market Access Capabilities Presentation 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.”
    • 18. PDCI PRODUCTS & SERVICES 18 ©2014 PDCI Market Access Capabilities Presentation 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
    • 19. 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 19 ©2014 PDCI Market Access Capabilities Presentation
    • 20. 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 20 ©2014 PDCI Market Access Capabilities Presentation
    • 21. 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 21 ©2014 PDCI Market Access Capabilities Presentation
    • 22. 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 22 ©2014 PDCI Market Access Capabilities Presentation
    • 23. 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. 23 ©2014 PDCI Market Access Capabilities Presentation
    • 24. 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 24 ©2014 PDCI Market Access Capabilities Presentation
    • 25. 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. 25 ©2014 PDCI Market Access Capabilities Presentation
    • 26. 26 ©2014 PDCI Market Access Capabilities Presentation QUESTIONS
    • 27. 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 27 ©2014 PDCI Market Access Capabilities Presentation pdci.ca

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