pdci capabilities and services

CAPABILITIES PRESENTATION

pdci.ca

©2014 PDCI Market Access Capabilities Presentation

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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

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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


4©2014 PDCI Market Access Capabilities Presentation

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


WHY PDCI – DIFFERENT FROM OTHER CONSULTANCIES

“Top Heavy” Consultancy

“N of 1” Consultancy

OTHER CONSULTANCIES


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Senior Consultants Junior AssociatesReimbursement Expertise Pricing Expertise

Experience with Large Pharma Experience with Start-upsEnglish French

WHY PDCI – DIFFERENT FROM OTHER CONSULTANCIES


PDCI SENIOR CONSULTING TEAM

Susan NealeDirector, Market Access & Payer

Research

Ara SalazarManager. Market

Access

Nancy Paul-RocManager, Pricing &

Market Access

Kaitlyn ProulxManager, Pricing &

Market Access

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Neil PalmerPresident

Arvind ManiDirector, Market Access and Policy

Research

Donna LawrenceManager, Health

Economics

Pieway HwangSenior Consultant


WHY PDCI

Knowledge

RelationshipsExperience


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.


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


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


PDCI APPROACH

PMPRB Pricing Assessment Reimbursement Submissions

Clinical Profile

Comparators + Dosing Regimen

Pricing

Clinical Summary

BIA Model

PE Model


PDCI SERVICES IN CANADA

Support Services

PreLaunch

Launch Post LaunchAssessment / Planning

01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 2000 20

R&D , Clinical TrialsHealth

CanadaDrug

PlansMarket 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 RegulationSubmission & 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

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


“[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


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


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


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


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


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


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.


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


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.



QUESTIONS

CONTACT INFORMATION

340 Albert St. Suite 1950Ottawa, ON, K1R 7Y6

Beth ReschDirector, Business Development1.613.742.8225 ext. 28 (office)

1.613.291.2871 (mobile)[email protected]

W. Neil PalmerPresident & Principal Consultant1.613.742.8225 ext. 25 (office)

1.613.851.4387 (mobile)[email protected]

Arvind ManiDirector, Market Access & Policy1.613.742.8225 ext. 31 (office)

613-864-8225 (mobile)[email protected]


pdci.ca

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http://www.pdci.ca/

https://twitter.com/PDCImktaccess

https://www.facebook.com/pages/PDCI-Market-Access/607054179356101

http://www.linkedin.com/company/732156?trk=tyah&trkInfo=tas:pdci%20m,idx:1-1-1