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The Quintiles Approach to
Global Value-Based Pricing
                 November 2012




                                 Copyright © 2012 Quintiles
Uniquely Positioned to Deliver
Unparalleled Insight…
                                                                                           Pricing Know-How

                                                                         Quintiles has unique datasets and extensive
                                                                          experience in developing global P&R strategies that
                                                                          aim to determine the value-maximizing price associated
        Pricing &                                                         with the optimal product positioning
         Access
       Know-how
                                                                                        14 years of global          Unique payer
                                                                                        pricing experience           database
  Global      Evidence-
Perspective Based Strategy

                                                                 Evidence-Based Strategy

                                                      • Our evidence-based market access strategies are
                                                        differentiated by their foundation in actionable health
                                                        economics, insight from our clinical teams, and
                                                        intelligence from our commercial teams


                                                                          Health Economists
                                                                                                        300 PhD’s
                                                                               on staff
                 Global Perspective

      Our global pricing experts have an extensive network
       in developed and emerging markets from which we
       can provide direct payer and regulatory insight


                     Offices in over         Over 200 global
                      60 countries            consultants

                                                                                                                                   2
Value-Based Pricing Introduction
The definition of value differs between various stakeholder groups. An understanding of
each groups’ perception of value is required to develop an evidence-based pricing
strategy




                                                                         Value-Based Pricing




Value-based pricing is a structured way of estimating price of a new asset based on its
perceived value (supported by evidence) by various stakeholders

                                                                                               3
Key Business Questions
Our analytics offering allows us to tackle several business questions related to our clients’
global pricing strategy



                  • Which stakeholder(s) are most influential for pricing decisions?
                    Does this vary across markets?                                           Solutions
 Who Matters?
                  • What are the interdependent relationships between
                    stakeholders?
                                                                                       • Clear understanding of
                                                                                         global stakeholder
                                                                                         dynamics
                  • How do stakeholders place value on products (e.g. health           • Proven methodology
What Matters to     economics, net price, cost reduction)?                               that can quantify and
   Them?          • What are the pricing thresholds they will tolerate and how do        relay product-specific
                    you develop access, and revenue strategies around those?             value

                                                                                       • Access to integrated
                                                                                         and unique data
                                                                                         sources
                  • What information and tools are needed to develop evidence
  How Do You        based strategies to convince your stakeholders?                    • Customizable
                                                                                         dashboards and tools
Influence them?   • How can you best integrate numerous unstructured data sets           to capture and
                    in a manner to derive value out of them?                             measure value




                                                                                                                  4
Approach to Pricing
      Four core pricing analytics verticals provide the pricing insights necessary to develop a
      comprehensive Evidence-Based Global Pricing Strategy



   12-18 Months Before Launch       6-12 Months Before Launch                 0-6 Months Before Launch




        Value-Based                        Revenue                    Payer Account                  Payer Contracting
          Pricing                         Optimization                Segmentation                       Strategy

 • Triangulation of three           • Quantitative research with   • Prioritizing market           • Developing revenue
   pricing inputs:                    key stakeholders (n = 75 –     opportunity with payers by:     maximizing contracting
   1. Value-based Price Appraisal     400)                           – Size/Coverage                 strategy with:
   2. Reference Price                                                – Formulary tier design        1. Formulary Mapping
                                    • Output
      Benchmarking                                                                                  2. Contract and Utilization
                                      – Price/demand equation        – Cost-control mechanisms
   3. Willingness-to-Pay                                                                               Analysis
      Assessment                      – Pricing scenarios            – Competitive positioning
                                                                                                    3. Scenario Cost Analysis
 • Qualitative sample size (n =       – Preference/share             – Decision making process
  20 – 25                               relationship
                                      – Revenue-optimizing
                                        pricing strategy




Phase I – Initial Assessment         Phase II – Refinement                       Phase III – Tactical


                                                                                                                                  5
VBP Framework
Anchored by our health economic modeling capability, we are able to develop evidence-
based pricing recommendation that holds up to stakeholders’ scrutiny


 Business Challenge
 Inability to financially quantify a product’s value and determine its stakeholders’ substantiated pricing potential

                                                                                   Value-Based Pricing Framework

 Our Framework
 Triangulation of three evidence-based methodologies:
 1. Health Economic Price Appraisal:
   - Formulates a pricing range based on a health
    economic appraisal of product benefits measured by a
    variety of metrics including cost-savings and cost-
    effectiveness potential                                                                  Health-
                                                                                            Economic
 2. Reference Price Benchmarking:                                                            Analysis
   - Assesses the pricing structure of comparable products
    including an evaluation of real-world dosing (contracts
    including risk-sharing deals also considered)                                          Value-based
 3. Willingness-to-Pay Assessment:                                                           Pricing
                                                                                            Recomm.
   - Utilizes qualitative feedback from key decision makers
    to understand price expectations and thresholds vis-à-
    vis current competitors and comparables
                                                                              Reference                  Willingness-
                                                                                Price                       to-Pay
                                                                            Benchmarking                 Assessment
 Outcomes
 Pricing potential predicated on estimated cost-benefit vis-à-vis comparable drugs, past experience with reference
 products, and willingness to pay in the marketplace
                                                                                                                        6
VBP Approach
     Leveraging a unique framework and all encompassing process-oriented approach to
     convert therapeutic area and market-specific insight into actionable pricing for clients




1. Pricing Insight:    2. Components Analysis:           3. VBP Framework:                      4. Value-Based
                                                                                                    Pricing:
  Existing Client
   Pricing Work


                                Comp.                                 Health-
                                                                     Economic
                                  1                                   Analysis

         HTAs
                            Comp Comp.                           Value-based
                              2    3                               Pricing
                                                                  Recomm.

                         Comp. Comp. Comp.
       Secondary           4     5     6                Reference                Willingness-
       Research                                           Price                     to-Pay
                                                      Benchmarking               Assessment




                                                                                                                 7
Illustrative - Oncology



            VBP Equation Overview
            Foundational components will be segregated into quantitative and qualitative components
            which will inform the pricing equation to derive a product’s value proposition

                     Foundational                                                   Additive

VBP
      =           Cost of Comparator + [(Clinical Differentiation            x      Evidence)               x    Market Forces)]
Range

                    • Cost of selected    • OS, PFS, ORR                         • Trial Design Results         • Affordability
     Components




                      comparator
                                          • % patients alive at Year 1 / 2       • Trial Type                   • Unmet Need
                                          • Route of Administration /            • Trial Size                   • Competition
                                            Dosage Frequency
                                                                                 • Biomarker Test               • Novelty
                                          • Maintenance of QoL                     Certainty
                                                                                                                • Time to Launch
                                          • Adverse Events
                                          • Treatment Duration (Mos)
     Source




                     • HECON Models       • HECON Models                         • Qualitative Interviews       • Qualitative Interviews
                                          • Quantitative Web Survey




                     • $’s                • % premium or discount                • % premium or discount        • % premium or discount
     Unit




                                                                                                                                           8
VBP and Market Access
Payer handling of specific assets will differ by market type as each market’s approach to
product evaluation is driven by different factors
                           Free Markets
            • Multiple-payer market; discrete
              decision making                                                                  Low Restrict              High Restrict            No Coverage
            • Specialty tiers and co-insurance                                           1
    US




                                                     Probability of Coverage at Level
            • Shifting burden of cost onto patient                                      0.9

                          HTA Markets                                                   0.8
                                                                                        0.7
            • Single-payer market; HTA-based
                                                                                        0.6
              decision making
                                                                                        0.5
            • Favorable handling if achieve break-
                                                                                        0.4
              even threshold of £30,000
    UK      • National vs. local decision makers
                                                                                        0.3
                                                                                        0.2
                                                                                        0.1
                    Innovative Markets
                                                                                         0
         • Single-payer market; innovation-driven                                        $15,000   $30,000   $45,000   $60,000   $75,000   $90,000 $105,000 $120,000
           decisions                                                                                            Annual Cost of Therapy

 Germany • Justify clinical benefits to de-anchor
           from generic price
         • National vs. local decision makers



VBP model outputs allow the user to understand the probability of coverage at a specific
cost by specific payer market type

                                                                                                                                                                       9
Market Research Analytics Overview
    A conjoint-based discrete choice exercise elucidates how multiple components interplay to
    drive price acceptance and access restrictions


                                            Several different profiles for                      Conjoint / Discrete
                                                each new product                                 Choice Analysis



          Comp.
            1

     Comp Comp.
       2    3

Comp. Comp. Comp.
  4     5     6




                                                Future Market Scenarios:                  Conjoint/Discrete Choice Analysis:
  Mutually Exclusive Attributes:        Future market scenarios created using an          Profiles are assessed via conjoint
 Limited number of components       experimental design to vary component values for          analysis to generate each
included in conjoint exercise for    each new product. Respondents rate their WTP           component’s importance & its
      each product profile.         and access restrictions for each product profile as    contribution towards price and
                                                   compared to SOC.                                     access


                                                                                                                               10
Preliminary VBP Model
The VBP model will calculate component values based on primary research and populate
a preliminary VBP equation
                                                      --Illustrative--



     1. User to select
        indication,
       country, and
        comparator




                                                                                 3. VBP ranges and
                                                                                  premium/discount
                                                                               automatically populated
                                                                                 based on selection




                                                         2. User to select
                                                      component values based
                                                         on asset under
                                                          consideration

                                                                                                         11
Illustrative Analytic Outputs
The visualization afforded by outputs will enable easier understanding of stakeholder
perception of various components




   Water Fall Charts –                 Price Access
        Component’s
                                                                    Tornado Diagram
                                       Relationship                 – Sensitivity Analysis
     contribution to price           – Efficiency Curves


  To assess the                   To analyze impact of            To display sensitivity
  relationship between            price increase on               analysis & relative
  components and                  coverage / approval             component importance
  variables towards               decisions (relative to
  calculating the value-          SOC)
  based price




                                                                                             12
Case Studies




               13
Quintiles’ Consulting Capabilities
The definition of value differs between various stakeholder groups. An understanding of
each groups’ perception of value is required to develop an evidence-based pricing
strategy

                                                              GOVERNANCE & QUALITY ASSURANCE


                                                                               Commercial
                                         Regulatory                               Brand Strategy
                                          & Quality                               Market Access
           R&D                                                                 Market Intelligence
                                                 Regulatory Strategy
                                                   R&D Compliance                      Outcomes
       Product & Portfolio Strategy
                                                    Pharmacovigilance                   Research
       Clinical Transformation
       Outsourcing Strategy                            Quality Systems Optimization
       Clinical Analytics

             Development                      Launch Prep               Peak               Mature
                               Submission                    Launch

                                          Process Optimization
                                      IT Strategy and Implementation
                                          Change Management
                                          Program Management
        RISK MANAGEMENT

                                                                                      14
                                                                                                     14
Case Study:
Preliminary Value-based Pricing Strategy
        Background
         Background                                                           Approach
   Duration: 20 Weeks
   Situation: The client sought to develop an evidence based
   pricing opportunity assessment framework that will support overall
   pricing development process by understanding the drivers and                            Quintiles Consulting Team
   barriers to pricing and market access in multiple markets
   1. The Quintiles Global Consulting (QGC) team conducted HTA               Primary Market Research                   Secondary Market
        assessment, primary stakeholder and secondary research:                                                           Research
                                                                                KOLs            Payer
        i. Reviewed historical HTA’s to identify the decision driving                                               Pharmaco-       Analyst and
             components and threshold values                                                                       economic and      Industry
                                                                                              Q Internal             Academic         Reports
        ii. Conducted a market and indication specific quantitative           HTA Expert                              Papers
                                                                                               Experts
             survey to understand individual attributes’ importance and
             contribution to overall premium
   2. QGC triangulated a pricing framework via three perspectives
                                                                                                 Pricing Methodology
        to develop a value-based pricing model in MS excel
        i. An analogue assessment for reference price
             benchmarking
        ii. A primary research willingness-to-pay assessment                                                Health-
        iii. A health economic analysis                                                                    Economic
                                                                                                            Analysis



    Benefits to Client                                                                                 Value-based
                                                                                                          Pricing
                                                                                                          Recom.
   1.   Review and analysis of the HTA decision rationale and                                  Reference          Willingness-to-
        indication level thresholds, pricing drivers and their sensitivity                       Price                  Pay
                                                                                             Benchmarking          Assessment
        to price
   2.   Quantification of clinical value components and market
        conditions that impact the overall price premium
   3.   Preliminary pricing range established using a flexible                Value Based Pricing Model and Strategy
        evidence-based excel model that is pre-populated with                           Recommendations
        stakeholder’s feedback and can be adjusted as product
        profile and market conditions evolve in future
   4.   A process map to optimally incorporate and “operationalize”
        the value-based pricing approach and framework


                                                                                                                                                  15
Case Study:
Value Based Pricing & Market Access Strategy

        Background
         Background                                                                   Approach
   Duration:         12 Weeks
   Situation:         The client sought a pricing estimation and an
   understanding of the drivers and barriers to formulary access and                                 Quintiles Consulting Project Team
   use for multiple IV anti-infectives in preclinical development

   1. The Quintiles Eidetics and Quintiles Global Consulting (QGC)
                                                                                  Physicians
      group s worked collaboratively                                                               Primary Research      Secondary Research
      i. Eidetics conducted a quantitative survey to investigate the
                                                                                   Payers
          effect of product attributes on perceptions and use                                                   Value-based
      ii. QGC input questions into the Eidetics survey and utilized                                             Pricing Model
          the output to guide their research and recommendations
   2. QGC conducted research in a comprehensive and structured
      manner:
      i. Assessed the anit-infectives pricing and reimbursement
          landscape including market access barriers and value                                 Market Access Strategy and Value Story
          drivers for competitors and market comparables
      ii. Calculating a value-based price predicated on its
          estimated cost-benefit vis-à-vis comparable drugs in the
          marketplace


       Benefits to Client                                                                                               Model Structure
  1.   Understanding of the hospital formulary decision-making process for IV anti-infectives
  2.   Insights into the drivers and barriers to access, restrictions and use for their products
  3.   An assessment of the thresholds / trade-offs of product attributes (efficacy, safety, cost , etc)
       driving access and use
  4.   Insights from analogous products, primary willingness-to-pay research, and from our treatment
       cost pricing model
  5.   Pricing recommendations from an evidence-based framework that can be adapted with new inputs
       as circumstances develop



                                                                                                                                              16
Case Study:
Global Pricing Reimbursement for Phase 2NCE
      Background
          Background                                                                                 Structure
Company:            Large Pharmaceutical Company
                                                                                                             Quintiles Consulting Project Team
Situation:
Client had a targeted breast cancer therapy that had finished Phase 2. The client
asked Quintiles to conduct research and develop a value-based pricing model to help              KOL                                                             Existing &
guide the pricing reimbursement decisions for the compound assuming that four                  Oncologists                                                        Product
proposed Phase 3 clinical trials would be carried out. The project goals were to:                                                                                 Pipeline
                                                                                                                   Primary                   Secondary
                                                                                                                  Research                   Research
                                                                                                Payers &
• Conduct secondary and primary research on this portion of the breast cancer market
  with respect to key clinical and pricing reimbursement characteristics
                                                                                               Influencers                                                       Patient
• Assess the clinical relevance and validity of the four proposed Phase 3 clinical trials as                                Value-Based                         Population,
  represented by the reactions of key opinion leader in oncology to those trials                                            Pricing Model                      Unmet Needs
• Analyze and compare the efficacy and side effects of the client’s NCE to other NCEs
  that would come to the market at the same time, and to existing therapies that would go
  off patent
• Collect data and interpret data on pricing reimbursement aspects, unmet needs, the
  burden of disease , and ancillary HC costs created or eliminated by the company’s
  NCE compared to competitor compounds,
                                                                                                  Critical Assessment of initial development phase and
• Develop value-based pricing (VBP) model: compute probability of failure against              Scenario Analysis of Pricing Reimbursement Options for NCE
  primary ORR endpoint; cost/benefit or side effect/efficacy tradeoff for PFS endpoint to
  determine various pricing reimbursement scenarios for the NCE




 Benefits to Client
 1.      Understanding KOL opinion of four proposed Phase 3 trials in different cancer settings with different combinations of therapies and competitor compounds and
         clinical trials. Related assessment of the client’s compound’s efficacy and side effect data and remaining unmet needs, treatment algorithms for these different
         settings and patients, including the necessity and value of biomarkers, genetic testing and patient segmentation by responders and non-responders

 2.      Understanding of how pricing reimbursement decision makers treat new targeted therapies for cancer, including how pricing is set, how formulary inclusion,
         exclusion decisions are made and how these decisions are likely to change in the next few years

 3.      Development and application of Quintiles’ value-based pricing model to assess the pricing flexibility the client would have under different scenarios of efficacy and
         side effects for its own and competitors’ compounds in light of new compounds coming to the market and existing compounds coming off patent

 4.      Client was advised that two of the proposed clinical trials were not viable, that two of the proposed trials were reasonable, and that a few other trials should be
         considered. The client also received a complete understanding of the pricing reimbursement range and flexibility for their NCE in its market/competitive situation



                                                                                                                                                                                 17
Case Study:
Quantitative Linked Model Pricing Optimization
        Background                                                           Approach
         Background
   Client: Major Biopharmaceutical Company                            Sample: Total N = ~500
   Situation: Client had novel compound and MOA coming                        • Countries:               • Respondents:
   into a class with an entrenched market leader. While clinical                    • US                       • Payers
   trials were still ongoing, there was a need to develop pricing                   • UK                       • PCPs
   prior to the trial results. By developing scenario-based
                                                                                    • Germany                  • CARDs
   alternatives, efficient commercialization progress regardless of
   the eventual outcome would be enabled. Key Questions                             • France                   • Patients
   included:                                                                        • Italy
   • How payers react to potential price scenarios and potential      Approach:
       price premiums for PRODUCT X?
                                                                      Quantitative linked model to demonstrate how the stakeholders
   • How physicians react to PRODUCT X’s price in the context         interact and achieve demand at each potential price point.
       of patient out-of-pocket cost , cost/day, and potential tier   Model allowed client to set revenue optimizing pricing for each
       status?                                                        potential outcome of their clinical trials.
   •   How likely patients will be to fill a prescription for
                                                                        The final linked model and Preference Share
       PRODUCT X based on out-of-pocket cost / tier status?
                                                                        SimulatorTM includes input from all three major

   Benefits to Client
                                                                        customer groups in the US.

                                                                                                     Preference
   • The identification of key endpoints and drivers that will make         The resulting
                                                                                                       Shares          User Inputs:
                                                                          preference share                             • MD Conversion-to-Ongoing-Use
     PRODUCT X favorable and competitive by market                                                                       Factor
                                                                          provides a multi-
                                                                                                                       • Clinical performance settings
   • An understanding of what will most impact PRODUCT X’s                 faceted view of
                                                                        PRODUCT X potential.                           • Price
     opportunity potential by stakeholder type
                                                                                                        MD
   • A measure of how each stakeholder influences and is
     influenced by the other based on different price and product
     profile scenarios
   • Price demand curves suitable for revenue optimization and
     other economic models - with confidence intervals for the                                 MCO                Patient

     market estimates

                                                                                                           18
                                                                                                                                                         18
                                                                                                                                                         18
Contact Information
Please contact any of the individuals below if you have any questions regarding the
materials presented here


Quintiles Consulting & Market Intelligence Services
www.quintiles.com/consulting
Mridul Malhotra, Pricing Director (Market Access)
+1-862-368-9799
Mridul.Malhotra@quintiles.com

John Doyle, Managing Director (Market Access)
+1-212-686-8642
John.Doyle@quintiles.com

Brian Griner, Chief Methodologist (Market Intelligence)
+1-908-300-4391
Brian.Griner@quintiles.com

Brad Perkins, Senior Director of Business Development (Market Intelligence)
+1-585-943-8499
Bradley.Perkins@quintiles.com
                                                                                      19

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Quintiles Approach To Global Value Based Pricing (Nov 12) Fs

  • 1. The Quintiles Approach to Global Value-Based Pricing November 2012 Copyright © 2012 Quintiles
  • 2. Uniquely Positioned to Deliver Unparalleled Insight… Pricing Know-How  Quintiles has unique datasets and extensive experience in developing global P&R strategies that aim to determine the value-maximizing price associated Pricing & with the optimal product positioning Access Know-how 14 years of global Unique payer pricing experience database Global Evidence- Perspective Based Strategy Evidence-Based Strategy • Our evidence-based market access strategies are differentiated by their foundation in actionable health economics, insight from our clinical teams, and intelligence from our commercial teams Health Economists 300 PhD’s on staff Global Perspective  Our global pricing experts have an extensive network in developed and emerging markets from which we can provide direct payer and regulatory insight Offices in over Over 200 global 60 countries consultants 2
  • 3. Value-Based Pricing Introduction The definition of value differs between various stakeholder groups. An understanding of each groups’ perception of value is required to develop an evidence-based pricing strategy Value-Based Pricing Value-based pricing is a structured way of estimating price of a new asset based on its perceived value (supported by evidence) by various stakeholders 3
  • 4. Key Business Questions Our analytics offering allows us to tackle several business questions related to our clients’ global pricing strategy • Which stakeholder(s) are most influential for pricing decisions? Does this vary across markets? Solutions Who Matters? • What are the interdependent relationships between stakeholders? • Clear understanding of global stakeholder dynamics • How do stakeholders place value on products (e.g. health • Proven methodology What Matters to economics, net price, cost reduction)? that can quantify and Them? • What are the pricing thresholds they will tolerate and how do relay product-specific you develop access, and revenue strategies around those? value • Access to integrated and unique data sources • What information and tools are needed to develop evidence How Do You based strategies to convince your stakeholders? • Customizable dashboards and tools Influence them? • How can you best integrate numerous unstructured data sets to capture and in a manner to derive value out of them? measure value 4
  • 5. Approach to Pricing Four core pricing analytics verticals provide the pricing insights necessary to develop a comprehensive Evidence-Based Global Pricing Strategy 12-18 Months Before Launch 6-12 Months Before Launch 0-6 Months Before Launch Value-Based Revenue Payer Account Payer Contracting Pricing Optimization Segmentation Strategy • Triangulation of three • Quantitative research with • Prioritizing market • Developing revenue pricing inputs: key stakeholders (n = 75 – opportunity with payers by: maximizing contracting 1. Value-based Price Appraisal 400) – Size/Coverage strategy with: 2. Reference Price – Formulary tier design 1. Formulary Mapping • Output Benchmarking 2. Contract and Utilization – Price/demand equation – Cost-control mechanisms 3. Willingness-to-Pay Analysis Assessment – Pricing scenarios – Competitive positioning 3. Scenario Cost Analysis • Qualitative sample size (n = – Preference/share – Decision making process 20 – 25 relationship – Revenue-optimizing pricing strategy Phase I – Initial Assessment Phase II – Refinement Phase III – Tactical 5
  • 6. VBP Framework Anchored by our health economic modeling capability, we are able to develop evidence- based pricing recommendation that holds up to stakeholders’ scrutiny Business Challenge Inability to financially quantify a product’s value and determine its stakeholders’ substantiated pricing potential Value-Based Pricing Framework Our Framework Triangulation of three evidence-based methodologies: 1. Health Economic Price Appraisal: - Formulates a pricing range based on a health economic appraisal of product benefits measured by a variety of metrics including cost-savings and cost- effectiveness potential Health- Economic 2. Reference Price Benchmarking: Analysis - Assesses the pricing structure of comparable products including an evaluation of real-world dosing (contracts including risk-sharing deals also considered) Value-based 3. Willingness-to-Pay Assessment: Pricing Recomm. - Utilizes qualitative feedback from key decision makers to understand price expectations and thresholds vis-à- vis current competitors and comparables Reference Willingness- Price to-Pay Benchmarking Assessment Outcomes Pricing potential predicated on estimated cost-benefit vis-à-vis comparable drugs, past experience with reference products, and willingness to pay in the marketplace 6
  • 7. VBP Approach Leveraging a unique framework and all encompassing process-oriented approach to convert therapeutic area and market-specific insight into actionable pricing for clients 1. Pricing Insight: 2. Components Analysis: 3. VBP Framework: 4. Value-Based Pricing: Existing Client Pricing Work Comp. Health- Economic 1 Analysis HTAs Comp Comp. Value-based 2 3 Pricing Recomm. Comp. Comp. Comp. Secondary 4 5 6 Reference Willingness- Research Price to-Pay Benchmarking Assessment 7
  • 8. Illustrative - Oncology VBP Equation Overview Foundational components will be segregated into quantitative and qualitative components which will inform the pricing equation to derive a product’s value proposition Foundational Additive VBP = Cost of Comparator + [(Clinical Differentiation x Evidence) x Market Forces)] Range • Cost of selected • OS, PFS, ORR • Trial Design Results • Affordability Components comparator • % patients alive at Year 1 / 2 • Trial Type • Unmet Need • Route of Administration / • Trial Size • Competition Dosage Frequency • Biomarker Test • Novelty • Maintenance of QoL Certainty • Time to Launch • Adverse Events • Treatment Duration (Mos) Source • HECON Models • HECON Models • Qualitative Interviews • Qualitative Interviews • Quantitative Web Survey • $’s • % premium or discount • % premium or discount • % premium or discount Unit 8
  • 9. VBP and Market Access Payer handling of specific assets will differ by market type as each market’s approach to product evaluation is driven by different factors Free Markets • Multiple-payer market; discrete decision making Low Restrict High Restrict No Coverage • Specialty tiers and co-insurance 1 US Probability of Coverage at Level • Shifting burden of cost onto patient 0.9 HTA Markets 0.8 0.7 • Single-payer market; HTA-based 0.6 decision making 0.5 • Favorable handling if achieve break- 0.4 even threshold of £30,000 UK • National vs. local decision makers 0.3 0.2 0.1 Innovative Markets 0 • Single-payer market; innovation-driven $15,000 $30,000 $45,000 $60,000 $75,000 $90,000 $105,000 $120,000 decisions Annual Cost of Therapy Germany • Justify clinical benefits to de-anchor from generic price • National vs. local decision makers VBP model outputs allow the user to understand the probability of coverage at a specific cost by specific payer market type 9
  • 10. Market Research Analytics Overview A conjoint-based discrete choice exercise elucidates how multiple components interplay to drive price acceptance and access restrictions Several different profiles for Conjoint / Discrete each new product Choice Analysis Comp. 1 Comp Comp. 2 3 Comp. Comp. Comp. 4 5 6 Future Market Scenarios: Conjoint/Discrete Choice Analysis: Mutually Exclusive Attributes: Future market scenarios created using an Profiles are assessed via conjoint Limited number of components experimental design to vary component values for analysis to generate each included in conjoint exercise for each new product. Respondents rate their WTP component’s importance & its each product profile. and access restrictions for each product profile as contribution towards price and compared to SOC. access 10
  • 11. Preliminary VBP Model The VBP model will calculate component values based on primary research and populate a preliminary VBP equation --Illustrative-- 1. User to select indication, country, and comparator 3. VBP ranges and premium/discount automatically populated based on selection 2. User to select component values based on asset under consideration 11
  • 12. Illustrative Analytic Outputs The visualization afforded by outputs will enable easier understanding of stakeholder perception of various components Water Fall Charts – Price Access Component’s Tornado Diagram Relationship – Sensitivity Analysis contribution to price – Efficiency Curves To assess the To analyze impact of To display sensitivity relationship between price increase on analysis & relative components and coverage / approval component importance variables towards decisions (relative to calculating the value- SOC) based price 12
  • 14. Quintiles’ Consulting Capabilities The definition of value differs between various stakeholder groups. An understanding of each groups’ perception of value is required to develop an evidence-based pricing strategy GOVERNANCE & QUALITY ASSURANCE Commercial Regulatory Brand Strategy & Quality Market Access R&D Market Intelligence Regulatory Strategy R&D Compliance Outcomes Product & Portfolio Strategy Pharmacovigilance Research Clinical Transformation Outsourcing Strategy Quality Systems Optimization Clinical Analytics Development Launch Prep Peak Mature Submission Launch Process Optimization IT Strategy and Implementation Change Management Program Management RISK MANAGEMENT 14 14
  • 15. Case Study: Preliminary Value-based Pricing Strategy Background Background Approach Duration: 20 Weeks Situation: The client sought to develop an evidence based pricing opportunity assessment framework that will support overall pricing development process by understanding the drivers and Quintiles Consulting Team barriers to pricing and market access in multiple markets 1. The Quintiles Global Consulting (QGC) team conducted HTA Primary Market Research Secondary Market assessment, primary stakeholder and secondary research: Research KOLs Payer i. Reviewed historical HTA’s to identify the decision driving Pharmaco- Analyst and components and threshold values economic and Industry Q Internal Academic Reports ii. Conducted a market and indication specific quantitative HTA Expert Papers Experts survey to understand individual attributes’ importance and contribution to overall premium 2. QGC triangulated a pricing framework via three perspectives Pricing Methodology to develop a value-based pricing model in MS excel i. An analogue assessment for reference price benchmarking ii. A primary research willingness-to-pay assessment Health- iii. A health economic analysis Economic Analysis  Benefits to Client Value-based Pricing Recom. 1. Review and analysis of the HTA decision rationale and Reference Willingness-to- indication level thresholds, pricing drivers and their sensitivity Price Pay Benchmarking Assessment to price 2. Quantification of clinical value components and market conditions that impact the overall price premium 3. Preliminary pricing range established using a flexible Value Based Pricing Model and Strategy evidence-based excel model that is pre-populated with Recommendations stakeholder’s feedback and can be adjusted as product profile and market conditions evolve in future 4. A process map to optimally incorporate and “operationalize” the value-based pricing approach and framework 15
  • 16. Case Study: Value Based Pricing & Market Access Strategy Background Background Approach Duration: 12 Weeks Situation: The client sought a pricing estimation and an understanding of the drivers and barriers to formulary access and Quintiles Consulting Project Team use for multiple IV anti-infectives in preclinical development 1. The Quintiles Eidetics and Quintiles Global Consulting (QGC) Physicians group s worked collaboratively Primary Research Secondary Research i. Eidetics conducted a quantitative survey to investigate the Payers effect of product attributes on perceptions and use Value-based ii. QGC input questions into the Eidetics survey and utilized Pricing Model the output to guide their research and recommendations 2. QGC conducted research in a comprehensive and structured manner: i. Assessed the anit-infectives pricing and reimbursement landscape including market access barriers and value Market Access Strategy and Value Story drivers for competitors and market comparables ii. Calculating a value-based price predicated on its estimated cost-benefit vis-à-vis comparable drugs in the marketplace  Benefits to Client Model Structure 1. Understanding of the hospital formulary decision-making process for IV anti-infectives 2. Insights into the drivers and barriers to access, restrictions and use for their products 3. An assessment of the thresholds / trade-offs of product attributes (efficacy, safety, cost , etc) driving access and use 4. Insights from analogous products, primary willingness-to-pay research, and from our treatment cost pricing model 5. Pricing recommendations from an evidence-based framework that can be adapted with new inputs as circumstances develop 16
  • 17. Case Study: Global Pricing Reimbursement for Phase 2NCE Background Background Structure Company: Large Pharmaceutical Company Quintiles Consulting Project Team Situation: Client had a targeted breast cancer therapy that had finished Phase 2. The client asked Quintiles to conduct research and develop a value-based pricing model to help KOL Existing & guide the pricing reimbursement decisions for the compound assuming that four Oncologists Product proposed Phase 3 clinical trials would be carried out. The project goals were to: Pipeline Primary Secondary Research Research Payers & • Conduct secondary and primary research on this portion of the breast cancer market with respect to key clinical and pricing reimbursement characteristics Influencers Patient • Assess the clinical relevance and validity of the four proposed Phase 3 clinical trials as Value-Based Population, represented by the reactions of key opinion leader in oncology to those trials Pricing Model Unmet Needs • Analyze and compare the efficacy and side effects of the client’s NCE to other NCEs that would come to the market at the same time, and to existing therapies that would go off patent • Collect data and interpret data on pricing reimbursement aspects, unmet needs, the burden of disease , and ancillary HC costs created or eliminated by the company’s NCE compared to competitor compounds, Critical Assessment of initial development phase and • Develop value-based pricing (VBP) model: compute probability of failure against Scenario Analysis of Pricing Reimbursement Options for NCE primary ORR endpoint; cost/benefit or side effect/efficacy tradeoff for PFS endpoint to determine various pricing reimbursement scenarios for the NCE  Benefits to Client 1. Understanding KOL opinion of four proposed Phase 3 trials in different cancer settings with different combinations of therapies and competitor compounds and clinical trials. Related assessment of the client’s compound’s efficacy and side effect data and remaining unmet needs, treatment algorithms for these different settings and patients, including the necessity and value of biomarkers, genetic testing and patient segmentation by responders and non-responders 2. Understanding of how pricing reimbursement decision makers treat new targeted therapies for cancer, including how pricing is set, how formulary inclusion, exclusion decisions are made and how these decisions are likely to change in the next few years 3. Development and application of Quintiles’ value-based pricing model to assess the pricing flexibility the client would have under different scenarios of efficacy and side effects for its own and competitors’ compounds in light of new compounds coming to the market and existing compounds coming off patent 4. Client was advised that two of the proposed clinical trials were not viable, that two of the proposed trials were reasonable, and that a few other trials should be considered. The client also received a complete understanding of the pricing reimbursement range and flexibility for their NCE in its market/competitive situation 17
  • 18. Case Study: Quantitative Linked Model Pricing Optimization Background Approach Background Client: Major Biopharmaceutical Company Sample: Total N = ~500 Situation: Client had novel compound and MOA coming • Countries: • Respondents: into a class with an entrenched market leader. While clinical • US • Payers trials were still ongoing, there was a need to develop pricing • UK • PCPs prior to the trial results. By developing scenario-based • Germany • CARDs alternatives, efficient commercialization progress regardless of the eventual outcome would be enabled. Key Questions • France • Patients included: • Italy • How payers react to potential price scenarios and potential Approach: price premiums for PRODUCT X? Quantitative linked model to demonstrate how the stakeholders • How physicians react to PRODUCT X’s price in the context interact and achieve demand at each potential price point. of patient out-of-pocket cost , cost/day, and potential tier Model allowed client to set revenue optimizing pricing for each status? potential outcome of their clinical trials. • How likely patients will be to fill a prescription for The final linked model and Preference Share PRODUCT X based on out-of-pocket cost / tier status? SimulatorTM includes input from all three major  Benefits to Client customer groups in the US. Preference • The identification of key endpoints and drivers that will make The resulting Shares User Inputs: preference share • MD Conversion-to-Ongoing-Use PRODUCT X favorable and competitive by market Factor provides a multi- • Clinical performance settings • An understanding of what will most impact PRODUCT X’s faceted view of PRODUCT X potential. • Price opportunity potential by stakeholder type MD • A measure of how each stakeholder influences and is influenced by the other based on different price and product profile scenarios • Price demand curves suitable for revenue optimization and other economic models - with confidence intervals for the MCO Patient market estimates 18 18 18
  • 19. Contact Information Please contact any of the individuals below if you have any questions regarding the materials presented here Quintiles Consulting & Market Intelligence Services www.quintiles.com/consulting Mridul Malhotra, Pricing Director (Market Access) +1-862-368-9799 Mridul.Malhotra@quintiles.com John Doyle, Managing Director (Market Access) +1-212-686-8642 John.Doyle@quintiles.com Brian Griner, Chief Methodologist (Market Intelligence) +1-908-300-4391 Brian.Griner@quintiles.com Brad Perkins, Senior Director of Business Development (Market Intelligence) +1-585-943-8499 Bradley.Perkins@quintiles.com 19