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Best Practices in Utilizing Health
        Outcomes Data




       Best Practices, LLC Benchmarking Report
Table of Contents                                                                    Page
INTRODUCTION                                                                         5
SUMMARY OF KEY INSIGHTS                                                              7
KEY FINDINGS                                                                         8
UNIVERSE OF LEARNING                                                                 10
HEALTH OUTCOMES REPORTING STRUCTURE                                                  13
• Structure of Health Outcomes Function                                              14
• Health Outcomes Leadership Growing in Seniority                                    15
• More HO Groups Report to S&M than in 2009                                          16
UTILIZING HEALTH OUTCOME DATA                                                        17
• Most Common Decisions Made By Health Outcomes                                      18
• About 60 Percent Use Health Outcomes Data for Unsolicited and Proactive Requests   19
• How Companies Provide HO Data When They Offer Unsolicited and Proactive            20
• Health Outcomes Data Used Most Often with Managed Care Account
Managers and Medical Science Liaisons                                                21
• Almost All Companies Use Prospective Health Outcomes Data for
Promotional Purposes                                                                 22
• Variance Exists in Corporate Usage of Prospective Health Outcomes Data             23
• Retrospective Use of HO Data Remains Cautious                                      24
• Companies More Likely to Use Retrospective Health Outcomes Data
Off-Label than in 2009                                                               25
• Managed Care Account Managers Are Provided Data Most Often for
On-Label Purposes                                                                    26
• Health Outcomes Data Used More Often With Sales Reps Than in 2009,
Typically On-Label When Utilized                                                     27
Table of Contents                                                                       Page
 •Medical Science Liaisons Receive a Mix of Health Outcomes Data, More
 so Than Others                                                                         28
 • Brand Teams Receive Data Frequently for On-Label Purposes, and
 Off-Label Has Risen As Well                                                            29
 • Sales Training Receives Health Outcomes Data On-Label, But Less
 Frequently Than Other Groups                                                           30
 • About 50% Avoid Health Outcomes Data for Off-Label Purposes                          31
 • Health Outcomes Data Is Used in a Limited Manner with Other Groups                   32
  HEALTH OUTCOME DATA REVIEW PROCESS                                                    33
 • Medical, Legal and Commercial Reviews Are the Groups that Often
 Examine Health Outcomes Data                                                           34
 • Medical, Legal and Regulatory Consistently Sit on Health Outcomes Review Committee   35
 • Health Outcomes Data Reviewed Most Often at Brand Level                              36
  HEALTH OUTCOME DATA OVERVIEW                                                          37
 • Tiered Classifications Not Being Implemented By Health Outcomes Groups               38
 • Most Companies See a High Level of Risk With Health Outcomes Data
 For Off-Label Promotion                                                                39
 • Utilization of Health Outcome Data                                                   40-41
 • Strategic Planning A Critical Output From Internal Health Outcomes Data
 Usage                                                                                  42
 • Treatment Guidelines Top Use of Health Outcomes Data with Physicians                 43
 • Reimbursement and Drug Formulary Inclusion Most Used Activities with
 Health Outcomes Data Usage                                                             44
Table of Contents                                                                    Page
•Patients Not Seen As a Vital When It Comes to Health Outcomes Data                  45
• Process Flow for using Health Outcomes Data for Promotional/ Commercial Purposes   46
 HEALTH OUTCOME DATA BEST PRACTICES INSIGHTS                                         47
• Major Initiatives                                                                  48
• Best Practices for Utilizing Health Outcome                                        49
• Primary Elements in Health Outcomes Piece                                          50
 ABOUT BEST PRACTICES, LLC                                                           51
Project Methodology and Study Objectives
Optimizing the use of Health Outcomes data is vital to the success of biotechnology and
pharmaceutical companies. This report provides insight and best practices that are being
used by companies and reviews the use of Health Outcomes data in promotional/commercial
settings.

          This report seeks to understand how pharmaceutical and
          biotech organizations optimize and utilize health
          outcomes data in promotional settings and the possible
          Regulatory issues that arise as a result of their use.
          Key study objectives
                 Structure and Reporting Lines of Authority
                Health Outcomes Decisions
                Use of Health Outcomes Data Proactively and Retrospectively
                Who and How is HO Data Utilized with Different Groups
                HO Review Process and Structure


Copyright © Best Practices®, LLC             2
List of Participating Companies
The benchmark class includes 18 participants from 16 companies across the
pharmaceutical, biotech and medical device industries.

           2011                                                             2009

    Abbott                                                           Abbott
    Alfred Mann                                                      Allergan
    Foundation                                                       Amgen
    ASSESSmint                                                       Baxter
    Baxter                                                           Becton Dickinson
    Bayer                                                            Beckman Coulter
    Becton Dickinson                                                 Biogen Idec
    C. Kalb & Associates,                                            Boehringer Ingelheim
    LLC                                                              Eisai, Inc.
    Eisai Inc                                                        Laboratorios Esteve
    Laboratorios Esteve                                              Ethicon, Inc.
    Mahde Taban                                                      Gilead
    Medtronic                                                        GlaxoSmithKline
    Novo Nordisk A/S                                                 Medimmune
    Pfizer                                                           Merck & Co.
    Regeneron                                                        OrthoBiotech
    Pharmaceuticals                                                  Pfizer
    Shire                                                            Shire



Copyright © Best Practices®, LLC          3
Range of Career Levels Lend Insight
Research participants’ roles ranged from senior leaders to managers of medical affairs
to medical science liaisons.


                             2011                                   2009
       Associate Director, Health Outcomes             Chief Marketing Officer
       Chief Analyst                                   Clinical Marketing Manager - EMA
       Commercial Director                             CVM Category Head
       Director, Managed Markets Marketing             DIRECTOR (3)
       Director, Global HEOR                           Director of Marketing
       Director, Strategic Planning                    Director, Medical Sciences
       Division Vice President, Global Labeling,       Director, Regulatory Affairs
       Advertising & Promotion                         Director, Strategic Planning
       Health Economist                                Divisional VP - Global Clinical
       Managing Director Deputy in Marketing           Epidemiology and HEOR
       Medical Director                                Executive Director, GHO
       President                                       Head of Strategic Accounts
       Principal Reimbursement Analyst                 Medical Affairs Director (4)
       Sr. Director                                    National/Sales Manager (3)
       Sr. Director, HEOR                              Acting Director, Health Outcomes
       Vice President                                  Sr. Director, Global HEOR
       Vice President, Medical Services                Sr. Director/Commercial Team Leader
                                                       Sr. Manager Sales Training
                                                       Sr. Director Medical Affairs
                                                       Vice President , Medical & Scientific Affairs
Copyright © Best Practices®, LLC                   4
Structure of Health Outcomes Function
  As brand teams require accurate data to commercially position the information, 61 percent
  of participants indicated that Health Outcomes (HO) is a part of centralized organization.
  Responses Relative to 2009, other numbers appeared similar for decentralization or
  seating in a brand team.

            Which of the following best describes the structure of your Health Outcomes function?


                                                                                         Part of a local
           Part of a local      Other , 6%          Consultants                           brand team,
            brand team,                                                                       6%
                6%
Part of a global                                                      Part of a global
 brand team,                                                           brand team,
      6%                                                                    18%

                      Part of a                Part of a
                                                                                                                  Part of a
                    decentralized             centralized
                                                                                                                 centralized
                    organization,            organization,
                                                                          Part of a                             organization,
                        22%                      61%
                                                                        decentralized                               64%
                                                                        organization,
                                                                            22%




                                    N2011=18                                                               N2009=33
 Copyright © Best Practices®, LLC                                 5
Most Common Decisions Made By Health Outcomes
  Health Outcomes Research continues to remain the most common decision made by
  Health Outcomes groups. The importance of decisions made on marketing plans dropped
  dramatically in 2011, by about 24 percent. In contrast, the importance of decisions related
  to market access strategies have increased to 53 percent from 24 percent in 2009.

                                    What types of decisions are made by your Health Outcomes group (s)?


    Health Outcomes Research                                           Health Outcomes Research

Scientific Publication Strategies                                                  Marketing plans

      Market Access Strategies                                     Scientific publication strategies

                Reimbursement                                                      Reimbursement

           Clinical Development                                               Clinical development

      Drug Formulary Inclusion                                                              Pricing

                         Pricing                                         Market access strategies

                Marketing Plans                                                    New indications

                New indications                                          Drug formulary inclusion

          Treatment Guidelines                                               Treatment guidelines


                         N2011=17        Data provided in actual report.                        N2009=33

 Copyright © Best Practices®, LLC                              6
Health Outcomes Data Used Most Often with Managed Care
Account Managers and Medical Science Liaisons
Data that is used on-label tends to be utilized more across the board, but most companies
look to provide Health Outcomes data to their managed care groups and medical science
liaisons – as the two sets of employees can have the most influence with physicians and
managed care organizations.
                         With whom do you use Health Outcomes Data for promotional purposes?
                                   Prospective Data On-   Prospective Data   Retrospective   Retrospective
                  Item                    label              Off-Label       Data On-label   Data Off-Label
                                     2011        2009      2011     2009     2011     2009    2011    2009
           Managed Care
             Account
            Managers

             Sales Reps

          Medical Science
             Liaisons
                                      Data provided in actual report.
            Brand Teams

           Sales Training

                 Other
             Do Not Use

 N2011=14 N2009=29
Copyright © Best Practices®, LLC                           7
Health Outcomes Data Reviewed Most Often at
Brand Level
Benchmark participants clearly favor reviews done at the brand level in 2011. In 2009 there was
no clearly favored review process that was used, as 11 out of 21 companies reviewed Health
Outcomes data at the brand level and 10 out of 21 reviewed at the therapeutic level.


                             What is the scope and structure of the legal review committee?
                                          (Participants checked all that applied.)


 Reviews at a                                                       Reviews at a
                                                    75%                                               52%
 Brand Level                                                        Brand Level


 Reviews at a                                                       Reviews at a
 Therapeutic                             33%                        Therapeutic                      48%
    Level                                                              Level

 Located in                                                          Centralized
Corporate but                      17%                               Corporate                 29%
Decentralized                                                          Group

   Centralized                                                      Located in
   Corporate               8%                                      Corporate but         14%
     Group                                                         Decentralized

                          N2011=12                                                 N2009=21

Copyright © Best Practices®, LLC                          8
Utilization of Health Outcome Data
Reimbursement and drug formulary decision continue to remain the main usage of Health
Outcome data with managed care. Relative to 2009, the importance of using on-label data
internally for reimbursement has increased by 24% . In 2011, on-label data is mainly utilized
for explaining treatment guideline to physicians and patients.

      How does your company utilize Health Outcomes data with patients, managed care, physicians
                                            and internally?

                                    Internally     Managed Care        Physicians       Patients
             Item
                                   2011    2009    2011       2009   2011      2009   2011    2009

           Pricing


     Reimbursement
                                                  Data provided in actual report.
         Treatment
         guidelines

     Drug formulary
        inclusion

     New indications

  N2011=13 N2009=19
Copyright © Best Practices®, LLC                          9
Treatment Guidelines Top Use of Health Outcomes
Data with Physicians
More than three-fourths of companies use Health Outcomes data for reimbursement guidelines
for interactions with physicians while 69% of them use it to present data around drug formulary
inclusion. While in 2009, more than three-fourths of companies use Health Outcomes data for
treatment guidelines for interactions with physicians.

                         Q. How does your company utilize Health Outcomes data with physicians?

                                                      2011    2009

                              Treatment guidelines                                         77%
                                                                                     69%
               Scientific publication strategies                               50%
                                                                        38%
                                   Marketing plans          14%
                                                                        38%
                                   New indications                             50%
                                                                        38%
                        Drug formulary inclusion                  23%
                                                                        38%
                              Clinical development                       41%
                                                                     31%
                                                             18%
                                   Reimbursement                      31%
                        Market access strategies                    27%
                                                                  23%
                                           Pricing     9%
                                                            15%
  N2011=13 N2009=19
Copyright © Best Practices®, LLC                       10
About Best Practices, LLC



      Best Practices, LLC is a research and consulting firm that conducts work
      based on the simple yet profound principle that organizations can chart a
      course to superior economic performance by studying the best business
         practices, operating tactics and winning strategies of world-class
                                     companies.




                                   Best Practices, LLC
                      6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
                                          919-403-0251
                                    best@best-in-class.com
                                    www.best-in-class.com

Copyright © Best Practices®, LLC                11

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Health Outcomes Report Summary

  • 1. Best Practices in Utilizing Health Outcomes Data Best Practices, LLC Benchmarking Report
  • 2. Table of Contents Page INTRODUCTION 5 SUMMARY OF KEY INSIGHTS 7 KEY FINDINGS 8 UNIVERSE OF LEARNING 10 HEALTH OUTCOMES REPORTING STRUCTURE 13 • Structure of Health Outcomes Function 14 • Health Outcomes Leadership Growing in Seniority 15 • More HO Groups Report to S&M than in 2009 16 UTILIZING HEALTH OUTCOME DATA 17 • Most Common Decisions Made By Health Outcomes 18 • About 60 Percent Use Health Outcomes Data for Unsolicited and Proactive Requests 19 • How Companies Provide HO Data When They Offer Unsolicited and Proactive 20 • Health Outcomes Data Used Most Often with Managed Care Account Managers and Medical Science Liaisons 21 • Almost All Companies Use Prospective Health Outcomes Data for Promotional Purposes 22 • Variance Exists in Corporate Usage of Prospective Health Outcomes Data 23 • Retrospective Use of HO Data Remains Cautious 24 • Companies More Likely to Use Retrospective Health Outcomes Data Off-Label than in 2009 25 • Managed Care Account Managers Are Provided Data Most Often for On-Label Purposes 26 • Health Outcomes Data Used More Often With Sales Reps Than in 2009, Typically On-Label When Utilized 27
  • 3. Table of Contents Page •Medical Science Liaisons Receive a Mix of Health Outcomes Data, More so Than Others 28 • Brand Teams Receive Data Frequently for On-Label Purposes, and Off-Label Has Risen As Well 29 • Sales Training Receives Health Outcomes Data On-Label, But Less Frequently Than Other Groups 30 • About 50% Avoid Health Outcomes Data for Off-Label Purposes 31 • Health Outcomes Data Is Used in a Limited Manner with Other Groups 32 HEALTH OUTCOME DATA REVIEW PROCESS 33 • Medical, Legal and Commercial Reviews Are the Groups that Often Examine Health Outcomes Data 34 • Medical, Legal and Regulatory Consistently Sit on Health Outcomes Review Committee 35 • Health Outcomes Data Reviewed Most Often at Brand Level 36 HEALTH OUTCOME DATA OVERVIEW 37 • Tiered Classifications Not Being Implemented By Health Outcomes Groups 38 • Most Companies See a High Level of Risk With Health Outcomes Data For Off-Label Promotion 39 • Utilization of Health Outcome Data 40-41 • Strategic Planning A Critical Output From Internal Health Outcomes Data Usage 42 • Treatment Guidelines Top Use of Health Outcomes Data with Physicians 43 • Reimbursement and Drug Formulary Inclusion Most Used Activities with Health Outcomes Data Usage 44
  • 4. Table of Contents Page •Patients Not Seen As a Vital When It Comes to Health Outcomes Data 45 • Process Flow for using Health Outcomes Data for Promotional/ Commercial Purposes 46 HEALTH OUTCOME DATA BEST PRACTICES INSIGHTS 47 • Major Initiatives 48 • Best Practices for Utilizing Health Outcome 49 • Primary Elements in Health Outcomes Piece 50 ABOUT BEST PRACTICES, LLC 51
  • 5. Project Methodology and Study Objectives Optimizing the use of Health Outcomes data is vital to the success of biotechnology and pharmaceutical companies. This report provides insight and best practices that are being used by companies and reviews the use of Health Outcomes data in promotional/commercial settings. This report seeks to understand how pharmaceutical and biotech organizations optimize and utilize health outcomes data in promotional settings and the possible Regulatory issues that arise as a result of their use. Key study objectives Structure and Reporting Lines of Authority Health Outcomes Decisions Use of Health Outcomes Data Proactively and Retrospectively Who and How is HO Data Utilized with Different Groups HO Review Process and Structure Copyright © Best Practices®, LLC 2
  • 6. List of Participating Companies The benchmark class includes 18 participants from 16 companies across the pharmaceutical, biotech and medical device industries. 2011 2009 Abbott Abbott Alfred Mann Allergan Foundation Amgen ASSESSmint Baxter Baxter Becton Dickinson Bayer Beckman Coulter Becton Dickinson Biogen Idec C. Kalb & Associates, Boehringer Ingelheim LLC Eisai, Inc. Eisai Inc Laboratorios Esteve Laboratorios Esteve Ethicon, Inc. Mahde Taban Gilead Medtronic GlaxoSmithKline Novo Nordisk A/S Medimmune Pfizer Merck & Co. Regeneron OrthoBiotech Pharmaceuticals Pfizer Shire Shire Copyright © Best Practices®, LLC 3
  • 7. Range of Career Levels Lend Insight Research participants’ roles ranged from senior leaders to managers of medical affairs to medical science liaisons. 2011 2009 Associate Director, Health Outcomes Chief Marketing Officer Chief Analyst Clinical Marketing Manager - EMA Commercial Director CVM Category Head Director, Managed Markets Marketing DIRECTOR (3) Director, Global HEOR Director of Marketing Director, Strategic Planning Director, Medical Sciences Division Vice President, Global Labeling, Director, Regulatory Affairs Advertising & Promotion Director, Strategic Planning Health Economist Divisional VP - Global Clinical Managing Director Deputy in Marketing Epidemiology and HEOR Medical Director Executive Director, GHO President Head of Strategic Accounts Principal Reimbursement Analyst Medical Affairs Director (4) Sr. Director National/Sales Manager (3) Sr. Director, HEOR Acting Director, Health Outcomes Vice President Sr. Director, Global HEOR Vice President, Medical Services Sr. Director/Commercial Team Leader Sr. Manager Sales Training Sr. Director Medical Affairs Vice President , Medical & Scientific Affairs Copyright © Best Practices®, LLC 4
  • 8. Structure of Health Outcomes Function As brand teams require accurate data to commercially position the information, 61 percent of participants indicated that Health Outcomes (HO) is a part of centralized organization. Responses Relative to 2009, other numbers appeared similar for decentralization or seating in a brand team. Which of the following best describes the structure of your Health Outcomes function? Part of a local Part of a local Other , 6% Consultants brand team, brand team, 6% 6% Part of a global Part of a global brand team, brand team, 6% 18% Part of a Part of a Part of a decentralized centralized centralized organization, organization, Part of a organization, 22% 61% decentralized 64% organization, 22% N2011=18 N2009=33 Copyright © Best Practices®, LLC 5
  • 9. Most Common Decisions Made By Health Outcomes Health Outcomes Research continues to remain the most common decision made by Health Outcomes groups. The importance of decisions made on marketing plans dropped dramatically in 2011, by about 24 percent. In contrast, the importance of decisions related to market access strategies have increased to 53 percent from 24 percent in 2009. What types of decisions are made by your Health Outcomes group (s)? Health Outcomes Research Health Outcomes Research Scientific Publication Strategies Marketing plans Market Access Strategies Scientific publication strategies Reimbursement Reimbursement Clinical Development Clinical development Drug Formulary Inclusion Pricing Pricing Market access strategies Marketing Plans New indications New indications Drug formulary inclusion Treatment Guidelines Treatment guidelines N2011=17 Data provided in actual report. N2009=33 Copyright © Best Practices®, LLC 6
  • 10. Health Outcomes Data Used Most Often with Managed Care Account Managers and Medical Science Liaisons Data that is used on-label tends to be utilized more across the board, but most companies look to provide Health Outcomes data to their managed care groups and medical science liaisons – as the two sets of employees can have the most influence with physicians and managed care organizations. With whom do you use Health Outcomes Data for promotional purposes? Prospective Data On- Prospective Data Retrospective Retrospective Item label Off-Label Data On-label Data Off-Label 2011 2009 2011 2009 2011 2009 2011 2009 Managed Care Account Managers Sales Reps Medical Science Liaisons Data provided in actual report. Brand Teams Sales Training Other Do Not Use N2011=14 N2009=29 Copyright © Best Practices®, LLC 7
  • 11. Health Outcomes Data Reviewed Most Often at Brand Level Benchmark participants clearly favor reviews done at the brand level in 2011. In 2009 there was no clearly favored review process that was used, as 11 out of 21 companies reviewed Health Outcomes data at the brand level and 10 out of 21 reviewed at the therapeutic level. What is the scope and structure of the legal review committee? (Participants checked all that applied.) Reviews at a Reviews at a 75% 52% Brand Level Brand Level Reviews at a Reviews at a Therapeutic 33% Therapeutic 48% Level Level Located in Centralized Corporate but 17% Corporate 29% Decentralized Group Centralized Located in Corporate 8% Corporate but 14% Group Decentralized N2011=12 N2009=21 Copyright © Best Practices®, LLC 8
  • 12. Utilization of Health Outcome Data Reimbursement and drug formulary decision continue to remain the main usage of Health Outcome data with managed care. Relative to 2009, the importance of using on-label data internally for reimbursement has increased by 24% . In 2011, on-label data is mainly utilized for explaining treatment guideline to physicians and patients. How does your company utilize Health Outcomes data with patients, managed care, physicians and internally? Internally Managed Care Physicians Patients Item 2011 2009 2011 2009 2011 2009 2011 2009 Pricing Reimbursement Data provided in actual report. Treatment guidelines Drug formulary inclusion New indications N2011=13 N2009=19 Copyright © Best Practices®, LLC 9
  • 13. Treatment Guidelines Top Use of Health Outcomes Data with Physicians More than three-fourths of companies use Health Outcomes data for reimbursement guidelines for interactions with physicians while 69% of them use it to present data around drug formulary inclusion. While in 2009, more than three-fourths of companies use Health Outcomes data for treatment guidelines for interactions with physicians. Q. How does your company utilize Health Outcomes data with physicians? 2011 2009 Treatment guidelines 77% 69% Scientific publication strategies 50% 38% Marketing plans 14% 38% New indications 50% 38% Drug formulary inclusion 23% 38% Clinical development 41% 31% 18% Reimbursement 31% Market access strategies 27% 23% Pricing 9% 15% N2011=13 N2009=19 Copyright © Best Practices®, LLC 10
  • 14. About Best Practices, LLC Best Practices, LLC is a research and consulting firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 best@best-in-class.com www.best-in-class.com Copyright © Best Practices®, LLC 11