Winnie Nelson, PharmD, MS
Questions
 What are the barriers when delivering HEOR data?
 How to best quantify cost and benefit to stakeholders?
 How is HEOR influencing the new audiences?
 What to consider when communicating HEOR
  findings?
 What to do as a publication planning team?




                                                           2
One Size Does Not Fit All
 Heterogeneity of HTA across the globe
 Still evolving, particularly in emerging markets
 Main differences:
    Transparency
    Priority Setting
    Openness to stakeholder participation
 Suggestions:
    Scan you environment and be prepared
    Hold on to your local talents
    Support research on public policy and outcomes

                                                      3
Time and Cost of Publications
 Underestimation of time and cost
    Publications as an afterthought for a project
    Confusing HEOR as market research
    Designing HEOR studies difficult to publish
 Suggestions:
    Plan ahead
    Goal resetting: Generate data for external audience;
     publish on time and on strategy
    Think BIG: big issues, big knowledge gaps, big picture


                                                              4
Quantifying Cost & Benefits
      IS IT BEST TO QUANTIFY AT ALL?
 Are you proving the obvious?
 Are you proving the unbelievable?

 Next considerations:
   Feasible?
   Important to whom?
   Alignment with product benefit?
   Will the data be published well?

                                       5
Data Generation Decisions
              Feasibility    Importance      Alignment     Publication
Data         MUST HAVE       To whom?       Rank from      Think tier
Generation                                  good to poor   Think speed
Idea         Note            Use this                      Think big
             feasibility’s   attribute to   Use this       picture
             link with       prioritize     attribute to
             methodology                    prioritize     Use this
                                                           attribute to
                                                           refine idea



                 Go / No Go / Defer

                                                                          6
New HEOR Audience: HTA (system)
       High stakes getting higher


     EBM         HTA                   CER


            EBM = Evidence-based medicine
            HTA = Health technology assessment (approach)
            CER = Comparative effectiveness research

                                                            7
Treat Each HTA as Unique
          Political    National
         Traditions    Income

   Health
                                   Local
   System
                                  Practice
  Structure     Reimburse-
                   ment
                 Decisions



                                             8
HTA Best Practice
                               Suggestions:
         Trans-
         parent                 Maintain highest allowable
                                 involvement
                                  Attitude is KEY
        Ideal                     Trust-building is the GOAL
                    Predict-
Fair    HTA           able
       Practice                 Keep eyes open for the
                                upcoming development in
                                real-world data collection
        Efficient               methods

                                                             9
Agenda Conflicts: HTA & Mfr
 Agenda conflicts will ALWAYS exist and mostly remain
 unspoken
   HTA is accountable for healthcare budgets
   Manufacturer seeks to maximize profit & shareholder
    value
 Communication goals:
    Reduce mistrust
    Strive for open and honest dialogue
    Obtain accurate information for QUALITY decisions
    Encourage and request best practice from HTA
                                                          10
Pub Planning Considerations
             Speed and Timing


             Credibility
              • Peer-review journals
  SHORTCUT
              • Collaborators & authors
              • Research Methodology
             Communication
              • Micro-level
              • Macro-level
                                          11
Do’s & Don’ts
 Do:
   Follow-through and turn posters into papers
   Establish clear rules of engagement with academic
    partners
   Ongoing refinement of communication strategies
 Don’t
   Aim for the wrong tier
   Plan publications after a study
   Involve unsuitable internal reviewers


                                                        12
On Communication
Which is more helpful to decide whether to pay for a
consultant’s airline club membership?
1. The cost is $500 per year; the consultant travels
   between 10-20 trips a year based on previous years’
   data.
2. The cost is $500 per year, which is equivalent to 2
   hours of chargeable work.

   Good statistics aid decisions or shape opinions.1

                     1. Heath D & Heath C. The Gripping Statistic. Fast Company.
                        September 2009: 59-60.                                     13
Effective Pub Planning Team
                       To do: Start early
  Multi-disciplinary team
  Set rules of engagement
  Product values front and center
  Continuous refinement
      Watch competitive landscape
      Change with regulatory environment
      Advance with the current state of science

 Fortune Favors the Prepared and Adaptable!

                                                   14
Effective Pub Planning Team
                To do: Achieve alignment
  Align geographically
    Know what to leverage
    Know when to adapt

  Align functionally
    Need process to facilitate information flow
    Level of communication  effectiveness of resource use

  Align externally
    External collaborators: Opportunity to publish may be the
     only motivation
    Regulatory requirements  study design and publication
     deliverables
                                                                 15
Answers
 What are the barriers when delivering HEOR data?
    Heterogeneity of HTA; Time & cost involved requires careful
    planning
   How to best quantify cost and benefit to stakeholders?
    Make sure quantification is the way to go; then make decision
    systematically
   How is HEOR influencing the new audiences?
    HTA makes fateful decisions with HEOR data; Each HTA do it
    their own way; Keep up with the changes
   What are considerations when communicating HEOR findings?
    Accurate timing; Maximum credibility; Clear communication
   What to do as a publication planning team?
    Be prepared, adaptable, & connected

                                                                    16
Additional Readings
 Special Issue: Health Technology Assessment in
  Evidence-Based Health Care Reimbursement Decision
  Around the World: Lessons Learned. Value Health.
  2009;12(Suppl 2):S1-S49
 Kline R, Day P, Redmayne S. Managing scarcity.
  Priority setting and rationing in the NHS.
  Buckingham: Open University Press, 1996
 Raftery J. Review of NICE’s recommendations, 1999-
  2005. BMJ. 2005;332:1266-8


                                                       17

Effectively Communicating Pharmacoeconomic Research Winnie Nelson (Brief)

  • 1.
  • 2.
    Questions  What arethe barriers when delivering HEOR data?  How to best quantify cost and benefit to stakeholders?  How is HEOR influencing the new audiences?  What to consider when communicating HEOR findings?  What to do as a publication planning team? 2
  • 3.
    One Size DoesNot Fit All  Heterogeneity of HTA across the globe  Still evolving, particularly in emerging markets  Main differences:  Transparency  Priority Setting  Openness to stakeholder participation  Suggestions:  Scan you environment and be prepared  Hold on to your local talents  Support research on public policy and outcomes 3
  • 4.
    Time and Costof Publications  Underestimation of time and cost  Publications as an afterthought for a project  Confusing HEOR as market research  Designing HEOR studies difficult to publish  Suggestions:  Plan ahead  Goal resetting: Generate data for external audience; publish on time and on strategy  Think BIG: big issues, big knowledge gaps, big picture 4
  • 5.
    Quantifying Cost &Benefits IS IT BEST TO QUANTIFY AT ALL?  Are you proving the obvious?  Are you proving the unbelievable?  Next considerations:  Feasible?  Important to whom?  Alignment with product benefit?  Will the data be published well? 5
  • 6.
    Data Generation Decisions Feasibility Importance Alignment Publication Data MUST HAVE To whom? Rank from Think tier Generation good to poor Think speed Idea Note Use this Think big feasibility’s attribute to Use this picture link with prioritize attribute to methodology prioritize Use this attribute to refine idea Go / No Go / Defer 6
  • 7.
    New HEOR Audience:HTA (system) High stakes getting higher EBM HTA CER EBM = Evidence-based medicine HTA = Health technology assessment (approach) CER = Comparative effectiveness research 7
  • 8.
    Treat Each HTAas Unique Political National Traditions Income Health Local System Practice Structure Reimburse- ment Decisions 8
  • 9.
    HTA Best Practice Suggestions: Trans- parent  Maintain highest allowable involvement  Attitude is KEY Ideal  Trust-building is the GOAL Predict- Fair HTA able Practice  Keep eyes open for the upcoming development in real-world data collection Efficient methods 9
  • 10.
    Agenda Conflicts: HTA& Mfr  Agenda conflicts will ALWAYS exist and mostly remain unspoken  HTA is accountable for healthcare budgets  Manufacturer seeks to maximize profit & shareholder value  Communication goals:  Reduce mistrust  Strive for open and honest dialogue  Obtain accurate information for QUALITY decisions  Encourage and request best practice from HTA 10
  • 11.
    Pub Planning Considerations Speed and Timing Credibility • Peer-review journals SHORTCUT • Collaborators & authors • Research Methodology Communication • Micro-level • Macro-level 11
  • 12.
    Do’s & Don’ts Do:  Follow-through and turn posters into papers  Establish clear rules of engagement with academic partners  Ongoing refinement of communication strategies  Don’t  Aim for the wrong tier  Plan publications after a study  Involve unsuitable internal reviewers 12
  • 13.
    On Communication Which ismore helpful to decide whether to pay for a consultant’s airline club membership? 1. The cost is $500 per year; the consultant travels between 10-20 trips a year based on previous years’ data. 2. The cost is $500 per year, which is equivalent to 2 hours of chargeable work. Good statistics aid decisions or shape opinions.1 1. Heath D & Heath C. The Gripping Statistic. Fast Company. September 2009: 59-60. 13
  • 14.
    Effective Pub PlanningTeam To do: Start early  Multi-disciplinary team  Set rules of engagement  Product values front and center  Continuous refinement  Watch competitive landscape  Change with regulatory environment  Advance with the current state of science Fortune Favors the Prepared and Adaptable! 14
  • 15.
    Effective Pub PlanningTeam To do: Achieve alignment  Align geographically  Know what to leverage  Know when to adapt  Align functionally  Need process to facilitate information flow  Level of communication  effectiveness of resource use  Align externally  External collaborators: Opportunity to publish may be the only motivation  Regulatory requirements  study design and publication deliverables 15
  • 16.
    Answers  What arethe barriers when delivering HEOR data? Heterogeneity of HTA; Time & cost involved requires careful planning  How to best quantify cost and benefit to stakeholders? Make sure quantification is the way to go; then make decision systematically  How is HEOR influencing the new audiences? HTA makes fateful decisions with HEOR data; Each HTA do it their own way; Keep up with the changes  What are considerations when communicating HEOR findings? Accurate timing; Maximum credibility; Clear communication  What to do as a publication planning team? Be prepared, adaptable, & connected 16
  • 17.
    Additional Readings  SpecialIssue: Health Technology Assessment in Evidence-Based Health Care Reimbursement Decision Around the World: Lessons Learned. Value Health. 2009;12(Suppl 2):S1-S49  Kline R, Day P, Redmayne S. Managing scarcity. Priority setting and rationing in the NHS. Buckingham: Open University Press, 1996  Raftery J. Review of NICE’s recommendations, 1999- 2005. BMJ. 2005;332:1266-8 17