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Universidade do Estado do Rio de Janeiro
          Departamento de Clínica Médica
 Centro Latino Americano de Pesquisa em Biológicos




SHARED DECISION MAKING
 - The case of biosimilars -

         Mirhelen Mendes de Abreu, M.D., Ph. D.
                  mirhelen@ufscar.br
Universidade do Estado do Rio de Janeiro
                   Departamento de Clínica Médica
          Centro Latino Americano de Pesquisa em Biológicos


Agenda



• SDM approach to discuss biosimilar and biologic agents
   - ClaBio Project: SDM branch




                            mirhelen@ufscar.br                2
Universidade do Estado do Rio de Janeiro
                       Departamento de Clínica Médica
              Centro Latino Americano de Pesquisa em Biológicos




     Brief literature review

Key words     First      <1995        1996 –        2001 –   2006 –   2011
              citation                2000          2005     2010
SDM (1474) 1968          61           97            380      760      176


Biosimilars   2004       -            -             5        88       75
(168)


   Source: Pubmed/ Medline in December 13th, 2011


                                   mirhelen@ufscar.br                        3
Universidade do Estado do Rio de Janeiro
            Departamento de Clínica Médica
   Centro Latino Americano de Pesquisa em Biológicos




   Shared decision making
approach to discuss biosimilars
      - ClapBio Project -
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos




               Rationale
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos




                  mirhelen@ufscar.br                6
Universidade do Estado do Rio de Janeiro
                     Departamento de Clínica Médica
            Centro Latino Americano de Pesquisa em Biológicos


Rationale

1. Implementing       shared      decision          making   will   require
   techniques that will enable the decision makers to
   communicate effectively about:

   – Defining the decision
   – Creating the working knowledge base
   – Value-based tradeoffs
   – Reaching a decision

                               mirhelen@ufscar.br                             7
Universidade do Estado do Rio de Janeiro
                  Departamento de Clínica Médica
         Centro Latino Americano de Pesquisa em Biológicos

• A model of decision making




                                          Adapted from Haynes et al BMJ 2002; 324: 1350
                           mirhelen@ufscar.br                                   8
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos




 Research scope and aims




                  mirhelen@ufscar.br                9
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


Research questions



1. What is stakeholders’ perspective on SDM approach to guide
    decisions in healthcare?



2. Is SDM a feasible approach to guide discussions on
    biosimilars from society’s perspective?


                               mirhelen@ufscar.br               10
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


Research questions

3. What barriers are experienced by providers seeking to
    implement explicit priority setting? How can these barriers
    be addressed?



4. What barriers are experienced by patients/populations
    seeking to implement explicit priority setting? How can
    these barriers be addressed?
                             mirhelen@ufscar.br                   11
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


Aims

1. To explore stakeholders’ perspective on SDM approach to
    guide decisions in healthcare

2. To develop, test and validate a Biosimilar x Biological Agents
    Decision Aid for Latin America to guide discussions on
    biosimilars and biological agents (taking into account each
    country’s culture and values)

                             mirhelen@ufscar.br                     12
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


Stages

Stage 1 – International survey

• SDM approach and reception in Latin America

• Investigate society’s posture to issues regarding biosimilars
  and biological agents and acceptance

Stage 2 – Development, testing and validation of a Biosimilar x
  Biological Agents Decision Aid for Latin America

                             mirhelen@ufscar.br                   13
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos



Stage 1 – International survey



       The international survey will be designed to provide a
  picture of SDM acceptability in some Latin American
  countries, taking biosimilars and biological agents into
  account.



                             mirhelen@ufscar.br                 14
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


Stage 1 – International survey

• Electronic format

• Pilot study

   – To qualify language, format and type of questions in
     different countries. It aims to refine feedback

   – To provide elements to guide sample calculation and
     statistical analysis

                             mirhelen@ufscar.br                15
Universidade do Estado do Rio de Janeiro
                   Departamento de Clínica Médica
          Centro Latino Americano de Pesquisa em Biológicos


Stage 2 – Biosimilar x Biological Agents Decision Aid for Latin
  America - Development, testing and validation

• A basic component framework for the decision aid

   – Evidence

   – Stakeholder involvement

   – Decision process



                            mirhelen@ufscar.br                    16
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


EVIDENCE

• Incorporate the best level of evidence available for each
  alternative

• Expose the evidence in an appropriate language for each
  stakeholder, considering the SAME content
   – Stakeholder Panel
      • Language adequacy regarding stakeholders’ culture and
        literacy

                             mirhelen@ufscar.br                 17
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


EVIDENCE

• Provide a brief overview including the concept of biological
  agents, biotechnology and biosimilar agents in a legal
  language

   – Evidences regarding risk and benefits of each option,
      without naming them.

   – “Option 1” AND “Option 2” to avoid bias


                             mirhelen@ufscar.br                  18
Universidade do Estado do Rio de Janeiro
                  Departamento de Clínica Médica
         Centro Latino Americano de Pesquisa em Biológicos


EVIDENCE – A BASIC DECISION AID MODEL




                           mirhelen@ufscar.br                19
Universidade do Estado do Rio de Janeiro
                Departamento de Clínica Médica
       Centro Latino Americano de Pesquisa em Biológicos


STAKEHOLDERS INVOLVEMENT

• Explore the level of involvement of each stakeholder group
  in decision-making processes

• Introduce changes in stakeholders participation in
  decision-making process
     Processes to enhance public and patient involvement in
     priority setting
     Public consultation processes
     Processes to enhance clinical engagement
                         mirhelen@ufscar.br                    20
Universidade do Estado do Rio de Janeiro
              Departamento de Clínica Médica
     Centro Latino Americano de Pesquisa em Biológicos


STAKEHOLDERS INVOLVEMENT – INCLUDE DIFFERENT
 PERSPECTIVE




                       mirhelen@ufscar.br                21
Universidade do Estado do Rio de Janeiro
               Departamento de Clínica Médica
      Centro Latino Americano de Pesquisa em Biológicos


DECISION PROCESS

 To offer a model of decision to guide discussion and to
 present options on micro level decision

 To explore the level of comprehension about the points
 under discussion (self-test evaluation)

 Decision-tree framework



                        mirhelen@ufscar.br                 22
Universidade do Estado do Rio de Janeiro
               Departamento de Clínica Médica
      Centro Latino Americano de Pesquisa em Biológicos


DECISION PROCESS – INCLUDE DIFFERENT SCENARIOS




                        mirhelen@ufscar.br                23
Universidade do Estado do Rio de Janeiro
                   Departamento de Clínica Médica
          Centro Latino Americano de Pesquisa em Biológicos


The research team will provide documents including


  Ethical frameworks used

  Policy documentation

  Presentations and workshop notes

  Meeting agendas



                            mirhelen@ufscar.br                24
Universidade do Estado do Rio de Janeiro
                     Departamento de Clínica Médica
            Centro Latino Americano de Pesquisa em Biológicos


Future directions

   Expected Results

   •    This study seeks to be an investigative platform to future
       studies that aim:
          To map potential barriers and challenges to the full development
          of SDM to guide decisions on biosimilars discussion;

          To provide a substratum for the development of decisions
          /regulatory strategies;

                                    mirhelen@ufscar.br                       25
Universidade do Estado do Rio de Janeiro
                 Departamento de Clínica Médica
        Centro Latino Americano de Pesquisa em Biológicos


• Future directions
  – Next step

    To apply the Biosimilar x Biological Agents
    Decision Aid for Latin America – another project.




                          mirhelen@ufscar.br                26
Schedule
Write the project in detail                 1m

Forms preparation                                1m

                                                 1m
Submission to Institutionals Review Board
Interviewers screening and training                   2m

Contact with persons in charge of the                 1m
sites to be included in the study

Patients enrollment                                        6m

Follow-up                                                       12
                                                                m
Data input and information validation                                2m

Data analysis                                                             2m

Results discussion                                                        2m

Preparation of the report/manuscript for                                       1m
publication

Total, months                                                                  27
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos




       Ongoing projects on
     Shared Decision Making




                  mirhelen@ufscar.br                28
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos




                  mirhelen@ufscar.br                29
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos




                  mirhelen@ufscar.br                30
Universidade do Estado do Rio de Janeiro
                   Departamento de Clínica Médica
          Centro Latino Americano de Pesquisa em Biológicos




Ongoing projects


    Rheumatology Interprofessional Research and Care Team –
   Research Project: improving communication to enhance the
                       clinical encounter




                            mirhelen@ufscar.br                31
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


First step. Understanding the stakeholders’ point of view

Project 1. Quality of care: reference and counter reference from
   family physicians and rheumatologists' perspectives in São
   Carlos – SP, Brazil

Project 2. Communication in multiprofessional teamwork and
   shared decision making: the case of Family Health Units in
   São Carlos – SP, Brazil

                                                  Sponsored by FAPESP
                             mirhelen@ufscar.br                         32
Universidade do Estado do Rio de Janeiro
                    Departamento de Clínica Médica
           Centro Latino Americano de Pesquisa em Biológicos


First step. Understanding the stakeholders’ point of view



Project 3. Shared decision making at the Family Physician Unit:
   the patient’s perspective

Project 4. Shared decision making in secondary care:
   rheumatologic patient’s perspective



                                                  Sponsored by FAPESP
                             mirhelen@ufscar.br                         33
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos
Universidade do Estado do Rio de Janeiro
         Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos




THANK YOU!



                  mirhelen@ufscar.br                35

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16 12 11_-_sdm_project[1] [modo de compatibilidade]

  • 1. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos SHARED DECISION MAKING - The case of biosimilars - Mirhelen Mendes de Abreu, M.D., Ph. D. mirhelen@ufscar.br
  • 2. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Agenda • SDM approach to discuss biosimilar and biologic agents - ClaBio Project: SDM branch mirhelen@ufscar.br 2
  • 3. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Brief literature review Key words First <1995 1996 – 2001 – 2006 – 2011 citation 2000 2005 2010 SDM (1474) 1968 61 97 380 760 176 Biosimilars 2004 - - 5 88 75 (168) Source: Pubmed/ Medline in December 13th, 2011 mirhelen@ufscar.br 3
  • 4. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Shared decision making approach to discuss biosimilars - ClapBio Project -
  • 5. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Rationale
  • 6. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos mirhelen@ufscar.br 6
  • 7. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Rationale 1. Implementing shared decision making will require techniques that will enable the decision makers to communicate effectively about: – Defining the decision – Creating the working knowledge base – Value-based tradeoffs – Reaching a decision mirhelen@ufscar.br 7
  • 8. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos • A model of decision making Adapted from Haynes et al BMJ 2002; 324: 1350 mirhelen@ufscar.br 8
  • 9. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Research scope and aims mirhelen@ufscar.br 9
  • 10. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Research questions 1. What is stakeholders’ perspective on SDM approach to guide decisions in healthcare? 2. Is SDM a feasible approach to guide discussions on biosimilars from society’s perspective? mirhelen@ufscar.br 10
  • 11. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Research questions 3. What barriers are experienced by providers seeking to implement explicit priority setting? How can these barriers be addressed? 4. What barriers are experienced by patients/populations seeking to implement explicit priority setting? How can these barriers be addressed? mirhelen@ufscar.br 11
  • 12. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Aims 1. To explore stakeholders’ perspective on SDM approach to guide decisions in healthcare 2. To develop, test and validate a Biosimilar x Biological Agents Decision Aid for Latin America to guide discussions on biosimilars and biological agents (taking into account each country’s culture and values) mirhelen@ufscar.br 12
  • 13. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Stages Stage 1 – International survey • SDM approach and reception in Latin America • Investigate society’s posture to issues regarding biosimilars and biological agents and acceptance Stage 2 – Development, testing and validation of a Biosimilar x Biological Agents Decision Aid for Latin America mirhelen@ufscar.br 13
  • 14. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Stage 1 – International survey The international survey will be designed to provide a picture of SDM acceptability in some Latin American countries, taking biosimilars and biological agents into account. mirhelen@ufscar.br 14
  • 15. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Stage 1 – International survey • Electronic format • Pilot study – To qualify language, format and type of questions in different countries. It aims to refine feedback – To provide elements to guide sample calculation and statistical analysis mirhelen@ufscar.br 15
  • 16. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Stage 2 – Biosimilar x Biological Agents Decision Aid for Latin America - Development, testing and validation • A basic component framework for the decision aid – Evidence – Stakeholder involvement – Decision process mirhelen@ufscar.br 16
  • 17. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos EVIDENCE • Incorporate the best level of evidence available for each alternative • Expose the evidence in an appropriate language for each stakeholder, considering the SAME content – Stakeholder Panel • Language adequacy regarding stakeholders’ culture and literacy mirhelen@ufscar.br 17
  • 18. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos EVIDENCE • Provide a brief overview including the concept of biological agents, biotechnology and biosimilar agents in a legal language – Evidences regarding risk and benefits of each option, without naming them. – “Option 1” AND “Option 2” to avoid bias mirhelen@ufscar.br 18
  • 19. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos EVIDENCE – A BASIC DECISION AID MODEL mirhelen@ufscar.br 19
  • 20. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos STAKEHOLDERS INVOLVEMENT • Explore the level of involvement of each stakeholder group in decision-making processes • Introduce changes in stakeholders participation in decision-making process Processes to enhance public and patient involvement in priority setting Public consultation processes Processes to enhance clinical engagement mirhelen@ufscar.br 20
  • 21. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos STAKEHOLDERS INVOLVEMENT – INCLUDE DIFFERENT PERSPECTIVE mirhelen@ufscar.br 21
  • 22. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos DECISION PROCESS To offer a model of decision to guide discussion and to present options on micro level decision To explore the level of comprehension about the points under discussion (self-test evaluation) Decision-tree framework mirhelen@ufscar.br 22
  • 23. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos DECISION PROCESS – INCLUDE DIFFERENT SCENARIOS mirhelen@ufscar.br 23
  • 24. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos The research team will provide documents including Ethical frameworks used Policy documentation Presentations and workshop notes Meeting agendas mirhelen@ufscar.br 24
  • 25. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Future directions Expected Results • This study seeks to be an investigative platform to future studies that aim: To map potential barriers and challenges to the full development of SDM to guide decisions on biosimilars discussion; To provide a substratum for the development of decisions /regulatory strategies; mirhelen@ufscar.br 25
  • 26. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos • Future directions – Next step To apply the Biosimilar x Biological Agents Decision Aid for Latin America – another project. mirhelen@ufscar.br 26
  • 27. Schedule Write the project in detail 1m Forms preparation 1m 1m Submission to Institutionals Review Board Interviewers screening and training 2m Contact with persons in charge of the 1m sites to be included in the study Patients enrollment 6m Follow-up 12 m Data input and information validation 2m Data analysis 2m Results discussion 2m Preparation of the report/manuscript for 1m publication Total, months 27
  • 28. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Ongoing projects on Shared Decision Making mirhelen@ufscar.br 28
  • 29. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos mirhelen@ufscar.br 29
  • 30. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos mirhelen@ufscar.br 30
  • 31. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos Ongoing projects Rheumatology Interprofessional Research and Care Team – Research Project: improving communication to enhance the clinical encounter mirhelen@ufscar.br 31
  • 32. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos First step. Understanding the stakeholders’ point of view Project 1. Quality of care: reference and counter reference from family physicians and rheumatologists' perspectives in São Carlos – SP, Brazil Project 2. Communication in multiprofessional teamwork and shared decision making: the case of Family Health Units in São Carlos – SP, Brazil Sponsored by FAPESP mirhelen@ufscar.br 32
  • 33. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos First step. Understanding the stakeholders’ point of view Project 3. Shared decision making at the Family Physician Unit: the patient’s perspective Project 4. Shared decision making in secondary care: rheumatologic patient’s perspective Sponsored by FAPESP mirhelen@ufscar.br 33
  • 34. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos
  • 35. Universidade do Estado do Rio de Janeiro Departamento de Clínica Médica Centro Latino Americano de Pesquisa em Biológicos THANK YOU! mirhelen@ufscar.br 35