From evidence to consequence The (new) reality for real world evidence

Transcription

1 From evidence to consequence The (new) reality for real world evidence DLI MI ND NORDIC CONFERENCE ON REAL WORLD DATA, COLLABORATION BETWEEN PHARMA INDUSTRY AND ACADEMIA 1

2 What we would like to discourse with you Why do decision-makers in similar markets make different assessment of the same evidence? Case: Introduction of biosimilars in Denmark Why is evidence not enough? What does this mean for you Real World Studies? In sum 2

3 We know that it has been a long day 3

4 Our question today: Why do decision-makers in similar markets make different assessment of the same evidence? Public medical & clinical perspective Public Epidemiology Public budget and economic priority perspective the BIG Story Quality registries Application to the council Discounts Added clinical value Costs Public Economical Agenda Clinical routine Negotiation mandate Budget impact MEDICAL RWE ECONOMICAL Patient Characteristics Medical Message Comparator Pricing Pharma-businesses medical & clinical value and patient life-quality perspective Competitive profile Patient populations Commercial Global Value Dossier Because local values play a significant role in translating evidence into consequence Pharma-businesses' commercial healthcare perspective 4

5 What we would like to discourse with you Why do decision-makers in similar markets make different assessment of the same evidence? Case: Introduction of biosimilars in Denmark Why is evidence not enough? What does this mean for you Real World Studies? In sum 5

6 Case: Biosimilars -the introductory climate in Denmark 6

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8 Public medical & clinical perspective Public Public budget and economic priority perspective MEDICAL ECONOMICAL Pharma-businesses medical & clinical value and patient life-quality perspective Commercial Pharma-businesses' commercial healthcare perspective 8

9 Public medical & clinical perspective Public Public budget and economic priority perspective MEDICAL ECONOMICAL Pharma-businesses medical & clinical value and patient life-quality perspective Commercial Pharma-businesses' commercial healthcare perspective 9

10 However, other Nordic markets interpreted the evidence differently Ex of introduction of a selected biosimilar 10

11 What we would like to discourse with you Why do decision-makers in similar markets make different assessment of the same evidence? Case: Introduction of biosimilars in Denmark Why is evidence not enough? What does this mean for you Real World Studies? In sum 11

12 Why do decision-makers include values/norms in their decision (i.e. why is evidence not enough?) 12

13 The emerging challenge in pharma: Connect evidence with norm-based decisions 13

14 What we would like to discourse with you Why do decision-makers in similar markets make different assessment of the same evidence? Case: Introduction of biosimilars in Denmark Why is evidence not enough? What does this mean for you Real World Studies? In sum 14

15 When designing your study, success is created from understanding the players involved Conflict- axis Public needs Scientific interest Scientific research communities: -Unbiased -Hypothesis driven Budget improvement National & regional payers: -Improvement of budgets -Maximize use of resources Treatment Conflict-axis Economic Citizen protection Public authorities/ data access: -Data privacy -Societal relevance -Proportionality of data vs. relevance Patient advocacy Patient organization: -Political impact -Secure public resources -Improved treatment for members Individual rights 15

16 And internally, different questions must be aligned 16

17 In sum Evidence is not enough when introducing new medicines normbased decisions/criteria s play a significant role Consequently, when conducting Real World Studies, recipient stakeholders criteria s must be considered in the study design, collaboration, and execution of the study This entails a change in: 1. Thinking, i.e. evidence is needed but is not enough 2. Method, i.e. study design must be transparent but stakeholder perspectives must be included 3. Collaboration with academia, i.e. acceptance that studies are embedded in a larger context (e.g. The Big Story) 17

18 Thank you DLI MI Niels Christian Hirsch, Arun Micheelsen, 18