Business case for a new technology: checklist to secure reimbursement.

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2. Things to think about when considering how your technology might secure reimbursement What follows is a checklist based on our 16 years of experience completing around 700 projects. Not every item is relevant to every product but we hope you find it helpful in thinking through your positioning, capitalising on what you do know, and working out how best to bridge any gaps in the evidence supporting the case you want to make.

3. Business case for a new technology: Mind Map

4. © Translucency Limited, 2015 To whom does it apply?  Disease/condition  Age  Sex  Geography/location  Numbers  Co-morbidities/past history  Ethnicity

5. © Translucency Limited, 2015 What happens now?  What Tx options are there?  Where is Tx given?  What are the outcomes?  Survival  Quality of life  Activities of daily living  Other  What are the problems? 1

6. © Translucency Limited, 2015 What happens now?  What is the economic cost?  Patients • Travel • Time off work  Healthcare system • Provider • Payer  Welfare  Employer • Financial cost • Loss of productivity  Carers/families 2

7. © Translucency Limited, 2015 What happens now?  What is the non-economic cost  Patient • Travel time • Time in hospital • Unpleasantness of treatment • Aesthetic considerations  Healthcare system • Provider(s) • Payer  Carers/families  What are the upsides? 3

8. © Translucency Limited, 2015 Description of technology  Medical device  Pharmaceutical  Biotech product  Mixed/combination product  Process  Diagnostic test  Software  Monitoring  Surgical procedure

9. © Translucency Limited, 2015  What Tx options are there?  Where is Tx given?  What are the outcomes?  Survival  Quality of life  Activities of daily living  Other  What are the problems? 1What will happen if the case is accepted?

10. © Translucency Limited, 2015  What is the economic cost?  Patients • Travel • Time off work  Healthcare system • Provider • Payer  Welfare  Employer • Financial cost • Loss of productivity  Carers/families 2What will happen if the case is accepted?

11. © Translucency Limited, 2015  What is the non-economic cost  Patient • Travel time • Time in hospital • Unpleasantness of treatment • Aesthetic considerations  Healthcare system • Provider(s) • Payer  Carers/families  What are the upsides? 3What will happen if the case is accepted?

12. © Translucency Limited, 2015  Costs (including timing)  Patients  Healthcare system • Provider(s) • Payer(s)  Other (welfare, employer etc) 1Incremental cost-effectiveness of pathway

13. © Translucency Limited, 2015  Benefits (including timing)  Clinical outcomes  Savings • Patients • Healthcare system – Provider(s) – Payer(s) • Welfare • Employer – Financial cost – Loss of productivity 2Incremental cost-effectiveness of pathway

14. © Translucency Limited, 2015  Externalities  Effects on other parties • Healthcare providers – Same (other departments) – Others • Social services • Other parties  ROI  Step (marginal) effects 3Incremental cost-effectiveness of pathway

15. © Translucency Limited, 2015  Financial  Artificial (reimbursement architecture)  Poor cost-effectiveness  Insufficient ROI  Cannot be adopted within current budget constraints  Non-financial  Shortage of skilled staff  Absence/insufficiency of equipment  Absence/insufficiency of infrastructure 1Barriers to adoption

16. © Translucency Limited, 2015  Requires extensive implementation effort  New buildings  New staff  New processes  Not perceived as a priority  Not part of performance management  Not included in policies/guideline 2Barriers to adoption

17. © Translucency Limited, 2015  Speed of adoption  Price-demand relationship  Target market size  Financial consequences  Outcomes  Step (marginal) effects Likely adoption curve

18. © Translucency Limited, 2015  Health sector  Past  Present  Future/ongoing  Other sectors (eg innovation, trade, research)  Past  Present  Future/ongoing  Effect on variation/equality Relevant policies and guidelines

19. © Translucency Limited, 2015  Clinical  Managerial  Financial  Are savings real? • Cash-releasing • Non-cash-releasing – Consequences of redeployment  Perspectives of relevant parties • On whom do the costs fall? • To whom do the benefits accrue? Summary case for adoption

20. © Translucency Limited, 2015  Quality of studies  Applicability/generalizability of studies  Patients  Current local practice • Staff • Buildings • Tests • Treatment options  Unit costs  Patterns of disease  Quantity of evidence  The degree to which the evidence speaks with a 'clear voice’  Evidence gaps Evidence

21. © Translucency Limited, 2015  Provider(s)  Who in the organisation? • Budget-holder • Clinician • Manager  Which bit of the organisation? • Whole provider organisation • Department  Payers • Which organisation(s)? • Who in the organisation? 1Target audience for business case

22. © Translucency Limited, 2015  Other parties  HTA agencies  Other health service funders  e.g. Innovation bodies  Private healthcare providers  private medical insurers  self-pay 2Target audience for business case

23. © Translucency Limited, 2015  Staff benefits  Academic/career  Working conditions  Satisfaction  Organisation benefits  Business continuity  Ease of supply/storage  Overcoming skill shortages  Overcoming capacity constraints Adoption opportunities

26. © Translucency Limited, 2015  What assumptions have been made?  How sensitive is the case to the assumptions? Assumptions

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