1. 1 Value of Information in relation to risk management  Prof. Dr. Jan J.V. Busschbach

2. Change in policy  Now: evaluate all new medication  Future: only when risk are high  When is an economic evaluation useful?  When there is doubt about cost effectiveness  Low on information about cost effectivenesss 2

3. The 3 meanings of doubt 1. The cost effectiveness might be invalid  Methodologically unsound  The CFH judges the validity using guidelines 2. The cost effectiveness might be to high  To high = bad  The ACP values the height of cost effectiveness  The CFH has no judgment 3. The cost effectiveness might be uncertain  Much error variance  Unclear who is dealing with this….ACP? CFH?  Room for more risk management 3

4. Uncertainty is linked to CE-ratio 4

5. Interested in both costs and effect Less effectiveMore effective Low costs (savings) High costs Not cost effective cost effective 5

6. Sensitivity analysis Less effectiveMore effective Low costs (savings) High costs Superb! Forget it! Difficult… 6 Good Better

7. Cost-effectiveness plane 7 Not cost effective Cost effective

8. Cost Effectiveness Acceptability Curve (CEAC) 8

9. Risk management  We can judge if we are in need of more information  Value of Information analysis 9

10. Value of Information (VoI) 10 Low VoI High VoI Low VoI Low reduction of risk High reduction of risk

11. 11 Risk management  Make prototype cost effectiveness analysis  Do a value of information analysis  Triage:  Unconditional reimbursement: If CE-ratio is far much below threshold Value of information is (most likely) low  Conditional reimbursement If CE-ratio is close to threshold Value of information is high  Unconditional reject of reimbursement Value of information is low

12. Arguments not to do so…  We should reimburse all effective drugs  We should evaluate all (new) effective drug  Assumes that we have the resources to do so  We do not have a threshold  We can not make acceptable prototypes 12

13. We have an indication of a threshold… 13 Wetenschappelijke Raad voor het Regeringsbeleid, 2006

14. Example prototype model: Lucentis evaluated in the ACP 14

15. Patel et al, 2010 15

16. Avastin versus Lucentis 16

17. Conclusion 17  Risk management relates to value of information  Conditional reimbursement can be done on prototype cost effectiveness analysis  Only invest in (cost-) effectiveness, if  Risks are high  Value of Information is high

18. CFH procedure  Standard procedure  Test of the validity of the cost effectiveness analysis  Using the guidelines  Orphan and expensive hospital drugs  Conditional reimbursement  Approval of a four year data collection To arrive ad a valid cost effectiveness analysis  After 4 years Test of the validly of the cost effectiveness analysis  Using guidelines  Valuing cost effectiveness = other committee  Advies Commissie Pakket (ACP) 18

19. Uncertainty relates to threshold  If:  CE-ratio = € 15.000 per QALY  Threshold = € 25.000 per QALY  Then intervention is cost effective  But what if CE-ratio is an interval:  Threshold = € 25.000 per QALY  CE-ratio = € 10.000 till € 30.000 per QALY  Then intervention might be cost effective  If:  Threshold = € 11.000  Then intervention most likely not cost effective  If:  Threshold = € 29.000  Then intervention is most likely cost effective 19

20. 20 65 Citations in PubMed

21. Why is evidence valuable? 21 How things could turn out Net Health BenefitBest we could do if we knew Treatment ATreatment BBest choice Possibility 1812B Possibility 2168A Possibility 3914B Possibility 41210A12 Possibility 51016B Average111214 How much evidence? What’s the best we can do now?Could we do better? Maximum value of more evidence is 2 QALYs per patient Choose B Expect 12 QALYs, gain 1 QALY But uncertain Wrong decision 2/5 times If we knew Expect 14 QALYs

22. Methods 22 Treatment A QALYCost Clinical effect Disease Progression QALY Costs Random sampling AsymptomaticProgressive Dead Treatment A AsymptomaticProgressive Dead Treatment B Model Structure Treatment B QALYCost 1 £10,000 2 £30,000 0 £ 5,000 3 £20,000 2 £15,000 4 £40,000 1 £10,000 3 £30,000

23. Is the evidence sufficient? 23 How things could turn out Net Health BenefitBest we could do if we knew Treatment ATreatment BBest choice Possibility 1912B Possibility 21210A12 Possibility 31417B Possibility 41110A11 Possibility 51416B Average121313.6 Would more evidence improve health? What’s the best we can do now?Could we do better? Choose B, expect additional net benefit of 1 QALYGet an extra 0.6 QALY Maximum benefit of more evidence is 0.6 QALYs or £12,000 per patient Right decision 3/5 times (p = 0.6) Wrong decision 2/5 times (1-p = 0.4)

24. How uncertain is the decision? 24 B A C Choose AChoose B ICER = £25,000 per QALY

25. Do we need more evidence? 25 Choose AChoose B Cost of research

26. 26 Alan Williams

27. 27