Value of Information in relation to risk management

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

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

4. Uncertainty is linked to CE-ratio

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

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

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

8. Cost Effectiveness Acceptability Curve (CEAC)

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

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

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

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

14. Example prototype model: Lucentis evaluated in the ACP

15. Patel et al, 2010

16. Avastin versus Lucentis

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 Conclusion

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)

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

20. 65 Citations in PubMed

21. If we knew Expect 14 QALYs Choose B Expect 12 QALYs, gain 1 QALY But uncertain Wrong decision 2/5 times How much evidence? Why is evidence valuable? What’s the best we can do now? Could we do better? Maximum value of more evidence is 2 QALYs per patient

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

23. Is the evidence sufficient? 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 QALY Get an extra 0.6 QALY Right decision 3/5 times (p = 0.6) Wrong decision 2/5 times (1-p = 0.4) Maximum benefit of more evidence is 0.6 QALYs or £12,000 per patient

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

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

26. Alan Williams