1. Promoting high quality, cost effective drug therapy throughout the Military Health System Identification and Use of Published Health Economic Evaluations to Support Formulary Decisions at the MTF Joshua Devine, Major, USAF, BSC

2. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 2 Objective Outline an effective approach for the systematic searching and use of published health economic evaluations

3. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 3 Outline Explain the definition and purpose of economic evaluation studies Highlight the characteristics of a health economic evaluation Examine how economic evaluation studies are indexed in MEDLINE, a major bibliographic database Discuss simple methods for determining if the results from economic evaluations are useful in your setting

4. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 4 Purpose of Economic Evaluation Studies To ensure that the benefits from a health care program implemented are greater than the opportunity cost of such a program Addressing questions of –technical efficiency or –allocative efficiency

5. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 5 Economic Evaluation Studies A FULL economic evaluation compares BOTH the costs AND consequences of two or more interventions Requires –identification –measurement –valuation of both costs and benefits

6. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 6 Economic Evaluation Methodologies cost-minimisation analysis (CMA) cost-effectiveness analysis (CEA) cost-utility analysis (CUA) cost-benefit analysis (CBA)

7. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 7 Economic Evaluation Methodologies Evaluative TechniqueBenefitsUnit of Measurement cost-effectiveness analysis quantity of Life OR quality of Life life years gained OR natural units cost-utility analysis quantity + quality of life health years e.g., QALYs, HYE cost-benefit analysis quantity + quality of life money e.g., willingness to pay

8. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 8 Partial Economic Evaluation Studies cost comparison/cost analysis study cost of illness study cost outcome description cost description

9. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 9 Quality of Health Economic Evaluations Poor study design –weak data sources –failure to define clearly the economic evaluation method used –use of an inappropriate method if economic evaluation to address the research question –omission of sensitivity analysis to test robustness of modelling

10. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 10 Quality of Health Economic Evaluations Inadequate reporting –lack of transparency by authors –journal editorial policy surrounding economic submissions Publication bias –publication bias in the clinical literature –motivation for conducting an economic evaluation

11. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 11 Research by Zarnke and colleagues Bibliographic databases searched between 1991-1995 for cost-benefit analyses Identified studies were classified according to standard definitions The comprehensiveness of identified studies were also evaluated Mislabeling and Comprehensiveness of Economic Evaluations Zarnke et al. 1997; Journal of Clinical Epidemiology

12. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 12 Mislabeling and Comprehensiveness of Economic Evaluations Percent of identified studies employing appropriate methodology Not Appropriate Comprehensiveness of analysis Appropriate Zarnke et al. 1997; Journal of Clinical Epidemiology

13. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 13 Studies labeled as CBAs in the health care literature often offer only partial program evaluation Health care decision-makers should apply the results of these studies cautiously You must carefully review the methods and assumptions used in this type of analysis Mislabeling and Comprehensiveness of Economic Evaluations Zarnke et al. 1997; Journal of Clinical Epidemiology

14. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 14 Systematic review of cost-effectiveness studies published in 2006 Bibliographic databases searched between 1976-2001 for cost-effectiveness analyses Identified 494 english language studies Examined the distribution of incremental cost effectiveness ratios in dollars Bias in Published Economic Evaluations Bell et al. 2006; BMJ

15. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 15 Bias in Published Economic Evaluations Bell et al. 2006; BMJ

16. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 16 Most published analyses report favorable incremental cost effectiveness ratios Studies funded by industry were more likely to report ratios below the three thresholds Studies of higher methodological quality were less likely to report ratios below $20,000/QALY Bias in Published Economic Evaluations Bell et al. 2006; BMJ

17. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 17 Bottom Line Use caution when interpreting economic evaluations in the literature Critical appraisal is a must

18. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 18 Searching Bibliographic Databases for Economic Evaluations Indexing policy –availability of controlled vocabulary –specificity of indexing terms Indexing accuracy –clarity of description –accurate labelling –consistency

19. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 19 MEDLINE MeSH is the U.S. National Library of Medicine's controlled vocabulary used for indexing articles for MEDLINE/PubMed Using this terminology should greatly enhance your efficiency Can also use – related links – a command to identify similar articles

20. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 20 Link to MeSH Database of Search Terms Brief Tutorial Links on How to Use MeSH Terms for Searches

21. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 21 Example How would you search for relevant articles on nose bleed using MeSH terminology?

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27. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 27 MeSH Terms for Economic Evaluations Economics –Costs and Cost Analysis Cost Allocation Cost-Benefit Analysis ***Target MeSH Term*** Cost Control (+) Cost of Illness Cost Sharing (+) Health Care Costs (+) Health Expenditures (+)

28. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 28 Example How would you identify published economic evaluations for the treatment of glaucoma using MeSH terminology?

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38. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 38 Other Sources for Economic Evaluations Databases CEA Registry Tufts/NEMC (formerly Harvard CUA Database) Multiple European Databases (NHS EED, HEED, EURONHEED) Journals Traditional medical journals (JAMA or NEJM) Focus on health economics (HSR or MDM)

39. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 39 Using Economic Evaluations for Formulary Decisions Are the results from an economic evaluation useful to me in my setting? 1)Is the methodology employed in the study appropriate? 2)If the results are valid, would they apply to my setting?

40. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 40 Guidelines for Economic Evaluations Conduct –Pharmaceutical Reimbursement (WellpointRx) –Methodology (NICE, PHS Panel) Reporting –BMJ Guidelines (Drummond et al. 1996) Appraisal –BMJ Guidelines (Drummond et al. 1996) –Methods for the Economic Evaluation of Health Care Programmes (Drummond et al. 2005)

41. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 41 Check-List Example for Appraisal of Economic Evaluations Was a well-defined question posed in answerable form? –Did the study examine both costs and effects of the drug under study? –Did the study involve a comparison of alternatives? –Was a viewpoint for the analysis stated and was the study placed in any particular decision- making context? Drummond et al. 2005

42. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 42 Check-List Example for Appraisal of Economic Evaluations Was the effectiveness of the various treatments established? –Did the study use data from randomized, controlled clinical trials? –Was the information collected and summarized through a systematic overview? –Were observational data or assumptions used to establish effectiveness? Drummond et al. 2005

43. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 43 Check-List Example for Appraisal of Economic Evaluations Were all relevant costs and consequences valued accurately and credibly? –Was the range wide enough for the research question at hand? –Were the sources of all values clearly identified? Drummond et al. 2005

44. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 44 Check-List Example for Appraisal of Economic Evaluations Drummond et al. 2005 Was an incremental analysis of costs and consequences of alternatives performed? –Were the additional costs generated by one alternative over another compared to the additional effects, benefits, or utilities generated?

45. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 45 Check-List Appraisals of Economic Evaluations Unrealistic to expect every study to satisfy all of the points in a check-list However, it can help identify and assess the strengths and weaknesses

46. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 46 Application of Results from Economic Evaluations Once deemed valid, the next step is to determine if the study results apply to you No clear answers to this question However, several factors are worth considering when evaluating results from economic evaluations

47. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 47 Factors Likely to Affect Cost- Effectiveness in the MHS Basic demography and epidemiology of disease in the population studied Availability of health care resources and variations in clinical practice Incentives to health care professionals and institutions Relative prices or costs Population values

48. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 48 Use of Economic Evaluations Momentum for use of economic evaluations continues to build Useful as an aid for making comparisons between interventions Could provide a framework for evaluating proposals for formulary additions In general, can be used as a systematic way of thinking or structuring problems

49. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 49 Conclusion Identification of economic evaluations is easily accomplished through MEDLINE The existing literature has shown gaps in quality but is improving Appraisal and transferability of these studies are key issues for consideration Economic evaluations should play a role in the formulary decision-making process

50. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 50 References Health Economics Information Resources: A Self-Study Course – available through the National Information Center on Health Services Research and Health Care Technology (NICHSR) Drummond et al. (2005) Methods for the economic evaluation of health care programmes (3 rd ed.) Gold et al. (1996) Cost-effectiveness in health and medicine