Health Technology Assessment ارزیابی فناوری سلامت

1. Health Technology Assessmentارزیابی فناوری سلامت

2. چارچوب مطالب • تاریخچه شکل گیری ارزیابی فناوری سلامت در دنیا • تعریف فناوری و ارزیابی فناوری سلامت • مراحل انجام یک پروژه ارزیابی فناوری سلامت • مدل بومی تدوین اسناد ارزیابی سلامت • مثالی از یک پروژه ارزیابی فناوری سلامت

3. ارزیابی فناوری سلامت • ارزیابی فناوری سلامت بعنوان یکی از ابزارهای کلیدی تصمیم گیری و اولویت بندی در اغلب کشورهای در حال توسعه هنوز مفهومی جدید می باشد. • این روش به سرعت در حال گسترش می باشد چرا که تصمیم گیران و سیاستگذاران بخش سلامت سراسر جهان نیازمند شواهد علمی و جامعی هستند که HTA تولید می کند. • سازمان جهانی بهداشت نیز تقریباً از دو دهه قبل تاکید زیادی بر ارزیابی فناوری سلامت داشته است.

4. سازمان های HTA در کشورهایی نظیر مالزی، فیلیپین، تایلند، چین و پاکستان خود گواهی است بر این مقوله که ارزیابی فناوری سلمت در کشورهای در حال توسعه روند رو به رشدی دارد.

5. سرانه کل هزینه های سلامت: 3187 دلار سرانه کل هزینه های سلامت: 247 دلار

6. کلیه مداخلات ضروری بودن درمان؟ اثربخش بودن درمان؟ کارا بودن درمان؟ توانایی بیمار در پرداخت هزینه درمان؟ مداخلات بسته پایه Dunning Funnel

7. Health Technology Assessment New or Necessary? “Not everything that is new in health care technology is good… Not all that is good is needed”

8. Health Technology Assessment The Consequence of Decisions “every decision we make has consequence”

9. History of Technology Assessment • Technology assessment (TA) arose in the mid 1960s from an appreciation of the critical role of technology in modern society and its potential for unintended and sometimes harmful consequences. • Experience with the side effects of a multitude of chemical, industrial and agricultural processes.

10. Early Assessments • Early assessments concerned such topics as offshore oil drilling, automobile Pollution, nuclear power plants and supersonic airplanes

11. The term “Technology assessment” was introduced in 1965 during deliberations of the “Committee on Science and Astronautics of the US House of Representatives”. • Congressman Emilio Daddario emphasized that the purpose of TA was to serve Policy making.

12. HTA

13. TA methodology drew upon a variety of analytical, evaluative and planning techniques. • Among these were systems analysis, Cost-Benefit analysis, Consensus methods (e.g. Delphi method), Clinical trials, Market research, technological forecasting and others.

14. HTA : Definition • Any process of examining and reporting properties of a medical technology used in health care, such as safety, efficacy, feasibility, and indications for use, cost, and cost-effectiveness, as well as social, economic, and ethical consequences (Institute of Medicine 1985)

15. Health Technology assessment considers the effectiveness, appropriateness and cost of technologies. It does this by asking four fundamental questions: • Does the technology work, for whom, at what cost, and how does it compare with alternatives? (UK National Health Service 2003)

16. Technology? • Technology is the practical application of knowledge • Three ways to describe health care technology include its material nature, its purpose, and its stage of diffusion

17. Technology is a key driver of health care costs • Technology accounts for 50% to 60% of the health care cost inflation • 50% of all diagnostic treatment methods used today did not exist 10 years ago • More than 20000 drugs in Canada, an estimated 490000 medical devices

18. Material Nature • Drugs • Biologics • Devices and Equipment • Medical and surgical procedures • Support systems • Organizational and management systems (e.g. HMOs,DRG,EFQM,CQI,CG,..)

19. Purpose or Application • Prevention • Screening • Diagnosis • Treatment • Rehabilitation

20. Stage of Diffusion • Future • Experimental • Investigational • Established • Obsolete, outmoded, abandoned

21. Purpose of HTA • Regulatory agencies (FDA,…) • Health care payers (BP) • Clinicians and patients • Health professional associations • Hospitals, health care networks • Standards-setting organization • Lawmakers and other political leaders • Health care product companies • Investors

22. Timing of Assessment • There are tradeoffs inherent in decisions regarding the timing for HTA • On one hand, the earlier a technology is assessed, the more likely its diffusion can be curtailed if it is unsafe or ineffective • On the other hand, to regard the findings of an early assessment as definitive or final may be misleading.

23. Timing of Assessment • As one technology assessor concluded about the problems of when to assess : • “Its always too early until, unfortunately, its suddenly too late ! “ (Buxton 1987) • Further, the “Moving target problem” can complicate HTA (Good man 1996)

25. Alternative procedures to clarify the problem • Primary research project • Systematic Literature review/Meta analysis • Economic analysis • Health Technology Assessment • Clinical Practice Guideline • Decision-making in usual administrative framework • Clinical audit

27. Efficacy vs. Effectiveness • In HTA, efficacy refers to the benefit of using a technology for a particular problem under ideal condition. • Effectiveness refer to the benefit of using a technology for particular problem under general or routine condition.

28. Different in : • Patient Population • Procedures • Testing Conditions • Practitioner

30. Technology Quality Required Infrastructure Efficacy Effectiveness Compliance Human Resource

31. The Process of HTA • Scoping • Assessment • Appraisal • Technology Impact Assessment

32. The Scoping workshop • After consultees and commentators have submitted their comments on the draft scope, a meeting (Scoping workshop) is held. • The workshop aims to generate discussion on the scope of the appraisal from different perspectives in order to produce an appropriate final scope of the appraisal and to lead to the development of a protocol.

33. Scoping • Different steps • The depth of any Steps

34. فناوری جدید مشکل فناوری جایگزین

35. نکته • فناوری جایگزین در کشورهای مختلف و حتی مناطق مختلف می تواند متفاوت باشد. • آیا نتایج ارزیابی فناوریهای انجام شده در سایر کشورها عیناً قابل استفاده می باشد؟

36. Scoping • پیامد را با چه واحدی اندازه گیری کنیم؟ • هزینه هایی را به چه شکلی (چه دیدگاه و عمقی) محاسبه خواهیم کرد؟ • بازه زمانی محاسبه پیامدها و هزینه چقدر است؟ • از کدام شواهد استفاده خواهیم کرد؟ • چطور از Efficacy به ٍEffectiveness می رسیم؟ • کجا از شواهد جهانی و کجا از شواهد بومی استفاده خواهیم کرد؟ • ملاحظات اجتماعی و ... را چگونه لحاظ خواهیم کرد؟

37. Process of HTA • Scoping • Assessment • Systematic Review on Safety and Efficacy of Technology - Systematic Search - Quality Assessment - Data Extraction - Data Analysis & Synthesis • Economic Evaluation - Literature review - Local Economic Evaluation

38. Appraisal • Accessibility, Affordability • Acceptability, Preference --Literature reviews --adverse effect --Patient survey • Feasibility --Case study --Feasibility Studies --- infrastructure ---Trained human ---Culture

39. Technology Impact Assessment • Equity Concerns • Organization issues • Economic Impact Assessment • Health Impact Assessment

40. Technology Assessment Review Date A Revision Plan 3-4 year Technology dynamics

41. Selection of Technologies for HTA Assessment of Health Needs Identification of Possible Technologies Priority Setting of Topics for HTA

42. Principles of HTA Priority Setting • There are three important aspects that need to be tackled and handled with flexibility: 1.The Criteria 2.The Process 3.The People Involved

43. The Process of HTA • Scoping • Assessment - Evaluation of Efficacy and Safety of Technology - Economic Evaluation of Technology • Appraisal • Accessibility, Affordability • Acceptability, Preference, Compliace • Feasibility • Technology Impact Assessment - Social and Equity impact - Organizational Impact - Economic Impact - Health Impact

45. What is cost-effectiveness analysis? • Cost-effectiveness analysis systematically compares decision option in terms of their monetary cost and effectiveness • Cost-Effectiveness analysis is particularly valuable to compare different interventions for a specific condition and, on a broader scale, may allow comparison of alternative uses of societal resources (Resource Allocation)

46. Benefit, Effectiveness,Utility • Cost-Effectiveness analysis : - Benefit in health units(e.g. AIDS cases prevented, lives saved) • Cost-utility analysis : - Benefit in utility(quality-of-life) units (e.g. QALYs) • Cost-Benefit analysis: - Benefit in dollar units (e.g. willingness to pay for result)

47. Effectiveness CE CE Cost ? ------ CE NO ? NO NO When an intervention is called cost-effective

48. سایت موسسه ملی تحقیقات سلامت : الگوی ارزیابی سریع فن آوری های سلامت Rapid Health Technology Assessment

49. مراحل انجام یک ارزیابی سریع فناوری سلامت • فراخوان ارایه پیش طرح (زمان صفر و شروع طرح و عقد قرارداد) • گزارش اولیه طرح • گزارش ثانویه طرح • گزارش نهایی و ارایه طرح

50. Scope Trip