Health technology assessment in the United States

1. Health Technology Assessment
In
The United States

2. 2
Outline
 History
 Structure
 Organization
 HTA Component
 Use of HTA in Decision Making

3. 3
History
 1967 ： The term was used in the US Congress
 1972: Office of Technology Assessment (OTA) was
established
 1978: National Center for Health Care Technology
 CT scanner was the first target for HTA
Source: Perry 1988

4. 4
Structure
 The US has not a national HTA framework
 Public and private mix structure
 HTA is quite fragmented and uncoordinated
 Includes both public and private sector initiatives
 In contrast to other Developed countries, the current state of
technology assessment the US is
 Decentralized
 Fragmented
 Duplicative
Source: Perry 1988, ISPOR

5. 5
Structure
 In contrast to federal HTA activity, the growth of HTA
organizations within the private sector has been consistent
and significant.
 The growth of HTA in the United States has been largely
restricted to the private sector
 In the U.S., both government-funded and private entities
generate HTAs.
Source : Haas 2007, Ware 2009

6. 6
Structure
 The purposes, scope, methods, and other characteristics of
HTAs that are conducted or sponsored by these organizations
vary widely
 However, the structure, procedures, and goals of each of
these organizations differ greatly from one another.
Source: Haas 2007

7. 7
Public sector has HTA activities:
 Minnesota Health Services Advisory Council (HSAC)
 Oregon Health Resources Commission (HRC)
 Washington Health Technology Assessment Program (WA-
HTA)
 VA (Veterans Administration)
 FDA(Food and Drug Administration)
 AHRQ(Agency for Health Research and Quality )
Source: Sullivan 2009

8. 8
Private sector has HTA activities:
 Insurance Companies
 Hospitals
 Medical/device Manufacturers
 Consulting Firms
 Health Professional Organizations
 Academic Medical Centers
Source :Perry 1997

9. 9
HTA organizations existed in the US
Source :Perry 1997
Type of organization Number Time per assessment
Federal 7 1-24
State 3 6-9
Hospitals 5 2-10(w)
Health insurance 11 1-10(d)
Health professions 8 6-36
Academic/Not for profit
research
12
2-120(d)
Consulting firms 4 3-6(w)
Drug/device
manufactures
3
1-120(d)

10. 10
Distribution of US HTA programs in 1995 by type of organizations
Source: Perry 1997

11. 11
The Office of Technology Assessment
 The OTA was established in 1972
 Technology assessments to inform federal funding decisions
about emerging health and no health technology
 The OTA model was adopted by many of the current well-
established international HTA programs
 CT scanner was OTA’s first target for HTA
 The OTA was disbanded in 1995
Source: Oregon 2011, Sullivan 2009

12. 12

13. 13
Why did these efforts fail?
 First, HTA was perceived as a threat to investing in innovative
medical technologies.
 Second, HTA was perceived to threaten organized medicine’s
medical autonomy.
 Third, HTA was perceived to threaten access to the latest
innovations by patient advocacy groups.
 Fourth, to the extent that economic evaluation was included, HTA
was seen by these stakeholders as a way to ration health care to
contain cost.
Source : Luce 2009

14. 14
Programs
State
Oregon
Washington
Minnesota
FederalCMS
AHRQ
VATAP

15. 15
Food and Drug Administration
 This agency does not conduct
formal technology assessments.
 Instead, FDA staff evaluates pre licensing studies of safety and
efficacy submitted by manufacturers in support of their new
drug applications.
Source: Sean, 2009

16. 16
Agency for Healthcare Research and Quality
 AHRQ historically has been the largest
federal funder publicly available HTA in the United States
 The most prominent federal agency that supports HTA
 Key Factor Analyzed: quality, safety, efficiency and effectiveness of
healthcare
 Type of Technologies :drugs, medical devices, tests, surgeries, or
ways to deliver health care
Source: Sean 2009 , Luce 2009

17. 17
Agency for Healthcare Research and Quality
 Mission: AHRQ's mission is to conduct and support studies of
the outcomes and effectiveness of diagnostic, therapeutic and
preventive health care services and procedures.
 The AHRQ supports HTA research primarily through three
external research networks coordinated within the Agency’s
Effective Healthcare Program.
Source: INAHTA

18. 18
Agency for Healthcare Research and Quality
 The Technology Assessment (TA) Program at the AHRQ
provides technology assessments for the Centers for
Medicare & Medicaid Services (CMS).
 These technology assessments are used by CMS to inform its
national coverage decisions for the Medicare program as well
as provide information to Medicare carriers.
Source: AHRQ

19. DEcIDE
CERTs
EPCs
HTA Reports
Systematic
reviews
1)Effectiveness
2)Comparative
effectiveness
3)Safety
4) Cost-
effectiveness
(rare)
External research
networks

20. EPCs
GoalsPolicy
The Evidence-based
Practice Centers
To improve the
quality and
effectiveness of
healthcare
through
technology
assessments
To inform public and
private insurers’ coverage
determinations

21. CERTsThe Centers for Education and
Research on Therapeutics
1)Drugs
2)Biological
interventions
3)Devices

22. DEcIDE
EPCs
Developing Evidence to Inform
Decisions about Effectiveness
conduct and
support
1)Treatment
appropriateness
2)Health
outcomes
3)comparative
effectiveness

23. DEcIDE
CERTs
EPCs
HTA Reports
Systematic
reviews
1)Effectiveness
2)Comparative
effectiveness
3)Safety
4) Cost-
effectiveness
(rare)
External research
networks

24. 24
The Centers for Medicare and Medicaid Services (CMS)
 The agency’s internal Coverage and
Analysis Group (CMS-CAG) conducts
technology assessments for the topics under review and issues
coverage determinations.
 CMS-CAG may request formal HTAs conducted by AHRQ
 For topics that involve conflicting or complex medical information,
the agency may request an independent evidence review by the
Agency for Healthcare Research and Quality (AHRQ)
Source: Pinson 2011

25. 25
Veterans Administration Technology Assessment
Program (VATAP)
 VATAP is a program dedicated to advancing evidence-based
decision making, and helps senior policymakers to determine
"what works" in health care by carrying out systematic reviews
of the medical literature on health care technologies.
 VATAP evaluations encompass devices, drugs, procedures,
and organizational and supportive systems used in health care.
Source: RIPSA

26. 26
Minnesota Health Technology Advisory Committee
(HTAC)
 The HTAC was created in 1993
to be an objective, state-specific source of
technology evaluation for both public
and private sector decision makers.
 HTAC was made up of nineteen representatives from physician
groups, technology industry representatives, health plans, and
ethicists.
 The group made recommendations on emerging technologies.
Source: Wulsin 2008

27. 27
Oregon Health Resources Commission (HRC)
 The OR HRC was created in 1990s
 The program include criteria for
selection of the medical technologies
to be assessed.
 This was the first large-scale public attempt to apply cost-
effectiveness analyses
Source: Pinson 2011

28. 28
Washington Health Technology Assessment Program
(WA-HTA)
 The WA-HTA was established
in 2006
 The assessments will gauge the safety
, clinical effectiveness, and cost-effectiveness of selected
technologies.
 The goal is to promote the purchase of excellent health care by
investigating and paying for tests and treatments proven safe,
effective, and cost effective.
Source: wulsin 2008, Curtis 2012

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HTA Component
 Program Purpose
 Structure of HTA organization
 Scope
 Stakeholder Involvement:
 Topic Nomination
 HTA Products
 Use of HTA in Decision Making
Source: Pinson 2011

30. 30
Program Purpose: Role of a HTA program in relationship to
policy making
 Advisory with respect to evidence only
 OR HRC
 VATAP
 Advisory with respect to evidence and policy options
 MN HSAC
 Authority to make coverage determinations
 CMS-CAG
 WA-HTA
Source: Pinson 2011

31. 31
Structure of HTA organization
 Government agency
 CMS-CAG
 VATAP
 MN HSAC
 OR HRC
 WA-HTA
Source: Pinson 2011

32. 32
Scope of HTAs
 Source: Pinson 2011
HTA Types of Technologies Key Factors
CMS-CAG Services covered by Medicare – specific
types not specified
Effectiveness
VATAP
Vaccines, Pharmaceuticals
Devices ,Procedures
Organizational and support systems
Medical , Social
Ethical ,Economic
MN HSAC Health care services paid for by state
program
Effectiveness ,Cost
OR HRC
Pharmaceuticals ,Medical equipment and
devices , Medical or surgical procedures,
Supportive systems
Effectiveness
WA-HTA
Medical and surgical devices and
procedures , Medical equipment
Diagnostic tests
Safety ,Efficacy
Cost-effectiveness

33. 33
Stakeholder Involvement(Committees)
 CMS-CAG: industry and consumer representatives, and external
subject area experts
 MN HSAC: health care professional and consumer representatives
 OR HRC: physician, pharmacist, hospitals, insurance, business,
labor, and consumer representatives
 WA-HTA & VATAP: No information
Source: Pinson 2011

34. 34
Target Audiences
 CMS-CAG: CMS – Medicare Coverage Decisions
 VATAP : Senior VHA decision makers
 MN HSAC: Department of Human Services
 OR HRC : Oregon Health Authority
 WA-HTA : State direct purchased health care program
Source: Pinson 2011

35. 35
Topic Selection
 OR HRC: factors such as utilization (including overall
utilization, trends and variability in utilization) and costs
(including overall costs as well as cost variability)
 WA-HTA: select topics based on technology review priorities
established in law
 VATAP: No information

36. 36
Topic Selection
 CMS-CAG: CMS-CAG requests HTAs for NCDs where there
is conflicting or complex medical and scientific literature
available, or when it is believed an independent analysis of
literature will be helpful for coverage decisions
 MN HSAC: impact to health and budget, availability of
literature, and political relevance
Source: Pinson 2011

37. 37
Use of HTA in Decision Making
 CMS-CAG: Provides advisory recommendations
 VATAP : No information
 MN HSAC: Summary documents as a starting point for discussion
 OR HRC : Shares results of HTAs
 WA-HTA : Coverage decisions based on the health technology
assessment
Source: Pinson 2011

38. 38
HTA Product
 CMS-CAG: Systematic review conducted by AHRQ
 VATAP : Brief Overview; bibliography
 MN HSAC: Evidence summary, including proposed coverage
decision
 OR HRC : Evidence summary; Brief Clinician Summaries
 WA-HTA : Health technology assessments; findings and coverage
decisions
Source: Pinson 2011

39. 39
Criteria to prioritize and select topics(WA-HTA)
 Concerns about its safety, efficacy, or cost-effectiveness,
especially relative to existing alternatives, or significant
variations in its use
 Actual or expected state expenditures are high, due to demand
for the technology, its cost, or both
 Adequate evidence available to conduct the complete review
Source: Pinson 2011

40. 40
Secondary criteria(WA-HTA)
 Number of persons affected per year
 Severity of condition treated by technology
 Policy related urgency
 Diffusion concern
 Potential or observed variation
 Special populations
 Ethical concerns
Source: Pinson 2011

41. 41
formal health technology assessment process
I. Horizon scanning
II. Topic determination and queuing
III. Collection and assessment of evidence
IV. Funding and policy implementation

42. 42
Horizon scanning involves the early examination and
active monitoring of emerging technology to determine, in
part, potential evidence requirements, and budgetary
implications.
Topic determination and queuing activities focus on
setting priorities and sequencing of emerging and
previously considered technologies for assessment or
reassessment.
The assessment function entails the process of
collecting, evaluating, and systematically reviewing all
available evidence for the technology under consideration.

43. 43
Appraisal is the decision-making function and is often
distinguished by an external body (e.g., a pharmacy and
therapeutics committee in the United States) that considers and
weighs the summarized evidence in order to render a
recommendation to the payer.
Funding and policy implementation are the final steps in the
HTA process.

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