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A
Setting Priorities for Health
Technology Assessment: A Mode' Process
Executive Summary
Committee on Priorities for Assessment and
Reassessment of Health Care Technologies
The Institute of Medicine (10~ Committee on Priorities for Assessment and
Reassessment of Health Care Technologies was charged to propose a process for
setting priorities for technology assessment in the Office of Health Technology
Assessment (OHTA) of the Agency for Health Care Policy and Research
(AHCPR) and in other assessment organizations. (AHCPR is part of the U.S.
Public Health Service.) In responding to this charge, the committee organized
its work and this report at three levels of specification: general principles, a
proposed process, and information about how to implement the process in OHTA
and other organizations that conduct health technology assessment.
This summary reviews the main points of the report: the rationale for the
process developed by the committee,the committee's 1 1 recommendations, seven
steps needed to implement the proposed process, anticipated resources and
penodicity of the process, and implementation issues that require consideration.
Further, it examines how the proposed priority-setting process might be used or
adapted by other organizations and for purposes other than technology
assessment.
Excerpt from Institute of Medicine, Setting Priorities for Health Technology
Assessment: A Model Process. M.S. Donaldson and H.C. Sox, Jr., eds. Washington,
D.C.: National Academy of Press, 1992.
77
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78
SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
RATIONALE
Clinicians, payers, and policymakers turn to technology assessment to help
provide better information for clinical decision making, to guide coverage
decisions, and to set national health policy. Technology assessment can play a
valuable role in the entire process of improvement of health and health care. For
example, an assessment may show that the data needed for a complete evaluation
of a technology are not available. This finding may serve as an impetus to
initiate research to supply the missing information. Similarly, an assessment may
lead to changes in practice norms when it yields a conclusion that differs from
common clinical behavior.
Yet efficient use of resources for technology assessment requires a
systematic priority-setting process. In the legislation establishing AHCPR, the
IOM was asked to develop a process and criteria for setting priorities for health
care technology assessment and reassessment to assist OHTA in is expanded role
within that agency.
recognition ofthe need to look systematically at the value of health care services
in improving health. This kind of assessment uses measures of effectiveness as
a means of better understanding the appropriate use of new and established
technologies; the expansion of the role of OHTA to develop a comprehensive
process to guide this work is consistent with that goal. Such a process should
also be of value to other organizations that, notwithstanding their different goals,
must develop priorities for the use of limited assessment resources.
"7~
The establishment of AHCPR itself can be seen as
METHODS OF PRIORITY SETTING
The committee described several examples of priority setting from a number
of different organizations or groups: (1) the Health Care Financing
Administration; (2) a research-intensive pharmaceutical company; (3) the Clinical
Efficacy and Assessment Program ofthe American College of Physicians end the
Diagnostic and Therapeutic Technology Assessment Program of the American
Medical Association; (4) the priority-setting process used by the IOM's Council
on Health Care Technology in its 1990 pilot study; (5) the Food and Drug
Administration; two examples of quantitative models of priority settings
David Eddy's Technology Assessment Priority-Setting System and (7) the
Phelps and Parente model; and (8) the process developed under the Oregon Basic
Health Services Act to set priorities for Medicaid spending.
The committee drew on these examples to derive a set of principles for
developing a process for OH1 A to use in setting priorities. Although individual
assessment organizations may have various goals in assessment, the public as a
whole has an interest in the effects and use of medical technologies. Public
agencies need a comprehensive, proactive process of public input to ensure that
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APPENDIX A
79
the technology assessment provides the greatest gain into the health ofthe public.
In addition, priority setting must be accountable to the public. It cannot be
private, implicit, or internal to the organization, and it must include a process that
is open, fair, and credible to discriminate among the array of possible
technologies that it might assess or reassess.
There are a number of benefits to be derived from the use of analytic
models they structure thinking, use what data are available, open the process
to review and accountability, and are amenable to examination and adjustment
of both the results and the methodology. Such models move the technology
assessment process closer to a realization of its potential for strengthening the
scientific basis for decision making. The use of analytic models, however, is
more complex and requires more resources (at least initially) and expertise than
an implicit process that simply reacts to requests for technology assessment. The
committee concluded that any analytic model must include a process to review
its product, and a way to include issues of equity, as well as unusual ethical and
legal dimensions presented by health care technologies. Nevertheless, priority
rankings established by means of an analytic model should be understood as
inputs to a final decision process, not the final product of the process itself.
GUIDING PRINCIPLES
The committee formulated several general principles to direct its
development of a priority-setting process. The first such principle is that any
priority-setting process for technology assessment must be consistent with the
mission of the organization that uses it. For a public agency, the values of the
public that the agency serves need to be incorporated into the priority-setting
process. Such a process for OHTA will have to assemble information about the
potential of a technology to improve health outcomes, to reduce inappropriate
expenditures, to redress inequity among those receiving health care, and to
inform special social issues.
Second, the priority-setting process must consider the information needs of
users. The process designed for OHTA should, in general, focus on technology
assessment for specific clinical conditions and on alternative approaches to
management of those conditions.
Third, the priority-setting process must be efficient so that scarce resources
for technology assessment are not needlessly consumed in the process of setting
assessment priorities. OHTA should seek broad input at the outset, but it should
also have some relatively simple mechanism to identify the important topics.
The process should also take advantage of available data or, where data are
lacking, of subjective judgments, rather than require the collection of new data.
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SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
Finally, the priority-setting process must be sensitive to its political context;
it must be and must appear to be-objective, open, and fair; it must invite input
from a variety of interested parties; and it must present the logic of the process
clearly and carefully to others.
THE PROCESS PROPOSED BY THE IOM COMMITTEE
Steps in the Process
The committee presents below the description of a process that can be
understood as logically deriving from consideration of the issues noted in the
above principles. Figure S.1 shows seven elements: (1) selecting and weighting
criteria for establishing priorities: (2) eliciting broad input for candidate
conditions and technologies; (3) winnowing the number of topics; (4) gathering
the data needed to assign a score for each priority-setting criterion for each topic;
(5) assigning criterion scores for each topic, using objective data for some
criteria and a rating scale anchored by low- and high-priority topics for
subjective criteria; (6) calculating priority scores for each condition or technology
and ranking the topics in order of priority; and (7) requesting review by the
AHCPR National Advisory Council.
Seven Criteria
The committee recommended and defined seven priority-setting criteria and
explained how to assign scores for each of them. Three of the criteria are
objective prevalence, cost, and clinical practice variations; they are scored using
quantitative data to the extent possible. Four of the criteria are
subjective- burden of illness, and the likelihood that the results ofthe assessment
will affect patient outcomes, costs, and ethical, legal, and social issues; these
criteria are scored according to ratings on a scale from 1 to 5.
Reassessment
Certain aspects of priority setting apply only to reassessment of previously
assessed technologies: these include recognizing events that trigger reassessment
(e.g., changes in the nature of the condition, in knowledge, or in clinical
practice); the need to track information related to previous assessments; and the
obligation to update a previous assessment as a fiduciary responsibility and to
preserve the credibility of the assessing organization.
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APPENDLY A
ACTIVITY
1. Select priority-setting criteria and assign I | Panel
weight to each
1 - 1
1 1
2. Solicit nominations of candidates for I I Staff
technology assessment
It
3. Reduce a large list of nominees to those on
which to obtain the data set needed for priority
ranking
4. Obtain data set for priority ranking
RESPONSIBLE
PARTY
~1
Panels
Staff
_ _
S. For each topic, assign a score for each | Priority-setting model
attribute
6. Calculate priority score and rank topics in
order of priority
_
7. AHCPR panel reviews priority list
_ | Staff
I?IGURE 1 Overview of the IOM priority-setting process.
81
r - 1
Because the committee believes that OHTA has a special obligation to
consider previously assessed topics as candidates for reassessment, it also
believes that the agency should maintain a process for monitoring the published
literature on previously assessed topics and should place candidates for
reassessment on the same competitive footing in the priority-setting process as
candidates for first-time assessment.
ills
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82
SETTING PRIORITIES FOR CLINIC,4LPRACTICE GUIDELINES
Priority-Setting Cycle
lThe committee envisions priority setting as occurring in a cycle. The panel
(see below) sets criterion weights approximately every 5 years. The
priority-setting cycle itself repeats at least once every 3 years and leads to a
rank-ordered list of conditions and technologies. The priority-setting cycle
begins and ends with involvement of persons arid institutions outside the federal
government. At the beginning, OHTA asks a broad range of persons and
institutions to nominate conditions and technologies that they wish to have
assessed. OHTA staff collect the data required to set objective criterion scores
and convene panels to assign criterion scores to each condition or technology.
Human Resources Required to Implement the Process
A broadly representative panel would set criterion weights, reduce the list
of nominations of conditions or technologies, and assign criterion scores to each
of these topics. Subpanels might be required to divide the workload; the
subpanels would need to be separately constituted to assign subjective or
objective criterion scores. The subpanel~s) assigning subjective criterion scores
would tee composed of individuals with the same range of perspectives as the full
panel. The subpanelts) assigning objective criterion scores would require experts
in epidemiology and health statistics to review the data collected by OHTA staff
and to develop estimates when necessary.
Publicly Available Products
The committee envisions two products of the priority-setting process that
would be publicly available: a list of the priority-ranked technologies and the
data base used to construct the list. Both would contribute to a priority-setting
document published by OHTA. Each highly ranked technology should also be
accompanied by a discussion of the features that contributed to its ranking, the
data sources used, the level of confidence the panels assigned to the data, and
any strongly held minority views.
Topics for Which There Is Insufficient Evidence to
Conduct an Assessment Based on Review of the Literature
OHTA should adopt methods that will enable it to conduct preliminary
assessments even when there is not yet adequate evidence on which to base a
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APPENDIX A
83
strong clinical policy recommendation. For topics that are of high priority for
assessment but for which there is insufficient evidence, the committee
particularly recommends using decision analysis as a way to identify which
missing evidence is most important for decision making. These results can then
be used as input to the development of an agenda for empirical research
sponsored by AHCPR. This concept of linking priority setting, assessment ofthe
evidence, and a research agenda is very important to the future of technology
assessment and of evidence-based medical practice.
RECOMMENDATIONS
The committee's recommendations are listed and described briefly below.
Recommendation 1
OHTA should adopt a systematic process to assist decision making
about which medical conditions and technologies it should assess or reassess.
The process should involve a broad spectrum of interested parties and
should be open to public view, resistant to control by special interests, and
clearly understandable.
The process proposed by the committee would be conducted in two
phases the setting of weights for criteria, which is performed approximately
every 5 years, and the rest of the priority-setting process, which is performed
approximately every 3 years.
Recommendation 2
OHTA technology assessment, whenever feasible, should focus on a
clinical problem (e.g., diagnosis of coronary artery disease) rather than on
a technology per se (e.g., exercise thallium radionuclide scan). Similarly,
priority setting should address clinical conditions.
Although concern about a new test or treatment often leads to calls for its
assessment, whenever possible, a technology should be evaluated within the
context of the clinical condition for which it is being used. There are two
reasons for proposing this orientation. First, technology assessment should be
comparative, implying that it should answer a useful clinical question: Which
technology should a practitioner use and under what clinical circumstances?
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SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
Second, a technology can only be evaluated in the context of what it does, which
is to help solve a clinical problem.
Recommendation 3
OlITA technology assessments should compare the alternative
technologies for managing a clinical condition. Similarly, the priority-setting
process should include alternative technologies for managing a clinical
condition.
The data required to determine the assessment priority of a clinical condition
depend on which technologies are relevant to its management. (For example, the
expected cost of managing a condition depends on the costs of the individual
technologies that might be used.)
Many parties need information about alternative technologies for managing
a condition. For instance, clinicians and patients must choose among alternatives
tests and treatments. Third parties, too, are concerned about the marginal effects
of a technology the additional benefits and risks represented by one technology
in comparison with another. This recommendation holds true even when a new
technology is the first to be applied to a clinical problem: when there are no
obvious comparative technologies, watchful waiting without therapeutic
intervention is always a valid, and important, alternative.
The comparison oftechnologies should take place on a"level playing field";
that is, the same methods and similar circumstances should be applied to all of
the technologies.
Recommendation 4
OlITA should identify criteria that best characterize a topic's
importance as a candidate for assessment. The committee recommends the
following objective criteria:
· prevalence of the specific condition;
· unit cost of the technologies commonly used to manage the condition
(or the unit cost of a technology and its alternatives); and
· variation in the rate of use of a technology for managing the condition
(or variations in the rates of use of the technology and its alternatives).
Ordinarily, the data required to characterize a candidate topic may be found
in the published literature or elsewhere in the public record. Prevalence is the
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APPENDIX A
85
number of people with the condition per 1,000 persons in the general population.
Unit cost is the total direct and induced cost of conventional management for a
person with the clinical condition. Variation in rates of use across different
settings of care is measured by the coefficient of variation. A high coefficient
of variation frequently implies a low level of consensus about clinical
management.
The committee also recommends the following subjective criteria:
· burden of illness imposed by the clinical condition;
· potential of the results of the assessment to change health outcomes;
· potential of the results of the assessment to change costs; and
· potential of the results of the assessment to inform ethical, legal, or
· ~
socla Issues.
Although objective data may exist with which to characterize a candidate
topic, integration of these data often requires a subjective estimate. Burden of
illness, which is estimated at the level of the patient rather than of society, is the
difference between the quality-adjusted life expectancy (QALEJ of a patient who
has the condition and who receives conventional treatment and the QALE of a
person of the same age who does not have the condition. The potential of the
results of the assessment to change health outcomes is the expected effect of the
result of the assessment on health outcomes for patients with the illness. It
includes consideration of the findings of the assessment and of the likelihood of
policy and administrative changes, clinical practice changes, and patient
acceptance. The potential of the results of an assessment to change costs is the
expected effect of the results of an assessment on the costs of illness for patients
with the illness. It includes direct costs to the patient and induced costs.
The committee anticipates that most conditions will be adequately ranked
based on the first six criteria listed above. The seventh criterion the potential
of the results of the assessment to inform ethical, legal, or social issues Ives
the priority-setting panelists the opportunity to take a broad social perspective
and to ask whether there is anything that has not been captured in the first six
criteria that would alter the priority listing of a particular topic.
Recommendation 5
OHTA should use an explicit process to determine a candidate topic's
priority ranking. In the ranking process, the criteria that are important in
deciding whether to do an assessment determine a topic's priority rank.
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SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
The committee recommends the use of a process that can be examined,
challenged, and adjusted on the basis of tests of its reliability and validity. Use
of a quantitative model as part ofthis process allows assumptions to be explicitly
stated and individually assessed; it also permits the use of data, whenever they
are available.
Recommendation 6
The committee recommends a specific quantitative method to calculate
a priority score for each candidate topic using the following formula:
Priority Score = W,ln`S~ + W21nS2 + . . . + W71r~S7,
where W is he criterion weight, 5 is the criterion score, and In is the natural
logarithm of the criterion scores.
A panel of people from a broad spectrum of interests should set the
criterion weights.
In the process proposed by the committee, a broadly based panel would be
created to lead the necessary activities. Its first task would be to establish the
criterion weights through one of several possible procedures that are detailed in
the full report. Once established, these criterion weights remain constant for the
entire priority-setting process (i.e., across all candidate topics).
A topic's priority score determines its priority rank. According to the
committee's method, each candidate topic receives a criterion score for each of
the seven criteria (for example, S. might be prevalence expressed as a number
per 1,000 persons in the general population). In addition, each criterion has a
criterion weight that reflects its importance in determining priorities for
technology assessment. (W., for example, might be a weight of 2 for prevalence,
relative to a burden-of-illness criterion weight of 3.)
Each candidate topic has its own combination of criterion scores (Sn) for the
seven attributes. The panel noted above (or a subset of its members) reviews
data prepared for each topic by OHTA staff and assigns the criterion scores.
Objective criterion scores are determined by a subpanel with expertise in clinical
epidemiology and statistics. Subjective criterion scores are determined by a
broadly representative panel (or subpa~el) with expertise in health care.
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APPENDIX A
87
Recommendation 7
OHTA should actively solicit nominations of topics to be considered for
assessment. The solicitation should include payers, health professionals and
their representative organizations, manufacturers of medical products,
business, labor, government agencies, and consumers of health care.
lithe committee judged that a widespread solicitation of topics is crucial to
the success of the priority-setting effort. In particular, the solicitation should be
broad enough to ensure that important technologies are not omitted inadvertently
from consideration and that all important constituencies are included in the
process.
Recommendation 8
OlITA should develop a structured procedure for reducing the number
of nominations.
The initial number of nominations will almost certainly far exceed staff
capacity to collect the data required to assign criterion scores to each topic.
Therefore, the committee proposes that a formal procedure be adopted to reduce
that initial list to a manageable size a technique it calls "winnowing." The full
report describes three possible methods of winnowing and proposes one for
OHTA.
Recommendation 9
OHTA should consider all previously assessed topics as candidates for
reassessment.
OHTA has a special obligation as an influential public agency to revisit any
previously assessed topics whose recommendations may be based on outdated or
now erroneous information. A change in the nature of the condition, expanded
professional knowledge, a shin in clinical practice, or publication of a new,
conflicting assessment might trigger consideration of a condition and technology
for reassessment.
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SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
Recommendation 10
OHTA should maintain a data base on each topic that has been
previously assessed and should catalog information pertaining to the topic.
A catalog will make it easier for OHTA to know when to consider topics for
reassessment and when newly published information is relevant to a topic that
has been previously assessed. Information should include descriptions of data,
populations, and methods used in the earlier assessment, the impact and
controversy generated, and a topic-specific estimated date or interval for
considering reassessment.
Recommendation 11
OHTA should set priorities among topics for reassessment at the same
time and on the same footing that it sets priorities for first-time assessment.
That is, the committee recommends that OHTA create one rank-ordered list
that contains both topics for reassessment and topics for first-time
assessment.
The process of determining the need for reassessment can be accommodated
within a priority-setting process for first-time assessments with the addition of
several specific components: (1) a system for tracking previous assessments and
events that prompt recognition that a major factor (e.g., a clinical condition or
practice, information) has changed relative to the old assessment; (2) evaluation
of literature that suggests that reassessment Night be needed; (3) a decision by
the priority-setting panel that a technology or clinical practice has changed
sufficiently to warrant reassessment; and (4) a sensitivity analysis that suggests
that the conclusion of an initial assessment might change when a reassessment
is conducted.
ADOPTION OF THE IOM'S PRIORITY-SETTING
PROCESS BY OTHER ORGANIZATIONS
Many organizations evaluate health technology, although the major
categories of such organizations are third-party payers, such as the Health Care
Financing Administration (HCFA) arid the Blue Cross arid Blue Shield
Association (BCBSA), and associations that represent physicians, such as the
American College of Physicians. The committee developed this proposal for a
priority-setting process with the expectation that the process would apply and be
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APPENDIX A
89
useful to these and similar organizations, as well as to OHTA. That expectation
is based on the following:
· Although these organizations are part of the private sector, they also
constitute a major public resource, both individually and collectively. The more
they structure their technology assessment activities, including priority setting,
as a public service, the greater the good they will do for their own private
purposes and for their mission of public service. By focusing on clinical
conditions rather than on individual technologies, their assessments are more
likely to compare relevant alternative patient care strategies.
· The argument that priorities for assessment should be determined by
several attributes is quite generalizable. An organization that uses only one
dimension (e.g., cost, burden of illness) is oversimplifying a very complex
matter. The trade-off between cost and effectiveness is one of the most
important questions that physicians and patients must understand and resolve
daily in the office or hospital.
· Because the committee's process accommodates the choice of any
priority-setting criteria, an organization may choose criteria that serve its own
interests. The committee argues, however, that public trust, which sustains any
large organization of payers or professionals, requires criteria that are responsive
to the public interest, as exe~nplif~ed by the committee's seven criteria.
· If one accepts the argument that any organization performing health
technology assessment, or the officers of that organization who are responsible
for the technology assessment, are accountable to the public, at least in very
general terms, it would seem to follow that any process of establishing priority
rankings should be open, explicit, and understandable.
· The process of soliciting nominations is one element of an ideal process
that could be designed to satisfy the needs of a specific organization without
compromising the public interest.
· The committee believes that any program of technology assessment must
encompass a commitment to reassess topics that have been previously assessed.
This commitment must be supported by a program to monitor previously
assessed topics for new information that might prompt a reassessment. The
rationale for this recommendation is public accountability, but it applies to
private interests as well. For example, an organization of physicians should not
have a potentially obsolete policy on the public record. Neither should a payer
continue to provide or to withhold coverage on the basis of information that may
have been superseded by newly published data.
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SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
Technology Assessment and Clinical Practice Guidelines
The committees priority-setting process may also be useful in setting
priorities for developing practice guidelines. Clinical practice guidelines,
according to another IOM committee's definition, are "systematically developed
statements to assist the practitioner and patient in decisions concerning
appropriate health care for specific clinical circumstances."
Clinical practice guidelines are one vehicle for disseminating the results of
technology assessment, and technology assessment is one method of producing
information for a practice guideline. In particular, clinical practice guidelines
may use the synthesis of available evidence and projection of outcomes that are
a part of technology assessment as a foundation for statements that are clinically
useful in individual patient care. Good practice guidelines go one step further,
however, to rely on expert consensus to develop practical advice for clinicians
in situations not directly addressed by clinical research.
What further distinguishes practice guidelines from technology assessment
is the requirement that guidelines very carefully and explicitly describe the
thinking that links the evidence (that is, the product of the technology
assessment), or the lack of evidence, with the advice. Nonetheless, because
technology assessment is so closely related to the development of practice
guidelines, the priority-setting process proposed in this report appears to be
largely, if not completely, applicable to guidelines development as well.
POTENTIAL PROBLEMS WITH
THE PRIORITY-SETTING PROCESS
The report discusses several potential problems with the proposed
priority-setting process. For example, will a numerical priority score lead to
unrealistic inferences about the precision of the ranlcs? Does codifying an
idealized process lead to inflexibility? Will there be a bias toward choosing
topics that are quantifiable? The committee believes that most of these apparent
difficulties are the result of misperceptions stemming from the use of a
quantitative model to calculate a priority score for an assessment candidate. The
great advantages of the model process are that it is explicit, that it contains a
representation of the values of society, and that it defines the
nformation-gathering tasks involved in priority setting.
CONCLUDING REMARKS
Although this committee has recommended a specific step-by-step
methodology as a priority-setting process, it believes that the four principles
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APPENDLY A
91
noted earlier in this summary are far more important than the specifics of its
model. In the case of OHTA, satisfying the first principle will require
determining which assessments are most likely to result in improvement in the
health of the public, reduction of inappropriate health care expenditures,
reduction of inequities in access to effective health care services or of
maldistribution across equally needy populations, and the informing of other
ethical, legal, and social issues.
OHTA and other organizations may wish to modify some of the components
of the process as proposed. Experience with using this method or others will
provide a sound basis for change, and organizations should constantly reexamine
their methods for setting priorities. When making any changes, these groups
should consider carefully whether modifying a given element might adversely
affect the performance of the entire process.
In proposing a strategy for an optimal priority-setting process, the committee
realizes that funding for technology assessment is already constrained and that
its proposed priority-setting system will require some additional resources.
Given the potential value of priority setting, however, the funding for this effort
appears to be justified.
The committee views its report as a strategic effort to look ahead to
reasonable goals for AHCPR and OHTA and to create a process that will be
credible, sound, and defensible. During the process of compiling data for the
quantitative model, OHTA will create a valuable data base and a ranking of
priorities; both will be important resources for other organizations as well as for
OHTA itself. Indeed, such a program could lead not only to wise use of public
and private resources for technology assessment but also to an increase in public
support for the entire technology assessment process.
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Representative terms from entire chapter:
clinical practice
