Policy Brief

Alternatives to QALY-Based Cost-Effectiveness Analysis for Determining 

the Value of Prescription Drugs and Other Health Interventions

National Council on Disability

November 28, 2022
National Council on Disability (NCD)

1331 F Street NW, Suite 850

Washington, DC 20004

Policy Brief: Alternatives to QALY-Based Cost-Effectiveness Analysis for Determining the Value of 

Prescription Drugs and Other Health Interventions

National Council on Disability, November 28, 2022

Celebrating 38 years as an independent federal agency

This report is also available in alternative formats. Please visit the National Council on Disability 

(NCD) website (www.ncd.gov) or contact NCD to request an alternative format using the following 

information:

ncd@ncd.gov Email

202-272-2004 Voice

202-272-2022 Fax

The views contained in this report do not necessarily represent those of the Administration, as this and 

all NCD documents are not subject to the A-19 Executive Branch review process.
Letter of Transmittal

November 28, 2022

The President

The White House

Washington, DC 20500

Dear Mr. President:

On behalf of the National Council on Disability (NCD), I am pleased to submit this policy brief, titled 

Policy Brief: Alternatives to QALY-Based Cost-Effectiveness Analysis for Determining the Value of 

Prescription Drugs and Other Health Interventions.

This brief supplements our 2019 report, Quality Adjusted Life Years and the Devaluation of Life with 

a Disability, which described the design and discriminatory impact of QALY-based cost-effectiveness 

analysis (Standard CEA) – a method of comparing the cost and effectiveness of two or more healthcare 

interventions and determining if the value of an intervention justifies its cost. Its goal is to inform 

decision-makers about the allocation of healthcare resources. The report described how use of the 

QALY in Standard CEA results in undervaluing prescription drugs that extend the lives of people with 

disabilities, resulting in restricted insurance coverage in countries where it is commonly utilized to 

inform coverage decisions. The report further described how the discriminatory impact of the QALY 

on patients overseas led to its prohibition in the United States and to the Affordable Care Act of 2010 

prohibiting the Secretary of the Department of Health and Human Services from using the QALY, or 

similar measure, to determine coverage, reimbursement, or incentive programs under the Medicare 

program. Currently, however, state Medicaid programs have no prohibition on referencing QALY-based 

value assessments of new drugs and treatments, and pharmacy benefit managers, companies that 

manage prescription drug benefits on behalf of health insurers, reference these assessments when 

negotiating the prices they will pay for prescription drugs. 

Health economists have recognized the ethical concerns and discriminatory aspects of the QALY in 

Standard CEA regarding people with disabilities, and several novel methodologies have been developed 

that aim to address these deficiencies. This policy brief describes these alternatives, their strengths 

and weaknesses; highlights organizations that are using or implementing alternative methodologies 

for valuing health interventions; and makes recommendations for further research and further 

development of alternative methodologies. The methodologies described in this brief are: Equal Value 

of Life Years Gained (evLYG); The Efficiency Frontier (EF); Health Years in Total (HYT); Burden Augmented 

by Deadliness and Impact (BADI); Multi-Criteria Decision Analysis (MCDA); and Generalized RiskAdjusted Cost-Effectiveness (GRACE) framework. They utilize a modified QALY, a QALY alternative, or 

avoid the QALY altogether. Each is an example of movement toward a new era in value assessment. 

Also described is Augmented or Extended Cost-Effectiveness Analysis, which is Standard CEA with 

added considerations of what patients value.

National Council on Disability

An independent federal agency making recommendations to the President and Congress 

to enhance the quality of life for all Americans with disabilities and their families.

1331 F Street, NW ■ Suite 850 ■ Washington, DC 20004

202-272-2004 Voice ■ 202-272-2074 TTY ■ 202-272-2022 Fax ■ www.ncd.gov
The efficient use of healthcare resources is an important goal for the United States. When assessing 

value of drugs and treatments there are many considerations that impact value. Healthcare equity 

should be at the forefront of decisions on which methodologies to employ, and continued investment 

should be made to evaluate and strengthen the methodologies that seek to achieve it.

NCD appreciates your commitment to addressing healthcare disparities and ensuring equity in 

healthcare. We hope that the information in this brief can help further support those efforts.

Respectfully,

Andrés J. Gallegos J.D.

Chairman

2 National Council on Disability

(The same letter of transmittal was sent to the President Pro Tempore of the U.S. Senate and the Speaker of the 

U.S. House of Representatives.)
National Council on Disability Members and Staff 

Members

(Council membership at the time of the vote)

Andrés J. Gallegos, Chairman

Jim Brett, Vice Chair

Jim Baldwin

David D’Arcangelo

Munr Kazmir, M.D.

Rick Rader, M.D.

Neil Romano

Daniel C. Schreck

Mary G. Vought

Staff

Anne C. Sommers McIntosh, Executive Director

Joan M. Durocher, General Counsel & Director of Policy

Lisa Grubb, Director of Administration, Finance, and Operations

Stacey S. Brown, Staff Assistant

Kimie Eacobacci, Legislative Affairs Specialist

Netterie Lewis, Administrative Support Specialist

Amy Nicholas, Senior Attorney Advisor

Nick Sabula, Public Affairs Specialist

Amged Soliman, Senior Attorney Advisor

Ana Torres-Davis, Senior Attorney Advisor

Keith Woods, Financial Management Analyst

Policy Brief 3
4 National Council on Disability
Contents

Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  

A. Alternatives to Standard Cost-Effectiveness Analyses (CEA) . . . . . . . . . . . . .

i. Equal Value of Life Years Gained (evLYG). 

ii. Health Years in Total (HYT). 

iii. The Efficiency Frontier (EF). .

iv. Generalized Risk-Adjusted Cost-Effectiveness (GRACE). .

v. Burden Augmented by Deadliness and Impact (BADI). .

B. Augmented or Extended Traditional CEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

C. Multi-Criteria Decision Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

D. Frameworks for Determining Value to Individual Patients . . . . . . . . . . . . . . 

i. Shared Decision Making: Costs and Trade-Offs of Health Care at 

the Individual Level. .

ii. Patient Preference Information: Stated Preference. .

E.  Organizations Conducting Value Assessments or Advanci

Methodologies Outside QALY-Based CEA . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1

i. Patient-Centered Outcomes Research Institute (PCORI). .

ii. Innovation and Value Initiative (IVI). .

iii. The Patient-Driven Values in Healthcare Evaluation (PAVE) Center. .

iv. National Health Council (NHC). .

Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2

Endnotes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2

Policy Brief 5
The purpose of this brief is to present 

an overview of methodologies that 

seek to correct the distributional issues 

raised by standard [cost-effectiveness 

analysis (CEA)] by promoting equity and 

nondiscrimination. It highlights their

strengths and weaknesses and makes 

recommendations aimed at federal investment in continued research to further develop these methodologies

6 National Council on Disability
Background

In NCD’s 2019 report on quality-adjusted lifeyears (QALY),1

 we critiqued the use of standard 

cost-effectiveness analysis (CEA) to determine 

the value of prescription drugs and treatments 

because of its use of the QALY. As described fully 

in that report, standard CEA utilizes the QALY 

in an analysis that compares the benefits and 

values of different drugs and treatments, and 

the results are used to inform the allocation of 

health care resources. Our critique focused on 

the fact that this analysis puts lesser value on 

drugs and treatments that extend the lives of 

people with disabilities as compared to the lives 

of people without disabilities or chronic illnesses. 

We highlighted the fact that this methodology 

has resulted in restricted access to drugs and 

treatments for people with disabilities and 

chronic illnesses in countries where it is applied 

in nationalized health care systems, like NICE 

in the United Kingdom. Additionally, the data 

underlying the QALY, as utilized in standard CEA, 

is not reflective of patients’ experiences with 

illness and disability, contributing to standard 

CEA’s devaluation of life-extending drugs and 

treatments.

We recommended that both federal and 

private health insurers utilize, or reference, value 

assessments determined through alternative 

methods—ranging from well-established 

methods already used by federal agencies, 

such as cost-benefit analyses, to promising 

alternatives that use patient preferences to 

determine the value of prescription drugs and 

health care treatments and could be used in a 

nondiscriminatory manner. We recognized that 

alternatives may themselves be discriminatory 

if used in certain contexts, or if they are used 

without paying sufficient attention to the 

possibility that discrimination may occur.

Several alternatives to standard (QALYbased) CEA have been developed in response 

to criticism that standard CEA is incomplete, 

for example, it is focused on the health sector 

perspective, undervalues life extension for 

people with disabilities, and does not consider 

the societal perspective or patient perspectives. 

The purpose of this brief is to present an 

overview of methodologies that seek to correct 

the distributional issues raised by standard CEA 

by promoting equity and nondiscrimination. 

It highlights their strengths and weaknesses 

and makes recommendations aimed at federal 

investment in continued research to further 

develop these methodologies.

A. Alternatives to Standard CostEffectiveness Analyses (CEA)

Alternative methodologies to standard CEA differ 

from one another in a variety of ways, including 

whether they serve all of the same functions as 

Policy Brief 7
standard CEA, whether the alternative has been 

used in practice or is theoretical, and what data 

underpins the method. Some of the alternatives 

rely on the QALY but apply it differently than 

does standard CEA. The order of alternatives 

presented does not indicate importance or level 

of efficacy.

i. Equal Value of Life Years Gained (evLYG)

In response to concerns that the QALY does not 

give the same weight to gains in the length of 

the life of people with chronic illnesses and longterm disabilities provided by a drug or treatment, 

as it does healthier populations, in 2018, the 

Institute for Clinical and Economic Review (ICER)

introduced the equal value of life years gained 

(evLYG) metric as an alternative to the QALY, and 

has since incorporated it in its 2020–2023 Value 

Assessment Framework to be a component of 

all their new health technology assessments 

(HTAs).2 According to ICER, the evLYG, “evenly 

measures any gains in length of life, regardless 

of the treatment’s ability to improve patients’ 

quality of life. In other words, if a treatment adds 

a year of life to a vulnerable patient population—

whether treating individuals with cancer, 

multiple sclerosis, diabetes, epilepsy, or a severe 

lifelong disability—that treatment will receive 

the same evLYG as a different treatment that 

adds a year of life for healthier members of the 

community.”3

The evLYG is a modification of the Equal Value 

of Life (EVL) approach, which was introduced 

in 1999 to address societal concerns with the 

QALY. Under EVL, any extension of life is valued 

at a quality-of-life weight of 1 (the highest value 

possible);4 however, it has been criticized for 

undervaluing interventions that both extend life 

and improve quality of life (QOL).5 Under ICER’s 

modified version of the EVL approach, the evLYG, 

any extension of life is valued the same across 

every population, at a quality-of-life weight of the 

general population.

A 2021 report by a disability advocacy 

organization critiqued evLYG as not going far 

enough; opining that while evLYG eliminates 

the risk of undervaluing life-extension for people 

with disabilities, it affords no value to qualityof-life improvements.6

 In contrast, a 2021 

examination of how the evLYG works, conducted 

by health economists, found that evLYG does 

capture those improvements as well, explaining, 

“Arguably, the name ICER chose for this outcome 

is a misnomer, as it implies that there is no 

quality-adjusted component; however, that would 

be an incorrect assumption, as evLYs do include 

improvements in quality of life.”7 ICER clarifies 

that the evLYG assigns the same quality-of-life 

weight during any extension of life while also 

allowing for quality-of-life improvements during all 

other time periods (i.e., time observed while on 

standard of care).8

ii. Health Years in Total (HYT)

In 2019, researchers from the University of 

Washington introduced the Health Years in 

Total (HYT) method, which seeks to address 

the shortcomings of the QALY, the EVL, and the 

evLYG. HYT utilizes a modified QALY and the 

researchers assert that HYT enables patients 

with “lower quality of life” to fully benefit from 

interventions that extend life expectancy and that 

HYT may provide a viable alternative to QALY 

and evLYG. They advocated for further “critique, 

development, application and testing of the HYT 

framework.”9 HYT separates life expectancy 

effects from QOL impacts using an additive, 

rather than multiplicative, approach (Figure 1).

8 National Council on Disability
HYT has limitations. It does not directly 

address distributional issues regarding whether 

populations with higher QALY shortfalls or other 

equity factors should receive more resources. 

However, explicit independent methods to 

address the distributional problems can be applied 

to these metrics.10 More research is needed 

to understand HYT’s impact on technology 

prioritization and the appropriate value or 

budget thresholds.11 One critique called the HYT 

framework a “poor substitution” for the QALY, 

acknowledging the metric reduces distributional 

inequity “but does not altogether fix it.”12

Disability rights advocates have described HYT 

as a better approach to standard CEA because 

it removes the devaluation of life extension 

of people with disabilities.13 Though there are 

positive attributes to HYT, one shortcoming 

among all the utility-based metrics is that they 

have often relied on utility values generated 

based on the general population’s preferences, 

although it can incorporate utilities derived from 

either patients or general population preferences. 

A ‘utility value’ is a number between 0 (death) 

and 1 (perfect health) that individuals assign to a 

health state.

Policy Brief 9

Figure 1. Health years in total (HYT) framework and contrast with the traditional

quality-adjusted life-year (QALY) and the equal value of life (EVL) frameworks
iii. The Efficiency Frontier (EF)

The Efficiency Frontier (EF) is an alternative to 

cost-effectiveness analysis that makes use of 

condition-specific measures. It benchmarks 

the price and benefit afforded by a new drug 

to the value provided by existing drugs. The 

particular outcomes and costs of existing drugs 

are displayed in an efficiency plot—costs on 

the horizontal axis and value of benefits on the 

vertical axis. The efficiency of the new drug in a 

“cost per unit of benefit” is then compared to 

that of the most efficient existing treatments 

(i.e., those on the frontier). This helps to establish 

a maximum reimbursement rate for a particular 

treatment14 by deriving the price at which it 

would be just as efficient. Treatments that are 

demonstrated to be below the frontier require 

further justification for reimbursement at that 

price, or a price reduction. Of note, the entire 

process is carried out for a specific indication—

there is no attempt to somehow prioritize across 

indications (Figure 2).

In our 2019 report,15 we highlighted that the 

German Institute for Quality and Efficiency in 

Health Care had adopted the efficiency frontier.16

The main benefit of the efficiency frontier 

approach is that it is clear, easy to use, and 

transparent. Additionally, it does not require the 

use of QALYs as the measure of a treatment’s 

benefit.17 By using existing, condition-specific 

10 National Council on Disability

Figure 2. The horizontal gradient (=0) indicates no efficiency while the vertical

gradient (=90) indicates infinite efficiency. Positive gradients (e.g., betwe

points 6 and 7) reflect additional benefit for increased cost. Negative gradients

(e.g., between points 6 and 7) indicate less benefit at more co
clinical metrics as its measure of value, the 

efficiency frontier does not need the QALY’s 

EQ-5D-derived utilities and thus avoids their 

discriminatory assumptions. For the same 

reason, it does not require the development of 

alternative, disability-friendly health utilities.18

Though this is an improvement over traditional 

cost-effectiveness analysis that uses the QALY, 

the efficiency frontier has its own drawbacks. 

It looks at either one benefit of a health care 

treatment at a time (implying multiple frontiers), 

or aggregation of different benefits into a single 

score.19 Moreover, because it is based solely 

on existing clinical metrics, it cannot account 

for benefits provided by a new treatment that 

are not incorporated into such an existing 

measure. The efficiency frontier does not allow 

for direct comparisons across conditions, and 

its reliance on the efficiency of existing drugs 

means it cannot be used directly to assess the 

value of the first drug in a therapeutic area. The 

frontier may be less applicable if there has not 

been recent pharmaceutical innovation in that 

therapeutic area.20 Further empirical testing of its 

feasibility and usefulness is required to build on 

existing examples where it has been applied.21

Additionally, as with any other cost-effectiveness 

metric, its relevance depends on having the 

condition-specific information needed to measure 

outcomes that matter to people living with the 

condition being treated.

iv. Generalized Risk-Adjusted CostEffectiveness (GRACE)

The Generalized Risk-Adjusted CostEffectiveness (GRACE) framework is a 

generalization of traditional cost-effectiveness 

analyses that eliminates the need to assume 

constant returns to health-related quality of life 

under traditional (QALY-based) CEA methods.22

It was developed to respond to the QALY’s 

discriminatory aspects.

The authors of the GRACE framework 

demonstrate mathematically that the method 

implies cost-effectiveness thresholds become 

more generous for more severe illness.23 Therefore, 

this method shows more worth to quality-of-life 

gains for people with disabilities.24 The framework 

seeks to incorporate uncertainty in health 

outcomes into the model using a “Generalized 

risk-adjusted QALY.” The formula used to compute 

cost-effectiveness in the GRACE framework 

implies people with “lower quality of life” are more 

willing to trade life expectancy for improved quality 

of life—it therefore accommodates permanent 

disability in its formulation as well as a wider 

range of risk preferences. The model has evolved 

over time, with a recent article noting that “under 

GRACE, disability always increases the [willingness 

to pay] for [quality-of-life] gains.”25 By incorporating 

the patient-preference perspective that qualityof-life gains are more highly valued than life-year 

extensions for certain people with disabilities, this 

new framework will encourage more investment 

in rigorous patient preference studies and in 

technologies addressing unmet needs for people 

with disabilities.26

The GRACE framework comes with its own 

shortcomings, underscoring the continued need 

for better data, including new estimates of 

attitudes toward risk in health outcomes. Like 

traditional CEA, the GRACE method currently 

relies on health utilities of a “representative 

individual” that do not necessarily incorporate 

issues such health inequities, on which topic the 

authors suggest future research. In a forthcoming 

book from Oxford University Press,27 the GRACE 

framework has been extended to show that 

Policy Brief 11
treating people with disabilities has increasing 

value as the extent of a disability increases.

Further analysis of the GRACE framework 

is needed to understand what discriminatory 

attributes of QALYs may continue to be 

considered in the framework’s formula. We 

caution that it is important to consider that 

patient preference data on how people value 

quality-of-life gains versus life-year extensions 

must be applied in a manner that accurately 

reflects the differences in values among 

people with differing disabilities and coexisting 

conditions. As with the HYT framework, the 

GRACE framework would benefit by use of health 

utilities that are based on more fulsome survey 

instruments and with the input of a broader group 

of stakeholders, including people with long-term 

disabilities and those with chronic illnesses.

v. Burden Augmented by Deadliness 

and Impact (BADI)

The Burden Augmented by Deadliness and 

Impact (BADI) measure of health benefit is an 

alternative to the QALY that seeks to address 

how a disease reduces life span (deadliness) and 

increases the negative consequences on quality 

of life (impact). Both are quantified in relation to 

the burden of senescence, also known as aging. 

As described in the literature, the measure of 

“deadliness” gives priority to urgent, potentially 

fatal conditions and to diseases manifesting 

earlier in life, while the measure of “impact” 

captures reduced quality of life beyond that which 

is expected with aging.28 “BADI does not use 

the QALY.” It takes the same two dimensions 

in the QALY and decompartmentalizes them, 

looking at relative (not absolute) improvements 

12 National Council on Disability
from the current standard of care. In an interview 

with Dr. Jaime Caro, developer of the BADI and 

the efficiency frontier, he described the BADI as 

being “completely non-discriminatory because it 

only deals with the impact of that disease,” and 

the method “removes a lot of the problems with 

the QALY.”29

The BADI is described as an improvement in 

value frameworks centered on what is important 

to patients. It is credited for addressing disease 

impact, accounting for impacts that are deadly 

and not deadly, not imposing a trade-off 

between prioritizing the likelihood of a condition 

to be fatal versus the quality-of-life impact of 

the disease and applying to any disease or 

intervention.30

However, while the BADI approach is novel and 

merits further exploration, it does not yet offer a 

specific tested method.31 It is yet to be established 

for most diseases, nor have practical ways to 

measure the effectiveness of interventions 

(especially on impact universally) been developed. 

More research on the impact of aging without 

disease would be very helpful and experience with 

this measure must be accumulated to describe 

its practical limitations and any distributional 

implications.32

B. Augmented or Extended 

Traditional CEA

Standard CEA is conducted from a health care 

sector perspective, a viewpoint for conducting 

a cost-effectiveness analysis that includes 

formal health care sector (medical) costs 

borne by third-party payers and paid out of 

pocket by patients. But cost and value may 

also come from other sources and accrue to 

multiple stakeholders. Some health economists 

have advanced the idea of augmenting or 

extending standard CEA (ACEA/ECEA) to include 

nonmonetary elements of value to patients, 

rather than replacing the QALY.

In 1996, the U.S. Public Health Service’s 

Panel on Cost-Effectiveness in Health and 

Medicine established a set of standard methods 

to improve the quality and comparability of 

CEAs. They recommended using the QALY 

(health sector perspective) as a health outcome 

measure in CEAs and also as a societal 

perspective—a viewpoint for conducting a costeffectiveness analysis that incorporates all costs 

and health effects regardless of who incurs the 

costs and who obtains the effects.33 The societal 

costs proposed were the cost of health care 

services; costs of patient time expended for the 

intervention; costs associated with caregiving; 

other costs associated with illness, such as 

child care and travel expenses; economic costs 

borne by employers, other employees, and the 

rest of society, including so-called friction costs 

associated with absenteeism and employee 

turnover; and costs associated with non-health 

impacts of the intervention, such as on the 

educational system, the criminal justice system, 

or the environment.34 Twenty years later, the 

Second Panel on Cost-Effectiveness in Health 

and Medicine was convened to provide an 

updated guideline reflecting methodological 

advances and consideration of ethical and 

distributional issues.35 It found that since 

publication of its recommendations in 1996, 

there had been a substantial increase in the 

number of published CEAs, and many had not 

used a societal perspective as defined by the 

original panel. One study found, for example, 

that only 341 (29 percent) of 1,163 QALY 

analyses published through 2005 adopted 

a societal perspective.36 The Second Panel 

Policy Brief 13
recommended, once more, that CEAs reference 

the health care sector perspective and a societal 

perspective.37

In addition, between 2011 and 2018, there 

were several studies suggesting that the 

weakness of standard CEA would be improved 

by incorporating societal values, such as the 

value of knowing and the value of information.38,39

For example, patients value treatments that 

provide “option value,” the value to patients that 

some treatments allow them to survive until the 

discovery of even more effective treatments.40,41

Patients also value “hope,” the added value 

placed on treatments that increase not just 

median survival, but also “tail of the curve” 

survival.42,43

In 2018, a Special Task Force of the 

Professional Society for Health Economics 

and Outcomes Research (ISPOR) published a 

report with the purpose broadening the view 

of what constitutes value in health care and to 

spur new research on incorporating additional 

elements of value into CEA.44 Twelve potential 

elements of value were considered. Four of 

them, QALYs, net costs, productivity, and 

adherence-improving factors, are conventionally 

considered in value assessments. Eight others, 

which would be more novel in economic 

assessments, were discussed: reduction 

in uncertainty, fear of contagion, insurance 

value, severity of disease, value of hope, real 

option value, equity, and scientific spillovers.45

The authors noted that most of these are 

theoretically well understood and available 

for inclusion in value assessments, but equity 

and scientific spillover effects are not and 

will require more theoretical development 

and consensus. The task force believes that 

considering these additional elements would 

result in a more comprehensive CEA and that 

possible approaches include integrating them 

as part of a net monetary benefit calculation, 

including elements as attributes in health state 

descriptions, or using them as criteria in a 

multicriteria decision analysis.46

A 2018 study put this enhanced version of 

CEA into practice by creating a cost-effectiveness 

analysis that included factors of value to patients 

and society.47 In addition to the traditional 

payer components (medical costs; adverse 

events; survival benefit; quality of life/patientreported outcomes), researchers included 

societal components, including productivity 

loss, nonmedical costs (transportation, patient 

time costs), caregiver burden, option value of 

treatment, and the value of hope. The study 

indicated more net monetary benefit when 

incorporating broader societal components, but 

due to limitations in the research, more studies 

are needed to fully develop this concept. It will 

be important in building and exploring this type 

of methodology to advance parallel efforts to 

develop better health state utilities and patientreported outcomes data to use within the 

models.

C. Multi-Criteria Decision Analysis

Multi-Criteria Decision Analysis (MCDA) is 

neither augmented nor enhanced CEA, nor a 

method that does not utilize the QALY. Rather, 

it is a methodology that acknowledges the 

complexity of health care decision making and 

responds to concerns that CEA is incomplete—

particularly for factors such as equity and 

fairness in determining value. MCDA allows 

varied decision makers to consider many 

distinct factors relevant to a health care 

decision—such as cost, clinical outcomes, and 

14 National Council on Disability
administrative burdens—and determine how 

important each of these factors is to them. Its 

focus is eliciting decision makers’ preferences 

in order to create decision weights. It then 

measures performance of each intervention 

candidate along each specified criterion that 

formally shows the trade-offs among them.48

For example, a payer using MCDA would first 

rank each factor that is relevant to the decision 

against one another.49 Each criterion would then 

be given a weighted “score” representing that 

criterion’s importance to the decision maker 

ranked in the order of importance, sometimes 

with as many as 15 criteria. Next, researchers 

would compare how each of the treatments 

being considered relate to one another, such 

as for clinical outcomes and costs. Depending 

on the decision to be made and the criteria 

being assessed, the method generates a single 

average weighted score for each treatment that 

is the aggregate of both how the treatment 

scores on each of the criteria and how 

important those criteria are to the decision 

maker, which then shows the relative value of 

the treatments to one another.50

A particularly strong asset of MCDA is 

transparency to the public regarding the data 

used in assessing value and the decision making 

process. MCDA prioritizes gathering data on 

what is important to improving the decision, 

driving investments in data improvement.51

It can be used at various levels of decision 

making, from choices on what should be 

covered benefits, to helping people choose 

among therapies, to informing choices among 

competing health plans.

Policy Brief 15
A potential problem with MCDA is the use 

of standard CEA-based methods to measure 

QALY gains for disabled people as one of 

the multicriteria inputs. Experts on MCDA and 

health economics organizations agree that the 

MCDA can and should use QALYs as measures 

of health. Because MCDA allows societally 

determined weights to emphasize the differential 

value of health gains for various subgroups, 

when properly used, it can approach the goal 

of patient-centered measures of value, even 

with use of the QALY. To do this, the MCDA 

model would measure QOL and life extension 

(LE) gains for different groups of people and 

would include higher weights on health gains for 

people related to the extent of disability.52

An ISPOR task force has also stated that 

specific measures of health gains such as 

QALYs are necessary core elements in any 

broader MCDA model of value in health 

care but emphasizes that health gains to 

different subpopulations can be included in 

MCDA measures with higher weight given to 

subgroups of interest, unlike QALY application 

in standard CEA.53

The Innovation and Value Initiative (IVI) 

specifically includes QALYs in its use of MCDA. 

The IVI, an organization that focuses on patientcentered outcomes and preferences in value 

assessment models and that advocates for 

transparent, open-source model development,54

includes the CEA-based measure of QALYs as 

an outcome in its open source value models,55

while recognizing limitations and concerns about 

discrimination against people with disabilities.56

IVI explains that despite concerns about this 

use of the QALY measure, “including QALY as a 

metric in the model, along with many other key 

outcomes, will allow the flexibility to understand 

and evaluate the importance of looking at a wide 

range of outcomes and will allow comparison 

with prior economic evaluations that have used 

this metric.”57

D. Frameworks for Determining Value 

to Individual Patients

i. Shared Decision Making: Costs 

and Trade-Offs of Health Care at the 

Individual Level

Unlike the other methodologies discussed, 

which all work at a population level to determine 

clinical and cost-effectiveness, shared decision 

making is a process that is between doctors 

and their patients: an exchange of information, 

values, and preferences between beneficiary 

and practitioner to arrive at a treatment decision 

that is based on the beneficiary’s values and 

preferences. It is a strategy for improving 

an individual patient’s health care decisions 

that also has potential for cost savings by 

improving the patient’s health outcomes,58

reducing expensive adverse events from 

failed treatment,59 and eliminating care that 

people do not want or need.60 The Affordable 

Care Act (ACA) required U.S. Health and 

Human Services (HHS) to establish a shared 

decision making program with the purpose 

of collaborative processes between patients, 

caregivers or authorized representatives, and 

clinicians that engages them in decision making, 

provides them with information about tradeoffs among treatment options, and facilitates 

the incorporation of patient preferences and 

values into the medical plan.61 It requires HHS to 

contract with an entity to establish consensusbased standards for patient decision aids for 

preference sensitive care62 and a certification 

process for patient decision aids for use in the 

16 National Council on Disability
federal health programs and by other interested 

parties.63 In the past 10 years, the HHS Center 

for Medicare and Medicaid Innovation (CMMI) 

has financially supported the shared decision 

making program.64 It is unclear whether it has 

established a certification process for patient 

aids and if patient decision aids are being 

used in federal health programs, for example, 

Medicare and Medicaid.

Shared decision making using patient 

decision aids is a practice in health care 

organizations across the United States and 

both Medicare and Medicaid beneficiaries 

are likely participants. In 2018, the National 

Quality Forum published the National Quality 

Partners PlaybookTM: Shared Decision Making 

in Healthcare (hereafter Playbook) defining 

standards for health care stakeholders to 

reference how to achieve high-quality shared 

decision making using high-quality patient 

decision aids such as those being developed 

by the Innovation Center. The Playbook gives 

examples of how health care organizations 

are integrating and improving shared decision 

making in clinical practice. In one example, “ . . . 

men diagnosed with an enlarged prostate used 

online decision aids to learn more about which 

treatment options are most suited to their care 

preferences before meeting with a urologist. 

After analyzing data from patients, the urology 

department changed its process to offer patients 

who expressed a preference for nonsurgical 

care the choice either to see a urologist for 

specialized care or return to their primary care 

physician for follow-up care.”65

As of February 2022, the Patient-Centered 

Outcomes Research Institute (PCORI) has funded 

55 comparative clinical effectiveness research 

studies related to shared decision making and 

seven implementation projects that seek to 

integrate effective shared decision-making 

approaches in health care settings and help 

patients and their clinicians make choices that are 

best for them.66

ii. Patient Preference Information: 

Stated Preference

Patient preference information is an essential 

component of both value assessment and 

shared decision making in health care if it is to 

reflect value to patients. ISPOR acknowledges 

that “accurate and meaningful measures of 

patient-centered outcomes and preferences 

are critical to numerous decisions throughout 

product development, clinical research, 

regulation, technology assessment, and 

healthcare delivery,” and there is a need for 

research to improve the methods for translating 

outcomes related to a disease or condition into 

utilities, especially for people with disabilities.”67

ISPOR recognizes that stated-preference 

research is useful for value judgments about 

different treatments and their health outcomes. 

In fact, ISPOR’s recently updated Consolidated 

Health Economic Evaluation Reporting 

Standards (CHEERS) statement—created to 

ensure health economic evaluations are able to 

be identified, interpreted, and useful for decision 

making—states that patient perspectives are 

needed from the outset of value assessment.68

PCORI and other entities have funded research 

related to patient preferences.69 Methods 

to collect patient preference information 

indicate that it can be done in a manner that is 

systematic, with consistency of preferences 

for certain treatment attributes, though more 

research is needed across patient groups.70

Patient preferences can be integrated into 

Policy Brief 17
clinical effectiveness studies to improve their 

responsiveness to patient values.71

E. Organizations Conducting 

Value Assessments or Advancing 

Methodologies Outside 

QALY-Based CEA

i. Patient-Centered Outcomes Research 

Institute (PCORI)

PCORI was authorized to be established in 

2010 as part of ACA to fund comparative clinical 

effectiveness research with a duty to identify 

national priorities that consider patient needs, 

outcomes, and preferences in its work.72 Since its 

establishment, PCORI has become the leader in 

developing strategies for patient engagement 

in research to assure that its funded studies 

capture outcomes that matter to patients. In 2019, 

PCORI’s funding was reauthorized by Congress. 

As part of the reauthorization, Congress mandated 

that PCORI-funded research be designed, as 

appropriate, to capture “the full range of clinical 

and patient-centered outcomes,” including “the 

potential burdens and economic impacts” of 

the utilization of medical treatments, items, and 

services.”73

PCORI is prohibited from developing or 

employing the QALY (or similar measure that 

discounts the value of life because of an 

individual’s disability) as a threshold to establish 

what type of health care is cost effective or 

recommended and does not fund studies 

that conduct comparative cost-effectiveness 

analysis. PCORI will fund studies that directly 

compare patient and/or family cost burden 

as secondary outcomes, providing specific 

examples such as out-of-pocket costs, time 

costs associated with an approach, and 

financial toxicity. PCORI-funded studies capture 

perspectives of people living with disabilities 

and chronic conditions, which could be used 

to improve the accuracy of health utilities 

used in value assessments—a critical need 

for non-QALY methods. Burden and economic 

impact data collected and analyzed as part of 

PCORI-funded studies can be useful to improve 

decisions made by patients and their providers. 

It could also add quality data to help define how 

a treatment impacts a patient’s QOL. This data 

is also useful for the development of shared 

decision making tools and generation of patientreported outcome measures.

ii. Innovation and Value Initiative (IVI)

IVI is a nonprofit research organization that 

invests in research that emphasizes patient 

perspectives on value and strives to improve the 

flexibility and application of value assessment 

methods and models. IVI’s work is delivered in an 

open-source environment, providing transparency 

to its users.74 IVI states that its work is intended 

to support improved health care decision 

making, serving as a laboratory for testing new 

methods to improve value assessment. Thus 

far, IVI is unique in having developed alternative, 

disease-specific value models for rheumatoid 

arthritis, non–small cell lung cancer, and major 

depressive disorder. IVI’s leadership has stated 

publicly, “Structural deficiencies in the models 

that underlie value assessment have perpetuated 

health inequities. Communities of color and other 

groups are generally not represented in the data 

used to make health care decisions, routinely 

disadvantaging them. Yet this broken framework 

is what value assessment continues to be built 

on.”75 As described earlier in this brief, IVI does 

use Multi-Criteria Decision Analysis, which 

utilizes the QALY as an output.

18 National Council on Disability
iii. The Patient-Driven Values in 

Healthcare Evaluation (PAVE) Center

The Patient-Driven Values in Healthcare 

Evaluation (PAVE) Center is a Center of 

Excellence in Patient-Driven Value Assessment 

at the University of Maryland dedicated to 

promoting “value-based decision-making 

through a diverse multistakeholder collaboration 

and engaging patients from an extensive 

network of partners to build technical expertise 

in patient-centered outcomes research, 

education, and dissemination.”76 Its mission 

includes developing approaches to value 

assessment that solicit meaningful input from 

patients, ensure transparency in methods 

and decisions, and develop creative solutions 

to meet the needs of all health care decision 

makers. For example, the PAVE Center is 

working to advance a patient-perspective 

approach to guide value assessments of 

COVID-19 vaccines,77 hepatitis C treatment,78

and depression (in partnership with IVI).

iv. National Health Council (NHC)

National Health Council (NHC) is a nonprofit 

organization made up of over 140 national healthrelated organizations and businesses, including the 

nation’s leading patient organizations.79 In 2018, 

NHC convened representatives of organizations 

producing value frameworks and/or assessments 

with participants from patient groups that have 

interacted with those organizations to articulate a 

shared vision for what marks success in enhanced 

patient centricity in value assessment.80 NHC 

identified recommendations for gathering patient 

input through meaningful patient engagement 

in a manner that is incorporated into the design, 

conduct, and translation of real-world research 

reflecting patients’ lived experiences.81 NHC has 

created a “Value Classroom” with support from 

PCORI to help patients access basic information 

about health economics, value assessment 

terminology, and information to help patients and 

organizations engage in the value assessment 

process.82

Policy Brief 19
20 National Council on Disability
Recommendations

U.S. Department of Health and Human Services (HHS) Center 

for Medicare and Medicaid Innovation (CMMI)

CMMI should study alternatives to standard CEA that assess the value of drugs and other 

health interventions such as the Efficiency Frontier, Burden Augmented by Deadliness 

and Impact, Health Years in Total, Multi-Criteria Decision Analysis, and the Generalized 

Risk-Adjusted Cost-Effectiveness framework. To the extent that a method utilizes the 

QALY, the examination should determine whether these methods can be applied in a 

nondiscriminatory manner.

CMMI should implement a formal shared decision making program for both Medicare and 

Medicaid that applies the shared decision making standards and patient decision aids that 

have been developed through its grant-funded projects under the ACA.

Patient-Centered Outcomes Research Institute (PCORI)

PCORI should fund research that further develops and tests alternative methods and 

frameworks for determining the value of prescription drugs and other health interventions, 

that is, the Efficiency Frontier; Burden Augmented by Deadliness and Impact; Health Years in 

Total, Multi-Criteria Decision Analysis, and the Generalized Risk-Adjusted Cost-Effectiveness 

framework. The studies should focus on developing utilities/weights needed to use with 

the alternatives because this is the most needed research in this area. To the extent that a 

method utilizes the QALY, the examination should determine whether these methods can be 

applied in a nondiscriminatory manner.

Policy Brief 21
Agency for Healthcare Research and Quality (AHRQ)

The Agency for Healthcare Research and Quality (AHRQ) should fund research to continue 

the development and testing of alternative methods to standard CEA for assessing the value 

of prescription drugs and other health interventions, that is, the Efficiency Frontier; Burden 

Augmented by Deadliness and Impact; Health Years in Total, Multi-Criteria Decision Analysis, 

and the Generalized Risk-Adjusted Cost-Effectiveness framework. The studies should focus 

on developing the weights needed to use with the alternatives because this is the most 

needed research in this area. To the extent that a method utilizes the QALY, the examination 

should determine whether these methods can be applied in a nondiscriminatory manner.

The Institute for Clinical and Economic Review (ICER)

ICER should continue to examine and empirically pilot innovative approaches that do not rely 

on the QALY, and further develop its existing engagement with patient groups to inform its 

reports with patient perspectives on value.

22 National Council on Disability
Endnotes

1 “Quality-Adjusted Life Years and the Devaluation of Life with Disability,” National Council on Disability, 

November 6, 2019, https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf.

2 “Cost-Effectiveness, the QALY, and the Evlyg,” ICER, May 21, 2021, https://icer.org/our-approach/methods

-process/cost-effectiveness-the-qaly-and-the-evlyg/.

3 Ibid.

4 Nord, Erik, et al. “Incorporating Societal Concerns for Fairness in Numerical Valuations of Health 

Programmes,” Health Economics 8, no. 1 (1999): 25–39.

5 Johannesson, Magnus. “Should We Aggregate Relative or Absolute Changes in QALYs?,” Health Economics 10, 

no. 7 (2001): 573–77.

6 “ICER Analyses Based on the QALY Violate Disability Nondiscrimination Law,” Disability Rights Education & 

Defense Fund, September 21, 2021, https://dredf.org/2021/09/23/pharmaceutical-analyses-based-on-the-qaly

-violate-disability-nondiscrimination-law/.

7 O’Day, Ken, and Dylan J. Mezzio. “Demystifying ICER’s Equal Value of Life Years Gained Metric,” Value & 

Outcomes Spotlight, January/February 2021, https://www.ispor.org/publications/journals/value-outcomes

-spotlight/vos-archives/issue/view/overcoming-vaccine-hesitancy-injecting-trust-in-the-community/demystifying

-icer-s-equal-value-of-life-years-gained-metric.

8 Technical review comment of Dr. Steve Pearson of the Institute of Clinical and Economic Review.

9 Basu, Anirban, Josh Carlson, and David Veenstra. “Health Years in Total: A New Health Objective Function for 

Cost-Effectiveness Analysis,” Value in Health 23, no. 1 (2020): 96-103, https://doi.org/10.1016/j.jval.2019.10.014.

10 Basu, Anirban, one of the researchers who developed the HYT methodology: “It is actually advantageous 

to keep the calculations of the units of health produced separate from how that should be valued in 

different subgroups. For example, it would be important to establish that new treatments produce the same 

incremental life years in patients with diabetes and also patients with metastatic cancer. But distributional 

methods can put more weight on the gains for the latter group as they may have greater Life Year shortfall.” 

Comment made August 2022.

11 See endnote 4.

12 Browne, John, Donna R. Cryer, and Warren Stevens. “Is the QALY Fit for Purpose?” AJMC 9, no. 2 (2021), 

https://www.ajmc.com/view/is-the-qaly-fit-for-purpose-.

13 See endnote 6.

14 Technical review comment of Dr. Jaime Caro.

15 National Council on Disability. “Quality-Adjusted Life Years and the Devaluation of Life with Disability.” 

November 6, 2019, https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf. 

16 Shafrin, Jason. “The Efficiency Frontier in Health Economics,” Healthcare Economist (blog), June 9, 2014, 

https://www.healthcare-economist.com/2014/06/09/the-efficiency-frontier-in-health-economics/.

17 Institute for Quality and Efficiency in Health Care. “Methods for Assessment of the Relation of Benefits to 

Costs in the German Statutory Health Care System,” Version 1.1, September 10, 2008:13–15.

18 See endnote 1.

19 Mühlbacher, Axel C., and Andrew Sadler. “The Probabilistic Efficiency Frontier: A Framework for CostEffectiveness Analysis in Germany Put into Practice for Hepatitis C Treatment Options,” Value in Health 20, 

no. 2 (2017): 266.

Policy Brief 23
20 See endnote 6.

21 Caro, J. Jamie. et al. “The Efficiency Frontier Approach to Economic Evaluation of Health-Care Interventions,” 

Health Economics 19, no. 10 (2010): 1117–27; Neyt, Mattias, and Hans Van Brabandt, “The Importance of 

the Comparator in Economic Evaluations Working on the Efficiency Frontier,” Pharmacoeconomics 29, no. 11 

(2011): 913–16; Migliaccio-Walle, Kristen, Dale Rublee, and Teresa A. Simon. “Anticoagulation Prophylaxis 

in Orthopedic Surgery: An Efficiency Frontier Approach,” Postgraduate Medicine, 124, no. 1 (2012): 41–49; 

Gissel, Christian, et al., “Cost-Effectiveness of Interferon-Free Therapy for Hepatitis C in Germany – An 

Application of the Efficiency Frontier Approach,” BMC Infectious Diseases 15 (2015): art. no. 297.

22 Lakdawalla, Darius N., and Charles E. Phelps. “Health Technology Assessment with Diminishing Returns 

to Health: The Generalized Risk-Adjusted Cost-Effectiveness (GRACE) Approach,” Value in Health 24, no. 2 

(2021): 244–49, https://www.valueinhealthjournal.com/article/S1098-3015(20)34446-6/pdf.

23 Lakdawalla, Darius N., and Charles E. Phelps. “Health Technology Assessment with Risk Aversion in Health,” 

Journal of Health Economics 72 (2020): 102346.

24 Lakdawalla, Darius N., and Charles E. Phelps. “A Guide to Extending and Implementing Generalized 

Risk-Adjusted Cost-Effectiveness (GRACE),” European Journal of Health Economics 23, no. 3 (2022): 

433–51.

25 Lakdawalla, Darius N., and Charles E. Phelps. “Generalized Risk-Adjusted Cost-Effectiveness (GRACE): 

Ensuring Patient-Centered Outcomes in Healthcare Decision Making,” ISPOR 7, no. S2 (2021): 5–10, https://

www.ispor.org/publications/journals/value-outcomes-spotlight/vos-archives/issue/view/patients-versus

-process-the-data-and-the-drivers-behind-patient-centered-outcomes/generalized-risk-adjusted-cost

-effectiveness-(grace)-ensuring-patient-centered-outcomes-in-healthcare-decision-making.

26 Ibid.

27 Phelps, Charles E., and Darius N. Lakdawalla. Valuing Health: The Generalized Risk Adjusted Cost 

Effectiveness (GRACE) Model (New York: Oxford University Press, 2023).

28 Shelby Reed et al., “Novel Approaches to Value Assessment Beyond the Cost-Effectiveness Framework,” 

Value in Health, June 2019. https://www.valueinhealthjournal.com/action/showPdf?pii=S1098-3015

%2819%2932129-1.

29 Interview with Dr. Jaime Caro, November 12, 2021.

30 See endnote 29.

31 See endnote 29.

32 See endnote 29.

33 Siegel, J.E., et al. Panel on Cost-Effectiveness in Health and Medicine, “Recommendations for Reporting 

Cost-Effectiveness Analyses,” JAMA 276, no. 16 (1996): 1339–41.

34 Siegel, J.E., et al. Panel on Cost-Effectiveness in Health and Medicine, “Consensus Statement,” JAMA 276, 

no. 15 (1996): 1253–58, at 1255.

35 Sanders, Gillian D., et al. “Recommendations for Conduct, Methodological Practices, and Reporting of CostEffectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine,” JAMA 316, no. 10 

(2016): 1093–1103, https://doi.org/10.1001/jama.2016.12195.

36 P. J. Neumann, “Costing and Perspective in Published Cost-Effectiveness Analysis, supplement 1, Medical 

Care 47, no. 7 (2009): S28–S32.

37 Id. at endnote 38.

38 Garrison, L. P., S. Kamal-Bahl, and A. Towse, “Toward a Broader Concept of Value: Identifying and Defining 

Elements for an Expanded Cost-Effectiveness Analysis,” Value in Health 20, no 2 (2017): 213–16.

39 Garrison, L., J. Mestre-Ferrandiz, and B. Zamora, “The Value of Knowing and Knowing the Value: Improving 

the Health Technology Assessment of Complementary Diagnostics” (white paper. Office of Health 

Economics, EPEMED, London, 2016).

40 Cook, Joseph P., et al. “Real Option Value and Path Dependence in Oncology Innovation,” International Journal 

of the Economics of Business 18, no. 2 (2011): 225–.

24 National Council on Disability
41 Julia Thornton Snider et al., “The Option Value of Innovation,” Forum for Health Economics & Policy 15, no. 2 

(2012).

42 Shafrin, Jason, et al. “Patient Versus Physician Valuation of Durable Survival Gains: Implications for Value 

Framework Assessments,” Value in Health 20, no. 2 (2017): 217–23.

43 Lakdawalla, Darius N., et al. “How Cancer Patients Value Hope and the Implications for Cost-Effectiveness 

Assessments of High-Cost Cancer Therapies,” Health Affairs 31, no. 4 (2012): 676–82.

44 Lakawalla, Darius N., et al. “Defining Elements of Value in Health Care – A Health Economics Approach: An ISPOR 

Special Task Force Report,” Value in Health 21, no. 2 (2018): 131–39, https://doi.org/10.1016/j.jval.2017.12.007.

45 Ibid.

46 Ibid.

47 Shafrin, Jason, et al., “An Exploratory Case Study of the Impact of Expanding Cost-Effectiveness Analysis for 

Second-Line Nivolumab for Patients with Squamous Non-Small Cell Lung Cancer in Canada: Does It Make a 

Difference?,” Health Policy 122, no. 6 (2018): 607–13, https://doi.org/10.1016/j.healthpol.2018.04.008.

48 Phelps, Charles E., et al. “Approaches to Aggregation and Decision Making – A Health Economics Approach: 

An ISPOR Special Task Force Report [5],” Value in Health 21, no. 2 (2018): 146–54, https://doi.org/10.1016/j.jval

.2017.12.010.

49 Innovation and Value Initiative. “Application in the Real World,” updated 2019, https://www.thevalueinitiative

.org/application-real-world/.

50 Thokala, Praveen, et al. “Multiple Criteria Decision Analysis for Health Care Decision Making–An Introduction: 

Report 1 of the ISPOR MCDA Emerging Good Practices Task Force,” Value in Health 19, no. 1 (2016): 1–13, 

https://doi.org/10.1016/j.jval.2015.12.003.

51 See endnote 50.

52 Technical review comment of Charles Phelps, August 2022.

53 Phelps, Charles E., et al. “Approaches to Aggregation and Decision Making – A Health Economics Approach: 

An ISPOR Special Task Force Report [5],” Value in Health 21, no. 2 (2018): 146–54, https://doi.org/10.1016/j.jval

.2017.12.010.

54 “Who We Are.” Innovation and Value Initiative. https://www.thevalueinitiative.org/who-we-are/.

55 “Open-Source Value Project (OSVP) IVI RA-Model Version 1.0.” p. 78. Innovation and Value Initiative. https://www

.thevalueinitiative.org/wp-content/uploads/2018/09/OSVP-IVI-RA-Model-v1.0-Process-Summary_FINAL.pdf.

56 “Frequently Asked Questions About the IVI Draft Protocol for Major Depressive Disorder.” 

Innovative and Value Initiative. January 11, 2022, https://www.thevalueinitiative.org/

frequently-asked-questions-about-the-ivi-draft-protocol-for-major-depressive-disorder/.

57 Ibid.

58 Millenson, Michael, and Robert Berenson. “Shared Decisions in in :Cancer Care: Is Medicare Providing a 

Model?,” U.S. Health Reform – Monitoring and Impact. Urban Institute, 2017, https://www.urban.org/sites

/default/files/publication/89901/2001242-shared_decisions_in_cancer_care_is_medicare_providing_a

_model_0.pdf.

59 Hess, Erik P., et al. “Shared Decision Making in Patients with Low-Risk Chest Pain: Prospective Randomized 

Pragmatic Trial,” BMJ 355 (2016): i6165, https://doi.org/10.1136/bmj.i6165.

60 Arterburn, David, et al. “Introducing Decision Aids at Group Health Was Linked to Sharply Lower Hip and Knee 

Surgery Rates and Costs,” Health Affairs Journal 31, no. 9 (2012), https://www.healthaffairs.org/doi/abs

/10.1377/hlthaff.2011.0686.

61 Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148 S. 3506: Program to Support Shared 

Decision-Making.

62 Preference-sensitive conditions are medical conditions for which the clinical evidence may not clearly support 

one treatment option, and the appropriate course of treatment depends on the values or preferences of the 

beneficiary regarding the benefits, harms, and scientific evidence for each treatment option.

63 Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148 S. 3506(c)(1).

Policy Brief 25
64 See, e.g., https://innovation.cms.gov/innovation-models/health-care-innovation-awards/iowa.

65 National Quality Partners PlaybookTM: Shared Decision Making in Healthcare (National Quality Forum, 2018). 

https://www.qualityforum.org/Guidance_to_Improve_Shared_Decision_Making.aspx.

66 “Shared Decision Making,” PCORI, accessed June 16, 2022, https://www.pcori.org/topics/shared-decision

-making.

67 ISPOR. “Science Strategy.” 2022. https://www.ispor.org/strategic-initiatives/science-strategy.

68 Husereau, Don, et al. “Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) 

Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force,” Value Health 25, 

no. 1 (2022): 10–31.

69 “Patient-Centered Outcomes Research Institute,” accessed January 23, 2022, www.pcori.org.

70 Marsh, K., and N. Krucien. “Evaluating the Consistency of Patient Preference Estimates: Systematic Variation 

in Survival-Adverse Event Trade-Offs in Patients with Cancer or Cardiovascular Disease,” Patient 15, no. 1 

(2022): 69–75, https://doi.org/10.1007/s40271-021-00513-3.

71 Marsh, K., et al. “How to Integrate Evidence from Patient Preference Studies into Health Technology 

Assessment: A Critical Review and Recommendations,” International Journal of Technology Assessment in 

Health Care 37, no. 1 (2021): E75, https://doi.org/10.1017/S0266462321000490.

72 Social Security Act, U.S. Code 42 S. 1181 (1320) (e).

73 Further Consolidated Appropriations Act of 2020, Pub L. No. 116-94 S. 104 (e) (2019).

74 “Open-Source Value Project.” Innovation and Value Initiative. Accessed January 23, 2022. https://www

.thevalueinitiative.org/open-source-value-project/.

75 Bright, Jennifer, and Richard H. Chapman. “Getting Value Right,” Innovation and Value Initiative, April 15, 2021, 

https://www.thevalueinitiative.org/getting-value-right/.

76 “PAVE One-Pager.” Patient-Drive Values in Healthcare Evaluation, University of Maryland. Accessed January 23, 

2022. https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/pave/pdf/pave

-one-pager.pdf.

77 dosReis, Susan. “Value Assessment and COVID-19 Vaccines.” Patient-Drive Values in Healthcare Evaluation. 

University of Maryland. Accessed January 23, 2022. https://www.pharmacy.umaryland.edu/centers/patient

-driven-values-healthcare-evaluation-pave/patient-perspective-guide-value-assessments-covid19-vaccines/.

78 “Patient-Centered Value Assessment: Hepatitis C (HCV) treatment.” Patient-Drive Values in Healthcare 

Evaluation. University of Maryland. Accessed January 23, 2022. https://www.pharmacy.umaryland.edu

/media/SOP/wwwpharmacyumarylandedu/centers/pave/pdf/pave-hep-c-report-summary.pdf.

79 “About Us.” National Health Council. Accessed January 23, 2022. https://nationalhealthcouncil.org/about/.

80 “A Dialogue on Patient-Centered Value Assessment: Overcoming Barriers to Amplify the Patient Voice.” 

National Health Council. August 3, 2018. https://www.nationalhealthcouncil.org/dialogue-patient-centered

-value-assessment-overcoming-barriers-amplify-patient-voice.

81 Oehrlein, E. M., et al. Patient-Centered Real-World Evidence: Methods Recommendations from an EvidenceBased Process Consensus (Washington, DC: National Health Council, May 2021). https://nationalhealthcouncil

.org/patient-centeredrwe.

82 “Value Classroom.” National Health Council. Accessed January 23, 2022. https://nationalhealthcouncil.org

/education/value-classroom/.

26 National Council on Disability
National Council on Disability 

1331 F Street, NW, Suite 850 

Washington, DC 20004