**Supplemental Comments of Pfizer, Inc.:**

**Medicare Prescription Drug Improvement and Modernization Act Section
1013:**

**Priority Topics for Research on Outcomes of Health Care Items and
Services**

**\[Docket No. 2004S-0170\]**

Pfizer, Inc. (Pfizer) respectfully submits these supplemental comments
in response to the Agency for Healthcare Research and Quality's (AHRQ)
request for comments on its longer-term priorities under Section 1013 of
the Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA).

Pfizer is a research-based pharmaceutical company with enormous
experience applying objective data to clinical problems. We maintain the
largest privately funded biomedical research establishment in the world,
and have a global enterprise dedicated to obtaining, understanding, and
applying the very best evidence from basic and clinical sciences to
human health. This experience in the discovery and development of
pharmaceuticals, and our keen understanding of the clinical environment
in which our products are used, provides a unique perspective on the
value and role of AHRQ's activities under MMA Section 1013.

**Executive Summary**

Pfizer recognizes that policy makers must make health care resource
allocation decisions, and that purchasers and consumers of health
services are increasingly concerned with the value of the care being
provided. That said, Pfizer believes clinical judgment and patient
choice, within the bounds of accepted medical practice, must always be
the overriding force in decisions about individual care. To provide
quality, individualized care, physicians must have the opportunity for
multiple treatment options. Dosing, packaging and different metabolic
pathways may make particular compounds in a therapeutic class suitable
for one person but not for another with the same condition.[^1] As
Pfizer Chairman and CEO Dr. Henry McKinnell told the World Health Care
Congress on January 28, 2004, Pfizer believes our health care system
"should allow doctors and patients to choose the best courses of
care...rather than settling for the lowest common denominator of
'average care for the average person.'"

Unfortunately, numerous articles have shown that aggregating and
analyzing comparative clinical effectiveness studies is difficult
because the methods used can differ widely.[^2] Methodologies currently
relied upon by policymakers often lack rigor, and in some cases, the
underlying studies are ill conceived or undertaken by a researcher with
a clear agenda or insufficient qualifications. More consistent and
transparent methods and reporting must be achieved for comparative
clinical effectiveness analysis to become useful.[^3]

Given these limitations, Pfizer strongly believes that the resources
provided under MMA Section 1013 should be employed in an open, ongoing
process for obtaining input from stakeholders, and AHRQ to consider all
stakeholder objections as the agency develops and employs any standards
for comparative clinical effectiveness analysis. The application of such
standards and methodologies in specific areas should be reviewed
regularly via a notice and comment process.

Moreover, any studies undertaken should apply equally to all health care
interventions, both diagnostic and therapeutic, and should be applied in
the context of disease states, rather than for product- or product
class-specific cost-cutting objectives. It is critical that such
standards include measures to ensure that all costs are included in
comparative cost effectiveness analyses, including the harm that would
be caused to certain populations by excluding or disfavoring treatments.
Additionally, all health care stakeholders should be held to the same
level of rigor in analysis and transparency in presentation,
particularly when the outcomes research and comparative effectiveness
studies are done for comparison purposes.

Pfizer strongly believes the agency should research the underutilization
of appropriate treatment as well as the comparative costs and outcomes
from all available treatments for the most burdensome health conditions.
Based on this belief and a literature review to determine the most
costly, most treatable health conditions or those with the greatest
disparities in care, Pfizer recommends that AHRQ study the following
seven categories of health care:

1.  Heart disease

2.  Cancer

3.  Chronic kidney disease

4.  Diabetes

5.  Maternal and child health

6.  Respiratory diseases

7.  Long term care

8.  Mental health

Pfizer also believes it would be advisable for AHRQ to further research
the benefits of disease management and other methods of improving
coordination of care, including case management and improved information
systems. Generally, disease management studies conducted around the
country indicate that closely managing patients with chronic diseases
can reduce the cost of physician and hospital services these patients
require and at the same time improve quality of life for the
patient.[^4] Disease management can prevent or delay the onset of the
more severe and costly stages of a disease and in many cases may be the
most cost-effective method of treatment.

Finally, Pfizer believes AHRQ must be vigilant in ensuring that its
studies are not misapplied to support cost containment strategies. Only
after patients and physicians are aware of clinical options and
available outcome data is it proper for issues of cost and coverage to
enter into the decision. Restricting access to important medicines not
only harms patients, but also inflates overall health care costs as a
greater number of patients frequently require costly hospital care and
other medical services as a result of untreated and worsening
conditions. MMA Section 1013 was intended to facilitate studies of
various therapeutic areas: it does not mandate a narrow focus on the
comparative clinical effectiveness of pharmaceutical treatments, and
certainly not for facilitating or influencing drug payment decisions.

AHRQ's overall mission is to improve the quality, safety, efficiency and
effectiveness of health care for all Americans. Given the agency's
objectives, it is important that it supports research designed to
improve the outcomes and quality of health care, address patient safety
and medical errors, and broaden access to effective services, not to
develop cost containment strategies that limit patient access to
life-saving therapies.[^5] In particular, while Pfizer recognizes the
substantial cost of many novel pharmaceutical treatments, we also
recognize the impact these treatments have on the health and lives of
the patients who take them. To that end, Pfizer believes that AHRQ
should recognize that the 10.5% of health care spending used to pay for
prescription pharmaceuticals helps reduces spending on other, more
expensive interventions.[^6] It is critical that AHRQ not allow the
resources provided under MMA Section 1013 to be used to develop cost
containment strategies that limit access to new therapies.

With all of theses issues in mind, the following comments are intended
to:

-   **Outline the purpose and scope of MMA Section 1013 --**
    Specifically, Pfizer believes that Section 1013 of the Medicare
    Prescription Drug Improvement and Modernization Act of 2003 was
    intended to facilitate studies of various therapeutic areas, not
    just focus on the comparative clinical effectiveness of
    pharmaceutical treatments.

-   **Discuss the purpose of AHRQ's research --** Pfizer believes
    comparative clinical effectiveness and outcomes research cannot
    replace the patient-physician relationship. The primary decision as
    to treatment should be made by the physician and patient, and only
    after patients and physicians are aware of all clinical options and
    available outcomes data is it proper for issues of cost to enter
    into the decision making process.

-   **Propose basic standards for evidence -** Pfizer believes all
    outcomes research and comparative effectiveness research must be (1)
    transparent, (2) objective, and (3) consistent. The best research,
    no matter its use, must be easily shared, dissected and understood.

-   **Recommend disease states for study -** Pfizer believes additional
    research must be done on the comparative clinical effectiveness of
    treatments for the most costly disease states. Additionally,
    analysis must be undertaken to understand the underutilization of
    appropriate treatments by the patient populations most susceptible
    to these diseases.

-   **Discuss the benefits of disease management -** Pfizer believes
    disease management systems should be in place for each disease state
    as a context for pharmaceutical outcomes research or comparative
    effectiveness analysis. This will enable policy makers to make
    rational economic and clinical choices between therapeutic
    alternatives.

-   **Warn against aligning payment policies with quality improvement
    goals -** Pfizer believes that payment for health care technologies
    must encourage the development of novel methods to improve the value
    obtained for the resources expended.

# Introduction

Applying scientific evidence, generally gained by studying groups of
patients, to individuals, is perilous. That experience has given us
enormous respect for the importance of clinical judgment and the need
for flexibility in addressing individual patient circumstances and
values. We recognize that the practice of medicine requires that each
patient is cared for individually, meaning that appropriate evidence
needs to be applied to reflect the clinical situation and needs of the
patients who may differ in their genetics, co-morbidities, medications,
metabolic status or preferences. Among the core strengths of American
medicine is the ability of practitioners to interpret and apply evidence
in individual clinical settings. Therapeutic discretion allows for
improvements in care, but requires continuous review with dissemination
of outcomes to foster recognition and elimination of ineffective or
dangerous practices.

Unfortunately, in today's health care marketplace, outcomes research and
comparative effectiveness studies are frequently undertaken with a
cost-cutting rather than quality agenda. In other words, cost savings in
disconnected areas of treatment are emphasized over systemic
cost-consciousness. Pfizer is quite concerned that state, federal and
private payers will design drug-oriented cost-containment processes
around AHRQ's studies without regard to quality patient care. While the
concept of assembling comparative clinical information on products
within a class is inherently attractive and for some very limited
purposes may be sound, using such analyses as a cost-saving measure may
endanger patients. Indeed, just as Pfizer regularly must prove that its
drugs are both safe and effective, proponents of this cost-driven
approach should be forced to ensure that the restrictions placed on
patient access do not in fact cause patient harm.

Pfizer believes it is inconsistent with the legitimate goals and values
of comparative clinical effectiveness and outcomes research to permit
such studies to be used by health care payers to make product-specific
decisions with the goal of controlling costs. Recognizing that
cost-efficiency must be achieved within the health care system, Pfizer
believes financial decisions must be kept separate from clinical
decisions in order to preserve the quality of care achieved by
respecting the core physician-patient relationship in medicine.

Pfizer holds itself to the highest standards of excellence and believes
we, as a company, have a responsibility to patients and the physicians
that care for them to ensure that our medicines are analyzed in a
thorough, fair, and objective manner.

**II. Purpose and Scope of MMA Section 1013**

Section 1013 of the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA) was intended to facilitate studies of
various therapeutic areas. The provision does not mandate a narrow focus
on the comparative clinical effectiveness of pharmaceutical treatments,
and certainly not for facilitating or influencing drug payment
decisions.

Specifically, Section 1013 calls on AHRQ to conduct studies to improve
the quality, effectiveness, and efficiency in the Medicare, Medicaid,
and State Children Health Insurance (SCHIP) programs. Under the statute,
the studies must focus on (1) the outcomes, comparative clinical
effectiveness, and appropriateness of health care items and services
(including prescription drugs); and (2) strategies for improving the
efficiency and effectiveness of such programs, including the ways in
which such items and services are organized, managed, and delivered
under such programs. Notably, as stated by AHRQ in its request for
comments, "the statute does not limit the scope of the initial priority
list". Therefore, as discussed throughout these comments, Pfizer
believes AHRQ should look to improving the clinical return on overall
money spent by examining disease management, prevention programs, and
various other long-term strategies for treating chronic conditions,
rather than short-term cost containment.

In addition to conducting studies, the statute charges the Secretary of
HHS with: (1) ensuring that there is broad and ongoing consultation with
relevant stakeholders in identifying the highest priorities for
research, demonstrations, and evaluations; (2) including health care
items and services which impose a high cost on such programs, as well as
those which may be underutilized or overutilized and which may
significantly improve the prevention, treatment, or cure of diseases and
conditions (including chronic conditions) which impose high direct or
indirect costs on patients or society; and (3) ensuring that the
research and activities undertaken pursuant to this section are
responsive to the specified priorities and are conducted in a timely
manner.

Once the studies are complete, the statute requires that the Secretary:
(1) evaluate and synthesize available scientific evidence related to
health care items and services (including prescription drugs) with
respect to the comparative clinical effectiveness, outcomes,
appropriateness, and provision of such items and services; (2) identify
issues for which existing scientific evidence is insufficient with
respect to such health care items and services (including prescription
drugs); (3) work in voluntary collaboration with public and private
sector entities to facilitate the development of new scientific
knowledge regarding health care items and services (including
prescription drugs).

Notably, Congress expressly required that "research, evaluation, and
communication activities performed pursuant to this section shall
reflect the principle that clinicians and patients should have the best
available evidence upon which to make choices in health care items and
services, in providers, and in health care delivery systems, recognizing
that patient subpopulations and patient and physician preferences may
vary." Thus, the Secretary must be very careful to make certain that
these studies are not used to facilitate cost-driven approaches aimed at
restricting the pharmaceutical care available to patients.

**III. Purpose of Research**

As noted, the primary decision as to treatment should be made by the
physician and patient, and only after patients and physicians are aware
of all clinical options and available outcomes data is it proper for
issues of cost to enter into the decision making process. Moreover, when
costs are considered, all relevant costs should be included across the
system of care and over the length of a treatment for the patient.
Simply focusing on short-term financial savings or a single treatment
option may result in increased long-term costs to the overall health
care system, and a disparate impact on vulnerable patients, such as the
poor and those on multiple medications. Assessing interventions in
isolation risks overlooking the main drivers of health care costs.

This approach was mistakenly taken in New Hampshire. There, to reduce
state drug spend for a burgeoning budget, the Medicaid Prescription Drug
List limited the number of psychiatric drugs available for patients.
Unfortunately, unilaterally restricting access to these important
medicines not only harmed patients, but also inflated overall health
care costs as more patients were admitted to psychiatric hospitals as a
result of untreated and worsening conditions.[^7] The result was a large
increase in overall costs to the New Hampshire Medicaid system.

Pfizer believes AHRQ should explicitly acknowledge that conducting
comparative clinical effectiveness and outcomes research and analyses
will not remove the need for difficult resource allocation decisions, it
will only help inform policymakers and caregivers of the benefits of new
technologies in the overall context of care. Comparative clinical
effectiveness analysis cannot resolve the question of whether society
should pay for a new technology. To determine whether a technology
should be covered, it will be necessary to determine how much society is
willing to pay for the health benefits derived from the technology. This
decision cannot be resolved by looking exclusively at the benefits of
one new technology as compared with another.

Finally, AHRQ must address the fact that the applicability of most
comparative clinical effectiveness reviews will be extremely short-lived
due to the rapidly evolving nature of clinical evidence and technology
development. As new treatments emerge, comparative clinical
effectiveness analyses must be constantly updated. Moreover, research
done on prior incarnations of technologies may not be applicable. Pfizer
recognizes, and AHRQ should acknowledge, that medical treatment is
dynamic, and therefore static comparative clinical effectiveness
analysis will be of no help -- and may in fact be detrimental -- to
health care policy decision-makers.

**IV. Appropriate Standards for Evidence**

Pfizer believes all outcomes research and comparative effectiveness
research must be (1) transparent, (2) objective, and (3) consistent. The
best research, no matter its use, must be easily shared, dissected and
understood.

[Transparency]{.underline}

AHRQ outcomes research and comparative effectiveness studies will only
be beneficial to health care policy-makers if the studies are conducted
and produced in a transparent manner. The best way to accomplish this
goal is to require all AHRQ-funded researchers to publish the design of
their studies, prior to implementation, for a public comment period.

Pfizer believes the recent interest of state, federal and private payers
in processes that are not transparent and position comparative clinical
effectiveness analysis as quality improvements highlights the need for
AHRQ to have a transparent process for reviewing outcomes research and
comparative effectiveness data. These entities are employing narrowly
focused clinical trials to compare medicines and inappropriately
conclude, absent direct contrary evidence, that the medicines are
equivalent for entire populations and that restricted access to certain
medicines is justified. The motives of those drawing these conclusions
are often not acknowledged.

The need for transparency is further highlighted by the drug formulary
experience. Managed care organizations have been using drug formularies
for many years. However, the processes by which these organizations have
made formulary decisions frequently lack transparency and scientific
rigor. Generally, the pharmacy and therapeutics committees overseeing
formulary decisions for a managed care organization determines which
drugs should be covered based on scattered literature reviews, anecdotal
information from physicians, and the price of the product. Frequently
the broader health and economic consequences to the health plan or
hospital and individual patient needs are not heavily weighted in these
considerations.

While the concept of assembling comparative clinical information on
products within a class is inherently attractive and for some purposes
may be sound, designing the analysis as a cost-saving device introduces
insurmountable bias and may be harmful to patients. Scientific evidence
is routinely being misapplied by these entities to support elevating
cost containment over appropriate care for individual patients. Adding
such transparency will give a voice to physicians, patients, and other
interested parties, and add to the ultimate credibility of legitimate
cost and efficiency measures.

> [Objectivity]{.underline}

Pfizer believes AHRQ should establish guidelines to make certain all of
the outcomes research and comparative effectiveness research it sponsors
is objective. Specifically, to ensure objectivity, Pfizer believes it is
imperative that: (1) AHRQ make certain that standards of evidence that
impact access to care are defined independently of, and prior to,
consideration of costs; (2) the interpretation and analysis of evidence
is conducted by objective specialists and open to review (this also
addresses the transparency issue above); and (3) manuscripts should
disclose funding sources. Pfizer believes allowing a period for review
of studies by all stakeholders and establishing a process under which
stakeholders could request a third party review would go a long way to
ensuring objectivity.

> [Consistency]{.underline}

Unfortunately, studies on comparative clinical effectiveness and patient
outcomes frequently contradict one another with regard to the economic
benefits of a product or therapy. Studies have shown that one reason for
this inconsistency is that the methods used to estimate comparative
clinical effectiveness could differ widely based on the use of varying
methodologies to complete the analysis.[^8] Health care decision makers
need to be assured that the information they are reviewing has been
produced using an appropriate methodology and that the results are valid
and consistent. No good is served by generating information if the
validity of the information is called into question because the results
of various studies are inconsistent due to varying methodologies or
study techniques.

In particular, AHRQ must ensure that for all such research a consistent
mechanism is used for capturing indirect costs. Indirect costs include
hard to quantify items like change in productivity, increased quality of
life and fewer side effects brought about by the intervention. [^9] When
comparing outcomes and comparative clinical effectiveness, inconsistent
and/or non-transparent mechanisms for capturing these costs can easily
skew results and preclude accurate and fair comparisons.

Finally, the impact of underutilization must always be considered. As a
component of such efforts, AHRQ should look to the RAND/UCLA
Appropriateness Method (RAM) when considering how to analyze the
underutilization of treatments. The rationale behind the RAM method is
that randomized clinical trials often are either not available or cannot
provide evidence at a level of detail sufficient to apply to the wide
range of patients seen in everyday clinical practice. Consequently, the
RAM method combines the best available scientific evidence with the
collective judgment of experts to yield a statement regarding the
appropriateness of performing a procedure at the level of
patient-specific symptoms, medical history and test results.

**V. Targeting High Impact Areas**

Pfizer believes additional research must be done on the comparative
clinical effectiveness of treatments for the most costly disease states.
We also believe it is essential to analyze and understand the
underutilization of appropriate treatments by the patient populations
most susceptible to these diseases.[^10] To that end, for each disease
state studied by AHRQ, Pfizer believes it is essential to study the
disparate treatment of the disease in minority populations.

Health care spending is highly concentrated. Between 1995 and 1999 the
most costly 5 percent of Medicare beneficiaries accounted for 47 percent
of total Medicare spending.[^11] During the same time period, the most
costly 20 percent of beneficiaries accounted for 84 percent of spending.
By contrast, the least costly 40 percent of beneficiaries accounted for
1 percent of spending.[^12] For this reason, Pfizer believes it is
essential that AHRQ focus its studies on the most costly diseases as
well as on populations that tend to not receive appropriate care and
therefore live less healthy lives. Therefore, the following areas are
recommended for study, in that almost 90 percent of beneficiaries in the
top 5 percent of annual Medicare spending had at least one of the
following:

1.  Heart disease

2.  Cancer

3.  Chronic kidney disease

4.  Diabetes

5.  Maternal and child health

6.  Respiratory diseases

7.  Long term care

8.  Mental Health

> [Heart Disease]{.underline}

The tremendous impact heart disease has on the U.S. health care system
is well documented. The leading cause of death for men and for women in
the United States, heart disease was responsible for over 700,000 deaths
in 2000.[^13] It was also the third leading cause of activity
limitation. About 4.8 million Americans have heart failure, and 550,000
Americans develop heart disease each year.[^14] The economic cost of
heart disease is estimated to be \$214 billion, including \$115 billion
in health care expenditures. Two of the most common heart diseases are
coronary heart disease and heart failure.[^15] About 12.6 million
persons have coronary heart disease and over 1 million heart attacks
occur each year.[^16]

> [Cancer]{.underline}

The second leading cause of death in the United States, cancer causes
one in four deaths.[^17] In 2003, approximately 1.5 million persons in
the United States were diagnosed with cancer.[^18] More than half of new
cancer cases and cancer deaths can be attributed to four cancers: lung,
colorectal, breast and prostate.[^19] While cancer incidence rates have
increased gradually in recent years, cancer death rates have declined
because the medical community has made great strides in treating the
disease. Perhaps most importantly to AHRQ, the economic costs of cancer
are high: in 2002, total costs exceeded \$171 billion, and direct costs
for physicians, hospitals, and drugs exceeded \$60 billion.[^20]

> [Kidney Disease]{.underline}

Chronic kidney disease has been defined as structural or functional
damage to the kidney with or without impairment of the kidney's ability
to filter water and waste from the body.[^21] Using this definition, 11%
of the U.S. adult population has chronic kidney disease.[^22] Of the
nearly 19.2 million persons with kidney disease, 8.3 million have
moderate impairment of the kidney function and almost 400,000 have End
Stage Renal Disease (ESRD) requiring renal replacement therapy to
sustain life.[^23] Each year, almost 100,000 new ESRD patients begin
treatment with either dialysis or renal transplantation, and about
70,000 ESRD patients, 19% of the total ESRD population, die.
Expenditures of the ESRD program totaled over \$19 billion in 2000, of
which the Medicare program paid \$14 billion.[^24]

> [Diabetes]{.underline}

Diabetes afflicts over 17 million people in the United States, including
20% of persons over age 65. One million new cases of diabetes are
diagnosed annually. [^25] Diabetes was the sixth leading cause of death
in 2003, when about 200,000 death certificates listed diabetes as an
underlying or contributing cause of death.[^26] Diabetes is also the
leading cause of many other diseases including: blindness, non-traumatic
lower extremity amputation and it increases the risk of heart disease,
stroke, neuropathy, and complication of pregnancy. The costs of diabetes
total about \$132 billion, including over \$90 billion in direct medical
expenditures and about \$40 billion due to lost productivity and
premature death.[^27]

> [Maternal and child health]{.underline}

Childbirth and reproductive care are the most common reasons for women
of childbearing age to use health care. With more than 11,000 births
each day in the United States, childbirth is the most common reason for
hospital admission.[^28] In 2001, 11.9% of infants were born preterm,
7.7% were born with low birth-weight, including 1.4% with very low
birth-weight. [^29] Over time, rates of preterm birth and low and very
low birth-weight have increased, although rates of infant mortality have
decreased.[^30] Comprehensive prenatal care can prevent complications of
pregnancy and reduce neonatal mortality. Given that birth outcomes have
effects that accrue over a lifetime, prenatal care is highly
cost-effective.[^31]

> [Respiratory diseases]{.underline}

Respiratory diseases cause activity limitation in 2.6 million persons.
Annual costs of respiratory diseases exceed \$116 billion, including
\$65 billion in health care expenditures.[^32] Asthma, perhaps the most
well known respiratory disease, affects about 15 million persons.[^33]
Each year, about 11 million persons experience asthma attacks and 5,500
persons die of the disease. Pneumonia, another common respiratory
disease, is a leading cause of hospitalization among children and the
elderly. Treatment costs for pneumonia in the United States exceed \$9.7
billion.[^34]

> [Long-term care]{.underline}

As the number of elderly Americans increases from 35 million in 2000 to
an estimated 71 million in 2020, the need for long-term care is expected
to increase.[^35] Long-term care includes the provision of services at
home, in the community, and in special facilities. In 1999, about 12,000
home health care agencies provided care to 8.8 million persons, about
two-thirds of whom were aged 65 and above.[^36] Nursing home care costs
on average, \$56,000 per person per year, and expenditures total almost
\$90 billion, about half of which is paid by Medicaid and Medicare.[^37]
It is estimated that in 2020 approximately 80% of nursing home residents
are supported in part by Medicaid. [^38]

[Mental Health]{.underline}

The cost of untreated and mistreated mental illness is estimated at
\$113 billion annually.[^39] The Journal of the American Medical
Association in July 2003 reported that lost productivity stemming from
depression alone totals \$44 billion annually. However, the National
Institute of Mental Health has shown that success rates of treatment for
disorders such as schizophrenia (60%), depression (70-80%) and panic
disorder (70-90%) surpass those of other medical conditions (heart
disease, for example, has a treatment success rate of 45-50%).

**VI. Health Care Disparities**

As recently noted by AHRQ in its "National Health Care Disparities
Report," health care disparities are costly.[^40] Poorly managed care or
missed diagnoses, which more regularly occur in certain populations
result in expensive and avoidable complications. As discussed in a
recent Institutes of Medicine Report, "to the extent that minority
beneficiaries of publicly funded health programs are less likely to
receive high quality care, these beneficiaries---as well as the
taxpayers that support public health care programs---may face higher
future health care costs."[^41]

In addition to costs directly borne by taxpayers, unfortunate outcomes
resulting from health care disparities may contribute to higher health
insurance and malpractice premiums, both of which threaten the viability
of our health care system. While difficult to quantify precisely, the
costs of lost productivity and the indirect costs to families are
probably very high. Thus, Pfizer believes the elimination of health care
disparities, specifically the impact of underutilization of appropriate
medications in certain populations and the comparative clinical
effectiveness of appropriately treating these populations should be
studied by AHRQ and should become a top public policy priority.

The following statistics outline the health care disparities issue for
each of the disease states Pfizer believes should be studied by AHRQ:

> [Heart Disease]{.underline}

Racial, ethnic, and socioeconomic disparities in cardiovascular care
have been extensively reviewed and documented.[^42] Specifically: (1)
heart disease deaths are higher among African Americans compared with
non-Hispanic whites; and (2) coronary heart disease is more prevalent
among African Americans compared with whites and the prevalence among
African Americans is rising while the prevalence among whites is
falling. [^43] In addition, coronary heart disease mortality is higher
among African Americans compared with whites.[^44]

[Cancer]{.underline}

Cancer incidence and death rates vary by race and ethnicity. African
Americans have a 10% higher cancer incidence rate and a 30% higher
cancer death rate compared with whites.[^45] Compared with whites
Hispanics have higher rates of cervical, esophageal, gallbladder, and
stomach cancer and Asians have higher rates of stomach and liver
cancer.[^46]

Cancer care varies by race, ethnicity, and socioeconomic status.[^47]
Differences in screening for and primary treatment of breast cancer,
cervical cancer, colorectal cancer, early stage lung cancer and prostate
cancer exist.[^48] Research also indicates that there are both
differences in follow-up care after diagnosis of breast cancer.[^49]

> [Kidney Disease]{.underline}

Racial and ethnic minorities develop ESRD at a younger age and have
rates of ESRD that are several-fold higher than whites.[^50] Research
has also indicated that racial and ethnic disparities in care for
chronic kidney disease exist.[^51] There are significant differences in
the rate of referral to renal transplant centers, placement on a waiting
list, timing of placement on a transplant waiting list, and receipt of a
kidney transplant.[^52]

> [Diabetes]{.underline}

Significant racial, ethnic, and socioeconomic differences in diabetes
have been observed. The prevalence of diabetes is higher among African
Americans and Hispanics and among less educated persons.[^53] African
Americans, American Indians and Hispanics have higher diabetes death
rates. African Americans also have higher rates of serious complications
from diabetes, including higher rates of ESRD due to diabetes and higher
rates of lower extremity amputation.[^54] African American diabetics are
less likely than white diabetics to receive patient education and more
likely to be treated with insulin.[^55]

> [Maternal and child health]{.underline}

There are significant racial and ethnic differences in birth rates.
Non-Hispanic African Americans and Hispanics, have higher birth defect
rates than non-Hispanic whites. [^56] African American, American Indian,
and Hawaiian mothers are more likely to have preterm, and low
birth-weight compared to white mothers. Similarly, Hispanic mothers are
more likely to have preterm infants but less likely to have low
birth-weight compared with non-Hispanic white mothers.[^57] During the
first year of life, black infants are more likely to die than
non-Hispanic white infants. [^58]

> [Respiratory diseases]{.underline}

There are racial and socioeconomic differences in respiratory disease
prevalence. For example, asthma is more prevalent among minorities and
low-income persons, and asthma attack rates and mortality are higher
among African Americans compared with whites.[^59] Tuberculosis is
highly concentrated in two populations: foreign-born persons and
U.S.-born non-Hispanic African Americans. [^60] Non-Hispanic African
Americans account for almost half of all cases among U.S.-born persons.
In addition, there are differences in influenza vaccination among
Medicare beneficiaries and in management of asthma among managed care
enrollees.[^61]

> [Long-term care]{.underline}

Studies indicate that racial, ethnic, and socioeconomic disparities in
nursing home care exist, particularly with respect to differences in the
management of pain and the receipt of rehabilitative services.[^62]

Mental Health

Racial and ethnic minority groups are generally considered to be
underserved by the mental health services system.[^63] Despite the lack
of care, the prevalence of mental disorders is estimated to be higher
among African Americans, Hispanics and Native Americans than among
whites.[^64] Additionally, among adults, the evidence is considerable
that persons from minority backgrounds are less likely to seek
outpatient treatment in the specialty mental health.[^65] Thus, AHRQ
should examine the underutilization of mental health treatment by
minority populations.

**VII. Disease Management**

Pfizer believes it would be advisable for AHRQ to further research the
benefits of disease management. Disease management is "a system of
viewing health care disease by disease and examining the interrelated
elements in the treatment process with outcomes research to improve
quality and lower costs.\"[^66] We believe disease management systems
should be in place for each disease state and should serve as the
context for pharmaceutical outcomes research or comparative
effectiveness analysis. This will enable policymakers to make economic
and clinical choices between therapeutic alternatives.

Generally, the purpose of a disease management program is to: (1)
establish best practices in care delivery for a condition; (2) improve
outcomes (clinical, utilization, perceived well-being and satisfaction);
(3) promote involvement between patients, practitioners and the health
plan (e.g., case management); (4) implement interventions for common,
costly, complex and chronic conditions; (5) promote early disease
detection and diagnosis; (6) integrate prevention, wellness and disease
management strategies across the continuum of care; and (7) minimize or
forestall inpatient hospitalizations or emergency room visits.[^67]

In order to accomplish the goals of disease management programs, the
following components are frequently included as part of the program:

1.  [Systematic population identification]{.underline} - defining
    criteria for patient identification and implementing systematic
    processes for ongoing patient identification is essential for
    successful disease management.

2.  [Evidence-based practice guidelines]{.underline} - guidelines
    provide practitioners and patients with access to the most current
    accepted recommendations for clinical care.

3.  [Integrated, collaborative practice model]{.underline} - each member
    of the health care team is responsible for defining and delivering
    the best care in his/her area of expertise and for communicating and
    collaborating with the patient, family and all other health care
    team members.

4.  [Patient education]{.underline} - patient education must be ongoing,
    and educational information must be current and evidence-based.

5.  [Performance measurement]{.underline} - disease management programs
    should measure: (1) clinical data (e.g., mortality, morbidity and
    complications); (2) utilization; and (3) functional status.[^68]

Pfizer believes that the success of the Pfizer/Florida-sponsored disease
management program "Florida: A Healthy State" demonstrates the need for
further study of disease management programs. Under the program, Pfizer
has paired more than 16,000 of the highest risk; highest cost
chronically ill patients with 50 specially trained care managers. These
patients have received one-on-one attention and more than 28,000 home
health aids, such as peak flow meters for asthmatics and blood pressure
cuffs for hypertensives, to reinforce physician treatment and care
recommendations and help better monitor their conditions. The
demonstrated program success and behavioral and clinical results have
lead to lower utilization of high cost inpatient services and emergency
department visits for acute medical events. Overall hospital days of
those under care management provided through this program declined 12%
compared to those who were not under care management. For those who
joined the program at inception, hospital days have declined over twice
the rate as shown among all patients (27%).

Pfizer believes that only when a coordinated system of preventive,
diagnostic and therapeutic measures is put in place can cost-effective,
quality health care be provided to a patient population. Currently,
organizational barriers obstruct the disease management perspective on
treatment. Notably, coordination between health care entities (like a
pharmaceutical company and HMO) about patient experiences is heavily
regulated by the Health Insurance Portability and Accountability Act of
1996 ("HIPAA"), thereby making coordination of care between and among
various health care entities more complex. However, ongoing industry
changes, particularly the forthcoming entrance of pharmaceutical
companies into the Medicare Discount Drug Card Program and the growing
use of PBM services by HMOs, could help facilitate the development and
use of disease management programs.

**VIII. Aligning Payment Policies With Quality Improvement Goals**

Payment policies have a tremendous influence on how health care
organizations and health care professionals deliver care and how
patients select and use that care. These goals are relevant regardless
of whether the ultimate purchaser of the care is an employer, insurer or
patient/consumer. However, AHRQ should recognize that payers might
misuse the agency's comparative clinical effectiveness and outcomes
research to limit patient access to life saving drugs. The result is
payment policies that may be at odds with quality goals.

Managed care organizations and pharmacy benefit managers, purporting to
rely upon comparative clinical effectiveness research, have been
developing methods for controlling prescription drug expenditures rather
than achieving quality care and good patient outcomes. While the use of
such data may, in fact, lower cost for the insurer, it also limits the
therapeutic alternatives available to physicians treating patients. This
blurring of the boundary between clinically and economically driven
decisions poses measurable risks to patients.

The growing popularity of tiered formularies presents an example. Tiered
processes act as a mechanism to shift cost from payers to patients but
are often justified on clinical grounds, implicitly conveying to
patients and physicians that the more expensive medicine is unjustified.
These formularies, \"regardless of the particular details...lead to
higher out-of-pocket costs to consumers and to some patients\' going
without prescription drugs."[^69] As noted, related concerns about
opaque economic conflicts apply to various cost control strategies
including cost driven treatment guidelines and prior authorization
policies.

While it is understood that payers desire to contain costs, these
policies can result in inappropriate medication usage patterns, which
can be associated with higher total health care costs and poorer
clinical outcomes. These practices beg the question, "What is the
evidence that restricted drug access policies do not harm patients?"
Healthcare expert Dr. S. B. Soumerai has recently attempted to answer:

> Given the rapid increase in the use of PA \[prior authorization\]
> policies and other cost-control mechanisms in Medicaid, the relative
> lack of data on their risks and benefits is cause for concern. It is
> sobering to realize that if such policies were considered for a
> clinical study, the possible risks of reduced access to essential
> medicines would likely result in failure to obtain human-subject
> approval from most institutional review boards (IRBs). These policies
> can be viewed as massive experiments on vulnerable populations.[^70]

Indeed, the risks of bad decisions in restricting pharmaceutical access
threatens to exacerbate what is already a one of the most serious
problems in achieving quality in health care: drug underutilization. The
most recent report of the RAND group's comprehensive Assessing the Care
of Vulnerable Elders (ACOVE) project, *The Quality of Pharmacologic Care
for Vulnerable Older Patients*, suggests that underutilization of
medications is one of the most important factors in addressing quality
care in the older population.[^71] ACOVE presents in-depth findings
pertaining to the 43 quality indicators that address medication
treatment. Among other important findings:

-   Vulnerable elders with chronic conditions are not prescribed
    recommended medications 50% of the time. 

-   Education about prescribed medications occurred only 81% of the
    time.

-   Medication monitoring occurred only 64% of the time.

Clearly these results indicate a gap in quality when it comes to quality
medication care, which would only be worsened by inappropriate reliance
on cost shifting to patients. The lesson is not that cost containment
strategies are necessarily bad, but instead that they need to be
explicitly identified with concurrent processes instituted to detect and
avoid negative outcomes, and should not be weighted against
pharmaceuticals, which are often the best choice in terms of quality
care.

Moreover, Pfizer believes that payment for health care technologies must
encourage the development of novel methods to improve the value obtained
for the resources expended. The research and development of new
prescription drugs is extremely costly because most new drug candidates
fail to reach the market. [^72] Typically, less than 1 percent of the
compounds examined in the pre-clinical period make it into human
testing. [^73] Only 20 percent of the compounds entering clinical trials
survive the development process and gain FDA approval.[^74] Furthermore,
the full research and development process from synthesis to FDA approval
involves undertaking successive trials of increasing size and
complexity. The pre-clinical and clinical testing phases generally take
more than a decade to complete and cost more then \$800 million.[^75] In
order to encourage companies to undertake this long and costly process,
it is essential that payers not limit patient access to new and novel
drugs, which often provide substantial leaps in terms of quality patient
care.

**IX. Conclusions and Recommendation\
**

Pfizer believes all AHRQ research should work towards the goals of
making healthcare available to everyone, affordable to all tailored to
the individual information driven and oriented towards prevention.
Additionally, Pfizer believes the patient's health must come first, the
physician-patient relationship is essential and would not be
compromised, and health care financing and payment levels must ensure
quality and innovation. As noted, to ensure quality care for American
patients, Pfizer believes AHRQ research must be highly transparent,
objective, and consistent. Moreover, the agency should focus its
research on the analysis of all available treatments for the most costly
health conditions as well as the underutilization of appropriate
treatments by patient populations most susceptible to these diseases.
Specifically, Pfizer recommends that AHRQ study the following eight
categories of health care: (1) heart disease; (2) cancer; (3) chronic
kidney disease; (4) diabetes; (5) maternal and child health; (6)
respiratory diseases; (7) long term care; and (8) mental health. Pfizer
also believes AHRQ should research the affect disease management
programs could have on each of these conditions.

Finally, to enhance the quality of care, AHRQ must ensure that its
studies are not misapplied to support inappropriate cost-containment
strategies, which undermine patient care and beneficial innovation.

Pfizer thanks AHRQ for this opportunity to provide comments, and looks
forward to working with the AHRQ as it implements MMA Section 1013.

Respectfully submitted,

Lisa Egbuonu-Davis, M.D.

Vice President, US Medical

Pfizer Global Pharmaceuticals

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[^2]: P.J. Neumann et al., "A Formal Audit of 228 Published Cost-Utility
    Analyses" (Working paper, Harvard School of Public Health, 1999).

[^3]: I.S. Udvarhelyi et al., "Cost-Effectiveness and Cost-Benefit
    Analyses in the Medical Literature: Are the Methods Being Used
    Correctly?" *Annals of Internal Medicine* 116, no. 3 (1992):
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    Cost-Utility Analyses"; and K. Gerard, I. Smoker, and J.
    Seymour,"Raising the Quality of Cost-Utility Analyses: Lessons
    Learnt and Still to Learn," *Health Policy* 46, no. 3 (1999):
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[^4]: Teutsch, S. M., presentation at third meeting of the
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[^5]: See \[http://www.ahrq.gov/about/profile.htm\]

[^6]: Frank R. Lichtenburg, "Benefits and Costs of Newer Drugs: An
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[^7]: Huskamp, HA, et al., "The Effect of Incentive-Based Formularies on
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[^8]: I.S. Udvarhelyi et al., "Cost-Effectiveness and Cost-Benefit
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[^10]: Please note, per AHRQ's request, these comments focus on
    pharmaceutical utilization/underutilization. Pfizer does, however,
    believe that in addition to these areas, AHRQ should utilize MMA
    Section 1013 to study other areas critical to improving quality and
    efficiency, such as coordination of care, information technology and
    health care delivery processes.

[^11]: Pfizer believes AHRQ should devote more resources to the study of
    waste in the Medicare system. For example, a recently published
    article by Fisher, et. al, *The Implications of Regional Variations
    in Medicare Spending***,** notes that the overutilization of certain
    services, caused by the skewed apportionment of physicians
    throughout the United States is causing a drain on the Medicare
    system.

[^12]: See "Congressional Report on National and Medicare Spending" at:
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