Cancer Economics
Enhancing Cancer Care and Clinical Trials: New Paradigms for Success
Robert Comis, MD, Chairman, and
Andrew Kelahan, PhD, Executive Director of External Affairs
Eastern Cooperative Oncology Group
Oncology practice and economic realities are inexorably linked today.
Developments in cancer economics are explored in this regular feature.
Introduction
The rapid expansion in our understanding of the natural history of cancer has created
opportunities to develop unique and exciting therapeutic strategies that will improve our
ability to treat and prevent cancers of all types. Since meaningful analysis of new
therapies requires testing in formal clinical trials, the translation of these new ideas
into proven clinical applications will create a greater demand for clinical trial
development and, more importantly, for patient participation in those trials. The current
national accrual of adult cancer patients to clinical trials — approximately 2% to 5%
— is inadequate to meet this new demand.
Impediments to Trial Accrual
The reluctance of patients to participate in clinical trials appears to stem from
misunderstandings about the trial process and from perceived or real inconveniences that
may occur in protocol-based care. The Eastern Cooperative Oncology Group (ECOG) has
already initiated efforts to provide patients with educational materials on clinical
trials, to include them in the development process of trials, and to make clinical trials
less cumbersome to participants. In an effort to improve patient participation in the
design process of trials, ECOG has formed the very active Patient Representative
Committee. In addition, the ECOG Special Populations Program will investigate the effects
of gender, culture, and ethnicity on cancer treatment, prevention, and access to cancer
care.
Some of the concerns identified by patients are also shared by their physicians. These
concerns affect the decision of physicians to offer clinical trials as treatment options.
Physicians have indicated that less stringent eligibility criteria, less frequent
follow-up studies, and objectives with greater clinical relevance are improvements that
would increase their participation in the clinical trial process, and ECOG is currently
designing trials in accordance with these improvements. In addition, summaries of
ECOG’s protocol information and patient education materials will soon be made
available on the Internet.
Payer reluctance to reimburse the incurred costs of care that is part of a defined
clinical trial is a continuing concern to the cancer community. Such policies not only run
counter to the belief that protocol-based care is the highest quality care, but also
threaten the continued progress in clinical cancer research and are contrary to the best
interests of individual patients and society. Therefore, we propose the following approach
as a proposal to payers:
- All patient-oriented therapeutic cancer trials will be considered integral parts of
high-quality cancer care.
- All trials of treatments in emerging and leading alternative categories that are
approved by National Cancer Institute (NCI) Cooperative Groups will be considered
medically appropriate approaches for eligible patients. Components of treatment may
include agents intended to act directly or indirectly against cancer cells, agents that
are adjuncts to or in support of active therapy, and agents intended to treat symptoms or
side effects.
- All direct patient care costs associated with participation in approved clinical trials
will be covered.
- All categories of providers who are cooperative group members, from solo or group
practice in the community through comprehensive cancer center, will be included in the
coverage program since each plays an important role in providing cost-effective,
high-quality care.
- Payers will provide preferential access to treatment by out-of-plan providers who are
members of Cooperative Groups or who will treat the patient on Cooperative Group trials.
- Within the group, the more exploratory trials of emerging treatments will occur in
selected institutions that are qualified to provide such treatments.
When enacted, this program will provide direct benefits to patients, providers, and
payers, strengthening interactions among them.
Benefits to Payers
Benefits to the payers in the proposed system include answers to problems that arise
from limited patient access to specialists in a timely fashion, use of drugs for
indications that are outside those approved by the Food and Drug Administration, and
resolution of criticism based on failure to reimburse for patient care costs associated
with different kinds of trials. It is our belief that clinical trial-based therapy
provides (1) the highest quality care through peer-reviewed protocols, (2) consistent care
across participating institutions, (3) the most expeditious means to improve today’s
standard therapy, and (4) cost-effective care.
National Initiatives
Currently, two major national initiatives to increase support of clinical cancer trials
by third-party payers are being considered: one by the NCI and one by the American Society
of Clinical Oncology (ASCO). These proposals are intended to designate a minimum set of
cancer treatments and trials in which associated patient care costs would be covered by
third-party payers. The NCI proposal is being enacted through interagency agreements with
OCHAMPUS (Office of Civilian Health and Medical Programs of the Uniformed Services) and
the Department of Veterans Affairs, for adoption by the Health Care Financing
Administration. The ASCO proposal has been introduced to the US Senate by Jay Rockefeller
(D-WV) and Connie Mack (R-FL) in the form of the Medicare Cancer Clinical Trial Coverage
Act of 1996. The Rockefeller/Mack bill includes provisions only for a Medicare
demonstration project, a temporary program. The scope of these mandates furthermore is
limited to programs under direct regulatory control of the federal government.
Need for Regional Initiatives
The proposals by the NCI and ASCO are intended to apply universally across the United
States, a strategy that may not be the most feasible approach for improving reimbursement
for a broader range of clinical trials. An initiative that takes a more regional approach
makes sense because (1) payers generally conduct business on a local level, either in one
state or across a limited geographical region, and are most attuned to react to changes in
the local operating environment, and (2) many payers offer multiple payment programs
— traditional HMOs, nontraditional HMOs, PPOs, traditional fee-for-service plans, and
point-of-service options. Since each of these payment systems is guided by a unique set of
contracts, each system of coverage must be approached from a unique perspective when
designing benefits for payment of cancer trials. Because most of the individual and
institutional members of payer networks and managed care organizations are members of a
multimodality Cooperative Group, the Cooperative Group system is uniquely structured and
situated to provide a platform not only for devising a system of cancer care based on the
strategic provisions of the NCI and ASCO initiatives, but also for using the tactical
resources of group members. Cooperative Group members include institutions at all levels
of the cancer care delivery system (eg, clinical cancer centers, academic clinical cancer
centers, community hospitals, and group practices). Cooperative Groups have strong
policies and procedures in place for quality control of trials, institutional members, and
individual members. Based on prior experience in the trial payment arena, payers will
likely pursue the option of defining networks of cancer treatment centers where trials
will be covered. Such network arrangements are typically strongly organized around strict
entry criteria with mechanisms for continual review for quality. Cooperative Groups
maintain the largest and most comprehensive databases on adult cancer; in exchange for
support payment of clinical trials, payers will ask for access to these databases to use
as benchmarks for quality outcomes.
ECOG Proposal as an Example of a Cooperative Group Initiative
ECOG is comprised of approximately 4,600 physician and non-physician members who treat
or support adult cancer patients at 365 institutions located throughout the country. ECOG
designs, conducts, and analyzes clinical trials in cancer diagnosis, treatment, and
control that are performed at NCI-designated comprehensive cancer centers, at academic
institutions and their affiliated hospitals, at institutes that are members of Community
Clinical Oncology Programs, and by members of Cooperative Group Outreach Programs.
The goals of the ECOG initiative are to promote the highest quality cancer care system,
to highlight the important role of clinical trials in maintaining this quality, and to
help to ensure payment for the patient care costs associated with all phases of cancer
clinical trials. We view these goals as complementary to the existing NCI and ASCO
initiatives.
The ECOG initiative is viewed as inclusive rather than exclusive relative to other
cooperative groups since they are similar to ECOG in organization. Fig 1A summarizes the
current system for undertaking clinical trials and payment status. Fig 1B summarizes the
ECOG initiative as proposed herein. The ECOG proposal is expressly presented as a binary
system for institutions and types of treatment protocols in order to best
fit with a binary medical payment system.
The intent of our proposal is to acquire coverage for both categories of clinical
studies (ie, those of emerging treatments and those of leading treatment alternatives)
that can be conducted on a group-wide or limited-institution basis. Such coverage will be
packaged into a basic or, if necessary, a specialized benefits package as defined by the
type of study and the institutional participation. At a minimum, the studies in the
emerging treatment program will require approval by the Food and Drug Administration under
an investigational new drug (IND) exemption and will generally be performed at main member
institutions. However, there will be times when trials of a drug that is approved under an
IND exemption will enroll patients broadly across the group.
Cooperative Group Institutions
The proposal defines two sets of institutions and matches each with a set of cancer
trials. The first set includes trials that can be activated by any and all Cooperative
Group member institutions. These trials are designed to test the relative efficacy of two
or more treatment alternatives that have already been proven to be safe and effective. To
demonstrate the significance of a difference in treatment outcome with reasonable
statistical certainty, these trials must accrue large numbers of patients. Furthermore,
for results to be widely applicable in practice, a broad representation from the
population is required. Approximately 75% of Group-sponsored trials fall into this
category. Conversely, emerging treatment trials require relatively few patients who can be
accrued on a local or regional basis. Trials in this category will be available only at
institutions that are experienced in conducting such studies and that meet an added level
of institutional review.
Two programs are under development to demonstrate medical appropriateness of cancer
care at ECOG institutions to payers and to improve existing trial mechanisms. First, ECOG
will define and continually refine dynamic treatment guidelines for major cancers.
The treatment strategies will be flexible but designed to retain methodological rigor to
answer clinically important questions. The guidelines will include index treatments and
trials as opposed to treatments otherwise defined as “standard” or
“experimental” treatments. The treatment strategies for breast cancer,
small-cell and non-small-cell lung cancer, colon cancer, and rectal cancer have already
been defined. Second, future ECOG trials will be designated as emerging treatment
or leading treatment alternatives. This system more accurately describes the
developmental role of clinical trial treatment.
Target Sites for the ECOG Cancer Care and Clinical Trials Initiative
The variability in payer representation from region to region and the different types
of payment systems in operation suggest that a program of “one size fits all”
for reimbursing patient care costs in clinical trials is not a feasible goal. Instead,
trial payment initiatives must be designed to accommodate different types of third-party
payer systems and experiences. ECOG has targeted Florida, Illinois, Minnesota,
Pennsylvania, and Wisconsin as test sites for Cooperative Group trial payment initiatives.
Conclusions
Access to the highest quality care is in the best interest of patients, physicians, and
payers. Highest quality care is not, however, a static entity. Until cancer is considered
preventable or curable, we must work together to improve available approaches. The
definition and timely completion of well-designed cancer clinical trials are crucial to
this process and must be considered as integral parts of any high-quality cancer treatment
program. This goal can be attained if patients, providers, and payers cooperate to define
a cancer care delivery system that benefits all parties.
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