[Federal Register Volume 59, Number 219 (Tuesday, November 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28000]


[[Page Unknown]]

[Federal Register: November 15, 1994]


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DEPARTMENT OF DEFENSE
Office of the Secretary

 

Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS); Breast Cancer Treatment Clinical Trials

AGENCY: Office of the Secretary, DoD.

ACTION: Notice.

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SUMMARY: This notice is to advise interested parties of a demonstration 
project in which the DoD will participate in breast cancer treatment 
clinical trials under approved National Institutes of Health, National 
Cancer Institute (NCI) clinical trials for high dose chemotherapy with 
stem cell rescue (HDC/SCR). Participation in these clinical trials will 
improve access to HDC/SCR for CHAMPUS eligible female family members 
when their conditions meet protocol eligibility criteria. DoD financing 
of these procedures will assist in meeting clinical trial goals and 
arrival at conclusions regarding the safety and efficacy of HDC/SCR in 
the treatment of breast cancer. This demonstration project is under the 
authority of 10 U.S.C., chapter 55, section 1092.

EFFECTIVE DATE: September 15, 1994.

FOR FURTHER INFORMATION CONTACT:
Martha M. Maxey, Health Care Policy Analyst, Program Development 
Branch, Office of Civilian Health and Medical Program of the Uniformed 
Services (OCHAMPUS), Aurora, Colorado 80045-6900, telephone (303) 361-
1227.

SUPPLEMENTARY INFORMATION: 

A. Background

    Breast cancer is the leading cause of cancer deaths for women aged 
15 to 54 years and, after lung cancer, the second leading cause of 
cancer deaths. An estimated one in eight women will develop the disease 
in her lifetime.
    The five-year survival rate for early stage breast cancer is 70 
percent, but it decreases to only 4 percent if it has advanced and 
metastasized. Initial uncontrolled clinical trials of HDC/SCR for 
patients with advanced metastatic breast cancers reported a five-year 
survival rate of 16 percent. Initially, the procedures themselves 
carried a 10 percent or greater mortality rate but this has decreased 
to less than 5 percent at experienced centers.
    The interest sparked by these early trials led the National Cancer 
Institute (NCI) in 1990 to approve scientifically rigorous, controlled 
phase III clinical research protocols under the auspices of the 
National Institutes of Health. The goal is to compare the safety and 
efficacy of HDC/SCR for breast cancer with a standard chemotherapy 
regimen. Currently, the protocols are only about 50 percent complete. 
HDC provides some effectiveness in eradicating the breast cancer cells 
but does tend to disable the body's immune system. By removing the stem 
cells from the bone marrow or blood before HDC, and then replacing them 
after the HDC has occurred, a level of immune response is restored.
    The American Cancer Society considers HDC/SCR experimental for 
breast cancer, but has established it as proven therapy for certain 
other less common cancers at specific stages.

B. CHAMPUS Experience

    CHAMPUS, by regulation, does not approve payment for experimental 
or investigational procedures and any change in the experimental status 
of HDC/SCR logically awaits the findings from the Phase III clinical 
trials. Meanwhile, professional support for the procedure is not 
universal, but there is growing public sentiment that the procedure is 
a right of patients with advanced breast cancer despite the fact that 
this procedure is not clearly better than standard treatments.
    The result has been multiple court cases to force third party 
payers, including CHAMPUS, to pay for the procedure in specific 
instances although many third party payers consider the procedure 
experimental or investigational and exclude payment.

C. Caseload, Costs

    Approximately 3,000 CHAMPUS female family members are diagnosed 
with breast cancer each year, based on age adjusted incidence rates. 
Some 600 family members each year would have breast cancers that would 
be eligible for the NCI clinical trials, and of these, 200 to 300 could 
be expected to participate.
    Some of them would be randomly selected for conventional treatment 
as part of a control group. The three military treatment facilities 
authorized to serve as protocol centers report a total annual 
capability of about 20 breast cancer cases per year with little 
potential for expansion.
    The probable number of cases receiving HDC/SCR payable with DoD 
breast cancer research support funds is roughly estimated at from 200 
to 250. The number may grow as awareness of the trials increases the 
potential pool meeting the protocol eligibility requirements, and as 
new NCI studies are established for a wider variety of breast cancer 
treatments.
    Applicable literature reports first year treatment protocol costs 
of from $125,000 to $140,000 per case. Case costs have been decreasing 
recently but the reported range is used to avoid underestimating total 
costs.
    Resulting net annual estimated costs: $25 million to $35 million.

D. Operation of the Demonstration

    The Assistant Secretary of Defense (Health Affairs) will designate 
a Project Officer in the Office of the Deputy Assistant Secretary of 
Defense for Clinical Services.
    The Project Officer will provide clinical oversight, and will 
determine the list of the NCI protocols and institutions which will 
participate in the demonstration.
    All family members eligible for CHAMPUS would be eligible to 
participate in the demonstration. Active duty members would continue to 
be eligible for direct care system services.
    OCHAMPUS will contract for and provide day to day oversight of 
contractor case referral, case coordination, demonstration funds 
disbursements and maintaining the integrity of those funds, 
identification of the limited services for HDC/SCR patients that are 
payable under CHAMPUS and TRICARE, and all related tracking and 
reporting requirements.
    Patients with breast cancer would undergo an initial evaluation by 
their physician. After discussing the various treatment options with 
the patient, if the patient agreed to enter a clinical study, the 
physician would contact one of the oncology cooperative groups to 
determine which centers are currently participating in the NCI clinical 
trials. The physician would then arrange for evaluation of the patient 
at the selected center. Physicians at the center involved in the 
clinical trial would make the actual patient selection based upon the 
clinical criteria for their study.
    The contractor(s) would not be involved in clinical issues or in 
directing patients to a particular institution or a specific clinical 
trial. The contractor(s) would be the single point of contact for 
nationwide provider and patient information and HDC/SCR claims 
adjudication and payment.

E. Possible Future Expansion of Demonstration Project

    At present, this demonstration project is limited to the Phase III 
(randomized and non-randomized) HDC/SCR treatment for breast cancer. It 
is possible that in the future, other protocol-based clinical 
investigations which have been NCI approved may be added to this 
demonstration project. If this occurs, an amendment to this notice will 
be published in the Federal Register.

    Dated: November 8, 1994.
Patricia L. Toppings,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 94-28000 Filed 11-14-94; 8:45 am]
BILLING CODE 5000-04-M