Cost savings to Medicare
Through Growth in the Use of Medical Isotopes
Resulting from Re-Start of the Fast Flux Test Facility

In the United States, healthcare accounts for more than 22% of the Gross National Product. The National Institutes of Health estimates the nationwide cost of cancer to be as high as $180 billion ("Cancer Facts & Figures 2001," American Cancer Society). Skyrocketing healthcare costs are nearing crisis proportions. Clearly, any investment that could improve cancer care and reduce government costs would be greatly welcomed and should be seriously considered. The re-start of the Fast Flux Test Facility (FFTF) has the potential to be such an investment, since the supply of medical isotopes directly impacts our ability to perfect and utilize promising new treatments and diagnostic procedures. Viewed from this perspective, investment in FFTF could pay for itself many times over in government Medicare/Medicaid savings.

Nuclear medicine is a well-established branch of radiology because it provides diagnostic and therapeutic procedures that are more effective and more cost-effective than alternatives. Insurers recognize these advantages by reimbursing a standard and growing set of nuclear medicine procedures. New medical isotope treatments that are now becoming available and FDA approved have proven their safety, efficacy and cost-effectiveness through research and clinical trials, and the potential for developing more safe, effective drugs through this same process is real. The FFTF plays a key role in the development of new treatments by assuring an ongoing supply of a variety of high-quality medical isotopes. It is also an absolute necessity if we are to support upcoming FDA-approved radiopharmaceuticals with the larger supply of isotopes that will be needed.

Following are a few examples of ways in which production of medical isotopes at the Fast Flux Test Facility could pay off in healthcare cost savings. While limited time and resources and the complexity of issues in healthcare financing prevent this from being an exhaustive study, some estimations based on known data and conservative predictions make a compelling case for the positive impact of FFTF on healthcare in the United States. Providing a continuous supply of needed medical isotopes can reduce costs because the development of promising disease-targeting treatments will improve patient outcomes. It will lengthen life, improve quality of life and increase productivity.

Health Benefits-
Of the $180 billion lost annually by the United States because of cancer, two-thirds is estimated to come from loss of productivity, while one-third ($60 billion) is attributable to direct medical costs ("Cancer Facts & Figures 2001," American Cancer Society). Improvements in human health through the use of medical isotopes for more accurate diagnosis and more effective treatment could certainly have a positive effect on productivity, thereby saving untold millions to billions. For example, with outpatient medical isotope brachytherapy for localized prostate cancer, patients can return to work within days as opposed to weeks with surgery ("Prostate Cancer Comparative Modalities"). Improved response rates for a number of medical isotope treatments indicate a healthier, more productive work force. For example, new treatments for non-Hodgkin's lymphoma show impressive improvements in patient response. Possible impacts on direct medical costs are discussed below.

Heart Disease-
Heart disease is America's #1 killer. Cardiologists are greatly impressed with results from new developments in which a radioisotope is applied during heart treatment. Dr. Warren Lasky, Associate Director of Cardiology at the University of Maryland Medical Center said, "This is the latest and most promising technology we've heard about in the last 15 years," ("Radioactivity is tried to keep 'stents' clear', The Baltimore Sun).

Angioplasty is performed over 900,000 times per year in the United States to reduce artery blockage (American Heart Association). About 80% of angioplasty patients receive a stent to keep the artery open and prevent re-blockage, yet every year 200,000 people experience re-clogged arteries. Applying a radioisotope to the stent appears to reduce re-clogging by at least half. An estimation, then is that if, with a radioisotope administered during angioplasty, half of the re-clogging patients were spared a repeat angioplasty at a cost of $10,000, the national savings would be $1 billion - approximately the amount of money spent to build FFTF.

Leukemia--
Blood cancers such as leukemia, lymphoma and multiple myeloma are some of the most expensive cancers to treat, yet medical isotopes show excellent promise to increase effectiveness and prolong life for those with blood-related cancers. A treatment for non-Hodgkin's lymphoma is nearing FDA approval. A multiple myeloma treatment using a short-lived FFTF isotope is moving into Phase III clinical trials. Our ability to use the potent alpha-emitting isotopes against leukemia has now been demonstrated.

Dr. David Scheinberg and colleagues at Memorial Sloan-Kettering Cancer Center have successfully utilized alpha-emitting isotopes against acute myelogenous leukemia. Currently only 30 to 40% of the over 15,000 patients diagnosed annually with acute leukemia are cured by chemotherapy ("Cancer Facts & Figures 2001" American Cancer Society). Initial clinical trials with alpha-emitting isotopes show a reduction in relapse by "cleaning up" residual cancer cells after a first treatment. How much does a round of chemotherapy cost for acute leukemia? How many patients can be spared relapse through the addition of alpha-emitting isotope therapy? How many Medicare dollars does that represent?

We are too early in the exploration of these treatments to generate definitive numbers. However, a hypothetical scenario indicates a significant savings: If 20% of the 15,000 people diagnosed annually with acute leukemia (3000 patients) could each be spared $50,000 worth of costs in avoiding just one repeat round of chemotherapy, the resulting savings could be over $150 million dollars. Avoiding expensive bone marrow transplantation for 10% of the patients at a cost of $100,000 would save another $150 million, resulting in a potential savings of $300 million annually - enough money to run FFTF for 5 years or more (Some data drawn from"Funding the Treatment of Leukaemia: Many Points to Consider" Drug & Ther Perspect 14(8): 13-16, 1999@ 1999 Adis International Limited).

We have only begun to explore the potential of alpha-emitting isotopes to more effectively target blood cancers and cancers that have spread throughout the body. Once fully developed, they may increase effectiveness and save costs on a wide variety of cancers. However, the savings doesn't have to wait until the drugs are fully developed. Recently released studies also indicate that developing new treatments through clinical trials does not increase costs on a per patient basis ("Evidence Mounts That Clinical Trials Are Not Costly").

Thyroid, Prostate & Breast Cancer-
Thyroid cancer was one of the very first cancers to be targeted with medical isotopes. Currently medical isotopes are administered as a standard of care in the most common forms of thyroid cancer, resulting in a 95% cure rate and at a cost less than $15,000 per patient. This compares with an average of about $47,000 per patient in direct medical costs from all types of cancer. Thyroid cancer represents a very minor portion of the overall national cancer costs - a true medical isotopes success story.

Thyroid cancer treatment with medical isotopes represents a "gold standard" of the low-cost, high-success protocol possible with effective disease targeting with medical isotopes. If a method of targeting similar cancers, such as that of the prostate or breast, could be developed, the per patient costs on those cancers might be drastically reduced. Reducing breast cancer treatment by $10,000 per patient would result in an annual savings of over two billion dollars - a little less than the total cost to replace FFTF.

Biotechnical companies are investing heavily in the promising area of monoclonal antibody targeting, with dozens of new targeting agents expected to be on the market within ten years (Roth, Robert I., "Magic Bullets Finally Find Their Mark," Journal of the American Pharmaceutical Association, Vol. 41 #3, pp. 383-391, 2001). It is not unrealistic to assume such agents could be successfully paired with medical isotopes to form a "magic bullet" for a number of cancers not yet widely treated with medical isotopes. With medical isotopes easily available from FFTF, targeted treatments for a number of cancers can be expected, resulting in improved outcomes and cheaper therapies. Without medical isotope availability, these treatments will never become widely utilized.

Expenditures on purchase of isotopes-
The United States imports over 90% of the isotopes used in medical applications. Depending on other countries to supply our isotopes results in a compromised system and increased headaches for isotope users. Constricted availability results in limited choices and increased costs for users. Such costs must inevitably be passed on to the patient, their insurers, and Medicare/Medicaid. Providing a reliable supply of isotopes from FFTF will encourage more competitive pricing.

Customs costs for import of radioisotopes runs in the millions of dollars annually. With FFTF up and running, companies can purchase isotopes domestically, save this cost, and pass the savings on to the patients.

FFTF is capable of supplying high purity radioisotopes such as HSA Iodine-131 for medical purposes. Using high purity isotopes in radioimmunotherapy applications will likely increase effectiveness of the treatments and reduce costs spent on expensive monoclonal antibodies, since the number of "wasted" antibodies would be drastically reduced.

Another cost savings area that could be explored is the possible production of moly-99 at FFTF for use in diagnostic applications. Currently moly-99 is produced outside the United States through a fission process which increases costs because of the need for enriched uranium targets and also resulting high level waste. FFTF could produce moly-99 through a capture process thereby avoiding the disadvantages and resulting costs. Capture moly-99 is now used in Asia for nuclear medicine diagnosis, largely because of lowered cost. In addition, the recent development of a capture moly generator at Oak Ridge National Laboratory makes widespread use of this new product possible.

Scientific Studies Documenting Cost Savings-
The Society of Nuclear Medicine met in June of 2001, during which over 2000 studies were presented. One study described a healthcare cost savings analysis on a medical isotope procedure capable of more accurately assessing breast cancer, thereby avoiding unnecessary biopsies. The study calculated an $885 million dollar annual savings for this one medical isotope procedure (J.M. Zubeldia, et al, "Economic impact of adding 99mTc-SESTAMIBI Scintimammography to mammography in patients with dense breasts and birad 3 category: A cost analysis" State University of New York at Buffalo, Buffalo, NY).

Positron Emission Tomography (PET), a new medical isotope diagnostic tool, is making great waves in the medical community because of its ability to more accurately identify recurrent disease and help doctors make better decisions on the best methods of treating their patients. For example, a recent study showed PET to be seven times more accurate in evaluating children's cancers than conventional diagnostic procedures. PET generally utilizes very short-lived isotopes that would not be produced in the FFTF, but its success in reducing costs through better diagnosis merits mention. In addition, some researchers are looking into the use of FFTF isotopes for new PET applications.

A study of the cost-effectiveness of utilizing PET for lung cancer, recurrent colorectal cancer and metastatic melananoma found PET to be 20% to 30% more sensitive in detecting tumors. Better detection, obviously, means better treatment. In many cases unnecessary surgeries were thus avoided, resulting in an overall savings of $3,700 per patient (Valk, Peter E., M.D.,"Impact of FDG PET on Oncologic Patient Management"). If just 10% of the annual population of lung, colorectal and melanoma patients were to benefit from PET procedures, the national savings would be over $131 million annually.

While PET is more expensive than several standard diagnostic systems, its advantages cause one to accurately view the expense as an investment, since ultimately, PET saves money while improving quality of life. The same can be said of the Fast Flux Test Facility. Those concerned about the costs to re-start and run the reactor overlook the broader and more accurate picture - FFTF is a worthwhile investment in our national healthcare system. Wise investment in FFTF will pay off in better diagnosis and treatment of the diseases that currently sap our national strength.

While no one can predict the future, it appears clear that medical isotopes will increasingly improve the diagnosis and treatment of cancer and other diseases. Medical isotopes bring us exciting new diagnostic procedures that are many times more effective in detecting the spread of cancer, targeted treatments often administered on an outpatient basis, and highly promising possibilities for zapping many kinds of cancer with alpha emitters. Our investment in isotope supplies and medical research will increase and expand the availability of such treatments, improving our lives and saving money. The Fast Flux Test Facility is an investment well worth its potential to put a serious dent in our out-of-control national healthcare budget.

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Updated: August 24, 2001