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September 1, 2005 Centers for Medicare and Medicaid Services
We are writing on behalf of the members of the American Thyroid Association, the leading organization of physicians and scientists dedicated to better understanding and treatment of thyroid diseases. Thyroid cancer is the most common endocrine cancer in the United States and the most rapidly increasing cancer in incidence among women. Our members are at the forefront of innovations in the diagnosis and treatment of thyroid cancer. Human recombinant thyrotropin (Thyrotropin alfa, thyrotropin alfa for injection) is a unique drug used in the management of thyroid cancer patients and no other drug can be substituted. The availability of thyrotropin alfa has had a major impact on the approach to diagnosis, treatment, and surveillance of thyroid cancer. The major advantage of thyrotropin alfa, compared to the previous approach of thyroxine withdrawal for whole body radioiodine scanning, is that patients do not need to suffer weeks of hypothyroidism with symptoms that are often disabling. This is a special problem in the elderly, in whom thyroid cancer occurs more commonly and is more often an aggressive malignancy compared to its presentation in younger individuals. Consequently, older thyroid cancer patients typically require more intensive disease surveillance. Without thyrotropin alfa, this would mean more cycles of thyroid hormone withdrawal in these individuals. We request that thyrotropin alfa be included in the list of drugs available through the Medicare competitive acquisition program (CAP). Our members practice in a range of clinical settings, but for those in private practice, the financial risk and administrative efforts to obtain thyrotropin alfa without Medicare coverage are a significant barrier to its clinical use. Permitting physicians the option of using a CAP vendor to obtain thyrotropin alfa is important to assure thyroid cancer patients the widest possible access to the drug. We urge you to reconsider and include thyrotropin alfa in the vendor bid process. Thyrotropin alfa is a key element in the diagnosis and treatment of thyroid cancer. Allowing physicians to obtain Thyrotropin alfa through CAP will ensure that Medicare beneficiaries will have access to this major advance in thyroid cancer care. Sincerely,
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