Managed Care - February 2009 - (Page 48) TOMORROW’S MEDICINE The major source of I123 in North America is a company in Canada. The company ships the radioactive material to the local pharmacy (of which there are about 300 in the United States). The pharmacy then compounds the isotope with iobenguane and ships it to the hospital’s nuclear medicine department for eventual patient use. All of this takes time, adds expense, and produces a non-FDA approved product lacking consistency in the manufacturing process and quality. In addition, since the availability of pharmacies that are capable of creating this diagnostic agent is not geographically uniform and the process is difficult, many physicians and hospitals could only use the easier-to-produce I131 version of this product because of its longer shelf life. A recent FDA approval has solved this. General Electric understood that to provide a highly consistent I123 labeled iobenguane that could be made available to any nuclear medicine practice in the United States, it had to be able to manufacture this isotope at will. The company also had to control the precise manufacturing time to ensure that the rapidly decaying isotope was still fresh, and to deliver it to the nuclear imaging laboratory in a highly controlled and choreographed manner. The product, AdreView, is an orphan drug indicated for use in detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. The safety and efficacy of AdreView was studied in an open label, multicenter, multinational trial of 251 subjects with known or suspected pheochromocytoma or neuroblastoma. Patients ranged in age from 1 month to 88 years. Diagnostic efficacy was determined by three independent experts who compared the increase in radionuclide uptake and who were blinded to the clinical data presented on planar scintigraphy. Illinois cyclotron Since I123 is created in a cyclotron, the company built one in centrally-located Illinois, allowing for rapid transport to the entire country. ADVERTISING INDEX ACADEMY OF MANAGED CARE PHARMACY 21st Annual Meeting 23 CENTOCOR ORTHO BIOTECH INC. Corporate C2 FOREST LABORATORIES Bystolic 9–10 Namenda 17–18 GENOMIC HEALTH Oncotype DX 29 PRESCRIPTION SOLUTIONS Corporate C4 WELLPOINT nextRx 3 Consistent, predictable An overview of the entire FDA submission is beyond the scope of this article, but physicians now have for the first time an FDAapproved product that is available for use throughout the United States and that is manufactured in a consistent and predictable high-quality manner. Pricing was not available from the manufacturer, but because of the nature of the prior process of manufacturing, which required multiple vendors and several transportation events, the price is likely to be similar to or even less than unapproved substitutes. The use of I123 will enable production of improved images that are likely to allow a more reliable reading and diagnosis. AdreView again reinforces the view that technology, backed by a large nationally recognized corporation, is capable of providing improved diagnostic options for Tomorrow’s Medicine! MC The author is a director in the value-based health department at Genentech Inc. During the three years before taking the Genentech position, he received honoraria or other financial benefits from: Amgen, Amylin Pharmaceuticals, AstraZeneca, Biogen Idec, Centocor, Galderma, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Procter & Gamble, Q-Med, Sanofi-Aventis, Teva Pharmaceuticals Industries, UCB, and Wyeth. The views expressed in Tomorrow’s Medicine are the author’s alone. 48 MANAGED CARE / FEBRUARY 2009
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