by Lauren Dubinsky
, Senior Reporter | September 14, 2016
It's very likely that there will be a severe molybdenum-99/technetium-99m supply shortage after October 2016, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS). The shortage will last at least until the current global suppliers finish their plans to expand capacity.
There was a major shortage of Mo-99 in 2009 and since then there has been skepticism about meeting future needs for Tc-99m. Because of the aging reactors outside of the U.S., there have been efforts around the world to ensure a reliable supply of the radioisotope.
There are also ongoing efforts to eliminate the use of highly enriched uranium (HEU) during Mo-99 production. The U.S. Department of Energy's National Nuclear Security Administration (DOE/NNSA) is providing funding for research and development of domestic Mo-99 production methods that don't use HEU.
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The NAS report states that 75 percent of the current global supply of Mo-99 for medical use is generated using HEU and the remaining 25 percent is produced with low enriched uranium (LEU).
Global suppliers of Mo-99 have committed to eliminating the use of HEU in reactor targets and medical isotope production facilities. But the widespread availability of Mo-99 produced with HEU is putting companies that use LEU at a competitive disadvantage.
There are currently four projects underway, supported by the NNSA, that are expected to supply half or more of the Mo-99 that the U.S. needs. But the report states that substantial domestic supplies will most likely not be available before 2018 because of technical, financial, regulatory and market challenges.
The report outlined a series of efforts that can be made to promote the use of non-HEU-produced Mo-99 and Tc-99m. It suggests that the U.S. government should continue to work with the Canadian government on a plan to restart the Canadian supply if needed.
It believes that CMS should continue to offer the $10 add-on reimbursement for Tc-99m from non-HEU sources until HEU sources are eliminated from the U.S. The agency should also assess the costs of medical procedures that use Tc-99m from non-HEU sources.
The Tc-99m generator manufacturers and nuclear pharmacies could make a stronger effort to increase the use of Mo-99 from non-HEU sources. The U.S. Congress could place a restriction or financial penalty on the importation of Mo-99 produced with HEU.
Sally W. Schwarz, president of the Society of Nuclear Medicine and Molecular Imaging, warned that a short-term Mo-99 shortage is a serious concern, but that producers, processors, and generator manufacturers will work with the Association of Imaging Producers & Equipment Suppliers (AIPES) to manage any problems that may occur.
“The innovative, safer production methods and facilities that will be coming online over the next few years will certainly help ensure a safe, reliable supply of Mo-99," she said in a statement.