In response to suggestions from non-proliferation advocates that highly enriched uranium (HEU) used in the production of medical isotopes should be eliminated due to security concerns, the U.S. Department of Energy and National Nuclear Security Administration have developed the “Global Threat Reduction Initiative.” As part of this initiative, the following goals have been established:
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CONVERT medical radioisotope production from highly enriched uranium (HEU) to non-HEU or low enriched uranium (LEU) sources;
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REDUCE reliance on non-U.S. reactors as the source for the Molybdenum-99 (Mo-99) used in medical radioisotope production by encouraging development of non-HEU technologies to produce Mo-99 in the United States;
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ASSIST global producers of Mo-99 with conversion of their production processes to use low enriched uranium (LEU) targets.
The nuclear medicine industry supports this transition. Through the Council on Radionuclides and Radiopharmaceuticals, the industry continues to work with CMS, DOE and the U.S. Food and Drug Administration to examine methods to “pull” more non-HEU based Mo-99 into the United States.
Currently the two U.S. manufacturers of Mo99 generators are in the midst of a complex period of transition between HEU and non-HEU molybdenum production. Full conversion to non-HEU reactor sources is expected to be complete in or around 2017. In addition, a number of new technologies are in development, with support of U.S. Government grants, with the goal of developing non-HEU alternatives to traditional production processes.
Supply Availability
Non-HEU derived radiopharmaceuticals are available for order through your Jubilant Radiopharma, Radiopharmacies Division pharmacy. Please note that, until reactor conversion is complete, the following limitations may apply:
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The initial availability of products sourced from non-HEU generators is limited. Manufacturers indicate that, at least in 2016, LEU generators will only be available one or two days each week.
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Because the Molybdenum-99 sourced from these generators is a rapidly decaying material, the current limited availability of non-HEU generators means that nuclear pharmacies are unable to guarantee availability of non-HEU sourced doses every day of the week.
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CMS has implemented a $10/dose reimbursement that applies to doses sourced from non-HEU generators. That reimbursement only applies to Medicare Hospital Outpatient doses. Again, the limited supply issue has an impact here, as hospitals claiming reimbursement for a Medicare dose must correlate the dose administered to ensure that non-HEU product was available on the day that the dose was administered.
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To help ensure the most efficient use of non-HEU materials, and thereby the lowest cost, Jubilant Radiopharma, Radiopharmacies Division encourages our customers who choose to use non-HEU materials to adjust their Medicare patient scheduling to coincide with the days that such materials are most available.
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There may be a waiting period of up to six (6) weeks to add or to discontinue a non-HEU generator, so prior planning is necessary.