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6 Molybdenum-99/Technetium-99m Historic and Projected Demand
Pages 159-186

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From page 159...
... . Technetium generator sales are not publicly disclosed by generator suppliers, and there is no centralized source of information on numbers of Tc-99m radiopharmaceutical doses dispensed in hospital and nonhospital settings in the United 159
From page 160...
... , supply can be less than weekly demand. When that occurs available doses are rationed, requiring some imaging procedures to be performed with reduced Tc-99m activity or delayed or cancelled, and some pro cedures to be shifted to other modalities.
From page 161...
... In the United States, trends in utilization of nuclear cardiac procedures in general, or nuclear MPI in particular, are a proxy for overall trends in utilization of Tc-99m radiopharmaceuticals. Nuclear cardiac procedures represent more than half of the nuclear medicine procedures performed in the United States (Delbeke and Segall, 2011)
From page 162...
... b Data that contributed to the average reported decline estimate are the following: OECD NEA, expert opinions of nuclear cardiologists and Mo-99 supply chain participants, and the committee's analysis of Medicare Part B, Nuclear Pharmacy A, and Nuclear Pharmacy B data. See text for details.
From page 163...
... . • A report on imaging utilization in six large integrated health care systems across the United States described a decrease in nuclear medicine use from 32 to 21 per 1,000 enrollees from 1996 to 2010 1  Ira Goldman, Lantheus Medical Imaging, verbal communication, June 2, 2015; and Scott Claunch, Cardinal Health, verbal communication, August 11, 2015.
From page 164...
... These data are summarized by billing code for specific diagnostic and therapeutic radiopharmaceutical doses approved for Medicare Part B reimbursement. These billing codes are known as the Healthcare Common Procedure Coding System (HCPCS)
From page 165...
... However, services performed under Medicare Advantage are not reflected in the publicly available Medicare Part B National Summary Data. Medicare Advantage beneficiaries represented 16 percent of the total Medicare beneficiaries in 2006 and 31 percent of the total Medicare beneficiaries in 2014 (Henry J
From page 166...
... The decline in utilization of nuclear medicine diagnostic procedures during the period 2006-2014 does not include PET radiopharmaceutical utilization. In fact, PET utilization, which accounts for less than 4 percent of all nuclear diagnostic procedures in 2006, increased twofold from 2006 to 2014 among Medicare beneficiaries (purple line in Figure 6.1)
From page 167...
... also increased among Medicare beneficiaries during this period.7 These data are not shown. 7  For this analysis the committee used CPT codes for one common MRI and CT procedure: MRI of the lumbar spine (CPT codes 72148, 72149, 72158)
From page 168...
... About 95 percent of the nuclear medicine doses delivered by these nuclear pharmacies were to outpatients and 5 percent were to inpatients. Data from Nuclear Pharmacy A show a 42 percent decline in utilization of Tc-99m radiopharmaceutical doses from 2008 to 2014 and a 32 percent decline from 2010 to 2014 (blue line in Figure 6.2)
From page 169...
... is similar to that for Tc-99m MPI diagnostic doses (green line in Figure 6.3) and for non-PET FIGURE 6.3  Radiopharmaceutical doses dispensed at Nuclear Pharmacy B: 2008 to 2014.
From page 170...
... Older populations are more likely to be diagnosed with heart disease and have MPI procedures. 6.3  FUTURE GLOBAL DEMAND FOR Mo-99/Tc-99m Past attempts to estimate future Mo-99/Tc-99m demand have met with limited success, primarily because of the difficulties in forecasting medical, economic, and market developments that affect future demand.
From page 171...
... is driven by population aging, which as noted previously should increase the demand for Tc-99m-based procedures. Projected out 5 years, this demand increase would amount to an additional 225 6-day Ci per week over the current estimated global demand (9,000 6-day Ci per week)
From page 172...
... 6.4.1  Factors That Could Decrease Future Demand for Mo-99/Tc-99m The committee identified eight factors that could decrease future demand for Mo-99/Tc-99m in the United States: • Reduced reimbursements for medical imaging procedures • Transitioning away from the fee-for-service health care model • Decline in the number of nuclear medicine experts • More efficient use of technetium generators and Tc-99m-based radiopharmaceuticals • Widespread acceptance and further development of appropriate use criteria • Slow progress in new Tc-99m radiopharmaceutical development • Increasing preference for competing imaging modalities • Radiation exposure concerns These factors are described in the following subsections. The committee judges that the first six of these factors could be particularly important for modulating domestic demand over the next 5 years.
From page 173...
... . These changes in reimbursement policies resulted in an abrupt and nearly threefold reduction in the number of office-based nuclear medicine procedures (primarily MPI studies)
From page 174...
... measured by the costs of individual episodes of care starting from 3 days prior to admission to 30 days after discharge. The switch from fee-for-service to capitation and value-based health care models could further reduce the number of imaging procedures performed, including those utilizing Mo-99/Tc-99m.
From page 175...
... 6.4.4.4  More Efficient Use of Technetium Generators and Tc-99m-Based Radiopharmaceuticals Regional commercial nuclear pharmacies have replaced many hospitalbased nuclear pharmacies over the last few decades. These commercial nuclear pharmacies have improved the efficiency of technetium generator utilization by more effectively matching generator supplies with Tc99m radiopharmaceutical demand, primarily through economies of scale and more effective scheduling.
From page 176...
... . Further penetration of these procedural changes in nuclear pharmacies and imaging centers could further increase Tc-99m utilization efficiencies and decrease demand for Mo-99/Tc-99m.
From page 177...
... The use of AUC in other disciplines could lead to the further decline in imaging procedures, including those that utilize Tc-99m, if those AUC were to give greater weight to alternate imaging modalities. 6.4.4.6  Slow Progress in New Tc-99m Radiopharmaceutical Development Several Tc-99m radiopharmaceuticals have been removed from the U.S.
From page 178...
... . Two new PET agents received FDA approval in 2016.19 6.4.4.7  Increasing Preference for Competing Imaging Modalities Advancements in medical imaging have enabled the development of new imaging modalities for disease diagnosis, some of which compete with SPECT imaging.
From page 179...
... FIGURE 6.5  Relative frequency of cardiac imaging procedures performed among Medicare Part B beneficiaries in the United States. NOTES: CcaS = coronary artery calcium scoring; CCTA = cardiac computed tomography angiography; stress echo = stress echocardiography.
From page 180...
... Further dose reductions are most likely to be obtained from further reduction in unnecessary imaging procedures. 6.4.2  Factors That Could Increase Future Demand for Mo-99/Tc-99m The committee identified two factors that could increase future demand for Mo-99/Tc-99m in the United States: • Aging populations • Greater access to health care These factors are described in the following two subsections.
From page 181...
... However, many of the Tc-99m MPI SPECT scans performed in the United States are already covered by Medicare, so the growth in Tc-99m-based imaging procedures could be less than for imaging procedures in general. 6.5  DOMESTIC DEMAND FOR I-131 AND Xe-133 AND FUTURE PROJECTIONS The committee is not aware of any published estimates of future demand for the medical isotopes I-131 and Xe-133.
From page 182...
... . The revised guidelines include a recommendation to not use I-131NaI to treat patients who are at very low risk of cancer recurrence after surgery, and also to use reduced doses of I-131-NaI to treat patients who are at low risk of recurrence and have no residual disease after surgery 22  See http://seer.cancer.gov/statfacts/html/thyro.html.
From page 183...
... Most of these studies are done in conjunction with Tc-99m macroaggregated albumin (MAA) lung perfusion imaging for the diagnosis of pulmonary embolism.
From page 184...
... aerosol (an off-label use of an FDA-approved agent for renal and brain imaging. Xe-133 utilization declined 24 percent during the period 2006 to 2014 among Medicare beneficiaries (blue line in Figure 6.7)
From page 185...
... 6.6 FINDING The committee developed one finding to address the demand side of the fourth study charge to assess the "adequacy of molybdenum-99 supplies to meet future domestic medical needs, particularly in 2016 and beyond." The finding is presented below. FINDING 4A:  Domestic demand for molybdenum-99/technetium-99m for medical use has been declining for at least a decade.
From page 186...
... This decline is reflected in all nuclear imaging procedures except PET. OECD-NEA's latest estimates for future growth in global demand for Mo-99 are 0.5 percent in mature markets (including the United States)


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