Special report: Is the SPECT supply chain at the breaking point?

June 20, 2011
by Sean Ruck, Contributing Editor
This report originally appeared in the June 2011 issue of DOTmed Business News

The parallels between the U.S. gas crisis and the one affecting nuclear medicine are uncanny.

In 1973, the United States was faced with an unprecedented gas shortage. During the gas crisis, drivers were lined up at the pump for hours. Rationing meant drivers were only able to fuel on even or odd days of the month, depending on whether their license plate ended with an even or odd number.

For last summer’s medical imaging isotope shortage, thousands of patients were backlogged as they awaited needed procedures, in some cases for months at a time. “We saw wait time increasing and patients being turned down,” says Sergio Calvo, marketing director of molecular imaging with Siemens Healthcare. “Some patients who couldn’t wait went to other studies – so nuclear cardio went to echo-cardio for example, so that was a problem.”

Both shortages raised the awareness of our dependency on foreign supplies and prompted conversations about self-sufficiency as a nation, either by developing our own supplies or by improving technology to reduce our needs. For the gas crisis, economy cars were introduced to the market, while after the isotope shortage, single-photon emission computed tomography equipment has gotten more efficient. Doctors have also started turning to hybrids like SPECT/CT, which allow for ultrafast cardiac imaging, translating to less isotope use. Some facilities have even experimented with reducing the dose used during scans to see if they could provide the same quality of care.

A fragile chain
The fragility of the isotope supply chain gained worldwide attention less than two years ago, when an inspection of the National Reactor Universal in Chalk River, Ontario uncovered a leaky reactor vessel. In mid-May, 2009, the nearly 60-year-old reactor, which supplies half the United States’ supply of molybdenum-99, the isotope from which technetium-99m is derived, was taken offline for repairs. Initially estimated to take as long as eight months to complete, repairs actually took nearly twice that long, with the reactor finally reopening last August.

During the shutdown, the domestic nuclear medicine community turned to overseas reactors to alleviate the shortage. However, the condition of the Chalk River reactor spurred concerns about the remaining reactors and a thorough inspection was conducted for the High Flux Reactor in Petten, Netherlands, the second-largest supplier of Mo-99 for the U.S. Inspectors found corroded pipes in immediate need of repair, and that reactor was also taken offline for six months. Of the three remaining reactors in the world capable of supply moly at that time, two were used largely for research needs and not configured to produce radioisotopes year-round, and the Safari-1 in Pelindaba, South Africa, the only functioning major supplier of Mo-99, was also undergoing intermittent repairs.

The supply chain is only as strong as . . .
At the time of this writing, the NRU is offline for repairs yet again, in this case, routine maintenance, but rather than the typical five-day shutdown, this shutdown will span nearly five weeks. Still, it’s not the catastrophe of 2009, since this was not a forced shutdown and it’s also (at least currently) not coinciding with a long shutdown of any of the five plants that produce most of the world’s Mo-99. But the fact remains, whether the shutdown is five days or five weeks, the NRU is ancient in terms of a nuclear plant.

Even optimists must feel shaky with a growing demand draining a supply that can’t be stockpiled, since Mo-99 decays in hours. Advocates for a domestic plant can point out that they’re generally safer than nuclear power plants, but with the Fukushima Daiichi nuclear plant disaster in Japan unlikely to come to a close until early 2012 at best, few people are opening their arms in welcome over plans to build any new nuclear plants.

An aging fleet
And that’s a problem, because the current crop of reactors is nearing the end of their working lives. The HFR reactor in Petten is currently slated to be decommissioned in 2015, with the NRU reactor to be shuttered the following year. Building a plant in the U.S. requires a lengthy approval process between state and federal government and the Nuclear Regulatory Committee. In fact, the process has proven so daunting that it has been more than three decades since any new plant has been built.

Still, isotope suppliers are exploring their options. For instance, some progress is being made in the effort to create Mo-99 with smaller reactors utilizing a liquid core of low-enriched uranium. Lantheus Medical Imaging Inc., a radiopharmaceutical company, is working with NTP Radioisotopes Ltd., a subsidiary of the South African Nuclear Energy Corporation, to commercially produce the first Mo-99 sourced from LEU.

But even if they succeed, the U.S. is unlikely to see a similar plant within the next few years, which means it’s a game of wait and see to determine not if, but when, lives and livelihoods will again be facing a supply chain stretched to the limit.

EXTRA:

SPECT abides
Supply chain uncertainties might make it seem like a grim situation for SPECT equipment sales, but with thousands of existing systems in the U.S. being used until they fulfill their returns on investment, there’s one final piece of reassurance that still allows SPECT manufacturers to sleep at night— experience. There wouldn’t be thousands of machines performing millions of procedures every year if there weren’t well-trained professionals operating them.

In addition to the cost involved with replacing the unit, facilities have to consider the cost involved in educating those with significant SPECT experience to learn the ropes of PET or a PET hybrid. Time is also money and to send those individuals off for training means a slowdown in providing service to patients and for health care providers already gun-shy about patient loss after the supply shortage, it’s not an attractive proposition.

One of the other reasons SPECT will maintain its large share of the U.S. market is because it’s relatively affordable and justifiable as a loss-leader for private practices. “Mobile cardiac SPECT in the office is often about patient retention and services,” says Joe Mathews, director of sales and operation for Nuclear Medicine Professionals Inc.

By managing as much of their patients’ care as possible before handing off to a specialist, doctors increase the likelihood of retaining that patient. If a patient is able to take care of more at a specialist, there’s the possibility they’ll shift their business there or maybe to a general practitioner near the specialist for the sake of convenience. “Small practitioners have to offer a variety of services, even if some are only at a break-even because they’re considering the global worth of that patient,” says Mathews.

Private offices feel the pain
Of the 18,000 nuclear cameras in the U.S., more than a third are dedicated to nuclear cardiology. This means more than 6,000 cameras rely on a steady supply of technetium-99m to keep them running. And nuclear cardiology is largely a service provided by private cardiology offices.

Those private offices, already hammered by 36 percent cuts in reimbursement and a required utilization rate increase from 50 percent to 90 percent, really took the brunt of the damage from the shortage.

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