The tenuous supply of molybdenum-99 (Mo-99) in recent years has resulted in a double-digit price increase at many nuclear medicine facilities across the U.S., as well as the canceling or rescheduling of appointments and fewer after-hours exams.
Those findings come from a survey conducted this past summer by the Society of Nuclear Medicine and Molecular Imaging (SNMMI). A total of 522 members responded to the poll.
According to the survey, 90% said their radiopharmaceutical prices have increased since December 2013, with a majority describing the hike as a "significant." Respondents with access to pricing information reported an average increase of 12% over the past two years. By a margin of three to one, facilities with no hard pricing data said their increase was "major."
Despite the price hikes, 87% of the respondents said they were still able to accommodate their patients, but 13% noted they could not accept the increases without experiencing a loss in revenue and less take-home pay for their employees.
The greatest hardship was in scheduling, according to the survey. Some facilities were forced to change appointments to match isotope supply, while others had to cancel scans because isotopes were unavailable.
The price increase also forced some centers to accept fewer patients, charge patients for missed appointments, reduce their emergency backup or standby isotope supply, reduce after-hours exams, and switch to other radiopharmaceuticals when possible.
To help offset Mo-99 price increases, 9% of respondents who work in a hospital outpatient setting are billing or plan to bill for the $10 per dose premium offset payment -- HCPCS code Q9969 -- offered by the U.S. Centers for Medicare and Medicaid Services (CMS). The payment is intended for the costs of procedures performed with technetium-99m (Tc-99m) that is not derived from highly enriched uranium (HEU). (Mo-99 is the parent isotope of Tc-99m.)
The U.S. government has been trying to transition industries away from HEU sources because they could potentially be used by terrorist organizations or governments to build nuclear weapons or improvised explosive devices. Non-HEU production methods may initially be more expensive than traditional HEU-based techniques, however.
Of the 9% who plan to utilize the additional payment, 22.1% reported that $10 per dose is sufficient to cover any additional costs, but respondents also indicated that an average payment of at least $35 would better enable them to cover higher costs.
Most third-party payors follow Medicare's lead regarding reimbursement for Tc-99m, but Medicare is often behind the curve in adjusting for price increases. Medicare collects data at the end of a fiscal year, analyzes it, and implements it in the following year.
"There is a two-year delay between when people in the business see price increases and when Medicare includes that in terms of their reimbursement schedule," said Robert Atcher, PhD, chair of the SNMMI isotope task group and program manager at Los Alamos National Laboratory in New Mexico. "So we are always dealing with two-year lag and often dealing with a three-year lag."
Because of all of the markets factors, end users have become more efficient in using medical isotopes.
Speaking at last month's American Society of Nuclear Cardiology (ASNC) annual meeting, Roy Brown, director of strategic alliances at Mallinckrodt, said the amount of Mo-99 used globally peaked at approximately 12,000 Ci per week in 2010. Since then, consumption has decreased to approximately 10,000 Ci per week this year for the same number of studies.
Unlike during the severe Mo-99 shortage of 2009 and 2010, Mallinckrodt and Lantheus Medical Imaging now have multiple sources from which to obtain the isotope; 10 or 20 years ago, most of the North American supply came from a single nuclear reactor in Canada.
"Almost everybody at every level is multisourced now," said Ira Goldman, Lantheus' director of strategic supply and government relations, at the ASNC meeting. "That does reduce risk. It also means that if there is some sort of outage, it may not be accentuated in one area so much."
(According to the SNMMI survey, 86% of respondents were generally pleased with the way suppliers informed them of upcoming shortages. They received at least one week of notice and on average one month of notice through email, phone calls, or letters with their shipments.)
If one or more suppliers go offline, Mallinckrodt and Lantheus can tap their outage reserve capacity at another reactor to fill the gap.
"If we need, say, eight target positions in a reactor, we go ahead and pay for 10 or 12 target positions," Brown explained. "If one reactor goes down, we can turn to one of the other reactors and irradiate one of the other targets."
He estimated that the strategy can increase available capacity by as much as 30% to 40%.
"The upside is we have the capacity now, but the downside is that it is costly," Brown said. "We have to pay for them whether we use them or not. So if we are paying for 12 positions at a time and we are only using eight routinely, we are still paying for 12."
The additional cost of outage reserve capacity is one of three key components that determine the price of Mo-99. Another contributor is the conversion of nuclear reactors from HEU to low-enriched uranium (LEU).
"Everyone who has converted so far is showing around a 20% reduction in production efficiency going from HEU to LEU, because physically, chemically, and metallurgically, you are not able to pack as much uranium density onto an LEU target as an HEU target," Brown said. "So we are seeing a 20% reduction in the production efficiency of the conversion."
There is also the concept of full cost recovery, in which reactor operators can charge more money to manufacture Mo-99, as their government subsidies to operate the reactor decrease. "The cost of producing molybdenum then, in turn, affects the cost of technetium," Brown said.
How much longer will Mo-99 supply issues continue to haunt imaging centers?
"There is a part of me that says, 'We are whistling past the graveyard,' " Atcher said. "We are getting into a period where things will be very tenuous in terms of any unanticipated outages."
The next big shutdown will come in February 2015, when Belgian Reactor 2 (BR2) is scheduled to go offline from 14 to 16 months for major refurbishment.
For now, some of the lost Mo-99 supply could be filled by Atomic Energy of Canada's (AECL) National Research Universal (NRU) reactor in Chalk River, Ontario. The facility is still in service, but the target date for its permanent closure is October 31, 2016.
One of the benefits of the NRU reactor is that it has "an incredible capability to cover four-, six-, and even eight-week periods when one of the other reactors is offline," Atcher said. "Chalk River could increase its production by 50%. They were going from 30% to almost half of the global market under those circumstances. When NRU goes offline, the reserve capacity goes offline as well."
So there remains a fair amount of concern about future sources and supplies of Mo-99. Quoting a colleague, Atcher concluded by saying, "If you are not worried, you're not looking far enough into the future."