US suppliers to join the Mo-99 market, high-energy materials gaining traction

June 12, 2019
By Leah Gannon

Last year’s announced shutdown of two international research nuclear reactors, utilized to create the products necessary for SPECT imaging, again revealed the weakness of the radiopharmaceutical supply chain. The American market relies on these reactors to produce a radioisotope called molybdenum-99 (Mo-99), which is then is eluted in nuclear pharmacies to make its daughter isotope, technetium-99 (TC-99).
TC-99 is the main radioactive material used in 80 percent of nuclear imaging tests, including SPECT (single photon emission computed tomography). When maintenance or unexpected reactor issues disrupt the delivery of this product, the effect is felt immediately.

Shaking confidence even more, The New York Times reported last year that nervous pilots had refused to fly with the radioactive materials onboard. The lack of essential, raw radioactive materials to prepare radiopharmaceutical doses hinders the ability of providers to perform unique diagnostic functions and therapeutic treatment of cardiovascular, neurologic and oncologic disease, which puts patients at risk.

While the ongoing supply chain fragility of Mo-99 is cause for concern, there is reason to be cautiously optimistic about the longer term availability of these “low energy” radioactive materials. New domestic sources are emerging that will increase the ability to acquire radioactive isotopes. Additionally, there is a lot of market buzz about the expansion of positron emissions tomography (PET) imaging, which utilizes “high energy” radioactive materials.

US suppliers to join the Mo-99 market
In 2018, the National Nuclear Security Administration (NNSA) issued a funding opportunity announcement for the production of Mo-99. Four U.S. companies received funding awards in the first quarter of 2019 from the NNSA to further the efforts toward establishing a reliable domestic supply of nuclear isotopes. These efforts also support continued progress to reestablish the domestic production for non-HEU (highly-enriched uranium) Mo-99, which had been unavailable since 1998.

The four companies receiving NNSA funding are:
• NorthStar Medical Radioisotopes, located in Beloit, Wisconsin
• SHINE Medical Technologies, located in Janesville, Wisconsin Northwest
• Medical Isotopes, located in Corvallis, Oregon
• Niowave, located in Lansing, Michigan

And that’s just the beginning. The NNSA is reaching out to six other companies with potential funding opportunities as well. That’s potentially 10 new players supplying the U.S. market, meaning less reliance on foreign medical reactors to produce the medical isotope. How quickly this comes to fruition is yet to be seen, but the outcome should inspire the trust of clinicians and patients.

The basic nature of the supply chain issue can be found in the very fast radioactive decay of the isotope, which requires constant production and short inventory life. It’s also in regulatory issues, which surround the isotope’s production and transportation to U. S. shores. The vast majority of supply chain disruptions happen abruptly, with supplies vanishing days before a new product can be delivered.

Here are a few ways to prepare for possible disruptions in the current radiopharmaceutical supply chain:
1. Stay in contact with your nuclear pharmacy provider on when to place orders. During a supply shortage, healthcare organizations should check with their nuclear pharmacy for the days when activity is highest for Technetium-99m. Tc-99m is the decay product of Mo-99 and is used in approximately two-thirds of all diagnostic medical isotope procedures in the U.S. Review the delivery schedule and see how you can best accommodate it. Communication is key to ensuring you will have the right radiopharmaceuticals with the highest radioactivity to safeguard diagnostic efficacy.

2. Order ahead. Plan to order unit doses of Tc-99m when the bulk material is known to face a cutback. When supply is interrupted, Tc-99m bulk doses are typically the first to be cut by nuclear pharmacies.

3. Adjust office hours. Because certain radiopharmaceuticals are unavailable during a shortage, it is critical to consider extending your office hours to account for patient reschedules. This may give the supply chain time to rebound and later in the week your nuclear pharmacy should have better insight on which days Tc-99m will be in greater abundance.

More companies entering the supply chain should inspire a healthy competition, creating better stability in the market. When that happens, look for reduced prices to follow.

High-energy materials gaining traction with theranostics, PET imaging
There’s good news for the other 20 percent of nuclear medicine — known as the “high energy” side of the radiopharmaceutical market. One of the industry’s latest buzz words is “theranostics” — a new type of treatment that integrates diagnostics and therapeutics in individualized disease management.

A study by Taiib, et al. (2016), outlines how nuclear medicine is ideally positioned to play a central role in theranostics by allowing visualization of molecular targets and thus enabling so-called in vivo immunohistochemistry. Once enabled, targeted drugs labeled with therapeutic radionuclides can be administered to patients and real-time monitoring of physical responses to them can be viewed.

Additionally, the medical imaging community is buzzing with excitement over reports that include gallium-68 (Ga-68) prostate-specific membrane antigen (PSMA) for the staging of prostate cancer as well as lutetium-177 (Lu-177).

Five years after an Australian hospital began using Ga-68, clinicians are now using the PSMA PET/CT (computer tomography) for primary and secondary staging in 95 percent of cases. German researchers have also determined that patients who received Lu-177 as a therapy early in treatment lived longer.

PET scans are also showing positive impacts on chronic traumatic encephalopathy, Alzheimer’s disease and atherosclerotic disease and inflammation.

Additionally, there’s good news for improvement of reimbursement for radiopharmaceuticals. Several industry trade groups are working on Capitol Hill to bring better solutions to bundled payment models that include radiopharmaceuticals. One strategy being considered is to look at paying for them much like traditional pharmaceuticals.

If we unbundle reimbursement models appropriately, it should free manufacturers from having to raise prices to meet certain thresholds. The hope is that nuclear pharmacies can then better focus on the preparation of these products, and health care organizations can provide more of these important therapies and diagnostic tests instead of less efficacious imaging modalities.

Clearly, there's much to be hopeful about as more U.S. manufacturers enter the supply chain. However, until there is more stability in the market, you must make sure you have a plan for the next break in the radiopharmaceutical supply chain.

Leah Gannon
About the author: Leah Gannon is director of pharmacy sourcing, oncology and radiopharmaceutical distribution for Vizient Inc. She helps health care organizations achieve their cost-reduction initiatives and increase their operational efficiencies by providing Vizient members competitively bid contracts and other cost-savings solutions. Other areas of expertise include market dynamics related to radiopharmaceutical and contrast media agents in the diagnostic-imaging markets.