While attending the National Nuclear Security Administration 2016 Mo-99 conference in St. Louis last week, I learned of a report from the National Academies of Sciences, Engineering, and Medicine (NAS) citing the 50 percent likelihood of a shortage of molybdenum-99 (Mo-99). Mo-99 is used to produce technetium-99m (Tc-99m), which is used in millions of diagnostic procedures annually.
The report bases this projection on the scheduled shut down next month of the National Research Universal (NRU) reactor in Canada. While the industry has been preparing for the NRU shutdown, the report highlights the fragility and challenges in this market. And, as the supply chain for nuclear isotopes using Mo-99 becomes less stable, the price is expected to increase and here’s why:
Mandates for method of production
According to NAS, about 75 percent of the world’s supply of Mo-99 is currently produced using targets containing highly enriched uranium (HEU) – referred to as weapons-grade uranium. Mo-99, and similar medical isotopes, can also be developed using non-HEU sources. However, the price for the non-HEU components is currently more expensive than traditional HEU sources, and in many cases unfeasible for most nuclear medicine departments.
Additionally, there have been various international and national mandates aimed at increasing national security by producing only non-HEU based Mo-99. Although these mandates will ultimately increase overall radiopharmaceutical costs, it has been put in place to create a safer and more stable supply chain.
CMS provides an add-on payment for using non-HEU sources, but the token payment doesn’t fully offset the cost of the non-HEU isotope. The marketplace is limited so the price is expected to continue rapid inflation as HEU sources become less available.
Sole source/proprietary manufacturers
Many of the nuclear imaging products are produced by sole source/proprietary manufacturers, which could also be considered sole source generic products. Marketplace trends have suggested that these manufacturers could follow the lead of other generic sole source manufacturers and increase prices in response to market dominance.
Also, because of its compound structure, many of the sole source/proprietary manufacturers have also had to increase their costs in the supply chain due to the price to secure the active pharmaceutical ingredient and other costs of production, therefore adding to the overall cost to health care organizations.
Nuclear pharmacy compliance
Nuclear pharmacies, which handle the radioactive isotopes and prepare it for end-users, are facing dramatic increases in their costs as a result of new compounding regulations. In the near future, nuclear pharmacies will be required to adopt costly changes to their pharmacies to ensure the compliance with USP <797>, which includes higher clean room specifications, air handling, traffic movement, gowning and surveys within the nuclear pharmacy and adoption of other methods to handle the drug preparation.
With the added cost of the isotope, and increased operational costs, the added expense will be passed along to the end-user.
What can the health care industry do?
As an industry, I believe the following actions can help mitigate the looming challenges to cost and quality of care:
- Increased need for adoption of appropriate reimbursement for non-HEU procedures, either as part of the imaging bundle, or separating the cost of the nuclear component from the bundle using an ASP+6 style-reimbursement for the component
- Evaluate key molecular imaging tests that could be affected and take steps to mitigate the risk of using a less efficacious test
- Work with the payor markets (government and commercial) to develop a solution that helps relieve the health care organizations from some of the cost pressures, but also allows them to make the right decision for the patients
Stay tuned for more as this situation evolves.
About the author. In her role as senior portfolio executive of radiopharmaceutical distribution sourcing, Leah looks to identify opportunities to help health care organizations achieve their cost-reduction initiatives and increase their operational efficiencies by offering competitively bid contracts and cost-savings solutions. In addition to her in-depth technical expertise, she possesses a keen understanding of the market dynamics related to radiopharmaceuticals.