Technetium-99m (Tc-99m) is the most commonly used radioisotope in nuclear medicine (NM) diagnostic scans. It is essential for diagnostic scans of a broad range of body parts, and thus for accurate diagnoses of diseases, such as cancer, heart disease and neurological disorders including dementia and movement disorders, and effective patient care in health systems of OECD countries. It is also the most common diagnostic radioisotope, estimated to be used in approximately 85% of all NM diagnostic scans worldwide. The properties of Tc-99m, however, make its supply chain complicated. Tc‑99m is obtained from radioactive decay of its parent isotope, Molybdenum‑99 (Mo‑99). Neither of these products can be stored for very long. Mo‑99 has a half‑life of 66 hours, that is, its radioactivity decreases by half in 66 hours, and the half-life of Tc‑99m is only six hours. Therefore, supply is a just-in-time activity, combining a mix of governmental and commercial entities, and requires sufficient capacity for ongoing production of Mo‑99 plus a reserve in case of unplanned outages.

This report explores the use and substitutability of Technetium‑99m (Tc‑99m) in health care and the main economic reasons behind its unreliable supply. It proposes policy options to help address the supply issue.

Technetium-99m (Tc-99m) is the most commonly used radioisotope in nuclear medicine (NM) diagnostic scans. It is essential for accurate diagnoses of diseases and effective patient care in health systems of OECD countries. For example, Tc‑99m is used for diagnoses of cancer, heart disease and neurological disorders including dementia and movement disorders.

Nuclear medicine diagnostic procedures support diagnoses of disease in a broad range of medical specialties, organ systems and clinical indications. Prior experience illustrates that substitutes are available for some Technetium-99m-based scans. Cardiac and bone scans, which are a large share of all diagnostic scans, are notable examples of where substitution is possible. In some areas, alternatives to Tc-99m, such as PET scans in myocardial perfusion imaging, may in fact offer improved diagnostic performance. However, even where substitution is possible from a clinical point of view, it might not be easy to achieve in practice. For example, the current base of PET, CT and MRI equipment and workforce may not be able to absorb the additional volume of scans necessary to substitute for the use of Tc-99m. Substitution may also imply cost increases for health systems. No comparable substitutes are available in indications such as breast, melanoma and head/neck cancer sentinel lymph node studies, and in a range of diagnostics in children. In some areas Tc-99m-based scans also continue to be the preferred standard of care, such as whole-body bone scans to screen for skeletal metastases. Tc-99m will therefore continue to be an essential product for health systems.

Diagnostic imaging modalities using Technetium-99m account for around 30 million examinations worldwide every year and approximately 85% of all nuclear medicine diagnostic scans. Following a decrease with the 2009/10 supply crisis, demand for Tc-99m has been flat in recent years and little growth is forecast for OECD countries through 2023. Imaging rates vary significantly between countries, from 2‑3 Tc-99m-based scans per 1 000 population per year in some Eastern European countries to 30‑50 in Belgium and North America. The ten most populous countries and countries with high scan rates account for more than 90% of the aggregate volume of Tc-99m-based scans across the countries in scope of this Report. There are also significant differences between countries in the utilisation patterns by organ system and anatomical areas scanned. The potential impacts of future shortages and the scope for substitution are therefore not the same across countries.

Nuclear medicine (NM) providers receive prospectively set payments for their services, which cover service bundles of varying breadths. Outpatient providers are typically paid fee-for-service (FFS). The breadth of bundling increases with the provider size and hospitals are often paid for broad service bundles, such as diagnosis-related groups, or through global budgets. The cost of Tc‑99m is included in these payments in all countries, with some exceptions in Belgium, Germany, Japan, and in the United States. Because payments are set prospectively and providers bear financial risk related to differences between payments and their costs, providers have an incentive to control input costs, including the cost of Tc‑99m. Such incentives are stronger where payments are low and where providers have little scope to substitute activities. Thus, increases in Tc‑99m prices may be difficult to absorb for small providers who rely exclusively on NM scans for revenue and whose FFS payments are not responsive to input costs. Hospitals with a wide range of activities may be able absorb increases more easily. But provider payments are revised regularly in most countries, allowing providers to negotiate increases if costs increase. Australia and France are exceptions, where fees have not been updated for several years.

Supply of Technetium‑99m (Tc‑99m) is a just-in-time activity requiring continuous production in a complicated and aging supply chain that combines a mix of governmental and commercial entities. Governments control the availability of enriched uranium required for medical isotope production and also largely control the regulatory framework and the legislation around health care provider payment for nuclear medicine diagnostic scans. The central steps of the supply chain, including processing and generator manufacturing are mainly commercial. Processors and generator manufacturers wield market power and market concentration has increased in these parts of the supply chain, while supply continues to be supported by some government funding of nuclear research reactors that perform irradiation and of some processors. The resulting inability by reactors to increase prices sufficiently for full cost recovery and insufficient outage reserve capacity at various steps of the supply chain leave security of supply vulnerable and the market economically unsustainable.

The structure of the supply chain, the cost structure and funding of nuclear research reactors (NRRs) and the resulting behaviours of supply chain participants are the main barriers to full-cost recovery. NRRs have high fixed costs while marginal costs of irradiation are low. NRRs are captive to local processors and have little choice but to continue supply even at prices that are too low, while government funding sustains their operations. Downstream, price competition creates a disincentive for processors and generator manufacturers to increase prices unilaterally. Although health care provider payment must not be neglected, it is not the main barrier because Technetium-99m (Tc‑99m) is a small item in the overall cost structure of nuclear medicine providers who could absorb necessary price increases in most cases. A number of policies could help achieve full-cost recovery and improve the reliability of Tc‑99m supply. A phased and co-ordinated discontinuation of government funding of irradiation-related costs for NRRs could catalyse price increases. This could be accompanied by policies ranging from increased price transparency to price regulation. Funding of irradiation by end-user countries could be an alternative option. However, no single policy can be recommended as the preferred solution and each option has strengths and weaknesses. Governments need to co-ordinate their efforts and evaluate options in more depth in co-operation with all stakeholders to identify the most acceptable solutions in their respective jurisdictions.