The Supply of Medical Isotopes

Foreword
Acknowledgements
Abbreviations and acronyms
Executive summary
Key findings
	Some health systems rely heavily on Tc-99m and substitution would be costly
	Technetium-99m supply is a complex and just-in-time activity, and supply remains unstable
	The main barrier to price increases is found in the supply chain
	Health care provider payment must not be neglected, but provider incentives to contain the cost of Tc-99m are likely to be weak in most cases and are not the main barrier to price increases
	Policies could catalyse price increases in the supply chain
	Notes
1 Health care systems require Tc-99m to maintain patient care
	1.1. Introduction
	1.2. Clinical overview of NM and other diagnostic imaging modalities
		1.2.1. NM diagnostics are used for a wide range of indications
		1.2.2. Hybrid imaging techniques have improved diagnosis
		1.2.3. The evidence base for traditional Tc-99m-based NM diagnostics is relatively weak
	1.3. There are alternatives to Tc-99m but substitutability may be limited
		1.3.1. Substitution of Tc-99m-based scans is possible for some indications but may encounter practical difficulties
		1.3.2. Strategies to respond to shortages
			Canada
			United States
	1.4. The future of Tc-99m-based nuclear medicine procedures
		1.4.1. Radiation dose
		1.4.2. Innovation in Tc-99m-based products lags behind other fields of NM
	1.5. Conclusion
	References
	Notes
2 The use of nuclear medicine diagnostics and Tc-99m varies significantly across countries
	2.1. Introduction
	2.2. Global demand for Mo-99/Tc-99m has been flat since 2012
	2.3. A small number of populous countries and countries with high scan rates account for a large share of utilisation
	References
	Notes
3 Health care providers have varying incentives to contain the cost of Tc-99m
	3.1. Introduction
	3.2. Three main health care provider types deliver nuclear medicine diagnostic services
	3.3. Provider payment mechanisms and attendant financial incentives vary by provider type
		3.3.1. There are three main payment mechanisms for NM diagnostic services
		3.3.2. Most countries do not compensate providers directly for the actual cost of Tc-99m
		3.3.3. Country Details
			United States
				Medicare and Medicaid
				Private insurers
			Canada
				Alberta
				British Columbia
				Manitoba
				Newfoundland and Labrador and Nova Scotia
			Japan
			Germany
				Specialist Offices
				Hospitals
			France
				Specialist Offices and Other Outpatient Providers
				Hospitals
			United Kingdom (England)
			Belgium
			Australia
			Other countries
	3.4. What financial incentives arise from these payment mechanisms?
	3.5. Conclusion
	References
	Notes
4 The Tc-99m supply chain is technically complex and characterised by market imperfections
	4.1. Introduction
	4.2. Overview of the supply chain
	4.3. There are five main steps in the current supply chain
		4.3.1. Patients and health care providers
		4.3.2. Nuclear pharmacies
			The role of the nuclear pharmacies varies significantly between countries
			Nuclear pharmacies can have market power in some countries
			Nuclear pharmacies drive the efficiency of Tc-99m use through patterns of delivery and elution
		4.3.3. Generator manufacturers
			Technetium Generators are delivered at least weekly
			“Package deals” determine market prices and generators are often loss leaders
		4.3.4. Processors
			Processors are the main co-ordinators of Mo-99 production
			Processors contract with nuclear fuel fabricators in a highly regulated environment
		4.3.5. Nuclear Research Reactors
			Irradiation and processing are geographically close or integrated except in Europe
			Two main operating patterns dictate the flexibility and efficiency of irradiations
	4.4. Irradiation capacity is co-ordinated globally
	4.5. Despite progress, the supply chain remains unviable
		4.5.1. Some historical barriers to full-cost recovery remain
			Historical irradiation prices were too low to cover costs and support investments
			Irradiation prices were also too low to cover costs and support infrastructure investments
			Some governments continue to subsidise irradiators
			Processors have market power
			Conversion to low enriched uranium increased costs
			Irradiation price increases were not absorbed in the downstream supply chain
		4.5.2. Progress has been made but FCR is not yet achieved
			A further 40% price increase by irradiators is necessary to achieve FCR
			Outage reserve capacity is still undervalued
			Market entry remains difficult and unattractive for new players
			Latest estimates confirm that the industry is unsustainable
	4.6. Conclusion
	References
	Notes
5 Barriers to Full-Cost Recovery and Policy Options
	5.1. Introduction
	5.2. Competitive pressures in the supply chain constitutes the main barrier to FCR
		5.2.1. Health care provider payment plays a role but does not constitute the main barrier to FCR
		5.2.2. The structure of the supply chain, the cost structure and funding of NRRs and the resulting behaviours of supply chain participants are barriers to full-cost recovery
		5.2.3. The Mo-99/Tc-99m supply chain is unique
	5.3. Policies to increase the reliability of Tc-99m need to tackle barriers in the supply chain
		5.3.1. Options to continue moving towards full cost recovery within the current Mo-99/Tc-99m supply chain
			Option 1: Phased and co-ordinated discontinuation of funding of NRR costs attributable to Mo-99 production by governments of producing countries
			Option 2: Increasing price transparency in the supply chain
			Option 3: Direct price regulation in the supply chain
			Option 4: Introducing a commodities trading platform for bulk Mo-99
		5.3.2. Possible alternative to a market-based approach
			Option 5: Direct funding of Mo-99 production by end-user countries
		5.3.3. Options to reduce the reliance on the current Mo-99/Tc-99m supply chain
			Option 6: Increasing use of substitute diagnostic imaging modalities or substitute isotopes
			Option 7: Move towards alternative methods to produce Mo-99/Tc-99m
	5.4. Conclusion
	References
	Notes
		Annex A. Broader responses to the 2009/10 Mo-99/Tc-99m shortage
Annex A. Broader responses to the 2009/10 Mo-99/Tc-99m shortage
Annex B. NM Diagnostic activity by country – Data sources and comparability
Annex C. OECD Health Division Survey on Health Care Provider Payment for Nuclear Medicine Diagnostic Services
Annex D. Current unbundled Tc-99m payments in Germany and Japan