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Mo-99 Supply
Ira GoldmanProject Director, Strategic Supply
Toward a More Secure Future?
Lantheus at a GlanceLantheus Medical Imaging
Headquarters: Billerica, Massachusetts
Offices: Puerto Rico, Canada, Australia
Marketed Products: 9
Products in Development: 3
Global Presence: Over 600 employees• R&D• Clinical and Medical affairs• Sales & Marketing• Manufacturing• Distribution• Rx/unit doses (Australia, Canada, PR)
2
Current Product Portfolio
3
TheReactors
NRU
LVR-15
HFR
Osiris
Safari
MariaBR2
LEU - OPAL, RA-3, SAFARIHEU – BR2, HFR, LVR-15, Maria, NRU, Osiris
Mo-99 TARGETS
RA-3
Processors
NTP
Nordion
IRE
Covidien
LEU – ANSTO, CNEA, NTP HEU – Covidien, IRE, Nordion
CNEA
Current U.S. Mo-99 Supply Matrix
HFR ReactorNetherlands
BR2 Reactor Belgium
OSIRIS Reactor France
NRU Reactor Canada
SAFARI Reactor S. Africa
Reactor Mo-99 Extraction
Mo-99 Purification Tc-99m Generator Manufacturer
OPAL Reactor Australia
Maria Reactor Poland
CovidienNetherlands
IREBelgium
NTPS. Africa
AECLCanada
NordionCanada
ANSTOAustralia
Covidien
Lantheus
LVR-15 ReactorCzech Republic
RIAR Reactors Russia Under
Development
Medium and Long term Mo-99 Supply Chain
• S.99 American Medical Isotopes Production Act of 2011• U.S. Domestic Projects
• 4 DOE/NNSA cooperative grants (non-HEU projects)
• GE Hitachi-Clinton – power reactor, neutron activation, LSA (Northstar & NuView)
• Babcock & Wilcox – MIPS aqueous solution reactor
• Morgridge Institute for Research(SHINE) – accelerator-driven fission process
• Northstar –Mo-100 accelerator LSA w/Tc-99m separator
Medium and Long term Mo-99 Supply Chain
• North American production• Other (potential) projects
• Northstar/MURR - Mo-98 NA LSA w/Tc-99m separator
• Coqui Radiopharmaceuticals – fission, 2015?• MURR – fission ?• Perma-Fix (with PNNL) – neutron activation?• MiPod - fast fission (238U(n,f)99Mo)
• Canada – NISP grant (Non-reactor-based Isotope Supply Contribution Program)• Cyclotron-produced Tc-99m• Photon/accelerator production
Medium and Long term Mo-99 Supply Chain
• Europe – New RRs:
• FRM II Reactor – 2015• Jules Horowitz Reactor – 2016• Pallas Reactor – 2020?• MYRRHA Reactor – 2022?
•Processors Conversion to LEU – 2015~?
•Australia – Phase 2 , 2015
•South Africa - Safari 2 DIPR, 2020?
Medium and Long term Mo-99 Supply Chain
Russia – Rosatom/Isotope, 2013?(thru Nordion)
Argentina – CNEA new reactor & processing, 2018
South Korea – New RR, fission 2017
India, China – fission 2014, 2015?
Diagnostic RP Reimbursement Advocacy Separate Medicare payment for dRPs in hospital outpatient (most
important setting for using RPs) was discontinued by CMS in 2008 Separate Medicare payment for dRPs continues in physician offices Since 2008 LMI, CORAR, and medical societies continued strong
advocacy with CMS to restore separate Medicare payment for dRPs in HO setting to maintain patient access to newer and better dRPs.
Increased cost of Mo-99 and Tc-99m is another very important reason for restoring such separate payment for dRPs in HO
CMS/CORAR meeting of 7/26/2011 indicated that Congressional action may be necessary in order to restore separate Medicare payment for dRPs in hospital outpatient setting
LMI Mo-99 Leadership Secure, reliable, globally diversified supply chain, focused on reactors
and processors NRU, SAFARI, BR2, OSIRIS, HFR, LVR-15 Nordion, NTP, IRE, ANSTO
Secured FDA approval for new reactor (LVR-10) and LEU Mo-99 1st commercial sale of NTP LEU Mo-99 (Dec. 2010) 1st FDA approval ANSTO LEU Mo-99 processes (June 09, Apr. 11’) regular commercial shipments from NTP and ANSTO
(May-June 2011 and ongoing) Active engagement with Mo-99 projects Advocacy to restore separate reimbursement
for diagnostic RPs in hospital outpatient
•Impact of reactor outages (2009-10), medical reimbursement pressures, and medical radiation concerns have decreased demand for Tc-99m
How will future demand evolve?•The Mo-99 production landscape is changing - many new projects, including domestic U.S., on drawing board
How many will succeed? When? 2016-2018 situation unclear (post-NRU)
•LEU-based production will be the future of Mo-99 supply•Medicare reimbursement landscape is changing with payments decreased and/or “bundled” with procedures
Need for separate Medicare payment for dRPs to
compensate for Mo-99/Tc-99m cost increases
Lantheus has taken a leadership role in securing future Mo-99 supply
Toward a More Secure Future?Conclusions
Thank you!
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