Nuclear Science Advisory Committee Meeting

Domestic Medical Isotope Supply Review

Erin Grady, MD

Society of Nuclear Medicine and Molecular Imaging

February 26, 2014

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Overview

• About SNMMI

• Climate for Clinicians and Patients

• State of Tc-99m - How did we get here?

• GTRI Program Review

• Recommendations

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SNMMI

• Represents professionals in the field of nuclear medicine

– Physicians

– Technologists

– Scientists

– Pharmacists

• 18,000 members

• Members from the United States and 79 foreign countries

• Publishes three journals and conducts two national meetings each year

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Nuclear Medicine in the United States

• Vital part of diagnostic and therapeutic management of patients

• We conduct 18 million imaging studies per year

– Tc-99m is used in 80 % of these studies

– Nuclear cardiology represents 50 %

– Nuclear oncology represents 25 %

– Other imaging of brain, endocrine system, lungs, GI & GU tract, bones, infection...and the list goes on

• Tc-99m radiopharmaceuticals are used in 100 clinical trials

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Nuclear Medicine Makes a Difference

• My 67 year-old male patient with prostate cancer and multifocal pain

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Nuclear Medicine Makes a Difference

• My 45 year-old female patient with low blood counts and uncertain site of bleeding

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Nuclear Medicine Makes a Difference

• My 59 year-old male patient with atypical chest pain

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State of Tc-99m Today – Strengths and Weaknesses

• Strengths

– Available from a Mo-99/Tc-99m generator

– Mo-99 has a 66 hour half-life, allowing for delivery of radiopharmaceutical doses to rural areas

– The six hour half-life of Tc-99m allows for wide distribution of doses from central radiopharmacies

– Excellent photon energy

– Low radiation dose to patient

• Weaknesses

– After the NRU reactor shuts down in 2016, no Mo-99 produced in the western hemisphere

– After 2016, the US is completely dependent on foreign producers for Mo-99

– Only two vendors of Mo/Tc-99m generators for US market

– High barrier to market entry

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At low energy – resolution loss due to difficulty in locating gamma hits in the crystal by centroid calculation.

At high energy - resolution loss due to difficult in collimating high energy gamma rays.

Gamma Photon Energy (keV)

0 100 200

Res

olu

tio

n (

1/F

WH

M)

“Sweet spot” of the gamma camera

Energy of Tc-99m is Best for Gamma Camera Imaging

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State of Tc-99m Today – Opportunities and Threats

• Opportunities

– Revival of domestic production

– Viable options for Mo-99 production

• Threats

– No replacement production for Canadian Mo-99 in 2016

– Environmental factors: e.g. weather, volcanoes

– Aging infrastructure yielding shortages

• “Shortage fatigue” and higher costs

– Strikes

– Border security challenges

• We had to petition for Mo-99 delivery after 9/11

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http://www.boston.com/bigpicture/2010/04/more_from_eyjafjallajokull.html

Where Our Focus Should Be

• Our patients

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Alternate Studies

CT scans and other technologies used in place of Tc-99m during a shortage will likely result in:

• Poorer medical care

• Other modalities provide anatomical information rather than nuclear medicine’s unique functional information

• Higher radiation exposure

• Lower quality information

• Much higher cost

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Example Radiation Comparison

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Low-Dose Perfusion

(99mTc MAA)*

Ventilation/Perfusion (99mTc MAA +

133Xe gas)*

CT Pulmonary Angiography

Breast Dose (mGy)

0.2 0.9-1.4 15-50

Total body effective dose

(mGy)

0.4 1.9-2.3 5-13

* ICRP Reports 53 and 80 AJR 2010;194:881-889

Even when accounting for the effects of breast shields, the total dose to the breast is the highest in the setting of CT pulmonary angiography.

State of Tc-99m – How did we get here?

• National Academy Report

• Predictions about ease of conversion have not occurred

• Challenges have been more substantial than assumed

– Requirement to change target composition to increase density

– Target design is still under development

– Much more costly than predicted

– Increasing concerns on waste handling issues

– Reliance on cost data from Canada

» Need to use up-to-date market surveys for US market given its supply chain complexities

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The GTRI Program – Concerns

• Four new technologies were initially funded for a domestic supplier. Only two are still active but have yet to produce any Mo-99 on a commercial scale and will not be ready until well after 2016.

• Shift in focus from production to nonproliferation

• Two major Mo-99 processors will require HEU shipments beyond 2014 to ensure no shortages

• Providing adequate supply of non-HEU materials 16

NSAC Review Questions

• Are NNSA GTRI programmatic goals for establishing domestic supply well defined?

• Have risks been fully identified?

• What is the current status of implementation?

• Is the strategy for implementing the NNSA goals complete and feasible within a global context?

• What steps should be taken to improve the program’s effectiveness?

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Goals of the Global Threat Reduction Initiative (GTRI)

Are NNSA GTRI programmatic goals for establishing domestic supply well defined?

• The goals of the program are well defined and have little to do with domestic supply

• The main goal of GTRI is nonproliferation – we need the initiative to emphasize reliable supply for patients

• Of the six principles mentioned in the White House letter of 2012, only one mentions supply

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GTRI Goals - Have risks been fully identified?

• Little effort has been spent on identifying and communicating the risks, for example:

– What is the risk of not having domestic supply when the Canadian effort ceases in 2016?

– What financial risks exist for the program and those participating in the program?

– What regulatory hurdles have to be overcome regarding NRC, FDA, EPA and other issues?

– What is the path for managing radioactive waste and the cost of waste disposal?

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GTRI Goals – What is the Current Implementation Status?

• Concerns about success of the program are increasing

– GE Hitachi withdrew

– Babcock & Wilcox withdrew

– The SHINE project has lost the Morgridge Institute as a partner and is having difficulty raising capital

– Northstar has a generator design that is still under review by the FDA, hence still unproven in clinical practice. In addition, they have yet to demonstrate the commercial feasibility of their ultimate goal of (gamma,n) production

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GTRI Goals - Is the Strategy Complete and Feasible?

• The global strategy at this point has been focused on conversion from HEU to non-HEU targets for production – need greater emphasis on supply

• In parallel, the HLGMR has been focused on trying to establish full cost recovery, however anti-competitive concerns persist

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GTRI Goals - Steps to Improve the Program

• Full cost recovery should be implemented before the conversion from HEU to other production technologies

• Ensure there is a reliable, affordable domestic supply of non-HEU material before cutting off HEU exports

• NNSA must continue to look for additional domestic sources

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GTRI Goals - Steps to Improve the Program

• NNSA must continue working with CMS, FDA, NRC and others on reducing the complexity of the regulatory and reimbursement structure

– Many unknowns still exist, e.g. cost of the waste take back program, conversion costs not borne by NNSA, etc.

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Attack the Problem Where it Exists

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The nonproliferation agenda needs to be focused at the site of production, not the patient imaging procedure - we need the initiative to emphasize reliable supply for patients

Additional Recommendations

• Lacking any ability to address charge compression and adequately cover the increasing costs of the radiopharmaceutical and the procedure reimbursement, there needs to be more contemporary updating of reimbursement than a two year lag.

– SNMMI is working with stakeholders to develop options both in the current methodology and outside the existing methodology for CMS and others to consider in future rulemaking.

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Additional Recommendations

• There needs to be adequate and appropriate reimbursement.

Initial SNMMI survey data from 36 states with regard to the

$10 add-on suggests some resistance to the non-HEU product

based on: – Price, Availability, Logistical complexity; segregating Medicare

from non-Medicare patients

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Conclusion

In principle, SNMMI supports the objectives of the program in controlling access to fissile material. However, the cost of a national security program should not be borne by patients who are undergoing diagnostic and therapeutic procedures for heart disease, cancer and other medical problems.

Thank You

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