Transcript Winners and Losers

Derek Martinig
Suzanne Lane
Julia Barnscher
REGULATIONS AND PET
TECHNOLOGY
POSITRON EMISSION TOMOGRAPHY
FDG (18-fluoro-2-deoxyglucose) –
Radioactive F in place of O in glucose
 Fluoride decays back to Oxygen and emits
positrons
 Cellular consumption of glucose molecules
can be observed using a PET scanner
 Used for research, cancer, blood clots,
Alzheimers

BACKGROUND
1952 – First positron imaging device
 Mid 70s – First PET scanners using Fluoride
 Late 70s – first PET scanners using in clinical
settings
 1980s – Research showing clinical utility
 1988- U.S.A – Medicare funded first PET Scan
 1992 – Australia’s first PET Facility

BARRIERS
Lack of Personnel
 High Costs
 Accessibility of FDG
 Lack of Standardized Protocols
 Government Regulations

FDG

Radiopharmaceutical drug - Investigation
drug - Biologics and Genetic Therapies Directorate (BGTD)
branch of Health Canada
Over 5,000 studies demonstrating safety
and benefits of FDG
 Support from:

Canadian Association of Radiologists
 Canadian Society of Nuclear Medicine
 European Association of Nuclear Medicine
 American Society of Nuclear Medicine

The power of PET over traditional imaging modalities
CASE STUDIES
CASE STUDY #1

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72 year old Male
Diagnosed with
Esophageal Tumor
CT scan revealed
abnormality in distal
esophagus
Treatment Plan:
radiation & chemo. then
Surgery

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
PET/CT Imaging
revealed two
undiagnosed lymph
nodes
Staging and treatment
volume were both
altered.
Studies found that up
to 62% of treatments
were adjusted as a
result of a PET Scan
CASE STUDY #2
•82 year old female with Rectal Bleed
•Mass found in Right transverse colon during colonscopy
•CT performed and revealed mass in presacral area
•Liver was unremarkable on CT Scan
•Patient underwent colectomy and 8 out of 9 nodes tested
were positive for metastases
•Follow up PET Scan was completed after surgery
•The presacral mass was localized once again
•Two additional liver metastases were identified
•Findings would have resulted in patient not undergoing
surgery
REGULATION OF FDG IN CANADA
REGULATION OF FDG
Regulations changed in
2003
 Approval for production
and use of FDG by BGTD

 New
drug submission
 4 manufacturers approved
for limited uses

Non approved uses must
be carried out under
clinical trial applications
PET SCANNING IN CANADA

Limited number of funded scans per province
 Not
related to size of population or availability of
scanning facilities
Not available in all provinces
 Public and private not equivalent
 Up to 6 week waiting period

PET SCANNING IN CANADA

Canada approves scans for fewer conditions
than other countries
 US,
European Union, Australia
 Lung, breast, colorectal cancers

Revisions suggested as of March 2009
 Will
not have any rapid effect to increase availability
of FDG
Those impacted by the Current Regulations on PET in Canada
WINNERS AND LOSERS
Pros:
Still Pending....
Cons:
-”Brain Drain” still exists as a result
of limitations on research
(6 months in US, 3 years in
Canada)
-Costly and time consuming clinical
trials
-Redundancy of research
-Lack of motivation to continue with
research in the field.
RESEARCHERS
PROVINCIAL
GOVERNMENT
Pros:
-Limit initial healthcare
spending
-Capital Investments
-Exam Reimbursement
Cons:
-Less cost-effective
-Reduction in Surgeries
-More effective treatment
regiments
-Perception of not providing
best possible care.
Pros: Monopoly Power....really?
Cons: Expensive licensing costs & Low demand lead
to Inability to control pricing
MANUFACTURERS
PATIENTS
DOESN’T MATTER HOW YOU SPIN IT...
.... EVERYONE’S STILL A LOSER
What needs to be done to fix this problem...
REGULATION REFORM
THREE STEP PROCESS
STEP ONE
Remove the Clinical Trial
Label
 Eliminate Redundancy
of NDS
 Provide Guidelines for
Production of FDG
_____________________
 Result in Increased
Provision!

STEP TWO
Collaboration of College
of Physicians and
Government
 Set Fee Structure
 Cover cost of PET under
provincial health plans
_____________________
 Resulting in Increased
Utilization and Provision

STEP THREE
Advertising and
Promotion of PET
 Increase Physician
Awareness
 Increase Patient
Awareness
 Increase Research
_____________________
 Optimal Utilization of
PET

QUESTIONS??