Derek MartinigSuzanne 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

72 year old Male Diagnosed with

Esophageal Tumor CT scan revealed

abnormality in distal esophagus

Treatment Plan: radiation & chemo. then Surgery

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

RESEARCHERS

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.

PROVINCIAL GOVERNMENTPros:-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.

MANUFACTURERS

Pros: Monopoly Power....really?Cons: Expensive licensing costs & Low demand lead to Inability to control pricing

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??